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Cedex Bio HT

1. 21 03 03 Oe J14 mn z D i a S S S a l S 5 11 jii Operator s Manual Version 1 2 Cedex Bio HT 21 Appendix Keyboard shortcuts Keyboard shortcuts The following Cedex Bio HT keyboard shortcuts are available F1 F3 F5 F6 F7 F8 F9 F10 F11 F12 Ctrl A Ctrl C Ctrl V Ctrl X Ctrl Z Ctrl Arrow Shift F3 Shift F5 Shift F7 Shift F8 Esc Tab Alt F4 Alt Print Screen Print Screen Display Help for tab page or dialog box Find Status work area Orders work area Results work area Service work area Print Select menu bar Start Stop Select All Edit menu Copy Edit menu Paste Edit menu Cut Edit menu Undo Edit menu Flip through dialog box tabs Log on or off View Messages dialog box Memo Pad Configuration work area Equivalent to clicking the Cancel or Close button in a dialog box Move focus to next object Shut Down the system equivalent to File menu gt Shut Down Copy the current window as a bitmap to the clipboard Copies the desktop as a bitmap to the clipboard Operator s Manual Version 1 2 21 Appendix Menu structure Menu structure Cedex Bio HT vl Menu op
2. Requesting a dilution on page B 107 B 20 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Daily routine with sample barcode and without host gt To review test result details Click the Validate tab on the Results work area 2 Inthe To Validate folder select a sample calibration or control order 3 Double click a result line in the list of results The Result Detail dialog box is displayed 4 Click Rate Info The Rate Info dialog box is displayed 5 Review the information to check the reason for the flag Tips e Select an order and click Edit to switch to the Orders work area for editing e Right click an order in the Blocked folder and choose Detail from the context menu to see the test status of the blocked order on the Results Detail Test Orders dialog box To accept a result 1 Click the Validate tab on the Results work area 2 Inthe To Validate folder select a sample calibration or control order 3 Select a result from the list of results and click Accept Tips e Click Accept All to accept all the results of the selected order e Set the filter option of the Validate tab to Unaccepted to display only the unaccepted results of the selected order Printing the Final Report gt To print the Final Report 1 Choose File gt Print Report gt Final Report from the menu bar The Print Result Query dialog box is displayed 2 Define the ranges for Order ID and Order Da
3. Operator s Manual Version 1 2 gt Caution gt Caution gt Caution Ezi Ezi x D Cedex Bio HT Cleaning and maintenance Incorrect cleaning and maintenance can cause damage to personnel and equipment Perform cleaning and maintenance according to the procedures described in this publication Environmental conditions Incorrect location can cause incorrect results and damage equipment components Follow the installation instructions carefully Relocating the Cedex Bio HT analyzer should be carried out by Roche Service only Cleaner Incorrect cleaning materials can damage the Cedex Bio HT analyzer Organic solutions damage cuvettes tubing and other plastic materials Use only 70 ethanol solution to clean the equipment Disposal recommendations All electrical and electronic products should be disposed of separately from the municipal waste system Proper disposal of your old appliance prevents potential negative consequences for the environment and human health Disposal of Control Unit Components Components of your Control Unit such as the computer monitor keyboard etc which are marked with the crossed out wheeled bin symbol are covered by the European Directive on Waste Electrical and Electronic Equipment WEEE These items must be disposed of via designated collection facilities appointed by government or local authorities For more information about disposal of your old product ple
4. Operator s Manual Version 1 2 2 System description Cedex Bio HT Panels and logos Panels and logos You can open access panels when you need to work on the internal parts of the instrument Logos on the panels help you to find your way around o Figure 0 9 Access panels A Main front cover gives access to the PCB fuses pipette module and cleaner reservoir transfer arm and probes initialization posts and wash station Always lift the cover as far as it will go when opening it B SE access panel open downwards to pull out the ISE module See Parts of the ISE module on page F 5 C Rack access panel open downwards to load or remove racks See Loading samples on page B 38 D Cuvette waste panel open downwards to remove and replace the cuvette waste box See Replacing the cuvette waste box on page B 48 E Cuvette reservoir access panel lift up to remove the cuvette reservoir when you need to Bag add more cuvettes See Refilling the cuvette reservoir on page B 44 F Service access panel lift up to remove for example a stuck cuvette When opening the panel make sure to secure the panel with the Locking Device Auxiliary Front Panel When closing the panel again first release the bracket and then close the panel slowly A 16 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Panels and logos Do n
5. The calibrator is supplied as either a set of bottles or a single bottle from which the individual calibrators are made up automatically With a single calibrator and automatic dilution B 136 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration About calibration e There is only one calibrator to place on a rack e The system automatically makes up different dilutions of the calibrator to produce the required calibration points With a multi calibrator set e Each calibrator has a different concentration of the analyte The calibrators are placed in order on a rack with the calibrator with the highest concentration in the lowest numerical rack position The software identifies individual calibrators as Std 1 highest concentration Std 2 next highest concentration and so on All the calibrators in the set must be placed in adjacent slots on the same rack Calibration modes Possible calibration modes are shown in the following table Calibration mode Attributes Linear regression Calibration curve A straight line based on a calculated slope and offset Number of calibration points 0 6 Curve parameters Ro F lt e If no calibrators are used both curve parameters Rg and F are specified in the test definition file e If one calibrator is used one of the curve parameters Ro or F is specified in the test definition file Linear interpolation Calibration curve A straight line bet
6. last calibration or control 21 not on board activator 23 calibrators controls diluents 20 deproteinizer 23 etcher 23 ISE solution 23 samples cassettes or diluents 69 not ready ISE module 23 Note service action status 14 notes with service actions 14 No xii one point calibration 9 online Help 55 Operating system state 44 options selecting 51 tions tab View Message dialog box 8 order IDs predefined 101 specifying 95 unique 101 orders adding tests 105 at a glance 85 blocked 19 confirming 18 copying tests 106 creating 12 17 25 95 deleting 60 deleting all of specific date 132 deleting at BOD 109 deleting from Results work area 131 deleting single 109 deleting tests from 108 displaying information 125 displaying specific group of 123 finding 102 ID 84 limiting the number displayed 123 multiple copies 106 overview 84 preconditions for purging 109 printing results of 56 purging 60 66 purging manually 109 reviewing tests 105 selecting tests for 96 working with 102 Orders work area 87 Calibration tab 93 menu structure 14 Quality Control tab 94 Sample tab 91 Worklist tab 89 O ring sealing 27 OUT OF RNG flag 13 OUT OF RNG flag ISE 46 OUTLIERS flag 13 overflow collector ISE tower 23 overview Cede
7. Daily start up Loading cleaners diluents and ISE solutions amp To load cleaners diluents and ISE solutions 1 Check the printed Begin of Day report for cleaner diluent and ISE solutions to be loaded 2 Load the cleaner and diluents on their correct rack positions indicated in the Begin of Day report 3 Insert the racks Tip After loading or replacing ISE solutions on the ISE rack the ISE Rack Replaced dialog box is displayed On the dialog box select the ISE solutions that you have replaced Leave the check boxes cleared for ISE solutions you have not replaced _ Replacing the cleaner on page B 43 Replace ISE solutions on the ISE rack on page F 32 Loading and mixing cassettes Warning amp To load cassettes on board 1 Click the Cassettes tab in the Status work area to check what cassettes you need to load for the daily routine Check the printed Begin of Day report for additional cassettes to be loaded 2 Unwrap the cassettes and pierce the aluminum foil on the bottles containing lyophilized or granulate reagents using the tip of the unlock rack tool 3 Place the required cassettes on a cassette rack Insert the rack into a free slot in the cassette area gt Loading cassettes on page B 40 Tip e Each cassette is automatically checked for correct filling when it is placed for the first time on the instrument If the integrated cassette volume check fails a message is display
8. Roche recommends to use the Roche Activator for Cedex Bio HT systems as ISE Activator Use only the Activator Bottle set for Cedex Bio HT systems which contains the appropriate 11 mL plastic bottles For further details refer to the Activator for Cedex Bio HT systems package insert Caution Confirm replacement for bottles that have been interchanged on the ISE rack Prior to this you have to change the rack positions for the ISE solutions and or diluents Use Configuration Lab Reserve Positions Operator s Manual Version 1 2 Cedex Bio HT 17 ISE module Technical specifications Technical specifications on page H 4 Technical specifications Operator s Manual Version 1 2 17 ISE module Cedex Bio HT Technical specifications F 14 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions ISE service actions Maintenance tasks for the ISE module This chapter describes the service actions and maintenance tasks for the ISE module It provides step by step procedures to guide you through the service actions It lists the potential hazards and precautions in each case General maintenance procedures related to the ISE module are also described In this chapter Chapter 18 About ISE service actions c cccssssssssssessssssssssesesesesscsesessscsesesesescsessessscsesesesesseseseeseneaess F 16 General safety precautions 0 c ccseessessesssessesseesessessessessessesses
9. Validate Y Sample Calibration H Blocked H 2 Not on Board To Validate A GLU CAL GLU B x GLU ac Cc invalid Sample A Calibrator B Control C Order amp To display detailed information for individual results E Click Results on the navigation bar ar Click the Validate Sample Calibration or Quality Control tab Select an item in the list on the left side A ON Double click a result line in the Results list on the right side The corresponding Results Detail dialog box is displayed The format of the dialog box is determined by the type of result that you are viewing For example when you double click a sample the Sample Test Detail dialog box is displayed Operator s Manual Version 1 2 B 125 9 Results Displaying detailed information A Cedex Bio HT Result Sample Gluc Detail x jorder ID F11 476_01 Sample Less than test range The result is lower than the lowest limit for the test a Action Rerun the sample with post concentration Note for ISE result Less than test range The result is lower than the lowest limit for the test Check ISE reading mV Sample was probably not pipetted only water was measured indirect gt Gluc Sample 0 01 g L Comment D 15 03 2012 14 24 ADMIN Sample and order details Recommended user actions based on the flags generated A B C Test name result value and unit and reference
10. 1 Switch off the instrument at the main switch 2 Ensure that at least one cassette slot is empty to improve the air circulation inside the cooling box 3 Switch on the main switch 4 Allow the system to start up and complete its initialization 5 Run the system with at least one spare cassette rack slot for about ten minutes E 32 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Hardware After this you can use all the slots for cassette racks 6 Ifthis does not fix the problem contact Roche Service Operator s Manual Version 1 2 E 33 16 Troubleshooting Cedex Bio HT Software error messages Software error messages gt The process lt process name gt is no longer responding 1 Click Shutdown in the message dialog box The Cedex Bio HT software is shut down and restarted 2 Create a problem report Creating a problem report on page E 44 For messages that are identified by an ID see Message Help on page A 68 E 34 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Data station accessories Data station accessories Connections Monitor Printer This section lists problems that may be associated with the data station including connection problems and other basic problems with the computer monitor printer and barcode reader Cables detached or damaged 1 Ensure that all the required connections are made Connections check
11. Click Results on the navigation bar Click the Quality Control tab Click the button at the top of the column until it shows By Test Click H to open a test folder Use the From button on the toolbar to define a period to reduce the number of results displayed Select the Precision option if available for the selected control Operator s Manual Version 1 2 B 177 11 Quality controls Cedex Bio HT Reviewing and validating control results The results are displayed to the left of the graph the graphical display looks like this A Sodium direct 4 Date amp Time 3s 2s Is X s 25 35 Flags Action 15 Mar 2012 13 26 138 1 A l 15 Mar 2012 13 26 1606 Calibration parameter 4 4 4 a changed r 12 Mar 201214 29 154 2 H NORIS B 12 Mar 201214 29 136 4 m R 4s gt Statistics Precision C Accuracy Limit C A Legend showing the symbols for each control B Control point s outside 3 standard deviations C Ifa control mode is not available for this test it is grayed out Tips e Red symbols represent flagged results e Gray entries represent results that either were excluded from the statistics or have the status Deleted a rerun was ordered To review accuracy controls 1 Click Results on the navigation bar 2 Click the Quality Control tab 3 Click the button at the top of the column until it shows By Test 4 C
12. Green OK to use processing complete Close the rack access panel Use the worklist to check your sample placements Tips You must use only one tube type per rack Racks must be defined for a particular tube type To check this use Configuration Lab Racks If you use any other types of tubes than those defined on your system you risk damaging the probes which have to be replaced before you can continue An orange blinking LED on the rack status display means the system could not identify the barcodes Remove the rack from the instrument check the sample and rack barcodes and insert it again Operator s Manual Version 1 2 B 39 6 Routine tasks Cedex Bio HT Handling test materials The samples on the left most rack rack in slot with lowest position letter are measured first followed by those on the rack next to it on the right Loading calibrators controls and diluents You have to load the calibrators controls and diluents that the system needs to process the daily workload If calibrators and controls have barcodes you can simply load them on board The system identifies the locations of the calibrators and controls from the barcodes If you do not use barcodes assign solutions to rack positions in Configuration Lab Reserve Positions You can then print the assigned rack positions or you can view them in the Samples tab in the Status work area Tips e Ifyou have a set of calibrator l
13. No action required Priority 41 Group CNTL TEST Concentrated The result was generated using a concentrated sample and the concentration was automatically applied to the result calculation Only applicable to tests defined to use predilution No action required Priority 42 Group CNTL TEST Operator s Manual Version 1 2 C 21 12 Result flags Cedex Bio HT Flags and recommended actions C 22 Operator s Manual Version 1 2 Service Part D describes the routine maintenance tasks called service actions that you must perform to keep the instrument running at maximum throughput It describes how the system reacts to service actions when they are due and how to change service intervals if necessary It also provides step by step instructions on how to perform each service action plus a few related tasks Cedex Bio HT 13 Service action software Service action software Using the Service work area for preventative maintenance Service actions are an essential part of your maintenance strategy Completing service actions correctly and on time helps to ensure that your laboratory gets the maximum benefit from your instrument This chapter describes the Service work area and the procedures that are used to track and initiate service actions When you perform a service action a set of online instructions is displayed to show you how to clean or replace parts of the instrument In this chapter Cha
14. pipettes 31 probes 32 drop down lists 51 due date move that of calibration 147 due service actions 50 Due tab Service work area 7 due time of service actions 15 electrical safety xiii electrode block location 5 part ISE module 6 Electrode service ISE service action 18 electrodes activating 19 damage 10 11 19 disabling 82 enabling 82 general service 18 positions of 78 reference 8 9 11 27 replacing 27 servicing 10 18 status of 78 troubleshooting 43 electronics 41 empty activator 23 calibrators controls diluents 20 cassettes 69 deproteinizer 23 etcher 23 ISE solution 23 emptying waste water reservoir 47 enabling ISE electrodes 82 ISE module 82 tests 82 end of day tasks 27 environmental conditions specifications 5 EP UNSTAB flag 8 error messages 4 ISE 40 etcher See ISE solutions evaporation of samples 27 expired cassettes 69 exporting data for problem report 44 raw data 69 external connectors 37 external waste reservoir emptying 47 external water reservoir cleaning 33 refilling 45 external water reservoir filter replacing 64 Failed service action status 14 features of system 4 User Manual Version 2 7 Index Fibrin clots samples with 27 filters for data on the QC tab 122 for data on th
15. 3 Insert sample racks carefully to avoid disturbing the samples Clots or particles in the sample 1 Re centrifuge the sample if necessary 2 Alternatively transfer some sample free of clots or particles into a secondary cup Probes not clean 1 Perform the service action Deproteinize Probes 2 Perform the service action Clean Probes Manually 3 Ifthis does not work replace the probes Leaking tubing or connections Leaking tubing or connections in the fluid system may lead to pipetting errors Leakage on page E 30 Air bubbles in one or more pipettes on page E 31 Dripping pipettes on page E 31 Dripping probes on page E 32 Evaporation or deterioration of the sample 1 Use fresh material if possible 2 Ifthe sample is in a secondary cup transfer a new aliquot to a new cup from the original primary sample System water quality is unsuitable 1 Check the quality of the input water according to the instructions provided by the manufacturer of the deionized water supply system 2 You must use reagent grade type 1 water or equivalent If the water quality is not within specification take the necessary action as recommended by the manufacturer of the deionized water supply system Wash station is defective Check for leakage on the bench under the wash station 2 Check that the waste connector is properly connected and that the tubing is not clogged 3 Ifany leaks persist contact Roche S
16. 3 Select the By Test view 4 Select the required test from the By Test list 5 Click Statistics 6 Select one of the control mode buttons The Statistics dialog displayed depends on the mode selected The Statistics dialog box shows the assigned and calculated values for the mean and standard deviation of selected results for each control The following example shows precision controls when a control is selected in the By Control list Results Qc Statistics Gluc Precision Assigned Assigned Calculated Calculated Calculated Control Lot Mean SD n Mean SD Cv PNorrm 160344 0 87 0 04 3 0 90 0 01 1 02 PPath 163546 2 27 0 11 3 2 2 0 04 1 95 Accuracy Limit Help Print Close The following example shows precision controls when a test is selected in the By Test list Results QC Statistics Gluc Precision Assigned Assigned Calculated Calculated Calculated Control Lot Mean SD n Mean SD Cv PNorrm 160344 0 87 0 04 3 0 90 0 01 1 02 PPath 163546 2 27 0 11 3 2 27 0 04 1 95 Accuracy C Limit Help Print Close Operator s Manual Version 1 2 B 175 11 Quality controls Reviewing and validating control results Accuracy controls Limit controls Understanding control results Cedex Bio HT The Statistics dialog box shows the assigned value permissible deviation the number of results in the statistic n the calculated mean and the calculated bias for the
17. A Test name B This calibration is not accepted dashed line instead of the date C Shows when the next calibration is due Tips e Double click a calibrator line to display the Calibration Detail dialog box e Double click a test in the By Test list to show the Test Status dialog box Operator s Manual Version 1 2 B 151 10 Calibration Cedex Bio HT Validating calibration results lt A paper clip at the beginning of a calibration line indicates a comment in the detail dialog box e Scroll to the right to display lot numbers of the calibrator and reagent A horizontal dotted line shows a lot change of a calibrator e Press F1 to display Help for this tab gt To review calibration details 1 Click Results on the navigation bar 2 Click the Calibration tab 3 Select a test from the By Test list 4 Double click a calibration line The Calibration Detail dialog box is displayed Result Calibration GLU Quantitative Detail x A Cassette GLUB LotNo 00000021 Calibrator GLU LotNo 57132459 B mm butof range Calibration curve or slope does not fall within EJ D programmed range Action Check calibration curve Repeat with fresh calibrators Ifthe calibrators were incorrectly positioned replace the calibrators correctly and repeat the calibration v E 4 Calc Rate c 10 0567771 3970 6405 ee Fat e a 0 30 _ 0 13158 dA __ Ho F PEET a a eee ea r Gamnan
18. Ambient room temperature Relative humidity in operation Maximum altitude 15 32 C 59 89 F Maximum 80 at 32 C 89 F Minimum 30 2000 m 6500 feet Pollution Degree 2 IEC 61010 1 Purity Laboratory Reagent Grade type NCCLS bidistilled or deionized water gt 0 6MQcm or lt 1 5uS cm lt 0 05 Silicate mg L as SiOz Maximum microbiologic content of 10 colony forming units mL Particulate matter gt 0 2 um lt 500 L Organic compound via activated carbon treatment Supply From external reservoir or via direct connection to Usage Drainage Minimum flow rate deionized water supply optional Approximately 2 L h 0 53 US gallon h in operating mode 0 2 L min 0 053 US gallon min Connection Fluid waste disposal Optional direct connection to deionized water supply Fluid waste disposal via direct connection to sanitary sewer system Operator s Manual Version 1 2 21 Appendix Cedex Bio HT Technical specifications Waste handling e Cuvettes with samples and reagents are disposed into an enclosed container inside the instrument The container can be removed and disposed of by the user Liquid waste Danger of infectious waste material This can cause severe illness Avoid direct contact with waste The pH of the liquid waste varies between pH 3 and 5 depending on the assays and the Warni ng sequence of the assays run Liquid waste must be treated as po
19. Buttons on the navigation bar e Flags on results from samples calibrations and controls You can also often see that something is wrong before any results are produced A dripping probe for example will affect the generated results Preventative maintenance The most common sources of problems are related to service actions and water purity e For service actions the main problem is a failure to keep to the maintenance schedules as defined by the service actions Ensuring that the instrument is correctly maintained is the most effective thing that you can do to reduce problems e Poor water quality can cause problems over a long period of time and can be difficult to troubleshoot especially if the water quality varies from day to day System water quality is unsuitable on page E 27 Operator s Manual Version 1 2 E 17 16 Troubleshooting Cedex Bio HT Start up problems Start up problems This section lists potential problems arising from start up or system initialization gt Computer mains power connector is not plugged in 1 Insert the plug into the socket 2 Switch on the instrument 3 Switch on the computer gt Instrument main power cord is not plugged in Switch off the instrument 2 Insert the plug into the socket Shut down the computer The computer is switched off automatically Switch on the instrument 5 Switch on the computer Laboratory power supply has been interrupted 1 Check
20. Cedex Bio HT 2 System description Functional systems D E D B F G c Figure 0 13 Pipette module A Dosage pipette B D Clot detection sensor G Wash pipette C B Wash pipette B E Fluid control block C Cleaner bottle housing F Dosage pipette C The dosage pipettes control the pipetting of the required amounts of sample and reagent or other fluid through the probes The wash pipettes supply water and cleaner to clean the probes in the wash station after every pipetting action and to prevent carry over between tests There are several service actions you must perform related to the pipettes Chapter 14 Service actions Wash cycle After each pipetting action the system automatically moves the probes over to the Wash station wash station and then starts a wash cycle During this cycle the probes and tubing are flushed with water and cleaner There is one wash pipe for each probe The wash station is made of clear plastic All waste water from the wash station is removed to the system waste You must disassemble the wash station for routine cleaning according to the service action schedule Clean wash station on page D 30 Operator s Manual Version 1 2 A 21 2 System description Functional systems Water supply Internal water reservoir Waste connection Pumps Cedex Bio HT Figure 0 14 Wash station disassembled A Plastic cover D Wash pipes B Noise damper E Overflow connector C Waste tubi
21. Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software To replace the dosage pipette s Select Replace dosage pipette in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 The dosage pipettes are positioned automatic step The probes are positioned inside the wash pipes automatic step 5 Open the main front cover A to access the pipettes Operator s Manual Version 1 2 D 61 14 Service actions Cedex Bio HT Replace dosage pipette B or C 6 Remove the cleaner reservoir B 8 Unscrew the dosage pipette from the pipette fluid distributor D 9 Pull the pipette forward to remove it from the module 10 Discard the used pipette according to your local requirements for the disposal of potentially hazardous waste 11 Take the new pipette and pull out the piston E 12 Insert the piston into the glass barrel and half fill the pipette with water 13 Install the pipette seal cap F 14 Reinstall the pipette 15 Wipe away any drops of water from the pipette module the probes G and the D 62 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace dosage pipette B or C splash guard H 16 Reinstall the cleaner reservoir
22. Status Orders Results and Configuration Status Orders Results and Configuration Status Orders Results and Configuration Status Orders Results and Configuration Results Status Orders Results and Configuration Service Service Service Service Status Orders Results and Configuration Status Orders Results and Configuration File gt Print Report gt Begin of Day File gt Print Report gt Final Report Tools gt Journal then click Print File gt Print Report gt Loadlist File gt Print Report gt Missing amp Blocked File gt Print QC Report File gt Print Report gt Results File gt Print Report gt Service Counters File gt Print Report gt Service Intervals File gt Print Report gt Service Notes File gt Print Report gt System Counters Tools gt Test Counters then click Print File gt Print Report gt Worklist The reports are described in the following sections Tip Your printing rights are defined in Configuration General User Level Printing the Begin of Day report The Begin of Day report serves as a check list during daily start up see Daily start up on page B 8 The report provides information on events that took place while the Begin of Day actions were performed and it also lists actions that were not performed successfully and therefore may require user intervention The Begin of Day report is structured in
23. The system activates the buttons on the navigation bar You now have access to the system depending on your user access level Tip Your user access level determines the system features that are available to you Contact your system supervisor if you do not have the privileges you require The user privileges are defined in Configuration General User access and Configuration General User level Check whether you have typed your password and user ID correctly e Spaces are not allowed The password is case sensitive so make sure that you type it exactly as it is defined For example the following are different passwords DOWnie downie DOWNIE Ask the other user to log off or click Log Off in the User Log On dialog box You can then log on B 34 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Logging off and shutting down the system Logging off and shutting down the system Q The following procedures apply to the hardware configuration of Cedex Bio HT analyzer only For steps to be performed in connection with messages and troubleshooting Putting the system into Standby on page E 11 Stopping and restarting the system on page E 12 Logging off the system Logging off leaves the system ready for the next user When you log off the system removes your user ID as the current user and replaces it with None gt To log off 1 Use one of the following methods to open t
24. 3 Instrument 4 Computer The monitor On Off switch is situated at the bottom right on the front of the monitor To switch on the monitor Press the switch The green indicator on the left lights up indicating that the monitor is on Standard printers go into Standby mode as soon as they are connected to the mains power If there is an On Off switch on your printer switch on the printer and follow your printer instructions To turn on the instrument press the main switch A Operator s Manual Version 1 2 B 31 6 Routine tasks Cedex Bio HT Starting up and logging on to the system Switching on the computer amp To switch on the computer Press the On Off switch of the computer The green indicator lights up as soon as the computer starts up and the first text row is displayed on the monitor screen The computer gives an audible signal After completing the startup procedures the user interface of the Cedex Bio HT software is displayed Startup may take a few minutes Do not switch off the computer if the user interface is not displayed on the screen after a few minutes The computer may be recovering the database for example after a power failure Switching off the computer could cause loss of data Caution Starting the instrument The method of starting up the instrument depends on its state P when you start work The Status button A on the navigati
25. 5 Daily workflow End of day End of day Removing sample racks gt To remove sample racks 1 Open the rack access panel 2 Remove all sample racks Deleting results and orders Caution Do not delete the results of the day if you archive the results on the system To delete selected results Click Results on the navigation bar 2 Click the Sample tab Right click the date folder you want to delete and choose Delete from the context menu 4 Click Yes to confirm the deletion Tip To delete a single result right click a result in the Results list and choose Delete from the context menu Purging results on page B 130 To purge orders 1 Choose Tools gt Purge Orders 2 Click Yes on the Confirm Purge Orders dialog box Tips Depending on the setup of your system orders are deleted automatically at BOD time e Ifyou archive the results in the results work area you need to purge the results regularly The Cedex Bio HT analyzer is not designed to store large quantities of results on the system As part of data management you should periodically purge results manually At least every 2 months is recommended Purging and deleting orders on page B 60 Operator s Manual Version 1 2 B 27 5 Daily workflow Cedex Bio HT End of day Complete the remaining service actions gt To complete the remaining service actions Click Service on the navigation bar Select th
26. Activate Electrodes ISE service action used to activate electrode surfaces so that the correct potentials are measured Activator Activator for Cedex Bio HT systems is used to coat ISE electrodes tubing and sample probes after cleaning procedures Analyte The constituent in the sample that is to be determined Analyzer See Photometry analyzer Analyzer Rotor Disk that holds cuvettes temperates them and carries them to the appropriate workstations Antigen Excess Check This check detects samples having excess antigen and thus avoids underestimation of the analyte Archive Storage of data on samples orders and results in Results work area Assigned Mean The mean ofan analyte in a control material or sample pool assigned by the user in order to establish a precision control Assigned Standard Deviation Deviation determined for a sample during precontrol and assigned for use of materials as precision controls Assigned Value The assigned value reflects the quantity or activity of an analyte contained in an accuracy control sample This value is established by the control manufacturer and is supplied with the package insert The assigned values of Roche controls can be entered with a barcode pen Table of contents Auto Start Automatic instrument start function Instrument measurements start automatically following order entry or sample rack insertion Backup Saving of data onto supplementary storage media disks tape
27. Backup database 11881 0 hests rlit 7iays iv Paes nim ct a Replace ventilation filters 11870 500th tet 90 days i 1 Replace Abs halogen lamp i si zooo 1161 0 ys i E Replace probe B 1362 50000 tests 1164 0 days 4 Replace probe C ost i 50000 tests 1164 0 poys i Replace plunger tip dosage pipette B a 50000 tests 1161 E days H 1 Replace plunger tip dosage pipette C oon 50000 tests Heri 0 ideys vf Replace dosage pipette B jasan 200000 ests f 16 i fl ays 3 d e gt The current number of tests hours or hours idle that have occurred for a service action When this number has increased to match the number in the Due column the service action must be performed The number of tests hours or hours idle that must occur before the service action is performed The current number of days that have passed since the service action was last performed The number of days that must pass before the service action is performed moo w The symbol shows which service actions are performed at the Begin of Day Service intervals are the values of the counters and timers that cause a service action to become due You can change the values on this tab You normally must have user access level 6 to edit values on this tab Once a counter or timer reaches the defined percentage of the service interval the service action is displayed in the Due tab of the Service work area The permissible percentage range lies between 80 and 100 a
28. Barcode scanner cannot read the barcodes Check that the barcode scanner window is free of grease and dirt 2 Clean the barcode scanner window if necessary Check whether the barcode setup including the reading of the installation barcodes was properly completed Check whether the printing quality of the barcode labels is sufficient 5 Check whether there is condensation on the barcode labels E 36 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting External connectors External connectors The connectors that you may need to check are located either at the back of the instrument A or on the right side near the back B as shown below A Waste water and power connectors not visible here B Data connectors Waste water and power connectors The waste water and power connectors are located at the back of instrument Mains input connector Mains supply for example for optional printer Water reservoir level sensor Not used Waste reservoir level sensor Water reservoir connector A B c D E F G Tips Waste reservoir connector Do not touch mains cables if your hands are wet Operator s Manual Version 1 2 E 37 16 Troubleshooting External connectors Data connectors Cedex Bio HT Do not attempt to connect or disconnect either of the mains cables if the instrument is switched on If any power connector becomes worn or frayed it
29. Key Function F5 Go to the Status work area F6 Go to the Orders work area F7 Go to the Results work area F8 Go to the Service work area gt Work areas on page A 49 Tooltips Tooltips provide prompts to help you when you are not familiar with the user interface or when you are using a feature for the first time gt To view a tooltip 1 Place the cursor over an item and holdit Balai mlie a l T there for a couple of seconds Pin A m Definitions The corresponding tooltip A is displayed 2 Check the status bar B for an expansion of pimmecoen the tooltip Tip If you are not familiar with the user interface use the tooltip function to find out what each button in the navigation bar does Drag and drop Use this technique for example to place items on a rack 1 Move the cursor over the item you want to place 2 Press the left mouse button and hold it down 3 Move the mouse so that the item is dragged across the screen 4 When your item reaches the required destination release the mouse button A 54 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help Online Help Displaying context sensitive and general Help from the system This chapter describes the Help system for the Cedex Bio HT analyzer It explains how to use context sensitive links how to access general Help and how to access additional information in Acrobat format Note Help facilities and content are subjec
30. Orders are created by users or downloaded from the host system These data are stored in the on board database until it is deleted manually or purged e Results The data from calculated test calibration and control results e Raw data Data from the physical measurements made by one of the measuring modules when the system processes test orders calibrations and controls e Definitions Database tables containing the current parameters for all test and related definitions on the system e Message log This log contains the most recent messages e Journal Results listed in the order in which they were pipetted After they have been processed orders are kept on the system for a user configurable time period Orders older than this are automatically purged at the next BOD You can set the time period in Configuration Database Automatic Actions Delete Orders after For example if you specify Delete Orders after as two days all orders older than two days will be deleted at the next BOD Purging orders removes the order ID from the Orders work area This means that you can reuse an order ID after purging orders In the Results work area the order ID is still visible the results are not removed Each order ID is associated with a date and time so that you can always refer to a specific order by its number its date and its time stamp This ensures that each order is unique You can only purge an order when e There are no
31. Recommended action Unknown fluid Recommended action Blocked orders tests calibrations or controls 4 Re insert the rack into a free slot in the sample or cassette area e Last calibration is not accepted e Last control not accepted The last calibration or control result was not accepted and a further calibration or control request has been made either by the system as a result of a cassette change for example or by the user Note that you can only request a further calibration or control once the calibration or control results are accepted you may request a rerun though 1 Accept the last calibration or control results in the Validate tab in the Results work area 2 Ifthe last calibration or control result was not accepted because it was flagged follow the recommended action for the displayed flag Accepting flagged calibrations without taking appropriate action will cause all subsequent sample results also to be flagged e No calibration definition available e No control definition available Install the required calibration or control definitions See Online Help for details e No fluid in sample cup No fluid level was detected in a tube or cup Possible reasons are o The tube or cup is empty o The tube or cup is overfilled o Wrong tube definition Do one of the following e Refill the sample tube or cup e Remove some sample from the tube or cup e Check the parameters Trigger Point and Lowe
32. Roche recommends working with the Reset Rack Positions at Begin of Day function Configuration Database This function resets each day the starting positions for automatic placement as part of the Begin of Day actions When working with barcodes the Automatically Assign Rack Position function must be disabled To disable this function use Configuration Database and clear the Automatically Assign Rack Positions check box on the Automatic Actions tab Manually assigning samples to rack positions To assign a sample manually F 1 From the Sample Type list select a sample type other than Automatic If you select a sample type other than Automatic drop down lists assist you in assigning the sample to a rack position These lists contain the available rack numbers and positions r Tests amp Profiles Sample Test Summary Sample Type Sampe l Sample bossas E opone T B Test Profile Rack Name Tube Type Sample Type of Rack 3 SAMPLE Sarstedt20mL Sample 4 SAMPLE Sarstedt20mL Sample 5 SAMPLE Sarstedt20mL Sample 6 SAMPLE Sarstedt2 0mL Sample 101 CAL COBAS cup Sample 102 QC COBAS cup Sample Ml A There is a default tube type assigned to each rack B Sample types that are assigned to a rack are displayed Select a rack number from the first Position list Operator s Manual Version 1 2 B 97 8 Orders Cedex Bio HT Creating an order Once a rack number is selected you can
33. Tests amp Profiles p Sample Test Summary Sample Type Sample zl a I T iei B f Cus On Tube I OAND i c GroupfGeneral_ d i 7 roup General aD 1 KD i D EEr fea y aD 1 ac i 1 aD 1 Gh an au oe eee jol Rou H E IGGLB KD TAC WH It aD 1c i I naD NH3 i i SE E A A oe eras 1 i i i 1 STAT Save Clear G H l J admin 29 03 2012 20 38 Use to display or specify order details if you are creating a new order or modifying an existing one To manually assign a sample to a rack position first select a rack from the first drop down list and then select an available rack position from the second drop down list Type a test name a profile name or a test number and then press Enter The specified tests are added to the Sample Test summary group Alternatively you can use the test and profile buttons Select a test group to customize the type and number of test buttons displayed Each test can belong to one or more groups depending on the configuration of your system When you specify the name of a group in the Group box only buttons for tests that belong to that group are displayed Click one or more of the profile and test buttons to select the tests for the order you are creating For tests only you can remove a test from an order by clicking the corresponding button a second time Use the scroll bars to display more tests if necessary Use the Group list to select a pre
34. The Due date column shows only Begin of Day service actions that were completed after the due date e Make the list more specific by clicking Query The Service Notes Query dialog box is displayed You can reduce the items in the list by specifying one or more of the following o A type of service action o A time period o A user e Check any service notes added by any user since the last work day Double click items with a paper clip next to them e Check any user actions as these may contain information relevant to you Operator s Manual Version 1 2 D 13 13 Service action software Cedex Bio HT Service notes Service action states A service action has one of these states State Meaning Passed The service action was completed successfully Aborted The service action was canceled before completion Failed The service action failed Manual The service action was performed without the assistance of the service action software and marked as performed by clicking Done on the All tab This reset the counters to zero CycPassed Some service actions can be performed while the instrument is running Is a service action displayed in the Due list and the system is in running mode a successfully passed service action gets the state CycPassed This state is also listed in the Service Notes Note A user action that may contain comments You type additional comments into the note Adding service notes a
35. Use the menu bar to access Help functions For example you can e Specify whether the Help window stays on top of the main program window e Create a bookmark in the Help so that you can quickly return to a topic later e Add an annotation to a Help topic to allow other users to read when they open the Help In topics such as reference information of dialog boxes or tabs clicking buttons in the banner bar takes you to the corresponding subsections of the topic In general Help topics clicking Top in the banner bar brings you back to the beginning of the current topic Use the buttons on the button bar to display other topics within the Help system The following buttons are available in a window Click this button In order to Help Topics Close e Hide the navigation pane to work with the full screen topic area to make space for large graphics for example e Display the navigation pane when working with the full screen topic area Go back to the Help topic you displayed before the current topic Click repeatedly to go back several steps Print the current topic Browse backwards Go to the preceding topic in the Help file Browse forward Go to the next topic in the Help file Display the glossary Display a list of shortcuts to important related topics This button is only active if there is at least one such shortcut on the current topic Close the Help window Different icons
36. Validate This tab lists orders calibrations and controls that either require validation are blocked or are not on board You can accept a result or rerun it You can request a dilution for tests that you decide to rerun Sample This tab lists all results of all orders Calibration Use this tab to review the calibration results and the calibration Quality Control history of a test Use this tab to review the quality control history of a test Results for the quality controls are displayed graphically allowing you to quickly locate those that are out of range You can right click a sample order calibration control or result in any tab to display the context menu It contains one or more of the following frequently used commands Context menu item Function Accept Accept All Delete Detail Demographics Edit Exclude from statistics List by Print Preview Rerun Retransmit Statistics Test Status Accepts the selected result Accepts all the results in the list Deletes the selected item Displays detailed information for the selected item Displays demographics for the selected order Displays the appropriate tab on the Orders work area Excludes the selected control result from statistics The result is grayed out in the Quality Control tab Switches between the available column headings to determine how the list is sorted Displays the report on screen for you to review or print Reruns t
37. assette amp Interval gt Context menus right mouse button on page A 53 Use the scroll bars when the list is longer than the available space ay Noten Board ad C f a s Std 1 10 Click and hold the scroll bar and then move the A ctas Std2 40 _ GLU4 10 mouse up or down on a vertical scroll bar A or Sail oll A left or right on a horizontal scroll bar B aeua h zA GLU Std 1 10 xl GLU Std 2 10 Tip fl PNarm ioi ia You can use the Arrow keys and the Page Up and Page Down keys instead of the mouse 1 Click the required option A to select it Precision Accuracy Limit 2 Clear the option by selecting one of the other options A Operator s Manual Version 1 2 A 51 3 User interface Cedex Bio HT Working with the user interface Tip Options in the same frame the rectangular box around the options are mutually exclusive Options in other frames are treated separately Toolbars Click a toolbar button to quickly start specific a4 7 alo elela El A functions The content of the toolbar A depends on which work area is displayed This is what the toolbar buttons do Button Function Button Function x Archive Definitions archive Detail display a Detail dialog box l current definitions and system B about the currently selected item settings You can then reload them in the event of a system failure Load Definitions load archived Find fin
38. d AcceptAll Ascept Berun I admin 20 04 2012 09 30 Ik l Repeat calibration The resultis associated with an erroneous or corrected quality control result GLU Sample 0 06 g L A Check all results located in the To Validate folder on the Validate tab of the Results work area B Double click a result line in the list of results The Result Detail dialog box is displayed where you get information about recommended actions for flagged results C Perform the recommended actions for flagged results Recommended actions include e Rerun the test with dilution or concentration e Repeat the test e Check the required items as listed in the recommended actions of the Results Detail dialog box e Review test result details e Accept the result D Validate tab on page B 117 Working with results on page B 128 To rerun or repeat a test Click the Validate tab on the Results work area In the To Validate folder select a sample calibration or control order 3 Select the result in question from the Results list and click Rerun The Dilutions dialog box is displayed if you have selected a test order 4 Doone of the following e Select a dilution factor to rerun the test order with dilution e Select As Original to repeat the test order with the setting defined in the test definition Requesting a dilution on page B 107 Operator s Manual Version 1 2 B 15 5 Daily workflow Cedex Bio H
39. you want to find Help information To find the topic that contains a certain word A ON Click the Search tab Type the first few letters of the word into text box 1 A Select a matching word from box 2 B Select the topic you want to display from the list in box 3 C The information is displayed in the topic area Operator s Manual Version 1 2 A 63 4 Online Help Finding information Lai Contents Index A Search 1 Type the word s you wish to find A 7 H 2 Select matching words to narrow s B DATs f 3 Choose topic to display About calibration Cc About controls Glossary Limit Loading cassettes POS value POSITIVE f Cedex Bio HT Browsing Help information is thematically grouped together Browsing through the topics is a good way of getting a quick overview on the subject you are interested in gt To browse Click or on the button bar to browse through Help information A 64 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help Context Help Context Help Context Help is always specific to the particular area that currently has focus that is the object that your next click or key press will act upon On the Cedex Bio HT analyzer context Help is generally displayed in a Help window rather than a pop up window Displaying context Help Context Help window Which context Help topic is displayed depends on the object that ha
40. 101 tests 101 Missing amp Blocked report printing 55 Missing amp Blocked tab Status work area 68 mixing cassettes 9 modes of calibration 136 137 of controls 162 INTEGRA 400 plus modifying calculated results definitions 14 calibration details 8 concentration details 8 control parameters 9 correlation parameters 9 critical ranges 9 default unit parameters 9 dilution details 8 interval sequence 9 profiles 12 reference ranges 9 sample types 8 test class 11 test groups 10 test sequence 10 warning levels 15 modules analyzer 38 initialization 18 ISE 23 of instrument 18 ipette 20 monitor completely black 35 dim or dark 35 partially black 35 monitoring scheduled orders 22 Mouse icon 22 mouse with context menus 53 multi calibrator set 137 multiple controls 177 multiple copies of orders 106 multi tests 11 navigating to another Help topic 59 within Help topic 59 navigation buttons 48 navigation bar 48 navigation pane on Help windows 60 new messages 6 no definition of calibration or control 21 NO FLUID flag 45 no ISE electrode 24 NO ISECAL flag 45 NON LINEAR flag 12 I 20 User Manual Version 2 7 Index INTEGRA 400 plus NON MONO flag 12 non database storage 72 non linear calibration 136 not accepted
41. 154 status of 70 updating lot values manually 154 updating lot values using the barcode pen or handheld barcode scanner 155 viewing details 140 cassette history viewing 15 cassette racks 11 27 29 icon 29 cassettes areas for 27 barcodes 30 blocked 69 definitions 15 details 81 empty 69 20 expired 69 for racks 29 handling 10 integrated volume check 30 9 interchange xv labels 30 loading 40 loading and mixing 9 lot number 136 not on board 20 position of 72 problems when loading 41 racks 30 specifications 8 status 72 Cassettes tab Status work area 72 Caution symbol xiii check boxes 51 checking BOD report 8 cassette volume 30 9 Memo Pad 51 resources 10 when calibration is due 140 checklist for connectors 38 for replacing fuses 40 circuit boards 40 Clean and lubricate the rotor service action 43 Clean external water reservoir and fluid waste reservoir service action 33 Clean instrument service action 36 Clean internal water reservoir service action 27 Clean ISE tower automatically ISE service action 21 Clean ISE tower manually ISE service action 22 Clean probes and splash guard service action 24 User Manual Version 2 7 Index Clean the waste box fitting service action 42 C
42. 20 Open the cuvette waste access panel S 21 Remove the cuvette waste box T Make sure shaking is not performed while you remove the box Put a rectangular sticker over the holes on the top of the waste box and dispose of it according to your local requirements for the disposal of potentially hazardous waste 22 Remove the cuvette waste box tray 23 Clean the cuvette waste box tray with a tissue moistened with water 24 Clean the cuvette waste box housing using 70 ethanol 25 Reinsert the cuvette waste box tray or replace it with a new one if needed 26 Install a new cuvette waste box 27 Clean all the access panels and the main front cover with soap and water D 40 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean instrument 28 Clean the barcode scanner window U with a dry tissue 29 Reinsert all the racks 30 Click Next 31 The instrument is fully initialized automatic step 32 Click Finish Operator s Manual Version 1 2 D 41 14 Service actions Clean the waste box fitting Cedex Bio HT Clean the waste box fitting Overview Duration Interval Tools and materials Hazards Precautions Further information Regular cleaning of the waste box fitting ensures proper functioning of the ISE module 1 minute Every 30 days or after 2000 ISE tests are run e Deionized water e Protective gloves e Paper tissue The ISE module including the to
43. 3 Turn off the external water supply and reconnect or replace the water tubes if necessary 4 Ifthe leakage is from the internal fluid system on the instrument perform a shutdown and switch off the system then contact Roche Service Air bubbles in one or more pipettes Dripping pipettes Air bubbles are a sign that the fluid system most likely a pipette is leaking or that the cleaner is running low or the water supply is not properly connected Pipette not correctly installed 1 Reinstall the pipette or the piston ensuring no air bubbles are trapped 2 Check for air bubbles appearing after reinstallation 3 Ifair bubbles reappear call Roche Service Replace plunger tip dosage pipette B or C on page D 57 Water supply or cleaner not properly connected 1 In Status Analyzer check whether the cleaner is running low If necessary replace the cleaner Check the connections to the cleaner and water supply 3 Perform the service action Prime the fluid system Replacing the cleaner on page B 43 Waste water and power connectors on page E 37 Prime the fluid system on page D 46 If a visual inspection shows that either of the pipettes is leaking you must take immediate action Pipette not correctly installed e Reinstall the pipette Replace plunger tip dosage pipette B or C on page D 57 Piston worn out 1 Replace piston or pipette 2 Ifthe piston only is replaced and drips reappea
44. B USB Ports Information can be saved on USB Memory Stick C Diskette drive In older Cedex Bio HT systems information can be saved on 3 5 inch diskettes Barcode pen or You use the barcode pen or handheld barcode scanner to read calibrator and control handheld barcode scanner lot data located on the barcodes of the package inserts Figure 0 5 Using the barcode pen left or handheld barcode scanner right gt Setting up calibrators on page B 154 Operator s Manual Version 1 2 A 7 1 System overview Cedex Bio HT Overview of user tasks Overview of user tasks Figure 0 6 shows some of the main access points for tasks you perform regularly A B c D E Figure 0 6 Main access points to the instrument A Cassette rack with reagent cassettes B Sample rack with samples or calibrators controls and diluents C ISE rack with ISE solutions special cleaners and diluents D Curette reservoir for new cuvettes E Disposable cuvette waste box autoclavable for used cuvettes F Connections to water and waste are made on the rear panel not shown G Data connectors Here are some important user tasks e Perform service actions e Prepare resources for example mix cassettes e Replace consumables such as cleaners cuvettes and dispose of used ones e Print reports for example the Loadlist e Load racks containing samples reagents cassettes calibrators controls cleaners and
45. By default results from sample tests calibrations and controls are kept on the system indefinitely Purging removes completed results from the system After purging these results are no longer available on the system you cannot retrieve them from the Results work area any statistics that were calculated using the results are recalculated using the remaining results when requested Purging results manually can take a considerable time During this time the system must remain in Standby you should not attempt to insert a rack while a purge is in progress A sample test result is purged provided that e The associated sample is not on board The result is accepted The result has been transferred to the host if you work with a host system The associated order ID is purged as well provided that e There are no pending test orders associated with this ID Tips e Provided the above conditions are met order IDs are deleted even if tests were never performed for these orders for example after inserting a rack with barcoded sample tubes and removing it again e Purge regularly typically every two months Before you purge results you should archive your current calibration control and sample results File gt Archive Results Operator s Manual Version 1 2 D 67 14 Service actions Managing data What information is deleted What information is not deleted Cedex Bio HT When purging res
46. Cedex Bio HT 9 Results 2 The Purge Results dialog box is displayed m Caution The system must be in Standby or Sleeping Do not add or remove racks during the operation m Purge Results M Calibration M Quality Control M Samples To 19 04 2012 Working with results 3 Select or clear the Calibration Quality Control and Samples check box to choose the kind of test results you want do delete 4 Ifyou selected the Samples box select the Purge all samples box to delete in a further step all samples that will be without associated orders and results The samples are deleted irrespective of the date specified on this dialog box 5 Inthe To box type the date up to which you want to delete the results All results older than that date will be deleted 6 Click Purge A status window is displayed while the results are being purged The purging action may take quite some time depending on the number of results that need to be deleted gt To delete a single result B 1 Click Results on the navigation bar ar 2 On any of the tabs right click an item and choose Delete from the context menu The Confirm Delete dialog box is displayed The text on this box tells you exactly what data will be deleted 3 On the Confirm Delete dialog box click Yes Tip Depending on your user rights this option may not be available to you Deleting orders gt To delete an order For details on
47. Configuration Database Demographics Selecting tests for the order You can add tests one at a time or you can select a test profile amp To add tests to an order Fi In the Sample tab in the Orders work area 1 Click the required profile buttons 2 Click the required test buttons 3 Click Save Tips e The buttons for profiles are listed above those for individual tests e Selected tests are shown in white and listed in the Sample Test Summary group e Ifa test belongs to two profiles and both profiles are selected the test is only run once e You can also select a test or profile by typing its name in the Test Profile box Assigning samples to racks In some cases for example if you do not use barcodes or when a sample barcode could not be read you must assign each sample to a specific position on a rack You can do this in two ways e Use the Automatically Assign Rack Position function to automatically assign samples to rack positions Roche recommends using this method if you work with non barcoded samples e Manually assign samples to racks using either Sample Handling dialog box Use this method if you prefer to create an order and then specify all the sample positions for that order before moving on to the next order o Place Items dialog box Use this method if you want to assign all the samples on a rack at one go Automatically assigning samples to rack positions To create an order using Auto
48. Purging results on page B 130 Preconditions for purging results on page B 130 To purge results on page B 130 To delete a single result on page B 131 Database Reorganization Caution The Database Reorganization function is closely related to the Purge Results function and should be performed when you just purged large numbers of results for example the results of the last three months It reconditions the database and improves the system performance Prior to Database Reorganization you should 1 Backup the database 2 Purge the results e Database Reorganization should only be performed under guidance of Roche Service personnel e Database Reorganization may take up to one hour Do not interrupt this process Operator s Manual Version 1 2 B 61 6 Routine tasks Purging and deleting information and items To reorganize the database 1 Click Service on the navigation bar A 2 Choose Tools gt Database Reorganization The Database Reorganization dialog box is displayed Database Reorganization x Caution Once started this function cannot be stopped it takes about 45 minutes Perform Database Reorganization if database capacity has reached its limit Only use this function if you have already purged results from the database as follows 1 perform the Backup Database service action 2 purge all results sample quality control and calibration Help Print St
49. Setting up controls Tips e Step 5 Type the ID in the format 97 nnnn n where n is a number between 0 and 9 e Step 10 When you click Save an empty Test list is displayed Tests are listed here when you have assigned the non Roche control to tests e To determine the statistical values required you have to run the control as a sample enough times for statistical accuracy To assign a non Roche control to a test 1 Click Tests in the Definitions group 2 Click the Control tab 3 Select a test from the Installed Tests list 4 Select the non Roche control from one of the drop down lists in the Controls group Specify interval sequence details for the control Click Save Click Close N o1 Tips e Repeat this procedure for all tests that use the non Roche control e Step 5 The Precision P Accuracy A and Limit L boxes remain blank until you specify values for them in Configuration Controls Lot To specify Precision Accuracy and Limit values for a control Click Controls in the Definitions group Click the Lot tab Select the control from the Controls list Select a test from the Test list a fF WN Specify Precision Accuracy and Limit values For a precision control a Select the Precision box b Specify values for the assigned mean and standard deviation For an accuracy control a Select the Accuracy box b Specify values for the assigned value and the permissible deviation For
50. To clean probes and splash guard Select Clean probes and splash guard in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 Open the rack access panel on the front of the instrument A 4 Remove all sample racks C and the ISE rack D D 24 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean probes and splash guard You do not have to remove the cassette racks B 5 Click Next The transfer head is positioned in the sample area automatic step Open the main front cover E to access the probes and splash guard 8 Remove the splash guard F Pull down the clip at the back of the splash guard to disengage it from the housing 9 Clean both probes G with a tissue moistened with 70 ethanol Clean the probes from top to bottom 10 Clean every part of the splash guard with soap and water 11 Rinse and dry the splash guard Operator s Manual Version 1 2 D 25 14 Service actions Clean probes and splash guard 12 Reinstall the splash guard 13 Click Next 14 The transfer system is initialized automatic step 15 Reinstall sample racks and the ISE rack 16 Click Next 17 Make any necessary notes and click Finish Cedex Bio HT D 26 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean internal water reservoir Clean internal water reservoir Overview Duration I
51. When are service actions nearly due You must perform a number of service actions to ensure that your instrument runs reliably Use the Service work area to track and perform service actions When any service action is due the Service icon on the navigation bar turns yellow If the Service icon is red it means that the backup database service action is overdue Generally the instrument must be in Standby when you are performing service actions The ISE service actions Activate electrodes and Prime ISE calibrators are exceptions to this Chapter 18 ISE service actions The due time for a service action is determined by the counters and timers that are maintained by the system For example with the default values the Clean probes and splash guard service action is listed on the Due tab either e after 3000 tests or e after 7 days The system uses the service interval number of tests or number of days that occurs soonest Service intervals can be changed by your system supervisor When the service action has been performed the counters and timers are reset The system defines service actions to be nearly due by using a percentage of the service interval For example using 90 for the Service Action Due at calculation the Clean probes and splash guard service action is listed on the Due tab either e after 2700 tests have been done 90 of 3000 or e after 6 3 days have passed 90 of 7 The percentage can
52. calibrations and controls are kept indefinitely Purging removes completed results from the system After purging these results are no longer available on the system you cannot retrieve them from the Results work area When requesting statistics information the statistics values are recalculated on the basis of the remaining test results Purging results manually can take considerable time During this time the system must remain in Standby you should not attempt to insert a rack while a purge is in progress The system should be in the Standby or Sleeping state A sample test result is purged provided that e The associated sample is not on board The result is accepted The result has been transferred to the host if you work with a host system The associated order ID is purged as well provided that e There are no pending test orders associated with this ID Tips e Provided the above conditions are met order IDs are deleted even when tests were never performed for these orders for example after inserting a rack with barcoded sample tubes and removing it again e Results e Calculated results that were derived from purgeable results e Test orders e Order IDs Tips e Before you purge results you should archive your current calibration control and sample results File gt Archive Results To purge results 1 Choose Tools gt Purge Results on any work area B 130 Operator s Manual Version 1 2
53. etc If such data is again required but no longer available from main storage hard disk it can be restored see Restore from a backup copy Barcode An alphanumeric code used to identify a newly loaded cassette identify samples and read in calibration and control lot data from the package inserts Barcode Pen A device used to read barcodes on package inserts of calibrators and controls Barcode Scanner A device which reads barcodes on tubes racks and reagent cassettes using a rotating mirror to scan a laser beam across the barcode A sensor detects the dark and light reflections from the barcode changing them into electrical pulses which are interpreted by software Begin of Day BOD The time when the instrument starts its Begin of Day Action see Begin of Day Action This time can be specified in the Configuration work area Begin of Day Action The Cedex Bio HT software enables the user to define a specific time as the Begin of Day for example 6 00 a m At this time the system automatically carries out service actions and other procedures Begin of Day Report A report that is automatically generated after the Begin of Day The report lists service actions that have failed Bottle A glass or plastic container having a lid and used for liquids Some bottles may be used directly on systems Others have to be used on specific racks e g ISE rack Calculated Result Ratio Result calculated on the basis of two
54. gt Pipetting error The volume of fluid delivered by the dosage pipettes is incorrect Leakage on page E 30 Air bubbles in one or more pipettes on page E 31 Dripping pipettes on page E 31 Dripping probes on page E 32 gt Reagent in the cassette has deteriorated 1 Check the cassette expiration date in Status Cassettes If the cassette has reached its expiration date replace it with a new cassette when the rack is released 2 Check the results of the last calibration or control If the results deviate significantly from the previous calibration or control order a new calibration or control If the results are still wrong check the calibrator or the control material If these are OK replace the reagent cassette 3 Check when the next calibration is due Status Test Status If the due time is some time away and the last calibration was performed some time back order a new calibration Test results not reproducible Results are obtained but are frequently flagged In particular when a particular test is rerun the results are not consistent with earlier values E 26 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Results Air bubbles or foam on the surface of the sample Carefully remove air bubbles or foam from the surface of the sample 2 When transferring samples to secondary cups pipette the sample carefully to avoid the introduction of air bubbles or foam
55. on cassettes 30 reading 35 sample tubes with 38 sample tubes without 38 supported types 35 Begin of Day electrode service 10 overview 12 toolbar button 52 user defined service actions 10 Begin of Day report checking 8 printing 52 Begin of Day tab Service work area 9 biological safety xiii blocked ISE tower 22 samples cassettes or diluents 69 tests 12 tests orders controls 19 BOD See Begin of Day browsing 64 buffer message log 7 button bar on Help windows 59 INTEGRA 400 plus buttons Archive 52 Back 59 Barcode 52 Begin of Day 52 Calculator 52 Clear 52 Close 59 Copy 52 Detail 52 Find 52 for commands 51 for navigation 48 for online Help navigation 59 for options 51 Glossary 59 Help Topics 59 Load Definitions 52 Messages 4 on Help windows 59 on toolbar 52 Paste 52 Place Items 52 Print 52 59 Restart 37 Save 52 See also 59 70 Service 50 Start 42 48 37 Stop 42 48 37 Test Calibrations 52 C flag 6 c flag 6 cables detached from computer 35 detached or damaged 35 CAL xii CALC ERROR flag 7 calculated results about 13 creating definitions 13 deleting definitions 14 modifying definitions 14 on Results work area 112 Calculated Resul
56. or e Choose Help on the menu bar of the currently displayed dialog box and then choose the appropriate option To close online Help and return to the application interface e Click Close on the button bar of the Help window or e Choose File gt Exit in the Help window Operator s Manual Version 1 2 A 57 4 Online Help Cedex Bio HT Help window Help window In Windows XP the Help screen is available in English only The Help window is divided into the header navigation pane and topic area The header contains the menu and button bars which provide access to standard Windows Help functions e The navigation pane consists of three tabs each providing a specific way of finding information in the Help e The topic area displays the information contained in a Help topic The following figure shows an example of a context Help topic amp Cedex Bio HT Help System _ Of x File Edit Bookmark Options Help B a ee eo e View Messages H Status work area H Orders work area D E Results work area ict Service work area B A Configuration work area Overview E Configuration work are Use the ID tab to load test definitions create new definition details for E A Configuration Test De tests and view modify and delete existing definitions Confi tion Test i Pe E Configuration Tes Basic Test types are individual tests B E General tab Multi Test types are for multiple te
57. reviewing definitions 167 reviewing for validation 172 reviewing results 173 reviewing statistics 174 reviewing status 166 rules 186 setting up 181 specifying a new lot 184 specifying an interval 187 status of 70 viewing on board 166 viewing when missing 167 conventions for user interface xi in documentation x units xii cooling unit fuse 42 coordinates 36 Copy toolbar button 52 copy function 53 copying tests 106 correlation parameters modifying 9 counters 15 test counters 59 creating calculated results definitions 13 orders 12 17 25 95 problem reports 44 profiles 12 test classes 11 test groups 10 critical ranges modifying 9 Ctrl key 53 Cup on Tube using 100 cups adapters 33 types 32 CUR DIR flag 8 cursor 54 curve parameters of calibrations 136 Custom Query dialog box 123 cut function 53 cuvette reservoir icon 16 refilling 44 cuvette waste icon 16 cuvette waste box replacing 48 cuvettes buffer 26 common for pipetting 13 conveyor belt 26 feeder 26 many unused 29 maximum volume 24 minimum volume 24 optical path length 24 refilling the reservoir 44 replacing the waste box 48 reservoir 25 slide 26 specifications 8 transport system 23 waste 12 waste box 26 Cyc P
58. ss ssssssssssssssssssssssssssssssssstessssssssnnrsereeessssssss E 32 Sample prime Clot erro rcssssszscsasssstebsiasesessbeie saadasecnsstaces aia AE ia ak E 32 Leakagen hatina a E a eA E 32 Air bubbles in one or more pipettes cssesesssessesessessesseessessessnessessesseseessess E 33 Dripping Pipettes sipiin ea p aR ie hanea RE RRE EES aE ieee E 33 Dripping probes nir EEE GEEA E 34 Temperature controlas E E E S E O E E 34 Operator s Manual Version 1 2 E 15 Cedex Bio HT 16 Troubleshooting Software error MESSAGES is psio ars a S R E E EER E 35 Data station accessories ccsccccseesesseeseeseeseeseeseesesseseseeseeseeseeseenecsesucseeseseseeseeneeseeneeneanees E 36 Connections MoO TitOr nssascs susivesasacessissosasenesssssorassedesasenecatsnssesesosucseresessasassaeasansseeedelasdsenssoscaesassieteds PADET syaa E E recor netecasieemuar ees BarcOde SCAnM er snra i ASE VNA E 37 External c nnectors anair A EEE ANTT E 38 Waste water and power Connectors cessesseessessesseessestesessesstessessessessessesseseessess E 38 Data COMMECtOLS secsessesessessesseseeseeseeseeseeseesesnessesecseeseseeseeseeseescenesseseeseeseeneeneeseaneanenees E 39 GConmectionsscheck siiin ninan enan e E 40 Checking and replacing fuses niisiis in ESES i EEES E Sis E 41 Replacing an instrument mains fuse oes eesessesseessesseescssessessessessnesseeseese E 41 Replacing the cooling Unit fuse sssini aiiai E 43 Replacing controller
59. used The Cup on Tube function on the Sample Handling dialog box is only available if the selected rack has the appropriate tube type assigned to it the rack position is entered and the rack is not on board Assigning samples to racks on page B 96 Selecting Cup on Tube on page B 100 Operator s Manual Version 1 2 B 13 5 Daily workflow Daily routine without sample barcode and without host Cedex Bio HT Loading samples on board 3 Start processing p To load samples on board 1 Choose File gt Print Report gt Loadlist from the menu bar and click OK to print the loadlist Use the loadlist to place the sample tubes and cups on the correct rack position 3 Insert the rack into one of the slots in the sample area Tips e Cup on Tube samples are not displayed in the list e You can use only one tube type per rack e Ifyou use tubes that are not defined on your system you may damage the probes e Before you move a rack wait until the status light above the rack is green gt Loading samples on page B 38 To start processing e Ifthe system is in Standby press F11 or click Start on the navigation bar e If the system is in Sleeping press F11 or click Start on the navigation bar As soon as the system is in Standby press F11 again Tip If you work with Auto Start Configuration General System the system starts processing automatically as soon as you insert a rack
60. 1 2 B 25 5 Daily workflow Cedex Bio HT Daily routine with sample barcode and with host Tip Change the test group in the Group box to limit or expand the display of test and profile buttons Select General to display all available test and profile buttons Selecting tests for the order on page B 96 If you want Then do this To limit or expand the display Select the appropriate Group in the Test amp Profiles group of test and profile buttons in the Test amp Profiles group To delete a test from the Right click the test in the Test Summary group and choose Sample Calibration or QC Delete from the context menu tab To request a dilution for a Right click the test in the Sample Test Summary group and sample test choose Dilutions from the context menu Select or type a factor in the Dilutions dialog box To add a sample test several Right click the test in the Sample Test Summary group and times to an order choose Multiple Tests from the context menu Type the number of test in the Multiple Tests dialog box To create multiple copies of Right click in the Sample Test Summary group and choose an order Copy Order from the context menu Right click again in the Test Summary group and choose Paste Multiple from the context menu Type the number of orders you wish to create and accept or change the first order ID for the new orders B 26 Operator s Manual Version 1 2 Cedex Bio HT
61. 166078 D ents amp GLN2 COBAScup 1028 57132565 E ain Wy cue j icca amp GLN3 COBAScup 1029 57132554 3 29 GLU 1 COBAS cup 1025 67132491 ees of KO ac LDH aD 1 Gu F eM NH ay GLU2 COBAS cup 1026 57132556 D 1 GLU aS GLU3 COBAScup 1027 57132556 aD 1 GLU Fi 3 23 PNorm COBAS cup 102 1 160344 eD 1 NAD ef 1 LDH wD 1 KD 5 5 PPath COBAS cup 102 2 163546 A sO 1 LDH eD 1 NA D ne s D 1 K D Save me O I admin 29 03 2012 10 34 A Click the Place Item button to place samples on the rack while defining orders for samples whose barcode could not be read especially if you work with a host system You can select a test or profile for the quality control request by typing in its name or number here oO In the Configuration work area tests can be assigned to groups You can use this feature to reduce the number of test buttons displayed at one time Select another group if you do not see the required test Click a profile button to request controls for all tests in the profile A control request has been made for this test Click test buttons to request a control for the test f you select a control here only the tests that are associated with the control are displayed The Controls Test Summary lists all current requests for controls ro 7 Mm Oo Click Save to save the quality control request Tips To review completed or flagged controls use the Quality Control tab or the Valida
62. 1997 I SERTS Last Modified 05 01 2000 By MK v Keep Old Lab Settings Help Deselect AIl SelectAll Cancel Select the calibrators that you require Click Load A progress indicator is displayed When the calibrators have been loaded click Cancel to close the Load Calibrator Definitions dialog box If you work with a barcode pen or handheld barcode scanner perform step 11 and then read the barcode with the pen or scanner Select a calibrator from the Calibrator list 10 Click the Lot tab to review the lot information 11 Click Save 12 Click Close B 158 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Setting up calibrators Tips e You may be asked to update calibrator definitions from the Test Application Software TAS from time to time e Update the assigned values for a new calibrator lot from the data given on the package insert To delete a calibrator definition 1 Click Configuration on the navigation bar 2 Double click Calibrators in the Definitions group 3 Click the ID tab 4 Select a calibrator from the list 5 Click Delete 6 Click Yes in the Confirm Delete dialog box Tip If you decide not to delete a selected calibrator after pressing the Delete key you can click No or Cancel in the Confirm Delete dialog box Preconditions e You have sufficient user access privileges The system is in Standby or Sleeping mode e The rack containing the cali
63. 2 F 11 17 ISE module ISE solutions summary ISE solutions summary Cedex Bio HT Solution Cap Location Position Usage ISE Solution 1 Yes ISE rack 6 Two point calibration of sodium chloride and potassium and for the three point calibration of lithium Also used for the initialization of the ISE module ISE Solution 2 Yes ISE rack 5 Two point calibration of sodium chloride and potassium and for the three point calibration of lithium ISE Solution 3 Yes ISE rack 4 Three point calibration of lithium only ISE Calibrator Direct ISE module One point calibration after each ISE direct measurement which is performed once every ISE cycle when the module is in ISE direct mode Also used during ISE standby and for servicing purposes ISE Calibrator Indirect ISE module One point indirect ISE calibration which is performed once every ISE cycle ISE Reference Electrolyte ISE module Used in all ISE measurements of sodium potassium chloride and lithium ISE Etcher Yes ISE rack 3 A cleaning solution intended for use with the ISE module for cleaning the sodium electrode during ISE service ISE Deproteinizer Yes ISE rack 8 A cleaning solution intended for use with the ISE module for cleaning the probes during BOD the ion selective electrodes ISE tower and tubing during ISE service Activator No ISE rack 2 Activates the electrodes in ISE service actions and is also used for the initialization of the ISE module and for BOD
64. 2 0 absorbance with less than 1 deviation at a path length of 0 5 cm The measurement system uses blank positions on the rotor to monitor the background signal for the electronic adjustment of drift The measurements are taken without removing the cuvette from the analyzer rotor Operator s Manual Version 1 2 A 39 2 System description Functional systems Wavelengths for the absorbance photometer FP photometer Computer systems Cedex Bio HT The life expectancy of the absorbance halogen lamp is 800 hours The system informs you when you need to replace the lamp Replace Abs halogen lamp on page D 51 The absorbance photometer makes measurements at the following wavelengths e 340 nm e 480 nm e 552nm e 652 nm e 378nm e 512nm e 583 nm e 659 nm e 409 nm e 520 nm e 629nm e 800 nm All wavelengths are measured at the same time but only one wavelength for monochromatic measurements or two wavelengths for bichromatic measurements are used The FP photometer makes measurements on samples based on the principle of fluorescence polarization The cuvettes are temporarily removed from the rotor by workstation FP and then the FP measurements are made For FP measurements The light source for the FP photometer is a blue LED The photometer uses a polarization filter which rotates to let through either the parallel or the perpendicular component of the light The measurements are made wi
65. 4 parts of 5 priming ISE calibrators 20 purpose 4 replacing electrode 27 replacing ISE calibrators 34 replacing ISE module tubing 25 replacing ISE solutions 32 34 replacing ISE tower 36 safety precautions 16 sensors 6 service actions 10 15 specifications 9 Standby mode 10 STAT orders 10 tower 21 22 INTEGRA 400 plus racks 6 icon 29 position of ISE solution 33 ISE reference electrolyte See ISE solutions service action bout 16 Activate electrodes 19 Clean ISE tower automatically 21 Clean ISE tower manually 22 Condition ISE module tubing 31 Electrode service 18 Initialize ISE module 17 Prime ISE calibrators 20 Replace bottles on the ISE module 34 Replace electrode 27 Replace ISE module tubing 25 Replace ISE solutions on the ISE rack 32 Replace ISE tower 36 ISE service actions 10 16 31 ISE solution 1 2 and 3 See ISE solutions ISE solutions activator 12 33 calibrator direct 5 6 12 42 poe indirect 5 6 12 deproteinizer 8 12 33 etcher 8 12 33 expired 50 location 12 positions 78 reference electrolyte 5 6 12 replacing 82 34 replacing on ISE rack 32 solution 1 12 33 solution 2 8 12 33 solution 3 8 12 33 summary 12 ISE standby 10 ISE tab Status work area 78 ISE tests 11 ISE tower c
66. A E E E E C 22 C 4 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags About result flags About result flags Flag groups Flag priority Flag display Flags are displayed and printed together with the results They are also displayed with the results in the Results and Orders work areas Flags are grouped according to the measurement method and the way the result is evaluated CAL Flags from calibration measurement and result evaluation CNTL Flags from quality control measurement and result evaluation RAT Flags from calculated result ratio evaluation TEST Flags from sample measurement and result evaluation Within each of the flag groups a priority level is assigned to each flag and it is the flag with the highest priority with the lowest priority number that is displayed In the results lists on the tabs of the Results work area only one flag is shown To look at all generated flags double click the result and the flags are explained in the Details dialog box For details on individual ISE flags and recommended actions see Flags and user actions on page F 41 Operator s Manual Version 1 2 12 Result flags Flags and recommended actions Cedex Bio HT Flags and recommended actions gt ACC RNG Meaning Recommended action Attributes gt AG EXCESS Meaning Recommended action Attributes AIR FLUID AIR ISECAL c Meaning Recommended action Accu
67. Bio HT software Volume Management An internal software calculation mode It is based on volume information to find the correct immersion depth of the sample probe if a new bottle is placed on a specific position of the ISE rack Delivers information in percent about the filling status of bottles Waste The fluids samples cleaning solutions etc and solid materials cuvettes discarded by the instrument Waste Container The waste container collects used cuvettes and potentially infectious fluids Both the waste container and contents must be disposed of according to the local legal requirements associated with high level waste Work area Main areas of the user interface such as Results and Orders work areas 7 Operator s Manual Version 1 2 Cedex Bio HT Operator s Manual Version 1 2 8 Index INTEGRA 400 plus Index abbreviations used in documentation xii about Cedex Bio HT ix absorbance module specifications 8 absorbance photometer 4 39 wavelengths 40 abs xii accepting results 117 128 access panel ISE 5 access panels 16 access points on instrument 8 accessing online Help 57 accessories to data station 35 Accuracy control mode 162 accuracy ISE measurements 49 accuracy controls 176 reviewing 178 acronyms used in documentation xii Activate electrodes ISE service action 19 activator See
68. Cedex Bio HT 19 ISE flags and troubleshooting General ISE troubleshooting 3 Ifthis does not fix the problem perform the service action Replace ISE tower You may have to perform the service action Clean ISE tower automatically more frequently If so reduce the service interval in the Service work area Probes clogged or dirty 1 Perform the service action Deproteinize probes 2 Perform the service action Replace probe C if necessary ISE Reference Electrolyte or reference electrode expired Check the expiration and replacement dates of the ISE Reference Electrolyte and the reference electrode and replace if necessary ISE Reference Electrolyte not present or flow not sufficient Check whether there is enough ISE Reference Electrolyte in the bottle 2 Check the ISE Reference Electrolyte flow through the reference electrode The ISE Reference Electrolyte flow should look like a bead chain If it does not check the ISE Reference Electrolyte tubing and the floater for blockage salt deposits or leaks 3 Remove any blockages and replace the tubing if necessary Replace the ISE module tubing then perform the service actions Condition ISE module tubing and Prime ISE calibrators ISE module not used for one or more days Perform the service action Activate electrodes several times Operator s Manual Version 1 2 F 51 19 ISE flags and troubleshooting Cedex Bio HT General ISE troubleshooting F 52 Opera
69. Delete a calibration request Use Place Items or Sample Handling to manually assign calibrators to rack positions Review the status of pending calibration requests during operation Review flagged calibrations Display the Calibration Definitions dialog and then Rate info Accept or rerun an unaccepted calibration Delete a calibration if there are no dependent test results Review calibrations by test Review curve parameters Review the calibration history Display the Details dialog to review data for individual calibrations for replicates and rate info Rerun or accept a calibration from the Details dialog B 138 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Calibrations at a glance Use the following table to locate specific tasks in the Configuration work area Icon Tab Tasks General e Specify calibrator sample type and interval for a calibration and whether replicates are to be run Roche recommends to perform calibrations in Tests duplicate the assigned values for a selected calibrator and test J Lot e Specify a calibration lot number expiry date and Calibrators Operator s Manual Version 1 2 B 139 10 Calibration Cedex Bio HT Reviewing the status of calibrators on board Reviewing the status of calibrators on board You can check the status of the on board calibrators for example to find out when they need replacing gt To view the
70. Deproteinize probes Passed ADMIN 19 04 2000 06 04 Prime fluid system Passed ADMIN 18 04 2000 16 30 Prime fluid system CycPassed ADMIN 18 04 2000 06 09 Deproteinize probes Passed ADMIN 18 04 2000 06 03 Prime fluid system Passed ADMIN 17 04 2000 06 09 Deproteinize probes Passed ADMIN 17 04 2000 06 03 Prime fluid system Passed ADMIN 16 04 2000 06 09 Deproteinize probes Passed ADMIN 1604 2000 _ 06 03 _ Prime fluidsystem _ Passed ADMIN ___ x B 15 04 2000 06 09 Deproteinize probes Passed ADMIN 14 04 2000 res 15 04 2007 TET Prime fuid JARN TT TTT eee eee een Passed ADMIN T47047Z000 14 04 2000 06 02 Deproteinize probes Failed ADMIN 14 04 2000 06 02 Prime fluid system Failed ADMIN 13 04 2000 15 10 Deproteinize probes Passed NONE 10 04 2000 13 04 2000 15 04 Prime fluid system Passed NONE 10 04 2000 12 04 2000 12 05 Backup database Passed ADMIN 12 04 2000 Help Export Add Note Query Print E A User action not directly related to a particular service action The paper clip indicates that the note was added by a user B Service action listed with the date and time it was performed its status and the user who performed it C Click to export notes D Click to add a service note to the selected service action If no service action is selected a user action is added to the list E Click this button to specify parameters that reduce the number of items displayed in the list Tips
71. Etcher is empty ISE solution is empty Open the Empty folder in Status Missing amp Blocked to see the empty Activator ISE Deproteinizer ISE Etcher or ISE solution and their correct rack positions Remove the ISE rack from the instrument Refill the empty Activator ISE Deproteinizer ISE Etcher or ISE solution Re insert the ISE rack into slot O The ISE Rack Replaced dialog box is displayed On the dialog box select the ISE solutions that you have replaced Leave the check boxes cleared for ISE solutions you have not replaced ISE module is not ready The ISE module is not initialized Possible reasons are o The last ISE initialization was not successfully completed o Not all required solutions are available for example Activator or Std 1 o The ISE module was recently enabled but no ISE initialization was performed Make sure all solutions are on board Operator s Manual Version 1 2 E 23 16 Troubleshooting Cedex Bio HT Blocked orders tests calibrations or controls Disabled Recommended action No electrode Recommended action Error Recommended action Hardware errors Abs error Recommended action FP error Recommended action FP disabled Recommended action e Perform the service action Initialize ISE module in Service All ISE module disabled The ISE module was disabled manually 1 Open Status ISE 2 Select Enable ISE Module to enable the ISE measure
72. Help windows 62 indirect mode IS 4 initialization posts 38 Initialize ISE module service action 17 Initializing system state 44 initializing system 33 installing test definitions 7 instrument access points 8 cleaning 9 36 main features 5 serial number 76 starting up 32 status of 66 system ID 76 temperature 77 instrument connectors 38 internal water reservoir 22 cleaning 27 interrupting sampling 37 interval sequence modifying 9 User Manual Version 2 7 Index intervals calibration 156 control 163 specifying for controls 187 in xii ISE xii flagged results 40 icon 16 module 23 poor accuracy 49 racks 32 troubleshooting 49 ISE calibrator direct See ISE solutions ISE calibrator indirect See ISE solutions ISE deproteinizer See ISE solutions ISE electrodes disabling 82 enabling 82 positions of 78 status of 78 ISE etcher See ISE solutions ISE flags list of 41 user actions 41 ISE measurements 4 making 11 ISE module 3 activating electrodes 19 calibration intervals 9 cleaning ISE tower automatically 21 cleaning ISE tower manually 22 conditioning ISE tubing 31 disabling 78 82 electrode service 10 18 enabling 78 82 initializing 17 ISE solutions on 6 location 5 measuring modes 4 operation 8 11 overview
73. ISE solutions adapters for cups 33 for tube height 31 adding tests to an order 105 addresses iii air bubbles in pipettes 31 in samples 27 AIR FLUID flag 43 AIR ISECAL flag 43 alerts system wide 66 all slopes out of range ISE 50 All tab Service work area 8 analyzer module 38 rotor 38 rotor specifications 8 Analyzer tab Status work area 76 ANSI Z535 safety classification xiii Archive toolbar button 52 archived results reviewing 133 archiving data locations for archives 73 definitions and system parameters 19 results 132 system information 63 areas for racks 27 assigning samples to racks 96 tests to orders 96 user level to functions 21 user level to user 20 assigning samples automatically 96 manually 97 using Place Items 98 using Sample Handling 98 automatic startup 12 Automatically Assign Rack Positions feature 96 uto service system state 44 Back Help button 59 backing up data 41 72 database 48 locations for backup data 73 Backup database service action 48 banner bar Help 59 Barcode toolbar button 52 User Manual Version 2 7 l 9 Index barcode pen 7 connectors 39 description 7 updating calibrator lot values 155 updating control lot values 185 barcode scanner 35 does not read 36 handheld 7 barcodes 32
74. Missing calibrators identified B Rack number and position Tip During operation missing calibrators are also listed in the Blocked folder on the Worklist tab of the Orders work area B 142 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Loading calibrators on board Loading calibrators on board There are two ways of loading calibrators depending on whether the calibrator tube has a barcode or not To load calibrators with barcodes Fr ON Prepare each calibrator according to the instructions on the package insert Remove the rack from its slot Transfer the calibrators to barcoded tubes on the rack Load the rack into an available slot Tips When you load a multi calibrator set o All calibrators must have the same barcode o Contact Roche for barcode specifications o The calibrators must be placed consecutively on the rack in descending concentration order Start by placing the most concentrated solution in the available rack position with the lowest number The barcode reader identifies each calibrator as the rack is loaded You do not need to use either the Reserve Positions function or the Place Items dialog box if you are using barcodes Use slot I if available for calibrators This slot is in the cassette area which is cooled Alternatively you can use any available slot because the system identifies the rack and its contents as it is loaded To load calibrators with
75. ON Double click a calibrator line The Calibration Detail dialog box is displayed 5 Click the Rate Info button The Result Detail Rate Info dialog box is displayed Result Calibration GLU Detail Rate Info xi Cassette GLUB LotNo 00000021 Reaction Raw Data l E Calibrator GLU LotNo 57132459 GLU 030 g L 013075 dA FE n a SS SSeS Abs Kate 101 F SEME 6 RI C Re 200 A Calc First 0 05642 00 03 10 A TO 0 05642 00 03 10 iga B CalcLast 0 18717 00 12 11 E si G 0 00 0 00 5 00 10 00 a t minutes Number of Measured Cycles 69 Time per Cycle sec 10 6 Help Print Close A The cassette and calibrator names and their respective lot numbers B The calibration standard to which this data applies C Select a replicate D Measurement details The parameters used and the calculation are test dependent E Click the Raw Data tab to review the numerical raw data vs cycle number for this calibration F Test name G Kinetic of the reaction graph of the raw data over time Double click the graph to expand it Drag the cursor along the line to see rate values for each point Operator s Manual Version 1 2 B 153 10 Calibration Setting up calibrators Cedex Bio HT Setting up calibrators Information about a calibrator for a test is stored in the test and calibrator definitions which you can access through the Configuration work area Specifying values for a new cali
76. Operator s Manual Version 1 2 Cedex Bio HT 19 ISE flags and troubleshooting Flag descriptions 6 Re install the electrodes 7 Contact Roche Service if the message reappears NO FLUID Meaning No fluid was detected at one of the fluid sensors 1 or 2 Message IDs 14 3248 08 010 xxx Possible cause Recommended actions NO ISECAL Meaning Message ID Possible cause Recommended actions 14 3248 08 011 xxx The fluid sensors could not detect any liquid because The liquid was not pipetted e The ISE tower is clogged The ISE module tubing is blocked e Fluid sensor 1 or 2 is defective If only one result is flagged 1 Repeat the measurement 2 Check the sample tubes for clots 3 Ensure ISE solution bottles on the ISE rack are available and check the level of liquid replace if necessary If the error message is displayed 1 Replace ISE tower use the service action Clean ISE tower manually 2 Check ISE module tubing for leaks or blockages 3 Contact Roche Service No calibrator was detected at fluid sensor 2 14 3248 08 027 xxx Fluid sensor 2 could not detect a calibrator because One or more calibrator bottles are not available e The ISE module tubing is leaking or blocked e The ISE distribution block is leaking or blocked e Fluid sensor 2 is defective If only one result is flagged 1 Repeat the measurement 2 Ensure that the ISE Calibrators on the ISE module are available and check the l
77. Service on the navigation bar Select the required service actions from the Due tab Click Perform Perform the service actions according to the on screen instructions Click Help for full details Should you choose to not perform the Backup database service action automatically at BOD Service gt View Counters Service Intervals then if the Backup database service action is due perform it at the end of the day This service action may take about 5 minutes Database backup must be performed in regular intervals otherwise the accumulated data will fill all available space on the hard disk and the system will be blocked gt Chapter 14 Service actions Chapter 13 Service action software Loading calibrators and controls amp To load calibrators and controls on board 1 Check the printed Begin of Day report for the preassigned rack numbers and positions of the required calibrators and controls Load the calibrators and controls on their correct rack positions Insert the rack into a free slot in the sample or cassette area Tips Calibrations are performed automatically together with the next ordered test Automatic calibrations are only performed if a test is requested during the day If applicable request a calibration manually in Orders Calibration The preferred slot for calibrators and controls is slot I which is in the cooled cassette area You must put multi set calibrators in continuous p
78. Switch between Precision Accuracy and Limit Review statistics for a selected control Exclude a single control result from statistics Monitor control values for a test over time Print Quality Control reports B 164 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Controls at a glance Use the following table to locate specific tasks in the Configuration work area Icon Tab Tasks Control e Assign controls to tests e Specify a control interval for a test and whether QC results are checked for this test Tests Lot e Specify a control lot number and assigned values for a selected control and test e Create a new non Roche control definition Controls a QC Mode e Specify which QC rules are checked for all tests Database Quality Control Result Handling e Specify the automatic handling of flagged and unflagged quality control results Operator s Manual Version 1 2 B 165 11 Quality controls Cedex Bio HT Reviewing the status of controls on board Reviewing the status of controls on board What if The control is expired The control is empty The control is blocked The control is not on board The control definitions are missing You can check the status of the controls on board to find out if they need replacing for example To view the controls on board Click Status on the navigation bar 2 Click the Samples tab Samples controls and
79. Tips e When defining the number formats use a period as the Decimal symbol and make sure the Digit grouping symbol is not a period e When defining the date formats Roche recommends using the dd mm yyyy or mm dd yyyy format Make sure to use four digits for the year to avoid complications Double click the Sounds icon to review or modify the types schemes and events of sounds G 22 Operator s Manual Version 1 2 Appendix This appendix gives graphical overviews of the way in which the menus of the work areas and the fluid system are structured Comprehensive technical specifications and a list of the most commonly used keyboard shortcuts are also included Cedex Bio HT 21 Appendix Appendix Supplementary information about the Cedex Bio HT analyzer This appendix summarizes the technical aspects of the system and gives an overview on the keyboard shortcuts and the structure of the work area menus In this appendix Chapter 21 Keyboard shortcuts Techical specifications iinei a EA E E A ANA H 4 Phiysicaldimensions aeri a E E E E EA H 4 Power requirements instrument se ssesssesssesseessessresseeressressessressrosseosrenseesneesrenneensees H 4 Power requirements cComMputer s sssssssssessssessseessseessssessseessssesosseesssesosseeseessseeesseees H 4 Laser sources barcodescanner s scsssssssssssssssssssssscsesesesesesesesesesseseseseseseseseseseaeseaeees H 5 Environmental condi
80. Use Last Order Log on off Shift F3 Refresh All ane a Place Items Becliet Test Calibrations Results Missing amp Blocked Begin of Day Order Final Report H 14 Operator s Manual Version 1 2 Cedex Bio HT 21 Appendix Menu structure Results menus Service menus Ea amizanon Operator s Manual Version 1 2 H 15 21 Appendix Cedex Bio HT Menu structure Configuration menus tin TEI H 16 Operator s Manual Version 1 2 COBAS INTEGRA 400 plus Glossary and Index 1 Cedex Bio HT Table of contents Operator s Manual Version 1 2 2 Cedex Bio HT Glossary A Absorbance Photometer Device used to make absorbance photometry measurements It consists of a halogen light source optical groupings monochromator diffraction grating preamplifier filters and diode array See Absorbance Photometry Absorbance Photometry A measurement technique for determining concentrations of substances in body fluids Substances or substances bound to reagents absorb specific wavelengths of light The amount of absorbance is used to calculate the concentration in a solution Accept The accept function is used to validate results manually or automatically Accuracy Control Is run to detect systematic result errors See also Precontrol Precision Control and Quality Control
81. ZIP 9 Copy the file PR zip to your USB Memory Stick To create a problem report on diskette Remote diagnostics 1 Click Messages on the navigation bar 2 Click the Options tab 3 Click Report The Create Problem Report dialog is displayed Create problem report Create C Roche lnstrument Report Version txt 4 When the report has been generated the Problem Report dialog box is displayed telling you how many diskettes you need Problem Report ix The report has been completed Do you want to copy the report to floppy disk s ou will need 1 disk s Warming All existing files on the disk s will be ereased Message ID 28 1230 No 5 Insert a 3 5 inch diskette any data on the diskette will be deleted 6 Click Yes You can also create a problem report on diskette using the optional external Floppy Drive Tips e You can also create a problem report from the message dialog box for some types of messages e Contact your Roche contact person and send the disk or the PR zip file to your local Roche Service organization e Ifyou turn off the main switch and turn on again you may get a message prompting you to create a problem report before the system re initializes You can ignore this message Use the Roche remote diagnostics support service whenever you have a problem that you cannot resolve This service allows a Roche Service engineer to log on and control the system remotely F
82. a limit control a Select the Limit box b Specify values for the upper and lower limits Tips e Step 2 Tests to which you have assigned the non Roche control are now displayed in the Test list Step 5 You can select one or more of these options e Repeat this procedure for all the tests in the Test list Operator s Manual Version 1 2 B 189 11 Quality controls Cedex Bio HT Setting up controls B 190 Operator s Manual Version 1 2 Flags Part C provides details on all the flags that can be generated with results except those specifically related to the ISE module Cedex Bio HT 12 Result flags Result flags Understanding flags on results This chapter lists the flags that can be generated for the results of tests on samples calibrations or quality controls In this chapter Chapter 12 About result fa gsis ria een aii EEEE ii C 5 Flags and recommended actions 0 0 eeeeessessesseesessessesseseesseseeseeneescsnesessesscseaeeaeenseneenesses C 6 SACC RNG iyane KNK EAE E give REE E A ARAN C 6 gt AG EXCESS CALC ERROR lt Critical Range gt Critical Range CUR DIR pisii retienen ienei aeae aE E EIERE SAE a E eE EEEE DARK ERR EP UNS TAB E E A E R tens RAINS TA Boae E O E AE E cacsasusveccmuseen tas HIGH ABS siete a A ee HIGH A GY ve csicccssccntsccosutevedvastwcenvaavecensvavecssvosevasesaanvaareg overevaavecenernavasneentr a HIGH BK Gforce cera aie ee TSE UNS DAB svsscccsscccs
83. accuracy ISE 49 printing 55 purging 61 112 130 67 rate information 126 reference range 118 requiring validation 77 result handling 112 reviewing archived 133 validating 15 17 20 23 117 Results report printing 55 Results work area 116 Calibration tab 120 menu structure 15 Quality Control tab 121 Sample tab 119 Validate tab 117 reviewing accuracy controls 178 archived results 133 calibration details 152 calibration history 151 calibration results 149 calibrator status 140 confirmed messages 7 control results 173 control statistics 174 control status 166 limit controls 179 messages 4 precision controls 177 rate information of calibrations 153 sample results 119 status of tests 82 tests in an order 105 right mouse button 53 robotic transfer system 35 Roche service contacting 44 service action 47 rotor of analyzer 38 specifications 8 routine tasks 29 run interrupting 37 stopping 37 re starting 37 running man 4 safety absorbance photometer xiv approvals 10 biological xiii carry over of analytes xv cassette interchange xv cauterization dangers xv classification for xiii cleaners xvi correct use XV danger of contamination from samples xiv disposal of Control Unit Components xvi xvii
84. are separated by air segments Some user actions for flags include performing service actions Chapter 14 Service actions and Chapter 18 ISE service actions F 42 Operator s Manual Version 1 2 Cedex Bio HT 19 ISE flags and troubleshooting Flag descriptions Flag descriptions AIR FLUID Meaning Message ID Possible cause Recommended actions AIR ISECAL Meaning Message ID Possible cause Recommended actions The length of the fluid segment was too short 14 3248 0814 3248 08 023 xxx The sample segment was too short because e Air bubbles are present e The ISE tower is clogged e The dosing from the sample probe is inaccurate e The ISE module tubing is leaking or blocked or it is not conditioned e Mixing is too vigorous for the indirect mode If only one result is flagged 1 Repeat the measurement 2 Check the sample tubes and ISE solution bottles for foaming If the error message is displayed 1 Perform the service action Activate electrodes Replace the ISE tower use the service action Clean ISE tower manually Perform the service action Deproteinize probes Check the ISE module tubing for leaks or blockages Replace the ISE module tubing Use the service action Replace ISE module tubing a A OMN 6 Contact Roche Service The length of the calibrator segment was too short 14 3248 08 030 xxx The calibrator segment was too short because e Air bubbles are p
85. at a glance 138 15 Messages Reviewing the status of calibrators on board 140 About messages 4 Loading calibrators on board 143 New Messages tab 6 Requesting calibrations 145 Message Log tab 7 Postponing a calibration 147 Options tab 8 Validating calibration results 149 Working with messages 9 Setting up calibrators 154 Putting the system into Standby 11 E Stopping and restarting the system 12 11 Quality controls About controls 162 16 Troubleshooting Controls at a glance 164 Introduction 17 Reviewing the status of controls on board 166 Start up problems 18 Loading controls on board 169 Blocked orders tests calibrations or controls 19 Requesting controls 170 Results 26 Reviewing and validating control results 172 Hardware 29 Setting up controls 181 Software error messages 34 Data station accessories 35 Flags C External connectors 37 Checking and replacing fuses 40 12 Result flags Contacting Roche Service 44 About result flags 5 Flags and recommended actions 6 ISE measurements F Service D 17 ISE module Overview 4 13 Service action software How the ISE module works About service actions 5 Making ISE measurements 11 Service work area overview 6 ISE solutions summary 12 Due tab 7 Technical specifications 13 All tab 8 Begin of Day tab 9 18 ISE service actions Performing a service action 11 About ISE service actions l6 Service notes 13 Initialize ISE module 17 Counters and timers 15 Electrode service 18 Activate electrodes 19 14 Service action
86. available space on the hard disk and the system will be blocked 5 minutes Weekly None For general information about performing a service action see Chapter 13 Service action software D 48 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace ventilation filter Replace ventilation filter Overview Duration Interval Tools and materials Hazards and precautions Further information a The ventilation filters remove particles from the air that is circulated through the instrument There are two filters one each for the analyzer and the sample area You need to replace these filters according to the service action schedule in order to ensure that clean air can circulate 5 minutes Every three months or after 500 hours in Running or Standby e Analyzer module ventilation filter e Sample area ventilation filter None For general information about performing a service action see Chapter 13 Service action software To replace the ventilation filters Select Replace ventilation filters in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 Remove the filter covers at the right rear side of the instrument A Reinstall the filter covers Remove the left bottom panel C Operator s Manual Version 1 2 D 49 14 Service actions Replace ventilation filter Cedex Bio HT 7 P
87. be carried over from one sample to the next Take adequate measures to safeguard correct testing of high sensitive methods e g heterogeneous immuno assays Cassette interchange Do not interchange cassettes among different Cedex Bio HT systems and instruments Each cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only Each cassette has its own individual cassette number which the instrument uses to identify it Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect results If more than one Cedex Bio HT instrument is used in the same lab be sure to dedicate each cassette rack with its cassettes to one single individual instrument e g by color coding Sample Samples containing solids can produce false results and block probes Ensure that samples are free from insoluble particles Reagents Danger of cauterization and skin poisoning through contact with reagents Pay attention to the warnings on the cassettes Foam Danger of false results Avoid the formation of foam when handling reagents samples calibrators and controls Waste material Disposal of all waste material should be in accordance with local guidelines Correct use Use the Cedex Bio HT system only to measure liquid samples with the provided reagents User qualification Danger due to incorrect operation The Cedex Bio HT analyzer should be used by qualified users only
88. be changed by your system supervisor The Begin of Day tab lists only service actions that will be performed automatically at the next BOD Operator s Manual Version 1 2 13 Service action software Cedex Bio HT Service work area overview Service work area overview To access the Service work area click the Service button on the navigation bar The Service work area has the following tabs Tab Function Due This tab lists service actions that are nearly due due and overdue All This tab lists all the service actions Begin of Day This tab lists service actions that are to be automatically performed at the Begin of Day D 6 Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software Due tab Due tab The Due tab lists all due nearly due and overdue service actions It tells you how long the service action will take to perform and whether it is partially or fully automatic Is Service I Ble Edt View Tools Whdaw Help jg 8 al Begin of Day San S Ouretion min Type E S80 5 pen 229 C Jard 5 A Prime fluid system rad 11001 Stop Deproteinize probes te t i 4100 Initialize ISE module 1 6 1100 Electrode service 1 By I 4100 Prime ISE calibrators a a Jog l B al Selected Service Actions 5 minute s Done Print I ADMIN 04 20 2000 10 29 A Overdue items are highligh
89. board flses sceceesessesssesesseesesessessesstessessessssssssessessessess E 44 Contacting Roche Service Creating a problem report REmiOte Mia SN Osta cs sirenerne n e A EAEE E Operator s Manual Version 1 2 E 16 Cedex Bio HT 16 Troubleshooting Introduction Introduction Effective troubleshooting on a Cedex Bio HT system requires a good understanding of all basic operating procedures for the instrument and the system software However you can avoid most common problems if you observe the recommended procedures at all times and if the operating environment is effectively controlled For new users in particular there are the usual familiarization problems including e Connecting various parts of the computer system if necessary e Locating the main switch and function keys e Starting up the program and logging on e Finding your way around the user interface All the information you need is available either in the User Manual or in the online Help For details on flags error messages and recommended actions for ISE related problems see Flags and user actions on page F 41 and General ISE troubleshooting on page F 49 Information about problems The user interface keeps you informed about the status of the instrument as a whole and about particular hardware software and chemistry problems as they arise It does this through e Messages displayed on the screen e Status work area
90. calibration mode 137 Logit log 5 calibration mode 137 logos See icons looking up orders 102 samples 102 Lookup function 103 loops for sample pipetting 37 lot numbers of cassettes and calibrators 136 lot values of calibrators 154 155 updating those of controls 184 LOW ACT flag 11 LOW SIGNAL flag 12 main calibration ISE 9 mains instrument fuses 40 laboratory power 18 power connector 18 maintenance 3 21 overview 12 preventative 17 Manual service action status 14 measurement principles specifications 6 measurements making ISE measurements 11 photometric 38 measuring channel 8 location 9 User Manual Version 2 7 Index measuring modes ISE 4 Memo Pad 51 reading 51 writing a message 51 menu bar 48 49 on Help windows 59 menu structure overview 14 menus context 53 message log printing 10 Message Log tab View Message dialog box 7 messages buffer log 7 confirmed 7 confirming 9 dealing with 4 displaying details 9 finding Help for certain message ID 68 Help with 68 log 71 7 printing 10 reviewing 4 setting options 8 symbols used on 4 unconfirmed 6 viewing 9 3731 72 Messages button 4 clearing red or yellow colored 5 messages Help 68 missing controls 167 definitions 69 profiles
91. calibrator on board Control not on board Diluent not on board Load the required calibrators controls or diluents on their correct rack positions Insert the rack into a free slot in the sample or cassette area To check the correct calibrator control or diluent position do one of the following Open the Not on Board folder in Status Missing amp Blocked to see the missing calibrators controls or diluents and their correct rack positions Click a test folder in Status Test Status to see the calibrator control or diluent information of the selected test If you see for example a status of Diluent not on board and you replace the diluent while the system is in Standby the values for Status and Next Cal in the Test group are not updated until the system is in Operating status The information in the Diluents group however is updated immediately You may have to click Re Start on the navigation bar to get the system to Operating mode Calibrator empty Control empty Diluent is empty Open the Empty folder in Status Missing amp Blocked to see the empty calibrators controls diluents and their correct rack positions Remove the required rack from the instrument Refill the empty calibrator control diluent and cups or tubes E 20 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Not accepted Recommended action No definition Recommended action Samples No fluid
92. calibrators In this chapter Chapter 10 About Calibration A a a a aai Calibrators calibration points and curve parameters Calibrations ata Glance visitas aces A EE E R A E A Reviewing the status of calibrators on board sssssssssssssssssssssssssesssessnsrsesreessssssssereene Displaying the remaining calibration interval for tests c cssssessesseeseseeees B 139 Viewing rack positions for calibrators ceesessssseseesessesseessesseessessesseessesseeses B 140 Viewing missing calibrators cccssssssessesssesessessessessessscssesseescssesssessessnessessesaes B 141 Loading calibrators on p ardisoy aa e i pE L R RK B 142 Requesting calibrations ssiscnicisccsssiseccsscssstasessscenossscssvonapesonsscnesesstssenvenssassnasevacusseapesaneys B 144 Postponing a Calibration svcsssscvisscsssissonssesssnsasssssesnssssssseosssteonsssnocesstsssessveteassnassvecnstusteuesds B 146 Validating calibration results ceessessessessesseessessesssessessessessessessessesssessesseessesseeses B 148 Reviewing calibrations for validation c ceesessesesseessessesseescsseesessesseessesseeaes B 148 Reviewing calibration history cssesesssesessessessessessessesssessesseessessesseessesseeees B 150 Setting p Calibrators sse cssws sstasciad seisseretesssovehesoouceistescvoseacsdseseseasvoaeses TEA EER VEREER raS B 153 Specifying values for a new calibrator lot s sssssssssssssssssssssssstsssssssssssrsereesssssssss B 153 Spec
93. calibrators are displayed graphically The legend QC indicates the presence of a control 3 Double click a control to display details about that control For example Control IPNorm 102 1 Expiration 30 06 2013 459 days Lot 160344 Tip Double click the rack number to display name and position of all controls on that rack Replace the expired control with one that is not expired gt To manually update lot specific control values on page B 184 Replace the control Make sure that the lot number is the same as the previous control One or more of the tests for this control is not available for example the test cassette is empty Replace or load the cassette s as required Load the required control Make sure that the lot number of the control you load is the same as that specified in the control detail The system has detected a control but the control definition is missing or incomplete Loading and deleting control definitions on page B 181 Viewing rack positions for controls gt Typically controls have preassigned rack positions on sample racks that you should use You can also specify a location for a particular control for example if you intend to run control on a test that you do not run very often To view rack positions for controls 1 Click Status on the navigation bar 2 Click the Sample tab Or 1 Click E in the toolbar to open the Place Items dialog box B 166 Operator s M
94. can select your own sequence Custom e The Move buttons are active only if you select Custom e Test Sequence defines the display of the test buttons on the Sample tab of the Order work area To create a new test class 1 Click Class Group 2 Click the Test Classes tab 3 Click New 4 Type a Class Name for the new test class 5 Select tests to be included in the new class from the Available Tests list Click Add to add them to the Tests in Class list 6 Click Save Tips e Each test appears in one test class only e Roche defined test classes are displayed in blue user defined test classes are displayed in black e Class Name is up to nine alphanumeric characters e The Available Tests list shows all tests that are not yet assigned to a class e Use Remove to remove a test from the Tests in Class list and return it to the Available Tests list e Test classes are used for result handling To modify a test class Click Class Group Click the Test Classes tab Select a Class Name from the Test Classes list Use Add to move available tests to the Tests in Class list Use Remove move Tests in Class to the Available Tests list Click Save ow F WN Tip Roche defined test classes are displayed in blue user defined test classes are displayed in black About profile definitions What is a profile You use the Configuration Profile Definitions dialog box to create new profile definitions or modify or delet
95. click F7 The Status work area has six tabs each of which shows the state of a particular part of the system The tabs in the Status work area are as follows Tab Function Missing amp Blocked This tab gives information about e Cassettes e Calibration QC Cleaners Diluents ISE e Samples When there is a problem with one of the solutions for example if a cassette is empty or if an on board sample has no associated order the relevant information is displayed in this tab Samples This tab gives a graphical representation of the sample racks on the system The tube positions are color coded so that you can easily check the status of the samples Cassettes This tab gives a graphical representation of the cassette racks on the system The cassette positions are color coded so that you can easily check the status of the cassettes Test Status This tab allows you to display cassette calibration quality control and diluent information for a selected test Analyzer This tab gives an overview of the state of the system Bar graph indicators tell you about the state of sample processing and color coded icons tell you about system resources such as cuvettes and water supply or the instrument temperature ISE This tab gives an overview of the state of the ISE module Graphical representations of the electrodes solutions on the ISE module and solutions on the ISE rack are color coded so that you can quickly locate any block
96. deleting orders Preconditions y You can purge orders manually at any time or delete them automatically at BOD The main reason for purging orders is to free the order IDs for re use Purging orders removes the order ID from the Orders work area This means that you can reuse the IDs after purging orders In the Results work area the order ID is still visible the results are not removed Each order ID is associated with a date and time so that you can always refer to a specific order by its ID its date and its time stamp This ensures that each order is unique You can only purge an order when e The system is in Standby or Sleeping state e There are no pending tests belonging to this order e The associated results have been accepted e The associated results have been transmitted to the host if applicable e The associated samples have been removed from the system To purge orders manually 1 Choose Tools gt Purge Orders 2 Click Yes on the Confirm Purge Orders dialog box To delete orders automatically at BOD 1 Click Configuration on the navigation bar 2 Double click Database in the System group 3 Click the Automatic Actions tab 4 In the Delete Orders After box type the number of days after which the order should be deleted Click OK ol Tips e Type 0 zero to delete at the next Begin of Day all of today s orders that is all orders defined between the time of the last and the next Begin of Day t
97. described is kept low More complex steps are described in detail later in the manual and cross references are provided where appropriate Alternatively you can find detailed descriptions of the steps in the Online Help Follow these safety precautions at all times while using the instrument e Never open the instrument cover while the instrument is running e Never remove a rack from the rack area if the rack status indicators are red e Never touch any moving parts e Never place any objects bottles samples etc on top of the instrument e Follow the instrument messages View Messages e Perform maintenance as required e Remove the side panels only when the power supply is disconnected e Use the Cedex Bio HT analyzer only for determination of analytes in aqueous solutions Also follow the general safety precautions described on page ix Operator s Manual Version 1 2 B 5 5 Daily workflow Introduction Cedex Bio HT Working with a host computer Assumptions Daily startup Cassettes System shutdown Daily routine Sample barcode Rack position To allow efficient processing of the large quantities of test data generated by the Cedex Bio HT system a host computer may be installed This host computer while optional is recommended for most of the Cedex Bio HT applications Communication between the host system and the Cedex Bio HT system is provided by the Cedex Bio HT host interface The C
98. display a context menu 1 Select the item you are interested in 2 Place the cursor le over the item and click the right hand mouse button The context menu is displayed Tip Context menus are not available for all items but they are useful for some key actions that you have to perform frequently or simply to see what actions can be executed on the selected item You can often use the standard Windows functions cut paste and copy text for example in the Memo Pad These functions have the same shortcut keys that you find on any PC Use Ctrl C to copy Ctrl X to cut and Ctrl V to paste If you are not familiar with Windows you use Ctrl C for example as follows 1 Select text or an item 2 Press and hold down the Ctrl key 3 Press and release the C key 4 Release the Ctrl key The selected text or item is copied to the clipboard part of Windows You can retrieve it into another document later by using the Paste function Tips e The Windows Paste function is not quite the same as the Cedex Bio HT paste function but the general idea is the same There are two Ctrl keys one each side of the space bar They both perform the same function The cut function copies text or an item to the clipboard and deletes the original Operator s Manual Version 1 2 A 53 3 User interface Cedex Bio HT Tips and techniques Function keys The function keys A are located on the top row of the keyboard
99. display the available rack positions in the second list 3 Select the rack position from the second Position list Tips e A padlock symbol in front of an entry in the first Position list signifies that the rack is on board With on board racks you are alerted by a message if you try to assign a sample to a position you cannot use HE Use this method to create an order and then specify all the sample positions for that order before moving on to the next order amp To assign a sample manually using Sample Handling 1 Click Orders on the navigation bar 2 Click the Sample tab 3 Type the order ID in the ID box and press Tab 4 Choose View gt Sample Handling The Sample Handling dialog box is displayed See Sample Handling dialog box on page B 99 ol Specify the rack number and the position on the rack Click OK 7 Put the samples in the correct positions on the rack and load the rack o Tips e Normally you can assign positions only to racks that are not on board e Step 5 If the rack is not on board you can overwrite rack positions e Step 5 If the rack position you want to use is not available choose Tools gt Place Items and click Clear to clear previously assigned rack positions To assign a sample manually using the Place Items dialog box Click Place Items in the toolbar Select a rack from the list See C below Click H to expand the Samples folder See A below _ OO N D D
100. disposal of Instrument xvi xvii disposal recommendations xvi electrical components xiii environment xvi explosion dangers xiv fire hazards xiv foam xv FP photometer xiv general information xiii general precautions 5 infectious waste material xiv instrument in use xiv ISE 16 maintenance of instrument xvi malfunction of instrument xiv optical xiv skin poisoning dangers xv solids in samples xiv xv user qualifications xv waste disposal xv with service actions 5 6 sample area 27 sample dilutions modifying 8 Sample Handling using for assigning samples 98 Sample Handling dialog box 99 sample loops 37 sample racks 27 31 icon 29 User Manual Version 2 7 1 25 Index Sample tab Orders work area 91 Results work area 119 sample tubes 33 sample types modifying 8 samples assigning to racks 96 assigning to racks automatically 96 assigning to racks manually 97 assigning to racks using Place Items 98 assigning to racks using Sample Handling 98 blocked 69 details 80 displaying specific group of 123 evaporation of 27 finding 102 handling 10 loading 14 17 22 38 looking up 102 missing 77 no fluid in cup 21 pipetting 37 position of 70 result statistics 129 reviewing results 119 specifications 7 status of 70 unknown fl
101. dosage pipette plunger tip Select Replace plunger tip dosage pipette in the Service work area Click Perform The Service Actions dialog box is displayed follow the online instructions The dosage pipettes are positioned automatic step The probes are positioned inside the wash pipes automatic step Open the main front cover A to access the pipettes Operator s Manual Version 1 2 D 57 14 Service actions Cedex Bio HT Replace plunger tip dosage pipette B or C 6 Remove the tubing B from the cleaner reservoir 7 Remove the cleaner reservoir C 8 Loosen the dosage pipette locking bolt D 9 Unscrew the dosage pipette from the pipette fluid distributor E 10 Pull the pipette forward to remove it from the module 11 Pull out the piston F Make sure the seal cap is in place G D 58 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace plunger tip dosage pipette B or C 13 Insert the new tip into the tip tool I 14 Press the piston into the tip J Ensure that tip is flush with the piston L If it is not K you must repeat the procedure A m 15 Insert the piston into the glass barrel and half fill the pipette with water 16 Reinstall the pipette Ensure that the seal cap G is correctly positioned 17 Wipe away any drops of water from the pipette module the probes N and the Operator s Manual Version 1 2 D 59 1
102. fF WN To modify a formula calculated result units and or reference ranges for the calculated result definition click the Formula Laboratory or Evaluation tab and modify the values as required 6 Click Save Tip Steps 3 and 4 are only possible for customer calculated results not for Roche calculated results To delete a calculated result definition 1 From any tab choose a calculated result from the list 2 Press the Delete key or click Delete 3 Click Yes in the Confirm Delete dialog box Tip If you decide not to delete a selected calculated result after pressing the Delete key you can click No or Cancel in the Confirm delete dialog box Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration About the Definitions group About calibrator and control definitions Calibrator definitions Once tests have been loaded the corresponding calibrators are automatically installed in the Calibrators list The Configuration Calibrator Definitions dialog box is used to update lot numbers and values for existing calibrators or to create a user defined calibrator Setting up calibrators on page B 154 To update a calibrator lot number using the barcode pen or handheld barcode scanner on page B 155 Control definitions You use the Configuration Control Definitions dialog box to load control definitions create a user defined control or update the lot number and values for an existing control definitio
103. for online information for each service action General safety precautions Danger Caution Before removing main cover disconnect mains plug from socket Hazardous voltage is present on ISE power supply even if main switch is off Danger of electric shock when touching power supply components Read and understand the Roche safety precautions at the beginning of this manual and the hazards and precautions contained in this chapter This information should be made available to all employees and kept for further reference Users must not perform any servicing except as explicitly described in this manual Automatic service actions Hazards Precautions Automatic ISE service actions do not require any specific precautions however you should always observe the following warnings The ISE module including the tower fluid waste tubing and electrodes is potentially infectious e Sample material is potentially infectious e There is a danger of cauterization and poisoning through skin contact with the reagents e Make sure you read all the warning labels on the cassettes e Use protective gloves to avoid direct contact with sample material e Remove any spillage of sample material immediately Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Initialize ISE module Initialize ISE module Overview Duration Interval Begin of Day System state Tools and materials Hazard
104. for the selected test If a dotted line is displayed in the Date amp Time column instead of the date the control is running or is not accepted If a single control is selected and a dotted line is displayed across all columns control lot values have been changed Use Statistics to display statistics for the selected test and its assigned controls The statistics displayed depend on which control mode Accuracy Precision or Limit is selected The Results QC Statistics dialog box shows the statistics for the selected test and control s Tips Results are removed from the Results work area if you use a new control lot Click the column header at the top of the Test list to switch between By Test or By Control The option you choose determines how the list is sorted The Test list has a search facility click anywhere in the Test list and type the first few characters of the test name to find a test Up to three controls can be displayed for one test Each control is displayed using a unique symbol a square diamond circle etc Flagged results are displayed in red To show results for one control only select the control Position your cursor over a column heading in the Date amp Time row for example X or 1s to view the assigned limit and the standard deviations Operator s Manual Version 1 2 B 121 9 Results Cedex Bio HT Quality Control tab Position your cursor over a result to display the control na
105. force the system from Sleeping into Initializing by pressing F11 or clicking Start The Service icon is displayed when the system or a user is performing a service action The system must be in Standby before you can start manual service actions The system automatically goes to Standby when the service action is complete Auto service means the system is automatically performing Begin of Day actions If the system is in Operating the Begin of Day service actions are not performed until the system goes into Standby System automatically goes into Standby after completing BOD actions A 44 Operator s Manual Version 1 2 Cedex Bio HT 2 System description System states Tip The following parameters concerning system states are defined in Configuration General System End of Sequence e Autostart e Sleeping Mode e BOD You can review these parameters to alter them you must have the required user access level Operator s Manual Version 1 2 A 45 2 System description Cedex Bio HT System states A 46 Operator s Manual Version 1 2 Cedex Bio HT 3 User interface User interface An overview of the Cedex Bio HT software You control the day to day operation of the instrument through the Cedex Bio HT user interface This chapter describes the main features of the user interface and how to move between the main work areas It also provides some tips to help you work more efficien
106. from the list 3 Modify the Profile Name or Profile No as required 4 Click the Tests tab to modify the tests to be included in this profile 5 Click one or more test buttons to select tests for the profile 6 Click Save To delete a profile definition 1 From any tab select one or more Profiles from the list 2 Press the Delete key or click Delete 3 Click Yes in the Confirm Delete dialog box Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration About the Definitions group Tip If you decide not to delete a selected profile after pressing the Delete key you can click No or Cancel in the Confirm Delete dialog box About Calculated Result definitions What is a calculated result You use the Configuration Calculated Result Definitions dialog box to add calculated result definitions or modify or delete existing definitions A calculated result is a mathematical relationship involving one or more test results and optionally numerical constants The system automatically calculates a calculated result if all the tests specified in the calculated result definitions are requested in an order Calculated results use the results from 1 to 4 tests in a mathematical formula to obtain another value which can then be checked against a reference range and flagged gt To use the Configuration Calculated Result Definitions dialog box Ant z 1 Click Configuration on the navigation bar 2 Double click the Calc
107. hours ISE Standby helps to prevent the following problems e Overflow of ISE Reference Electrolyte backwards into the measuring channel which can damage the electrodes because of the high ion concentration of the ISE Reference Electrolyte e Crystallization of salts in the tubing blockage The service of the ISE module is supported by online service software The software guides you through the service procedures to be performed at fixed time intervals or at other times depending on the work load User defined service actions can be defined to be performed automatically by the system during the Begin of Day BOD procedure Chapter 18 ISE service actions Technical specifications on page H 4 F 10 Operator s Manual Version 1 2 Cedex Bio HT 17 ISE module Making ISE measurements Making ISE measurements Caution a The ISE module is a fully integrated part of the Cedex Bio HT system You make requests for orders and place samples in the same way that you do for other types of tests However you must ensure that the ISE solutions and auxiliary reagents are in their correct positions To make ISE measurements 1 Check the positions of solutions and reagents on the ISE rack a If necessary remove the ISE rack Wait until the ISE rack LED on the rack status panel is green before removing the rack b Confirm that the ISE solutions and auxiliary reagents cleaners diluents are in their correc
108. interrupt specifications 6 STAT orders 10 states of the system 42 statistics displaying of QC results 121 of controls 174 results of a sample 129 status of controls 166 of racks 29 39 of resources 42 of system 12 of the system 66 resource icons 42 status bar 48 54 Status work area 66 67 Analyzer tab 76 Cassettes tab 72 ISE tab 78 menu structure 14 Missing amp Blocked tab 68 Samples tab 70 Test Status tab 74 stop processing 12 sampling 37 system 12 Stop button 42 48 37 storing data in database 66 not in database 72 switching on computer 31 instrument 31 monitor 31 printer 31 system 31 symbols Caution xiii Danger xiii used in documentation x used on messages 4 Warning xiii system checking resources 42 description 15 initializing 33 logging off 35 logging on 33 main features 4 overview 3 problems with starting 18 shutting down 35 13 starting 12 states 42 status 12 66 stopping and restarting 12 User Manual Version 2 7 1 27 Index system counters printing 59 system definitions location on disk 71 System group 20 system ID 76 system logs 72 system messages Help with 68 system parameters archiving 19 system principle specifications 6 system resources chec
109. its own pump A 22 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Water filters Cleaners Fluid waste Degasser unit External water supply unit optional ISE module Clot detection Functional systems Water filters remove small particles from the water These are located in the internal and external water reservoirs and between the water reservoir pump and the internal water reservoir The service action tells you when you need to change these filters Probes and tubing are cleaned with water and cleaner The cleaner reservoir contains 1000 mL of cleaner The system informs you when you need to replace the cleaner Replacing the cleaner on page B 43 Where specified in the test definition special cleaner is also used to improve the effectiveness of probe cleaning if particular reagent combinations are in use The special cleaner is supplied in cassettes which are placed on the cassette rack Waste fluids from the probes and tubing are removed automatically to the fluid waste reservoir or directly to the laboratory s sanitary waste system if connected Fluid waste from the ISE module goes directly to the cuvette waste box Fluid waste from the cuvettes is automatically discarded with the cuvette The degasser is a unit containing special filters that remove dissolved gases from the fluid system Excessive amounts of air in the fluid system can affect the accuracy of any results obt
110. manually 28 sample 27 31 status 29 status LEDs 29 status panel 39 system 26 with sample handling 84 rate information 126 raw data 112 153 deleting 60 70 exporting 69 reading barcodes 35 reagent cassettes specifications 8 User Manual Version 2 7 I 23 Index reagents cassettes 30 empty 20 handling 10 not on board 20 pipetting 37 rebooting system 14 reference electrode 8 9 11 27 expired 51 reference electrolyte expired 51 insufficient flow 51 not present 51 reference electrolyte ISE See ISE solutions reference ranges 112 118 modifying 9 refilling cuvette reservoir 44 external water reservoir 45 Regional Settings icon 22 regulatory compliance 11 re initializing system 13 related topics 70 releasing racks manually 28 remote diagnostics 45 reorganizing database 61 Replace Abs halogen lamp service action 51 Replace bottles on the ISE module ISE service action 34 Replace dosage pipette B or C service action 61 Replace electrode ISE service action 27 Replace external water reservoir filter service action 64 Replace ISE module tubing ISE service action 25 Replace ISE tower ISE service action 36 Replace plunger tip dosage pipette B or C service action 57 Replace probe B or C service action 54 Re
111. more rules when the rule is broken a flag is generated on the control result Control mode Checks whether control results Rules and flags Precision Have violated rules according to the Westgard rules Shewhart procedure commonly known _ R 1 2s R10x R 1 3s R 2 2S as the Wesigard rules Depending on R 4s R4 1s the rules violated a systematic or random error may have been generated Accuracy Are within a range defined by the gt ACC RNG accuracy range assigned value of an assayed control and exceeded a permissible deviation When control results are out of range a systematic error may have been generated Limit Have exceeded either upper or lower gt Up Limit lt Low Limit upper limits or lower limit exceeded You can view a single control with any combination of the precision accuracy and limit modes if the appropriate definitions are made in the control definition The priority of quality control modes is 1 Precision 2 Accuracy 3 Limit Each test can have up to six controls at one time Only the first three can be used as precision controls The test definition defines which controls are used for a test and how often the control is run You can modify the test definition in Configuration Tests Control A control is valid for one test A control result that meets all the rules for a particular test does not generate any flags and all test results can be automatically accepted if this option i
112. must use the correct type of sealing O ring otherwise the ISE module will not run reliably 16 Reinstall fluid sensor 2 and its cover 17 Close the electrode block cover D 18 Reinstall the connector to fluid sensor 2 19 Release the spring catch and slide the ISE module back until it clicks into place 20 Click next 21 ISE calibrators are primed automatic step 22 The ISE module is checked for leakage automatic step 23 Ifa leak is found a message is displayed and you must check that all the connections in the ISE module are secure The following steps are performed e Fluid system is initialized if necessary automatic step e Transfer arm is initialized if necessary automatic step Operator s Manual Version 1 2 F 29 18 ISE service actions Cedex Bio HT Replace electrode e ISE module is initialized if necessary automatic step e Electrodes are deproteinized automatic step e Electrodes are etched automatic step e ISE module tubing is conditioned twice with Activator automatic step e Electrodes are rinsed with ISE calibrator automatic step e Electrodes are activated twice with Activator automatic step e ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes 24 When prompted a Indicate which electrode you have replaced b Click next c Specify the lot number of the new electrode 25 When all steps are complete
113. navigation bar 2 Click the Worklist tab 3 Open the Blocked folder and select a blocked order Detailed information of the selected order is displayed in the area on the right 4 Make a note of the Blocked Status Text and look up the corresponding recommended actions in the list below Tips Double click a blocked order in Results Validate to see the Blocked Status Text To get help on a blocked item select the Blocked Status Text and press F1 Operator s Manual Version 1 2 E 19 16 Troubleshooting Cedex Bio HT Blocked orders tests calibrations or controls Cassettes and cleaner Not on board Recommended action Empty Recommended action Not Enough for Worklist Recommended action 4 Reagent not on board Cleaner not on board Place the required reagent or cleaner cassette in a cassette rack Insert the cassette rack into the cassette area Reagent is empty Cleaner empty Locate the rack position of the empty reagent or cleaner cassette in Status Cassettes Remove the cassette rack from the cassette area Replace the empty cassette with a new one Re insert the cassette rack into the cassette area The cassette is loaded but there is not enough material to run all the tests in the current worklist Place an additional cassette of the same kind on a rack Calibrators controls and diluents Not on board Recommended action Empty Recommended action vol 2 Tip No
114. navigation bar ar Click the Sample tab 3 Select an item in the Samples amp Orders list The corresponding results are displayed in the Results list 4 Right click a result in the Results list and choose Statistics The Results Sample Statistics dialog box is displayed Results Sample Statistics x Tests 58 Gluc Mean SD 07 g L 3 39 3 035 89 57 Range Low High Extremes 0 00 10 37 68 Confidence 0 35 6 42 95 Confidence 2 68 9 46 Te OD Help Print A Select a different test from the list Tip If the test selected was a rerun only the last measured results are included in the statistics Operator s Manual Version 1 2 B 129 9 Results Working with results Cedex Bio HT Deleting information from the Results work area Purging results Preconditions for purging results When purging results the following information is deleted In the Results work area you can delete test results orders samples and data generated on a particular date If your system is not set up to perform an automatic purge at BOD you can manually delete results so that you can re use order numbers The Cedex Bio HT analyzer is designed to store safely large quantities of results typically for one year As part of long term data management you should periodically delete results manually at the very latest when the Database Full system message is displayed By default results from sample tests
115. number of tests have been run You can request a control manually at any time Recommendation You should not accept a flagged control result without further investigation Requesting a control manually You can request a control at any time in the Orders work area gt To request a control manually Click Orders on the navigation bar Click the Quality Control tab In the Tests amp Profiles group click the test for which you want to request a control Tests amp Profiles Test Profile Qc All v Group General M GL GLN GLU Gluc IGGHB IGGLB K D LAC LDH NA D NH3 4 Click Save Tips What if I can t see the test I want Step 3 In the Control Test summary the name of the test is added to the folder of the required control White symbols indicate new tests gray symbols point to tests with results Only controls with current requests are displayed in the Control Test Summary Controls for a test are run automatically depending on the test definition In the Tests amp Profiles group select All from the QC list or ensure that the group you have selected contains the required test Click the Class Group button in Configuration Tests to find out which tests are assigned to which groups Deleting a control request If you find that you do not want to run a control you can delete the request B 170 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Requesting
116. of the backup is to ensure that you can reload all system data including all definitions and results up to the last backup if disk drive C were to fail The system can then be restarted as it was at the last backup Backup database on page D 48 If you see the message 3731 part of the database allocation for a particular resource is at least 80 full The most likely causes are that the system is e Storing too many orders e Storing too many results e Keeping raw data too long Failure to deal with this message promptly can lead to poor system performance In extreme cases the system may stop Message 3731 may reappear during the next BOD action if remedial action is not taken before the BOD Recommended actions gt If you see message 3731 1 Purge orders Tools gt Purge Orders if you have not already done this as part of your daily startup 2 Purge results Tools gt Purge Results D 72 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Where to save your data Managing data Delete any unwanted unaccepted results Reduce the time period over which raw data is kept Configuration Database Automatic Actions Specify a value of less than six days consider specifying one day and exporting the raw data to drive F You can also consider reducing the time that journal data is kept Configuration Database Automatic Actions and reducing the size of the message log View Messages O
117. on the same side of the assigned mean 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Priority 51 Group CNTL Westgard rule 6 violated There were 10 consecutive quality control results falling on the same side of the assigned mean 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Priority 52 Group CNTL Less than reagent range The Absorbance value of the lowest calibrator is below the lower defined range 1 Check the calibration curve and cassette expiry 2 Repeat with fresh lowest calibrator 3 Ifthe flag reappears replace cassette the reagent may be contaminated Priority 14 Group CAL Greater than reagent range The absorbance value of the lowest calibrator is above the upper defined range 1 Check the calibration curve and cassette expiry 2 Repeat with fresh lowest calibrator C 18 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags Attributes gt REPL DEV Meaning Recommended action Attributes lt RR value Meaning Recommended action Attributes gt RR value Meaning Recommended action Attributes SEG FLUID SEG ISECAL SOL 1 F DEV gt STD DEV Meaning Flags and recommended actions 3 Ifthe flag reappear
118. or assign temporary placements using the Place Samples dialog box Diluents can also be identified by barcode G 16 Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration Loading test application software Loading test application software Overview Precondition Test application software TAS such as test calibration control or diluent definitions are are either delivered on diskettes or as file which can be loaded to a USB Memory Stick You can conveniently load TAS information by using the Load TAS Diskette function Loading TAS files is performed in two phases Ina first step your existing TAS files are copied to a backup directory on your hard disk This directory is created automatically if it does not exist Default name C Roche Instrument TAS backup Next the new compressed TAS files are copied to your hard disk and automatically expanded Both in the backup and in the TAS directory existing files with identical file names are overwritten No files are deleted You need user access level 6 e TAS files Test Application Software files are usually sent as zip files e TAS files are always named pbxx xxx ickvxxxxvx e The following procedure to load a TAS via USB Memory Stick uses the TAS 35 19v2 as example To load a TAS via USB Memory Stick Save the zip file pb11 022 ickv3519v2 end zip to the hard disk of a computer Double click the saved zip file to show its
119. or corrected quality control result The quality control has not been accepted zi Elek GLU Sample 0 06 g L Comment x 10 04 2012 13 20 al Delete Print Rate Info jy Accept Rerun Close Help gt Accept All Accept Rerun I admin 20 04 2012 09 30 iE c A Check all results located in the To Validate folder on the Validate tab of the Results work area B Double click a result line in the list of results The Result Detail dialog box is displayed where you get information about recommended actions for flagged results C Perform the recommended actions for flagged results Recommended actions include e Rerun the test with dilution or concentration e Repeat the test e Check the required items as listed in the recommended actions of the Results Detail dialog box e Review test result details e Accept the result D Validate tab on page B 117 About results on page B 112 To rerun or repeat a test Click the Validate tab on the Results work area In the To Validate folder select a sample calibration or control order Select the result in question from the list of results and click Rerun The Dilutions dialog box is displayed if you have selected a test order 4 Doone of the following e Select a dilution factor to rerun the test order with dilution e Select As Original to repeat the test order with the setting defined in the test definition
120. or handheld barcode scanner optional Mouse Keyboard Printer optional sm OO DW gt Computer You can control the user interface with the mouse and keyboard The user interface is structured as a series of work areas the main ones are Status Orders Results and Service Each work area contains two or more tabs By clicking a tab you can move around the work area You can display any test results on the monitor or print reports containing information on samples orders and results Connection to a local printer is optional You can manually enter orders for tests on samples in the Orders work area Alternatively the system receives orders electronically from a host system if your Cedex Bio HT is connected to such a system System messages are displayed in the Messages work area and you can communicate with other users by using the Memo Pad Chapter 3 User interface The computer performs tasks in connection with order processing data management and user interface management It makes it possible to simultaneously manage data and enter new orders Figure 0 4 shows the appearance of the computer for Cedex Bio HT systems Operator s Manual Version 1 2 Cedex Bio HT 1 System overview A first look at a Cedex Bio HT analyzer Figure 0 4 Computer for Cedex Bio HT systems Newer model left and older model right A DVD drive Used for upgrades and data mirroring
121. other electrical power sources and inform your in house service personnel 2 When the power is re established the system will restart automatically wait until the system is initialized System cannot initialize due to a fault in one or more of the analyzer modules 1 Check the displayed message s and take the necessary action 2 Ifthe initialization is incomplete and no error is shown contact Roche Service bm System remains inactive in Operating mode Check all the resources on the Samples Cassettes Analyzer and ISE tabs of the Status work area E 18 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Blocked orders tests calibrations or controls Blocked orders tests calibrations or controls The following main conditions must be fulfilled before you can successfully run any test on the Cedex Bio HT All required reagents diluents cleaners calibrators and controls are on board and have enough volume to run the test The last calibration and control results are accepted for calibration and control tests The sample is on board and has enough volume to run the test The test and the measurement modules are enabled The instrument and the measurement modules are in an error free state If any of these conditions are not fulfilled the test will be blocked and the cause must be eliminated To check the cause of blocked orders tests calibrations or controls Click Orders on the
122. page E 40 with exception of point 6 See below for the exact location of the cooling unit fuse A Replacing controller board fuses The controller board fuses protect the electronic controller circuit boards that are located under the main front cover To see if a fuse has failed check the LEDs there is one for each fuse a green LED means that the fuse is working The layout of the controller board fuses is as follows E 42 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Checking and replacing fuses OOOO 2AT 2AT 5V 15V 15V 24V Resource Reagent 2AT 24V Resource Sample 2AT 24V Transfer XY Cuvette 2AT 24V Measure 2AT 24V Analyzer Fluid Fuse 3 Fuse 3 Fuse 3 Fuse 3 Fuse 3 Fuse 3 Lamp Supply FP Fuse 2AT 24V Transfer Z Lamp Supply ABS Fuse 6 3AT Supply 36V Supply 100V Fuse 5AT Fuse 3 2AT To replace a controller board fuse 1 Wait for the instrument to go into Standby 2 Open the main front cover A Main front cover Danger of injury due to closing main front cover If the main front cover is not opened completely it might close unintentionally by itself Whenever you open the main front cover be sure to open it as far as it will go Caution 3 Identify the fuse s to replace LED not lit Make a note of the fuse type and rating as shown next to the fuse 4 Choose File gt Shut Down Your are asked
123. paper clip at the beginning of the line indicates a comment in the detail dialog box An asterisk at the beginning of the line indicates an accepted test You only see asterisks in the Validate tab if the option in the list on the toolbar is set to display all results rather than only the unaccepted ones G Flags are shown for each result Only the flags with the highest priority are displayed Double click the result line to display detailed information on all flags The results line is grayed out and the Flags Action column shows Reactivated if a rerun has been requested H Accept all results currently displayed in the Results list I Rerun the selected test with dilutions The Dilutions dialog box is displayed J Accept the selected result s Operator s Manual Version 1 2 B 117 9 Results Cedex Bio HT Validate tab Tips e The Validate tab can contain the following folders and information Folder Contents Blocked Orders with at least one test with the Blocked status Not On Board Orders for which there are tests to be performed and for which the sample is not on board the system To Validate Orders with results that need validating e Only folders that contain entries are displayed in the Validate list e To follow the logical job sequence work through the entries in the list from top to bottom e Clicka sample calibration or control order in the Validate list to display the corresponding resul
124. persons or damage the instrument The system measures absorbance for 50 empty cuvettes at each wavelength The system fills the same cuvettes with water and measures the absorbance again at each wavelength Mean values are stored in the database and used to adjust results Water air calibration D 53 Operator s Manual Version 1 2 14 Service actions Replace probe B or C Cedex Bio HT Replace probe B or C Overview Duration Interval Tools and materials Hazards Precautions Further information For continuing accuracy you must replace one or both of the probes when this service action becomes due This service action can also be performed as a troubleshooting measure to overcome poor pipetting accuracy There is a separate service action to replace either of the two probes B and C You can replace individual probes or you can replace both probes at the same time Probe B is the one closest to you when you open the main front cover 9 minutes No interval Status will be checked during Roche Service visits Probe set Activator on the ISE rack Protective gloves The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious Reagents can cause burns irritation and poisoning through skin contact Wear protective gloves Double click the service action in the Due All or Begin of Day tab Click Help in the dialog box For general informa
125. process or about to begin e The rack cannot be identified because it is not defined on the system or e The barcode scanner could not read the barcode label e The rack has not been properly inserted or e The barcodes were not recognized or e Another rack on board has the same code platform You can remove the rack from the rack platform You can still remove the rack from the platform You cannot remove the rack while the red light is displayed Remove the rack and define it in Configuration Lab Racks Check the barcode label for damage Remove and reinsert the rack If blinking reoccurs check the messages for the reason Cassettes and cassette racks Figure 0 19 Cassette rack and cassettes A Cassette removed D Rack barcode F Press button for manual R SON release of the rack Do not B Vials for reagents and start E Barcode for confirming a release racks manually while reagents missing cassette from this osition C Rack number P the instrument is in operation See Unlock rack tool on page A 28 Operator s Manual Version 1 2 A 29 2 System description Functional systems Warning Cassette label Cassette barcode Cassette racks Integrated cassette volume check Cedex Bio HT The reagents for a test are supplied in a single cassette All cassettes have the same basic design Each cassette holds enough reagent for between 50 and 800 tests dep
126. profiles to an order Modify or delete an order Add or modify order information Assign samples to rack positions Request a dilution Review unaccepted flagged results Accept results that have not been automatically accepted Rerun a test for example with dilution Monitor results Review details and sample rate information for unaccepted results Review all results for an order whether accepted or not List results by order date and order ID Select results for specific orders dates and STAT or non STAT samples Review statistics on a specific test Operator s Manual Version 1 2 B 85 8 Orders Cedex Bio HT Orders at a glance Use the following table to locate specific tasks in the Configuration work area Icon Tab Tasks Barcode Specify barcode use e 14 General Sample Tubes Specify tube parameters H Specify Cup on Tube parameters Lab Racks Specify rack configuration define rack Database Reserve Positions Automatic Actions Demographics groups rack numbers and assign tube type Preassign cup and tube positions for ISE solutions diluents calibrators and controls Specify Start Order ID to enable automatic order numbering and automatic assigning of samples to rack positions Predefine the comments for up to three comment boxes in order demographics B 86 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Orders work area
127. reproducible 26 reviewing in an order 105 ae teviewing status of 82 Bstopping 12 viewing definitions 8 throughput specifications 6 time and date 48 timers 15 toolbar 48 buttons 52 tools unlock rack 28 37 tooltips 54 tower See ISE tower transitions between system states 43 transmitting data to host 73 troubleshooting 17 tube height adapter 31 1 28 User Manual Version 2 7 Index INTEGRA 400 plus tubes for samples 33 types 32 tubing leaking 27 of ISE module 31 replace in ISE module 25 turning on computer 31 instrument 31 monitor 31 rinter 31 system 31 unavailable cassettes 20 unconfirmed messages 6 unit parameters modifying 9 units lab units 112 used in documentation xii Unknown fluid cassette status 72 sample status 21 unlock rack tool 28 37 unlocking racks 28 user deleting 21 user access 20 user actions ISE flags 41 result flags 6 service actions 14 user ID 48 33 35 user interface conventions xi main features 6 overview 48 user levels assigning to functions 21 assigning to user 20 User Manual how to use x user password 33 35 user tasks overview 8 Validate tab Results work area 117 validating calibration results 149 control results 172 results 15 17 20 23 117 vent
128. results of all controls of the test will be printed irrespective of what level you selected on the By Test list of the Quality Control tab The Only Selected Test option is only available while a test is selected in the folders list of the Quality Control tab gt To print a Quality Control report from the By Test view 1 ge 2 3 4 5 6 7 8 Click Results on the navigation bar Click the Quality Control tab Click the column header to display the By Test View Select a test in the By Test column if you want to print a report for a certain test Choose File gt Print QC Report from the menu bar The QC Report dialog box is displayed Use From to set the period for which the QC report should be generated Select the control types for which a report should be generated Choose whether a report should be generated for the controls of the selected test Operator s Manual Version 1 2 B 57 6 Routine tasks Printing reports Printing service counters Printing service intervals Printing service notes Cedex Bio HT only or of all tests Click Print The Progress of QC Report dialog box is displayed You can click Cancel to stop the report generation Tips The period you set for which the QC report should be generated is valid for generating the report only It does not affect the filter settings set in the Results work area Step 5 To simply print the statistics of the selected test click Statist
129. selected results for each control Results QC Statistics PNorm Lot 160344 Assigned Calculated Calculated Test Value Dev n Mean Bias Gluc 0 18 49 94 g 1 70 842 76 K D 1 00 1 00 2 3 66 266 39 LAC LDH NA D Precision Accuracy C Limit Help Print Close The Statistics dialog box shows the predefined lower and upper limits the number of results in the statistic and the calculated mean Results QC Statistics PPath Lot 163546 Assigned Calculated Test Limit Limit n Mean Gluc 0 15 0 18 9 1 74 K D LAC LDH NA D E Precision Accuracy Help Print Close Each result for the selected test is displayed numerically and as a point on a graph The type of graph depends on which QC mode precision accuracy or limit is selected Validate Y Sample Calibration Quality Control By Test Precinorm U m PNorm B Date amp Time jy GLN 3s 2s Is X ls 28 38 e GLU 15 Mar 201213 03 0 90 f n fay Cluc Calibration parameter i i i t c T changed i apui 14 Mar 2012 09 26 0 90 m PPath Calibration parameter 4 r changed h E IGGHB 12Mar20121429 089 n H S IGGLB A Numerical control results B Each control has its own symbol C Graphical display of a result in terms of the mean and standard deviation for precision controls The graphical display above shows the results from a sin
130. side panel B to access the internal water reservoir C 5 Unscrew the internal water reservoir D and E The reservoir may be full take care not to spill any water Empty the reservoir and clean it with 0 6 sodium hypochlorite solution Rinse the reservoir thoroughly with reagent grade type 1 water four times Clean the internal water reservoir level switch F and the suction pipes G using a tissue moistened with ethyl alcohol D 28 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean internal water reservoir 9 Rinse thoroughly with water 10 Replace the liquid filters H at the end of the suction pipes Wear clean protective gloves so that you do not contaminate the filters 11 Reinstall the clean empty internal water reservoir 12 Click Next 13 The internal water reservoir is filled and the system is primed automatic step 14 Check the wash pipettes for air bubbles J and K 15 Ifnecessary perform another prime fluid system until no air bubbles are visible Prime the fluid system on page D 46 16 Reinstall the left side panel and close the main front cover 17 Click Finish Operator s Manual Version 1 2 D 29 14 Service actions Clean wash station Cedex Bio HT Clean wash station Overview Duration Interval Tools and materials Hazards Precautions Further information You must clean the wash station a
131. sscatevet tesnustiteretubanevssscesseteoesorssstegerghagensys EEES B 26 Removing sample racks csceseessessssseesesssessesseessessessessessessscssesseesseesssessesseesnesseesees B 26 Deleting results and orders B 26 Complete the remaining service Actions cscccesessesesseessessesstssesseeesesseessesseeaes B 27 Logging OFF stsessvssiceitvsteestyvssautnvsssvianseescesseteonustucsovassocnssuasrvoswsseencauueressuasuconveciuonnsnsani B 27 B 4 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Introduction Q Safety precautions Caution Introduction This chapter guides you through your working day The optimized workflow makes sure that you get the most out of the Cedex Bio HT features The workflow is divided into the following three sections Daily start up Prepare your system for the day Daily routine Keep your system running for the routine work End of day Prepare your system for the next day The Daily routine tasks are further divided into three procedures reflecting the three main kinds of laboratory setup Sample barcode Host See subsection x x Daily routine without sample barcode and without host on page B 12 V x Daily routine with sample barcode and without host on page B 17 V V Daily routine with sample barcode and with host on page B 22 To provide you with a clear overview of the procedures the level of detail with which individual Steps are
132. system is initialized automatic step 14 The probes are activated and the fluid system is primed automatic step 15 Click Finish D 56 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace plunger tip dosage pipette B or C Replace plunger tip dosage pipette B or C Overview Duration Interval Tools and materials Hazards Precautions Further information The dosage pipettes deliver accurate quantities of liquid for each test performed To ensure the continuing accuracy of pipetting operations you must replace the dosage pipette plunger tips before they become worn as determined by the service action schedule 10 minutes No interval Status will be checked during Roche Service visits There is a separate service action to replace either of the two dosage pipette plunger tips B and C You can replace individual plunger tips or you can replace both at the same time Teflon seal 250 uL Tip tool Scalpel Paper tissues Protective gloves The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious Reagents can cause burns irritation and poisoning through skin contact Wear protective gloves Double click the service action in the Due All or Begin of Day tab Click Help in the dialog box For general information about performing a service action see Chapter 13 Service action software To replace the
133. tab on the Results work area for orders that are blocked or have no samples on board 2 Double click a sample calibration or control order in the folders Blocked or Not On Board The Results Detail Test Orders dialog box is displayed 3 On the Results Detail Test Orders dialog box select a blocked test and press F1 to get Help 4 Take the appropriate actions to resolve the problem Tips e The folders Blocked and Not On Board are only listed on the Validate tab if they contain at least one entry If the folders are not displayed no tests are blocked and all samples are on board B 22 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow oS Validating results Daily routine with sample barcode and with host Right click an order in the Blocked folder and choose Detail from the context menu to see the test status of the blocked order on the Results Detail Test Orders dialog box Select an order and click Edit to switch to the Orders work area for editing Validate tab on page B 117 Validate results on the Validate tab of the Results work area File Edit View Tools Window Help LIAERE Validate Y Sample Calibration Quality Contro invalid K42 i Blocked Pest Result unit Flags Action Ret Range w Not on Board GLU i g C A cain Guth Result Sample GLU Detail xj B Stu ae Order ID invalid Sample amp invalid Sa
134. test profile definitions A calculated result is the arithmetical combination of two or more test results to produce a new value A calculated result definition contains information about the formula and the tests to be used in the calculation Click the Calculated Results icon to review create modify or delete a calculated result definition A calibrator definition contains a list of all tests that are to be calibrated using a specific calibrator It also contains details for individual calibration points Click the Calibrators icon to review create modify load or delete a calibration definition A control definition contains a list of all the tests for which the control is to be used and for each test what type of control precision accuracy or limit it is Click the Controls icon to review create modify load or delete a control definition A diluent definition provides information about a diluent and the tests for which it is used Click the Diluents icon to review load or delete a diluent definition A cleaner definition provides information about a cleaner and the tests with which it is used Click the Cleaners icon to review or delete a cleaner definition ISE solutions are solutions used to perform calibrating deproteinizing etching and activating operations on the ISE module Click the ISE Solutions icon to review load or delete the existing definitions A cassette definition provides information a
135. tf 50000 tests r 0 days ue Replace plunger tip dosage pipette C 50000 tests 1 I T days ae 7 1 uM 1 1 1 Replace dosage pipette B H 200000 tests l 0 days Replace dosage pipette C H 200000 tests it 0 days FI i J X temo Sea SEE aaa Service Action Due at 30 Help Save Default Print E A Type the number of tests cuvettes hours or hours idle that must occur before the service action becomes due B Service actions are due when a percentage of the service interval is reached C Type the number of days that must pass before the service action becomes due D Select the check box if you want the service action to be performed automatically at the Begin of Day The service action becomes due when either the counter or the timer threshold value is reached When they are due selected service actions appear on the Due tab on the Service work area E Use this button to reset intervals to the Roche defined default values It can apply to a single selected service action or to all service actions The System Counters tab displays the internal counters maintained by the system The counters are updated automatically and all other counters are derived from them These counters are always maintained even through software updates You cannot change any values on this dialog box Operator s Manual Version 1 2 D 17 13 Service action software Cedex Bio HT Counters and timers Choose View gt Counters gt Syst
136. the correct position on the sample racks To print the load list 1 Click either Status Orders Results or Configuration on the navigation bar 2 Choose File gt Print Report gt Loadlist from the menu bar The Print dialog box is displayed B 54 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Printing reports 3 Click OK Printing the Missing amp Blocked report Printing results The Missing amp Blocked report allows you to produce a printout of the information stored on the Missing amp Blocked tab in the Status work area The entries are listed under the headings e Cassettes e Calibrators Controls Cleaners ISE e Samples To print a Missing amp Blocked report 1 Click either Status Orders Results or Configuration on the navigation bar 2 Choose File gt Print Report gt Missing amp Blocked from the menu bar The Print dialog box is displayed 3 Click OK amp Missing amp Blocked tab on page B 68 There are two ways of printing results 1 You can print a cumulative results report e The Results report lists every result accepted and unaccepted on the system e You can specify ranges for order ID and for the order date The results are listed by order ID in ascending order e For each order creation date a new page is started 2 You can print the results of a single order To print the Results report 1 Click Results on the navigation bar 2 Choose Fi
137. the following way only those headings are listed in the report for which there are entries Following Begin of Day actions were not completed Service actions that are programed to be performed automatically at BOD but were not completed successfully B 52 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Printing the Final Report Printing reports Following service actions need to be performed Service actions that are due An Elapsed value of 100 means that the action is due now a value smaller than 100 means it will be due soon a value greater than 100 means that the action has been due for some time This list includes all service actions that are due Test with pending calibration or control requests Tests with postponed calibration Required Calibrators Controls Cleaners Diluents and ISE Fluids The required calibrators controls cleaners diluents and ISE Fluids necessary to run the pending calibrator and control requests together with their status for example Blocked are displayed Following cassettes need to be handled This information is identical with that displayed in the Cassettes group on the Missing amp Blocked tab of the Status work area To print a Begin of Day report Choose File gt Print Report gt Begin of Day from the menu bar The Print dialog box is displayed Click OK Place all calibrators on the system before you print the BOD report The sy
138. the workstation adds a new cuvette at the end of the cycle it removes the used cuvettes for disposal into the cuvette waste box The cuvette waste box is a disposable plastic container that can hold 1000 used cuvettes Fluid waste from the ISE module goes directly to the cuvette waste box The box is automatically shaken to make room for newly discarded cuvettes You can remove the waste box seal it and then autoclave it A warning message tells you when the waste box is full and needs to be replaced Replacing the cuvette waste box on page B 48 The rack system allows you to physically place reagents cassettes samples calibrators controls special diluents and ISE solutions onto the instrument The rack system contains slots for three different types of racks e Cassette rack e Sample rack e ISE rack These racks are all different sizes and fit into different sized slots on the system A 26 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Functional systems A barcode scanner automatically reads barcodes on any items loaded into the rack system Figure 0 17 The rack system racks not shown A Cassette area cooling box C Cooled sample rack D Sample area E Barcode scanner B Cassette area Rack areas and You access the rack area by opening the rack access panel see logo left Inside there platforms are two rack areas Cassette area Contains the cassette rac
139. to four test results from the same sample Calibration The procedure to standardize each application with material of known concentration Calibration establishes calibration curve parameters See Calibration Curve Parameter Operator s Manual Version 1 2 3 Cedex Bio HT Table of contents Calibration Curve A plot of known concentrations of calibrators against their signals established during calibration Calibration Curve Parameters A series of factors or constants used to mathematically describe the characteristics of a calibration curve The calibration curve parameters are used to calculate enzyme activity or analyte concentration based on the measured rate values Cedex Bio HT curve parameters are labelled Ro K A B etc Calibration Mode A mathematical model to describe the relation between a signal and a concentration in the calibration curve see Calibration Curve Calibrator Solutions with known amounts of added analytes They are used in different concentrations to adjust a measurement procedure Carry over The phenomenon by which part of an analyte or reagent of a previous pipetting is inadvertently present in the current analysis Cassette Area The cooled area where cassettes are loaded into the instrument Cassette Number A unique number that identifies a particular cassette Cleaner The solution used to wash the interior and exterior of probes to prevent carry over Clot Detection Det
140. to the pipettes in the fluid system The dosage pipettes control the volumes of liquids pipetted MG N Yad aaaaaaAEEEESSASEEEEEE EEE EE SEEEEEEE j Probe B Probe C Sample loops Splash guard Figure 0 24 Transfer head with the cover removed A Sample loop holder D Transfer head cover removed B Probe C E ProbeB C Splash guard e Pipettes reagents and sample for some tasks e The pipetting takes place at workstation B e Is located nearest to you when you open the main front cover e Pipettes both reagents and samples e The pipetting takes place at workstation C e Is located furthest away from you when you open the main front cover The sample loops are coils of tubing long enough to hold any liquid pipetted and to allow a complete change over of fluid The splash guard is a black plastic tray that prevents direct user access to the probes thus protecting them from accidental damage It also catches any drips of liquid on the outside of the probes preventing contamination of other parts of the instrument The system informs you when the splash guard needs cleaning as part of the service schedule Clean probes and splash guard on page D 24 Operator s Manual Version 1 2 A 37 2 System description Cedex Bio HT Functional systems Initialization posts The initialization posts are fixed surfaces that the instrument uses as transf
141. use e In Use None Yellow e Cal expired Replace the cassette See Loading cassettes on page B 40 e Req Mixing e Near Expiration or Replace the cassette See Loading cassettes Expired on page B 40 e Not enough for worklist The number of ordered tests is bigger than the or number of tests left in the cassette Cassette Tests Low The warning threshold defined for the cassette has been reached Configuration Cassettes ID Load additional cassettes See Loading cassettes on page B 40 Red e Empty Replace the cassette See Loading cassettes on page B 40 e Unknown fluid Definition not loaded See About cassette text shown on Details definitions on page G 15 only e Conflict with position Conflict of positions between cassettes Remove text shown on Details and re insert the rack See Rack system on only page A 26 Tip Cassettes whose barcode cannot be read are not displayed on the Cassettes tab You see a blinking red LED Check whether the label is damaged and reinsert the cassette Make sure the definitions for the cassette are available on the system You may have to replace the cassette with a new one Operator s Manual Version 1 2 B 73 7 Status Cedex Bio HT Test Status tab Test Status tab Use the Test Status tab to review detailed summary information about a test The tests are listed in folders based on the current test status Blocked Disabled or OK This tab also te
142. using Configuration Lab Reserve Positions Click Status on the navigation bar Click the Samples tab Identify the rack and position of the control from the graphic Remove the rack from its slot Place the control in the specified position on the rack oOo ao F amp F WwW N Load the rack into an available slot Tip You can use Place Items to identify rack and position of the controls You need to use this method if the rack is not on board when you start the procedure To load a control if rack positions have not been predefined Click Orders on the navigation bar Click the Quality Control tab Select All in the QC list Select the required control from the Controls Test Summary list 1 2 3 4 5 Choose View gt Sample Handling 6 Specify a value in the Rack column for the rack number 7 Specify a value in the Pos column for the position on the rack 8 Click OK 9 Place the control on the rack 1 O Load the rack into an available slot Tip You can use the Place Items dialog box instead of Sample Handling to assign controls to rack positions Operator s Manual Version 1 2 B 169 Cedex Bio HT 11 Quality controls Requesting controls Requesting controls Most controls are run automatically according to the intervals specified for the control in Configuration Tests Control You can choose to run controls automatically after a calibration and when a specified time period has elapsed or a
143. when touching power supply components Biological safety Samples analyzed with this instrument may contain potentially infectious material Samples derived from humans animals tissue culture or in vitro cultures should be handled and processed with appropriate safety precautions Such samples may contain bacterial fungal or viral agents Spills should be immediately disinfected with an approved disinfectant solution to avoid contamination of laboratory personnel and equipment Operator s Manual Version 1 2 xiii gt gt Danger gt Danger gt Warning gt Warning gt Warning gt Warning gt Warning gt Warning Cedex Bio HT Loss of sight due to staring into laser beam Barcode scanner contains a class 2 laser diode Do not stare into the laser transmitter beam as your eyesight may be severely damaged For position of the laser transmitters see Safety information for laser transmitters on page xxi Danger of explosion Danger of explosion through sparks Keep all potentially inflammable or explosive material for example anesthetic gas away from the instrument Fire risk Spraying liquid on the power supply parts can cause a short circuit and result in a fire Keep the cover closed while the instrument is connected to the main power supply and do not use sprays in the vicinity of the Cedex Bio HT analyzer During fire fighting operations disconnect th
144. you cannot resolve information about contacting Roche Service is also provided In this chapter Chapter 16 Mtrod cti n iaae a TE K NEE E N R E Information about problems ssssssssssssssssssssssssssssssserssttsessssssssnrstrttesssnssnnnesenssssnsseete Preventative maintenan E sasaa E E aS ER E E EEEREN SE EiS Starup problems ea irer E EE SE EA E EN EER Blocked orders tests calibrations or controls Cassettes and Cleaner o c ccccsesscsssssssscsssssscscsscscscsssscsssssesssssssscsssscsesssscsssssssssescessaesseses ReGuilltsiscsi2cc sostece sativcsnrestvcsnssivesstaeveswvosivesssustgesstanecesssunecenssenecesssuntuezsauniesstustecesaunteet aanieetacs Quality control results out Of range eeseesessesessssessessesessessesesseesesseesees Test results not reproducibl 6s ccsscccccsssciveswccencsstecsiensswsstisnccessesveuopnepnconcansucvossaanveswests Test results low or drifting Par dwar etisisscescessecisessiwcsvcscsstusctayyasvesnscoucervensusuunssnvesueaescosuevusseusonscsusanvetssausneannconcenioeetaaee Reacting to a hardware Message sesssssessesssessessesssssessessssssesseescssesstsssessessessessess CUVOtEES 22 2 csidecscetideseeethdedecatocsseechdevseesegesocssueavecsdebeteeysdostebedezweebtdessesSudesepesedensesedesese Clot error after pipetting from sample CUP ss ssssssssssssssessssssssrtessssssssnsesereesssssssss E 31 Glotted ttramster saiheste E E E S E 32 Clot error after sample probe washing
145. you have resolved the problem See also b Pittina the cvetem into Standhy Operator s Manual Version 1 2 A 69 4 Online Help Cedex Bio HT Related topics Related topics In many topics especially with context sensitive information you can click the See also button in the button bar to display a list of shortcuts to important related topics This button is only active if there is at least one such shortcut on the current topic gt To display related topics 1 Click See also on the button bar A list of headings of important related topics is displayed See also 2 Select one heading from the list The topic with this heading is displayed A 70 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help Glossary Glossary You can access the glossary from the button bar of any main Help window Use the letter buttons or scroll bar to move down the glossary amp Cedex Bio HT Help System _ Of x File Edit Bookmark Options Help H Introduction Howto Flags Troubleshooting and messagd Service Software reference information Messages Online books Quality Control QC A tool which verifies accuracy and precision of a Glossary results COBAS INTEGRA 400 quality control encompasses the functions Glossary of accuracy control precision contrpl limit control and precontrol Quality Control Rules A set of statistical rules that help to identify problems wi
146. 1 2 5 Daily workflow Cedex Bio HT Daily routine with sample barcode and without host amp To select the order ID Select the appropriate order ID from the Order ID list and press Enter Tips e The Order ID list lists all samples that are present on the system and have no orders assigned to them e Type asterisk in the Order ID box and press Enter to use the lookup function The Lookup dialog box is displayed with a list of all order IDs stored on the system gt Specifying an order ID on page B 95 amp To select tests and save the order 1 Click the buttons for the required profiles and tests 2 Click STAT for a high priority order 3 Click Save Tip Change the test group in the Group box to limit or expand the display of test and profile buttons Select General to display all available test and profile buttons gt Selecting tests for the order on page B 96 If you want Then do this To limit or expand the display Select the appropriate Group in the Test amp Profiles group of test and profile buttons in the Test amp Profiles group To delete a test from the Right click the test in the Test Summary group and choose Sample Calibration or QC Delete from the context menu Alternatively click the test tab button of the test To request a dilution for a Right click the test in the Sample Test Summary group and sample test choose Dilutions from the context menu Select or type
147. 1 Re install the noise damper making sure the notch faces outwards when you look at the wash station from above F F Operator s Manual Version 1 2 D 31 14 Service actions Cedex Bio HT Clean wash station 12 Clean the inner part of the wash pipes with cotton swabs G 13 Replace the wash pipe seals H 14 Rinse the wash station thoroughly using water 15 Connect the waste tubing and reinstall the wash station 16 When the wash station is in place install the plastic cover C The position of the cover must be with the wide end closest to you 17 Click Next 18 The transfer system is initialized automatic step 19 Click Finish D 32 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean external water reservoir and fluid waste reservoir Clean external water reservoir and fluid waste reservoir Overview Duration Interval Tools and materials Hazards Precautions Further information You must clean the external water reservoir and fluid waste reservoir to prevent the build up of contaminants which can affect the water quality and therefore the quality of the results produced This service action is not required if your instrument is directly connected to both a laboratory water supply and a laboratory fluid waste drain 5 minutes Every three months Liquid filters 0 6 sodium hypochlorite solution Clean beaker 1000 mL Reagent grade type 1 water Paper tis
148. 17 Click Next 18 The pipette module is initialized and the fluid system is primed automatic step 19 Click Finish I If necessary perform the service action Prime fluid system and repeat it until no air bubbles are visible See page D 46 Operator s Manual Version 1 2 D 63 14 Service actions Cedex Bio HT Replace external water reservoir filter Replace external water reservoir filter Overview Duration Interval Tools and materials Hazards and precautions Further information The liquid filter on the external water reservoir removes particulate matter from the water supply You must replace this filter according to the service action schedule or earlier if for example the water pressure is too low or the water throughput is insufficient 5 minutes Every three months Liquid filter None e Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software To replace the external water reservoir filter Select Replace external water reservoir filter in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 Pull out the tubing adapter A from the external water reservoir Rest the adapter in a clean beaker to avoid contamination of the adapter and of any work surfaces Do not disconne
149. 4 Service actions Cedex Bio HT Replace plunger tip dosage pipette B or C splash guard M VU 18 Reinstall the cleaner reservoir and the tubing 19 Click Next 20 The pipette module is initialized and the fluid system is primed automatic step 21 Click Finish If necessary perform the service action Prime fluid system and repeat it until no air bubbles are visible See page D 46 D 60 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace dosage pipette B or C Replace dosage pipette B or C Overview The dosage pipettes deliver accurate quantities of liquid for each test performed To ensure the continuing accuracy of pipetting operations you must replace the dosage pipettes before they become worn as determined by the service action schedule Duration 10 minutes Interval No interval Status will be checked during Roche Service visits There is a separate service action to replace either of the two dosage pipettes B and C You can replace individual pipettes or you can replace both at the same time Tools and materials Pipette 250 uL e Pipette seal cap e Paper tissues e Protective gloves Hazards The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious e Reagents can cause burns irritation and poisoning through skin contact Precautions Wear protective gloves Further information
150. 43 al Cuvettes See Refilling the cuvette reservoir on page B 44 Water See Refilling the external water reservoir on page B 45 Cuvette waste See Replacing the cuvette waste box on page B 48 Waste drain See Emptying the external waste reservoir on page B 47 Temperature See Replace ventilation filter on page D 49 See Checking and replacing fuses on page E 40 pape ISE solutions Check the ISE tab in the Status work area for more WU information See Replace ISE solutions on the ISE rack on page F 32 See Replace bottles on ISE module on page F 34 B 42 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Replacing the cleaner Tools and materials Precautions Danger Caution p Managing resources If the cleaner is nearly used up or if the cleaner temperature is between 36 6 C and 37 C the system warns you by displaying the cleaner icon with a yellow background The icon is displayed both on the navigation bar and in the Analyzer tab in the Status work area The system automatically detects that cleaner has been replaced and resets the icons to their normal states Replacement cleaner bottle must have a minimum volume of 250 mL If the system completely runs out of cleaner or if the cleaner temperature exceeds 37 5 C the icon turns red and the system stops e 1000 mL bottle of cleaner Art 07 5476 5 US 47048 or equivalent e Paper tissue
151. 5 For this level of support a connect 2 box or a cobas link gateway must be connected to the 2nd LAN port Creating a problem report You can create a problem report by default on a floppy disk or alternatively on a USB Memory Stick This report collates all the messages and other system information that the Roche Service engineers will need if you cannot solve a particular problem on your own You should create the report if possible before contacting Roche Service To create a problem report on USB Memory Stick Click Messages on the navigation bar Click the Options tab Click Report The Create Problem Report dialog is displayed Create problem report Create C Roche Instrument Report Version tat HEREEEE 4 When the report has been generated the Problem Report dialog box is displayed again telling you how many diskettes you need Problem Report x 2 The report has been completed Do you want to copy the report to ho i floppy disk s ou will need 1 disk s Warming All existing files on the disk s will be ereased Message ID 28 1230 No Click No 6 Insert a USB Memory Stick into a USB port of the computer of the Cedex Bio HT analyzer 7 Press Windows key E on the keyboard to open the Windows Explorer E 44 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Contacting Roche Service 8 Open the folder C Roche Instrument Report
152. 6 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls 3 4 5 Setting up controls Click the QC Mode tab Configuration Database x aeee D M a 4 Select the check box for each rule as required Click one of the following e OK to save your changes for all the tabs in this dialog box e Cancel to close the dialog box without making any changes Tips This dialog applies to the system as a whole That is if a rule is checked in this dialog it is potentially available for any control on a test if configured If you clear the check box for a rule that rule is not available for any control on any test on the instrument Specifying control intervals amp To specify a control interval a A WN Click Configuration on the navigation bar Double click Tests in the Definitions group Click the Control tab Select the Interval box Select either Tests and type the number of tests or select Hours and type the number of hours Select After Cal if you want a control to be run automatically after each calibration Select an interval sequence If more than one control is defined select consecutive Interval Sequence numbers Operator s Manual Version 1 2 B 187 Cedex Bio HT 11 Quality controls Setting up controls 8 Click Save QCTreatment M Interval Tests Controls C Hours m Controls Atter Control PNom AM CCCCCC A PPan O OME Ire A
153. Backups Electronics Working data is stored in a database on the hard disk of the data station computer This includes sample and order information and results Raw data that is the measurements taken by the instruments is stored only short term and is then deleted The results calculated from the measurements are stored longer term The data station computer maintains a backup of all current data You can start this manually from the service action Backup data or you can configure this as a Begin of Day action A backup can take more than 10 minutes to complete during which time the instrument cannot run any tests In addition the computer has a 3 5 inch disk drive before model rp5800 DS a USB Port and a DVD drive that can be used for e Loading updates to software and help e TAS test application software updates The disk drive or a USB Memory Stick can also be used for archiving data for long term storage and retrieval Control of the many automatic systems within the instrument is performed by a set of electronic printed circuit boards PCBs These are located in a controller rack in a closed cabinet above the cassette and sample areas The PCBs are protected by fuses each of which must have the correct rating The fuses are user replaceable Checking and replacing fuses on page E 40 Operator s Manual Version 1 2 A 41 2 System description System states System states Cedex Bio HT The current st
154. Cancel Select the cassette you wish to use Operator s Manual Version 1 2 B 145 10 Calibration Cedex Bio HT Requesting calibrations 4 Click Save Fie Edit View Tools Window Help EFICACES 3 ibrati el i Worklist Sample Calibration Quest F Tests amp Profiles j Calibrator Test Summary Cal All z Calibrator Tube Position Lot ea ANS COBAS cup 1013 3011 422up General z SA Ctas COBAScup 101 1 181488 GLN COBAS cup 1017 57132553 ey atu elle Gch a GLU COBAS cup 1015 57132459 a Stop i 1 1 1 G w jo eoi cw a_a NH3 ay ISE O 140 6 21414002 21413502 i 1 1 z 1 1 sai Fi m oov GL S O 1 Glue 65056701 eD 1 NAD sD 1 K D S SERTS COBAScup 1019 637709 i i ad Save _ _ aay admin 28 03 2012 10 12 gt You can select a test or profile for the calibration request by typing its name or number here In the Configuration work area tests can be assigned to groups This feature can be used to reduce the number of tests displayed at one time in this tab Select another group if you don t see the required test Click profile buttons to request calibrations for all tests in the profile Click test buttons to request a calibration for the test Calibration already requested for this test f you select a calibrator here only the tests that are associ
155. Cedex Bio HT Cassettes tab Cassettes tab Use the Cassettes tab to review the status of each cassette on board Color coding on the Cassettes tab Status File View Tools Window Help 2 6la S b Missing amp Blocked Samples Cassettes Test Status Analyzer ISE lt I ceske ber admin 27 03 2012 18 15 A Cassette name D Slot ID F Empty position B Number of tests left in the E Rack number G Empty slot cassette C Cassette status Tips The slot IDs are identified by the letters A through H Cassette barcodes are read automatically when you load them To display the details for a cassette do one of the following Double click the cassette o Right click the cassette then choose Item Detail o Select the cassette and press Space e Use the same techniques to display details for the whole rack but click the rack number e Racks that have been removed from the system are shown as greyed out racks in the Cassettes tab lt gt Loading cassettes on page B 40 e Press F1 to display Help for this tab The cassette graphics are color coded The following table shows the meaning of each of the colors and the action that should be taken by the user B 72 Operator s Manual Version 1 2 Cedex Bio HT 7 Status Cassettes tab Color Meaning User action Green e New cassette None e Ready None the cassette is ready for
156. Cedex Bio HT Operator s Manual Version 1 2 Cedex Bio HT Revision history Publication notice Intended use Copyrights Trademarks Instrument approvals Manual oftware ee oe S ves Revision date Changes version version 1 0 5 0 May 2012 First release 1 0 5 0 September 2012 Updated laser information 1 1 5 0 April 2013 Remote access diluent handling 2nd LAN connector 1 2 5 0 September 2013 Hardware specifications data handling via USB This publication is for users of the Cedex Bio HT analyzer Every effort has been made to ensure that all the information contained in this publication is correct at the time of publishing However Roche reserves the right to make any changes necessary without notice as part of ongoing product developments and improvements Any customer modification to the instrument will render the warranty or service agreement null and void The Cedex Bio HT analyzer is a fully automated computerized analyzer for professional use It is intended for determination of a wide range of analytes in various aqueous solutions like cell culture and fermentation media For use in quality control manufacturing process only 2012 2013 Roche Diagnostics International Ltd All rights reserved CEDEX COBAS and ISE are trademarks of Roche All other product names and trademarks are the property of their respective owners The Cedex Bio HT analyzer meets the protection requirements laid down
157. Context menu Orders work area To access the Orders work area click the Orders button on the navigation bar The Orders work area has the following four tabs Tab Function Worklist Sample Calibration Quality Control This tab gives a clear and comprehensive overview of the active orders and tests and provides easy access to the tasks you perform most frequently on these items such as editing and validating This tab allows you to e Request tests for a sample by creating an order e Request dilutions e Create multiple copies of an order e Give an order STAT priority This tab allows you to request calibrations for specific tests This tab allows you to request quality controls for specific tests You can right click a test order calibration or control in any tab to display the context menu It contains one or more of the following frequently used commands Menu item Function Clear Clears the text boxes Copy Copy to the clipboard text that was selected in a box Copy Order Copy the details of the current order to the clipboard Use with the Paste Order command to create multiple orders with the same content Cut Cut selected text from a box Delete Deletes the selected item Delete Order Detail Dilutions Edit Multiple Tests Deletes the current order Gives detailed information for the selected item for example for a test the on board cassettes are listed Request a dil
158. Counters and timers D 20 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Service actions Scheduled tasks for preventative maintenance This chapter provides step by step procedures to guide you through the non ISE service actions that require manual intervention It lists the potential hazards and precautions in each case General maintenance procedures are also described In this chapter Chapter 4 Safety informatio osani a AAEREN RAE AOR Deproteinize probes Clean probes and splash guard Clean internal water reservoir ssseessssssesssssseressssretessssetresssreressssrtressrresssrertesssreresssrrrres Clean wash station ceesessssssseeseeseesesscssesestesteseeseeneeseenees Clean external water reservoir and fluid waste reservoir cteseeseeseeseeseeseeseeseeneenees D 33 Clean instrument ssriisorisoiiie e ar K a i riai e D 36 GClean the waste Dox fitting eios R A A Ti D 42 Clean and lubricate th rotor isc sscissccessisscesssuzsessssezeeenocsvesueedtsstsssesecnonssstvessecvecesscssecusstee D 43 Prime the fluid Systeri sE En STASIE AEE S SIRE EE iia D 46 Roche SerVi Eer E A ie nei neeoaneivey D 47 Backup databasene inaasa aa Sia eE AaS eaaa D 48 Replac ventilation filten irae aprini aeaiee A aiai Enisa D 49 Replace Abs halogen lampiin ipni iad D 51 Replace probe B Or G itscasusccascsssiscevenssidehsscaddesocascveheasiicehosescrsbessdevettassssesnderebesssevehise
159. D F11 476_01 Sample Reaction Rew Data D J Gluc 0 01 g L 0 00188 dA E A Calc First 0 04558 00 05 49 Abs Rate 102 1 Bead 0 04800 00 06 00 C CalcLast 0 04746 00 12 11 F e alia lac ah ls aa loc 500 10 00 Number of Measured Oycles 69 t minutes SERS Ve ES eee eee Print Close A Order details B The calculation parameters differ depending on the type of test C The number of measured cycles and the time per cycle 10 6 sec D Click the Raw Data tab to review the numerical raw data E Result and rate of the test F Graph of the raw data over time Tip Raw data is automatically deleted after a number of days defined in Configuration Database Automatic Actions Operator s Manual Version 1 2 B 127 9 Results Cedex Bio HT Working with results Working with results You can perform the following tasks on the Validate and Sample tabs of the Results z work area e Accept results e Rerun results e Delete test results e Archiving results These tasks are described in the following sections Accepting result or rerunning tests When one or more results in an order are flagged all the results for that order are displayed in the Validate tab provided you have chosen All in the filter list on the toolbar to display all results You can accept all of the results or you can accept some and rerun others Note that results are flagged to indicat
160. ERS Reviewing tests in an order s sssssssssssssssssssssssssrstetiessssrrtstessssssssnrrsertessnsssssreett Adding tests to an existing order sssssssssssssssssssesstssssssssssrrtstessssssssnrsrerteessssssssreett Copying data from orders and tests Requesting a dilution i Deleting tests sninn casgeasesettogsaccicncensssenscnseeseanosnosts sisssneesstovanestesnecssetseecvsenstoestee Purging and deleting Orders cists ccsccisssscssesccnssssecnosnostsessessooessassansonesnecsdossessosenstooerse Operator s Manual Version 1 2 B 83 8 Orders About orders About orders Order IDs Racks and sample handling Caution Cedex Bio HT An order specifies the tests to be performed on a sample An order also contains information about the sample and supplementary information about the order order demographics Order demographics include information about the order creation date and time You can create orders manually in the Orders work area or your system may download orders automatically from the host system The way in which the sample and order information is presented depends on how your system is configured Each order must have an order ID which may be alphanumeric for example AA 1234 or numeric for example 1234 Your system may be configured to increment order IDs automatically This means that a new order ID is automatically displayed when you open the Orders work area or save the previous order O
161. G 16 About cleatier definitions ii ssscesiessch sessgetetbanscteibesscassbesseshassactensapierstiagentensennaaseys G 17 About diluent d finitions siia E G 17 Loading test application software cccesssssessesseessessessesssessessessesseescssessnessessessessessess G 18 Archiving and reloading definitions ssssssssssssssssssssssssssetssssssesertesessssssnrrrereeessssssssserene G 19 Systemi orOU Prai R ERA ERR G 20 User ACCESS siga rE R E RERA E ERR E G 20 Assigning and deleting user details ccescesesseessessesseesessesseessessesssesseesessesseeses G 21 Assigning user levels to functions Windows Sr OUP avis wiscvcevscssecsswistusncssuscoustaayvastustucevssauenssiencorwestuceuenssnuavyopncenestnecmmnviensene Operator s Manual Version 1 2 G 3 Cedex Bio HT 20 Configuration Configuration overview Configuration overview Definition tasks Configuration allows you to access the database and make modifications to support a wide range of system functionality requirements The procedures included here explain how for example you can modify test definitions profile calculated result calibrator and control details xl File Edt View Tools Window Help a e Sas b r Definitions r System m Windows Start 7 Z al oe 9 i S OO Profiles Calculated General Database Lab Keyboard Mouse Printers Stop Results asa t S W eg Calibrators Controls Diluents Result Processing Regional Sounds Han
162. Help A 68 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help lt Cedex Bio HT Help System File Edit Bookmark Options Help Topics Back Q Contents ES Index fiy Search E3 Introduction H Howto H Flags H Troubleshooting and messe a Service m Sofware reference informati cH Messages General messages EA Controller messages About controller mess Shutting down the sys E Confirming messages Re Starting and stop E Putting the system inte m Resource controller m Zranster controller m Abs photometer cont m Cuvette controller 2 0 Fluid controller E About fluid controll E 14 3235 05 005 02 14 3235 05 005 027 vo E 14 3325 05 3000 a xy transter controller a FP photometer contro H ISE controller Message Help Click Help On Message in the message dialog box to display Help on a controller message Joi Help Explanation Wash pipette B could not reach the correct position Recommended actions Click Stop In the Stop Action dialog box click Sampling Stop then click OK Check whether probe B is clogged or bent If itis perform the service action Replace Probe B Check that wash pipette B is correctly installed and undamaged Choose Tools Initialize System in the Service work area If the message reappears contact Roche Service Tips Probe B is closest to you when you open the main cover Confirrn the message when
163. ISE module is initialized if necessary automatic step Preparing ISE module for tube replacement automatic step N of F amp Refer to the cover of the tubing set to identify the correct tubing locations on the ISE module 8 Replace the tubing Operator s Manual Version 1 2 F 25 18 ISE service actions Cedex Bio HT Replace ISE module tubing 9 ISE calibrators are primed automatic step 10 ISE module tubing is conditioned twelve times with Activator automatic step 11 ISE module is initialized automatic step 12 ISE wash time is detected four times with Activator 13 ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes 14 When all steps are complete click Finish in the Service work area F 26 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Replace electrode Replace electrode Overview Duration Interval Begin of Day System state Tools and materials Hazards Precautions You must replace electrodes when their expiration date is exceeded or when the ISE results deteriorate despite regular service There are up to four ion selective electrodes and a reference electrode on the ISE module The replacement procedure is the same for each During replacing electrodes on the ISE module the system performs automatically the Electrode service service action This insures the pro
164. Ix ja e a 7 m e S aY b Warklist Sample Calibration Quality Contrai Start A oo be 9 j zj Stop r Tests amp Profiles r Sample Test Summary Sample Type Sampe gt Sample Tube Position l Position x v Cup OnTube EHaa Sample D 1 Gluc Test Profile Group General X D Glue New GL aD 1 GLU em E GU Gwe i B ry GLU Gluc IGGHB F IGGLB K D LAC LDH NAD NH3 x 1p m i admin 28 03 2012 13 22 A Add order ID on the Sample tab of the Orders work area B Select tests and click Save Creating an order on page B 95 gt To select the order ID Select the appropriate order ID from the Order ID list and press Enter 2 Depending on the configuration of your system add additional order information e In the text box to the right of the order ID type the text or select a predefined text from the list and press Enter Tips The Order ID list lists all samples that are present on the system and have no orders assigned to them e Type asterisk in the Order ID box and press Enter to use the lookup function The Lookup dialog box is displayed with a list of all order IDs stored on the system Specifying an order ID on page B 95 amp To select tests and save the order 1 Click the buttons for the required profiles and tests 2 Click STAT for a high priority order 3 Click Save Operator s Manual Version
165. L 1 Check reaction curve in Rate Info 2 Repeat with fresh control e TEST 1 Check reaction curve in Rate Info 2 Ifthe flag is for one sample Check the sample tube or cup to ensure there is sufficient sample and that there are no bubbles foam or fibrin clots which could interfere with normal pipetting 3 Ifthe flag is displayed for multiple samples for the same test Check the reagent pipetting system for clogged or bent needles and ensure the currently used reagent cassette with status in use is in place and contains sufficient reagent Priority 18 Group CAL CNTL TEST Less than lower limit For a limit control the result is lower than the defined lower limit Operator s Manual Version 1 2 C 11 12 Result flags Flags and recommended actions Recommended action LOW SIGNAL Attributes Meaning Recommended action NO FLUID NO ISECAL NON LINEAR Attributes Meaning Recommended action Cedex Bio HT 1 Check that the correct control material has been used 2 Rerun with fresh control 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Priority 55 Group CNTL Low signal For an FP measurement a parallel or perpendicular intensity measurement was too low 1 Repeat with fresh calibrators and SDRII diluent 2 Ifthe flag reappears use new cassette 3 Ifthe flag reappears contact Roche Service Priority 6 Group CAL CNTL TEST NO FLUID on p
166. Name is maximum 30 alphanumeric characters e Test No is a number in the range of 1 through 999 e The Short Name Long Name and Test Number are mandatory and must be unique for tests profiles and calculated results The ID is assigned by Roche and cannot be changed To modify default sample type and calibration details 1 Click the General tab 2 Select the required test from the Installed Tests list 3 Modify the Default Sample Type by selecting an alternative from the list Use Configuration Lab Sample Types to define the list 4 Modify the Calibration details a Select one of the Replicate options No replicates for ISE b For the Main Interval select the type of calibration interval and type the number of days required for the interval 5 Click Save Tip The calibrator required for each test is automatically added when the test is entered Modifications are only necessary where another calibrator is used To modify dilutions and or concentrations Click the Dilutions tab Select the required test from the Installed Tests list 3 Select Automatic Dilutions Off if no automatic dilutions are required Automatic Dilutions sequential should be selected to allow post actions as and when required 4 Select the dilution and type the dilution or concentration factor required for the test 5 Click Save Tip The default post handling factors are specific to each test and should not be modified G 8
167. Nore None z Interval Sequence QC Check __ B A Aan interval can be defined as a number of tests or a number of hours B This control is automatically run after each calibration C This control is run after two intervals 8 tests Tips A control can be run automatically after each calibration You can set additional control intervals based on time Hours or on the number of tests run The interval is reset after the control is run The QC Check columns tell you which QC modes are on for each control These are defined in Configuration Controls Lot Loading a non Roche control If you want to use a non Roche control you have to set it up and assign it to tests in this sequence 1 2 3 Create a control definition Assign the control to tests for each test specify an interval sequence For the tests to which the control is assigned specify the precision accuracy and limit values These procedures are detailed below To define a non Roche control 1 2 3 4 5 6 7 8 9 1 Click Configuration on the navigation bar Double click Controls in the Definitions group Click the ID tab Click New Control to clear the text boxes Type a short name ID and long name Click Save Click the Lot tab Click New Lot Type a lot number and expiration date 0 Click Save B 188 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls
168. Not on Board MemoPad Shift F7 Tabs In the Status Orders Results and Service work areas the information is arranged in Dialog boxes several tabs The tabs of a work area contain different but related information To open a different tab Click a tab or 1 Press the Tab key until the work area tab has focus You see a dotted line around the tab 2 Press the Right Arrow key to move left to right from tab to tab 3 Press the Left Arrow key to move right to left Tips e In Windows focus is the place where Service i the next command you make has its r F eee Hel effect When a tab or a button has c A focus in Windows the tab or button Due All BeginofDay is displayed with a dotted box A Service Action around it e Ifthe All tab A has focus pressing Service the Right or Left Arrow key moves the i Moai Window Help focus to the next tab EE B D All Begin of Das e Ifthe All tab does not have focus B a pressing the Arrow keys moves focus SeweeAsion to other items inside the tab Dialog boxes are secondary windows that are x Number of Gluc Tests k tt displayed on top of the main work area window Typically a dialog box requests or provides information that is supplementary to that in the main window You can access dialog boxes from within the work areas or through the menu bar Some dialog boxes are shared by different work areas A 50 Oper
169. Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration About the Definitions group gt To modify control parameters and the interval sequence Click the Control tab 2 Select the required test from the Installed Tests list 3 Select the QC Treatment check box to ensure that each control is checked according to Precision Accuracy and Limit rules 4 Select the Interval check box to perform controls automatically 5 Select Tests and type the number of tests that constitute one interval or select Hours and type the number of hours that constitute one interval 6 For each control you have selected you can select the After Cal check box if you want the control to be run automatically after every calibration 7 You can also select an interval sequence one through six for each control If more than one control is defined select consecutive Interval Sequence numbers 8 Click Save Tips e Controls unlike calibrators are not automatically installed with each test and should be selected as required e Control intervals can be based upon the number of tests run time number of hours or after calibration e For details on controls see Chapter 20 Quality controls gt To modify correlation and default unit parameters 1 Click the Laboratory tab 2 Select the required test from the Installed Tests list 3 Modify the Correlation Factor and Offset as required 4 Change the Lab Unit from the default if re
170. Orders list has a search facility click anywhere in the list and type the first few characters of the item you are trying to find e Select All or the user defined filter in the filter list on the toolbar to define what information is displayed on the tab e Press F1 to display Help for this tab Operator s Manual Version 1 2 B 119 9 Results Cedex Bio HT Calibration tab Calibration tab Use the calibration tab to review the calibration history of each test The functions on this tab are similar to those on the Validate tab lt amp Validate tab on page B 117 Results File Edt View Tools Window Help g 8 S a b Validate Y Sample Calibration Quality Conto Ix By Test Glucose V3 BioProcess Next Cal Due next lot Date Calibrated RO IP Flags Action GLUC3 15 Mar 2012 12 50 0 0017016 32 991226 65056701 14 Mar 2012 09 16 0 0014591 33 033851 65056701 12 Mar 2012 13 28 0 0016287 33 231793 65056701 Bele le el admin 27 03 2012 20 36 A The Test list shows all the tests on the system B The Results list shows the calibration history for the selected test Scroll right to display flags and actions and test and calibrator lot numbers If a dotted line is displayed in the Date Calibrated column instead of the date the calibration is running or is not accepted If a dotted line is displayed across all the columns a ne
171. Overview of user tasks 8 Basic principles 10 7 Status ae About Status 66 2 System description Status work area overview 67 Panels and logos 16 Missing amp Blocked tab 68 Modules and main components 18 Samples tab 70 Functional systems 19 Cassettes tah 72 System states Test Status tab 74 3 User interface Analyzer tab 76 A first look at the user interface 48 ISE tab 78 Work areas 49 Displaying item details 80 Working with the user interface 51 Selected tasks 82 Tips and techniques 53 8 Orders 4 Online Help About orders 84 Introduction 56 Orders at a glance 85 Starting and closing online Help 57 Orders work area 87 Help window 58 Worklist tab 89 Finding information 62 Sample tab 91 Context Help 65 Calibration tab 93 General Help 67 Quality Control tab 94 Message Help 68 Creating an order 95 Related topics 70 Working with Orders 102 Glossary te 9 Results About results 112 Operation B Results work area overview 116 5 Daily workflow Validate tab 117 Introduction 5 Sample tab 119 Daily start up 8 Calibration tab 120 Daily routine without sample barcode and without Quality Control tab 121 host 12 Selecting specific orders 123 Daily routine with sample barcode and without Displaying detailed information 125 host 17 Working with results 128 Daily routine with sample barcode and with host 22 End of day 27 User Manual Version 2 7 v INTEGRA 400 plus 10 Calibration Troubleshooting E About calibration 136 Calibrations
172. Repeat with fresh controls e TEST o Rerun the sample with postconcentration if a sample predilution factor is defined for this application Priority 30 Group CAL CNTL TEST Greater than test range The result is higher than the upper limit for the test e CAL o Repeat calibration e CNTL o Repeat with fresh controls e TEST o Rerun the sample with postdilution With TDM tests use manual dilution diluent or zero calibrator o Ifthe sample has already been postdiluted rerun the sample with a higher postdilution factor Priority 31 Group CAL CNTL TEST Greater than upper limit For a limit control the result is higher than the defined upper limit 1 Rerun with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve C 20 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags Attributes Meaning Recommended action Attributes Meaning Recommended action Attributes Meaning Recommended action Attributes Flags and recommended actions Priority 54 Group CNTL e CAL and CNTL Repeat The result was generated from a repeat e TEST Rerun The result was generated from a rerun No action required Priority 43 Group CAL CNTL TEST Diluted The result was generated using a diluted sample and the dilution factor was automatically applied to the result calculation
173. SE measurements are made in one of two measuring modes e Measuring direct e Measuring indirect In addition the electrodes are calibrated at regular intervals and recalibrated after each measurement You cannot switch between measuring modes manually this is always automatic Operator s Manual Version 1 2 F 9 17 ISE module How the ISE module works STAT orders Electrode service ISE Standby ISE service actions Cedex Bio HT ISE STAT samples are pipetted before routine samples Electrode Service is a service action that is automatically performed at Begin of Day BOD and during each electrode replacement While Electrode service is taking place the ISE module cannot carry out any tests An Electrode service contains the following steps The electrodes are cleaned with ISE Deproteinizer to prevent protein build up on the electrodes and in the tubing The surface of the sodium electrode is conditioned by etching e Electrodes are activated with Activator The Activator is pipetted into the ISE tower and drawn through the measuring channel Chapter 18 ISE service actions If there is no measurement after three minutes the ISE module switches to Standby state ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes ISE Calibrator Direct and ISE Reference Electrolyte are primed through the ISE module at fixed intervals every two
174. SE tower manually 3 If this does not fix the problem perform the service action Replace ISE tower You may have to perform the service action Clean ISE tower automatically more frequently If so reduce the service interval in the Service work area All electrodes 1 Perform the service action Electrode service 2 Calibrate and rerun the tests Clogged or dirty sample probes 1 Perform the service action Deproteinize probes 2 Replace probes if necessary Mixing washing or drying in the ISE tower not completed properly 1 Perform the service action Clean ISE tower automatically or Clean ISE tower manually 2 Contact Roche Service Electrode slope out of range for sodium or potassium Repeat the calibration with fresh ISE solutions 1 2 and 3 Perform the service action Electrodes service Repeat the calibration Replace the ISE tower use the service action Clean ISE tower manually a fF WN Check the expiration date of the electrodes Perform the service action Replace electrode if necessary All slopes out of range The measured slopes are outside acceptable limits ISE solutions expired Check the expiration date of all ISE solutions and replace those which have expired ISE tower clogged or dirty 1 Ifthe ISE tower is clogged replace it 2 Ifthe ISE tower is dirty perform the service action Clean ISE tower automatically or Clean ISE tower manually F 50 Operator s Manual Version 1 2
175. T Daily routine without sample barcode and without host gt To review test result details Click the Validate tab on the Results work area 2 Inthe To Validate folder select a sample calibration or control order 3 Double click a result line in the list of results The Result Detail dialog box is displayed 4 Click Rate Info The Rate Info dialog box is displayed 5 Review the information to check the reason for the flag Tips e Select an order and click Edit to switch to the Orders work area for editing e Right click an order in the Blocked folder and choose Detail from the context menu to see the test status of the blocked order on the Results Detail Test Orders dialog box gt To accept a result 1 Click the Validate tab on the Results work area 2 Inthe To Validate folder select a sample calibration or control order 3 Select a result from the list of results and click Accept Tips e Click Accept All to accept all the results of the selected order e Set the filter option of the Validate tab to Unaccepted to display only the unaccepted results of the selected order Printing the Final Report gt To print the Final Report 1 Choose File gt Print Report gt Final Report from the menu bar The Print Result Query dialog box is displayed 2 Define the ranges for Order ID and Order Date Click Print Tip Select Final Report in Configuration Database Automatic Actions to print the Final Report
176. You can check or change the grid position if you have the correct user access level on your system in Configuration Lab Racks Each rack has a number on the front tab of the rack and a barcode on the side The barcode scanner reads the sample and sample rack barcodes as you insert the rack into the sample rack platform Operator s Manual Version 1 2 A 31 2 System description Functional systems ISE rack Tubes and cups Cedex Bio HT In the rack definition dialog box Configuration Lab Racks each rack is assigned the following parameters Parameter Description Rack number A three digit number corresponding to the number you see on the sample rack label Rack code The number automatically read from the barcode label on the rack as it is inserted into the rack platform Rack name A user defined value that typically tells you the purpose of the rack For example a rack reserved for calibrators and control might be assigned a rack name of CAL QC Tube type Select the tube type for the specified rack Sample type Select the sample type for the specified sample rack Barcode If the box is selected the barcode labels on the samples tubes and adapters are read You can assign these positions in Configuration Lab Reserve Positions Slot O on the sample rack platform is reserved for the ISE rack Figure 0 21 ISE rack gt Chapter 17 ISE module You can use several different typ
177. You recognize the urgency of a message by the color of the icon on the Memo Pad navigation button e For urgent messages the icon text is displayed in white font on red background e For normal messages the icon text is displayed in white font on blue background e Ifthere are no messages the icon is displayed all white To read the Memo Pad Click Memo Pad on the navigation bar The Memo Pad dialog box is displayed Memo Pad x Time of Last Modification Monday 21 September 1998 14 By ADMIN Use the Memo Pad to leave messages for your colleagues f M Urgent Help Print Delete OK Cancel To leave a message for another user 1 Click Memo Pad on the navigation bar The Memo Pad dialog box is displayed Type your message Select the Urgent check box if the message is urgent Click OK Tip The Delete button deletes all text on the dialog box To delete selected text use the Delete key on your keyboard Operator s Manual Version 1 2 B 51 6 Routine tasks Printing reports Printing reports Cedex Bio HT The table below shows the reports that are available in each work area Report Available in work area Choose Begin of Day BOD Final Report Journal Loadlist Missing amp Blocked Quality Control Results Service Counters Service Intervals Service Notes System Counters Test Counters Worklist Status Orders Results Service and Configuration
178. a factor in the Dilutions dialog box To add a sample test several Right click the test in the Sample Test Summary group and times to an order choose Multiple Tests from the context menu Type the number of test in the Multiple Tests dialog box To create multiple copies of Right click in the Sample Test Summary group and choose an order Copy Order from the context menu Right click again in the Test Summary group and choose Paste Multiple from the context menu Type the number of orders you wish to create and accept or change the first order ID for the new orders Confirming the orders gt To print the worklist 1 Choose File gt Print Report gt Worklist from the menu bar and click OK to print the worklist B 18 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Daily routine with sample barcode and without host 2 Review the printed worklist to confirm that all orders have been entered correctly Printing the Worklist on page B 56 Start processing gt To start processing e Ifthe system is in Standby press F11 or click Start on the navigation bar e Ifthe system is in Sleeping press F11 or click Start on the navigation bar As soon as the system is in Standby press F11 again Tip If you work with Auto Start Configuration General System the system starts processing automatically as soon as you insert a rack provided there are orders that need to be proc
179. a and tab Work area Tab Tasks Status Missing amp Blocked Review missing and blocked orders and requests that could not be run no results Samples Review samples on board The color shows the status double click a rack position to display the details of the selected sample Analyzer Review the number of pending or blocked tests and the number of results to validate Orders All tabs No results are available in the Orders work Fi area HE Results Validate Review unaccepted results for orders Sample Calibration Quality Control calibrations and controls Accept sample calibration and control results that have not been automatically accepted Rerun tests as original or with dilution Rerun calibrations and controls as original Monitor controls over time Review rate information for unaccepted sample calibration and control results Find specific orders and samples Display specific information by selecting filter options Review all results whether accepted or not listed by order date and order ID Find results of specific orders Display specific information by selecting filter options Review details for specific tests or orders Review calibration curve parameters for a specific test Review calibration details in graphical form or as raw data Review QC results graphically by tests or controls Use the From button to review only a selection of QC results Select the control mode pre
180. ack of water B 46 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Managing resources e You do not have to disconnect the water reservoir B connectors from the rear of the instrument Emptying the external waste reservoir You do not need to perform this task if your system is connected directly to a laboratory waste system However you will get a resource alert if the laboratory waste system becomes blocked If the waste drain icon turns yellow or red in Status Analyzer or on the Status button you must empty the external waste reservoir Location The external waste reservoir is usually located underneath the instrument The reservoir is a 10 L yellow plastic container labeled Waste Tools and materials Protective gloves e Disinfectant e 1000 mL beaker Precautions Fluid waste is potentially infectious and must be handled using proper safety precautions e Always wear protective gloves while working with fluid waste e Clean any spills immediately according to the procedures established for your laboratory Warning gt To empty the external waste reservoir 1 Ensure that the system is in Standby or stopped switched off 2 Remove the tubing adapter A from the reservoir and place it temporarily in a clean 1000 mL beaker 3 Dispose of the fluid waste according to the procedures established in your laboratory 4 Rinse the waste reservoir with disinfectant and the
181. age F 45 NO ISECAL on page F 45 Non linear The first and last parts of the reaction curve have different slopes e CAL 1 Check reaction plot 2 Repeat with fresh calibrator e CNTL 1 Check reaction plot 2 Repeat with fresh control e TEST 1 Check reaction plot 2 Rerun with dilution or concentration if necessary Attributes Priority 20 Group CAL CNTL TEST NON MONO Meaning Curve not monotonic No calibration curve could be calculated because the rates of the calibrators were non monotonic C 12 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags Recommended action Attributes OUTLIERS Meaning Recommended action Attributes OUT OF RNG Meaning Recommended action Attributes p Meaning Recommended actions Attributes P Meaning Flags and recommended actions 1 Check the detail of the calibration 2 Ifthe calibrators were incorrectly positioned replace the calibrators correctly and rerun the calibration Priority 25 Group CAL Outliers For an FP measurement too many outliers occurred in the parallel or perpendicular intensity measurements Air bubbles in the sample or electronic noise may be the cause 1 Repeat with calibrators free of bubbles 2 Ifthe flag reappears contact Roche Service Priority 3 Group CAL CNTL TEST For ISE calibration see OUT OF RNG ISE on page F 46 Out of range Calibration curve or slope does not
182. agents vary between lots Therefore it is important to check the lot numbers each time you replace a cassette or a calibrator If you do not update the lot numbers and values recorded on the instrument erroneous results can occur Each calibration is assigned to a calibration mode by the manufacturer Each mode represents a type of calibration curve and calibration curve parameter From the calibration measurements the system calculates the values of the appropriate parameters called curve parameters based on the calibration mode Calibrators calibration points and curve parameters Linear calibrations Non linear calibrations Tests for most enzymes and substrates have linear calibration curves which require only a two point calibration For a linear calibration e A two point calibration is used one calibrator has a known amount of analyte the other is water which is the zero calibrator There are two curve parameters to be determined known as F and Ro e The calibrators are placed next to each other on a sample rack The calibrator with the highest concentration must be placed first lower numerical position on the rack Tests for some most specific proteins have non linear calibrations For a non linear calibration Between four and six calibration points are used depending on the calibration mode There are four Kc Rg A B or five Kc Ro A B C curve parameters depending on the calibration mode
183. ages Operator s Manual Version 1 2 B 67 7 Status Cedex Bio HT Missing amp Blocked tab Missing amp Blocked tab Use the Missing amp Blocked tab to see which samples calibrations or controls cannot be processed and why For example a sample may be listed as blocked because the cassette required to run a test on that sample is not on board Tas File View Tools Window Help ia S ia Se Missing amp Blocked Samples Cassettes Test Status Analyzer ISE Start Cassettes Samples a A Sy Expired 5 5 Not on Board goue E aSa Empty ar QC Cleaners Diluents ISE 4 B Z Expired o Lip e None 27 03 2012 11 43 A Click to expand if or contract if E the folder B Folder name tells you why the item is blocked C Double click any line to display detail for that item Tips The Missing amp Blocked tab does not show items that are correctly loaded and ready to run or items for which tests have already been run To display the details for an item do one of the following o Double click the item o Right click the item then choose Item Detail Select an item and press Space e Press F1 to display Help for this tab STAT orders are shown in bold Folders onthe Missing The following table shows the meaning and action required for each folder on the amp Blocked tab Missing amp Blocked tab B 68 Operator s Manual V
184. ailed information Double click a rack position on the Sample tab or an item on the Missing amp Blocked tab to display for example the following dialog box A Status of this sample B Slot ID rack number and position on the rack C Reasons why this sample is blocked Double click a rack number on the Samples tab to display the following dialog box SAMPLE 4 p o Cc F12 114_142HrFL Sample F12 113_142HrFL Sample F12 116_141HrSu Sample F12 115_141HrSu Sample F12 120 150 Sample D F12 113_141HrSu Sample F12 114 Sample F12 113 Sample F12 120 151 Sample Unknown fluid A Rack name Defined in Configuration Lab Racks B Order number control name or calibrator name C Sample type or other solution D STAT orders are shown in bold B 80 Operator s Manual Version 1 2 Cedex Bio HT 7 Status Displaying item details Cassette details Double click a cassette graphic on the Cassettes tab to display the following dialog box A Cassette In Use B NH3L D2 D Tests Left 66 150 E C pened 12 03 2012 Expiration 04 06 2012 69 days Lot No 65392201 Cassette No 2223 Tests Req d 0 A Status of this cassette B Cassette short name C Date this cassette was opened D Slot ID rack number and position on the rack E Number of tests remaining and total number of tests Tip The details box for cleaner cassettes looks similar Operator s Man
185. ained This option is required when connecting the laboratory water supply to the instrument thereby replacing the external water reservoir The ISE module uses system water from the water reservoir Fluid waste from the ISE module goes directly to the cuvette waste box Chapter 17 ISE module For each sample probe one pressure sensor for clot detection is mounted at the rear of the pipetting module They detect clots during aspiration of samples during washing of probes or when initializing the system When a clot is detected the probe is flushed and a message is displayed The run continues but no further pipetting is done from the sample cup that led to the clot detection or with the probe that is blocked No results are printed for the sample cup associated with the clot When an aspirated clot clogs the probe and the automatic washing steps cannot remove it the system stops sampling and goes into Standby as soon as all measurements are finished that currently are scheduled To remove the clot see Clot error after sample probe washing on page E 30 Clot detection can be enabled and disabled for each test individually in Configuration Tests General Cuvette transport system All photometric tests involving the FP and absorbance photometers are performed in transparent containers called cuvettes The cuvette transport system delivers new Operator s Manual Version 1 2 A 23 2 System description Ced
186. ally an order for the test that needs these cleaners or diluents Create an order for the sample or remove the sample e Ifa category has no entries the corresponding folders is not listed e A sample on the system without an order is listed as Without Order on the Missing amp Blocked tab e As long as the system is in Standby the status of blocked cassettes remains Blocked even if new cassettes were inserted As soon as the system goes into Operating state the status of the cassette is updated Operator s Manual Version 1 2 B 69 7 Status Cedex Bio HT Samples tab Samples tab Use the Samples tab to review the status and positions of samples calibrators controls and diluents loaded in slots I through N You can display details for individual tube positions or for a whole rack Status File View Tools Window Help 4 als t Missing amp Blocked Samples Cassettes Test Status Analyzer ISE 3 tart 1 Dil oe E 2 Cal ___ E F 3 Cal 9 4 ac fm a C a s a C 7 Cal mem 8 8 ft 3 3 i n 12 12 13 13 LP H 14 14 15 15 g ADMIN 23 10 2000 13 58 D A Samples E Diluent Double click ition to display details for that le ouble click any position to display details for that sample E Cator B Rack position G Quality control C Rack number H This rack has been removed Double click for more details D Slot iD Ti
187. an Deproteinize probes re i 100 Stop Clean probes and splash guard 16 12 gt iz Clean internal water reservoir tei gt gt l gi Clean wash station 8 gt gt a i A Clean ext water reservoir fluid waste 15 gt gt oi Clean instrument 1 16 gt gt a e Clean waste box fiting rti i anal 1 831 Miscellaneous ae i oh Prime fluid system ti 1 400 Sli B Roche service tai Pga a Backup database 20 i I 14 E Peplace nn T Replace ventilation filters 5 gt gt a1 Replace Abs halogen lamp 1261 oF 13 Replace probe B 9 gt gt 3i Replace probe C rat Loot iz Replace plunger tip dosage pipette B 110 1 gt 13 Replace plunger tip dosage pipette C 110 SS n 2i Replace dosage pipette B 10 to qi Replace dosage pipette C 104 root lal wood ae 1 Selected Service Actions 0 minute s Done Print raa ADMIN 20 04 2000 16 34 A Shows the time it takes to perform the service action in minutes gt gt is a service action with user intervention gt is an automatic service action without user intervention C Shows whether the service action is almost due less then 100 due 100 or overdue more than 700 D Click Perform to perform the highlighted service action The dialog box that lists the instructions for performing the service action is displayed E Click Done if you do not intend to perform the service action but wish to res
188. an reload them quickly in the unlikely event of a damaged disk When you archive or load definitions the data are stored in text files on a USB Memory Stick or on other media Archiving and reloading definitions on page G 19 The message log contains messages generated by the system You can access this log by clicking Messages on the navigation bar and then clicking the Message Log tab By default 200 messages are stored but you can change this number to a maximum of 2000 messages View Messages Options The oldest messages are automatically deleted when the system needs space for new messages To define the period during which message log information is kept Click Messages on the navigation bar Click the Options tab 3 Inthe Buffer Size box type the number of messages that should be kept in the message log The journal logs information about tests in the sequence in which they were pipetted The data in the journal older than a specified number of days are automatically deleted during BOD processing The journal is used most often in troubleshooting to help identify carry over problems between successive tests Most of the time you do not need to keep data in the journal for more than one day unless there are specific problems that you need to address To define the period during which journal information is kept 1 Click Configuration on the navigation bar 2 Double click Database Operator s Manual Ve
189. and replacing fuses Your are asked to confirm 2 Switch off the computer 3 Switch off the instrument at the main switch A 4 Isolate the instrument from the mains power supply by removing the power connector from the back of the instrument If you do not know how to do this do not attempt this procedure 5 When you are sure that the instrument is isolated from the mains power supply remove the left side panel B 6 Locate the two mains fuses C 7 Using a small screwdriver turn the fuse holder counter clockwise The fuse is spring loaded and pops out as you turn the fuse holder Operator s Manual Version 1 2 E 41 16 Troubleshooting Cedex Bio HT Checking and replacing fuses 8 Place the new fuse into the fuse holder and re insert 9 Replace the left side panel B 10 Reconnect the instrument to the mains power supply 11 Switch on the instrument at the main switch A 12 Switch on the computer 13 If the fuse fails again contact Roche Service Replacing the cooling unit fuse The cooling unit fuse is located on the left side of the instrument behind the left side panel It has the following rating Voltage range Fuse rating 100 125 VAC T8A 200 240 VAC T4A To replace the fuse you need the following tools and materials e Replacement fuse 4mm screwdriver To replace the cooling unit fuse 1 Follow the instructions To replace a mains fuse on
190. anee D 54 Replace plunger tip dosage pipette B or C w cceeesseessessesseessessesscsssesseessessesnesseeseess D 57 Replace dosage pipette B Or C eeceesessssesssssessesseessessesseesessessessessesssssessnessessessesseeseess D 61 Replace external water reservoir filter tee eesesseeseeseeseseeseeseesessesscsseseateneesseneeseeness D 64 Mama cing data sensan E E E yest Oates Database storag vosarisririn can seai Eai Ea EAEE EEN NESE iia Non database storage sess sseessssssessssssetressssettssssreressssrtressssrttessreresrertsssseertssserresssret Backing up your data Database messages ceviscicscccesccstvearvectecass iaiia iani i VE ia Where to save your datas niecnincnien onene ne i a a n D 72 Transmitting data to the host ssssssssessssssssssssessssssssessstteessnssssserseeeessnnersrteeesnssssssseeee D 72 Operator s Manual Version 1 2 D 21 14 Service actions Danger Warning Cedex Bio HT Before removing main cover disconnect mains plug from socket Hazardous voltage is present on ISE power supply even if main switch is off Danger of electric shock when touching power supply components Read and understand the Roche safety precautions at the beginning of this manual and the hazard and precaution notes contained in this chapter This information should be made available to all employees and kept for further reference Users must not perform any servicing except as explicitly described in this manual Main
191. anual Version 1 2 Cedex Bio HT 11 Quality controls Reviewing the status of controls on board 2 Select a rack from the Samples on Rack list and check the positions gt To load a control if rack positions have been predefined on page B 169 Tip Use Configuration Lab Reserve Positions to check the reserved positions Viewing missing and blocked controls If controls are requested and one or more of the required control s are not on board the missing controls are listed on the Missing amp Blocked tab in the Status work area and also on the Worklist tab in the Orders work area gt To view missing and blocked controls is 1 Click Status on the navigation bar 2 Click the Missing amp Blocked tab Cal QC Cleaners Diluents ISE m Expired H Blocked A Not on Board A Click amp to open the folder Controls are listed with their last rack number and position Alternatively 1 Click Orders on the navigation bar Fi 2 Click the Worklist tab Worklist Sample Calibration Quality Control F Blocked 4 Position Testname NH3 A Ee yNH3 a LN ij NH3 QC AMM AB fi Glue CAL Cas fOonral Status Blocked Status Text amp gluc postponed Senge AMM N Blocked Control not on board eE Not on Board 2 sj Calculated 6 sii New 2 A Double click the control to display information on the status of this control B The Blocked Status Text gives the reason why the
192. ard curve cannot be calculated due to calibration error CNTL Calculation error Concentration could not be calculated RAT Calculation error Result could not be calculated TEST Calculation error Concentration could not be calculated CAL 1 Repeat calibration with fresh calibrators 2 Ifthe calibrators were incorrectly positioned replace the calibrators and repeat the calibration CNTL o Repeat calibration and control RAT 1 Repeat calibration 2 Rerun sample with dilution TEST o Repeat sample Priority 24 Group CAL CNTL RAT TEST The result is below the critical low value Operator s Manual Version 1 2 12 Result flags Flags and recommended actions Recommended action Attributes gt Critical Range Meaning Recommended action Attributes CUR DIR Meaning Recommended action Cedex Bio HT Follow the laboratory procedure for critical value reporting Priority 56 Group RAT TEST The result is above the critical high value Follow the laboratory procedure for critical value reporting Priority 57 Group RAT TEST Curve direction The direction of the calibration curve is incorrect 1 Check the detail of the calibration 2 Ifthe calibrators were incorrectly positioned replace the calibrators correctly and rerun the calibration Attributes Priority 19 Group CAL d Meaning Deleted Std Result or replicate has been deleted Recommended action Reque
193. are positioned inside the wash pipes automatic step Probes are moved up and down automatic step Prime fluid system is performed automatic step Probes are activated automatic step SCAN OO F Ww Prime fluid system is performed automatic step Operator s Manual Version 1 2 D 23 14 Service actions Cedex Bio HT Clean probes and splash guard Clean probes and splash guard Overview You must clean the probes and splash guard regularly by hand to prevent any build up of deposits that may affect results The splash guard is a black plastic tray that prevents direct user access to the probes thus protecting them from accidental damage It also catches any drips of liquid on the outside of the probes preventing contamination of other parts of the instrument Duration 5 minutes Interval Weekly or after 3000 tests Tools and materials 70 ethanol solution e Protective gloves e Paper tissues e Soap Hazards The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious e Reagents can cause burns irritation and poisoning through skin contact Precautions Wear protective gloves e Take care not to bend the probes Further information Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software gt
194. area network this network must be protected against unauthorized access In particular it must not be linked directly to any other network or the Internet Customers are responsible for the security of their local area network especially in protecting it against malicious software and attacks This protection might include measures Warnin g such as a firewall to separate the device from uncontrolled networks as well as measures that ensure that the connected network is free of malicious code Q For further information contact Roche Service xviii Operator s Manual Version 1 2 Cedex Bio HT The 2nd LAN connector must only be used for Roche remote service connectivity If a remote I service connection is established over an insecure network via an AXEDA client the device os aa must be installed behind either a Roche connect 2 device or a cobas link gateway The use of Q an AXEDA client is the only approved and supported remote service solution Other non intended usage of the LAN connectors could lead to unauthorized database access resulting in possible disclosure or modification of sensitive data Operator s Manual Version 1 2 X X Safety labels on the system Cedex Bio HT Warning labels have been placed on the analyzer to draw your attention to areas of potential hazard The labels for the laser transmitter are listed below according to their location on the analyzer The safety labels o
195. art 3 Click Start Cedex Bio HT B 62 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Archiving system information Archiving system information Some useful hints Archiving the System Parameters Archiving the Complete Test Definitions To select what data you want to archive click Configuration on the navigation bar and choose File gt Archive Definitions What is stored General definitions Database definitions Processing definitions Result Handling definitions What is not stored ISE definitions General ISE Lab definitions What is stored Test definitions including user defined test definitions Calibrator definitions Control definitions Diluent definitions Cassette definitions Cleaner definitions only if the selected test is entered in the extra wash cycle table What is not stored Profiles definitions Calculated results Ratios definitions The following calibrator definitions lot number expiry date and values The following control definitions lot number expiry date and values Operator s Manual Version 1 2 B 63 6 Routine tasks Cedex Bio HT Archiving system information B 64 Operator s Manual Version 1 2 Cedex Bio HT 7 Status Status Review the status of your instrument This chapter describes the Status work area and how to use it It shows you how to review the status of samples cassettes tests system resource
196. ascvsssvaseeaasasdssbsvaceu raaa aE aaia ESR B 56 Printing the Work lists ssitss scsesssesstnascasevesstedessaadadennbabacevehossdsnnssesevestvastorsasesssanseasenstaven B 57 Operator s Manual Version 1 2 B 29 6 Routine tasks Cedex Bio HT Printing the journal sco eaer E E R E EEEE B 57 Printing Quality Control reports sssssssssssssssssssssssssssssssesststesssssssnneresssssnnesereeensssssss B 58 Printing service counters Printing service intervals Printing SErV1C NOLES esiciccccsssscsessteesestedSesevecaeccsteceeseweesees EE E Printing system counters Printing test counters cesses Purging and deleting information and items essessesesteseescsteseeneeseeneenennens B 62 Deleting raw data sssi pebra e aE A R Sa B 62 Purging and deleting orders sssssssssssssssssssssssessetssssssssssrstttesssssssnnsnsssnsssnneeereeessnsssss B 63 Purging results Database Reorganization Archiving system informatio spinii enin ean aE ER B 65 B 30 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Starting up and logging on to the system Starting up and logging on to the system vie Q7 The following procedures apply to the hardware configuration of Cedex Bio HT analyzer only Switching on the system Switching on the monitor Switching on the printer Switching on the instrument Always switch on the system components in the following order 1 Monitor 2 Printer
197. ase contact your city office waste disposal service or your local Roche Support personnel Disposal of the Instrument The instrument must be treated as biologically contaminated hazardous waste Decontamination i e a combination of processes including cleaning disinfection and or sterilization is required before reuse recycling or disposal Dispose of the instrument according to local and or labor regulations For more information contact your local Roche Support personnel Disposal recommendations All electrical and electronic products should be disposed of separately from the municipal waste system Proper disposal of your old appliance prevents potential negative consequences for the environment and human health xvi Operator s Manual Version 1 2 Cedex Bio HT z Disposal of Control Unit Components Components of your Control Unit such as the computer monitor keyboard etc which are marked with the crossed out wheeled bin symbol are covered by the European Directive on Waste Electrical and Electronic Equipment WEEE These items must be disposed of via designated collection facilities appointed by government or local authorities For more information about disposal of your old product please contact your city office waste disposal service or your local Roche Support personnel Disposal of the Instrument The instrument must be treated as biologically contaminated hazardous waste Decontamination
198. assed service action status 14 cycles duration 39 User Manual Version 2 7 Index d flag 8 daily routine with sample barcode and with host 22 with sample barcode and without host 17 without sample barcode and without host 12 daily startup 8 daily workflow 3 damage electrode 10 11 19 damaged cables 35 Danger symbol xiii DARK ERR flag 8 data backing up 41 72 location for storage 73 management 66 transmitting to host 73 types of 66 data handling specifications 10 data processing 41 data station 35 computer 6 main features 5 Database icon 20 database backup 48 full 72 messages 72 reorganization 61 storing data 66 database export 44 date and time 48 day to day tasks 3 29 default unit parameters modifying 9 definitions archiving 19 loading those of calibrators 158 missing 69 Definitions group 6 INTEGRA 400 plus deleting calculated results definitions 14 calibrator definitions 159 control definitions 182 control requests 170 in Results work area 130 orders 60 109 66 orders at BOD 109 orders from Results work area 131 orders of specific date 132 profiles 12 raw data 60 70 results 130 67 single order 109 single result 131 test definitions 9 tests from an order 108 users 21 Depro
199. associated flag s e RAT o Repeat calibration and tests after taking the appropriate action for the associated flag s e TEST o Repeat calibration and test after taking the appropriate action for the associated flag s Priority 39 Group CAL CNTL RAT TEST Erroneous result e CAL CNTL TEST The result is either erroneous or has been corrected recalculated and the result has been accepted e RAT Result calculated using erroneous sample results which have not been accepted e CAL 1 Check calibrator s reaction curve to establish the cause of the deviation 2 Repeat calibration with fresh calibrators e CNTL o Repeat test with fresh control Operator s Manual Version 1 2 C 15 12 Result flags Flags and recommended actions R 1 2s Attributes Meaning Recommended action R 1 8s Attributes Meaning Recommended action R 2 2s Attributes Meaning Recommended action Attributes Cedex Bio HT e RAT 1 Review controls 2 Repeat calibration 3 Repeat sample if necessary e TEST 1 Check reaction curve to establish the cause of the deviation 2 Repeat test Priority 38 Group CAL CNTL RAT TEST Westgard rule 1 violated One quality control result deviated from the assigned mean in either direction by more than 2 standard deviations 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibrati
200. associated tests To assign a control to a test 1 Click Configuration on the navigation bar 2 Double click Tests in the Definitions group 3 Select the required test from the Installed Tests list 4 Click the Control tab 5 Select the required control Controls After Interval Sequence QC Check A Control Cale e A E T 7 PAL Prom x P COP Poe A B PPa wR CPP PP None x None zi None B None zi A Click here to list all the controls then select the one you want to assign B No control defined Click here to list all the controls then select the one you want to assign 6 Select the QC treatment check box to enable the QC rules and ranges for this test The control results are automatically listed in the Results work area as they are calculated If you clear this check box QC rules and ranges are not checked Specifying control intervals on page B 187 Operator s Manual Version 1 2 B 183 11 Quality controls Cedex Bio HT Setting up controls x installed Tests ID General Dilutions Control Laboratory Evaluation A pN Glucose V3 BioProcess Load po A BSE o ori m IGGHB T Interval Tests Delete IGGLB a Hours F z ISE D Print K D Controls Help LAC LDH After Interval Sequence QC Check Control C 1 23456 PAL NAD peeseeese hii PNorm M m mm J c PPan AM COOP Pie i eae a None v None v No
201. ata Raw data are the numerical values of the physical measurements made by one of the measuring modules Since each result comprises many measurements the amount of raw data can become very large very quickly To prevent this from happening you can choose either of two options e Delete Raw Data after accepting results e Delete Raw Data after n days gt To delete raw data after accepting results Click Configuration on the navigation bar Double click Database in the System group 1 2 3 Click the Automatic Actions tab 4 Select the Delete Raw Data after accepting results check box 5 Click OK To automatically delete raw data after a certain period of time Click Configuration on the navigation bar Double click Database in the System group Click the Automatic Actions tab Select the Delete Raw Data after check box a AON In the Delete Raw Data after box type the number of days you want raw data to remain on the system 6 Click OK Tips e Type 0 zero to delete at the next Begin of Day all of today s raw data that is all raw data generated between the time of the last and the next Begin of Day time e Type 1 to delete at Begin of Day all raw data that were generated more than 24 hours before Begin of Day time Purging and deleting orders You can purge orders manually at any time or delete them automatically at BOD The main reason for purging orders is to free the order IDs for re use Pr
202. ate of the system determines what actions you can perform You can force some changes of state by pressing the function keys F11 and F12 or by clicking the Start and Stop buttons on the navigation bar all other changes are automatic Figure 0 26 shows some of the states and how the system moves between them The boxes represent the states and the arrows represent transitions between states The icons represent the Status button on the navigation bar when the system is in that particular state Operating E Auto Service Service A an A F12 Stop Start L F11 y Y Standby F12 Stop Initializing A A Start F11 y A Sleeping Figure 0 26 System states not all states are shown Automatic transition Manual transition user action F11 START key on the keyboard F12 STOP key on the keyboard Start Start button on the navigation bar Stop Stop button on the navigation bar Starting up and logging on to the system on page B 31 A 42 Operator s Manual Version 1 2 Cedex Bio HT 2 System description System states Transitions between states The following table shows the icons on the Status button and the predominant Operator s Manual Version 1 2 A 43 2 System description System states Cedex Bio HT background color for the main transitions between system states state 1 to state 2 S
203. ated with the calibrator are displayed The Calibrator Test Summary lists all current requests for calibrations romn mooo Click Save to save the calibration request Tips e Only calibrators with current requests are displayed A full calibration means that all the calibrators defined for the test up to a maximum of six must be run The calibrators must be placed in consecutive positions on the same rack e When precalibrating a second cassette make sure that the corresponding controls are loaded on the instrument If precalibration is performed without having the corresponding controls loaded on the instrument subsequent QC will be performed using the first calibrated cassette e Manual requests do not reset the automatic intervals until the calibration is accepted e For an ISE Multi test selecting a calibration for any ISE test performs the calibration for all electrodes No additional ISE tests are run until the calibration is accepted e You cannot delete calibrations that are running To delete a calibrator definition on page B 159 e Press F1 to display Help for this tab B 146 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Postponing a calibration Postponing a calibration Caution Preconditions When the system requests a calibration you can overrule this request by postponing the calibration You can postpone a calibration by moving the due date or event for the
204. ation Part of the Cedex Bio HT system consisting of computer monitor and optionally a printer Dead Volume Volume remaining in a cup or tube after the last correct pipetting of maximum possible sample pipetting volume Degasser A module that removes gas bubbles from the fluid system and helps to improve both accuracy and precision in systems where dissolved gases cause problems Demographics Information about an order Determination The process of quantifying the concentration of analytes Deviation Difference between the assigned value and an actual value of a control sample Diluent A liquid used to dilute samples for example physiological salt solution or to affect an analytical reaction Direct Mode ISE ISE measurements made on an undiluted sample Flag Generated by software printed with results and also displayed with individual results in the Results work areas Indicates that the limit of an internal check was exceeded or not reached Fluid System Consists of all tubing pumps valves filters and other devices that support sample reagent diluent and cleaner dispensing Fluorescence Polarization FP A measurement method where a sample is irradiated with light of a specified excitation wavelength Fluorophores in the reaction mixture for example fluorescein labelled reagents emit light at a second wavelength fluorescence and the emitted light is detected at 90 to the excitation beam A filter me
205. ation bar The icon identifies the resource shortage for example when the cuvette supply is low a cuvette icon is displayed The background color of the icon shows whether the alert is a warning yellow background or a critical situation red background The Analyzer tab in the Status work area shows the status of all the resources and system temperatures Additional information relating to the ISE module is displayed in the ISE tab Checking resources on page B 42 The system can perform a test only if all the items required for that test are loaded and all the items are current The system automatically identifies any missing and blocked items Item status Meaning Not on Board The item is not on board Blocked The test calibrator control or sample cannot run because a prerequisite has not been satisfied For example the system cannot run a test if the test cassette is not on board The test is labeled Blocked until you load the required cassette Missing and blocked items are listed on the Missing amp Blocked tab in the Status work area By reviewing this information regularly you can quickly identify the steps you need to take to maintain the throughput of tests on your system B 66 Operator s Manual Version 1 2 Cedex Bio HT 7 Status Status work area overview Status work area overview To access the Status work area click the Status button on the navigation bar choose Window gt Status or
206. ator s Manual Version 1 2 Cedex Bio HT 3 User interface Working with the user interface Working with the user interface Command buttons Check boxes Folders Drop down lists Context menus Scroll bars Option buttons The user interface contains many functions that are familiar to Windows users and a few that are unique to this interface Click a command button to perform a particular function For example click OK to request the specified number of tests Multiple Tests x Number of Gluc Tests p Click once on a check box to select the suggested value 7 TestEnabled 2 Click again to clear the check box I TestEnabled A grayed check box with or without a tick shows a preselected F Enabled value which you cannot change Typically this means that the values have been set in other dialog boxes or have been preset on your system It may also mean that you do not have sufficient user privileges to alter this box Tip You can select more than one check box at the same time in the same window 1 Double click a closed folder A to open it to show its A contents m Expired 5 Empty 2 Double click an open folder B to close it B 9 cus Tip You can also single click H to open the folder and single click H to close it 1 Click the Down Arrow to expand a drop down list Cassette amp Interval ow 2 Select an item from the list Nene Interval Cass Lot amp Interval
207. atory e Never tilt the waste box If you do so there is a risk of spilling of contaminated waste if the waste box is not properly closed e Store the removed waste box in an autoclaves plastic bag or dispose the waste box immediately e Dispose of the old cuvette waste box and its contents according to your local regulations for the disposal of hazardous waste To replace the cuvette waste box Wait until the system is in Standby 2 Construct the new cuvette waste box according to the instructions inside the cuvette waste access panel B The cuvette waste box is supplied with a yellow bio B 48 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Managing resources hazard sticker already in place A Remove the full cuvette waste box C taking care not to spill any of the contents 5 Puta rectangular sticker D over the holes in the top of the waste box 6 Insert the new waste box taking care to ensure that the lip around the middle of the box fits into the guide rails 7 Close the cuvette waste access panel The system asks you whether the cuvette waste box is empty Click Yes if the new box is empty 9 Dispose of the old waste box and its contents according to your local regulations for the disposal of hazardous waste Operator s Manual Version 1 2 B 49 6 Routine tasks Cedex Bio HT Checking due service actions Checking due service actions Service actions are tasks
208. automatically as soon as the last result of an order is accepted Printing the Final Report on page B 53 B 16 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Daily routine with sample barcode and without host Daily routine with sample barcode and without host Keep your system running Loading samples on board To load samples on board 1 Place the sample tubes and cups on the appropriate racks 2 Insert the rack into one of the slots in the sample area Tips e You can use only one tube type per rack e Ifyou use tubes that are not defined on your system you may damage the probes e Before you move a rack wait until the status light above the rack is green Loading samples on page B 38 Creating orders Create an order in three steps x File Edit View Tools Window Help CFAA EES Worklist Sample Calibration Quality Control Start A Nrdar liz T o n Stop Tests amp Profiles r Sample Test Summary Sample Type Semple zj Sample Tube Position Position v Cup On Tube M a I a uc Test Profile Group General xl D Glue New GL D 1 GLU B beens GU Gluc IGGHB F j IGGLB K D LAC LDH NAD NH3 Q F STAT Save Clear admin 28 03 2012 13 22 A Select an order ID from the list B Select tests and click Save lt lt Creating an order on page B 95 B 17 Operator s Manual Version
209. be clean so that the analyzer can perform an error free initialization of the transfer arms 16 minutes Every six months e 70 ethanol solution e Non abrasive soap e Cuvette waste box tray e Paper tissues e Cuvette waste box e Hex driver 3 mm unlock rack tool e Protective gloves e The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious e Reagents can cause burns irritation and poisoning through skin contact e Wear protective gloves e Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software To clean the instrument Select Clean instrument in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 Open the rack access panel on the front of the instrument A D 36 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean instrument 4 Remove cassette racks B sample racks C and the ISE rack D 5 Open the main front cover 6 Remove the cassette area initialization post insulator E 7 Use the unlock rack tool to remove the screw from the cassette rack platform F Remove the platform 8 Use the unlock rack tool to remove the screw from the sample rack platform G O
210. ble Name of the user logged on at the time the message was created The selected message Double click to display details on this message Click to confirm the selected message zo7 moOgo BD gt Click for Help on this dialog box this does not give Help on the selected message Tips e You click Confirm to inform the system that you have fixed the problem in the message e If you have not fixed the problem the system will either not restart or the same message will reappear again if the same conditions are met e Confirmed messages are automatically transferred to the message log E 6 Operator s Manual Version 1 2 Cedex Bio HT 15 Messages Message Log tab Message Log tab Use the Message Log tab on the View Message dialog box to review messages that you or other users have already confirmed as resolved Double click any message to display the Message Detail dialog box View Message x New Messages Message Log Options om7m7moo ws 8 27 9817 01 FP high voltage V out of range 300 700 LABTOS E 8 27 98 17 00 Database logon failed LABTO3 8 27 98 17 00 Rack position slot position 13 not defined ADMIN Be 8 26 98 14 31 A hardware problem has been detected in the resource controller i ISE solution standard 1 not on board LABTU3 F A 8 26 98 14 29 Error in file c roche instrument Log Trace tra occurred amp 7 16 9817 01 Diagnostics not start
211. ble click a message to get more information Follow any Help or instructions contained in the message to remove the cause or causes of the message if you have not already fixed the problem from the original message dialog box e Ifyou need to refer to the message again use the message log Displaying message details To display message details 1 Click Messages on the navigation bar 2 Click either the New Messages or Message Log tab Double click a message Jo oO Operator s Manual Version 1 2 E 9 15 Messages Working with messages Printing messages Cedex Bio HT The View Message Detail dialog box is displayed View Message Detail x Date amp Time 1970472000 14 46 Message ID fig 5e3 Message Not enough fluid was detected in slot J position 10 a peal the tid level in the tube or cup in this position Ifthe B lp On Message Print Help sample volume is too small for the tube being used transfer he sample to a smaller tube if possible fe Internal Information Threadname 0x86 DAM_ExpRec Session ID No Session Cc Message 8 of 158 A Long text of the message B Click for Help on this message C Service and diagnostics information D Click for Help on the dialog box not message Help You can print a list of messages from either the New Messages tab or the Message Log tab Tip To print a list of new messages Click Messages on th
212. bout a cassette including the test s for which the cassette is used and a list of cassette and lot numbers that have been used for this type of cassette G 6 Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration Development Channels About test definitions What is a test definition About the Definitions group Click the Cassettes icon to review load or delete a cassette definition Development Channels are used to run non Roche reagents on Cedex Bio HT systems Up to 10 Development Channels can be implemented This function is optional and has to be activated with an extra license Call Roche Service for further information You use the Configuration Test Definitions dialog box to load review and modify test definitions The dialog box lists all the currently installed tests on the left When you select a test the details are automatically listed on the right A test definition contains all the information the system needs to run tests including e Basic test information such as names and number e The default sample type e Calibrator name and calibration intervals e Automatic post dilution post concentration factors Controls and control intervals e Correlation factors and laboratory units e Result evaluation and reference ranges To use the Configuration Test Definitions dialog box 1 Click Configuration on the navigation bar 2 Double click the Tests icon in the Definitions group L
213. brator is not on board e There are no calibration results that were obtained on the basis of this calibrator e The calibrator is no longer assigned to a test You first need to assign a new calibrator to the test Configuration Tests General Assigning a new calibrator automatically deletes calibration results that were obtained on the basis of the previous calibrator Operator s Manual Version 1 2 B 159 10 Calibration Cedex Bio HT Setting up calibrators B 160 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Quality controls Validating tests to ensure the integrity of your system This chapter tells you how to load set up and request quality controls and how to analyze quality control results In this chapter Chapter 11 About controls a a oct Oat Controlsat a glance aneii E ERE Reviewing the status of controls on board Viewing rack positions for Controls Viewing missing and blocked controls ssseeseeee Reviewing a control definition Loading controls on board Requesting controls sca r EE ENEA Requesting a control manually csceesesssessessesssessesseessessessesssessesscssesseessesseeses B 168 Deleting a controlirequestizss sscsscsssssnssssssscensscsoovsesupevossibesvsscuserasevosascnssevesusosupevegent B 169 Reviewing and validating control results 0 ccecesesseessessesssessesseescsseessessesseessesseeaes B 170 Reviewing control
214. brator lot When you change calibrator lots you have to specify the lot number and expiration date and the assigned values of the new lot The procedure to update calibrator lot numbers and values depends on whether you scan the barcode or enter it manually gt To manually update a calibrator lot number fF ON Click Configuration on the navigation bar Double click Calibrators in the Definitions group Select the required calibrator from the Calibrators list Click the Lot tab Configuration Calibrator Definitions x Calibrators D Lot Calibrator for automated syst New Cal LotNo 161458 New Lot Load Exp Date 1703 2073 ane Delete Concentration fests Std 1 1 96 g L Std 2 0 00 g L Far lac Ea LDH Close Click New Lot Type new values for the Lot No Lot Number and Exp Date Expiration Date taking the values from the calibrator package insert Click Save Select a test from the Test List Type new values for each calibrator in the set Std 1 Std 2 and so on also taking these values from the calibrator package insert 10 Click Save Tips The system must be in Standby or Sleeping mode B 154 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Setting up calibrators e You must have the required user access level to perform this procedure e Results obtained using calibration curves on the basis of the previous lot values of this calibrator a
215. buttons and text formats assist you in moving around topics For moving to different topics see also Button bar on page A 59 Operator s Manual Version 1 2 A 59 4 Online Help Cedex Bio HT Help window Click this In order to w or the following Jump to a subsection of the topic blue text gt or the following Jump to another topic blue text Display path information in a pop up window You find this button in the banner bar of context Help topics 4 or the following Go back to the parent topic to which the current topic provides additional information blue text Sample pop up Display information on this word or expression in a pop up window Blue text In running text jump to another topic or to a subsection of the topic Go back to the beginning of a topic Becta Display a list of the most important related topics This button is only active if there is at least one such shortcut on the current topic Tips e Click S or on the button bar to browse through Help information and thus gain an overview on a particular subject e Some general Help topics provide at the beginning a list of subsections of the topic Click w or its associated text to jump to subsections Clicking amp in the banner bar brings you back to the beginning of the current topic To find a different subsection of the topic select another list element e In topics such as reference information on dialog boxe
216. calibration control and diluent definitions xii Operator s Manual Version 1 2 Cedex Bio HT Safety classifications Danger Warning Caution Safety information Danger Danger The safety precautions and important user notes are classified according to the following description Before you attempt to use the Cedex Bio HT analyzer you must be fully familiar with the following symbols and their meanings Indicates a direct danger that if not avoided may result in death or serious injury Indicates a possibly hazardous situation that if not avoided may result in death or serious injury Indicates a possibly hazardous situation that if not avoided may result in slight or minor injury or may result in damage to equipment Before operating the Cedex Bio HT analyzer it is essential that you both read and understand the safety information listed below Read all Roche safety notices carefully and make sure you understand them Electrical safety Danger of electric shock when touching power supply components Never attempt to access any parts of the instrument other than those specifically described in the user documentation In particular never open or manipulate any components on the rear of the instrument Electrical safety Before removing main cover disconnect mains plug from socket Hazardous voltage is present on ISE power supply even if main switch is off Danger of electric shock
217. calibration The period by which you can postpone a calibration depends on the way the calibration interval is defined for the test Due date or event Postponement period Interval Interval Each new cassette Until the next new cassette Each new lot Until the next new lot The Cedex Bio HT system is delivered with predefined calibration intervals for each test The calibration intervals are carefully defined to guarantee reagent performance within the set on board stability and shelf life of the reagents Roche does not recommend to change these default calibration intervals Any change may alter the reagent performance and as a result may lead to erroneous results The following conditions must be met before you can postpone a calibration e A sample order exists for the test e Anautomatic calibration for the test is due now the calibration interval has run out e When working with a host an accepted and unflagged calibration must have been transmitted to the host e The test is blocked Folders on the Missing amp Blocked tab on page B 68 To postpone a calibration 1 Click the Calibration tab on the Orders work area 2 Inthe Calibrator Test Summary group right click the test that now requires a calibration and choose Postpone Calibration from the context menu The calibration for the selected test is postponed by the period allowed for this test Tips e Inthe Calibrator Test Summary group you ca
218. calibrators on board s 1 Click Status on the navigation bar 2 Click the Samples tab Samples controls and calibrators are displayed graphically Cal indicates the presence of a calibrator 3 Double click a calibrator line to display details For example Calibrator Expired GLN Std 2 101 8 Expiration 30 09 2011 180 days Lot No 57132553 What if The calibrator is expired Replace the expired calibrator with one that is not expired Specifying values for a new calibrator lot on page B 154 The calibrator is empty Replace the calibrator Make sure the lot number is the same as the previous calibrator If the calibrator is from a new lot you need to update the lot number first Setting up calibrators on page B 154 Calibrators controls and diluents on page E 20 The calibrator is blocked One or more of the calibrators are not available or the test cassette is empty Replace the cassette s as required gt Blocked orders tests calibrations or controls on page E 19 The calibrator isnot on Load the required calibrator Make sure the lot number of the calibrator you load is board the same as that specified in the calibrator detail The calibrator definitions The system has detected a calibrator but the calibrator definition is missing or are missing incomplete Loading and deleting calibrator definitions on page B 157 Displaying the remaining calibration interval for tests Us
219. ce Check in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online prompts as required 3 ISE Calibrator Direct is transported to the electrode block and remains there for 45 seconds automatic step 4 Subsequently ISE Calibrator Direct is transported again to the electrode block and the first measuring starts automatic step Step 4 is repeated ten times ISE Calibrator Indirect is transported to the electrode block and remains there for 45 seconds automatic step 7 Subsequently ISE Calibrator Indirect is transported again to the electrode block and the first measuring starts automatic step 8 Step 7 is repeated ten times 9 Click Next 10 Click Show Values 11 The measured values Mean Min Max the Standard Deviation SD and the Coefficient of Variation CV for all electrodes in the respective modes are displayed 12 Click Print 13 Click Cancel Send the printout of the measured values to Roche Service Operator s Manual Version 1 2 F 37 18 ISE service actions Cedex Bio HT ISE Performance Check F 38 Operator s Manual Version 1 2 Cedex Bio HT 19 ISE flags and troubleshooting ISE flags and troubleshooting Solving problems with the ISE module This chapter describes some of the common problems that you may get with the ISE module and the actions you should take to overcome them It describes the result flags that may be generated with ISE measur
220. ce actions are called the BOD service actions While these service actions are being performed the system cannot run any tests However you can terminate BOD if you need to run urgent STAT orders Operator s Manual Version 1 2 A 13 1 System overview Cedex Bio HT Basic principles A 14 Operator s Manual Version 1 2 Cedex Bio HT 2 System description System description Finding your way around the system and its hardware This chapter gives an overview of the hardware and provides more detailed information about the main functional systems Some of the features described are available only if your system is configured to support them In this chapter Chapter 2 Panels and l gOS fiai eana aeaeaie aa aaae ESEE AAEE NAERA REEE A 16 External connetOtS isina E E a A 17 Modules and main components 00 0 scessesesessesesseseeseeseeseeseesssscsscsesesscseeaeeaeeseeseeneaness A 18 Functional systems Elid Sy St tin mirre E EO REE Cuvette transport system cccessssesesesessssssesesesessssesssescsssesssssssesssssssessessssessssseseesess A 24 Rack syst etiseri essentie enoii isiel A 27 Robotic transfer syst m sierra n y A 35 Analyzer m d lessirsiisesiiesirisiiii i a A 37 Computersysteme E A A E OA A 40 Systemi stats w cescsscsssscseierssstesesssersconssesecstsssseostscouesesec sedetetaresesesoreconssedecatbsesesstecounsedecstesesees A 41 Transitions between states t asestie rases ake s Eois retoke senna A 42
221. cel A Stop pipetting samples but finish processing tests that are already in progress B Stop all system operations immediately The system aborts all current activities The system may need special attention before it can resume its normal operation Tips e Ifthe system is already in Standby when you click Stop it goes into Sleeping e Ifyou stop the run immediately all the partially run tests are stopped In practice this means you lose all the reagent control calibrator and sample material for any tests that have been started but not yet completed Operator s Manual Version 1 2 Cedex Bio HT 15 Messages Restart processing Start Re initializing Stopping and restarting the system The background color of the Status button tells you what the current system state is green means Operating unless there is a resource alert System states on page A 42 You can also use F12 to stop the processing The Start button serves to start or restart a run When the system is in the Stopped AutoService or Operating status the text of the Start button changes to Restart Tips Clicking Restart causes the system to perform a re scheduling of all sample orders For example clicking Restart after inserting a new rack into the system while in Operating status causes the system to start pipetting on the sample rack that is positioned furthest to the left You can also use F11 to start or restart t
222. ces of tests run on the system or to troubleshoot the causes of carry over errors For example you can run a sequence of test trials to isolate which tests are responsible and then specify extra wash cycles to solve the problem The flag listed in the Journal for a specific test is not necessarily the final flag for that test The flag if any in the Journal is a temporary flag that was active when the pipetting took place This flag is often overwritten or removed from the final result To review flags for a result use the Sample Calibration or Quality Control tabs in the Results work area Caution gt To print the journal 1 Click either Status Orders Results Configuration or Service on the navigation bar 2 Choose Tools gt Journal from the menu bar The Journal dialog box is displayed 3 Select the items you wish to print and click Print Printing Quality Control reports Use the Quality Control reports to review the quality control history of individual tests You can select what results you want to include in the reports Content and layout of the report depend on the view type you selected in the folders list of the Quality Control tab B 56 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Printing reports Selected features of a Quality Control report A Quality Control report consists of several separate reports one for each test and one for each control type Each single report conta
223. chanism is used to Operator s Manual Version 1 2 4 Cedex Bio HT determine the parallel and perpendicular components polarization of the emitted light and thus the concentration of the analyte in the sample FP Photometer Device used to make Fluorescence Polarization measurements It consists of a blue LED light source See Light Emitting Diode optics shutter dc motor driving a two position polarization filter photomultiplier light amplification tube and associated high voltage electronics See Fluorescence Polarization Function Keys Keys F1 to F12 along the top of the keyboard used to enter specific commands Grid See Tube Height Adapter Host Computer External computer of the customer s Laboratory Information System communicating with the Cedex Bio HT instrument Allows rapid processing of the large quantities of data generated Communication between the Host and the Cedex Bio HT analyzer is provided by the Cedex Bio HT Host Interface See Host Interface Host Interface Hardware and software allowing bidirectional communication between the Cedex Bio HT data station and the Host Computer The hardware is an RS 232 serial interface See Host Computer Identification Number ID Number used to uniquely identify samples cassettes tests calibrators controls and diluents Indirect Mode ISE ISE measurements made ona diluted sample Initialization Status while the system performs any
224. check that no fluorescence comes from the sample control e TEST 1 Ifsingle sample flagged rerun with dilution 2 Ifthe flag reappears Check that no fluorescence comes from the sample control For some tests you need to dilute the sample with zero calibrators Attributes Priority 22 Group CAL CNTL TEST ISE UNSTAB ISE UNSTAB on page F 44 lt KIN READ Meaning Not enough kinetic readings C 10 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags Recommended action Attributes LOW ACT Meaning Recommended action Attributes lt LOW LIM Meaning Flags and recommended actions Insufficient absorbance readings were found in the linear part of the reaction to be able to calculate a rate Not enough readings in kinetic range for calc mode Kinetic or Kinsearch e CAL 1 Check Rate info reaction plot 2 Repeat with fresh calibrator 3 If little reaction occurs replace cassette e CNTL 1 Check Rate info reaction plot 2 Repeat with fresh control 3 If little reaction occurs replace cassette e TEST 1 Check Rate info reaction plot 2 Repeat with dilution if necessary 3 Iflittle reaction occurs replace cassette Priority 21 Group CAL CNTL TEST Low activity The absorbance change during the measurement is lower than the defined limit e CAL 1 Check reaction curve in Rate Info 2 Check if correct calibrator was used 3 Repeat with fresh calibrators e CNT
225. cision accuracy or limit Review statistics for each control mode Review details for QC results including lot numbers Display specific information by selecting filter options B 114 Operator s Manual Version 1 2 Cedex Bio HT 9 Results About results Use the following table to locate specific tasks in the Configuration work area Icon Tab Tasks Laboratory e Specify correlation factor and offset for each e Specify for each test lab units and a Tests conversion factor if necessary Evaluation e Specify the result evaluation mode for each test reference ranges cut off limits Automatic Actions e Specify the period after which result raw data Pp is automatically deleted Database All tabs e Turn result handling on or off Calibration e Specify actions for flagged and non flagged Result Handling Quality Control Sample Calculated Results calibrations for each test class Specify actions for flagged and non flagged control results for each test class Specify actions for flagged and non flagged sample test results for each test class Specify actions for flagged and non flagged calculated results Operator s Manual Version 1 2 B 115 9 Results Results work area overview Results work area overview Context menu Cedex Bio HT To access the Results work area click Results on the navigation bar The Results work area has the following tabs Tab Function
226. ck Clear to remove all the assignments from the rack e You can also use the Place Items dialog box to assign positions B 144 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Requesting calibrations Requesting calibrations Fi Most calibrations are scheduled to run automatically but you may need to request a calibration e Ifyou start a new calibrator lot e Ifyou change the test definition e Ifmore than one cassette for the test are currently on board e Ifcontrol measurements are outside the specified range e Ifall calibrations of the current lot are manually deleted Recommendations e You should run any related control measurements after a calibration If the calibration and control are not flagged you can accept the calibration provided this is not configured to be done automatically anyway e You should not accept a flagged calibration without further investigation To request a calibration 1 Click Orders on the navigation bar 2 Click the Calibration tab 3 Inthe Tests amp Profiles group click the buttons for the tests that you want to calibrate If more than one cassette for the test is currently on board the Calibrate dialog box is displayed when you click a test button in the Calibration tab in the Orders work area xl Calibration Full Correction Select cassette to calibrate Cfas Cassette Lot Position Status D22 65056701 Help Skip
227. cks When the instrument is not in operation you can release racks manually by using the unlock rack tool to press the release button shown in Figure 0 19 Do not release racks manually when the instrument is in operation If you try to press the release button while the instrument is pipetting there is a risk of damaging your hands and the probes Danger Rack status indicators The rack status panel A contains a set of small lights LEDs light emitting diodes that show the status of the rack immediately below the light The logo on each light tells you the type of rack cassette sample or ISE The color and whether the light is blinking or steady tells you the status of the rack A 28 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Functional systems Cassette rack Sample rack ISE rack The following table tells you the rack states and the user actions you can perform in each state If you see This means User action No light e There is no rack in the slot You can insert a rack into the rack Green light steady Green light blinking Red light steady Orange light blinking e The rack has been inserted correctly and is ready to be processed or The processing of the rack is completed e The rack is being loaded and rack identification is taking place or e The rack is being removed e The rack is locked because it is being processed Pipetting is in
228. click Finish in the Service work area A calibration is run before any new samples or controls are processed automatic step F 30 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Condition ISE tubing Condition ISE tubing Overview Duration Interval Begin of Day System state Tools and materials Hazards and precautions gt This is an automatic service action that does not require manual intervention When ISE module tubing has been replaced it must then be conditioned to ensure the ISE module runs correctly 3 minutes None No Standby e Activator e ISE Calibrator Direct Bio HT ISE Reference Electrolyte Bio HT See General safety precautions on page F 16 To condition tubing Select Condition ISE tubing in the Service work area Click Perform Probe C pipettes Activator into the ISE tower automatic step ISE module tubing is filled with Activator automatic step Activator is transported to the fluid waste automatic step Steps 3 4 and 5 are repeated twelve times N o Ff FF WOW ND ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes Operator s Manual Version 1 2 F 31 18 ISE service actions Replace ISE solutions on the ISE rack Cedex Bio HT Replace ISE solutions on the ISE rack Overview Tools and materials Hazards Precautions This is a gene
229. code lines that are represented by a red box in the Line Status group of the Barcode dialog box e Click Reset to delete all lines and restart the whole reading process 6 When all lines are read correctly all boxes are green the Barcode dialog box closes automatically and a message is displayed informing you of the successful conclusion of the reading process Tips e To read and edit the read lot information use Configuration Calibrators Lot or Configuration Controls Lot e Make sure Caps Lock on your keyboard is switched off e Ifyou work with laboratory units other than the Roche standard units the values read from the barcode sheet are automatically converted to your laboratory units provided you specified the Lab Unit Factor Configuration Tests Laboratory Specifying a calibration interval Caution The calibration intervals for each test are defined in the test definition You can reduce and extend the calibration interval of a test The Cedex Bio HT system is delivered with predefined calibration intervals for each test The calibration intervals are carefully defined to guarantee reagent performance within the set on board stability and shelf life of the reagents Roche does not recommend to change these default calibration intervals Any change may alter the reagent performance and as a result may lead to erroneous results To specify a calibration interval 1 Click Configuration on the nav
230. content Copy the file ickv3519v2 exe to a USB Memory Stick Switch the Cedex Bio HT analyzer to Standby mode a Fo nN Connect the USB Memory Stick to the USB port of the computer of the Cedex Bio HT analyzer 6 Press Windows key E on the keyboard of the computer of the Cedex Bio HT analyzer to open the Windows Explorer 7 Click the USB Memory Stick to display its content 8 Copy the file ickv3519v2 exe 9 Change directory to C Roche Instrument TAS in the open Windows Explorer 10 Insert the file ickv3519v2 exe into this folder 11 Double click the file ickv3519v2 exe The WinZip SelfExtractor dialog box is displayed 12 Click Extract to continue The message 557 file s successfully extracted is displayed 13 Click OK 14 Click Close to close the WinZip SelfExtractor 15 Click the X in the top right corner to close the Windows Explorer Operator s Manual Version 1 2 20 Configuration Loading test application software Cedex Bio HT amp To load a TAS via diskette 1 Choose Tools gt Load TAS Diskette from any work area The first Load TAS Diskette dialog box is displayed Insert the TAS diskette in the internal or external drive Click Yes to continue The second Load TAS Diskette dialog box is displayed On the second Load TAS Diskette dialog box e Select the a drive from the Drives list e Select TAS Files ick EXE from the List files of type list e Select the appr
231. control is blocked Reviewing a control definition A control definition contains information about a control and the tests for which it is used amp To review a control definition ee 1 Click Results on the navigation bar ar 2 Click the QC tab 3 Double click a control name Operator s Manual Version 1 2 B 167 11 Quality controls Cedex Bio HT Reviewing the status of controls on board The Control Definition dialog box is displayed Configuration Control Definitions x Controls ID Lot Precinorm U New Control LotNo 160344 New Lot Load Exp Date 06 30 2013 Gaus est List F ni Delete Assigned Mean 0 87 g L Print K D AssignedSD 0 04 g L LAC Help rts ete Pe ee cee es Me ee x v 1 A LDH 1 Accuracy F i 7 NAD Assigned Value 0 18 g L 7 B t 1 A List of tests that use the selected control B In this example the Accuracy QC mode is selected and the assigned values are entered B 168 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Loading controls on board Loading controls on board If the tubes containing your controls are barcoded place them on a rack with the barcode showing and load the rack onto the instrument If your system is not configured to use barcodes follow one of the following procedures To load a control if rack positions have been predefined Rack positions may have been previously defined for controls
232. controls gt To delete a control request Click Orders on the navigation bar Click the Quality Control tab y In the Control Test Summary click the H to open a control folder A ON Right click the required test name and choose Delete from the context menu Tip Controls that are running are grayed out and you cannot delete them Operator s Manual Version 1 2 B 171 11 Quality controls Cedex Bio HT Reviewing and validating control results Reviewing and validating control results If a control result falls outside the defined limits a flag is created and you must validate the result You should not accept a flagged control result without further investigation Controls that run without creating flags are accepted automatically provided the system is configured to do so Configuration Result Handling Quality Control To review flagged control results click the Validate tab in the Results work area To review control results that have been accepted either automatically or manually click the Quality Control tab in the Results work area Reviewing controls for validation Controls that require validation are displayed in the Validate tab in the Results work area gt To review controls for validation Click Results on the navigation bar Click the Validate tab Select the required test from the To Validate folder A ON Perform the actions required from the flags generated Double click the contro
233. ct the suction pipe or the level switch from the instrument B 4 Replace the liquid filter C 5 Reinstall the tubing adapter D 64 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace external water reservoir filter 6 Click Finish Operator s Manual Version 1 2 D 65 14 Service actions Managing data Managing data Database storage Purging and deleting orders Cedex Bio HT The system generates a large amount of data that is stored on local disks You must manage this data so that there is always enough space for the system to continue processing The system stores most of its data in tables in an on board database The amount of data that can be stored in these tables is limited also even if the tables are not full the system needs disk space for its own working data for example the system logs Users have no direct control over the operation of the database other than to define configuration parameters for the system The space for the database tables is allocated dynamically and is reclaimed automatically when no longer required The performance of the database is essential to the performance of the system The system issues messages to warn you if table space in the database is running out or if performance is likely to be impaired Follow the recommendations in the messages for dealing with these problems The following types of data are stored in the database e Orders
234. cunn els B 12 Loading samples on board esessessesssessesseessessesssessestessessessnessessessessessessessessese B 14 StArt PLOCESSIN Ges scicvcssissovssvsss sosvastevesvsnssenstessenvescssvessvessvessessevosvsvessestossessesssscessvesseeesaass B 14 Validating results ansann E aeee EE EEE B 15 Printing the Final REpOrtssscsccssssscsoscssovsstesesesstsvscesossssvessdanessssssecusstsssvusetotssensseseessthoys B 16 Daily routine with sample barcode and without host s sssssssssssssssssssssssessssssssssssseee B 17 Loading samples on board sninn aai naia B 17 Creating Order Serinin na an A E REAA E ARERR B 17 Confirming the Orders sena hni B 19 Start ProOceSSINE dpsie nir nS R E E EEE E ENE B 19 Validating res ul tse scccssetscos vessvessvensces paseceserastwesnutivesessasvstcostvessuanesesopueavegetpsavenspesideirts B 20 Printing the Final Report ieseni a E E E EEE B 21 Daily routine with sample barcode and with host occ csesseesessesseesesseens B 22 Loading samples on board seeessesesssesesseesessessessesnsssessesstessessesstessessesssessesseess B 22 Start PFOCE SSIS iaraa an aE E E E E REE eee B 22 Monitoring scheduled orders ceeessesssessessesssessessesssessesseescssesssessesseessessessessessese B 22 Validating resultsranisire irn an a ETAT B 23 Creating orders hitite eee ereas oa E e ae oase eisie eidi B 24 Operator s Manual Version 1 2 B 3 5 Daily workflow Cedex Bio HT Table of contents End Of Ay seccticsscat va
235. d lt Critical Range e For qualitative tests that depend on the direction of the reaction the following abbreviation is used o POS The value is above the cutoff limit The cutoff limit is defined in Configuration Tests Evaluation Calculated results ratio You can print a calculated result together with the tests these results are based on In Configuration Processing Report Layout Print Seq you can define where in the report the calculated results should appear You can choose to have the Final Report printed automatically without any user intervention To have a report printed automatically Click Configuration on the navigation bar Double click Database in the System group Click the Automatic Actions tab Select Final Report from the Automatic Printouts list Click OK The Final Report will be printed as soon as our WN o All tests of the order are complete o All results associated with the order are accepted The loadlist contains all orders known to the system They are listed by their rack positions in ascending order starting with the lowest rack position of the rack with the lowest rack number The list shows all rack positions to which samples were assigned either automatically by barcode reading or manually see Assigning samples to racks on page B 96 If you work with barcodes and without a host system or if you work without barcodes use this list to load the samples on
236. d an order ID A el definitions l Calculator open the calculator Paste copy details from a tool eB previously saved order into the current order Clear clear the current order If Print Print the current screen Z the order has not previously been E saved all details are lost z Copy copy details of the current Save save the current order order into memory so that you can j Orders work area retrieve them into another order later on Test Calibrations Show the test Se Begin of Day Start the Begin of calibrations Ed Day actions manually Place Items Display the Place Barcode Display the Barcode Items dialog box mj dialog box Tip If a function is not currently available the corresponding toolbar button is grayed out A 52 Operator s Manual Version 1 2 Cedex Bio HT 3 User interface Tips and techniques Tips and techniques Context menus right mouse button Windows shortcut keys Here are a few suggestions that may help speed up your work Use the right mouse button to display N a context menu A for the currently oD gerass selected item The context menu ap 1 K_ Sample Handing contains a list of frequently used aD1iG commands relevant to the item you i DIL Dilutions have selected a D 1 LI Copy Orde This is almost always quicker than Paste Order using the menu bar because you do Paste Multiple A not have to search the menus Delete Clear Reset Validate To
237. d to guide you through the steps Q To perform a service action the instrument must be in Standby status gt To perform a service action Click Service on the navigation bar is Do one of the following e Click the Due tab to display service actions that you must perform soon e Click the All tab to display all service actions whether they are due or not e Click the Begin of Day tab to display service actions that are performed automatically at the Begin of Day 3 Select the service action to be performed and click Perform The service action dialog box is displayed A typical example follows 4 Follow the instructions listed on the dialog box Service Clean ISE Tower Manually Caution Weer protective gloves Pull out the ISE module Remove the ISE mixing tower Immerse the ISE mixing tower into deproteinizer solution for 5 minutes Rinse the mixing tower thoroughly with deionized water Dry the mixing tower Reinstall the ISE mixing tower Insert the ISE module Click Next gt to perform a tube conditioning and to activate the electrodes Progress Time Remaining A Lists the instructions for you and the actions that the system performs B Click Next to go to the next set of steps Click Finish when you have completed the service action Click Cancel to cancel the requested service action Click Help for more information on the selected action Tips For more detailed informat
238. dd tests to a completed order Operator s Manual Version 1 2 B 105 8 Orders Cedex Bio HT Working with Orders Copying data from orders and tests You can copy a set of tests from one order to another or from one order to several others gt To copy tests from one order to another Click Orders on the navigation bar Click the Sample tab Display an existing order that contains the tests to be copied A OON Right click anywhere in the Sample Test Summary and choose Copy Order from the context menu Click Save to save the order o Click Clear to clear the text boxes Type a new order ID in the ID box This is the order to which the tests will be copied 8 Right click anywhere in the Sample Test Summary and choose Paste from the context menu The tests are displayed in the Sample Test Summary group 9 Add order demographics as required 10 Click Save Tips e You can modify the new order as required e Step 4 You can also choose Edit gt Copy Step 8 You can also choose Edit gt Paste gt To create multiple copies of an order 1 Click Orders on the navigation bar 2 Click the Sample tab 3 Create an order containing the tests to be copied 4 Right click anywhere in the Sample Test Summary and choose Copy from the context menu ol Click Save to save the order o Right click anywhere in the Sample Test Summary and choose Paste Multiple from the context menu The Paste Multiple d
239. defined group of tests for example all STAT tests Test groups are only available if they were previously defined in Configuration Definition Test Select the Cup on Tube check box to indicate that you want to use the predefined secondary cup on top of the primary tube for the selected sample type This option is only available if a sample type other than Automatic is selected The Sample Test Summary group lists the tests selected for the current order Select this check box to give the order STAT priority Click Clear to clear the boxes in the tab Click Save to save the current order Tips To request a dilution double click a test name to open the Dilutions dialog box or right click a test name and choose Dilutions in the context menu Requesting a dilution on page B 107 Operator s Manual Version 1 2 B 91 8 Orders Cedex Bio HT Sample tab To review the results of completed orders use the Sample tab in the Results work area To review flagged results use the Validate tab in the Results work area Working with Orders on page B 102 The system can handle up to 1000 test requests at any one time If you request more the system will accept 1000 tests and issue a message Press F1 to display Help for this tab B 92 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Calibration tab Calibration tab Use the Calibration tab to create modify postpone review or delete calibration re
240. deleting orders see Purging and deleting orders on page B 109 E 1 Click Results on the navigation bar ar Click the Validate tab In the Validate list right click an order and choose Delete from the context menu The Confirm Delete dialog box is displayed The text on this box tells you exactly what data will be deleted Operator s Manual Version 1 2 B 131 9 Results Working with results Deleting an empty orders folder Archiving results Cedex Bio HT 4 On the Confirm Delete dialog box click Yes to delete the order or No to cancel the deletion request Tips You cannot delete an order if a test belonging to that order is running or if the sample is on board You can delete orders in the Sample tab in the Results work area To delete all orders for a specific date Click Results on the navigation bar Click the Sample tab Right click the required date and choose Delete from the context menu The Confirm Delete dialog box is displayed On the Confirm Delete dialog box click Yes to delete all the orders or No to cancel the deletion request To delete an empty folder Click Results on the navigation bar Click the Sample tab Right click the folder in the Samples amp Orders list and choose Delete from the context menu The Confirm Delete dialog box is displayed On the Confirm Delete dialog box click Yes to delete the order or No to cancel the deletion request Type 0 zero in
241. dialog box Assigning user levels to functions To assign user levels Click the User Level tab 2 Select the user levels to be assigned to each function by clicking in the appropriate check boxes Selecting a function for a specific level automatically selects this function for all higher levels 3 Click OK to accept the new settings and close the dialog box Tips Click Default to return all the settings to the original pattern set by Roche There are six definable user levels that govern functionality for menus buttons and modifiable data Generally users with high user levels will find greater flexibility in using the system with more buttons menus and boxes enabled Operator s Manual Version 1 2 G 21 20 Configuration Windows group Windows group Keyboard Mouse Printers Regional Settings Sounds Cedex Bio HT Use the Windows group to configure or reset the following standard Windows features Double click the Keyboard icon to review or modify the layout language and other keyboard settings Double click the Mouse icon to review or modify the buttons speed and other settings for the mouse Double click the Printers icon to review or modify the choice of printer and printer settings Contact Roche Service before you install a new printer Double click the Regional Settings icon to review or modify e regional settings e number formats e date and time style keyboard settings
242. diluents Remove processed racks e Create orders and request calibrations and controls e Monitor the status of the instrument check resources and Missing amp Blocked in the Status work area e Validate results Troubleshoot problems A 8 Operator s Manual Version 1 2 Cedex Bio HT 1 System overview Overview of user tasks e Remove waste for example used cuvettes or waste liquid e Delete results and orders Cleaning the instrument externally Service actions You can clean the instrument externally with a cloth and a soap solution with mild disinfectant or a solution of 70 ethanol Incorrect cleaning materials can damage the Cedex Bio HT analyzer Do not clean the instrument while it is switched on e Do not use organic cleaning solvents for example petroleum benzene petrol or other solvents because they can damage cuvettes tubing and other plastic materials e Do not use an alcohol solution with a concentration of greater than 70 alcohol because this may damage transparent viewing windows Do not use sodium hypochlorite solution because it causes corrosion on metal parts You must perform all internal cleaning tasks according to the instructions given in the user documentation and provided online as part of the software assisted service actions You review and perform service actions in the Service work area The system prompts you when service actions are due Operator s Man
243. dling Settings ann la gp Cleaners ISE Cassettes Solutions tH E Develop Channels rch 02 21 2006 15 44 The tasks included are designed to help you become familiar with the following definitions e Tests e Profiles e Calculated results e Calibrators e Controls Diluents e Cleaners ISE Solutions e Cassettes Development Channels optional Configuration comprises three groups Definitions System and Windows However only those tasks primarily associated with the Definitions group have been included in this manual The exception is that the System group tasks of defining user access and level have also been included The primary function of each of the three groups in the Configuration work area is summarized in the table below Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration Further tasks Use this group Definitions System Windows Configuration overview To review or modify Definitions of tests calibrators controls profiles calculated results cassettes cleaners ISE solutions diluents archives and Development Channels optional System settings including general database lab setup result handling and processing Windows settings including printer keyboard mouse regional and sound settings e Archiving and reloading definitions e User Access You find more information about the Co
244. e depending on the number of results that need to be deleted Click Stop to stop purging results Note however that any results that were deleted before you pressed Stop are lost and cannot be restored D 68 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Archiving results Reviewing archived results Exporting raw data Managing data gt To delete a single result Click Results on the navigation bar 2 Onany of the tabs right click an item and choose Delete from the context menu The Confirm Delete dialog box is displayed The text on this box tells you exactly what data will be deleted 3 On the Confirm Delete dialog box click Yes Tip Depending on your user rights this option may not be available to you You can save results on the system for future reference If you archive results in this way you cannot reload them onto the system you can only review them To archive results Click Results on the navigation bar 2 Choose File gt Archive The Archive Results dialog box is displayed 3 Select the type of results to archive and optionally a date range Click Archive The Archive Result File dialog box is displayed 5 Select the F disk drive and specify a file name file type and a folder for the archive 6 Click OK Note This is not a backup facility You can use the review facility to browse the archived results To review archived results Click Results on the
245. e the folders are listed by sample type D Sample Test Summary O em o o o A Sample Sarstedt 2 0 mL 5 9 E aD 1 GLU B m 2 Gluc New c H 110 New A Sample type is given by the folder name Click to expand a folder or to collapse it B A duplicate has been ordered for this test You can order multiple tests so that you can run a variety of dilutions for example The Multiple Tests function is available for sample tests only ie Single test ordered with dilution Default tube type m Position of the sample on the rack TipsDouble click a test line to open the Dilutions dialog box to request dilutions Requesting a dilution on page B 107 Rack number information is available when o The sample is on board and has been identified by its barcode o The rack position for the sample has been manually assigned Click Save to save any changes that you have made to the order Adding tests to an existing order When you have created and saved an order you can open it at a later stage and add more tests To add tests to an existing order Click Orders on the navigation bar Click the Sample tab Type the order ID in the ID box Press Tab A ON The background in the ID box is grayed out so that you cannot alter the order ID o Click the required profile buttons Click the required test button 7 Click Save to save the order Tip You can a
246. e Cedex Bio HT analyzer from the main power supply Instrument in use Danger of injury to hands by moving parts Keep the instrument cover closed while initialization or measuring is in progress Malfunction of instrument and incorrect results due to interfering electromagnetic fields Devices that emit electromagnetic waves may cause the instrument to malfunction Do not use this device in close proximity to sources of strong electromagnetic radiation e g unshielded intentional RF sources as these can interfere with the proper operation Sample Danger of infectious sample material which can cause severe illness Avoid direct contact with sample material Clean contaminated surfaces immediately and dispose of waste according to regulations Sample Samples containing solids can produce incorrect results or block probes For good sample quality follow the instructions given by the primary tube manufacturers Light source Danger of eye damage from the bright light of the absorbance photometer lamp Always wear dark safety glasses when looking at the light Waste Danger of infectious waste material This can cause severe illness Avoid direct contact with waste xiv Operator s Manual Version 1 2 Cedex Bio HT gt Warning gt Warning gt Caution gt Caution gt Caution gt Caution gt Caution gt Caution Carry over Traces of analytes may
247. e Sample tab 119 for data on the Validate tab 118 for water 23 Final Report calculated results 54 printing 53 printing automatically 54 ranges 54 Find function 103 toolbar button 52 Find Orders dialog box 103 finding information in Help 62 information in other Help topics 59 information within Help topics 59 orders 102 related Help information 64 samples 102 words in Help topics 63 fire hazards safety precautions xiv flags in journal 72 ISE 43 51 of controls 162 of results 5 results 3 21 flags results and recommended actions 6 fluid sensor ISE module 8 28 fluid system 19 priming 46 schematic 11 fluid waste reservoir cleaning 33 fluorescence polarization 40 foam on samples 27 safety xv folders 51 deleting when empty 132 in Orders list 90 on Missing amp Blocked tab 68 on Validate tab 118 font size on Help window 61 FP xii FP photometer 40 eee 9 UNSTAB flag 9 front cover 16 INTEGRA 400 plus function keys 54 to access work areas 49 fuses replacing 40 replacing for controller 42 replacing for cooling unit 42 replacing on instrument 40 F11 key 42 13 2key 42 12 key 54 F6 key 54 F7 key 54 F8 key 54 General icon 20 general Help 67 displaying 67 Glossary Help button 59 glossary online 71 grid 31 halogen lamp replacing 51 handheld barc
248. e a problem and you should not accept them without careful consideration gt To accept a result B 1 Click Results on the navigation bar 2 Click the Validate tab 3 Inthe To Validate folder of the Validate list select an order calibration or control 4 Select a result and click Accept L O y gt l Accept All ecept Rerun pE ADMIN 14 05 2000 14 45 A A Accept all results which are listed for the selected item B Accept the selected highlighted results only gt To rerun atest 1 Click Results on the navigation bar 2 Click the Validate tab 3 In the Validate list select an order calibration or control 4 Select a result B 128 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Working with results 5 Click Rerun E Accept All Accept Rerun lt A ADMIN 14 05 2000 14 45 A Rerun the selected test Tips e When you click Rerun the Dilutions dialog box is displayed Requesting a dilution on page B 107 e Rerunning a calibration automatically reruns the corresponding controls and any sample tests for this test provided the results of the control and tests were not accepted Monitoring processes When the same test has been performed several times for the same batch you can use the statistics facilities to compare the test results over time amp To show statistics for results of a batch 1 Click Results on the
249. e existing ones You use profiles in the Orders work area to request groups of tests quickly without having to select individual tests Operator s Manual Version 1 2 20 Configuration About the Definitions group gt ll Cedex Bio HT To use the Configuration Profile Definitions dialog box 1 Click Configuration on the navigation bar 2 Double click the Profiles icon in the Definitions group Creating and modifying profile definitions gt To create a new profile definition 1 Click the ID tab 2 Click New 3 Type the profile name It can have up to eight alphanumeric characters 4 Type a profile number in the range of 910 930 This number must be unique among the test profile and calculated results ratio numbers ol Click the Tests tab and click one or more test buttons to select the tests for the profile Click Save Click Close N To load a Roche profile 1 Click Load 2 Specify the path where the source files are located The default path is C Roche Instrument TAS 3 Select the profile to be installed 4 Perform the following steps for each profile e Click the ID tab e Modify the short name of the profile if required The short name can have up to eight alphanumeric characters e Modify the long name of the profile if required The long name can have up to 30 alphanumeric characters To view and modify profile definitions 1 Click the ID tab 2 Choose a Profile
250. e menu bar or click H on the toolbar The Load Definitions dialog box is displayed Select the definition to be loaded Click OK Specify the path name of the archive from where the definitions are to be loaded Click OK Select the item to be loaded Click Load on Oo oO FF WwW KN Click Cancel to complete the process Operator s Manual Version 1 2 G 19 20 Configuration Cedex Bio HT System group System group Generally the system group is used to modify Cedex Bio HT system settings that have been loaded during the installation process by Roche Service personnel You can subsequently modify settings using the dialogs in the System group You can make modifications only if you have the appropriate user access level The procedures for defining new users and user access levels are described here Use the System group to configure general system settings and database setup You can also specify tubes and racks define how results are handled and modify processing options General Click the General icon to configure general details including user access and levels host interface system details barcode specification ISE settings Database Click the Database icon to configure the database for automatic actions order demographics result comments and activation of QC rules Lab Click the Lab icon to specify sample tubes and types assign tubes to racks and define racks for calibrators controls diluents and ISE so
251. e navigation bar The View Message dialog box is displayed Click the New Messages tab Click Print This procedure prints only non confirmed messages for problems that have not yet been resolved gt 1 3 a 1 2 Tip To print the message log Click Messages on the navigation bar The View Message dialog box is displayed Click the Message Log tab Click Print The message log contains messages that have been confirmed and therefore have been automatically removed from the list on the New Messages tab E 10 Operator s Manual Version 1 2 Cedex Bio HT 15 Messages Putting the system into Standby Putting the system into Standby How you do this depends on the state the system is already in The Status button on the navigation bar tells you what the system state is a EEEE Service Standby Operating Sleeping actions Initializing If the systemisin 1 Click Stop Operating state In the Stop Action dialog box click Sampling Stop 3 Click OK If the system is in Sleeping 1 Click Start state The system performs a partial initialization and then goes into Standby If the system is performing Wait until the BOD actions or service actions have finished The system returns to BOD actions or service Standby automatically GOONS Tip You cannot use Stop to force the system into Standby when it is performing BOD actions or service actions If the system is Initializing Wait until initializatio
252. e rack is on board With on board racks you are alerted by a message if you try to assign a sample to a position that is not free e Assume you work with barcodes and you have created an order while the rack was not on board and then you insert the rack If the system detects a discrepancy between the rack position you defined and the position read from the barcode the Sample Handling dialog box is displayed It contains the rack position read from the barcode e Changes in the system while the Sample Handling dialog box is displayed such as inserting a rack are not automatically reflected on the open Sample Handling dialog box Close and re display the Sample Handling dialog box to see the changes in the Rack and Position lists e You can print the Sample Handling dialog box Selecting Cup on Tube You can define one cup the Cup on Tube as the secondary cup you want to use on top of primary tubes Configuration System Lab Sample Tubes Cup on Tube Tip You cannot enable Cup on Tube using the Place Items function To enable Cup on Tube while working with barcodes Remove the sample rack from the system 2 On the Sample tab of the Orders work area type the Order ID barcode number and if necessary select the tests 3 Inthe Tests amp Profiles group select the sample type from the Sample Type list In the Tests amp Profiles group select the Cup On Tube check box This option is only available if the defaul
253. e required service actions from the Due tab Click Perform A OON Perform the service actions according to the on screen instructions Click Help for full details _ Chapter 14 Service actions Chapter 13 Service action software Logging off gt To log off 1 Double click the user ID in the status bar 2 Click Log Off Logging off and shutting down the system on page B 35 Logging off the system on page B 35 Shutting down the system on page B 35 B 28 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Routine tasks Performing everyday tasks to keep the system running This chapter describes the routine tasks that you need to perform to keep your instrument running In this chapter Chapter 6 Starting up and logging on to the system sssssssssssssssssssssssssssterssssssssntessssssssnnertttesssssssss B 31 Switching on the systemo tse datasets B 31 Starting thesinstruiment sirina a TEE EROE EEEE B 32 Logging onto thesysteni sriid eaa E AA B 33 Logging off and shutting down the system sss ssssssssssssssrsssssssssssssrersssssssretteesssssssnsrseee B 35 Logging off the systeM cesssssesssessesseessessesseessessesstessessessessesstescssessessessesssessesseess Shutting down the system Re Starting and stopping a run SLOP a disiscecssvivensssesescussetssvessnessesonssecsssveseasestosseveossgtorsessberseodeceusasbvvodcossevcosssensestego
254. e test in the Sample Test Summary group and sample test choose Dilutions from the context menu Select or type a factor in the Dilutions dialog box To add a sample test several Right click the test in the Sample Test Summary group and times to an order choose Multiple Tests from the context menu Type the number of tests in the Multiple Tests dialog box To create multiple copies of Right click in the Sample Test Summary group and choose an order Copy Order from the context menu Right click again in the Test Summary group and choose Paste Multiple from the context menu Type the number of orders you wish to create and accept or change the first order ID for the new orders To confirm rack positions 1 Check the automatically assigned rack number and position for each sample type listed on the Sample Handling dialog box Modify the position if required 2 Select the Cup on Tube check box if the sample is placed in a secondary cup on a primary tube 3 Click OK Tips The Sample Handling dialog box is displayed when you click Save When a sample type is used for the first time on a day you must assign it manually to the appropriate rack position using the Sample Handling dialog box Afterwards all other rack position assignments are done automatically by the system Enter the rack number and position for samples manually on the Sample Handling dialog box if the function Automatically Assign Rack Positions is not
255. e to be transmitted to the host Operator s Manual Version 1 2 D 73 Cedex Bio HT 14 Service actions Managing data gt To transmit selected results 1 3 Use Configuration Processing Result Output to select Host Interface Transmission for the kind of result you want to transmit Select the required results in the Results work area Choose Tools gt Transmit Selected Data from the menu bar Example Transmit specific sample results N o f F WN 9 Use Configuration Processing Result Output Check that Sample is enabled In the Results work area click the Sample tab Select the required folder Click H to open the folder Select the required results Choose Tools gt Retransmit Selected Data from the menu bar The Confirm Retransmit Data message is displayed Click Yes A Retransmit to Host message is displayed Check that the required data were sent 10 Click OK Tip Step 7 The command is shaded unless your selection contains one or more results Do not change any host interface settings unless you are sure they are incorrect D 74 Operator s Manual Version 1 2 Troubleshooting Part E describes messages generated by the system what they mean and how to deal with them It also describes specific problems and gives step by step procedures on how to deal with them Cedex Bio HT 15 Messages Messages General problem solving techniques This chap
256. ea 89 workstations 39 B 39 C 39 FP 39 In Out 26 39 writing message on Memo Pad 51 lt Critical Range flag 7 lt KIN READ flag 10 lt LOW LIM flag 11 lt REAG RNG flag 18 lt RR flag 19 lt TEST RNG flag 20 48 gt flag 21 gt ACC RNG flag 6 gt AG EXCESS flag 6 gt Critical Range flag 8 gt REAG RNG flag 18 gt REPL DEV flag 19 gt RR flag 19 gt STD DEV flag 19 gt TEST RNG flag 20 48 gt UP LIM flag 20 flag 21 INTEGRA 400 plus I 30 User Manual Version 2 7 Revisions Use this section of the manual as a repository for updates to the Cedex Bio HT Operator s Manual You can also use this section to insert your own notes about the system so that all information about the system is in one place
257. econditions You can only purge an order when B 60 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Purging results Purging and deleting information and items e There are no pending tests belonging to this order The associated results have been accepted The associated results have been transmitted to the host if necessary e The associated samples have been removed from the system To purge orders manually on page B 109 gt To delete orders automatically at BOD on page B 109 To delete a single order on page B 109 The Cedex Bio HT analyzer is not designed to store safely large quantities of results on the system As part of data management you should periodically purge results manually At least every 2 months is recommended The system should be in the Standby or Sleeping state when purging results When purging results the following information is deleted e Results e Calculated results that were derived from purgeable results e Test orders Order IDs If you archive the results in the results work area you need to purge the results regularly Tips e Before you purge results you should archive your current calibration control and sample results File gt Archive Results e To delete a sample use Results Sample o Right click the order ID and choose Delete o In the Confirm Delete dialog box click Yes For details and procedures on purging results see
258. ecting another group Group box or typing in the name of the test or profile Test Profile box Alternatively if the test is not installed contact your system supervisor to see if this test can be made available The automatic order numbering facility is enabled This means that each time you create an order the number is automatically increased for the next order You can manually type over the suggested order ID if you prefer Operator s Manual Version 1 2 B 101 8 Orders Working with Orders Cedex Bio HT Working with Orders y Finding orders Specifying search criteria When you have created an order you can perform the following operations in the Orders work area Look up orders Review the tests in an order Add tests to an existing order Copy tests from one order to another Make multiple copies of an order Request a dilution Delete tests Delete orders These operations are described in the following sections You can choose between two methods of finding certain orders With the Lookup function you type the search criteria directly in boxes on the Sample tab With the Find function you first start the function by clicking H on the toolbar and then type your criteria in the Find Orders dialog box This method offers more elaborate search criteria You can use a wildcard or in your search where represents a single character and represents one or more characters I
259. ects clots during aspiration and dispensing of samples during washing of probes or when initializing the system When a clot is detected a message is displayed Coefficient of Variation CV Statistical measurement used to evaluate imprecision Ratio of the standard deviation to the mean of a set of replicate measurements CV SD x 100 mean Consumables All materials used during operation that must be replaced regularly These include cuvettes cleaner water calibrators controls cassettes ISE solutions etc Control QC Material used to check accuracy and precision of a system Cup A small container used for pediatric samples as well as for calibrator and control material Preferred vessel if only small amount of fluid is available Only specific cups can be used on the instrument Cup on Tube A dead volume optimized configuration of samples having limited fluid quantities The fluid can be transferred into a smaller cup that is placed onto a primary tube using the original barcode data of that tube Cuvette Disposable plastic containers into which sample reagents diluent and water is pipetted where the reaction and sample predilution takes place Daily Start up Procedures which ensure optimum working conditions such as checking loading calibrators and controls emptying the waste container or replacing depleted reagents Daily Start up includes the Begin of Day BOD actions see Begin of Day Action Data St
260. ed SUPER A amp A 7 16 9814 42 Diagnostics not started SUPER Message 7 of 10 xl Help On Message rint a G fe me Icon showing the severity of the message if any The date and time when the message was created Short message text Click to get Help on the selected message if available Name of the user logged on at the time the message was created The selected message Double click to display details on this message Click for Help on this dialog box this does not give Help on the selected message Tips The message log contains only confirmed messages By default 200 messages are stored but you can change this number to a maximum of 2000 messages View Messages Options The oldest messages are automatically deleted when the system needs space for new massages Operator s Manual Version 1 2 15 Messages Cedex Bio HT Options tab Options tab Use the Options tab to specify the maximum number of messages stored in the message log Type a number in the Buffer Size text box and click Save You can increase or decrease the size of message log buffer as required A buffer size of 100 means that a maximum of 100 messages are stored in the log The system saves the most recent messages and if the log is full deletes the oldest messages to make way for the more recent ones x New Messages Message Log fi 5 Message Log Buffer Size 20 Save A B Proble
261. ed and the cassette access is denied Use another cassette if the volume check fails Do not interchange cassettes among different Cedex Bio HT systems and instruments Each cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only Each cassette has its own individual cassette number which the instrument uses to identify it Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect results If more than one Cedex Bio HT instrument is used in the same lab be sure to dedicate each cassette rack with its cassettes to one single individual instrument e g by color coding amp To mix cassettes 1 Click the New Messages tab in the Messages work area to check for messages of the format Cassette lt name gt on rack lt number gt Position lt position gt requires mixing 2 Click the Cassettes tab in the Status work area and check for cassettes with the Req Operator s Manual Version 1 2 B 9 5 Daily workflow Daily start up Cedex Bio HT Mixing status 3 Wait until the rack status light is green and remove the racks containing the cassettes to be mixed 4 Place the reconstituted cassettes on an external mixer for 10 minutes Place the cassettes needing periodical mixing on an external mixer for one minute Re insert the rack into the cassette area After the required mixing time is elapsed remove the rack again and put the reconstituted casse
262. ed with service actions Choose View gt Counters on the Service work area to open the Service Counters dialog box There are three tabs e Service Counters e Service Intervals e System Counters The Service Counters tab lists all the service actions with the counters and timers for each The current status of each counter and timer is displayed along with the value that must be reached for the service action to become due The service actions that are performed automatically at the Begin of Day are also shown here Operator s Manual Version 1 2 D 15 13 Service action software Cedex Bio HT Counters and timers Service Intervals tab Choose View gt Counters gt Service Counters on the Service work area to open the Service Counters tab Service Counters x Service Counters Senice Intervals System Counters Service Action Current Due Unit Current Due Unit BoD Deproteinize probes ne 600 tests i i i 1 Ways i v Clean probes and splash guard aia 2000 tests He 7 iays i Clean internal water reservoir RICH Oitests i 16 i i 180 ays k A Clean wash station iatan Ohests HB tigdas o Clean ext water reservoir fluid waste 14194 Oitests 1161 180 days 1 D Clean instrument 14190 Oltests 116 i 180 Kays Clean waste box fitting ay 2000 ests fa 30 ays A H Miscellaneous i TE j l Prime fluid system 1 oF 4ihidle stir thes tv Roche service 14194 150000 tests 16 f 180 idays
263. edex Bio HT host interface is hardware and software allowing communication between the Cedex Bio HT data station and the host computer Communication between the host and the Cedex Bio HT data station works on a master slave basis where the host is the master This allows the host to send orders to the instrument via the data station as well as to request results from the data station The data station being slave never sends data to the host unless the host first requests it Features of the host interface include Orders e Entry e Modification e Deletion e Host query Results e Single results e Collated results Host software including the host user interface is not supplied by Roche and is thus customer specific For information about the data display at your host or about the method of communication between host and data station including data formats please refer to the Host Interface Manual For a description of routine operation using a host computer see Daily routine with sample barcode and with host on page B 22 The Cedex Bio HT system can be set up in different ways to accommodate the way you work in your laboratory The workflows outlined in this user documentation assumes that your system is configured and used in one of the following recommended ways Cassettes stay on board during the night The system is not shut down during the night Working without barcode and without host To work without barcode on
264. em A on selective electrode C Measuring channel F Air segments B Samples controls calibrators D Reference electrode G Waste Activator ISE Etcher and ISE ne R Deproteinizer E SE Reference Electrolyte H Liquid junction The lithium electrode is not exclusively sensitive to lithium ions alone Sodium ions and to a lesser extent potassium ions also contribute to the measured signal These contributions are determined for each lithium measurement and each lithium result is corrected accordingly Therefore to make lithium determinations you must have both the sodium and potassium electrodes installed and working The ISE module requires frequent calibration to ensure the reliability of the test results obtained All the required calibrations are performed automatically although you can request a main calibration at any time Sodium potassium and chloride are calibrated with a two point calibration duration 126 seconds using ISE solutions 1 and 2 Lithium is calibrated with a three point calibration duration 168 seconds at fixed intervals using ISE solutions 1 2 and 3 The time interval for main calibrations is five hours The ISE module automatically performs a one point calibration with the corresponding ISE calibrator depending on the measuring mode For example in direct mode the ISE Calibrator Direct is used for the one point calibration One point calibrations are performed within the ISE cycle of 53 seconds All I
265. em Counters on the Service work area to open the System Counters tab Service Counters Test Counters dialog box For each test defined on your system the Service work area maintains counts for orders repeats and the total These counters are always maintained even through software updates however if you delete a test definition from the instrument the corresponding counters are also deleted D 18 Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software Counters and timers To open the Test Counters dialog box choose Tools gt Test Counters on the Service work area Test Counters 3 Samples Quality Control Calibration Test Orders STAT Repeats Orders Repeats Orders Repeats Std Total GLN 36 0 5 8 0 3 0 2 55 GLU 43 0 12 18 0 3 3 g 85 Gluc 58 0 14 6 0 3 0 2 84 IGGHB 12 0 0 2 0 0 5 19 IGGLB 2 0 0 0 0 0 0 6 2 KD 46 0 14 4 0 5 3 2 80 LAC 58 0 7 6 0 3 0 2 7 LDH 46 0 0 4 0 2 0 2 54 NAD 46 0 13 4 4 T 1 2 83 NH3 23 0 12 2 0 1 0 2 39 A Click this button to show the counts for the last n days a specific date range or a specific month B You can export the data in this table into a spreadsheet independent of the Service work area Tip To calculate the counters of a specific day click From and enter the same date in both the From and To boxes on the Test Counters Query dialog box Operator s Manual Version 1 2 D 19 13 Service action software Cedex Bio HT
266. ements Temperature The temperature inside the analyzer is maintained at A 38 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Cycle time Workstations Workstation In Out Workstation B Workstation C Workstation FP Photometers Absorbance photometer Functional systems e yellow icon 37 C 0 2 C e red icon 37 C 0 5 C If the temperature goes outside these limits the system automatically informs you Analyzer tab on page B 76 The cycle time of the analyzer rotor is 10 6 seconds The whole operation of the system is based on this cycle time with each measurement taking a whole number of cycles A cycle begins with workstation In Out loading a new cuvette onto the rotor Afterwards the rotor turns in an anti clockwise direction At cycle 70 the cuvette is removed by workstation In Out and dropped into the cuvette waste The workstations handle the cuvettes loading them onto the analyzer rotor and removing them temporarily for pipetting mixing and FP measuring Workstation In Out moves new cuvettes one at a time from the cuvette buffer slide and loads them onto the analyzer rotor When all the measurements for a particular cuvette have been completed workstation In Out removes the used cuvette and drops it into the cuvette waste box Workstation B temporarily removes a single cuvette from the rotor so that the cuvette can be accessed by probe B for reagent or sample p
267. ements and also provides guidance for general troubleshooting procedures To avoid problems always follow the service schedules defined for your system If you have any problems that you cannot resolve contact Roche Service In this chapter Chapter 19 ADOUUISE Mag RETENE ERATA AE TATAE ATATA F 40 Flags nd ser actis ieiunio aie aa aeai ie ia i i Rai F 41 Flap eSCriptiOns oranssia E R EE ntsc F 43 PI RGEL OLD irn RERE AE E KRR F 43 AIRI SECA D d RERE R R F 43 ISEUNS PAB e ER E E RE ERE F 44 NO FEUD o O TN F 45 NO ISECA D irr e rE EENE AEAEE F 45 OUT OF RNG ISE innoirea iinan F 46 SEG BIGOT y NSE ENE a aa F 46 SEGUISEGAT ccssscsissscsssideusestecsossssecenssevedsvssossdevasevsdevsnossdssuebedevsvevedorsssssdevssensdebsvosbdonecd F 47 SOILD BUDEY i ccidsccassidecsssbiceosesvacesvsusdovoessudessusosdevansssdosvabesevsvesedoroesshdovssestvevsvesneerecs F 47 ST ES TIRING seisisidasusssidetsdeedetssobudesssebedosvsotedetuebedstatettdedeavedetealudavesobedsbedevedsbedeveredess F 48 S LESTIRNG pehtni a a E RRE F 48 General ISE troubleshooting innana aiai ia F 49 POOF ACCULACY irissen ss sctsetcebbecscsssteses sasndsbbeaecsdbseutesdecsuteeseeeesiseossaceseseauesdensbecsd F 49 Results riot reproducible ccscscsstssstessusssitbsensetnsscadtvosseacesehendsvenssadevesdendabeascdsevessssdvechanes F 50 All sSlOpes OutOL aN Gest tsiere sekeren iiien TEE aan REA ESSE aao aE RAE aai F 51 Operator s Manual Version 1 2 F 39 19 ISE fla
268. emographics Results Review any results that have not been automatically F7 accepted by the system You can also review accepted results result history for samples calibrations and quality controls P Service Review when scheduled service procedures called 3 F8 service actions are due and perform them if necessary O Configuration Set up system parameters that define how the system Shift F8 runs For example you can specify the quality controls you are going to use with a particular test You cannot use these functions unless you have the required user access level which your system supervisor defines for you E Memo pad Leave messages on the system for other users You Shift F7 can type in the text manually and indicate if the memo is urgent You can use the menu bar which is available in the Status Orders Results Service and Configuration work areas to move to open a different work area To open a different work area from the menu bar 1 Click Window on the menu bar The Window menu is displayed The current work area is marked with V Operator s Manual Version 1 2 A 49 3 User interface Cedex Bio HT Work areas 2 Click the required work area name Status File View Tools EEDA Help amp alse Ih Messages Shift F5 s a b v Status F5 Missing amp BI Orders Fe Cassettes Results F7 Cassettes Service F8 Samples m Empty Configuration Shift F8 8g Blocked S
269. ending on the test Do not interchange cassettes among different Cedex Bio HT systems and instruments Each cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only Each cassette has its own individual cassette number which the instrument uses to identify it Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect results If more than one Cedex Bio HT instrument is used in the same lab be sure to dedicate each cassette rack with its cassettes to one single individual instrument e g by color coding The cassette name lot number expiration date content of active ingredients and other test specific information is written on the cassette label The system automatically reads the following information from the barcode label e Article number identifies the Roche product e Cassette number e Expiration date e Lot number A cassette rack holds up to four cassettes Each rack is identified by a number on the front tab of the rack and a barcode label on the side The barcode scanner reads the cassette rack IDs as the rack is inserted into the rack platform This function checks the reagent filling of each cassette It ensures that the system correctly aspirates the number of tests the cassette is specified for The cassette volume check is carried out once per cassette when the cassette is placed for the first time on the instrument Each cassette vial is checked
270. ent data such as the number of tests lot number and expiration date e When handling multiple cassette racks wait at least three seconds before you manually OL handle the next rack Q Warning e When inserting a cassette rack try to tilt the rack slightly clockwise 5 10 so that the barcode is not read at an exactly 90 angle This can help in case of barcode reading problems due to unwanted surface reflection from a glossy barcode label material Do not interchange cassettes among different Cedex Bio HT instruments Each cassette rack with its cassettes may be used on one individual Cedex Bio HT instrument only Each cassette has its own individual cassette number which the instrument uses to identify it Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect results If more than one Cedex Bio HT instrument is used in the same lab be sure to dedicate each cassette rack with its cassettes to one single individual instrument e g by color coding The list of on board tests is continuously monitored you are automatically notified when the supply is low Color coded cassette graphics tell you at a glance when you need to load new cassettes Once you load a new cassette the system automatically uses the new cassette as soon as the current one is used up The system tracks the reagents available on board and forecasts if additional cassettes are required based on your workflow statistics T
271. ep by step instructions Understand and take action on messages generated by the system You can also use the Help to Display general information about work areas tabs and dialog boxes Look up the definition of any term or component by using the glossary Access documents online in Acrobat format for additional information There are three types of online information on the Cedex Bio HT analyzer Context or context sensitive Help is standard Windows Help that explains the currently displayed work area dialog box or message You can display context Help directly from the current window or dialog box General Help is standard Windows Help that explains more about the function of the different work areas tabs and dialog boxes It also provides relevant background information to concepts and tasks You display general Help from the Help menu in the user interface Message Help works similar to the context Help It provides more detailed information on messages that are currently displayed by the system and gives hints or instructions towards the resolution of the problem described in the message Online books are documents presented in Acrobat format A 56 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help Starting and closing online Help Starting and closing online Help gt To display online Help information e Press F1 on the keyboard or e Click Help on the currently displayed dialog box
272. eparation time is required STAT Abbreviation for Short Turnaround Time Emergency order automatically given the highest priority Status Bar An area at the bottom of the main window where information and the current date and time are displayed Stop Button to achieve one of the following Stop pipetting samples but finish processing already scheduled activities without interruption or loss Stop all system operations immediately The system aborts all current activities The system may need special attention before it can resume its normal operation a Test Class A category of related tests which are handled in the same way Test Group A set of tests that are displayed in the Orders work area A test can belong to more than one test group Toolbar A bar positioned below the menu bar containing a series of shortcut buttons Tube Vessel for samples and Cal QC Dil fluids used on all kind of racks within the system It is a primary vessel and may or may not have a barcode label for positive sample identification A sample tube contains sample of one specific specimen sample type Tube Height Adapter Grid Device to adjust the height of tubes or cups on aluminum cup adapters User Access Access allowed to different users of the software Each level has its own password and its own group of operational permissions User Interface Link between the system and the user The sum of screen displays supported by the Cedex
273. er waste drain is removed When you reinstall the waste container a message is displayed for you to confirm that you have emptied the container Checking resources on page B 42 Operator s Manual Version 1 2 B 77 7 Status ISE tab ISE tab Cedex Bio HT Use the ISE tab to review information about the ISE solutions on the ISE module the ISE rack and the installed electrodes Ble View Toos Window Help ie Bos S Os Missing amp Blocked Samples Cassettes Test Status Analyzer ISE aa f ISE Module r A Standby 1 i A 1 l ag A F Enable ISE Module i i a A e ISE ACT G i N i ale b B e 1 oseo i i ee ie fe CF o JB aan eaten lo aoe i 1 Sodium i a ee ca E 1 Reference i i i 1 ISESoH i E E KEETE ERM SRO eros ECS i i f c L a Al 7 a ISE DEPR eos Nore eps Ane apne 1 A Select or clear this check box to enable or disable the ISE module B Select or clear these check boxes to enable or disable the ISE electrodes C Status of ISE solutions on the ISE module D The icon on the Status button changes depending on the status of the system E The ISE rack status display F Double click to display the status of this item Tips e Ifyou do not have an ISE module you must still place bottles of deproteinizer and activator on the ISE rack You can use the other positions for diluents The positions of the ISE sol
274. er Manual Version 2 7 Cedex Bio HT Preface This manual refers specifically to the Cedex Bio HT analyzer and software version 5 0 About the Cedex Bio HT analyzer The Cedex Bio HT analyzer is an advanced integrated system for monitoring of substrates and metabolites for process control of cell culturing and fermentation Testing of electrolytes carbohydrates amino acids specific proteins and enzyme activities is consolidated into one system with a convenient reagent cassette design Robust robotics an intuitive user interface and random sample access serve for optimized time management and streamlined workflows The ISE Ion Selective Electrode module allows the determination of sodium and potassium in parallel with absorbance and FP photometric measurements Reagent cassettes calibrators controls and samples are identified by a barcode scanner The high performance flexibility and versatility of the Cedex Bio HT analyzer make this system suitable as a routine analyzer as well as a dedicated instrument for specific tasks A Data station B Instrument Operator s Manual Version 1 2 ix How to use this manual Content Cedex Bio HT This manual is designed to help you perform all of the tasks that are required as part of your work with the Cedex Bio HT analyzer If you are a new user the manual will also help you to understa
275. er reference points during initialization There are four initialization posts e ISE module e Cassette area e Sample area e Wash station Figure 0 23 on page A 36 The positioning of the probes depends on the initialization posts the posts must therefore be kept clean In particular you clean the posts as part of the service action Clean instrument and at other times if you see that they are not clean Clean instrument on page D 36 Analyzer module The analyzer module is the part of the instrument where the reaction between the sample and the reagent s takes place and where the photometric measurements are made Figure 0 25 shows the main external components of the analyzer module Figure 0 25 Analyzer module with workstations and photometers A Workstation C E Rotor cover B Workstation B F Workstation FP C Workstation In Out G FP photometer D Curette buffer and slide H Absorbance photometer cuvette transport system Analyzer rotor The analyzer rotor is a ring like assembly that has slots into which cuvettes are loaded automatically from workstation In Out The rotor holds up to 71 cuvettes As the rotor turns it moves the cuvettes to the appropriate locations so that pipetting operations can be performed and photometric measurements can be made Typically these operations occur in parallel that is pipetting can be carried out on one cuvette while another is undergoing photometric measur
276. er than 0 25 s by overcoming their natural aversion response to the very bright light The following figure shows the position of the laser transmitter and the directions of its apertures on the Cedex Bio HT analyzer Figure 0 1 Location of laser transmitter A Laser transmitter behind rack access panel Operator s Manual Version 1 2 XX Cedex Bio HT Laser Location Usage Wavelength Pulse duration Output radiation A Behind rack access panel right side Barcode scanner 650 nm 132 us 1 1 mW xxii Operator s Manual Version 1 2 Overview Part A gives you an overview of the whole system It includes a general introduction plus a description of the hardware and its functional systems the user interface and the Help system Cedex Bio HT 1 System overview System overview A quick look at the Cedex Bio HT analyzer This chapter provides an overview of the Cedex Bio HT analyzer and its main features It also provides an introduction to some of the key ideas that are developed later on in the manual In this chapter Chapter a IEnla oa kiTa EOI BERR IATE AIAT A A satan taes Whatthesystem doso asresi ei EE E EEE E E A first look at a Cedex Bio HT analyzer Mistr ment sintine a EE R EEEE EEE E E NE IDEIEN ETOS o EEO EAA SOE EE E Overview of user tasks Cleaning the instrument externally Basiceprincip les sivssccictveccessassesed tvastescayeeseizasstdctvcevecctyessessbestict
277. erformed the system automatically logs the user date time and comments in accordance with standard good laboratory practice Context sensitive online Help provides troubleshooting information on hardware and software If you cannot solve a problem yourself you can contact Roche Service who can with your permission dial into your system via the connect 2 box or a cobas link gateway and control it remotely You can then work together to resolve errors quickly and efficiently without waiting for an on site service visit The liquid waste from rinsing and cleaning operations is automatically removed from the instrument Waste system water is transferred either to an external container or to the laboratory waste system Sample and reagent waste is removed with the cuvette Used cuvettes are automatically dropped into the cuvette waste box You have to remove the waste box and dispose of it according to your local procedures for dealing with hazardous waste ISE waste is transferred directly to the cuvette waste box At the beginning of each day the system goes through a series of automatic service actions Typically these actions are performed before the work day begins so that the instrument is ready to use when you start work A 12 Operator s Manual Version 1 2 Cedex Bio HT 1 System overview Begin of Day Basic principles The time allocated for these service actions is called Begin of Day BOD and the servi
278. erforming tasks e Information on flags Troubleshooting information and explanations on messages e Guidance on software supported service actions e Work area reference information providing information about specific tabs and dialog boxes within the user interface e Glossary Glossary on page A 71 Displaying general Help You can access general Help information either from the menu bar in a main work area or from any Help window e From a main work area choose Help gt General Help in the menu bar to display the default Help topic From any Help window use the Contents Index or Search tab to access general Help topics Finding information on page A 62 Operator s Manual Version 1 2 A 67 4 Online Help Message Help Message Help System messages Controller messages Cedex Bio HT You can access the Help system from a message dialog box You can display Help on a system message by clicking the Help On Message button in the message dialog box Some messages do not have a Help On Message button lt Cedex Bio HT Help System pa 5 File Edit Bookmark Options Help peptone Beck Bin ee oseey Giose Contents amp Index h Search re l iat HQ Introduction ce How to m Flags m Troubleshooting and messe a Service gt Software reference informati You cannot save the current data in the test definition because the eit Messages specified control sequence is not val
279. ers and perform a new calibration if necessary Check whether the barcode is damaged whether it is correctly positioned and whether the cassette is correctly inserted If the problem persists check the barcode scanner itself making sure that the beam is not cut off in any way Also check whether you have loaded the cassette definition for the cassette in question On the Cassettes tab in the Status work area the cassette is displayed in red with the status Unknown Fluid The system will detect this the button turns yellow Do not use expired cassettes Operator s Manual Version 1 2 B 41 6 Routine tasks Managing resources Cedex Bio HT Managing resources Checking resources Resource status Use the Analyzer tab in the Status work area to review the status of on board resources The color of each icon shows the status of the corresponding resource If you need to take some action to keep the system running efficiently the background color and the picture on the Status button change for example if cuvettes are running low you see the cuvette icon with a yellow background Background color Take action Red Immediately Yellow Soon when convenient Green or gray None If the analyzer icon is displayed there are no resource problems The Status button shows the resources that need to be replaced Status Resource User action button Cleaner See Replacing the cleaner on page B
280. ersion 1 2 Cedex Bio HT 7 Status Folder Blocked Clot detected Empty Expired Missing Information Not enough for worklist Not On Board Without Orders Tips Meaning The test is blocked because an item is missing or not correctly defined A test may be blocked because for example there is no relevant calibration A clot was detected in a probe or in the tubing The item is on board but it is empty The items listed have passed their expiration date For cassettes and diluents The item is on board but it is not correctly defined in the system For cassettes diluents and cleaners The item is loaded but there is not enough of it to run the tests in the current worklist For cassettes only The item is not on board The sample is loaded into the instrument but there is no order associated with the sample For samples only Missing amp Blocked tab User action Find the missing items in other folders and correct the problem Details about the calibration for a test can be found in the Test Status tab Replace the affected items Replace affected items Replace expired items Use the Configuration work area to load the definition Replace or add more of the missing item For example add additional cassettes Load the missing item For cleaner cassettes and diluent tubes the Not on Board status is generated only if there is actu
281. ervice Leakage on page E 30 Air bubbles in one or more pipettes on page E 31 Dripping pipettes on page E 31 Dripping probes on page E 32 Operator s Manual Version 1 2 E 27 16 Troubleshooting Cedex Bio HT Results Test results low or drifting Results are obtained but the values obtained are lower than expected Results are obtained but the values show a consistent trend to drift either up or down from their expected values gt Pipetting incorrect sample or reagent volumes Perform the service action Deproteinize Probes 2 Perform the service action Clean Probes Manually If this is unsuccessful a Replace the probes b Check the pipettes and pistons c Check for leaks Leakage on page E 30 Air bubbles in one or more pipettes on page E 31 Dripping pipettes on page E 31 Dripping probes on page E 32 Sample has deteriorated Sample has deteriorated for example due to instability of the analyte 1 Use fresh material if possible 2 Ifthe sample is in a secondary cup transfer a new aliquot to a new cup from the original primary sample E 28 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Hardware Hardware This section lists problems associated with hardware functions particularly regarding the cuvettes and the fluid system Reacting to a hardware message Cuvettes To react to a hardware message Read the me
282. es you can specify none a lower limit an upper limit or both a lower and an upper limit You can use the wildcards to represent a single character and to represent one or more characters If you do not want results to be filtered select All in the filter list on the toolbar You can run a previously defined query by selecting it in the filter list on the toolbar Operator s Manual Version 1 2 B 123 9 Results Cedex Bio HT Selecting specific orders gt To refine a query E 1 Click Results on the navigation bar 2 Click the Sample tab 3 Choose View gt Query gt Custom A blank Custom Query dialog box is displayed 4 Click New and complete the boxes as required Click the Advanced tab 6 Specify the refinements that you wish to apply to the query by selecting the appropriate check boxes and options for example order status order type Click Save 8 Click OK to run the query B 124 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Displaying detailed information Displaying detailed information You can double click any item in the Results work area to get more detailed information You can also access the same dialog boxes from the menu or by right clicking the item gt To display detailed information for orders E 1 Click Results on the navigation bar ar S 2 Click the Validate Sample Calibration or Quality Control tab 3 Double click an item in the list on the left side
283. es not require manual intervention The electrodes must be cleaned regularly to prevent the build up of deposits to maintain the efficiency of the instrument This service action includes etching deproteinizing and tubing conditioning steps Duration 8 minutes Interval Daily or e Every 3 days if less than 50 samples per day are processed Begin of Day Yes System state Standby Tools and materials Activator ISE Calibrator Direct Bio HT e ISE Deproteinizer Bio HT ISE Etcher Bio HT ISE Reference Electrolyte Bio HT Hazards and precautions See General safety precautions on page F 16 gt To service electrodes Select Electrode service in the Service work area Click Perform Fluid system is initialized if necessary automatic step Transfer arm is initialized if necessary automatic step ISE module is initialized if necessary automatic step Electrodes are deproteinized automatic step Electrodes are etched automatic step on oa FF WN ISE module tubing is conditioned twice with Activator automatic step 9 Electrodes are rinsed with ISE calibrator automatic step 10 Electrodes are activated twice with Activator automatic step 11 ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes A calibration is run before any new samples or controls are processed automatic step F 18 Operator s Manual Version 1 2 Ced
284. es of tubes and cups on the system although you must ensure that you use only types that have been predefined for your system This is done for you at installation by Roche service personnel A 32 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Sample tubes and cups Functional systems The following table summarizes which type of containers you can or must use with each type of solution on the system Solution Container s Samples Primary or secondary tubes or cups Controls Tubes or cups Calibrators Tubes or cups Diluents Bottles on the ISE rack or tubes on a sample rack Note It is possible but not recommended to place 9 NaCl solution or hemolysing diluent on a sample rack Always place hemolysing diluent in its original bottle and 9 NaCl solution in its original bottle or in a 25 mL dead volume optimized bottle on the ISE rack Cleaners Cleaner reservoir for the default cleaner Cleaner cassettes on the cassette racks ISE solutions On the ISE module itself or in bottles on the ISE rack The system can use both primary and secondary tubes The following types of tubes are predefined e COBAS cup Eppendorf cup e Sarstedt 5 mL e Sarstedt 5 5 mL e Sarstedt 7 5 mL e Vacutainer 7 mL e Vacutainer 10 mL You can use other types of tubes but these must be defined for your system in Configuration Lab Sample Tubes B TEE c Figure 0 22 Sample tubes and cups A Sa
285. essed amp To check the worklist Click Orders on the navigation bar and click the Worklist tab 2 Check the Worklist for orders that are blocked or have no samples on board and for samples that have no orders assigned to them 3 Take the appropriate actions to resolve the problem If you are sure all your scheduled orders are being processed properly and your first results are calculated switch to the Validate tab in the Results work area for result validation Tips e Select a blocked test and press F1 to get Help e Select an order and click Edit to modify the order or click Validate to switch to the Validate tab in the Results work area for result validation Worklist tab on page B 89 Operator s Manual Version 1 2 B 19 5 Daily workflow Cedex Bio HT Daily routine with sample barcode and without host Validating results Validate results on the Validate tab of the Results work area E File Edit View Tools Window Help ae 7 3 4 a B Validate Y Sample Calibration Quality Control invalid K42 yj Blocked test Result unit Flags Action Ref Range Not on Board GLU 0 06g ll To validate ee aw x E GLU ae Order ID invalid Sample a invalid Sample Result calculated using an erroneous or corrected calibration which has not been accepted Action l Check calibrators Repeat calibration The resultis associated with an erroneous
286. est data is stored even after a cassette has been removed Calibrations and quality controls Result handling Accepting results Calibrators and quality controls use the same types of tubes and racks as samples A refrigerated rack position improves the stability of on board calibrators and controls The system performs calibrations and controls automatically according to the specification in the test definition Alternatively you can request a calibration or control manually The system tells you when calibrations or controls are required and when there is not enough calibrator or control material on board to complete the request You can use precision accuracy or limit controls You can use up to six controls per test and you can exclude suspect controls from the statistics The system automatically generates flags for all results that do not meet the required specifications You can apply rules to ensure reliable results On screen Levey Jennings plots allow a quick review of results An auto accept feature means that you can choose whether appropriate results are accepted automatically for example if they have no test or quality control flags and are within range You can display all non accepted results for samples calibrators or Operator s Manual Version 1 2 A 11 Cedex Bio HT 1 System overview Basic principles Caution System status controls in the user interface For each non accepted result you ca
287. et the counters to zero The service action is removed from the Due tab Tips e Display the details for a particular service action by Double clicking the item in the list o Right clicking the item then choosing Detail e Choose View gt Notes to see a list of user actions and service actions that have been performed The paper clip indicates the presence of a note Service notes on page D 13 e Press F1 to display Help for this tab D 8 Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software Begin of Day tab Begin of Day tab Your system can be set up to perform the following service actions at the Begin of Day Service action When is the service action listed on the BOD tab Deproteinize probes Listed on the Begin of Day tab after a specified number of tests or number of days whichever is the shortest time has occurred Prime fluid system Listed on the Begin of Day tab after the instrument has been in Sleeping for a specified number of hours or after a specified number of days whichever is the shortest time Backup database Listed on the Begin of Day tab after a specified number of tests or number of days whichever is the shortest time has occurred Initialize ISE module ISE service actions listed on the Begin of Day tab after a Activate electrodes specified number of tests or number of days whichever is Electrode service the shortest time has occurred Pr
288. eter Light source Wavelength range Measuring range Grating monochromator and diode array Halogen lamp 100 W 340 800 nm 12 wavelengths Mono and bichromatic measurement 0 2 0 A for 5 mm path length H 8 Operator s Manual Version 1 2 Cedex Bio HT 21 Appendix Technical specifications FP photometer e Measuring principle Fluorescence polarization e Light source Light emitting diode LED e Measuring procedure 2 seconds parallel 2 seconds perpendicular e Measuring range 0 500 mP e Excitation wavelength 485 nm e Emission wavelength 515 nm ISE module e Measuring principle Potentiometry e Measuring method Direct Indirect e Measuring cycle 53 seconds e Calibration interval e Electrode life span e Measuring range Pipetting system One point calibration every sample measurement Main calibration every 5 hours Reference 2 years Na 6 months K 6 months Cl Labeled orange 3 months Cl Labeled purple 14 days or 2000 counts Lit 4 months Na 20 250 mmol L K 0 2 30 mmol L CF 20 250 mmol L Li 0 1 4 mmol L e Type e Automatic cleaning e Clot detection e Reproducibility e Level detection XYZ robotic syringe All probe tips Pressure sensor Sample reagent CV lt 1 5 Sample level Reagent level initial photometric cassette check Operator s Manual Version 1 2 21 Appendix Technical specifications Software and data
289. evel of liquid replace if necessary If the error message is displayed 1 Perform the service action Prime ISE calibrators 2 Check the ISE module tubing and the ISE distribution block for leaks or blockages 3 Contact Roche Service Operator s Manual Version 1 2 F 45 19 ISE flags and troubleshooting Cedex Bio HT Flag descriptions OUT OF RNG ISE Meaning Message ID Possible cause Recommended actions SEG FLUID Meaning Message ID Possible cause The electrode slopes were out of range None Electrode slope out of range This flag appears with calibrations because e There are problems with the ISE solutions on the ISE rack There are problems with the electrodes or an improperly serviced ISE module e The ISE Reference Electrolyte tubing is blocked or leaking The floater of the ISE Reference Electrolyte bottle is blocked The dosing from the sample probe is not accurate The preamplifier is not working properly If only one calibration is flagged 1 Repeat the calibration 2 Repeat the calibration with fresh ISE solutions 1 2 and 3 and check visually the correct flow of all ISE solutions and the ISE Reference Electrolyte If successive calibrations are flagged 1 Repeat the calibration with fresh ISE solutions 1 2 and 3 and check visually the correct flow of all ISE solutions and the ISE Reference Electrolyte N Check whether the electrode expiration date has passed Replace
290. evels to load you must have enough available positions on the rack for all the calibrator levels in the set You must put multi set calibrators in continuous positions on the same rack starting with the highest concentration standard furthest away from you when you insert the rack e Consider loading frequently used controls on a rack in slot I in the cooled cassette area e Ifbarcodes for calibrators with several standards are used label all standard cups with the same barcode e If you use any other types of tubes than those defined on your system you risk damaging the probes which may have to be replaced before you can continue Loading cassettes Cassettes contain up to three reagents and are usually refrigerated both before use and on the instrument Some reagents have to be reconstituted before use If a cassette is reloaded on the instrument for example after storage in the fridge in certain circumstances the cassette information may have been deleted from the database and the cassette can no longer be used This is the case if one or more of the following conditions were met while the cassette was off board e The lot expiry date had passed On board stability had expired e Atleast ten accepted calibration results exist for this cassette e The cassette had not been used for 180 days Do not interchange cassettes among different Cedex Bio HT systems and instruments Each cassette rack with its cassettes may be used on o
291. ex Bio HT 18 ISE service actions Activate electrodes Activate electrodes Overview Duration Interval Begin of Day System state Tools and materials Hazards and precautions gt This is an automatic service action that does not require manual intervention The electrode surfaces must be activated with Activator so that the correct potentials are measured 3 minutes e After every 50 measurements or e Daily if less than 50 samples per day are processed Yes Standby or Operating You can perform this service action at the same time as absorbance and FP measurements are made e Activator e ISE Calibrator Direct Bio HT e ISE Reference Electrolyte Bio HT See General safety precautions on page F 16 To activate electrodes Select Activate electrodes in the Service work area Click Perform Fluid system is initialized if necessary automatic step Transfer arm is initialized if necessary automatic step ISE module is initialized if necessary automatic step Probe C pipettes Activator into the ISE tower automatic step N of FF OWN The pipetted Activator is drawn into the electrode block automatic step e Ifthe ISE module is in Standby the Activator remains in the electrode block for 1 minute automatic step Ifthe ISE module is in Operating the Activator remains in the electrode block for 40 seconds automatic step 8 Steps 6 and 7 are repeated twice automatic ste
292. ex Bio HT Functional systems cuvettes to workstation In Out where they are fed into the analyzer rotor Figure 0 15 shows the location of the cuvette transport system Figure 0 15 Cuvette transport system Figure 0 16 shows the movement of cuvettes through the transport system starting at the cuvette reservoir and ending in the cuvette waste box e Cuvettes are made of optical quality acrylic plastic e The optical path length is 5 0 mm e Cuvettes are disposable They are used only once to guarantee optical consistency and to eliminate carry over in the cuvette e For optical measurements the minimum volume of liquid in a cuvette is 120 uL the maximum is 245 uL e A cuvette pack contains approximately 1000 cuvettes A 24 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Functional systems e The system quality checks the cuvettes before use by reading an empty cuvette and comparing it with an acceptable absorbance range A B c D H E G F I Figure 0 16 Movement of cuvettes through the cuvette transport system A Pack of cuvettes F Cuwvette buffer and slide B Curette reservoir G Workstation In Out C Curette conveyor belt H Analyzer rotor D Curette feeder channel I Cuvette waste box E Curette spiral feeder Cuvette reservoir The cuvette reservoir feeds cuvettes onto the conveyor belt You can pull out the cuvette reservoir and put the cuvettes in You ca
293. f Quit access to the system no current user is recorded Log On Gain access to the system by entering a user name and if required a password The given user name is taken as current user and may be printed on records Lot Consumables produced from the same materials in the same production run and subjected to the same quality control procedures Memo Pad Electronic note pad used to leave messages or supplementary information for the next user Message Message icons on the user interface informing the user that intervention is required An alarm sounds when an urgent message appears Navigation bar The column of buttons used for quick access to the work areas Online Help System in which the user can call up information in a context sensitive manner and search for any given term Just click the Help button or press F1 to access Online Help 5 Operator s Manual Version 1 2 Cedex Bio HT Operating Status while the system is performing pipetting measurement and calculation activities Order An entry in the Orders work area to run a sample measurement Order Demographics Customizable information for orders Order ID Unique identifier for an order Can only be used once on a given day The sample order identification refers to a number of sample tubes one or more specimen types of a given sample collected for a panel of different tests Password Log on identification allowing user access to
294. f you type In this box You find these values Order ID All values 77 Order ID All values beginning with 77 including 77 775 7756152 773A21 77 Order ID All values beginning with 77 and which have three characters including 77 775 776 77A 77B Glu Name Gluc Glut Glu Name Glut Gluc 5553 Order ID 55531 55532 55534 555311111012 555 1 Order ID 55531 55541 55581 Tips You can only use the wildcard at the end of a search string For example 77 7 7 are not valid B 102 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Lookup function Find function Accessing the Find function y Working with Orders e You can specify only one wildcard in a string For example 77 and 5 1 are not valid Use the Lookup function for a quick search for the tests of a certain order To look up an existing order 1 Type asterisk in the Order ID box and press Enter The Lookup dialog box is displayed containing a list with all order IDs stored on the system 2 Select the desired entry and click OK The data for the selected order is displayed on the Sample tab With the Find function you can search for orders by giving an order ID You can also specify a range of dates within which the order was created There are several methods of accessing the Find function e Click Al on the toolbar e Click Find on the tab e Press F3 on the keyboard The Find function is ava
295. fall within programmed range Check calibration curve 2 Repeat with fresh calibrators 3 Ifthe calibrators were incorrectly positioned replace the calibrators correctly and repeat the calibration 4 If flag reoccurs replace cassette Priority 26 Group CAL Result calculated using a postponed calibration which has been accepted Note Postponing a calibration may lead to erroneous results 1 Review results 2 Perform calibration if necessary Priority 35 Group CNTL RAT TEST Result calculated using a postponed calibration which has not been accepted Note Postponing a calibration may lead to erroneous results Operator s Manual Version 1 2 C 13 12 Result flags Flags and recommended actions Recommended actions Attributes POL ERR Meaning Recommended action Attributes POS value Meaning Recommended action Attributes POSITIVE Meaning Recommended action Attributes Meaning Recommended action Attributes Cedex Bio HT 1 Check all results carefully 2 Perform calibration if necessary Priority 34 Group CNTL RAT TEST Polarization error For an FP measurement the perpendicular measurement was higher than the parallel measurement 1 Repeat the measurement 2 Ifthe flag reappears contact Roche Service Priority 5 Group CAL CNTL TEST Positive The sample result is greater than or equal to the cutoff value For semi quantitative tests o
296. familiarization 17 information on 17 with calibrators 140 Processing icon 20 processing data 41 start 14 19 22 stopping manually 12 profiles creating 12 definitions 11 deleting 12 missing 101 modifying 12 viewing 12 pumps 22 peristaltic 6 purging orders 60 109 66 orders manually 109 preconditions with orders 109 preconditions with results 130 results 61 112 130 67 what is deleted with results 130 Q flag 15 q flag 14 QC See controls quality of water 27 Quality Control report selected features 57 Quality Control tab Orders work area 94 Results work area 121 quality controls out of range 26 printing reports 56 R flag 15 r flag 15 R 4s flag 17 R 1 2s flag 16 R 1 3s flag 16 R 10x flag 18 R 2 2s flag 16 R 4 1s flag 17 R7f flag 17 R7 flag 17 rack LEDs 39 racks area 27 assigning samples automatically 96 assigning samples manually 97 assigning samples to 96 assigning samples using Place Items 98 assigning samples using Sample Handling 98 code 32 controls 163 details 80 for cassettes 11 27 29 30 icon 16 IS 32 name 32 number 32 platforms for 27 position of calibrators 141 position of controls 166 position of ISE solution 33 preassigned positions 141 releasing
297. front cover Danger of injury due to closing main front cover If the main front cover is not opened completely it might close unintentionally by itself Whenever you open the main front cover be sure to open it as far as it will go For cleaning RD15 racks sample racks ISE rack and cassette racks use active oxygen based mild cleaning solution D 22 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Deproteinize probes Deproteinize probes Overview Duration Interval Tools and materials Hazards and precautions Further information This is an automatic service action that does not require manual intervention To maintain the efficiency of the instrument you must clean and deproteinize the probes regularly to prevent the build up of contaminants By default Deproteinize probes is a Begin of Day action but you can initiate it at any time from the Service work area 6 minutes Daily or after 600 tests e ISE deproteinizer on the ISE rack e Activator on the ISE rack None For general information about performing a service action see Chapter 13 Service action software To deproteinize probes Select Deproteinize probes in the Service work area Click Perform The Service Actions dialog box is displayed follow the online instructions Wash pipes are filled with deproteinizer automatic step Probes and sample loops are filled with deproteinizer automatic step Probes
298. g action is set to Stop Test in Configuration Result Handling 1 Open Status Test Status 2 Select the required test 3 Select Test Enabled Tip Check if the rules defined in Configuration Result Handling apply to the workflow in your laboratory and change the result handling if applicable See the Online Help for details e Test aborted Test was aborted either by stopping the run and selecting STOP Terminate Run and discard tests in progress or by switching off the instrument Restart the run E 22 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting ISE Not on board Recommended action Empty Recommended action 9 Not ready Recommended action Blocked orders tests calibrations or controls Activator not on board ISE Deproteinizer not on board ISE Etcher not on board No ISE solution available Open the Not on Board folder in Status Missing amp Blocked to see the solutions that are not on board and their correct rack positions Remove the ISE rack from the instrument Load the required Activator ISE Deproteinizer ISE Etcher or ISE solutions on their correct ISE rack positions Re insert the ISE rack into slot O The ISE Rack Replaced dialog box is displayed On the dialog box select the ISE solutions that you have replaced Leave the check boxes cleared for ISE solutions you have not replaced Activator is empty ISE Deproteinizer is empty ISE
299. g box is displayed follow the online instructions Probes are positioned outside the wash pipes automatic step Five wash cycles with system cleaner are performed automatic step Probes are positioned inside the wash pipes automatic step ao a E E WwW One wash cycle with system cleaner is performed automatic step D 46 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Roche service Overview Duration Interval Tools and materials Further information Roche service The whole instrument must be regularly serviced by Roche Service engineers This service action reminds you to contact Roche Service and arrange a visit Not applicable Between 4 and 8 months or after 150 000 tests None For general information about performing a service action see Chapter 13 Service action software Operator s Manual Version 1 2 D 47 14 Service actions Backup database Cedex Bio HT Backup database Overview Caution Duration Interval Tools and materials Further information This is an automatic service action that does not require manual intervention You must back up the database regularly to ensure the integrity of data on the system in the unlikely case of disk failure Ifa backup becomes overdue the background on the Service button in the navigation bar turns red Database backup must be performed in regular intervals otherwise the accumulated data will fill all
300. gle precision control run over a period of time Vertical lines show the relative positions of the mean and one two or three standard deviations on either side of the mean B 176 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Multiple controls Reviewing and validating control results Tips The date for unaccepted controls is displayed as a dashed line A paper clip at the beginning of the line indicates that a user comment has been entered in the detail dialog A dotted line across the graph indicates that the control range parameters were changed To view a different QC mode select Precision Accuracy or Limit in this window Position your cursor over a control symbol to display the control name and the Westgard rule if flagged or the result if not flagged Several controls can be displayed at the same time depending on the test selected Each control has its own unique symbol With multiple controls displayed each graph is scaled to its own reference values For example for a precision control the graphs are scaled to the respective mean and standard deviation for each control Tips Take care when making comparisons because different controls have different scales When you select a test only the first three controls are displayed even though up to six controls may have been run Only the first three results are used for statistics To review precision controls a AON
301. gs and troubleshooting Cedex Bio HT About ISE flags About ISE flags Flags and error messages Flag priority el Q Flags and result handling Q7 This section describes all the ISE flags generated by the Cedex Bio HT analyzer their associated error messages and the corresponding user actions ISE flags like other flags are automatically generated with results when the system detects a problem or a potential problem When a flag is generated it is displayed together with the result in the Results work area When you print a result the flag is also printed Some ISE flags trigger error messages if they appear in a consecutive sequence A flag counter monitors the number of consecutive flags and triggers an error message if the counter limit is reached Each flag has its own counter and counter limit as listed in Flags and user actions on page F 41 Ifa single ISE measurement does not generate a particular flag the flag counter is reset to zero With a single flag repeat the measurement or the calibration An error message indicates a more persistent error requiring further action for example performing service actions If the conditions in the ISE module are such that multiple flags could be generated for a single ISE measurement only the flag with the highest priority is displayed or printed with the result The lower the number the higher the priority The priority of each flag is given in the flag descri
302. guration Cleaner H Configuration ISE Soli H Configuration Genera H Configuration Databa Configuration Lab Buttons Load Save Delete z A Banner bar click an item to jump to a particular section within the current Help topic B Click See also to display a list of shortcuts to important related topics This button is only active if there is at least one such shortcut reference on the current topic Operator s Manual Version 1 2 A 65 4 Online Help Cedex Bio HT Context Help C Click Path to display in a pop up window the navigation path that leads to the dialog box for which the current Help information is displayed D Help hotspot click the underlined blue text to display in a pop up window information on the selected item E Pop up window that is displayed when you click the Help hotspot A 66 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help General Help General Help General Help provides additional information that is not available in the context Help It contains more detailed information about tabs and background information including About topics and step by step instructions for user tasks General Help gives you access to the following types of information e General information about some aspects of the system or its operation This includes essential safety information How to information providing step by step instructions for p
303. handling Cedex Bio HT e Computer e Operating system e Software languages e Online Help e Printer e Interfaces Intel Pentium 800MHz CPU or faster 512 MB RAM or more Hard disk and backup hard disk 3 5 in diskette drive 1 44 MB optional external diskette drive with newer models of data station DVD drive for software updates Integrated network card USB Ports Internal modem no longer included for data station model rp5800 and later US keyboard and Mouse PS2 19 inch flat screen monitor Windows XP English or Japanese Default English Optional French German Italian Spanish Context sensitive Standard laser printer optional Bidirectional RS 232 C interface for host connection host query mode Bidirectional RS 232 C interface for Power Ctrl connection USB 2 0 connector 2nd LAN port for remote service Parallel port for printer no longer included for data station model rp5800 and later Safety approvals CB Test Certificate IEC 61010 1 EN 61010 1 International Electrotechnical Commission 0s UL 61010 1 Underwriters Laboratories Inc CAN CSA 22 2 No 61010 1 Canadian Standards b US Association H 10 Operator s Manual Version 1 2 Cedex Bio HT 21 Appendix Fluid system schematic Fluid system schematic Operator s Manual Version 1 2 H 11 21 Appendix Cedex Bio HT Fluid system schematic Controller Rack J13
304. hapter provides step by step instructions for the daily workflow The daily routines are described for three typical laboratory setups working without sample barcodes and without a host system working with sample barcodes and without a host system and working with sample barcodes and with a host system In this chapter Chapter 5 Introductio Munkin ae aaae eaea aaa ae E oaa aaa SS Safety precautions Working witha Host COMpULET iersinii naanin B 6 ASSUMPH NS siasii pin aneksa in ar Ri ea aiSia aieea i si enri aan aae eas iiaae oea B 6 Daily start Upesi aaa aa AE Ea a EEEE B 8 Logging on and checking the Memo Pad nss sssssssssssssssssssssressrsssssssssssrserrreesssssssrseee B 8 Checking the Begin of Day report sssssssssssssssssssssssssssetsteesssssntretessssssnnrerertesssnsssss B 8 Loading cleaners diluents and ISE solutions 0 cessessesssessesscssesseessesesseesessessees B 9 Loading and mixing cassettes cecessessessesesessesseessessessesssessessesssessessesestessesseesees B 9 CHECKING resources rnor EAE T AEE ORE B 10 Performing service actiOns c scsccssesssessesesseescssesssessessesssssesseescssessesssssessessessess B 11 Loading calibrators and controls cecessessssssesessessessesessesseessessessessessessessesseess B 11 Daily routine without sample barcode and without host cscs B 12 Creating orders s civscstecceasteaeeitv nicianaullgaivnitve eisiussteetecaiucslpsnenstvaeenctueene
305. hat the male plug of the barcode pen is firmly plugged in keyboard socket of the computer Handheld barcode Check that the handheld barcode scanner is connected to an USB port scanner connection optional Water supply Check that the water supply is connected The instrument will not initialize properly if a water supply is not connected e Check that the water sensor is connected if you are getting your water supply from a water container The water sensor must be inside the water container Waste outlets Check that the waste outlet is connected to a suitable waste container or to a waste drain e Check that the waste level sensor is connected if your waste is going to a waste container The waste level sensor itself must be inside the waste container Operator s Manual Version 1 2 E 39 16 Troubleshooting Cedex Bio HT Checking and replacing fuses Checking and replacing fuses A set of fuses protects the instrument from excessive electrical currents If a fuse blows a message is displayed to inform you that you need to replace that particular fuse How do I know whethera Typically you get one or more messages from the appropriate controller informing fuse has blown you that the power to one or more subcomponents has failed Also the LEDs for the fuses for the controller boards are not lit when the fuse has blown normally they are bright green Where do I get the fuses A complete set of replacement fu
306. he User Log On dialog box e Double click the user ID in the status bar e Choose Tools gt Log on off in any work area e Press Shift F3 The Log On Off dialog box is displayed a User Log On x UserID Stevens Password Logon cares 2 Click Log Off Shutting down the system If you perform a shutdown the system waits for a convenient point in the processing then closes all work areas and dialog boxes closes down the operating system and cuts the power gt To shut down the system 1 Perform any necessary end of day tasks This step is not necessary if you shut down the system as part of a troubleshooting action 2 Choose File gt Shut Down Your are asked to confirm The computer is switched off automatically Operator s Manual Version 1 2 B 35 6 Routine tasks Cedex Bio HT Logging off and shutting down the system 3 Switch off the instrument at the main switch 4 Switch off the printer This step is only necessary if your printer has an On Off switch 5 Switch off the monitor Tips e Once you initiate a shutdown you cannot use the system for about 15 minutes e After shutdown certain maintenance procedures will be run automatically from a separate standby power supply e The instrument is designed to run continuously so there is no need to switch it off every day unless that is a requirement in your laboratory Shutting down the ISE The instrument provides an ISE standby power s
307. he last request Typically the system is set up to automatically accept unflagged results They are then displayed in the Sample Calibration and Quality Control tabs in the Results work area Flagged results are usually displayed in the Validate tab in the Results work area so that you can review them and either accept them manually or rerun them Flags and recommended actions on page C 6 You can specify how long raw data are kept in the database in Configuration Database Automatic Actions You can look at raw data values and a graph of the raw data over time in the Results work area To review rate information for a result on page B 126 If you want to use units that are different from the predefined standard units you can specify laboratory units as part of the test definition Configuration Tests Laboratory Enter an appropriate conversion factor If you want to compare results from the Cedex Bio HT analyzer with results from another instrument or methodology you can specify a factor and an offset value in Configuration Tests Laboratory to accommodate operational differences between the two instruments or methodologies The system applies the factor and offset to the results before displaying them in the Results work area A calculated result is a mathematical relationship involving one or more test results and optional numerical constants You can define calculated results for tests in Configuration Ca
308. he processing When the system is in Standby you can re initialize if necessary Sometimes you will be asked to do this in the recommended actions for a particular message You would also need to do this if your troubleshooting procedure caused you to knock or move an initialization post for example To re initialize the system Click Stop on the navigation bar to put the system into Standby state Click Service on the navigation bar 3 Choose Tools gt Initialize System System initialization takes a few minutes to complete 4 Click Restart if necessary Tips The system must be in Standby or Fatal Error state when you initialize The dialog box displayed after you click Restart is not listed here Stop processing on page E 12 In all messages and recommended actions in the Help your reaction to this dialog box is assumed Step 4 is not required if Auto Start is enabled in Configuration General System Shutting down the system Shutting down the system means that the Cedex Bio HT program is closed down and the instrument and computer are switched off 1 gt To shut down the system Choose File gt Shut Down Your are asked to confirm The computer is switched off automatically Operator s Manual Version 1 2 E 13 15 Messages Cedex Bio HT Stopping and restarting the system 2 Switch off the instrument at the main switch A After shutdown e All tests and procedures in progress a
309. he selected item Sends the results to the host again Displays statistical information for the selected result Displays information on the status of the test for the selected calibration or control B 116 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Validate tab B mo Validate tab The Validate tab lists all results that have not been automatically accepted You can accept the result or rerun it Use the flag information to help you to make the decision x Validate Y Sample Calibration cuatity contrat E Blocked 4 25 Not on Board S To Validate ga SLU S GLU Flags Action Raf Range CAL GLU Y 5 to Cee Helie zat seal A From the list select whether you want to display all results All or only the unaccepted results Unaccepted B The Validate list shows orders calibrations and controls whose results have not been accepted are blocked or are not on board STAT orders are listed in bold type To resize the columns position your cursor here and click and drag the divider to the left or right Use Edit to modify a selected order You are transferred to the appropriate tab in the Orders work area c D Use Find to display the results of a particular order E F The Results list shows results for the selected order calibration or control A
310. hotometry Abs fluorescence polarization FP photometry and for ISE measurements Colored LEDs light emitting diodes on the rack status indicator panel on the front of the instrument tell you the current status of on board cassette and sample racks Figure 0 2 A first look at the Cedex Bio HT instrument A Main cover B Status indicator panel C External waste water and power connections not shown D Data connectors for connection to the data station and the LAN E Main switch The system is designed to run continuously 24 hours a day if necessary However an On Off switch main switch is provided if you need to switch off the power to the system in an emergency or for troubleshooting Switching on the system on page B 31 Shutting down the system on page B 35 External waste water and power connections are made at the rear of the instrument The instrument may be connected to the laboratory waste and water system or you can use external waste and water reservoirs The data station comprises the elements shown below Operator s Manual Version 1 2 1 System overview A first look at a Cedex Bio HT analyzer User interface Computer Cedex Bio HT f Figure 0 3 A first look at the Cedex Bio HT data station Monitor Barcode pen optional
311. i 2a LOH S PNorm H f S PPath i Gy NAD PNorm f i t i T PPath i 3 a NH3 AMIN S AMM AB i i H AAIR Statistics Precision Accuracy C Limit admin 28 03 2012 10 58 A Click the column header to organize the information by controls or by tests B The folder for the selected test Each test can have up to six controls C Use From to specify or modify the date range Only the results within the specified range are listed in the Results list D Results are displayed in this area Each control has a unique symbol E Select the Precision Accuracy or Limit QC mode The available options depend on the control definition for the selected test lt lt Understanding control results on page B 176 Reviewing control statistics B gt To review statistics for a specified control Click Results on the navigation bar Click the Quality Control tab Select the By Control view A OON Select the required control from the By Control list B 174 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Reviewing and validating control results 5 Click Statistics 6 Select the required control mode using one of the option buttons The Statistics dialog displayed depends on the selected mode gt To review statistics for the controls used by a test eo Precision controls 1 Click Results on the navigation bar 2 Click the Quality Control tab
312. i e a combination of processes including cleaning disinfection and or sterilization is required before reuse recycling or disposal Dispose of the instrument according to local and or labor regulations For more information contact your local Roche Support personnel The electromagnetic environment should be evaluated prior to operation of the device This equipment has been tested and found to comply with the limits for Class B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interferences when the equipment is operated in a residential area However this equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the present user manual may cause harmful interference to radio communications Uninterruptible power supply UPS Depending upon the quality of electrical grounding of the local electrical power supply an uninterruptible power supply UPS may be required A UPS is not provided with the Cedex Bio HT analyzer The UPS should provide at least the maximum power listed in the Technical specifications provided in this manual Operator s Manual Version 1 2 xvii Cedex Bio HT Software virus warning Portable storage media can be infected with and transmit computer malware for example virus Trojan horse The Cedex Bio HT is not protected against malware The customers are resp
313. ialog box is displayed N Type the number of orders that you want to create and the order ID to start from Click OK A status dialog box shows how many orders are completed and how many remain Tips e Step 4 You can also choose Edit gt Copy e Step 6 You can also choose Edit gt Paste Multiple The order IDs that are created will be consecutive The new order IDs must not conflict with any existing order ID otherwise the order request will fail B 106 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Working with Orders Requesting a dilution Ifa test result is out of range or a sample needs diluting before a test is run on it you can request a test with one of the following types of dilution factor Dilution factor Description Factor Select a predefined dilution or concentration factor The system performs the dilution or concentration according to the factor you choose As Original Use the original dilution Specific Factor Select this option and type a dilution factor The system performs the dilution according to the factor you specify Manual Dilution Factor Select this option if you want to dilute the sample yourself Type the dilution factor you are going to use When you have performed the dilution replace the sample tube which now contains the diluted sample in its original position on the same rack All subsequent tests are performed on the diluted sample gt To
314. ibrators and electrodes Probes clogged or dirty 1 Perform the service action Deproteinize probes 2 Perform the service action Replace probe C if necessary Begin of Day actions not properly performed 1 Perform the service action Electrode service 2 Perform the service action Deproteinize probes Mixing washing or drying in the ISE tower not completed properly 1 Perform the service action Clean ISE tower automatically or Clean ISE tower manually 2 Contact Roche Service ISE Reference Electrolyte not present or flow not sufficient Check whether there is enough ISE Reference Electrolyte in the bottle 2 Check the ISE Reference Electrolyte flow through the reference electrode The ISE Reference Electrolyte flow should look like a bead chain If it does not check the ISE Reference Electrolyte tubing and the floater for blockage salt deposits or leaks 3 Remove any blockages and replace the tubing if necessary Replace the ISE module tubing then perform the service actions Condition ISE module tubing and Prime ISE calibrators Operator s Manual Version 1 2 F 49 19 ISE flags and troubleshooting Cedex Bio HT General ISE troubleshooting Results not reproducible Results are obtained but different measurements give different results ISE tower clogged or dirty If the ISE tower is clogged replace it 2 Ifthe ISE tower is dirty perform the service action Clean ISE tower automatically or Clean I
315. ically and a message is displayed informing you of the successful conclusion of the reading process Tips e Using the barcodes to enter control values is only possible for accuracy values All precision values first have to be established over a specified time period typically 20 working days and then to be entered manually e To read and edit the read lot information use Configuration Calibrators Lot or Configuration Controls Lot e Ifyou work with laboratory units other than the Roche standard units the values read from the barcode sheet are automatically converted to your laboratory units provided you specified the Lab Unit Factor Configuration Tests Laboratory e Certain controls have more than 40 barcode lines In this case read in the first 40 barcode lines Then reopen the Barcode dialog box to read in the rest of the barcode lines Turning control rules on and off If you need to run controls without using the control rules you can turn off control rules in the test definition gt To turn control rules off for a specific test Click Configuration on the navigation bar Double click Tests in the Definitions group Select the required test from the Installed Tests list Click the Control tab Clear the QC treatment box Click Save oar WN amp To specify which QC rules are checked 1k 1 Si Click Configuration on the navigation bar 2 Double click Database in the System group B 18
316. ice Actions dialog box is displayed follow the online prompts as required 3 The electrodes are rinsed with ISE Calibrator Direct to remove any sample residue automatic step Air is drawn into the ISE tower to empty the measuring channel automatic step 5 ISE Reference Electrolyte is drawn through the bypass automatic step 6 Open the ISE access panel A A 7 Pull out the ISE module using the handle B You have to pull quite hard because the ISE module is lodged firmly inside its housing Pull the module out until the spring catch C attached to the rear of the module is engaged 8 Remove the connector from fluid sensor 2 9 Open the electrode block cover D F 28 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Replace electrode 10 Remove the black cover for fluid sensor 2 E F E 11 Remove fluid sensor 2 F 12 Note the positions of the electrodes You must replace them in the same positions 13 Remove all the electrodes Before replacing the reference electrode shorten both tygon tubings of the new reference elec trode to a maximum length of 5 cm Warning 14 Replace electrodes as required Make sure that the electrodes G are reinstalled in their original positions Ensure that the electrodes and the electrode block are dry 15 Take care not to lose the sealing O rings H e Between the electrodes Between the fluid sensor and the adjacent You
317. ics and then click Print in the Results QC Statistics dialog box gt To print a Quality Control report from the Control view Click the column header to display the By Control view and proceed as when printing from the By Test view The service notes report contains the information of the Service Counters dialog box Service gt View gt Counters gt To print the service counters Click Service on the navigation bar Choose File gt Print Report gt Service Counters from the menu bar The Print dialog box is displayed Click OK Service Counters dialog box on page D 15 The service intervals report contains the information of the Service Intervals tab on the Service Counters dialog box Service gt View gt Counters gt To print the service intervals Click Service on the navigation bar Choose File gt Print Report gt Service Counters from the menu bar The Print dialog box is displayed Click OK Service Intervals tab on page D 16 The service notes report contains the information of the Service Notes dialog box Service gt View gt Notes Added notes to Service notes are printed immediately after the note they were added to The original note is marked with the symbol B 58 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Printing reports gt To print the service notes Click Service on the navigation bar 2 Choose File gt Print Report gt Ser
318. id CQ General messages E About messages What is a valid control sequence E Message Help E Creating a problem re ey ae IDs The occupied columns must always start at column 1 E 180 Unoccupied columns are allowed only on the right of the last occupied E 1620 column so there must be no unoccupied columns between occupied E 1683 ones 1823 A 2443 Rows with no check marks and the After Cal column are ignored in E 2890 the validity check An interval column is said to be occupied if it contains one or more check marks Explanation A valid control sequence must satisfy the following conditions See also gt Control tab pod gt About messages BSE ai 4 m amp Controller messages Message Help r You can also look up messages that have been generated by the system in the View Messages dialog box Chapter 15 Messages To find Help on a particular message Press F1 or click Help to open the Help system Click the Search tab in the navigation pane In text box 1 type the whole or part of the message number If necessary narrow your search by selecting an item from box 2 a fF OON Select the required message in box 3 For details on using the search facility see Search tab on page A 63 Tip Step 3 You can also type any word or phrase that identifies the message Warnings from the controller boards generate messages from which you can display
319. if you have selected a test order Operator s Manual Version 1 2 B 23 5 Daily workflow Cedex Bio HT Daily routine with sample barcode and with host 4 Doone of the following e Select a dilution factor to rerun the test order with dilution e Select As Original to repeat the test order with the setting defined in the test definition Requesting a dilution on page B 107 gt To review test result details _ Click the Validate tab on the Results work area N In the To Validate folder select a sample calibration or control order w Double click a result line in the list of results The Result Detail dialog box is displayed 4 Click Rate Info The Rate Info dialog box is displayed 5 Review the information to check the reason for the flag gt To accept a result 1 Click the Validate tab on the Results work area 2 Inthe To Validate folder select a sample calibration or control order 3 Select a result from the list of results and click Accept Tips e Click Accept All to accept all the results of the selected order e Set the filter option on the Validate tab to Unaccepted to display only the unaccepted results of the selected order B 24 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Daily routine with sample barcode and with host Creating orders If necessary create orders manually in three steps Orders File Edit View Tools Window Help
320. ifying a calibration interval eeesseesesseessessesseessessessessessessesseesssnesseess B 155 Loading and deleting calibrator definitions oo ees eseseeseeseeseeseeseeneeneenens B 157 Operator s Manual Version 1 2 B 135 10 Calibration About calibration Cedex Bio HT About calibration When calibrations are performed Validating calibrations Lot numbers Calibration modes and calculations Calibration is the process that establishes a relationship between one or more measured rates and the corresponding concentration of the calibrator The measured rates are derived from instrument measurements for example absorbance values Calibrations are performed at regular intervals defined in Configuration Tests General to compensate for changes over time in reagents and in the measurement systems Calibrations also have to be performed when certain physical events occur These include e A change in cassette reagent lot e A change in a defined interval Each new calibration has to be validated either automatically or manually No further calibration can be performed until the previous calibration has been validated and the results have been accepted If flags are generated you must determine their cause and decide whether to accept or rerun the calibration If a calibration for a particular test is not valid all the results obtained with that test should be checked The exact compositions of calibrators and re
321. ifying a calibration interval are None No calibration interval Interval Calibration at time interval only Cass Lot amp Interval Calibrate at each new cassette lot or specified interval whichever comes sooner Cassette amp Interval Calibrate at each new cassette or specified interval whichever comes sooner Loading and deleting calibrator definitions If you get an update to a calibrator definition for example from a new Test Application Software TAS use this procedure to load the new calibrator definition Operator s Manual Version 1 2 B 157 10 Calibration Setting up calibrators Cedex Bio HT To load a new calibrator definition 9 Click Configuration on the navigation bar Double click Calibrators in the Definitions group Click Load The Load dialog box is displayed You started the setup program to load Calibrator definitions into your system Specify the path where your source files are C Rache Instrument TAS Browse Help Cancel Click Browse and choose the drive and directory where the required calibrator definition is located By default the C Roche Instrument TAS path is selected Alternatively type the complete path Click OK The Load Calibrator Definitions dialog box is displayed Load Calibrator Definitions x Calibrator m Description Long Name Ammoniak CO2 Ethanol Std mi ID 07 5199 5 Bracing Version 50 1 I GLUB I Ise Created 10 07
322. igation bar 2 Choose File gt Barcode from the menu bar or click in the toolbar The Barcode dialog box is displayed Run the barcode pen over the first barcode line of the calibrator or control information sheet or read the barcode with the handheld barcode scanner Note The controls load as accuracy controls After reading the first line of barcode the information is displayed on the Barcode dialog box Barcode AQSVK S371861997900112 104636 1A4 Line Status Barcode line ok a ae ea P33 i o r _ B 5 6 F 8 9 10 The numbered boxes represent the barcode lines 4 Read the rest of the barcode lines of the control information sheet 5 Watch the Barcode dialog box Correctly read lines are represented by green boxes lines with reading errors by red boxes and a message on the Line Status box of the Barcode dialog box Barcode CAPS LOCK must be turned OFF BO VK S371861997900112 104636 1A Line Sais _ E o 3 E 5 6 16 T oe o m tf r Operator s Manual Version 1 2 B 185 11 Quality controls Cedex Bio HT Setting up controls e Using the barcode pen or handheld barcode scanner re read the barcode lines that are represented by a red box in the Line Status group of the Barcode dialog box e Click Reset to delete all lines and restart the whole reading process 6 When all lines are read correctly all boxes are green the Barcode dialog box closes automat
323. igation bar 2 Double click Tests in the Definitions group 3 Click the General tab B 156 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration 4 5 6 Setting up calibrators Select the required test from the Installed Tests list Complete the Calibration text boxes as required Click Save Configuration Test Definitions x Installed Tests ID General Dilutions Control Laboratory Evaluation Class Group Close Glutamine BioProcess Load Default Sample Type Sample zl seve B M ClotDetection enabled Delete Calibration Print Calibrator GLN Han l c a cee o i Cc 1 ee ee at ee D Main Interval Cassette amp Interval ow E days moOoO0O WD gt Selected test Sample type Roche calibrator f you select Duplicate or Triplicate a mean value is calculated for each standard Specify the interval type if necessary Tips Change the Sample Type only if necessary You can only use the predefined Roche calibrators This parameter can not be changed The system must be in Standby or Sleeping mode You must have the required user access level to perform this procedure You cannot modify a calibration interval if there is one or more unaccepted calibration curve for this calibrator or if there are unaccepted sample and QC results obtained on the basis of this calibrator You cannot modify the calibration interval of ISE tests at all The options for spec
324. ilable on the Worklist and Sample tabs of the Orders work area and also on the Validate and Sample tabs of the Results work area To find an existing sample or order 1 Click Orders on the navigation bar 2 Click the Sample tab 3 Click Al on the toolbar The Find Orders dialog box is displayed LL x SRC eae Socmococooscssecossssrssecaac Clear Help P OK B M Datefrom 26 03 2012 To 27 03 2019 1 eS Se J Cancel c A Enter text and wildcards B Specify a date range for the order C Specify the start and end dates for the search period D Start the search but leave the dialog box open 4 Type your search criteria in the Find Orders dialog box 5 Click Find The orders that match the search criteria are listed Operator s Manual Version 1 2 B 103 8 Orders Cedex Bio HT Working with Orders 6 Double click the order that you want to work with Tips e Be aware that the find function is case sensitive e Ifthe search is not successful remove or relax some of the search conditions e Use the Sounds Like facility to match sounds rather than spellings English language versions only B 104 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Working with Orders Reviewing tests in an order The Sample Test Summary group displays the details of the tests selected for the current order The tests are displayed in folders and are sorted by their short nam
325. ilation filters replacing 49 vertical scroll bars 51 View Message dialog box 6 Message Log tab 7 Options tab 8 viewing cassette history 15 cleaner definitions 16 cleaner history 16 diluent definitions 16 missing calibrators 142 profiles 12 rack positions of calibrators 141 test definitions 8 viewing messages 9 Warning symbol xiii vels a M 15 wash cycles 21 wash pipettes 21 wash station 21 cleaning 30 defective 27 waste connectors 37 cuvettes 26 disposal 12 emptying reservoir 47 fluid 23 instrument connections 22 reservoir cleaning 33 safety precautions xv specifications for handling 6 waste box 26 waste reservoir emptying 47 water connectors 37 filters 23 quality 27 supply 22 23 water requirements specifications 5 User Manual Version 2 7 1 29 Index water reservoirs external cleaning 33 external refilling 45 external replacing filter 64 internal 22 internal cleaning 27 water supply unit 23 wavelengths for absorbance photometer 40 Windows shortcut keys 53 13 without orders sample 69 work area Calibration 135 Orders 87 Results 116 Service 6 Status 67 work areas dialog boxes 50 overview 49 tabs 50 workflow 3 assumptions for sample workflow 6 Worklist printing 56 Worklist tab Orders work ar
326. ime e Type 1 to delete at Begin of Day all orders that were created more than 24 hours before Begin of Day time To delete a single order 1 Click Orders on the navigation bar 2 Click the Sample tab Operator s Manual Version 1 2 B 109 8 Orders Cedex Bio HT Working with Orders 3 Type the order ID in the ID box and press Tab 4 Right click anywhere in the Sample tab and choose Delete Order from the context menu The system prompts you to confirm the deletion 5 Click OK Tips e You cannot delete an order if the sample is on board e Step 4 You can also choose Edit gt Delete B 110 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Results Reviewing and validating results This chapter describes the Results work area and how to use it It shows you how to E review results for samples calibrations and controls You can also validate results and rerun tests You find more information on result handling in Chapter 10 Calibration and Chapter 11 Quality controls In this chapter Chapter 9 ADOUE TOS UNIS sssrinin araneae ar EREE Resultsata plances ane ERRET Results work area OVervieW seseesssssesssesesseesessesseessessessssseseessessesssssessesssessesseessessesses Validate tabiin ER EEE E Ni Sample CAD anre E a EE E EEE E E E TE S Calibrations taB eE r EE AE E En EE ea ei Er T A ETES Quality Comtrol tab aneia Ea RN Selecting specific orders sixesnszceseseertssusru
327. ime ISE calibrators Clean ISE tower automatically Condition ISE tubing Service Li File Edit View Tools Window Help e 5 als D Due All Begin of Day Service Action J Duration min Prime fluid system ry 1 i J Deproteinize probes 6 Stop meee O EL ol ADMIN 20 04 2000 16 37 A The service actions listed here will be performed at the next Begin of Day They may be actions that are due at the next BOD or actions that failed at the previous BOD B Shows the time it takes to perform the service action in minutes Tips e You can perform the service actions displayed on the Begin of Day tab manually if necessary e Display the details for a particular service action by Operator s Manual Version 1 2 13 Service action software Cedex Bio HT Begin of Day tab Double clicking the item in the list o Right clicking the item then choosing Detail e Choose View gt Notes to see a list of user actions and service actions that been performed The paper clip indicates the presence of a note Service notes on page D 13 e Press F1 to display Help for this tab D 10 Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software Performing a service action Performing a service action You can perform a service action from any of the three tabs in the Service work area A series of instruction dialog boxes are displaye
328. in e Council Directive 2004 108 EC on the alignment of the legal provisions of the Member States on electromagnetic compatibility EMC Council Directive 2006 95 EC on the alignment of the legal provisions of the Member States on electrical equipment for use within certain voltage limits Compliance is provided by means of the Declaration of Conformity Regulatory compliance is demonstrated by the following marks Complies with European Union EU Directives 2004 108 EC and 2006 95 EC Issued by Underwriters Laboratories Inc UL for Canada Aus and the US Operator s Manual Version 1 2 Cedex Bio HT Contact address Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany Made in Switzerland Operator s Manual Version 1 2 Cedex Bio HT Operator s Manual Version 1 2 INTEGRA 400 plus Table of contents Table of contents v 6 Routine tasks Preface ix Starting up and logging on to the system 31 Software virus warning xviii Logging off and shutting down the system 35 Safety labels on the system Re Starting and stopping a run 37 Safety information for laser transmitters Handling test materials 38 Managing resources 42 Overview Checking due service actions 50 Checking the Memo Pad 51 1 System OVErVIEW Printing reports 52 Introduction 4 Purging and deleting information and items 60 A first look at a Cedex Bio HT analyzer 5 Archiving system information 63
329. individually by aspirating reagent at the expected filling level into a cuvette Presence or absence of reagent is detected using the absorbance photometer If the integrated cassette volume check fails a message is displayed and the cassette access is denied The cassette volume check can be enabled in the Configuration work area Configuration General System The current status of the cassette volume check enabled or disabled is listed in the BOD report A 30 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Sample racks Caution Tube height adapter grid Rack number and rack code Functional systems Figure 0 20 Sample racks and tube height adapter A Tube height adapter grid D Tube B Sample rack label E Rack barcode C Barcode on an empty slot F Rack stabilizer foot A sample rack has 15 positions for tubes containing samples calibrators controls or diluents For samples both primary and secondary tubes can be used You can use only one type of sample tube or cup in each rack This is true whether the rack has been configured for a specific tube type or for a specific sample type You must not mix different tube types on the same rack Sample type specific racks are used when the barcodes on the samples do not contain sample information This enables the system to identify the sample type You can adjust the height of the tubes in the rack by using a grid device
330. ing for leaks or blockages Contact Roche Service Operator s Manual Version 1 2 F 47 19 ISE flags and troubleshooting Cedex Bio HT Flag descriptions lt TEST RNG Meaning Message ID Possible cause Recommended action gt TEST RNG Meaning Message ID Possible cause Recommended action The measured value is below the test range None The actual concentration in the sample is below the test range e Check the ISE reading mV The measured value is above the test range None The actual concentration in the sample exceeds the test range e Check the ISE reading mV F 48 Operator s Manual Version 1 2 Cedex Bio HT 19 ISE flags and troubleshooting General ISE troubleshooting General ISE troubleshooting Poor accuracy This section identifies some common problems that do not necessarily generate flags or messages Results are reproducible but do not match the known values ISE tower clogged or dirty If the ISE tower is clogged replace it 2 Ifthe ISE tower is dirty perform the service action Clean ISE tower automatically or Clean ISE tower manually 3 Ifthis does not fix the problem perform the service action Replace ISE tower You may have to perform the service action Clean ISE tower automatically more frequently If so reduce the service interval in the Service work area ISE solutions calibrators or electrodes expired 1 Check the expiration date of all ISE solutions cal
331. ing table lists possible placements of available diluents on the Cedex Bio HT analyzer Diluent Placement Capped NaCl Diluent 9 ISE rack Yes Sample rack No Pyridoxal phosphate liquid ISE rack Yes Sample rack No Accelerator ISE rack No Sample rack No HbA1c Hemolysis Reagent ISE rack Yes Sample rack No ISE Deproteinizer ISE rack Yes ISE Etcher ISE rack Yes ISE Activator ISE rack No ISE Solution 1 ISE rack Yes ISE Solution 2 ISE rack Yes ISE Solution 3 ISE rack Yes The onboard stability of the diluents is monitored by the system software when the diluent is placed on the ISE rack In contrast on sample racks the onboard stability cannot be monitored by the system In this case it has to be monitored by the operator For details about the onboard stability refer to the individual Method Sheets A 34 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Functional systems Barcode scanner Barcodes contain machine readable information in the form of black and white stripes All cassettes are barcoded so that they are automatically recognized when you load them on board You can attach barcodes to sample tubes and cup adapters to identify samples calibrators controls and diluents The barcodes supported are e Code 2 of 5 Interleaved e Codabar code 2 of 7 e Code 128 e Code 39 3 of 9 interleaved e UPC A E e EAN You can select other barcodes from the ones that are predefined i
332. ing the Test Calibrations function you can display for all loaded tests when the next calibration is due gt To check when a calibration is due 1 Choose Tools gt Test Calibrations on the menu bar B 140 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration gl Reviewing the status of calibrators on board The Test Calibrations dialog box is displayed Test Calibrations Calibrator Test Status Rack Position K D Required 15 03 2012 13 Days ISE OK 0140 6 Required 15 03 2012 13 Days ISE OK 0140 6 Required 19 03 2012 9 Days GLN Ok 101 7 next cassette or 29 03 2012 1 Days Gluc nextlot Chas OK 101 1 IGGHB next lot SERTS OK IGGLB next lot SERTS OK LAC nextlot Clas OK 101 1 LDH next lot Cas OK 101 1 NH3 nextlot AMM S OK 101 3 Tips This function is available from all work areas You can click the Test Calibrations button on the toolbar instead of choosing Tools gt Test Calibrations Place all calibrators on the instrument before you generate and print the list The system updates the calibrator status of onboard calibrators only Click a column header to sort the list Click Print to print a report with the contents of the Test Calibrations dialog box Viewing rack positions for calibrators Typically calibrators have a preassigned rack position on a sample rack Configuration Lab Reserve Positions You can also specify an ad hoc location for a particular ca
333. ins for one test the results of up to three controls of the same control type Should there be more than three controls for the same control type the report is split The first report contains the results of the first three controls the second report those of the next three or the remaining controls The page numbering in the printed Quality Control report refers to the single reports As part of the printing process you can specify the data you want to include in the report Choose File gt Print QC Report from the menu bar and the QC Report dialog box is displayed The following figure shows the QC Report dialog box with the By Test view selected QC Report x Select Criteria for the QC Report please r Interval of OC Results No limitation of time From 4 _ A r Control Type M Accuracy MV Precision B I Limit L r Test Selection All Tests C Only selected Test CA Help Cancel A Set the period for which the QC report should be generated B Select the control types for which a report should be generated These settings will remain active when this dialog is opened the next time If you do not select any type no report will be generated and printed If multiple control types are selected QC is printed more than once C Choose whether a report should be generated for the controls of the selected test only or of all tests If you select Only Selected Test the
334. inst the actual lot number on the package insert If these are different rerun the control with the correct control lot A paper clip at the beginning of the line indicates that a comment has been entered in the Details dialog box Press F1 to display Help for this tab Reviewing control results Use the Quality Control tab in the Results work area to review quality control results Operator s Manual Version 1 2 B 173 11 Quality controls Cedex Bio HT Reviewing and validating control results B amp To review control results 1 Click Results on the navigation bar 2 Click the Quality Control tab 3 Click the column header until it shows By Test 4 Click the H to open a test folder 5 Use the From button on the toolbar to define a period to reduce the number of results displayed x Fie Edt View Tools Window Help 72 8 4 S B Ai z _ From c Validate Y Sample Calibration Quality Control Start By Test Precinorm U m PNorm CLU 1 a DaeaTime g L 3s 25 Is X ls 25 35 Flags Action amp Glu2 i 15 Mar201213 09 0 90 3 n c u3 Calibration narmi i i S Glue i 14Mar 201209 26 0 90 GH a Calibration parameter 4 4 hi d i i i i S PPath 12Maram21428 089 i fm i B IGGHB EPEE ER SEN ER ER EEE AN VEE E EPE T S PNProt 1 2 IGGLB j i i baa KD i i i i PNorm f f Sy PPath H ea lac PNorm i i i i S PPath f
335. int Report gt Loadlist The Sample Handling dialog box serves to assign samples to rack positions and to confirm rack positions that were automatically assigned It also serves to enable the Cup on Tube function Sample Handling x Sample Type Sample LE Sarstedt2 0mL Sample 5 SAMPLE Sarstedt2 0mL Sample 6 SAMPLE Sarstedt2 0mL Sample 101 CAL COBAS cup Sample 102 QC COBAS cup Sample Operator s Manual Version 1 2 B 99 8 Orders Creating an order Cedex Bio HT You can display the Sample Handling dialog box at any time by right clicking a sample or a test in the Sample Test Summary group and then choosing Sample Handling from the context menu You can also choose View gt Sample Handling from the menu bar when an item is selected You cannot change the tube type in this dialog box If you do not work with barcodes the Sample Handling dialog box is automatically displayed when you click Save If you work with barcodes the Sample Handling dialog box is not displayed when you click Save Tips e While working with barcodes you cannot change positions that were fully identified with order ID and sample type as long as the associated rack is on board e You can overwrite positions of racks that are not on board the system without previously having cleared the position for example on the Place Items dialog box e A padlock symbol in front of an entry in the Rack list signifies that th
336. ion about performing a service action Double click the service action on the Due All or Begin of Day tab o Click Help on the dialog box Operator s Manual Version 1 2 D 11 13 Service action software Cedex Bio HT Performing a service action e You may perform some service actions without using the Service action software If you decide to do this select the corresponding service action on the All tab and click Done The counters and timers will be reset to zero Examples of the service actions where this is possible are replacing ventilation filters or cleaning the fluid waste reservoir Important Do not remove the internal water reservoir without using the Clean internal water reservoir service action Caution D 12 Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software Service notes Service notes Service actions that have been performed are listed on the Service Notes dialog box User actions are included in the list A paper clip indicates that a note has been attached to the service action or that the note was added by a user To open the Service Notes dialog box choose View gt Notes on the Service work area Service Notes ah x A 19 04 2000 14 37 Deproteinize probes Passed ADMIN 19 04 2000 14 31 Deproteinize probes Failed ADMIN 19 04 2000 13 19 Prime fluid system CycPassed ADMIN 19 04 2000 06 20 Backup database Passed ADMIN 19 04 2000 06 09
337. ipetting When the pipetting is finished the cuvette is rotated elliptically in the workstation to mix the fluids The cuvette is then put back onto the rotor to be moved around to one of the photometers for the measurement phase Workstation C temporarily removes a single cuvette from the rotor so that the cuvette can be accessed by probe C for reagent sample or diluent pipetting When the pipetting is finished the cuvette is rotated elliptically in the workstation to mix the fluids The cuvette is then put back onto the rotor to be moved around to one of the photometers for the measurement phase This workstation removes a single cuvette at a time from the rotor so that fluorescence polarization measurements can be made in the FP photometer When the measurements are complete the workstation returns the cuvette to the rotor At the absorbance photometer the measurement is made with the cuvette still in the rotor There are two photometers one for absorbance measurements and one for fluorescence polarization measurements For each cuvette slot the absorbance photometer measures light intensity at 12 different wavelengths The light beam from the absorbance halogen lamp passes through the cuvette and then into a photodiode array where the measurements are made The absorbance photometer makes both absorbance and turbidimetric measurements For absorbance measurements e Absorbance readings are linear in the range 0 0 through
338. ir G Curette waste box L Transfer head cover Q FP photometer C SE module H Barcode scanner M Transfer arm R_Cuvette transport system D Cooling box top l Main switch N Cuvette reservoir S Absorbance photometer E Cassette area J Internal water reservoir O Wash station not shown A 18 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Functional systems Fluid system Functional systems The Cedex Bio HT analyzer comprises these functional systems System Function Fluid system Cuvette transport system Rack system Robotic transfer system Analyzer module ISE module Computer systems Moves all the fluids used by the system including water samples reagents diluents and cleaners Provides a continuous supply of cuvettes in the correct orientation to the analyzer rotor also includes the cuvette waste Provides fixed slots into which different types of racks can be placed and accessed by the robotic transfer system This also includes the racks and the barcode scanner Pipettes samples reagents and other fluids from their containers into cuvettes for mixing so that measurements can be performed Contains the absorbance and FP photometers used for making measurements also contains the workstations which move the cuvettes for pipetting mixing and measuring Provides the instrumentation for performing ISE lon Selective Electrode measurements The circuit boards
339. irect measurements are mixed using an air stream Undiluted samples are not mixed Tubing not shown Tubing is used to connect the ISE module with the water and waste system Tubing is also used for sample waste ISE Reference Electrolyte and ISE calibrators which are contained in bottles on the ISE module Sample transfer arm not The sample transfer arm uses probe C to pipette samples shown into the ISE tower If required samples may be diluted automatically Valves not shown A set of valves controls the flow of liquids through the tubing Sensors A pair of sensors detects the presence of liquid or air and enables the correct placing of segments for measurement and cleaning ISE distribution block A transparent plastic block used for liquid and air distribution within the ISE module The following ISE solutions are stored in bottles that are located on the ISE module itself ISE Reference Electrolyte Bio HT e ISE Calibrator Direct Bio HT e ISE Calibrator Indirect Bio HT Replace bottles on ISE module on page F 34 The ISE module uses a special rack called the ISE rack which is always loaded into slot O to the right of the sample platform The ISE rack contains the ISE solutions essential for its operation You must place each solution in its correct position as defined in Configuration System Lab Reserve Positions The Activator and ISE Deproteinizer in particular need to be placed in the correct p
340. ix racks of 15 sample tubes on board LED icons indicating rack status Automatic predilution Postdilution and postconcentration with user definable factors Offline dilution factors can be entered Positive sample identification by barcode scanner Codabar 2 of 7 Code 39 Interleaved 2 of 5 Code 128 Calibration e Linear and nonlinear e Stability Multiple standards with single and two point correction Automatic dilution of multipoint standard curves Typically Each lot for enzymes substrates or serum proteins Operator s Manual Version 1 2 21 Appendix Technical specifications Reagent cassettes Cuvettes Photometry analyzer Absorbance module Cedex Bio HT Test capacity Cassette identification On board storage capacity Cassette storage temperature On board stability Test dependent Standardized cassettes for all tests Automatic barcode reading each cassette uniquely coded for inventory control 32 cassettes 10 15 C 50 59 F Test dependent typically 4 12 weeks Reaction volume Path length Composition Cuvette reservoir capacity Waste container capacity 120 245 uL 5mm PMMA acrylic plastic 1000 disposable cuvettes refilling possible during operation 1000 cuvettes Cuvette capacity System cycle time Temperature control 71 cuvettes with automatic loading unloading 10 6 seconds Heated air bath 37 C 99 F Spectrophotom
341. k platform This area is enclosed by the cooling box and the temperature inside is maintained at 10 jiii 15 C The cassette rack platform has slots for eight cassette S racks and one sample rack Sample area Contains the sample rack platform This area is not enclosed by a box the temperature is approximately room temperature The sample platform has five slots for sample racks and an additional dedicated slot for an ISE rack Operator s Manual Version 1 2 A 27 2 System description Cedex Bio HT Functional systems Figure 0 18 shows the rack platforms removed from the system left and a schematic layout of the rack platform from above right A B C D E F G H I J K LIMIN O Figure 0 18 Rack platforms callouts refer to both figures A Cassette area cooled to 10 15 C Slots A through H are for cassette racks B Slot in the cassette area also cooled is for sample racks typically used for calibrators and controls i Slot O is for the ISE rack D Sample area Slots through N are for sample racks You can remove cassette platforms individually for routine cleaning as part of a service action Clean instrument on page D 36 Unlock rack tool The unlock rack tool is supplied with the instrument It is located on the right of the cleaner reservoir You can use it to e Remove the rack platforms for cleaning Clean instrument on page D 36 e Manually release ra
342. kage NO FLUID 7 3 14 3248 08 010 xxx F 45 14 3248 08 011 xxx 14 3248 08 047 013 14 3248 08 048 013 NO ISECAL 8 3 14 3248 08 027 xxx F 45 OUT OF RNG 26 None None F 46 SEG FLUID 9 3 14 3248 08 012 xxx F 46 SEG ISECAL 10 3 14 3248 08 028 xxx F 47 SOL 1 F DEV 28 None None F 47 lt TEST RNG 30 None None F 48 gt TEST RNG 31 None None F 48 The following flags do not generate messages OUT OF RNG SOL 1F DEV lt TEST RNG and gt TEST RNG When a repeated flag generates a message the message number has the format aa bbbb cc ddd xxx as shown in the table above You can uniquely identify a message by the second cc and the third ddd groups of digits For example in the message 14 3248 08 012 xxx the digits 08 012 identify the message xxx means don t care that is these digits are not significant Operator s Manual Version 1 2 F 41 19 ISE flags and troubleshooting Cedex Bio HT Flags and user actions Terminology Flags and service actions If a message box is displayed you can get detailed information by clicking Help Message Help on page A 68 The following terminology is used in the flag descriptions that follow FLUID Any liquid sample control calibrator or other solution that is introduced into the ISE tower ISECAL ISE Calibrator Direct or ISE Calibrator Indirect SEG A segment of fluid that is drawn past the fluid sensor and therefore past the electrodes Fluid segments
343. kind of initialization e g of the fluid system or the transfer arms after power up or before being operative Integrated cassette volume check This function checks the reagent filling of each cassette It ensures that the system correctly aspirates the number of tests the cassette is specified for ISE Ion selective electrode ISE Module The ISE module is an electro mechanical device used to determine ionic concentrations in undiluted and diluted samples using electrodes selective to different ions The ISE module is one of the two measurement areas of the instrument the Photometry Analyzer being the other ISE Rack Contains most of the fluids Activator ISE Solutions 1 2 3 ISE Deproteinizer ISE Etcher needed to measure the ionic concentrations in a sample and to maintain the electrodes Diluents necessary for other tests can also be placed on the ISE rack Journal A list of all recent results and messages generated by the instrument This list can be accessed through the software Level Detection The automatic determination of the level of fluid by the probes Level detection establishes whether there is enough fluid to perform the incipient pipetting operation Light Emitting Diode LED Solid state lamp available in different colors For the Cedex Bio HT analyzer LEDs are used for the warning light and rack status indicators on the front of the instrument the fuse indicators the FP photometer etc Log Of
344. king 42 system states 42 Auto service 44 Initializing 44 Operating 44 parameters 45 Service 44 Sleeping 44 Standby 44 transitions between 43 systems cuvette transport 23 fluid 19 for racks 26 in instrument 19 pipette module 20 robotic transfer 35 tabs changing 48 on dialog boxes 50 TAS xii loading 17 tasks overview 8 technical specifications 4 temperature controlling 32 inside analyzer 38 of cleaner 43 of instrument 77 test application software loading 17 Test Calibrations toolbar button 52 test classes creating 11 modifying 11 test counters printing 59 INTEGRA 400 plus Bs Counters dialog box 18 test definitions and controls 162 deleting 9 loading 7 viewing 8 test groups creating 10 modifying 10 test sequences modifying 10 Test Status tab Status work area 74 tests aborted 22 adding to orders 105 assigning to orders 96 blocked 12 77 19 calibration history 120 controls history 121 copying data in an order 106 definitions 7 deleting from an order 108 detailed information 74 dilutions 107 disabled 22 disabling 74 82 enabling 82 loading definitions 7 maximum number of requests 92 missing 101 pending 77 rerunning 128 results low or drifting 28 results not
345. l line to display details on the result 5 Click the appropriate button Accept Accepts the selected control result Accept All Accepts all control results for selected test B 172 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Reviewing and validating control results Rerun Rerun the control The current results are deleted lx A fie Edt View Tonle Window tan jaie7o jaxb M l z z Fom Validate Sampie Calibration Quality Controt Restart Glue Control i To Validate Control Pesut Unit Flags Action Ref Range B agn PNorm SO4g L 0 78 0 96 Stop PPath lt 002g L lt TESTANG 205 2 49 Li o 1 EL A From the list select whether you want to display all results All or only the unaccepted results Find Edit Unaccepted B The selected control C To resize the columns position your cursor here and click and drag the divider D This control is flagged Double click for more information Accept All Tips Double click the test name in the Validate list to view details about the control order Double click the control result to view additional details about the control For a flagged control select the control then perform these steps o Follow the recommended action for each flag Chapter 12 Result flags o Check the assigned lot number of the control aga
346. lculated Results and specify how to handle calculated result flags in Configuration Result Handling Calculated Results The system automatically calculates a calculated result if all the tests specified in the calculated result are requested in an order Note When tests are requested in duplicate the calculated result is only calculated for the first run of the test You can define a general reference and a critical range for each test in Configuration Tests Evaluation If the test result falls outside the defined range the settings in Configuration Result Handling determine what happens next You can specify up to four automatic dilution factors for each test in Configuration Tests Dilutions The automatic dilution factors are used only when Automatic Dilutions is set to Sequential Results are stored in a database on the hard disk You can purge completed results to maintain disk space Tools gt Purge Results If the instrument is connected to a host the results are considered to be completed when they have been transmitted Without B 112 Operator s Manual Version 1 2 Cedex Bio HT 9 Results About results host connection the results are considered to be completed when they have been accepted Purging results on page D 67 Operator s Manual Version 1 2 B 113 9 Results About results Results at a glance Cedex Bio HT Use the following tables to locate specific tasks by work are
347. le gt Print Report gt Results from the menu bar The Print Result Query dialog box is displayed Print Result Query x From To Order ID Order Date 3 Type the values to define your selection If you do not provide any selection criteria all available results will be included in the report 4 Click Print to generate the report and print it Operator s Manual Version 1 2 B 55 6 Routine tasks Cedex Bio HT Printing reports gt To print the Results of a single order 1 Click Results on the navigation bar 2 Right click the order ID and choose Print Preview from the context menu 3 Click Print in the Report Preview dialog box Printing the Worklist The worklist contains all orders known to the system They are listed by their order IDs in ascending order It shows the orders that require completion the tests ordered for each sample and the status of each test If you work with barcodes and without a host system or if you work without barcodes use this list to get an overview on the orders and tests that need processing gt To print the worklist Click either Status Orders Results or Configuration on the navigation bar Choose File gt Print Report gt Worklist from the menu bar The Print dialog box is displayed Click OK A OON Printing the journal The journal lists all results in chronological order of their pipetting time Use this information to review the pipetting sequen
348. lean wash station service action 30 cleaner 23 empty 43 20 not on board 20 position of 70 precautions xvi replacing 43 temperature 43 cleaner definitions viewing 16 cleaner history viewing 16 cleaning external water reservoir 33 fluid waste reservoir 33 instrument 9 36 internal water reservoir 27 ISE tower automatically 21 ISE tower manually 22 probes and splash guard 24 segment 6 8 wash station 30 Clear toolbar button 52 clearing red or yellow of Messages button 5 Close Help button 59 closing online Help 57 Clot detected folder 69 clot detected after probe washing 30 during sample pipetting 29 during transfer 30 in sample probe 30 clot detection 23 color coding on Cassettes tab 72 on Samples tab 71 colors of resource icons 42 of Service button 50 command buttons 51 common cuvette 13 compliance with regulations 11 components ofinstrument 18 computer main features 6 INTEGRA 400 plus computing computer 40 instrument 40 concentrations modifying 8 Condition ISE module tubing service action 31 configuration 1 calculated results 6 calibrators 6 cassettes 6 cleaners 6 controls 6 Definitions tasks 4 diluents 6 ISE solutions 6 loading test definitions 7 ove
349. leaning 21 22 clogged or dirty 50 location 5 replacing 36 ISE UNSTAB flag 44 journal printing 56 Keyboard icon 22 User Manual Version 2 7 Index INTEGRA 400 plus keyboard shortcuts 13 for work areas 49 keys Ctrl 53 function 54 F11 42 F12 42 F5 54 F6 54 F7 54 F8 54 shortcuts 13 Lab icon 20 lab units 112 labels on cassettes 30 LAN connection instrument 38 laser sources specifications 5 LCD xii leakages 30 of connections 27 of tubes 27 LED light emitting diode xii for controller board fuses 42 rack status 39 significance 29 Limit control mode 162 limit controls 176 reviewing 179 linear calibration 136 linear interpolation calibration mode 137 linear regression calibration mode 137 me junction how the ISE module works 8 location 9 list of messages printing 10 lists drop down 51 Load Definitions toolbar button 52 loading calibrators 11 40 143 cassettes 9 40 control definitions 181 controls 11 40 169 definitions and system parameters from the archive 19 diluents 40 samples 14 17 22 38 test application software TAS 17 test definitions 7 Loadlist printing 54 log messages 7 logging off 35 logging on 33 Logit log 4
350. librator for example if you are calibrating a test that does not need calibrating very often The system may also use barcodes to identify calibrators To view preassigned rack positions for calibrators If the rack is on board 1 2 3 Click Status on the navigation bar Click the Sample tab Double click the rack number The calibration name for each position is displayed lt Samples tab on page B 70 If the rack is not on board 1 2 Click Configuration on the navigation bar Double click Lab in the System group Operator s Manual Version 1 2 B 141 10 Calibration Cedex Bio HT Reviewing the status of calibrators on board 3 Click the Reserve Positions tab To load calibrators without barcodes on page B 143 Tip You can also click Place Items in the toolbar and then select the rack Viewing missing calibrators If a calibration is requested and one or more of the required calibrator s are not on board the missing calibrators are listed in the Missing amp Blocked tab in the Status work area gt To view missing calibrators s 1 Click Status on the navigation bar 2 Click the Missing amp Blocked tab Double click the Not On Board folder in the Cals QCs Cleaners Diluents and ISE list Cal OC Cleaners Diluents ISE iy Expired 15 23 Not on Board poa A vi Cfas Std 11014 B g Ctas Sid2 11012 i W GLU Std 1 114015 1 32 GLU Std 2 1101 6 J A
351. lick to open a test folder 5 Select a control 6 Use the From button on the toolbar to define a period to reduce the number of displayed results N Select the Accuracy option if available for the selected control B 178 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Reviewing and validating control results The results are displayed to the left of the graph the graphical display looks like this A Glucose V3 BioProcess mPPeh i Date amp Time o t Ee xX High _ Flags Acion_ 1311 0 00 lt TESTRNG Calibration parameter changed 10 Apr 2012 12 37 0 95jem lt TEST RNG 10 Apr 2012 12 17 4 99 Bjc A Legend showing the symbols for each control Tips e Red symbols represent flagged results e Gray entries represent results that either were excluded from the statistics or have the status Deleted a rerun was ordered e For accuracy controls the graph is scaled relative to the assigned value and the high and low values associated with the permissible deviation Again each control has its own symbol amp To review limit controls Click Results on the navigation bar Click the Quality Control tab Click the button at the top of the column until it shows By Test Click to open a test folder Select a control oar WN Use the From button on the toolbar to define a period to reduce the number of displayed results 7 Select the Limit o
352. list on page E 38 2 Ifany cables are damaged contact Roche Service Computer 1 Switch off the computer 2 Insert the plugs in the correct sockets press them in firmly 3 Switch on the computer Screen is partially or completely black 1 Check that the monitor is plugged into the laboratory mains and that it is connected to the computer Check that the monitor is switched on LED on the front right hand side Move the mouse or press a key to deactivate the screen saver 4 Check the mains fuses Replacing an instrument mains fuse on page E 40 5 Ifthis does not fix the problem contact Roche Service Screen is dim or dark Check the screen brightness and contrast selections on the monitor using the buttons below the screen Printer connections and printer indicators OK but still no printout Check the printer settings in Windows XP 2 Check that the printer driver currently used as the default corresponds to the printer actually connected Modify the printer settings if necessary 3 Switch the printer off and back on again to re initialize 4 Ifprinting is still not possible shut down the system Restart and wait until the Operator s Manual Version 1 2 E 35 16 Troubleshooting Cedex Bio HT Data station accessories system is initialized Shutting down the system on page E 13 Restart processing on page E 13 5 Ifthe problem reoccurs contact Roche Service Barcode scanner
353. lls you when the next calibration for that test is due x File View Tools Window Help 2 4 a S b Missing amp Blocked Samples Cassettes Test Status Analyzer ISE Glucose V3 BioProcess CEDEX BIO HT r Test Gluc aok A cin Status OK I Test Enabled Stop an NextCal nextlot Pa QCInterval No interval B agn IE S GGHB Cassettes c6LB u03 022 M fm KD aro amp LDH eee a S NAD p Calibrators 1 i s j y E NH3 Cfas St1 104 Chas Std 2 1 401 2 od 1 i i i m Controls i t 7 x i i 1 y c PNorm 1 1021 1 1 F Enabled K PPath 1 1022 1 Enabled 1 1 1 1 ne 1 1 1 1 i i j al i O i i i i i i i 1 m Diluent i i i VA J L admin 27 03 2012 18 17 A Tests are grouped in folders depending on their status B Selected test whose details are displayed on the right C Slot ID rack number and position on the rack D Enable or disable the selected test Tests may be automatically disabled Configuration Result Handling E Status message Red background Take immediate action Yellow background Warning take action as soon as possible F Select or clear check boxes to enable or disable individual controls for the selected test The check boxes are selected by default Tips e Double click on items in the Cassettes Calibrators Controls and Diluents grou
354. lutions Result Handling Click the Result Handling icon to specify how flagged and unflagged results are automatically handled for samples controls calibrations and calculated results Processing Click the Processing icon to specify processing options for report layouts results uploaded to the host the test processing sequence and extra wash cycles for specific tests User access You use the Configuration General dialog box to add new users modify user details and define user access levels gt To use the Configuration General dialog box D 1 Click Configuration on the navigation bar 2 2 Double click the General icon in the System group Assigning and deleting user details To assign a user level to a user Click General Click the User Access tab Click Add A new information box is displayed indicated by an arrow Type the user name level user ID and password Click OK a A ON Tips e User name is up to 16 alphanumeric characters e Levels are 1 lowest to 6 highest 1 is the default G 20 Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration System group User ID is up to six alphanumeric characters and must be unique Password is up to six alphanumeric characters The password is case sensitive gt To delete a user A OON Double click General Click the User Access tab Select the required user and click Delete Click OK to confirm the new settings and close the
355. m Report Result Report A Specifies the number of messages in the message log B Click to change the size of the message log I The Options tab is also used to save the Problem and Result Reports for troubleshooting purpose E 8 Operator s Manual Version 1 2 Cedex Bio HT 15 Messages Working with messages Working with messages You can confirm messages display or print details on a message review confirmed messages or display Help on a message Chapter 4 Online Help Confirming messages A shortened form of each message is stored on the New Messages tab on the View Message dialog box When you confirm a message it is automatically removed from the New Messages tab and transferred to the Message Log tab The system can carry on running even if there are unconfirmed messages Recommendation Do not confirm a message until you are sure that you have resolved the problem that caused it to appear in the first place The running man on the Messages button remains until you confirm 1 The message that caused it to be displayed 2 All subsequent messages that could have caused a running man to be displayed To confirm a message 1 Click Messages on the navigation bar The View Message dialog box is displayed P 2 Click the New Messages tab 3 When you have fixed the problem select the message and click Confirm The selected message is automatically transferred to the message log Tips e Dou
356. matically Assign Rack Positions Fi 1 Define the order ID and demographics The sample type Automatic is displayed and the Position boxes are disabled Select tests for the order Click Save The Sample Handling dialog box is displayed B 96 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Creating an order See Sample Handling dialog box on page B 99 4 Confirm the automatically assigned rack number and position or modify them if required Tips To enable this function use Configuration Database and select the Automatically Assign Rack Positions box on the Automatic Actions tab Automatic rack position assignment assigns positions of racks that are not on board the system You need to define manually the first position for each sample type This is typically position 1 on the first rack allocated to the sample type in question All further position assignment for samples of this type will be done automatically Automatic rack position assignment works for samples not for calibrations or controls Automatic rack position assignment also works when Paste Multiple is used File gt Copy then File gt Paste Multiple Note that the racks must not be on board and that the Sample Handling dialog box is not opened automatically Automatic rack position assignment continues as long as there are free positions on racks that are allocated to the sample and tube type of the kind required by your order
357. me and the Westgard rule if flagged or the result if not flagged Right click a result and choose Exclude from Statistics to exclude the selected result from the statistical analysis Select All or the last user defined period in the filter list on the toolbar to define what information is displayed on the tab To define a period click From on the toolbar and use the View of QC Results dialog box to make the definitions Press F1 to display Help for this tab B 122 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Selecting specific orders Selecting specific orders Use the query function to filter orders displayed in the Sample result list according to the criteria you specify To select specific orders using a query is N OF Click Results on the navigation bar Click the Sample tab Choose View gt Query gt Custom A blank Custom Query dialog box is displayed Click New to display the text boxes Type the information in the boxes as required Click Save Click OK to run the query e E aI week 11 2012 Sample Order Advanced New Delete Reset Help Ra Ew Print OK A Type the name of the query B Specify an order ID range You can use the wildcards and C Specify a date range The date format is dd mm yyyy Tips Queries are valid only for the Sample tab in the Results work area Where you can specify a range of valu
358. mediately Yellow Take action soon Green or gray No action needed Tip Press F1 to display Help for this tab Analyzer tab information The Analyzer tab contains important information that you should review regularly and whenever the Status button on the navigation bar changes color System group System ID and serial The system ID is user defined in the Configuration work area The serial number number identifies your instrument uniquely and is supplied with the instrument B 76 Operator s Manual Version 1 2 Cedex Bio HT 7 Status Status icon Bar graphs indicators Temperature group Supplies group Analyzer tab The icon in the top left corner of the tab shows the current status of the instrument System states on page A 42 The Bar graph indicators show the number of e Tests waiting to be run e Samples that are not on board e Blocked tests for all sample control and calibration orders e Results requiring validation e Samples loaded that do not have an order associated with them The temperature of the analyzer where all the photometric measurements are made the cassette area and the cleaner is shown The icons change their background color when the supply is low yellow empty or full red The cuvette waste container counts cuvettes the count is restarted when you confirm that the cuvette waste container has been emptied The system detects when the fluid waste contain
359. ments Tip The instrument must be in Standby for enabling the ISE module e No ISE Electrode The ISE electrode is not defined or it is disabled Open Configuration General ISE Select the required electrode setting Click OK Open Status ISE Select Potassium or Sodium to enable the required electrodes a A ON e Error in ISE module Hardware error in the ISE module 1 Check for new hardware error messages in View Message New Messages 2 Select the message and click Help on Message to open the Online Help 3 Follow the recommended actions of the selected message e Error in Abs photometer Hardware error in the absorbance photometer module 1 Check for new hardware error messages in View Message New Messages 2 Select the message and click Help on Message to open the Online Help 3 Follow the recommended actions of the selected message e Error in FP photometer Hardware error in the fluorescence polarization module Check for new hardware error messages in View Message New Messages Select the message and click Help on Message to open the Online Help 3 Follow the recommended actions of the selected message e FP photometer disabled The FP photometer was disabled 1 Open Configuration General System 2 Select FP photometer to enable the FP measurements E 24 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Blocked orders tests calibrations or controls Ti
360. messages of these types may mean one or more measurement modules may not be able to run tests Critical error The system cannot continue You must fix the problem and then restart the system All messages that generate a dialog box are listed on the New Messages tab on the View Message dialog box To react to a message On the message dialog box click W to turn off the audible alarm if necessary Read the message and take appropriate action Click Help for additional information if available A OON Click Report if you want to create and save a problem report Creating a problem report on page E 44 ol Click Close when you have read the message Confirm the message Confirming messages on page E 9 Tips e Ifyou need to refer to the message again after confirmation use the Message Log tab Message Log tab on page E 7 All messages that generate a dialog box are listed on the New Messages tab on the View Message dialog box Double click a message for more details To get Help on a particular message _ Message Help on page A 68 Reacting to a hardware message on page E 29 The background color of the Messages button shown on the navigation bar indicates whether there are messages waiting to be viewed The background color also indicates the severity of the message E 4 Operator s Manual Version 1 2 Cedex Bio HT 15 Messages About messages Button Background Meani
361. module including the tower fluid waste tubing and electrodes is potentially infectious e Sample material is potentially infectious e There is a danger of cauterization and poisoning through skin contact with the reagents e Make sure you read all the warning labels on the cassettes e Use protective gloves to avoid direct contact with sample material e Remove any spillage of sample material immediately To replace ISE Calibrators Reference electrolyte on the ISE module 1 Wait until the system is in Standby F 34 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Replace bottles on ISE module 2 Open the ISE access panel A oo Pull out the ISE module using the handle B Pull the module out until the spring catch C attached to the rear of the module is engaged 4 Open anew bottle 5 Remove the empty bottle D from the ISE module 6 Remove the floater E from the empty bottle 7 Insert the floater into the new bottle 8 Place the new bottle in the assigned position on the ISE module 9 Repeat steps 4 through 8 for all empty bottles 10 Release the spring catch and slide the ISE module back until it clicks into place 11 Perform the service action Prime ISE calibrators Tip Place the solutions in their correct positions x y or z on the ISE module The positions are color coded to match the color on the corresponding bottle label Solution Color of posi
362. mple Result calculated using an erroneous or corrected calibration which has not been accepted Action l Check calibrators c Repeat calibration Find Edit The result is associated with an erroneous or corrected quality control result The quality control has not been accepted E X GLU Sample 0 06 g L Comment d 10 04 2012 13 20 a Delete Print Rate Info w Accept Rerun Close ___tee Help Is Ol gt AcceptAll Ascept Berun admin 20 04 2012 09 30 A Check all results located in the To Validate folder on the Validate tab of the Results work area B Double click a result line in the list of results The Result Detail dialog box is displayed where you get information about recommended actions for flagged results C Perform the recommended actions for flagged results Recommended actions include Rerun the test with dilution or concentration Repeat the test Check the required items as listed in the recommended actions of the Results Detail dialog box Review test result details Accept the result D Validate tab on page B 117 About results on page B 112 gt To rerun or repeat a test Click the Validate tab on the Results work area In the To Validate folder select a sample calibration or control order 3 Select the result in question from the list of results and click Rerun The Dilutions dialog box is displayed
363. mple barcodes on tubes D Any microcup for example Eppendorf cup B COBAS cup E Wide end of the cup adapter C Narrow end of the cup adapter Cup adapters For smaller quantities of samples you can use COBAS cups Eppendorf cups or other commercially available microcups You insert these cups into an adapter using the narrow end for COBAS cups and the wide end for Eppendorf cups You can attach a barcode on the side of the adapter You then insert the adapter together with the cup into a free slot on the rack Operator s Manual Version 1 2 A 33 2 System description Cedex Bio HT Functional systems Do not put COBAS cups into the wide end of the cup adapter This can cause pipetting errors leading to unreliable results Remove all caps from the sample tubes and cups primary or secondary before placing the rack with the tubes or cups inside the instrument Otherwise you may damage or block the Caution probe or obtain unreliable results due to level detection problems You can define one microcup as the Cup on Tube that is the cup you will use on top of a tube Configuration System Lab Sample Tubes Cup on Tube Diluent handling Accelerator I is supplied in vials that are incompatible with the ISE rack Therefore to use Accelerator I on the ISE rack pour it into extra bottles prior to placement If you prepare the 9 NaCl diluent yourself you must use dead volume optimized bottles The follow
364. must be replaced immediately with an approved cable Contact your Roche Service representative You must connect the waste sensor if you are using a separate waste container that is the instrument is not connected to the main laboratory waste system You must connect the water sensor if you are using an external water reservoir These connectors are located on the right hand side of the instrument near the back o OF gt COM O 60050 oO gt UPS e i DS HUB COM Serial communications connector AUX Auxiliary connector not used DS LAN Direct connection to computer HUB Not used Tip Serial ports if used are configured by your Roche Service representative Connections check list Mains connections Connections between computer and instrument Host connections Use this list if you need to check that your system is properly connected Check that the power cable of the computer is plugged in at both ends Check that the power cable of the instrument is plugged in at both ends Check that the power cable of the monitor is plugged in at both ends Check that the connection from the COM connector on the computer is made to the COM connector on the instrument Check that the connection from the DS connector on the computer is made to the DS connector on the instrument If you work with a host system check that the communication connection from the COM1 connector on the computer is made
365. n AD ys aR E NAE ISE service actions Making ISE measurements ISE solutions summary Technical specifications Operator s Manual Version 1 2 F 3 17 ISE module Overview Overview Measuring modes ISE measurements Cedex Bio HT The ISE module is a measurement system for electrolytes that runs independently of the fluorescence polarization FP and absorbance photometry systems The ISE module uses the same samples racks and tubes that are used for photometric measurements and the samples are transferred using probe C The ISE module also uses specific solutions some of which are kept in bottles on the ISE rack the others on the ISE module itself The Cedex Bio HT ISE module serves for quantitative determination of the following electrolytes e Sodium e Potassium e Chloride optionally Lithium optionally There are two measuring modes Measuring mode Description Direct mode The sample control and standard solutions are used undiluted Indirect mode The sample control and standard solutions are diluted with system water The dilutions and the mixing are performed automatically in the ISE tower The tests available in each mode are as follows ISE Direct ISE Indirect Sodium v v Potassium v v Chloride v v Lithium v x v available x not available ISE measurements and photometric measurements are carried out at the same time and are independent of each other ISE meas
366. n Configuration General Barcode if you have the required user access level Barcode reading can individually be set for each rack group Configuration Lab Racks Samples are automatically recognized when they are loaded if the sample tubes have barcodes on them and either of the following is true e The barcode contains sample type information e The barcode does not contain sample type information but the sample is assigned to a rack that is sample type specific For samples without barcode labels you can use the Automatically Assign Rack Positions feature and then accept the proposed assigned rack positions in the Sample Handling dialog box gt Loading samples on page B 38 Tips e Insert only one rack at a time The barcode scanner reads across the whole rack area and therefore a second rack could be obscured by the first Wait at least three seconds before the next rack movement e When you insert a rack the rack is blocked momentarily to allow the scanner to focus on the correct rack slot and rack barcode e Insert the rack in one clean motion stopping halfway generates an orange blinking light on the status indicator e When removing a rack remove it completely If you leave the rack partially removed other racks being inserted may be not be seen properly by the scanner Robotic transfer system The robotic transfer system automatically controls and moves the probes to the correct positions fo
367. n add cuvettes while the instrument is running Refilling the cuvette reservoir on page B 44 Operator s Manual Version 1 2 A 25 2 System description Functional systems Cuvette conveyor belt Cuvette feeder channel Cuvette spiral feeder Cuvette buffer and slide Workstation In Out Cuvette waste box Rack system Cedex Bio HT The cuvette reservoir holds up to 1400 cuvettes A light barrier detects when the supply of cuvettes is low and the system warns you when you have to refill the cuvette reservoir with new cuvettes Cuvettes drop from the reservoir onto the conveyor belt which transports them horizontally so that they can fall into the feeder channel below The movement of the belt is controlled by the number of cuvettes in the cuvette spiral feeder This ensures a controlled supply of cuvettes the cuvette buffer is kept full or nearly full without the spiral feeder overflowing The cuvette feeder channel guides cuvettes to the spiral feeder below as they drop from the conveyor The spiral feeder sorts the cuvettes into the correct orientation for feeding into the cuvette buffer The cuvette buffer holds up to 20 cuvettes aligned in a slide which feeds cuvettes into workstation In Out The cuvette buffer acts as a storage area to ensure that cuvettes are always available for the workstation In Out Workstation In Out feeds new cuvettes into the analyzer rotor At the start of a measurement cycle
368. n also choose Edit gt Postpone Calibration instead of right clicking the selection e You cannot postpone a calibration in advance This function is only available while a test is due for calibration e You can postpone a calibration more than once e Sample and control results calculated with postponed calibrations are marked with p e Tests with postponed calibrations are listed in the BOD report Operator s Manual Version 1 2 B 147 10 Calibration Postponing a calibration Cedex Bio HT The fact that a calibration was postponed is recorded in the View Message dialog box Messages gt New Messages If you select a calibrator in the Calibrator Test Summary group instead of a test the Postpone Calibration option is only available if the calibration can be postponed for all tests using this calibrator B 148 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Validating calibration results Validating calibration results If any result in a calibration produces a flag the whole calibration must be validated Calibrations that run without creating flags are accepted automatically provided the system is configured to do so Configuration Result Handling Calibration Ifa calibration is flagged you should not accept it without further investigation Reviewing calibrations for validation Calibrations that require validation are displayed in the Validate tab in the Results work a
369. n and enter values Setting up controls on page B 181 To update lot specific values using the barcode pen or handheld barcode scanner on page B 185 About cassette definitions You can use the Configuration Cassette dialog box to define warning levels for each cassette or view the cassette history gt To use the Configuration Cassette Definitions dialog box 4 1 Click Configuration on the navigation bar 2 Double click the Cassettes icon in the Definitions group Viewing and modifying cassette definitions To modify the warning level Click the ID tab Select a cassette from the list to display the information on the right Modify the warning level Click Save A ON Tips e You cannot change any of the cassette details apart from the Warning Level e Warning Level is used to generate a tests low warning message in Status The entry is the percentage of tests remaining in the cassette gt To view the cassette history 1 Click the History tab 2 Select a cassette from the list to display the information on the right Tip The Cassette History gives a list of the cassettes known to the system About cleaner definitions You can use the Configuration Cleaner dialog box to view existing definitions the cleaner history and to load a new cleaner definition Operator s Manual Version 1 2 G 15 20 Configuration Cedex Bio HT About the Definitions group gt To use the Configuration Cleaner Defi
370. n choose to accept the result or rerun the measurement for example with dilution If you accept flagged calibration or quality control results all results in tests that use those calibrations or controls will be suspect The system continually monitors its own status and informs you when resources are low You can then take the required action to keep the system running For example when the supply of cuvettes is low the icon and background color of the Status button on the navigation bar change The Missing amp Blocked tab in the Status work area and the Worklist tab in the Orders work area tell you which tests are blocked and what you have to do to remove the block For example if a test cannot run because a calibrator is not on board anda calibration is overdue the system tells you Once you have loaded the calibrator the system can perform the calibration and then the test Maintenance service and troubleshooting Waste disposal Automatic start up Essential maintenance activities referred to as service actions are automatically tracked by the system The system prompts you when you need to perform a service action Online wizards guide you through the service actions and additional step by step information is available in the online Help and later in this manual The system uses workload statistics to establish the interval between service actions rather than using a fixed number of days For each service action p
371. n is complete Operator s Manual Version 1 2 E 11 15 Messages Cedex Bio HT Stopping and restarting the system Stopping and restarting the system Stop processing Stop a gt You sometimes need to stop the system while troubleshooting There are two levels of stopping 1 Stop and continue processing 2 Shut down and restart the system Which method is appropriate depends not only on what you need to do in terms of corrective action but also what the system is doing the system state and how your throughput will be affected Check the messages and online Help to see which method is recommended for a particular case The procedure for a complete shutdown and restart of the system consists of the following steps 1 Stop processing 2 Shut down the system 3 Restart the system 4 Initialize the system 5 Restart processing If the system is in the Operating state for example when it is processing tests Click Stop on the navigation bar to interrupt sampling immediately or stop sampling as soon as the current actions are finished The precise function of the buttons depends on the current system status When clicking Stop the Stop Action dialog box is displayed which offers the Sampling Stop and Stop options Stop Action Lx A Stop has been pressed Indicate action to take Sampling Stop Tests in process are completed Stop Terminate run and discard testin process OK Can
372. n of Day provided the associated results were accepted and the racks are not on board Control intervals Controls are run automatically according to the control interval defined in Configuration You can also request controls manually in the Orders work area Printing control reports Printing Quality Control reports on page B 56 Operator s Manual Version 1 2 B 163 11 Quality controls Controls at a glance Controls at a glance Cedex Bio HT Use the tables below to locate specific tasks by work area and tab Work area Tab Tasks Status Orders Results x Missing amp Blocked Samples Test Status Worklist Quality Control Validate Quality Control Review missing controls for the current work load View controls on board color shows the status Click a position to display the details for the selected control List tests with QC interval controls and their rack positions and whether the control was accepted Review the status of pending control requests Review individual control requests Request a control Delete a control request Review flagged control results Display the Control Detail dialog and then Rate info Accept unaccepted control results or rerun the control Delete a control result to exclude it from statistics Review controls by test or by controls Review QC details dialog Specify a date range for a listed control
373. n on the navigation bar 2 Double click Controls in the Definitions group 3 Click Load The Load dialog box is displayed You started the setup program to load Control definitions into your system Specify the path where your source files are C Roche Instrument TAS Browse Help Cancel 4 Click Browse and choose the drive and directory where the required control definition is located By default the C Roche Instrument TAS path is selected Alternatively type the complete path 5 Click OK Operator s Manual Version 1 2 B 181 11 Quality controls Cedex Bio HT Setting up controls The Load Control Definitions dialog box is displayed Load Control Definitions x Control r Description Long Name AMM CO2 ETOH LEVEL I I AMM P ID 07 5240 1 ae Version 50 1 I PNU I PPP Created 10 06 1998 I ppu Last Modified 04 01 2000 By MK Keep Old Lab Settings Help DeselectAll Select All Cancel 6 Select the required controls 7 Click Load A progress indicator is displayed 8 When the controls have been loaded click Cancel o close the Load Control Definitions dialog box 9 Select the control from the Control list 10 Click the Lot tab to review existing lot information or to create a new lot Updating lot specific values for a control on page B 184 11 Click Save 12 Click Close Tips e You must have the correct user access level to load controls The system mu
374. n the instrument comply with the following standards ANSI Z535 IEC 61010 1 IEC 60417 DB 3M or ISO 7000 If the labels are damaged they must be replaced by Roche Service personnel For replacement labels contact your local Roche representative Safety label on analyzer Location and meaning Laser transmitter warning Situated inside of the rack access panel to designate the presence of a laser transmitter Do not stare into the laser transmitter Laser transmitter warning Situated outside of the rack access panel to designate the presence of a laser transmitter Do not stare into the laser transmitter For details see Safety information for laser transmitters on page xxi XX Operator s Manual Version 1 2 Cedex Bio HT Safety information for laser transmitters The Cedex Bio HT analyzer is a class 2 laser product It contains one laser transmitter Class 2 laser transmitter inside the barcode scanner on the right side of the analyzer behind the rack access panel to scan rack cassette and sample barcodes I Vie ae 2 Q s Loss of sight due to staring into laser beam Do not stare into the laser transmitter beam as your eyesight may be severely damaged Classification The mentioned class refers to the standard IEC 60825 1 e Class 2 Visible lasers Eye safe for accidental viewing However it may not be safe for a person who deliberately stares into the laser beam for long
375. n water 5 Replace the tubing adapter Operator s Manual Version 1 2 B 47 6 Routine tasks Managing resources Cedex Bio HT 6 Restart the system if necessary Tip Step 2 You do not have to disconnect the electrical and waste connectors B from the rear of the instrument Replacing the cuvette waste box Tools and materials Precautions Warning The cuvette waste box stores fluid waste from the ISE module and up to 1000 used cuvettes When the yellow Cuvette Waste Box icon appears in Status Analyzer or on the Status button you must replace the cuvette waste box as soon as possible and confirm that you have done so When the icon is red the system stops The cuvette waste box can store up to 1000 cuvettes and the Cuvette Waste Box icon turns yellow as soon as about 800 used cuvettes are in the box Tips e Replace the cuvette waste box while the system is in Standby and avoid replacing it while the box is being shaken The filling status of the waste container is determined only by the cuvette counter The waste volume is not monitored by the system A regular check of the waste container level is recommended e Protective gloves e Cuvette waste box Cuvette waste is potentially infectious and must be handled using proper safety precautions e Always wear protective gloves while working with cuvette waste e Clean any spills immediately according to the procedures established for your labor
376. navigation bar 2 Choose File gt Review The Review File dialog box is displayed 3 Select the folder file type and filename from where the results should be read Click OK The Review Results dialog box is displayed 5 Use Find to locate a specific test Click Close Most of the time you do not need raw data to assess sample results If you do need to keep raw data for a long time you can export the data to CD DVD or to a USB Memory Stick You can select which measuring module you want to save raw data for and also the format for the saved data Operator s Manual Version 1 2 D 69 14 Service actions Managing data Cedex Bio HT To export raw data Deleting raw data 1 Click Configuration on the navigation bar 2 Choose Tools gt Export Raw Data The Export Raw Data dialog box is displayed Export Raw Data x Help Close 3 Select the measuring module The Save As dialog box is displayed Save As 2 x Save in Bin z B cl Files m OO Save astype Excel with headers z one 4 Select the target directory and type the file name 5 Select the file format from the Save As type list 6 Click Save Tips e Exporting raw data does not delete the raw data from the database e Step 3 If you need to save raw data for more than one measuring module you must export the data separately for each measuring module Raw data are the numerical values of the physical measurements made by o
377. nd can be changed by your system supervisor Select View gt Counters in the Service work area click the Service Intervals tab and type the value in the Service Action Due at box To change the percentage you must have user access level 6 D 16 Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software System Counters tab Counters and timers Choose View gt Counters gt Service Intervals on the Service work area to open the Service Intervals tab Service Counters Service Intervals System Counters c Service Action Counts Time BOD z Clean a ee eae on Deproteinize probes i 600 tests i 1 days a Clean probes and splash guard 1 3000 tests i 1 7 days 1 i 3 k 1 1 1 1 Clean Meme Aata reserve 0 tests 1 180 days1 i Clean wash station t 0 tests 1 180 days s Clean ext water reservoir fluid waste H 0 tests 4 i 180 days i i Clean instrument i H tests Eo Eog J i i ae Clean waste box fitting 1 2000 tests 1 a 30 days I teas Miscellaneous i l i i ead Prime fluid system 1 4 hidle i 1 days a Roche servite i 150000 tests i T80 days D 1 1 1 1 1 1 Backup database i 0 tests H 7 days i a Replace e i i i 1 i Replace ventilation filters l 500 h r i 30 days Replace Abs halogen lamp tf 2000h i 0 days et Replace probe B i 50000 tests D days Replace probe C i 50000 tests H k 0 nayat i Replace plunger tip dosage pipette B
378. nd general hardware principles the user interface the status of the instrument and its modules You should familiarize yourself with these areas before attempting to perform daily tasks You can also find information about how to use the Cedex Bio HT analyzer in the Online Help The manual is divided into the following parts Part A Overview Contains general information about the Cedex Bio HT analyzer about the basic concepts of using the instrument the hardware the software and the online Help Part B Operation Starts with a workflow description for some typical laboratory setups using step by step instructions It then describes how to perform all the day to day tasks necessary to create orders monitor the status of the instrument view results and deal with some simple problems that do not require detailed analysis Part C Flags Describes the flags that are generated for unaccepted results and gives recommended actions Part D Service Describes how to start and perform service actions that are essential to maintain maximum productivity from this instrument Part E Troubleshooting Describes how to pinpoint potential problems and how to solve them Part F ISE measurements Describes the principles of operation of the ISE module and contains specialized sections on ISE flags and troubleshooting and ISE service actions Part G Configuration Describes some of the most common configuration tasks for a fully
379. nd the inner part of the wash pipes to ensure that no foreign materials build up 8 minutes Every six months e Wash pipe seals e Paper tissues e Cotton swabs e Soap e Protective gloves e Tweezers The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious e Reagents can cause burns irritation and poisoning through skin contact e Wear protective gloves e Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software To clean the wash station Select Clean wash station in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 Open the main front cover A 4 Move the transfer head to one side so that you can access the wash station D 30 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean wash station 5 Remove the two screws on the wash station B 6 Remove the plastic cover C Take note of the position of the cover so that you fit it correctly when reassembling the wash station 7 Lift the wash station so that you can access the waste tubing connector D 8 Disconnect the waste tubing not shown 9 Use tweezers to remove the noise damper E 10 Rinse the noise damper with water 1
380. nd user actions You can attach a note to a service action either when you complete the service action or later from the Service Notes dialog box You can also make your own entries on the Service Notes dialog box these are listed as User Actions and are not associated with a service action To add a service note 1 Click Service on the navigation bar 2 Choose View gt Notes The Service Notes dialog box is displayed 3 Select the service action to which you want to add the note 4 Click Add Note 5 Type your comments in the Service Add Note dialog box 6 Click OK To add a user action 1 Click Service on the navigation bar 2 Choose View gt Notes The Service Notes dialog box is displayed 3 Make sure that no service action is selected highlighted 4 Click Add Note 5 Type your comments in the Service Add Note dialog box 6 Click OK Tip To deselect a selected service action press and hold down the Ctrl key then click the selected service action Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software Counters and timers Counters and timers An example of a counter An example of a timer Counters timers and due time To keep track of the work that the instrument does the system maintains a set of counters and timers These are used to determine when the different service actions become due The Service work area tells you not only which service actions are due but also when se
381. ne individual Cedex Bio HT instrument only Each cassette has its own individual cassette number which the instrument uses to identify it Using a cassette already used on a different Cedex Bio HT instrument may lead to incorrect results Warning If more than one Cedex Bio HT instrument is used in the same lab be sure to dedicate each cassette rack with its cassettes to one single individual instrument e g by color coding B 40 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks What if I put the rack back in another slot I cannot print the worklist or loadlist I need to load multiple cassettes The new cassette belongs to a different test lot The system does not recognize the new cassette The new cassette is past its expiration date Handling test materials If you insert the rack into another slot the system will identify the rack and the slot Check whether the printer is connected switched on and whether there is a supply of paper in the printer Make sure you have the user access level for printing Configuration General User Level If a new printer was installed for your system ask your system administrator to check whether the appropriate Windows XP printer driver is installed Other drivers will not work on Windows XP You can load additional cassettes at any time If you have used up the current lot load a new cassette The system will detect the difference in lot numb
382. ne of the measuring modules Since each result comprises many measurements the amount of raw data can become very large very quickly To prevent this from happening you can choose either of two options e Delete Raw Data after accepting results e Delete Raw Data after n days To delete raw data after accepting results 1 Click Configuration on the navigation bar 2 Double click Database in the System group 3 Click the Automatic Actions tab 4 Select the Delete Raw Data after accepting results check box D 70 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Managing data 5 Click OK To automatically delete raw data after a certain period of time 1 Click Configuration on the navigation bar 2 Double click Database in the System group 3 Click the Automatic Actions tab 4 Select the Delete Raw Data after check box 5 Inthe Delete Raw Data after box type the number of days you want raw data to remain on the system 6 Click OK Tips e Type 0 zero to delete at the next Begin of Day all of today s raw data that is all raw data generated between the time of the last and the next Begin of Day time e Type 1 to delete at Begin of Day all raw data that were generated more than 24 hours before Begin of Day time Definitions The system automatically reserves enough space for test and related definitions in the Message log Journal database When the system is set up archive the definitions so that you c
383. ne v None v Class Group Close A Specifies whether control results are checked for QC rules and ranges B The selected test C Shows which QC modes are enabled Updating lot specific values for a control The procedure to update lot specific control values depends on whether you use a barcode pen or handheld barcode scanner or not gt To manually update lot specific control values Click Configuration on the navigation bar Double click Controls in the Definitions group Select the required control from the Controls list Click the Lot tab Fr OON Tests to which the control is assigned are listed here provided a lot exists Click New Lot Type new values for the Lot No Lot Number and Exp Date Expiration Date Click Save For each test select the control mode and type the values for this mode Click Save CoA N OU Tips The lot number is up to ten characters The format of the expiration date must be the same as that for the date in the bottom right hand corner of the screen e When you have saved the lot number and expiration date the tests that use the control are displayed in the Test list Enter and save new control values for each test B 184 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Setting up controls gt To update lot specific values using the barcode pen or handheld barcode scanner Click Configuration on the nav
384. neatves Handling test materials issir E nE RE NENESE Loading samples esictsscesvssisiessissctevssedevascssd sosssenssesssacobasisoadsinievehoas decshasndensbesasesebesedeced Loading calibrators controls and diluent sccessseessesseesessesstesesseesesseeseese B 40 Loading GASSELteS ss ii Ai aieea ihein B 40 Managing res rc s iiie iit eken ii seniori eisene nioni eeniserhesiseebanieseir osise riasn sei B 42 Checking Tesource Sigs en E E E E E E B 42 Replacitig thie cleanen ons nsn R R E deteceseysdiets B 43 Refilling the cuvette reser Voir nsere aE E E E B 44 Refilling the external water reservoir sssessssssrsssssssssssssssrssrsssnssreesteesssssssssreeee B 46 Emptying the external waste reservoir cecessessesssessesseessesseesessstessessessesseesess B 47 Replacing the cuvette waste DOX csceesesssessessesssessessesseessesstescssesseessessessessessess B 48 Checking dite service achn isyan nn aa AVEA B 50 Checking the Memo Pad svsnngsiisrea tar ea VAN B 51 Printing repottSi esters eit srir pieres eserse Seier a iaee rE Rer aE rederi iese esee B 52 Printing the Begin of Day report ssssssssssssissssssssssrtessssssnseessretessssssnnnssereeesessssss B 53 Printing the Final Reports iiien i a B 54 Printing the Loadlistssniiiisstiss tiio isi is E B 55 Printing the Missing amp Blocked report c scscssssesssessessesssessesseessessesseessesssesseesees B 55 Printing Pesull ts sssesecsstesctssstscaesaissetnssi
385. nfiguration work area in the online Help Operator s Manual Version 1 2 20 Configuration About the Definitions group Cedex Bio HT About the Definitions group Tests Test Group Sequence and Class Profiles Calculated results Calibrators Controls Diluents Cleaners ISE solutions Cassettes Generally definitions are loaded during the installation process where default values are set by Roche Service personnel You can subsequently create new definitions or modify existing ones using the dialogs in the Configuration Definitions group You can do so only if you have the appropriate user access level Definitions group functions are as follows A test definition contains all the information the system needs in order to run a test including the names of the calibrators controls cleaners and diluents Click the Tests icon to review load modify or delete test definitions You can define groups of tests for use in Orders and the sequence of the test buttons displayed You can also define test classes for result handling purposes From the Test Definitions dialog box click the Class Group button to define and modify test groups sequence and classes A test profile is a named group of tests In orders tests are added to an order by clicking a button which may have the profile name on it which adds all the tests in the profile to the order Click the Profiles icon to review create modify or delete
386. ng g Gray The messages that are occurring need no action T from the user Yellow Warning messages waiting to be dealt with You ii should deal with these messages promptly to ensure that a critical situation does not develop oy Red flashing Error or critical messages waiting to be dealt Running with You should deal with the causes of these if messenger messages immediately Clearing the Messages You can clear the red and yellow versions of the Messages button by confirming all button warning error and critical messages Confirming messages on page E 9 Operator s Manual Version 1 2 15 Messages Cedex Bio HT New Messages tab New Messages tab Use the New Messages tab on the View Message dialog box to review all currently unconfirmed messages listed by time View Message x New Messages Message Log Options E Date amp Time Message 8727 98 17 00 Rack position slot position 13 not defined 8 26 98 14 31 A hardware problem has been detected in the resource controller ISE solution sta 8 26 98 14 29 Error in file c roche instrument Log Trace tra occurred A 7 16 98 17 01 Diagnostics not started ndard 1 not on board Message 3of5 E D Help On Message Confirm Close Icon showing the severity of the message if any The date and time when the message was created Short message text Click to get Help on the selected message if availa
387. ng connector F Wash pipe seals The instrument can be connected to the laboratory water supply or to an external water reservoir Water must be reagent grade type 1 The external water reservoir or laboratory supply feeds into an internal water reservoir located behind the pipette module If your system uses an external water reservoir a sensor is connected so that the system can inform you when the water supply is nearly empty You must clean the reservoir according to the service action schedule Clean external water reservoir and fluid waste reservoir on page D 33 An internal water reservoir 1000 mL feeds the wash pipettes and the ISE module with reagent grade type 1 water You must perform the service action Clean internal water reservoir according to the service action schedule Clean internal water reservoir on page D 27 The instrument can be connected directly to the laboratory waste system or to the supplied external waste container This container has a level sensor so the system informs you when the container is nearly full Clean external water reservoir and fluid waste reservoir on page D 33 If the instrument is connected to an external water reservoir the water reservoir pump brings water to the internal water reservoir This pump is not required for instruments connected to a pressurized supply A separate pump the fluid waste pump removes the liquid from the wash station The ISE module has
388. nical specifications vie Cedex Bio HT Q These specifications are subject to change without notice Physical dimensions e Tabletop instrument e Printer paper format Width 135 cm 53 1 in Height 75 cm 29 5 in Height with open lid 108 cm 42 in Depth 66 cm 26 in Weight 210 kg 465 Ib A4 210 mm x 297 mm US 8 5 in x 11 in Power requirements instrument e Line voltage e Line frequency e Current e Power consumption e Thermal load e Insulation Coordination 100 125 V 200 240 V 10 15 50 or 60 Hz 5 4 A 230 V or 8A 115 V typical values single phase Typical value 700 VA 2400 BTU h 2520 kJoules h Installation category II IEC 61010 1 Power requirements computer e Line voltage e Line frequency e Current e Power consumption e Thermal load 100 127 V 200 240 V 50 60 Hz 2 7 A 220 V or 5 4 A 115 V typical values single phase 200 VA 680 BTU h 720 kJoules h Operator s Manual Version 1 2 Cedex Bio HT 21 Appendix Laser sources barcode scanner Technical specifications IEC USA Class 2 Laser Product in conformity to IEC 60825 1 2007 Max output 1 1 mW Pulse duration 132 us Emitted Wavelength 650 nm Complies with 21 CFR 1040 10 except for deviations pursuant to Laser Notice No 50 dated June 24 2007 Environmental conditions Water requirements Plumbing requirements
389. nitions dialog box 2 1 Click Configuration on the navigation bar 2 Double click the Cleaners icon in the Definitions group gt To view cleaner definitions 1 Click the ID tab 2 Selecta cleaner from the list to display the information on the right 3 Click Close Tips e You cannot change cleaner details e Used on tests gives a list of the tests using this particular cleaner e You can assign permanent rack positions to cleaners in Configuration Lab Reserve Positions or assign temporary placements using the Place Samples dialog box Cleaners can also be identified by barcode gt To view the cleaner history 1 Click the History tab 2 Selecta cleaner from the list to display the information on the right 3 Click Close About diluent definitions Diluent definitions are automatically installed with the associated test You can use the Configuration Diluent dialog box to view existing definitions the dilution history and to load a new diluent definition gt To use the Configuration Diluent Definitions dialog box H 1 Click Configuration on the navigation bar 2 Double click the Diluents icon in the Definitions group gt To view diluent definitions 1 Click the ID tab 2 Selecta diluent from the list to display the information on the right 3 Click Close Tips e You cannot change diluent details e You can assign permanent rack positions to diluents in Configuration Lab Reserve Positions
390. nly No action required Priority 66 Group TEST Positive The sample result is greater than or equal to the cutoff value For qualitative tests only No action required Priority 67 Group TEST The sample result is associated with an erroneous or corrected quality control result The quality control has been accepted 1 Repeat the quality control measurement in order to obtain an unflagged control result 2 Repeat the sample if necessary Priority 37 Group RAT TEST C 14 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags Flags and recommended actions Q Meaning The sample result is associated with an erroneous or corrected quality control result Recommended action Attributes r Meaning Recommended action Attributes R Meaning Recommended action The quality control has not been accepted 1 Repeat the quality control measurement in order to obtain an unflagged control result 2 Repeat the sample if necessary Priority 36 Group RAT TEST Erroneous result The result is either erroneous or has been corrected recalculated and the result has been accepted One or more of the replicates either is erroneous or has been corrected recalculated and the result has been accepted e CAL o Repeat calibration after taking the appropriate action for the associated flag s e CNTL 1 Check control performance 2 Repeat control after taking the appropriate action for the
391. nsecutive quality control results deviate from the assigned mean by more than 1 standard deviation in the same direction 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Priority 48 Group CNTL Precision control rule violated There were 7 consecutive decreasing quality control results 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Tip Check regularly that all Service actions were performed Priority 49 Group CNTL Precision control rule violated There were 7 consecutive increasing quality control results 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Operator s Manual Version 1 2 C 17 12 Result flags Flags and recommended actions Attributes R 7x Meaning Recommended action Attributes R 10x Meaning Recommended action Attributes lt REAG RNG Meaning Recommended action Attributes gt REAG RNG Meaning Recommended action Cedex Bio HT Tip Check regularly that all Service actions were performed Priority 50 Group CNTL Precision control rule violated There were 7 consecutive quality control results falling
392. nterval Tools and materials Hazards Precautions Further information You must clean the internal water reservoir to prevent the build up of contaminants which can affect the water quality and therefore the quality of the results produced At the same time you must also replace the liquid filters which filter out particulate matter from the water supply Do not remove the internal water reservoir unless you are using the service action Clean internal water reservoir 8 minutes Once every six months e 2new liquid filters e Protective gloves e Reagent grade type 1 water e Paper tissues e 0 6 sodium hypochlorite solution e The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious e Reagents can cause burns irritation and poisoning through skin contact e Wear protective gloves e Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box For general information about performing a service action see Chapter 13 Service action software To clean the internal water reservoir Select Clean internal water reservoir in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 Open the main front cover A Operator s Manual Version 1 2 D 27 14 Service actions Cedex Bio HT Clean internal water reservoir 4 Remove the left
393. nuously monitoring all system functions Color coded icons alert you to changes in the system status Connection to a host system allows for automatic transfer of results to and from the Cedex Bio HT analyzer What the system does The system consists of the instrument and the data station The instrument runs tests on samples calibrators and controls and produces the results The data station analyses and further processes the results Here are just some of the actions the system performs automatically e Delivers the correct volumes of samples reagents and other solutions to the measuring modules e Reads the barcodes on reagent cassettes samples if barcoded and other solutions e Performs washing and cleaning cycles to minimize carry over between tests e Takes the physical measurements on which the results are based e Calculates and ensures the integrity of the result generating flags for suspect ones e Keeps track of all samples tests and orders on the instrument e Collates results into reports for printing or transmission to another computer system e Stores the results on each sample and test in a database A 4 Operator s Manual Version 1 2 Cedex Bio HT 1 System overview A first look at a Cedex Bio HT analyzer A first look at a Cedex Bio HT analyzer Instrument Data station The instrument carries out all test orders automatically and is equipped with measuring modules for absorbance p
394. oading and modifying test definitions When loading test definitions all required files are loaded You are informed before existing files are overwritten To install and load test definitions In the Definition group double click Tests Click Load to open the Load dialog box Specify the path where the source files are located Click OK Select the tests to be installed a fF WN The Load Complete Test Definitions dialog box is displayed 6 Select the Keep Old Lab Settings check box to ensure that user defined parameters are preserved This box is selected by default Click Load The Load definitions in progress window is displayed Do not click Stop Click Cancel to return to the ID tab The newly installed tests are listed in the installed tests panel Tips The instrument must be in Standby or Sleeping state Operator s Manual Version 1 2 20 Configuration About the Definitions group Cedex Bio HT e User defined test parameters comprise the definitions made on the Configuration Test Definitions dialog box Configuration Test To view and modify basic test definitions d Click the ID tab Select a test from the Installed Tests list Basic test details are displayed on the right 3 Modify the Short Name Long Name and Test No if required 4 Click Save N Tips The instrument must be in Standby or Sleeping state e Short Name is maximum eight alphanumeric characters e Long
395. ode scanner 7 connector 39 description 7 updating calibrator lot values 155 updating control lot values 185 hardware description 15 hardware errors 24 reacting to 29 hardware messages Help with 68 User Manual Version 2 7 Index INTEGRA 400 plus Help accessing 57 65 banner bar 59 button bar 59 closing 57 Contents tab 62 context Help 65 finding Help information 62 font size 61 for messages 68 general 67 glossary 71 history window 61 Index tab 62 menu bar 59 navigation pane 60 online 55 overview 56 Search tab 63 types of information 56 with controller messages 68 with hardware messages 68 Help Topics Help button 59 Help topics printing 61 Help window 58 HIGH ABS flag 9 HIGH ACT flag 10 HIGH BKG flag 10 history of calibration 151 history window in Help 61 horizontal scroll bars 51 host transmitting data to 73 host interface general information 6 icons Database 20 for cassette rack 29 for cuvette reservoir 16 for cuvette waste 16 for ISE rack 29 for racks 16 for sample rack 29 General 20 ISE 16 Keyboard 22 Lab 20 Mouse 22 on instrument 16 Printers 22 Processing 20 Regional Settings 22 Result Handling 20 Sounds 22 ID xii IDs orders 84 95 user 48 Index tab on
396. of Day System state Tools and materials Hazards Precautions Warning The tubing must be replaced according to the ISE service action schedule This ensures proper functioning of the ISE module 38 minutes Every 180 days No Standby e Activator ISE Calibrator Direct Bio HT e ISE Calibrator Indirect Bio HT e ISE module tubing set ISE Reference Electrolyte Bio HT e ISE Solution 1 e Protective gloves e The ISE module including the tower fluid waste tubing and electrodes is potentially infectious e Sample material is potentially infectious e There is a danger of cauterization and poisoning through skin contact with the reagents e Make sure you read all the warning labels on the cassettes e Use protective gloves to avoid direct contact with sample material Remove any spillage of sample material immediately You must use the correct length of tubing as indicated in the tubing set Using the incorrect length will ultimately result in a malfunction of the ISE module Use the service action Replace ISE module tubing in the Service program Otherwise no ISE initialization is carried out To replace ISE module tubing Select Replace ISE module tubing in the Service work area Click Perform The Service Actions dialog box is displayed follow the online prompts as required Transfer arm is initialized if necessary automatic step Fluid system is initialized if necessary automatic step
397. of test results 15 minutes When advised by Roche personnel or every 3 months e Rotor Clean Lube tool This tool is included in the Accessories Kit supplied with the instrument Due to sample spills the rotor is potentially infectious This service action is not listed in the service work area of the system software e Wear protective gloves To clean and lubricate the rotor Perform a shutdown and switch off the instrument at the main switch 2 Open the main front cover A to access the transfer head 3 Move the transfer head to the left to get access to the analyzer rotor cover Unscrew the two screws B of the analyzer rotor cover 5 Remove the analyzer rotor cover C 6 Lift amp turn 90 degrees the three lever clips D on top of the rotor Operator s Manual Version 1 2 D 43 14 Service actions Cedex Bio HT Clean and lubricate the rotor 7 Carefully lift and remove the rotor 9 Slide back and forth the tool along the periphery of the rotor until the rotor is clean 10 Remove the tool and mount it again upside down 11 Slide back and forth the tool along the periphery of the rotor to lubricate the rotor balls 12 Reinstall the rotor D 44 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean and lubricate the rotor 13 The positioning pin E must fit into the alignment hole F of the rotor 15 Reinstall the analyzer rotor cover The whi
398. olutions on the ISE rack Position of ISE solutions on the rack The default positions are as follows Rack position Solution 1 2 Diluent for example SDR2 Activator Remove the cap from this bottle before placing it on the ISE rack ISE Etcher Do not use this solution after its expiration date ISE Solution 3 Sol 3 Do not use this solution after its expiration date ISE Solution 2 Sol 2 Do not use this solution after its expiration date ISE Solution 1 Sol 1 Do not use this solution after its expiration date Diluent for example NaCI ISE Deproteinizer Do not use this solution after its expiration date Warning You must not use any solution or reagent that is past its expiration date The use of expired solutions will yield wrong results Bottles on the ISE rack must be capped This does not apply to the Activator Confirm replacement only for bottles that have been exchanged Otherwise the monitoring of the bottle volume will be incorrect Confirm replacement for bottles that have been interchanged on the ISE rack Prior to this you have to change the rack positions for the ISE solutions and or diluents Use Configuration Lab Reserve Positions Tips The positions of solutions on the ISE rack are user defined To check the actual positions as defined for your system use the ISE tab in the Status work area You can change the rack positions for the ISE Solutions Use Config
399. on cassette expiry and reaction curve Priority 44 Group CNTL Westgard rule 2 violated One quality control result deviated from the assigned mean in either direction by more than 3 standard deviations 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Priority 45 Group CNTL Westgard rule 3 violated Two consecutive quality control results deviate from the assigned mean in the same direction by more than 2 standard deviations 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Priority 46 Group CNTL C 16 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags R 4s Meaning Recommended action Attributes R 4 1s Meaning Recommended action Attributes R7 J Drift Meaning Recommended action Attributes R7 7 Drift Meaning Recommended action Flags and recommended actions Westgard rule 4 violated The difference between two consecutive quality control results is greater than 4 standard deviations 1 Repeat with fresh control 2 Check that the correct control material has been used 3 Ifthe flag reappears check calibration cassette expiry and reaction curve Priority 47 Group CNTL Westgard rule 5 violated Four co
400. on bar shows the instrument state Start System states on page A 42 Stop Ete gt To start up the instrument Use the following table to decide which start up procedure to use State Button Start up procedure Power off instrument is Power on the instrument then the turned off computer The system performs a full initialization Sleeping instrument has not Blue Press F11 on the keyboard or click been used for a while background Start on the navigation bar to start a partial instrument initialization Standby instrument was Gray None You are ready to log on started by an earlier user E background B 32 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Starting up and logging on to the system Initialization After starting up from power off 1 The system goes through its Windows XP start up procedure 2 The Windows Desktop is displayed 3 The Cedex Bio HT main window is displayed showing the Status work area 4 The Status button on the navigation bar shows the system is initializing flashing arrow 5 The system goes into Standby a Tips Logging onto the system You must log on before you can access all the functions available to you If you switch on after the Begin of Day BOD time has passed all the BOD actions are run automatically before processing orders provided you had not switched on the system previously that day The system goes into Standb
401. on the instrument control the instrument The computer records measurements and calculates the results It also controls the database that is used to keep track of all orders and results and it manages the user interface The fluid system consists of all the valves pumps tubing pipettes fluid sensors water and waste reservoirs the wash station The fluid system transports all fluids around the system including samples reagents calibrators controls diluents cleaners system water and waste The fluid system delivers the correct amounts of fluids for the reactions dilutions and cleaning Operator s Manual Version 1 2 A 19 2 System description Cedex Bio HT Functional systems A B c D Figure 0 12 Main components of the fluid system A Pipette module D Wash station F External water reservoir H External waste reservoir t d fluid Ih tail B Cleaner reservoir E Internal water reservoir connectors sensorang pura yelow contaman cis G External waste connectors l External water reservoir white ISE module sensor and fluid container Pipette module The pipette module contains two dosage pipettes and two wash pipettes These are connected by tubing to the probes attached to the transfer arm The pipettes control the pipetting action of the probes Robotic transfer system on page A 35 A 20 Operator s Manual Version 1 2
402. onsible for IT security of their IT infrastructure and for preventing the Warning spread of malware from system to system Recommendations e Allow connection to authorized external devices only e Ensure that all external devices are protected by appropriate security software Ensure that access to all external devices is protected by appropriate security equipment Do not copy or install any software on the Cedex Bio HT unless it is part of the system software or you are instructed to do so by Roche Service Do not move or delete any software on control units unless you are instructed to do so by Roche Service e Ifadditional software is required contact Roche Service to ensure validation of the software in question Do not use the USB ports to connect other storage devices unless instructed to do so by the official user documentation or Roche Service e Exercise utmost care when using external storage devices such as USB flash drives CDs or DVDs Do not use them on public or home computers while connecting to the Cedex Bio HT e Keep all external storage devices in a secure place and ensure that they can be accessed by authorized persons only e Use the remote services modem only for contacting Roche Service or when instructed to do so by Roche Service Failure to observe these recommendations may result in wrong data lost data or the non availability of the system If this product is connected to a local
403. ool 5 Remove the right side panel A Operator s Manual Version 1 2 D 51 14 Service actions Cedex Bio HT Replace Abs halogen lamp Use a dry cloth D to push the lamp cover B forward towards the back of the instrument about 1 cm and then lift it out 7 Disconnect the lamp cable C and release the cable from its restraint 8 Release the lamp by unscrewing the securing bolt E on the lamp holder 9 Remove the whole lamp by lifting it with the bolt E 10 Replace the old lamp with a new one taking care not to touch the lamp itself 11 Screw the new lamp into position Do not screw the lamp in too tightly 12 Fit the cable into the restraint 13 Reconnect the lamp cable 14 Reinstall the lamp cover and click into place 15 Reinstall the right side panel 16 Click Next 17 The absorbance photometer is initialized automatic step 18 A water air calibration is performed see below automatic step D 52 Operator s Manual Version 1 2 14 Service actions Cedex Bio HT Replace Abs halogen lamp 19 New water and air constants are automatically saved 20 Click Finish e Ifthe halogen lamp is broken remove the glass splinters with a vacuum cleaner Remove the remaining rest of the halogen lamp carefully e While reconnecting the absorbance halogen lamp a small spark may be generated This is B not a malfunction and the energy of the system during this process is not enough to harm Caution
404. operational system Full details on all configuration procedures are given in the online Help Appendix Contains additional information including a technical specification of the instrument Glossary and index Provides reference and look up material Conventions used in the Cedex Bio HT documentation This section describes the conventions used in this manual including symbols user interface conventions and units Symbols The following symbols are used Symbol Used for gt Step by step procedure Cross reference Oo Checklist oe Notes X Operator s Manual Version 1 2 Cedex Bio HT User interface conventions The following conventions are used throughout the user documentation User action Meaning Configuration Tests ID Choose File gt Print Report gt BOD Report Shift F3 Click Click OK Click Status Click Print Right click Press Double click Open Close Click Configuration in the navigation bar 2 Double click Tests in the Definitions group 3 Click the ID tab 1 Click File in the menu bar 2 Select Print Report from the menu 3 Select BOD Report from the next menu Press the Shift key and hold it down press and release the F3 function key then release the Shift key Press the left button on the mouse or the equivalent button on the system keyboard Move the cursor to the OK button and then press the left mouse button Click the Status b
405. opriate file name in the File name list e Click OK When the copying process is completed a confirmation dialog box is displayed Remove the diskette from the drive Click OK Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration Archiving and reloading definitions Archiving and reloading definitions It is important to archive definitions regularly so that in the unlikely event of a system failure the archived definitions can be used to reload the system setup quickly and safely gt To archive definitions and system parameters 1 In the Configuration work area choose File gt Archive Definitions from the menu bar or click on the toolbar The Archive Definitions dialog box is displayed Select one set of definitions from the list Click OK The corresponding Archive dialog box is displayed Select the item s to be archived 5 Click Archive The Archive Destination dialog box is displayed Specify the path for the location of the archive Click OK The Archive in progress dialog is displayed where you may be prompted to confirm the action Tips e You can archive only one set of definitions at a time e Always archive data to drive F e You must have read write permission for each set of items you wish to archive Archiving system information on page B 63 gt To load definitions and system parameters from the archive 1 Inthe Configuration work area choose File gt Load Definitions from th
406. or this level of support a connect 2 box or a cobas link gateway must be connected to the 2nd LAN port Operator s Manual Version 1 2 E 45 16 Troubleshooting Cedex Bio HT Contacting Roche Service To enable a remote diagnostic session 1 Check that a connect 2 box is connected to the 2nd LAN port Data connectors on page E 38 Connections check list on page E 38 2 Ensure that both the instrument and the computer are on You do not have to be logged on the Service engineer will automatically log on using AXEDA 3 The Roche Service engineer can now access your system remotely Customer confidentiality When a service engineer logs on to your system remotely sample results are available on the remote system as are records of calibrations controls and service actions A message will be displayed on your system informing you that the system is currently accessed by remote access Make a note of the When you report a problem to Roche Service please have the following information following information available e Analyzer serial number e Maintenance information see service notes in the Service work area e System software version e TAS version of the test in question e TAS version installed on the system Description of the problem e Description of the last operations carried out immediately before the problem arose Problems with chemistry For chemistry troubleshooting you sho
407. ositions as the service action Clean Deproteinize probes cannot be performed You are recommended not to change the default configuration unless this is essential In this manual all references to the ISE rack assume the default configuration F 6 Operator s Manual Version 1 2 Cedex Bio HT 17 ISE module Overview You can review the status of solutions on the ISE rack by clicking the ISE tab in the Status work area Replace ISE solutions on the ISE rack on page F 32 The ISE rack must contain ISE Deproteinizer and Activator You can also use the ISE rack for solutions such as cleaners and diluents Operator s Manual Version 1 2 F 7 17 ISE module How the ISE module works Cedex Bio HT How the ISE module works The electrolyte module uses flow through ion selective electrodes and a reference electrode with an open liquid junction Each electrode has a membrane or capillary that is sensitive to a particular type of ion Principles of operation l 9 The sample is pipetted from the sample tube located on a sample rack into the ISE tower Depending on the pipetting mode the sample is diluted with system water Mixing is performed with four air jets arranged in a circle These jets blow air into the tower to produce a homogenous mixture The other ISE solutions ISE solution 1 3 ISE Deproteinizer ISE Etcher and Activator are pipetted from the ISE rack into the ISE tower by the sample p
408. ositions on the same rack starting with the highest concentration standard furthest away from you when you insert the rack If barcodes for calibrators with several standards are used label all standard cups with the same barcode Loading calibrators controls and diluents on page B 40 Operator s Manual Version 1 2 B 11 5 Daily workflow Daily routine without sample barcode and without host Cedex Bio HT Daily routine without sample barcode and without host Keep your system running Creating orders Create an order in three steps pores eee E4 File Edt View Toos Window Help a2laa e SiaS b Worklist Sample Calibration Quality Controt P a A te Y v re Stop Tests amp Profiles Sample Test Summary Sample Type Sampe z Sample Tube Position g k Position x Cup On Tube T a ht A uc Test Profie Group General aD 1 GU a GL Sample Handling x ma r J i B ain GLU Glue G Sample Type Rack Pos Tube Cup on Tub al GGL ko c 1 J Sampie I a a NAD NH3 a Q Help Print Cencel 1 fr r s e A Enter an order ID and if required a comment B Select tests and click Save admin 28 03 2012 13 20 C To confirm rack number and position for all sample types on the Sample Handling dialog box click OK Creating an order on page B 95 amp To add the order ID Type an order number in
409. ot attempt to remove items from any of these locations without first referring to the appropriate section in this manual or to the appropriate topic in the online Help Caution External connectors Always close any access panels you have opened when you have finished working on that part of the instrument The side panels are detachable You can remove them by pulling them as shown below When you reinstall the side panels make sure that they click securely into place Figure 0 10 Side access panels A Left side panel Provides access to the main fuses frequency selection switches internal water reservoir and drip tray B Right side panel Provides access to analyzer rotor absorbance photometer FP photometer and cuvette transport system C Rear panel not shown Not detachable without a tool set Does not provide access to any user serviceable parts The external connectors are located at the back water waste and power and on the right side data connectors of the instrument lt gt External connectors on page E 37 Operator s Manual Version 1 2 A 17 2 System description Cedex Bio HT Modules and main components Modules and main components Figure 0 11 shows how the modules and components are arranged inside the instrument Figure 0 11 Modules and main components A Pipette module F Sample area K PCB fuses P Rotor lid B Cleaner reservo
410. out barcodes N Oo of FF ND Prepare each calibrator according to the instructions on the package insert Remove a sample rack preferably the sample rack in the cooled cassette area Click Configuration on the navigation bar Double click the Lab icon Click the Reserve Positions tab Select the rack from the list see B below Click H on the Calibrator folder Operator s Manual Version 1 2 B 143 10 Calibration Cedex Bio HT Loading calibrators on board 8 Drag and drop the calibrator s into position on the Rack graphic Ix Configuration Lab Sample Tubes Sample Types Racks Reserve Positions Close A Calibrator to place requires one tube The number in parentheses shows the number of tubes required on the rack for this calibrator or calibrator set B Click here to choose the rack number and name of rack type C The rack is represented as a graphic and the tubes that have reserved positions on the rack are listed 9 Click Save 10 Click Close 11 Insert the sample rack Tips e Step 8 For a multi calibrator set the system automatically reserves the required number of positions in the correct order You cannot reserve positions for the calibrators if there are not enough positions without gaps available e Step 8 The Move calibrators icon that is displayed when you drag calibrators into position shows the number of calibrators being moved e Cli
411. p if the ISE module is in Standby If the ISE module is in Operating steps 6 and 7 are repeated three times 9 ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes Operator s Manual Version 1 2 F 19 18 ISE service actions Cedex Bio HT Prime ISE calibrators Prime ISE calibrators Overview This is an automatic service action that does not require manual intervention You must prime the ISE calibrators when you replace a bottle containing ISE calibrator or ISE Reference Electrolyte This ensures that no traces of a previous calibrator are left in the tubing and therefore prevents drift in the results Results produced with fresh calibrator bottles are not reliable unless you perform the service action Prime ISE calibrators Warning Duration 1 minute Interval Daily Begin of Day Yes System state You can perform this procedure at the same time as absorbance and FP measurements are made Operating Tools and materials ISE Calibrator Direct Bio HT e ISE Calibrator Indirect Bio HT e ISE Reference Electrolyte Bio HT Hazards and precautions See General safety precautions on page F 16 gt To prime ISE calibrators Select Prime ISE calibrators in the Service work area Click Perform Fluid system is initialized if necessary automatic step Transfer arm is initialized if necessary automatic step ISE module is initialized if necessar
412. p The instrument must be in Standby for enabling the FP photometer Fatal error e Fatal HW error The system has a fatal hardware error The robotic transfer system the ISE module and the analyzer including absorbance and FP photometer are not working due to a serious hardware problem No measurement of tests is possible Recommended action 1 Check the status of the system in Status Analyzer 2 Shut down and restart the system 3 Ifthe problem reoccurs Call Roche Service Operator s Manual Version 1 2 E 25 16 Troubleshooting Cedex Bio HT Results Results This section lists those problems that may occur when results are obtained from the instrument Quality control results out of range Quality control results are obtained but they are outside the expected range for the test gt Control or a diluent in the wrong position Use Status Missing amp Blocked to check which items are missing 2 Use Status Samples to check the current positions of all on board controls and diluents 3 Replace the controls or diluents in their correct positions as required gt Control material has deteriorated or was incorrectly reconstituted 1 Use Status Samples to check the current positions of all on board controls 2 Replace the controls with fresh or freshly prepared material in the correct rack positions gt Lot specific assigned values are not correct e Check the values in Configuration Controls Lot
413. pending tests belonging to this order e The associated results have been accepted e The associated results have been transmitted to the host if you work with a host system e The associated samples have been removed from the system To purge orders manually 1 Choose Tools gt Purge Orders 2 Click Yes on the Confirm Purge Orders dialog box D 66 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Purging results Preconditions Precaution Managing data To delete orders automatically at BOD Click Configuration on the navigation bar Double click Database in the System group Click the Automatic Actions tab fF ON In the Delete Orders After box type the number of days after which the order should be deleted 5 Click OK Tips e Type 0 zero to delete at the next Begin of Day all of today s orders that is all orders defined between the time of the last and the next Begin of Day time e Type 1 to delete at Begin of Day all orders that were created more than 24 hours before Begin of Day time To delete a single order 1 Click Orders on the navigation bar 2 Click the Sample tab 3 Type the order ID in the Order ID box and press Enter 4 Choose Edit gt Delete The Cedex Bio HT analyzer is not designed to store safely large quantities of results on the system As part of data management you should periodically purge results manually At least every 2 months is recommended
414. per functioning of the electrodes 13 minutes per electrode e Every 90 days for orange labeled chloride electrodes e Every 14 days or 2000 counts for purple labeled chloride electrodes Gen 2 electrodes e Every 120 days for lithium e Every 180 days for sodium and potassium e Every 720 days for the reference electrode No Standby e Activator e ISE Deproteinizer Bio HT ISE Etcher Bio HT ISE Calibrator Direct Bio HT e ISE Calibrator Indirect Bio HT ISE Reference Electrolyte Bio HT e Chloride electrode optional e Lithium electrode optional e Potassium electrode Reference electrode Sodium electrode e Protective gloves e The ISE module including the tower fluid waste tubing and electrodes is potentially infectious e Sample material is potentially infectious e There is a danger of cauterization and poisoning through skin contact with the reagents e Make sure you read all the warning labels on the cassettes e Use protective gloves to avoid direct contact with sample material Operator s Manual Version 1 2 F 27 18 ISE service actions Cedex Bio HT Replace electrode e Remove any spillage of sample material immediately Before replacing the reference electrode shorten both tygon tubings of the new reference elec trode to a maximum length of 5 cm Warning gt To replace an electrode Select Replace electrode in the Service work area 2 Click Perform The Serv
415. perator s Manual Version 1 2 D 37 14 Service actions Cedex Bio HT Clean instrument Remove the platform G 9 Remove the cooling box top a Remove the screw H1 under the front of the cooling box top or turn the two spring loaded latches 180 H2 b Pull the cooling box top forward through the open rack access panel 10 Clean both platforms with a tissue moistened with 70 ethanol 11 Clean the cooling box base with a tissue moistened with 70 ethanol 12 Reinstall both rack platforms 13 Remove the work station cover K 14 Clean the initialization surface of workstation B L with a tissue moistened with 70 ethanol 15 Clean both the inside and the outside of the work station cover with 70 ethanol Reinstall the cover D 38 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean instrument 16 Open the ISE access panel M and pull out the ISE module using the handle N 17 Use a tissue moistened with 70 ethanol to clean the initialization posts at the following locations e ISE module O e Wash station P e Cassette area Q Sample area R Operator s Manual Version 1 2 D 39 14 Service actions Cedex Bio HT Clean instrument 18 Reinstall the ISE module 19 Clean the cooling box top and the cassette area initialization post insulator using 70 ethanol Reinstall the cooling box top and the cassette area initialization post insulator
416. place ISE solutions on the ISE rack Replace ISE solutions on the ISE rack on page F 32 B 82 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Orders Creating modifying and reviewing orders This chapter describes the Orders work area and how to use it It shows you how to Fi request tests calibrations and quality controls In this chapter Chapter EJ PLRO a l E P E B 86 OEE E E E B 87 Orders WORK AL Ca es itsscasssssccscassrveessnveesscsosessissanecststsosaosetesusssessbsnodtubesesobens S Esra aS ei B 89 Context TNC arose catcat ssc st sacs ce sesesuczccsvsseusencsvoeautorasteqarizescoasiedestocosesseiatostseontteest B 89 WOrKHS ital serinin n TE r EE E EAEE TEESE B 91 SETO fol Tel o AAAA AEAEE PEEN EE PA EE B 93 blora tin I Tlo AE EE AE S B 95 Quality Control tab sssessssssesesssssssssssssssestesssssssssseseteesssssssnsrsetteeessssssnteessssssnnsnreeresssssssss B 96 Cr ating an Ordet sinisest a ee cavers ieas IESSE aE E ESSEE Eee IEA E aeni EiS B 97 Specifying an order D eee essessesseessessesseessessessessessesssessesseesssssesseessessssesseenees B 97 Selecting tests for the Order cssessessesssseessessessessessesssssesseesnesseenees B 98 Assigning samples to racks scsessessesssessesseessessesssessesnsssessessnsssessessnsssessesssseeesess B 98 Selecting Cupion Tube rikrin R B 103 Matii eesis naL AAE EA E EEE E EEEE B 104 Working With Orders airin i nE T EERE Pinding Orders erriei aiee EE E S EE
417. place solutions on the ISE rack ISE service action 32 Replace ventilation filters service action 49 INTEGRA 400 plus replacing abs halogen lamp 51 cleaner 43 controller fuses 42 cuvette waste box 48 dosage pipette 61 electrodes 27 external water reservoir filter 64 ISE module tubing 25 ISE tower 36 plunger tip dosage pipette B 57 plunger tip dosage pipette C 57 probe B 54 probe C 54 solutions on ISE module 34 solutions on ISE rack 32 ventilation filters 49 reports creating problem reports 44 printing 52 requesting calibrations 145 controls 170 dilutions 107 requests deleting for controls 170 rerunning test 128 resources checking 10 42 status 42 resources supply 77 restart processing 13 system 12 system after shutdown 14 Restart button 37 result flags 5 result flags and recommended actions 6 Result Handling icon 20 result handling 112 ISE flags 40 overview 11 l 24 User Manual Version 2 7 Index INTEGRA 400 plus Butts about 112 accepting 117 128 archiving 132 ata glance 114 calibration 149 comparing between instruments 112 control 162 deleting 130 67 deleting single 131 displaying information 125 flags 3 21 39 not reproducible ISE 50 out of range 26 overview 114 poor
418. pling once the current actions are finished When clicking Stop the Stop Action dialog box is displayed which offers the Sampling Stop and the Stop options Stop Action Lx A Stop has been pressed Indicate action to take Sampling Stop Tests in process are completed C Stop Terminate run and discard testin process OK Cancel A Stop pipetting samples but finish processing tests that are already in progress B Stop all system operations immediately The system aborts all current activities The system may need Special attention before it can resume its normal operation Tips e In terms of system states clicking Stop changes the state from Operating to Standby or from Standby to Sleeping e Tests that were interrupted are marked as blocked and displayed in the corresponding folders in the Status work area and in the Worklist Operator s Manual Version 1 2 B 37 6 Routine tasks Cedex Bio HT Handling test materials Handling test materials Loading samples The following table gives information about loading samples depending on whether the sample tubes have barcodes and the information given by the barcode Barcode Sample Comment information Yes Yes Load samples onto any rack defined for that tube type Barcodes are read automatically Yes No Load samples onto any rack with the correct default sample type No No Use the Automatically Assign Rack Position function to au
419. provided there are orders that need to be processed To check the worklist Click Orders on the navigation bar and click the Worklist tab Check the Worklist for orders that are blocked or have no samples on board Take the appropriate actions to resolve the problem A OON If you are sure all your scheduled orders are being processed properly and your first results are calculated switch to the Validate tab in the Results work area for result validation Tips e Select a blocked test and press F1 to get Help e Select an order and click Edit to modify the order or click Validate to switch to the Validate tab in the Results work area for result validation Worklist tab on page B 89 Printing the Worklist on page B 56 B 14 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Validating results Daily routine without sample barcode and without host Validate results on the Validate tab of the Results work area File Edit View Tools Window Help jae 7 o 6a 0 Validate Y Sample Calibration Quality Conto invalid K42 Lest Result GLU 0 jj Blocked Not on Board To Validate Sly ue Order ID invalid Sample amp invalid Sample l Check calibrators The quality control has not been accepted gt AAA Comment x 10 04 2012 13 20 ne r a Delete Print Rate Info w Accept Rerun Close Help
420. ps The color of the sample rack position tells you the status of the sample calibrator or control lt gt Color coding on sample rack positions on page B 71 e To display the details for a rack position do one of the following Double click the rack position o Right click the rack position then choose Item Detail o Select a rack position and press Space or press Enter to display details for the rack e Use the same techniques to display details for the whole rack but click the rack number e Racks that have been removed from the system are shown as greyed out H ce Loading samples on page B 38 B Loading calibrators controls and diluents on page B 40 B 70 Operator s Manual Version 1 2 Cedex Bio HT 7 Status Color coding on sample rack positions Samples tab e Press F1 to display Help for this tab The sample rack positions are color coded The following table shows the meaning of each of the colors Color Meaning None Empty position no cup or tube Gray Ready Green All tests have been calculated but not necessarily validated Yellow Cup or tube is blocked because a reagent or diluent is missing Red e Cup or tube is empty Sample is not known Position conflict between two samples No sample on this position adapter is present but not the cup Barcode cannot be read Clot detected Operator s Manual Version 1 2 B 71 7 Status
421. ps to display details information on the item e Clear the Test Enabled check box to disable a test Calibrations and controls can be run on disabled tests but samples cannot e You can disable a control temporarily here but you must re enable it here also Use the check box to the right of each control to enable or disable it e Next Cal and QC Interval These are values from the test definition e All cassettes associated with the selected test are listed even if they are not on board e The Calibration Postponed status indicates that for the selected test the calibration was due and that this calibration has been postponed B 74 Operator s Manual Version 1 2 Cedex Bio HT 7 Status Test Status tab e The Clot detected status indicates that a clot was detected e Ifyou see for example a status of Diluent not on board and you replace the diluent while the system is in Standby the values for Status and Next Cal in the Test group are not updated until the system is in Operating The information in the Diluents group however is updated immediately You may have to click Re Start on the navigation bar to get the system to Operating mode The Diluents group is empty if no diluent is used for the selected test e Press F1 to display Help for this tab Operator s Manual Version 1 2 B 75 7 Status Cedex Bio HT Analyzer tab Analyzer tab Use the Analyzer tab to review the system that is the status of te
422. pter 13 Safety informations sisscuvsscssevssissnnsssscesssvsenvostasssetsvesecvs twseneosissssensssvesweedpeseasteragesossvasssi esens ADOUt SEFVICE ACEIONS se ci5cscsccijchececleeibcesscctedleecetazisasthedagectosdidacesofagacteesyeceoatssesveeucnessesteees Service work area overview 5 i DITA E 1e AERE SAT AE EE E A E E AS VEIE el EE AEAT EATS EATE E EA A A E E A A E ET Begin of Day taD aa E aE AAE ARARE Aa Performing a service acti OM 2i csscs esesaiseesvssdaeesescsscnborsscvehnashebavsndstedevesenshndssesehosaserehesesaved Service NOLES sezcssvsssceceneecssevsssteeasesecegensss dete E S E A a S E E E E R E S Service ACtON States asns isi see r e e aea Ees ais iins Adding service notes and user actions Cou ntersand HM ETS aeina a a a Service Counters dialog boxissa a E E Lest Counters dialog DOx scrisa a a a n N Operator s Manual Version 1 2 D 3 13 Service action software Cedex Bio HT Important safety information Read and understand the Roche safety precautions at the beginning of this manual and the hazard and precaution notes contained in this chapter This information should be made z available to all employees and kept for further reference Warning Users must not perform any servicing except as explicitly described in this manual Operator s Manual Version 1 2 Cedex Bio HT 13 Service action software About service actions About service actions When are service actions due
423. ption All other flags with lower priority are shown in the result details Results without flags are automatically within the reference range and can be considered to be error free When a flag occurs processing is dependent upon result handling which is defined in Configuration Result Handling Results You can check the details held in result handling to review what your system does when it generates specific flags The system action can be different for calibrations controls and samples F 40 Operator s Manual Version 1 2 Cedex Bio HT 19 ISE flags and troubleshooting Flags and user actions Flags and user actions Q List of flags Messages number format The action you need to take in response to a flag for an ISE measurement depends on whether e Only a single flag was generated The flag was repeated and the error message for that flag was displayed Both cases are described in the flag descriptions Where a flag description gives a list of recommended actions work through each step in turn until you have solved the problem Proceed to the next step only after you have completed the previous one The following table lists the flags in alphabetical order Flag Priority Counter limit Message ID See page AIR FLUID 11 5 14 3248 08 023 xxx F 43 AIR ISECAL 12 5 14 3248 08 017 xxx F 43 ISE UNSTAB 13 5 14 3248 08 031 xxx through F 44 14 3248 08 038 xxx 14 3248 08 018 xxx lea
424. ption if available for the selected control The results are displayed to the left of the graph the graphical display looks like this Glucose V3 BioProcess 1 PPath 4 Date amp Time 1311 0 00 Calibration parameter changed 10 Apr 2012 12 37 0 95 m lt TEST RNG 10 Apr 2012 12 17 4 99 m c 10 Apr 201211 00 1 24 m c Upper Flags Action lt TEST RNG A Legend showing the symbols for each control Tips Red symbols represent flagged results Operator s Manual Version 1 2 B 179 11 Quality controls Cedex Bio HT Reviewing and validating control results e Gray entries represent results that either were excluded from the statistics or have the status Deleted a rerun was ordered B 180 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Setting up controls Setting up controls Information about a control is stored in the control definition and in the test definition The control definition is loaded from disk or can be set up manually in Configuration Tests Control Loading and deleting control definitions If you receive an update to a control definition use this procedure to load the new control definition 1 Load the control definition 2 Assign the control to tests 3 Update the lot information and values manually or use the barcode pen or handheld barcode scanner gt To load a new control definition ny 1 Click Configuratio
425. ptions If the problem reoccurs after completing steps 1 through 5 contact Roche Service The disk drives are organized as follows Drive Contains A Archived or exported data updates USB drive Archived or exported data updates B Not used C Programs and system data D Backup data E CD ROM F User data including archive data Tips Use drive F for all your own archive data You can save any definitions results and raw data still on the system for future reference Do not store any of your own data on drives C and D otherwise your system may run out of disk space Transmitting data to the host Transmitting all results Transmitting selected results In normal operation for systems that are enabled for host communication accepted results are uploaded to the host after the host has sent a query to the system After result upload the results are labeled internally as completed If you need to retransmit results to the host choose Tools gt Retransmit All Data from the menu bar This command retransmits all results on the system even if you are only interested in one or two Use Configuration Processing Result Output to enable or disable the function Retransmit All Data Depending on the content of the database the retransmission of all data can take multiple hours or days You can select one or more individual results results for a specific order or for a specific dat
426. quests on one or more tests You can select individual tests or a profile containing several tests All pending calibrations whether requested manually or scheduled automatically by the system are listed moons Z Orders Fie Edit View Tools Window Help EFATE FEN Worklist Sample Calibration Qugis Canna r Tests amp Profiles r Calibrator Test Summary Cal All xl Calibrator Tube Position Lot COBAS cup 101 3 163911 Stop Sup General 7 1 1429 Chas COBAS cup 101 1 161458 i EE Pofiet SD 1 Gluc 65056701 S GLN COBAScup 1017 57132553 1 an auv Ge so 3 43 GLU COBAS cup 1015 57132459 1 GeBe Ko Lac LDH D 1 Glu z NAD NH3 a ISE O 140 6 21414002 21413502 aD 1 NAD sD 1 K D i En S SERTS COBAS cup 1019 637709 i F 1 EL ey admin 29 03 2012 10 30 A You can select a test or profile for the calibration request by typing its name or number here B In the Configuration work area tests can be assigned to groups You can use this feature to reduce the number of test buttons displayed at one time Select another group if you do not see the required test C Click a profile button to request calibrations for all tests in the profile D Click test buttons to request a calibration for the test E Calibration already requested for this test F Select a calibrator to display only the tests that are associated wi
427. quired Modify the Lab Unit Factor 5 Select the number of Decimal places to be displayed in the reported result 6 Click Save gt To modify reference and critical ranges Click the Evaluation tab Select a test from the Installed Tests list 1 2 3 In the Result Evaluation Mode box select None Reference or Cutoff 4 Modify the appropriate reference or critical ranges or the cutoff limit as required 5 Click Save gt To delete a test definition 1 From any tab select one or more tests from the installed test list and click Delete 2 Click Yes to confirm the deletion in the Confirm Delete dialog box Preconditions e Remove the associated calibrator and control racks e Make sure there are no orders pending for this test e Make sure all results associated with this test are accepted Operator s Manual Version 1 2 G 9 20 Configuration About the Definitions group Cedex Bio HT Tips e If you decide not to delete a selected test after pressing the Delete key you can click No or Cancel in the Confirm Delete dialog box e If results exist for the selected test definition another Confirm Delete dialog box appears to allow you to confirm the deletion of results associated with the test Creating and modifying test groups sequences and classes gt Test groups are used in Orders to reduce the number of test buttons displayed Test sequences arrange the way test buttons are displayed in Orders and Te
428. r 1 2 Check the Memo Pad for messages A red icon points to an urgent message Checking the Memo Pad on page B 51 Checking the Begin of Day report The system performs preselected service actions and other automatic actions at the assigned Begin of Day BOD time No user action is required The Begin of Day report summarizes all information about the last performed BOD Use the report to plan your next steps such as preparing calibrators and controls loading cassettes or performing service actions that are due gt To check the Begin of Day report Choose File gt Print Report gt Begin of Day Click OK The Begin of Day report is printed Check the Begin of Day report for the following items and plan your next steps accordingly e Service actions that need to be performed e Required calibrators controls cleaners diluents and ISE fluids Only cassettes required for tests remain on board e Cassettes that need to be handled Tips To identify the required calibrators check also the status of the calibration intervals on the Test Calibrations dialog box Tools gt Test Calibrations Prepare calibrators and controls now so that they are ready for loading later on If no BOD was performed choose Tools gt Execute Begin of Day or click to start BOD manually gt Printing the Begin of Day report on page B 52 B 8 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow
429. r Sample Margin in Configuration Lab Sample Tubes e No sample type was detected Possible reasons are The sample type is not known o Position conflict between two samples o The barcode on the tube could not be read Do one of the following e Assign the sample to a position on the rack Operator s Manual Version 1 2 E 21 16 Troubleshooting Cedex Bio HT Blocked orders tests calibrations or controls Tests Disabled Recommended action Aborted Recommended action e Remove the rack and assign the sample to a new position on the rack Assigning samples to racks on page B 96 e Remove the clot e Manually enter the barcode information If you work with a host system 1 Remove the rack and identify the missing information 2 Re insert the rack after identifying the tubes whose barcode could not be read 3 Use the Place Items dialog box to define the orders and tests and for assigning the samples to rack positions If you work without a host system 1 Remove the rack and identify the missing information 2 On the Sample tab of the Orders work area create the orders and tests that were not read from the barcode 3 Assign the samples to the rack positions 4 Re insert the rack into the system e Test disabled Possible reasons are o Test was manually disabled o Test was automatically disabled due to a flagged calibration or quality control result This is the case if the fla
430. r after replacement replace the Operator s Manual Version 1 2 E 31 16 Troubleshooting Hardware Dripping probes Temperature control Cedex Bio HT complete pipette Replace plunger tip dosage pipette B or C on page D 57 If a visual inspection shows that either of the probes is leaking you must take immediate action Loose tubing connections 1 Check that the tubing connectors are firmly screwed into place and tighten if necessary do not over tighten any connections 2 Replace the complete probe and tubing assembly if necessary Replace probe B or C on page D 54 Damaged tubing or probe e Replace the complete probe and tubing assembly if necessary Replace probe B or C on page D 54 Valve is defective A Hardware Warning message may be displayed but not necessarily stating that a valve is defective e Contact Roche Service Damaged probes 1 Check the probes visually for damage and replace if necessary 2 Check whether there is any physical obstruction that might have damaged the probe if so remove the obstruction Replace probe B or C on page D 54 Due service actions not performed Due service actions related to pipettes and probes were not performed on schedule e Use Service All and perform all due service actions If the ambient temperature exceeds 30 C the refrigerant pressure becomes too high and the cooling system generates a hardware error
431. r all pipetting and cleaning actions There is one transfer arm to which the two probes are attached The transfer arm moves in a horizontal X and Y Operator s Manual Version 1 2 A 35 2 System description Cedex Bio HT Functional systems axes plane the probes also move up and down Z axis Figure 0 23 shows the parts and location of the transfer system including the initialization posts gt Figure 0 23 Transfer system and initialization posts A Transfer head cover D Cassette area initialization post and protective sleeve not visible in the main system part of the picture B Transfer arm 4 R P AEE Sample area initialization post C USE initialization post F Wash station initialization post not visible in the main system part of the picture Coordinates System messages relating to the transfer arms often refer to a specific direction of movement If you stand facing the instrument the direction axes are defined as follows X axis Left to right motion Y axis Backwards and forwards motion Z axis Up and down motion Probes There are two probes named probe B and probe C Their names are based on the workstation B or C where they pipette the required amounts of fluids into a cuvette A 36 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Functional systems The probes are thin hollow metal tubes attached to the transfer arm and directly connected by tubing
432. r the sample probe fF ON Check the onboard samples for clots Clean probes and splash guard on page D 24 Sample prime clot error Pressure sensors are fitted to detect clots during aspiration of samples during washing of probes or when initializing the system When a clot is detected a message is displayed Extensive clots have been detected in a sample probe which could not be removed automatically Therefore the system will not start measuring Look for other messages which may indicate the source of the clot 2 Wait until the system is in Standby Apply the cleaning procedure for the sample probe Clean probes and splash guard on page D 24 4 Check the onboard samples for clots Leakage Fluid leaks can sometimes occur especially when service actions for example Replace Dosage Pipette Plunger Tip are not properly completed gt Leaking pipettes 1 Check that the pipette is firmly screwed into place and tighten if necessary do not E 30 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Hardware over tighten any connections 2 Ifthe leak is from the barrel of the pipette replace the pipette or piston Leaking tubing or tubing connections 1 Check that the tubing connectors are firmly screwed into place and tighten if necessary do not over tighten any connections 2 Check the external water and external waste tubes and ensure they are properly connected and not damaged
433. racy range For an accuracy control the result is outside the permitted range 1 Check if the correct control material has been used 2 Repeat with fresh control Priority 53 Group CNTL Antigen excess The sample contains an excess antigen and a valid result cannot be calculated 1 Rerun the test with postdilution 2 Ifthe flag occurs after dilution rerun the test using a higher dilution factor Priority 29 Group CAL CNTL TEST AIR FLUID on page F 43 AIR ISECAL on page F 43 The result was calculated using an erroneous or corrected calibration which has been accepted e CNTL o Repeat calibration e RAT TEST 1 Review controls 2 Repeat calibration Attributes Priority 33 Group CNTL RAT TEST c Meaning Result calculated using an erroneous or corrected calibration which has not been accepted C 6 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags Recommended action Attributes CALC ERROR Meaning Recommended action Attributes lt Critical Range Meaning Flags and recommended actions CNTL 1 Check that the correct calibrators have been used and that the calibrator cups are correctly positioned 2 Check that the correct Assigned Value is defined in Configuration Calibrators Lot 3 Repeat calibration RAT TEST 1 Check calibration 2 Repeat calibration Priority 32 Group CNTL RAT TEST CAL Calculation error Nonlinear stand
434. rag and drop items from the Samples folder to the rack graphic The positions you choose must correspond to the actual placement of the samples on the rack ol Repeat step 4 for any other samples Click Save o B 98 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Sample Handling dialog box 7 Creating an order Place the samples on the correct positions on the rack and load the rack Place Items x fampes Without Positions m Samples on Rack 101 CAL x Place Samples ilCf a s Std 1 a a Sample a Diluent j ACCEL j tee COBAS cup Samnla T The Sample folder containing samples to be placed on racks Click to expand or H to contract the folders Rack placement graphic Rack identification list Click the arrow to display a list of available racks The padlock symbol means the rack is on board Order ID and sample type or name for other solutions Reset the assignments on this rack to what they were when 1 you opened this dialog box or 2 you last saved Click Clear to clear all assignments on this rack Click Save to save the new assignments Tips You can assign positions to both on board and off board racks Step 2 Click Clear to clear previously assigned rack positions if necessary Step 7 You can print out the sample positions by o Clicking Print in the Place Items dialog box o Choosing File gt Pr
435. ral procedure not a service action The ISE tab in the Status work area gives information about the status of the solutions on the ISE rack They must be replaced before the bottle is empty or as soon as the expiration date is reached Activator ISE Deproteinizer Bio HT ISE Etcher Bio HT ISE Solutions 1 2 and 3 3 only for lithium electrode Protective gloves There is danger of cauterization and poisoning through skin contact with the reagents ISE Solutions 1 2 and 3 must be replaced as soon as they have expired If you use solutions which are past their expiration date the results will not be reliable Roche recommends to use the Activator for Cedex Bio HT systems as ISE Activator Use only the Activator Bottle set for Cedex Bio HT systems which contains the appropriate 11 mL plastic bottles Make sure you read all the warning labels on the cassettes Use protective gloves to avoid direct contact with sample material Remove any spillage of sample material immediately To replace ISE Solutions on the ISE rack N of FF WN Open the rack access panel on the front of the instrument Remove the ISE rack Open the rack cover Replace the solutions as required Close the rack cover Reinstall the ISE rack You are prompted to indicate the solution s you have replaced Click the corresponding button s F 32 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Replace ISE s
436. rcode On Sample Cups check box in Configuration General Barcode The rack configuration depends on the information coded in the sample barcode e Ifyour sample barcode includes sample type information use tube type racks e Ifyour sample barcode does not include sample type information use sample type racks Working with barcode and with host The system identifies the samples by their barcode Therefore the function Automatically Assign Rack Positions is not used e Clear the Automatically Assign Rack Positions check box in Configuration Database Automatic Actions e Select the Reset Rack Positions at Begin of Day check box in Configuration Database Automatic Actions To work with barcode on sample tubes select the Use Barcode On Sample Cups check box in Configuration General Barcode The rack configuration depends on the information coded in the sample barcode e Ifyour sample barcode includes sample type information use tube type racks e Ifyour sample barcode does not include sample type information use sample type racks Operator s Manual Version 1 2 5 Daily workflow Daily start up Daily start up Cedex Bio HT Prepare your system for the day Logging on and checking the Memo Pad 2 To log on 1 Press Shift F3 2 Type your user ID and password 3 Click Log On Logging onto the system on page B 33 amp To check the Memo Pad Click Memo Pad on the navigation ba
437. rder IDs are valid until they are deleted Typically the system is configured to delete processed orders automatically every morning and with it the order IDs are deleted You then can use the same order IDs the next day You can purge orders only when the order has been processed that is when the results have been accepted and transmitted to the host provided you work with a host system The way in which you place samples in racks depends on how the racks are configured on your system Typically you will define racks for a specific tube type Configuration Lab Racks and have tubes of one type on the same rack You cannot mix tube sizes on the same rack For example you cannot put 5 mL and 7 mL tube types on the same rack B 84 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Orders at a glance Orders at a glance Use the following table to locate specific tasks by work area and tab Work area Tab Tasks Status Orders Missing amp Blocked Samples Worklist Sample Validate Sample Review missing and blocked samples for the current worklist Review samples on board color shows the status Double click a rack position to display the details for the selected sample Review the status of active orders and tests Access directly the areas where you perform the most frequent tasks on these items such as editing and validating Create an order Add tests or
438. re stopped e The Cedex Bio HT main window is closed Tip You can also perform a shutdown by pressing Alt F4 I x 1 g A f Q z After shutdown certain maintenance procedures will be run automatically from a separate standby power supply Restarting the system You should perform a restart only after the screen has become dark after shutdown gt To restart the system Switch on the instrument at the main switch 2 Switch on the computer The system undergoes the complete startup procedure The Cedex Bio HT program is automatically restarted Log on Shift F3 when the Log On dialog box is displayed Tips e After restarting o Windows XP is automatically restarted You do not have to log on to Windows XP o The Cedex Bio HT program is automatically started o The system is re initialized e When you log on type in your user ID and password as usual You must rerun tests that were in progress when the system was stopped E 14 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Troubleshooting General problem solving techniques This chapter explains how to identify and fix problems that can affect the running of the Cedex Bio HT analyzer It explains how to view and respond to system generated messages and how to troubleshoot problems that do not generate messages A description of how to identify and replace fuses is also included If you encounter any problems that
439. re not changed e Std 1 is the standard with the highest concentration e When updating the lot numbers for the ISE solutions enter both the lot number and expiry date of the solutions You can enter the lot definitions for all three solutions individually gt To update a calibrator lot number using the barcode pen or handheld barcode scanner 1 Click Configuration on the navigation bar 2 Choose File gt Barcode from the menu bar or click from the toolbar The Barcode dialog box is displayed 3 Run the barcode pen over the first barcode line of the calibrator information sheet or read the barcode with the handheld barcode scanner After reading the first line of barcode the information is displayed on the Barcode dialog box Barcode AQS VK S371861997900112 104636 1A Line Status Barcode line ok The numbered boxes represent the barcode lines 4 Read the rest of the barcode lines of the calibrator information sheet 5 Watch the Barcode dialog box Operator s Manual Version 1 2 B 155 10 Calibration Setting up calibrators Cedex Bio HT Correctly read lines are represented by green boxes lines with reading errors by red boxes and a message on the Line Status box of the Barcode dialog box Barcode CAPS LOCK must be turned OFF BO VK S371861997900112 104636 1A sd i diii D r ie Print Reset Cancel e Using the barcode pen or handheld barcode scanner re read the bar
440. re still available for use is displayed in the Analyzer tab in the Status work area You can perform this task at any time while the system is running When the icon is red the system stops The cuvette reservoir can hold a maximum of 1400 cuvettes Each pack contains approximately 1000 cuvettes Tools and materials Precautions New pack of cuvettes Pair of scissors Warning Make sure that you do not touch the surface of any cuvettes result accuracy may be affected Make sure that the cuvette drawer slide is always clean and that you replace it properly when you have completed this task B 44 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Managing resources gt To refill the cuvette reservoir 1 Open the cuvette reservoir access panel A 2 Remove the cuvette reservoir together with the covering slide Do not remove the slide from the reservoir 3 Turn the cuvette reservoir upside down Cut open the cuvette pack B and taking care not to touch the cuvettes pour the cuvettes into the reservoir 5 Reinsert the reservoir and the slide back into position C 6 Remove the slide taking care not to spill any cuvettes 7 Replace the slide D at the top or the reservoir E The system automatically detects that the cuvette reservoir has been refilled Refilling the external water reservoir laboratory water supply However you will get a resource alert if the laborator
441. rea They are also listed in the Worklist of the Orders work area Ifa calibration is not accepted any control or test results that depend on the calibration will be flagged and listed as well To review calibrations for validation Click Results on the navigation bar Click the Validate tab Select the required calibrator from the Validate list Resolve the action required from the flags generated a fF WN Click the appropriate button Accept Has the same effect as Accept All Accept All Accept all the calibration results for the selected calibrator Operator s Manual Version 1 2 B 149 10 Calibration Validating calibration results Cedex Bio HT Rerun Rerun the calibration The current results are deleted Any control or test that has not been accepted yet will be rerun automatically as well z Validate Y Sample Calibration Quality Control Restart Gluc Calibration E Blocked Standard Pesut_ _Unit Flags Action Ref Renge 2 5 To Validate Std 1 1 96 g L gt REPLDEV 1 Stop B f s Std 2 0 00 g L gt REPL DEV i oo Pe Sample i Fil A c 1 ER Find e f acceptan Accent O Beune A From the list select whether you want to display all results All or only the unaccepted results Unaccepted The selected calibration C To resize the columns position your cursor here and click and drag the divider Move the di
442. request atest with a dilution factor F 1 Click Orders on the navigation bar HE 2 Click the Sample tab 3 Inthe Sample Test Summary group right click the test and choose Dilutions from the context menu The Dilutions dialog box is displayed 4 Select the required option button for a predefined dilution factor a specific factor or a manual dilution Specify the dilution factor if required 6 Click OK Click Save in Sample tab when you have specified all the tests for the current Operator s Manual Version 1 2 B 107 8 Orders Cedex Bio HT Working with Orders order xi Order iD F11 476_03 Sample Glue 1 r Sample Treatment A Factora 1 10 As Original g 10 20 10 J20 A Select a predefined dilution factor for an automatic dilution B Use the original sample dilution C These factors have not been defined for this test D Select to specify a dilution factor for this test and sample Specify the values for an automatic dilution m Select this box if your sample has been diluted manually Type the dilution factor Tips e For an automatic dilution the diluent and sample are mixed automatically in a cuvette e For a manual dilution you mix the diluent and sample manually then load the tube containing the diluted sample onto a rack e Do not use barcoded sample tubes for samples that require manual dilution The barcode does not contain any informa
443. resent e The ISE distribution block is leaking or blocked e The ISE module tubing is leaking or blocked If only one result is flagged 1 Repeat the measurement 2 Ensure that the ISE Calibrators on the ISE module are available and check the level of liquid replace if necessary 3 Check the ISE module tubing and the ISE distribution block for leaks or blockages If the error message is displayed 1 Perform the service action Prime ISE calibrators 2 Check the ISE module tubing and the ISE distribution block for leaks or blockages 3 Contact Roche Service Operator s Manual Version 1 2 F 43 19 ISE flags and troubleshooting Cedex Bio HT Flag descriptions ISE UNSTAB Meaning Message IDs Possible cause Recommended actions Meaning Message ID Possible cause Recommended actions Meaning cause and action depend on the message ID which are divided into two groups e 14 3248 08 031 xxx through 14 3248 08 038 xxx e 14 3248 08 018 xxx leakage The signal from the electrode s was not stable during the measurement 14 3248 08 031 xxx through 14 3248 08 038 xxx The ISE measurements mV Values are unstable because There are air bubbles in the measuring segment The concentration of electrolyte in the sample is too low for example dialyzed samples The pH of the sample is too low for example pH lt 5 5 e One or more O rings are missing or damaged e The electrodes have not been se
444. robe C when required The sample is divided into segments with the aid of a special arrangement of valves The first shorter segments are used for cleaning followed by a longer segment on which the measurements are made The sample is passed to the ion selective electrodes by the action of the peristaltic pump The exact positioning of segments is ensured by fluid sensor 2 in the measuring channel In the meantime the ISE tower is washed with distilled water and dried ISE Reference Electrolyte is passed through the reference electrode and into the measuring channel downstream of the electrodes The ISE Reference Electrolyte completes the electrical circuits for each electrode so that measurements can be made When the measurements are made the sample and ISE Reference Electrolyte are stationary A one point calibration is performed after each sample measurement using the relevant calibrator which is located on the right side of the ISE module The electrolyte concentration of the sample is calculated 10 The measuring channel is cleaned before the next measurement Operator s Manual Version 1 2 Cedex Bio HT 17 ISE module Determination of lithium Calibrations Main calibration One point calibration Measuring modes Q7 How the ISE module works OQOQQQ c Lit Kt cr Nat Ref H Figure C 2 Principal parts of the ISE measurement syst
445. rol QC A tool which verifies accuracy and precision of results Cedex Bio HT quality control encompasses the functions of accuracy control precision control limit control and precontrol Quality Control Rules A set of statistical rules that help to identify problems with the instrument Query Command to find and display the entries in the work areas according to customized search criteria Rack Carrier holding containers used on specific systems Rack Number A number that identifies a particular rack This number is assigned when the rack is defined to the system Rack Status Display Consists of a set of lights that show the status of the racks The icon on each light indicates the type of rack The color and whether the light is flashing or steady indicates the rack status Random Access Analysis Ability to run analyses flexibly in any order as opposed to in batches Rate Absorbance difference between first and last measurement cycle AA or change in absorbance per minute AA min Ratio See Calculated Result Reference Wavelength Second wavelength in bichromatic ABS measurements which corrects for interfering constituents in the sample See Absorbance Photometry Repeat Command to perform a test calibration or control order as in the original run Replicates Multiple repeated measurements of the same sample calibrator or control Report A collated set of data related to the running of the instrumen
446. rsion 1 2 D 71 Cedex Bio HT 14 Service actions Managing data Flags in the journal 3 Click the Automatic Actions tab 4 Inthe Delete Journal after box type the number of days for which log entries should be kept in the journal Take care when evaluating results that are flagged in the journal The flag listed in the Journal for a specific test is not necessarily the final flag for that test The flag in the Journal is a temporary flag that was active when the pipetting took place This flag is often overwritten or removed from the final result To review flags for a result use the Sample Calibration or Quality Control tabs in the Results work area Non database storage Backing up your data Database messages Some data are stored on disk and are not part of the database e Archived definitions Data files containing the parameters but not necessarily the current ones for all test and related definitions on the system e System logs Data files used by the system to store data so that for example the system can restart after an electrical mechanical or database failure Generally not accessible to users e Backup data Data files used to restore the system after a disk failure These data are stored on drive D The system automatically backs up the database as a BOD service action The backup data is stored on disk D You can also request this service action manually in the Service work area The purpose
447. rther investigation Reviewing calibration history The Calibration tab in the Results work area shows the calibration history of each test A calibration history lists the date and time the curve parameters and cassette lot numbers for the previous and current calibrations of a particular test Use the calibration history to review trends for example to see if the instrument is running properly or to examine a specific calibration in detail You can display the calibration curve and raw data for each calibration provided these results have not been deleted To review the calibration history 1 Click Results on the navigation bar 2 Click the Calibration tab 3 Select a test from the By Test list Results x File Edt View Tools Window Help 72a ias Validate VY Samole Calibration Quality Conta 1 Start By Test Glutamate BioProcess Next Cal Due next cassette GLN Date Calibrated RO F Flags Action GLUB 12 58 0 008182 31779 92 gt REPL DEVY 00000021 aE 15 Mar 2012 14 43 0 000143 2286 2908 00000021 IGGHB 15 Mar 2012 13 37 0 0004300 2277 8771 gt 00000021 f IGGLB 15 Mar 2012 12 59 0 0567771 3970 6405 0000021 a K D 15 Mar 2012 12 5 J0000021 ley LAC 14 Mar 2012 09 18 0 0000179 2272 5215 00000021 a LOH 12 Mar 2012 13 30 0 000025 2274 8834 00000021 delge e I admin 20 04 2012 16 59
448. rvice e TEST 1 Check sample for bubbles and repeat measurement 2 Ifthe flag reappears contact Roche Service Priority 4 Group CAL CNTL TEST High absorbance The measured absorbance is greater than 2 0 A e CAL o Repeat with fresh calibrator e CNTL o Ifa single control is flagged rerun with a fresh control o Ifmore than one control is flagged perform a calibration e TEST o Ifa single sample is flagged rerun with dilution o Ifthe problem persists replace the cassette Priority 1 Operator s Manual Version 1 2 12 Result flags Flags and recommended actions HIGH ACT Meaning Recommended action HIGH BKG Attributes Meaning Recommended action Cedex Bio HT Group CAL CNTL TEST High activity The Absorbance change during measurement exceeds the accepted limit i e the reaction has taken off too fast Possibility of substrate exhaustion e CAL 1 Check reaction curve in Rate Info 2 Check if correct calibrators placed on the calibrator rack 3 Repeat with fresh calibrators e CNTL 1 Check reaction curve in Rate Info 2 Check control Repeat with fresh control e TEST 1 Check reaction curve in Rate Info 2 Rerun with dilution Priority 17 Group CAL CNTL TEST High background noise For an FP measurement there is an unacceptable level of background noise e CAL o Repeat with fresh calibrators e CNTL 1 Repeat with fresh controls 2 Ifthe flag reappears
449. rvice actions are about to become due You can define both counters and timers for a service action The system then uses whichever limit is reached first Performing a service action resets the counter and timer for that service action to zero The system holds the following counters The number of tests performed A limit for the number of tests that a probe for example can do before it must be cleaned The service action becomes due when the number of tests performed reaches the limit The system holds the following timers The number of days that have passed since a service action was last performed e A limit for the number of days that can pass before a probe for example must be cleaned The system defines service actions to be due by using a percentage of the service interval The permissible percentage range lies between 80 and 100 and can be changed by your system supervisor Select View gt Counters in the Service work area click the Service Intervals tab and type the value in the Service Action Due at box To change the percentage you must have user access level 6 Configuration General User Level Once a counter or timer reaches the defined percentage of the service interval the service action is displayed in the Due tab of the Service work area Service Counters dialog box Service Counters tab The Service Counters dialog box displays information about the counters and timers associat
450. rviced e The expiration date of the electrode has passed or the electrode is damaged e The ISE Reference Electrolyte tubing is blocked or leaking The floater of the ISE Reference Electrolyte bottle is blocked The preamplifier is not working properly If only one result is flagged 1 Repeat the measurement 2 Repeat the measurement with a suitable sample where pH gt 5 5 and correct electrolyte concentration to establish that the ISE module is OK 3 Check the position and condition of the O rings and replace if necessary If the error message is displayed Perform the service action Activate electrodes Perform the service action Electrode service Replace expired electrodes and perform the service action Electrode service Check the ISE Reference Electrolyte tubing for leaks or blockages Check the floater of the ISE Reference Electrolyte bottle for blockages Oo a F amp F WN Contact Roche Service A fluid leakage in the electrode block was detected 14 3248 08 018 xxx leakage The ISE measurements mV Values are unstable because e One or more O rings are missing or damaged The electrodes and or the electrode block are not dry Press F12 Stop 2 Inthe Stopping dialog box select Stop when in progress test have completed then click OK 3 Remove electrodes and clean and dry the electrode block Dry electrodes 5 Check the position and condition of the O rings and replace if necessary F 44
451. rview 4 profiles 6 tasks 5 test sequence and classes 6 tests 6 Configuration Cassette Definitions dialog box 15 Configuration Cleaner Definitions dialog box 16 Configuration Diluent Definitions dialog box 16 Configuration General dialog box 20 Configuration work area menu structure 16 confirming messages 9 orders 18 connections leaking 27 connectors barcode pen 39 checklist 38 external 17 37 handheld barcode scanner 39 on instrument 38 power 37 waste 37 water 37 contacting Roche Service 44 content of User Manual x Contents tab on Help windows 62 context Help 65 displaying 65 window 65 User Manual Version 2 7 Index INTEGRA 400 plus context menus 53 in Orders work area 87 in Results work area 116 mouse click 53 control definitions deleting 182 loading 181 reviewing 167 control intervals 163 control parameters modifying 9 control rules 186 controller messages Help with 68 controls and racks 163 ata glance 166 blocked 19 definitions 15 deleting a request 170 disabling 74 flags 162 3 intervals 163 loading 11 40 169 modes 162 multiple 177 non Roche 188 number per test 162 overview 11 162 position on racks 70 166 QC history of a test 121 requesting 170 results 162
452. s Do not perform this procedure if there are any ISE tests calibrations or service procedures running or pending If you remove the ISE module in these circumstances you may damage the instrument e Make sure you read all the warning labels on the cassettes e Use protective gloves to avoid direct contact with sample material e Remove any spillage of sample material immediately Toclean the ISE tower manually Select Clean ISE tower manually in the Service work area 2 Click Perform The Service Actions dialog box is displayed Follow the online prompts as required F 22 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Clean ISE tower manually 3 Open the ISE access panel A 4 Pull out the ISE module using the handle B You have to pull quite hard because the ISE module is lodged firmly inside its housing Pull the module out until the spring catch C attached to the rear of the module is engaged 5 Remove the ISE overflow collector D by pulling it upwards and rotating it from side to side as you do so 6 Carefully remove the tubing from the base ofthe ISE tower E 7 Remove the locking bolt F from the base of the ISE tower by rotating it counter clockwise one quarter of a turn and lifting it over the ISE tower E F 8 Remove the ISE tower E You can exchange the ISE tower at this point if it is badly blocked 9 Clean the inside of the ISE tower wi
453. s e Protective gloves Cleaner contains hydrogen chloride Use standard laboratory safety procedures when using hydrogen chloride solution e Wear protective gloves e Replace the cleaner bottle only while the system is in Standby or Sleeping status or while it is switched off e Do not open the front cover while the system is running Main front cover Danger of injury due to closing main front cover If the main front cover is not opened completely it might close unintentionally by itself Whenever you open the main front cover be sure to open it as far as it will go To replace the cleaner bottle 1 Open the main cover A be sure to lift it as far as it will go 2 Remove the cap B from the existing cleaner bottle and place the level detection Operator s Manual Version 1 2 B 43 Cedex Bio HT 6 Routine tasks Managing resources sensor and tubing carefully to one side Discard the used cleaner bottle Remove the cap from the new cleaner bottle and place the bottle in the slot provided C Reinsert the sensor and tubing The cap through which the tubing passes should fit loosely on the top of the bottle Close the main cover Refilling the cuvette reservoir ch When the cuvette icon turns yellow in Status Analyzer or on the Status button you il must refill the cuvette reservoir before the system runs out of cuvettes The number of cuvettes that a
454. s and the ISE module In this chapter Chapter POGUE SEU S eaei tyes B 68 Status work area OVELVICW 0 csecsesesesseseseeseesteseeseenessessessesteseeseeneesssuesesuesesteneeseeneeseeness B 69 Missing amp Blocked tab sissscssinsscssssosevstssansssscnvesssevonnvstsbesscnsatsvenestiovesasder ocassievevstesansssiedhiers B 70 SALI p les Gaby NO AAEE EE A EA T E E B 72 Cassettes ta Dek re E B 74 Tests tatis tA Dan nena ERR a a E E E EE B 76 Analyzer tabe ierra a EE EEE E N B 78 Analyzer tab information sssssssssssssssssssssssssstssssssssssesrestsssnneretttesssssnnnsrestsessnsnsnssnette B 78 USES ele aa A T A seraceuuesss gees B 80 Displaying item details eeesessessessessessesseesessessesssessesssssessesssessesseessessesssssessess B 81 Selected tas Ksenia a RARA RE O iets B 83 Operator s Manual Version 1 2 B 65 7 Status About Status About Status Cedex Bio HT The system continually monitors its status and displays this information in the Status work area Much of the information is presented graphically using the following color coding System wide alerts Missing and blocked Color Meaning Green OK Yellow Caution you need to do something soon Red Critical the system has stopped and you must take corrective action immediately The exact meaning of each color depends on the tab If the system cannot function due to a resource shortage an icon is displayed on the Status button on the navig
455. s osesesteseoeossedsscostuvesnsr sguvceseseseesusencer ecavens6evesnests Displaying detailed information Working With results cs iessss scsuscasdesesnesdeseseesseshscasgeveerestevtosenonsseostivensetbesnvensseveonestsdesner i Accepting result or rerunning tests ccsesessessseseseessesseesessesseessessesseessesseeses B 129 Monitoring Processes ys cs lt c ses cesstszedezenstedesssebsdevesevevetusestdebetesesesbetiievesenivssesedsies B 130 Deleting information from the Results Work area cecessesssesseseessessesseessesseenes B 131 Archiving results x scsccnsensssiesnsdssodenoscvessnacesstaesasvesotisenossuscasesuidsnnbonsssvosandcsvetenissrodasiends B 134 Operator s Manual Version 1 2 B 111 9 Results About results About results Result handling Raw data Lab units Comparing results between instruments Calculated Results Reference ranges Automatic dilutions Purging results Cedex Bio HT Result handling and the way that information is displayed in the Results work area is determined in the system configuration The sections below give examples You can specify what happens to flagged and unflagged results The possible automatic actions following a flag are None Accept Stop Test or Rerun the options available depend on whether the result was for a sample calibration control or calculated result Note When an automatic rerun is performed the dilution is the same as that used for t
456. s replace cassette the reagent may be contaminated Priority 15 Group CAL Greater than replicate deviation Deviation between replicates exceed programmed limit One or more replicates are erroneous 1 Check the calibrators for air bubbles and repeat the calibration 2 Ifthe flag reappears repeat with fresh calibrators Priority 23 Group CAL Less than reference range The result is lower than the low reference range limit No action required Priority 60 Group RAT TEST Greater than reference range The sample result is higher than the high reference range limit No action required Priority 61 Group RAT TEST SEG FLUID on page F 46 SEG ISECAL on page F 47 SOL 1 F DEV on page F 47 Greater than standard deviation A point in the calibration fell outside the defined limits Operator s Manual Version 1 2 C 19 12 Result flags Flags and recommended actions Recommended action Attributes lt TEST RNG Meaning Recommended action Attributes gt TEST RNG Meaning Recommended action Attributes gt UP LIM Meaning Recommended action Cedex Bio HT 1 Check calibration curve 2 Repeat with fresh calibrators 3 Ifthe calibrators were incorrectly positioned replace the calibrators correctly Priority 27 Group CAL Less than test range The result is lower than the lowest limit for the test e CAL o Repeat calibration e CNTL o
457. s Prime ISE calibrators 20 Deproteinize probes 23 Clean ISE tower automatically 21 Clean probes and splash guard 24 Clean ISE tower manually 22 Clean internal water reservoir 27 Replace ISE module tubing 25 Clean wash station 30 Replace electrode 27 Clean external water reservoir and fluid waste Condition ISE tubing 31 reservoir 33 Replace ISE solutions on the ISE rack 32 Clean instrument 36 Replace bottles on ISE module 34 Clean the waste box fitting 42 Replace ISE tower 36 Clean and lubricate the rotor 43 ISE Performance Check 37 Prime the fluid system 46 Roche service 47 19 ISE flags and troubleshooting Backup database 48 About ISE flags 40 Replace ventilation filter 49 Flags and user actions 4l Replace Abs halogen lamp 51 Flag descriptions 43 Replace probe B or C 54 General ISE troubleshooting 49 Replace plunger tip dosage pipette B or C 57 Replace dosage pipette B or C 61 Replace external water reservoir filter 64 Managing data 66 vi User Manual Version 2 7 INTEGRA 400 plus Configuration g 20 Configuration Configuration overview 4 About the Definitions group 6 Loading test application software 17 Archiving and reloading definitions 19 System group 20 Windows group 22 Appendix 21 Appendix Technical specifications 4 Fluid system schematic 11 Keyboard shortcuts 13 Menu structure 14 Glossary and Index Glossary 3 Index 9 Revisions User Manual Version 2 7 vii INTEGRA 400 plus viii Us
458. s and precautions gt This is an automatic service action that does not require manual intervention The ISE module must be initialized at regular intervals to ensure proper transportation of fluids through the ISE module tubing The ISE module is automatically initialized during the Service action Replace ISE module tubing 6 minutes Daily can be assigned to BOD Yes Standby e Activator ISE Calibrator Direct Bio HT ISE Reference Electrolyte Bio HT ISE Solution 1 See General safety precautions on page F 16 To initialize the ISE module Select Initialize ISE module in the Service work area Click Perform Fluid system is initialized if necessary automatic step Transfer arm is initialized if necessary automatic step ISE Solution 1 is pipetted into the tower automatic step ISE Solution 1 is transported to the fluid sensors automatic step Probe C pipettes Activator into the ISE tower automatic step on oa FF wWN The pipetted Activator is drawn into the electrode block automatic step 9 Steps 7 and 8 are repeated five times 10 The ISE tower is washed and dried automatic step 11 ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes Operator s Manual Version 1 2 F 17 18 ISE service actions Cedex Bio HT Electrode service Electrode service Overview This is an automatic service action that do
459. s enabled A control result that falls outside the defined limits generates a flag on that control result This means that all the results for this test since the last unflagged control require validation Typically this involves rerunning the control otherwise you may have to use other controls or recalibrate the test Accepted control results are automatically removed from the Validate tab in the Results work area and put into the controls archive in the Quality Control tab in Results B 162 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls About controls Controls and calibrations All controls depend on calibrations If a calibration is flagged the controls that depend on it are not accepted automatically they are assigned an unaccepted calibration flag Racks and controls If the tubes containing your controls are barcoded put them into the correct rack with the barcode showing and load the rack onto the instrument If your system is not configured to use barcodes use one of these methods e Rack positions may have been previously defined for controls using Configuration Lab Reserve Positions Place the controls in the pre defined positions and load the rack e Use the Place Items or Sample Handling dialog box to assign rack positions to the controls Place the controls in the defined positions and load the rack The rack positions that you assign in this way are cleared at the next Begi
460. s focus when you press F1 To display context Help check which type of object currently has focus e Ona tab ensure the focus is on the tab click the tab and then press F1 on the keyboard e Ina dialog box click the Help button if available or press F1 e Ina message box click the Help on Message button if available Pressing F1 displays the main Help window lt gt Message Help on page A 68 The figure below shows a typical context Help window amp Cedex Bio HT Help System Lol File Edit Bookmark Options Help Help Topics Beck Bin gt Goesey ao W Contents Index Search 1K a 5 0 Software reference informati f H View Messages H Static work aroa See also E Orders work area H Results work area H Service work area B A Configuration work area E Configuration work are 5 A Configuration Test De E Configuration Test ID tab eneral tab Dilutions tab Control tab Laboratory tab E Evaluation tab H Test Groups Sequen Configuration Profile C Overview Use the Control tab to define the interval and sequence for running controls on the selected test What s this Information about specific items in this tab page General Long name Long name The long name for the selected test is displayed at the top of the tab It can be modified on the ID tab H Confi
461. s for validation 0 eeessessessesssessessessessesssessesseessessesstessessesaee B 170 Reviewing control results Reviewing control statistics Setting Up COMO S sissesssssscassissineswdssst Souasstesoussadehusisecndaseiovesivasucobasndersbenss cobnaslecehdsndersiesaded Loading and deleting control definitions cccesesseessessesseescsseessessesseessesseenee B 179 ASSigning COntrols to tests nisnin nn a K E NE B 181 Updating lot specific values for a control ssssssssssssssssssssssrsssssssssrsrsertssssssssssseese B 182 Turning control rules on and off ssssssssssssssssssssssssseteessserereteesssssssnererrtesesssssssseene B 184 Specifying control intervals sisin E E B 186 Loading a non Roche control ssssesssssssssssssssssssssssetsessssrstrteensssssnnnsssrtesesssssnsseete B 186 B 161 Operator s Manual Version 1 2 11 Quality controls About controls About controls Control modes Priority of quality control modes Number of controls Controls and test definitions Control flags and test results Cedex Bio HT The Cedex Bio HT Quality Control QC function supports established control rules that can be customized to satisfy individual requirements It supports all test groups including routine chemistries specific proteins and electrolytes There are three control modes each with its own set of rules Three modes are recognized accuracy precision and limit Each is characterized by one or
462. s or tabs click the banner bar buttons to jump to subsections of the current topic e In workflow topics click a number symbol in the banner bar to jump to the corresponding step Navigation pane For Help topics with large graphics such as the service action topics you can hide the navigation pane so that you can see the whole graphic Click Help Topics to hide and redisplay the navigation pane The navigation pane is divided into the Contents Index and Search tabs each providing a different method of searching and accessing Help topics Pop up window You open a pop up window either by clicking underlined blue text or by clicking in the banner bar of a context Help window A 60 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help Some practical hints Help window The pop up window remains open until you close it by clicking anywhere in the Help window Only one pop up window is displayed at a time User Name Use to add or modify the name of a user The name can consist of up to 16 alphanumeric characters Default user groups ADMIN Access to all menus and functions OPERATOR Access to a subset of menus and functions GUEST View access only Click Help Topics to expand the topic area to the full width of the Help window Click Help Topics again to redisplay the navigation pane Right click in the topic area to display a context menu with options that lead to useful func
463. sample tubes clear the Use Barcode On Sample Cups check box in Configuration General Barcode To automatically assign samples to rack positions select the Automatically Assign Rack Positions check box in Configuration Database Automatic Actions B 6 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Rack configuration Rack position Sample barcode Rack configuration Rack position Sample barcode Rack configuration Introduction To reset rack position at Begin of Day select the Reset Rack Positions at Begin of Day check box in Configuration Database Automatic Actions The rack configuration depends on the number of different tube types and sample types used in your laboratory e Ifyou use only one tube type and one sample type use tube type racks e Ifyou use more than one tube type and more than one sample type use tube type racks for the most often used tube and sample types and use sample type racks for infrequently used tube and sample types Working with barcode and without host The system identifies the samples by their barcode Therefore the function Automatically Assign Rack Positions is not used e Clear the Automatically Assign Rack Positions check box in Configuration Database Automatic Actions e Select the Reset Rack Positions at Begin of Day check box in Configuration Database Automatic Actions To work with barcode on sample tubes select the Use Ba
464. search for a specific order ID oo FW gt Click Edit to access the appropriate tab where you can edit the order This function is only available if there are related data on the system m Click Validate to access the Validate tab of the Results work area where you can validate the results This function is only available if the selected order has test results that need validating F The information displayed in the samples and tests list depends on the type of the selected order sample calibration control and on the folder the selected order is placed in The samples and tests list provides a good overview of the status of the selected sample calibration or control order Tip e Press F1 to display Help for this tab Operator s Manual Version 1 2 B 89 8 Orders Worklist tab Orders list on the Cedex Bio HT This area contains the folder view of the sample calibration and control orders Worklist tab D El Blocked 4 Sy NH3 QC AMM AB E yj NH3 QC AMM N 5 Gluc CAL C fas F gluc postponed Sample a Not on Board 1 E gluc04 10 Sample 5 2 Calculated 6 a GLU Qc GLU 3 amp GLU QC GLU 2 amp GLU CAL GLU fm 1 Sample ia 3 Sample 5 invalid Sample A Number of entries in the folder This number is automatically updated An increase of the number for example points to new entries B Test name C Order ID D Kind of order calibration quality con
465. seescssessessessesssessessees F 16 AULOMALIC SELVICE actin S ern F 16 Initialize ISE module o 2 2 cc csiscccaciseckcssesteesieecesesasacenosisecsvectesueatasesteetieecesesasactnettzesssetins F 17 Electrode service Activate electrodes Prime JSE calibrators cc aii adad at aida A A A ARAE F 20 Glean ISE tower automaticaly F 21 Clean ISE tower manually sssini iania eaa a aia EAE Eaei F 22 Replace ISE module t bingeni S R SR F 25 Replice electrodes isene S e EE teas estes E s F 27 Conditi n ISE AUDI srin pa E E E EE F 31 Replace ISE solutions on the ISE racK sssse ssesssessssessssssreresssseeressserresssserresssrerresssreressss F 32 Replace bottles on ISE moddlesissresiiiiiieia iina K F 34 Replace ISE toweksa tanaan EN NE T F 36 ISE Perforimarice Check isisisi eiia F 37 Operator s Manual Version 1 2 F 15 18 ISE service actions Cedex Bio HT About ISE service actions About ISE service actions ISE service actions work in the same way as the non ISE service actions and are listed in the Service work area where you start them in the same way ISE service actions also use the same type of service action dialog boxes to help guide you through the steps you need to take Some of the service actions do not need manuel interaction From those you can choose a set to run automatically at the beginning of day BOD Chapter 13 Service action software You can click Help in the Service Actions dialog box
466. seeuctvdstanrs ER Sample handling Cassettes and reagents Calibrations and quality controls cceeesesssesesseesesseessessesseessessessesesseesesseesees Operator s Manual Version 1 2 Result handling SYVSUEM Stat si ssis cei sacescnsesdscsesssscestescetods dosdboctecsseveicsesecetesesevesstasisexscssscessssesieiaerstossdeses Maintenance service and troubleshooting cccceessssesessesssessesseesesseestesesseess A 12 Waste Cisposal s ssscsscsesvssissshastiecetesssiiestecesshesdsevsseasiseosasnaseanseasevosanstecsiednasradssuavehsseseend A 12 AUTO MAL CG star Upe eieaa reisha annei rantan aA RES rae rA eae an A RESE ieat A 13 A 3 1 System overview Cedex Bio HT Introduction Introduction The Cedex Bio HT system is a random and continuous selective analyzer designed to operate from a table top There are three separate measurement systems supporting four different measurement principles Measurement system Measurement principle FP photometer Fluorescence polarimetry Absorbance photometer Absorbance photometry Turbidimetry ISE lon Selective Electrode module lon selective potentiometry Samples are automatically transferred from a sample tube or cup to the module where the measurements are made All optical measurements use the same transparent plastic containers called cuvettes The graphical user interface provides quick and easy access to sample control and calibration data while conti
467. ser ID For the currently logged on user G Date and time Date and time automatically updated displayed in the current Windows format H Navigation bar Click a navigation button to open the corresponding work area l Start and Stop buttons Start or restart a run interrupt or stop sampling once the current actions are finished J Navigation button For example click this button to open the Orders work area A 48 Operator s Manual Version 1 2 Cedex Bio HT 3 User interface Work areas Menu bar gt Work areas A work area is a window where you can perform a set of generally related tasks You can open a work area by e Clicking one of the buttons on the navigation bar e Pressing the appropriate function key see below Using the Window menu from the menu bar Navigation g Work area What you can do button Messages Display system messages You can also review the i Shift F5 message log for all the system messages particularly those that have resulted from errors or problems Status Display the status of the system including the status E5 of samples calibrators quality controls diluents and cassettes You can check the status of any test and find any missing or blocked items for the current worklist Orders Check the status of the orders create new orders and Fi F6 make requests for calibrations and quality controls You can create and modify a set of details about an order order d
468. ses is delivered in the start up kit from Why is the correct fuse If you use a fuse that has too low a rating it will almost certainly blow again This important wastes time but is not in itself dangerous If you use a fuse that has too high a rating your system will not be protected from excessive currents This is very dangerous and can lead to a situation where a fire develops Even without a fire you can get temperature control problems or other electrical faults if the underlying problem reoccurs Fire hazard For continued protection replace fuses only with fuses of the same type and rating Danger of electrocution Always disconnect the instrument from the mains before attempting to replace any fuse Do not Dan ger attempt to work with fuses if your hands are wet or if there is excess moisture on any fittings or components Replacing an instrument mains fuse There are two mains fuses both of which must have the same current rating which depends on the mains voltage supplied to the instrument Mains voltage Fuse rating 230 VAC 200 VAC 8A 115 VAC 100 VAC 15A ee Q 7 The mains input voltage is pre selected by a jumper on the voltage selection unit To replace the fuse you need the following tools and materials e Replacement fuses e 4mm screwdriver To replace a mains fuse 1 Choose File gt Shut Down E 40 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting Checking
469. ssage and follow the instructions in the Help text to this message If this does not solve the problem click Stop The Stop Actions dialog box is displayed a If you can continue processing orders select Sampling Stop b If you cannot continue processing orders select Stop Perform the Initialize System service action If this does not solve the problem perform a system shutdown and restart the system If this does not solve the problem contact Roche service To react to a message on page E 4 Re Starting and stopping a run on page B 37 Re initializing on page E 13 Shutting down the system on page B 35 Switching on the system on page B 31 Roche service on page D 47 Cuvettes must meet stringent optical specifications before they can be used on the instrument Defective cuvettes are discarded automatically gt System discards a large number of unused cuvettes Remove several cuvettes from the reservoir Check whether they are cloudy scratched or dirty If so empty the cuvette reservoir manually and refill with new cuvettes If this is unsuccessful open the analyzer cover and carefully remove some cuvettes from the cuvette buffer slide with tweezers If these cuvettes are scratched or dirty contact Roche Service Clot error after pipetting from sample cup Pressure sensors are fitted to detect clots during aspiration of samples during washing of probes or when initializing the sys
470. st anew measurement Attributes Priority 40 Group CAL DARK ERR Meaning Dark error The dark measurement taken for an FP test was higher than the test measurement Recommended action 1 Repeat the measurement 2 Ifthe flag reappears contact Roche Service Attributes Priority 2 Group CAL CNTL TEST EP UNSTAB Meaning Endpoint unstable The absorbance values near the endpoint show unacceptable fluctuation Recommended action CAL C 8 Operator s Manual Version 1 2 Cedex Bio HT 12 Result flags Flags and recommended actions 1 Repeat with fresh calibrators if only calibration is flagged 2 If flag is on controls and samples also or repeats on calibration replace cassette e CNTL 1 Ifonly one control is flagged repeat with fresh control 2 If flag on more than one control and sample replace cassette e TEST 1 Rerun diluted 2 Ifonly one sample repeat with fresh sample 3 If flag is on more than one sample or repeats replace cassette Attributes Priority 16 Group CAL CNTL TEST FP UNSTAB Meaning FP measurements unstable Recommended action Attributes HIGH ABS Meaning Recommended action Attributes The result from the parallel or perpendicular intensity measurement was inconsistent e CAL 1 Check the calibrator for air bubbles or foam and repeat the measurement 2 Ifthe flag reappears contact Roche Service e CNTL 1 Check control for bubbles and repeat measurement 2 Ifthe flag reappears contact Roche Se
471. st be in Sleeping or Standby mode e Use the New Control button to create a control definition manually e Controls loaded from Roche disks have IDs with the format 07 xxxx xx You cannot change this ID e Ifyou work with a barcode pen or handheld barcode scanner click Save after step 8 and then read the barcode with the pen or scanner amp To delete a control definition Click Configuration on the navigation bar Double click Controls in the Definitions group Click the ID tab Select a control from the list Click Delete Click Yes in the Confirm Delete dialog box oar WON B 182 Operator s Manual Version 1 2 Cedex Bio HT 11 Quality controls Setting up controls Tips If you decide not to delete a selected control after pressing the Delete key you can click No or Cancel in the Confirm Delete dialog box e You can press the Delete key instead of clicking Delete Preconditions e You have sufficient user access privileges The system is in Standby or Sleeping mode The rack containing the control is not on board The control is no longer assigned to a test You first need to assign a new control to the test or define that no control is required Configuration Tests Control Assigning a new control automatically deletes control results that were obtained on the basis of the previous control Assigning controls to tests When you have loaded a control definition it can be assigned to the
472. st classes are used in Result handling Profiles are not affected by these definitions You may not have the necessary user access level to create and modify test groups sequences and classes Ask your system manager for assistance To define and modify test groups sequence and classes click the Class Group button from the Configuration Test Definitions dialog box To create a new test group Click Class Group Click the Test Groups tab Click New Type a Group Name for the new group a AON Select tests to be included in the new group from the Installed Tests list Click Add to add them to the Tests in Group list 6 Click Save Tips e Group Name is up to nine alphanumeric characters and must be unique e Use Remove to remove a test from the Test in Group list and return it to the Installed Tests list To modify a test group Click Class Group Click the Test Groups tab 1 2 3 Select a Group Name from the Test Groups list 4 Use Add to move installed tests to the Tests in Group list 5 Use Remove to move Tests in Group tests to the Installed Tests list To modify a test sequence 1 Click Class Group 2 Click the Test Sequences tab 3 Select the Sequence in which test buttons in Orders are to be displayed 4 Click Save Operator s Manual Version 1 2 Cedex Bio HT 20 Configuration About the Definitions group Tips e Sequence can be arranged in alphabetical order by Test Class or you
473. stem updates the calibrator status of onboard calibrators only The Final Report lists order details and accepted test results for a single sample The header information of the Final Report is defined in Configuration Processing Report Layout To specify the reporting order for tests use Configuration Processing Report Layout and click Print Sequence System specific flags are not included in the report They would be of no use to the doctor gt To print a Final Report Click Status Orders Results or Configuration on the navigation bar 2 Choose File gt Print Report gt Final Report from the menu bar The Print Result Query dialog box is displayed Print Result Query x j From Order ID E C d Order Date wer Ra e 3 Type the values to define your selection Operator s Manual Version 1 2 B 53 6 Routine tasks Printing reports Printing the Final Report automatically Printing the Loadlist Cedex Bio HT If you do not provide any selection criteria all available results will be included in the report 4 Click Print to generate the report and print it Test specific ranges and limits shown on the report e Reference ranges are given in numbers e For quantitative tests results outside the defined reference range are presented the following way o H high stands for gt RR and gt Critical Range o L low stands for lt RR an
474. stem when you click Save Operator s Manual Version 1 2 20 Configuration About the Definitions group p p Cedex Bio HT e There are predefined Roche calculated results available for loading To load a Roche calculated result Click Load 2 Specify the path where the source files are located The default path is C Roche Instrument TAS 3 Perform the following steps for each calculated result e Click the ID tab e Modify the short name of the calculated result if required The short name can have up to eight alphanumeric characters Be aware that the short name affects the calculated result name in the user interface e Modify the long name of the calculated result if required The long name can have up to 30 alphanumeric characters e Click the Laboratory tab e Enter the correlation factor and the correlation offset if correlating two different methods e Enter the unit of the calculated result ratio and the factor and offset if the lab units are different from the specified units if required Enter the number of decimal places of the result e Click the Evaluation tab Enter a general range and critical range if required e Click Add and enter reference ranges To view and modify calculated result definitions Click the ID tab Choose a calculated result from the list Modify the Short Name Long Name or Calc Result No as required Select or clear the Common Cuvette box a
475. sts and orders temperature and resources Status xi File View Tools Window Help lealmxit Missing amp Blocked Samples Cassettes Test Status ISE Start System Supplies l SystemID CEDEXBIO HT Pe i Stop EUe INR 1 Cleaner Status Standby 1 H i 1 A 1 ae i 1 Tests Pending I 5 A Cuvettes B Samples NotonBoard 1 i i i 1 Tests Blocked o i Fi fl es Results to Validate 0 i a Water 1 1d H Without Orders 0 2 i 1 i E t 1 1 i a 1 Cuvette Waste 1 LD i oo 0o70 Temperature 1 1 i 1 cR E 1 Waste Drain Analyzer oc i i a 1 A han Cassettes oc ossa J Cleaner oc c admin 27 03 2012 18 19 A Shows the temperature of the analyzer cassette area and cleaner f the temperatures are not within the required limits the system stops B The icon on the Status button changes depending on the system status see System states on page A 42 and the resource status see Resource status on page B 42 C Check the resource icons The Cleaner icon shows the status of the cleaner fluid bottle The Cuvettes icon shows the status of the cuvettes reservoir The Water icon shows the status of the water supply The Cuvette Waste icon shows the status of the cuvette waste box The Waste Drain icon shows the status of the waste drain or reservoir The icons are color coded Red Take action im
476. sts fram the same pipetting and cuvette E Dilutions tab There are individual basic test files associated with each Multi Test E Control tab definition Example ISE tests E Laboratory tab E Evaluation tab H Test Groups Sequen What s this Configuration Profile C Information about specific iterns in this tab page H Configuration Calcula H Configuration Calibrat Configuration Control General H Configuration Cassett H Configuration Diluent H Configuration Cleaner Long Name ae Configuration ISE Soli D H Configuration Genera aa H Configuration Databa Test No H ConfigurationLab fl Test details Short Name A Menu bar contains the standard Windows Help menus Button bar contains buttons for the Help window The actual buttons displayed may be different to those shown here C Tabs in the navigation pane provide different ways of accessing Help topics See Finding information on page A 62 D Navigation pane click Help Topics in the button bar to show or hide this pane E Banner bar this part of the topic area remains static and visible when you scroll up and down the Help topic g Click an item to jump to a subsection of the topic G This part of the topic area contains the actual information of the topic A 58 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help Menu bar Banner bar Button bar Navigation aids Help window
477. suction assembly 10 Fill the external water reservoir with reagent grade type 1 water 11 Reinstall the external water reservoir and insert the tubing adapter 12 Pull out the tubing adapter F from the fluid waste reservoir Rest the adapter in a clean beaker to avoid contamination of the adapter and the work surfaces Do not disconnect the waste pipe or the level switch from the instrument G G D 34 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean external water reservoir and fluid waste reservoir 13 Empty the fluid waste reservoir according to your local requirements for the disposal of potentially hazardous waste 14 Pour 1000 mL of 0 6 sodium hypochlorite solution into the fluid waste reservoir and shake vigorously 15 Repeat steps 13 and 14 16 Clean the level switch H with a tissue moistened with ethyl alcohol 17 Reinstall the fluid waste reservoir and insert the tubing adapter 18 Click Finish Operator s Manual Version 1 2 D 35 14 Service actions Clean instrument Cedex Bio HT Clean instrument Overview Duration Interval Tools and materials Hazards Precautions Further information You must clean the instrument regularly to ensure that contaminants do not build up and affect the efficiency of the instrument as a measurement system e Check the waste area for contamination and clean if necessary e The surface of the initialization posts must
478. sues Protective gloves Ethyl alcohol The sample area analyzer module ISE module fluid waste cuvette waste and transfer head are potentially infectious Reagents can cause burns irritation and poisoning through skin contact Wear protective gloves Double click the service action in the Due All or Begin of Day tab Click Help in the dialog box For general information about performing a service action see Chapter 13 Service action software To clean the external water reservoir and the fluid waste reservoir 1 Select Clean external water reservoir fluid waste reservoir in the Service work area Click Perform The Service Actions dialog box is displayed follow the online instructions Pull out the tubing adapter A from the external water reservoir Rest the adapter in a clean beaker to avoid contamination Operator s Manual Version 1 2 D 33 14 Service actions Cedex Bio HT Clean external water reservoir and fluid waste reservoir Do not disconnect the suction pipe or the level switch from the instrument B 4 Empty the external water reservoir 5 Pour 1000 mL of 0 6 sodium hypochlorite solution into the external water reservoir and shake vigorously 6 Repeat steps 4 and 5 Rinse with reagent grade type 1 water four times 8 Clean the level switch C and suction pipe D with a tissue moistened with ethyl alcohol 9 Replace the liquid filter E on the external water reservoir
479. system service action 46 principles of operation ISE module 8 Print Help button 59 toolbar button 52 printer not working 35 Printers icon 22 printing automatic of Final Report 54 Begin of Day report 52 Final Report 53 Help topic 61 journal 56 list of messages 10 Loadlist 54 message log 10 messages 10 Missing amp Blocked report 55 QC reports 56 reports 52 results 55 results of single order 56 Results report 55 service counters 58 service intervals 58 service notes 58 system counters 59 test counters 59 Worklist 56 priority of flags 40 of sample measuring 10 probes 36 cleaning 24 clogged or dirty 51 deproteinizing 23 dripping 32 not clean 27 replacing 54 troubleshooting 49 problem reports creating 44 I 22 User Manual Version 2 7 Index INTEGRA 400 plus problem solving air bubbles 31 blocked orders and tests 19 calibration and QC requests 20 cassettes not available 20 computer power 18 connectors 35 Be station 35 hardware 24 instrument power 18 instrument remains inactive in Operating mode 18 ISE 23 49 laboratory power 18 leakages 30 module initialization 18 QC results 26 software messages 34 starting the system 18 test results 26 28 problems
480. t for example test results resource requirements or service actions performed Reports are automatically generated and printed on request Rerun Command to perform the same test with a concentrated or diluted sample either by decreasing the diluent or by increasing the sample volume Restore Command to reload data from an external storage medium to the data station hard disk See Backup Rotor See Analyzer Rotor Operator s Manual Version 1 2 6 Cedex Bio HT Sample Area The area on the instrument where sample racks and the ISE rack are located Sample Cup See Cup Sample Tube See Tube Scroll Bars Thin rectangles normally found along the right side and bottom of windows The bars have arrows at each end anda single rectangular box in them Clicking on the arrows moves the contents of the window in the same direction The box of the scroll bar can be moved with the mouse to provide the same effect as clicking on the arrows Service Action A service procedure that must be performed to keep the instrument running correctly Shutdown Command to switch off the software and instrument for longer breaks or if severe errors occur Sleeping Status while the system is in energy conservation mode Standard Deviation SD The square root of the average of the squares of the deviations from the mean Standby Status when the system does not perform any measurement activities but only a limited initialization pr
481. t es 0 30 0 13126 dA i 0 30 0 13189 dA 3 1 a ee a ee y 15 03 2012 12 59 aii Delete Help Print Rate Info The cassette and calibrator names and their respective lot numbers Recommended user actions based on the flags generated Calibration curve parameters according to the calibration mode A B c D Graph of the calibration Double click the graph to expand it Drag the cursor along the line to see rate values for each point m Calibrator standard for which values are listed Mean values for the selected calibrator Replicate values Select the appropriate check box B 152 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Buttons Validating calibration results Button name Function Delete Delete this calibration The calibration results will be lost Print Print details of this calibration Rate Info Display rate information for this calibration Rerun Rerun the calibration The existing calibration results are deleted Accept Accept this calibration The values from this calibration will be used from now on to calculate results for this test Help Display Help for this dialog box Close Close this dialog box Tv Use the arrow buttons to display values for a previous or following calibrator To review rate information for a calibration Click Results on the navigation bar Click the Calibration tab Select a test from the By Test list A
482. t positions on the ISE rack gt ISE solutions summary on page F 12 2 Ensure that all the bottle caps except for the Activator which has no cap are closed firmly Replace bottles on ISE module on page F 34 3 Check that the ISE calibrators and ISE Reference Electrolyte are in their correct positions Replace bottles on ISE module on page F 34 ISE Reference Electrolyte Bio HT The ISE Reference Electrolyte Bio HT is not a calibrator and it should not be used as such The ISE Reference Electrolyte is automatically used with the reference electrode and only the reference electrode to make the electrical circuit with the measuring electrodes Using the ISE Reference Electrolyte Bio HT as a calibrator or a sample will damage the electrodes 4 Create an order Create an order for ISE tests in the Orders work area in the same way as other tests are ordered ISE tests are multi tests in that all ordered ISE tests for one sample are performed simultaneously with one sample pipetting Creating an order on page B 95 5 Load samples Place your sample in any convenient position on a sample rack just as you would with any other test barcoded samples or use the Place Items dialog box Tools Place Items Loading samples on page B 38 6 Check results The results are displayed in the same way as any other results Working with results on page B 128 Operator s Manual Version 1
483. t takes too long for a calibrator segment to reach the electrodes because e The ISE module tubing is leaking or blocked e The ISE distribution block is leaking or blocked If only one result is flagged 1 Repeat the measurement 2 Ensure that the ISE Calibrators on the ISE module are available and check the level of liquid replace if necessary If the error message is displayed 1 Perform the service action Prime ISE calibrators 2 Check ISE module tubing and ISE distribution block for leaks or blockages 3 Contact Roche Service Solution 1 factor is not within the permissible range None Deviation of Sol 1 Factor This flag occurs with calibrations because The dosing from the sample probe is not accurate e The ISE tower is blocked e There may be problems with the ISE module tubing the electrodes or an improperly serviced ISE module Contaminated calibrator or bottle placed in wrong position If only one calibration is flagged 1 Repeat the calibration If successive calibrations are flagged 1 Check whether the calibrators are in the correct positions Perform the service action Activate electrodes Replace the ISE tower use the service action Clean ISE tower manually Perform the service action Prime ISE calibrators a AOON Check whether the electrode expiration date has passed Replace the expired electrode if necessary and perform the service action Electrode service Check the ISE module tub
484. t to change within a software release Please check the current Help for details In this chapter Chapter Introductio Meo aiarren V T VRE SEE VENA R VRE NRA A 54 Starting and closing online Help cesesssessessessessesseessessesssessesseesessessesessesssesseesees A 55 Help Wind Ow nenia ERAR E EENAA Finding Informati OD nn ARIER NIR IS SITES SRTR Context Heper En ER ca see tes eae oes seat eceecse esata Displaying context Help Context Help wit dow eieae eraan S eaa Eana Aaen EAA General Help sessscasnsdisssstsstesevesevetascsasshossactesoustavehasesssebens sedesoustssshaetsseetenss sebsustaashesadetedewstives Displaying general Helps siessccsisiescistuaciecstasseniiassaitaessaancieneaniiestiaisantaesseanesiele Message Help oxssisicect cotecssssivesosssscenctncenseatscateresttenestidetaanesvecutitesscansdetonseesscatidatn sivas System messages Controller messages Related TOPICS poisina a E E E E GISSA i T R V ES Operator s Manual Version 1 2 A 55 4 Online Help Introduction Introduction Types of online information Cedex Bio HT The Cedex Bio HT analyzer has a comprehensive Windows Help system that provides information to help you to Perform the most common tasks in your daily work Understand the content of each work area tab and dialog box as you are using them Perform tasks associated with running the instrument Perform service actions and other routine manual tasks using st
485. t tube type for the rack allows the use of cups on these tubes 5 Click Save Re insert the sample rack into the system B 100 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Caution What if An order with the same order ID already exists I can t find the test I need on the buttons I see predefined order IDs when I open the Samples tab Creating an order Tip When working with a host system you first insert the sample rack into the system and the host sends the orders You then follow the standard procedure To enable Cup on Tube while working without barcodes The procedure for enabling Cup on Tube is basically the same as when working with barcodes The difference is that you select the Cup on Tube check box on the Sample Handling dialog box rather than in the Tests amp Profiles group 1 Remove the sample rack from the system 2 On the Sample tab of the Orders work area create the sample order and if necessary select the tests 3 On the Sample Handling dialog box select the Cup on Tube check box and click OK 4 Re insert the sample rack into the system Re inserting the rack before having selected and saved Cup On Tube may lead to serious damage to the probes Order IDs must be unique so you have to specify an order ID that does not already exist However you can use the same order ID if the orders were made on separate days or if the order IDs have been purged Try sel
486. tate 1 State 2 Comments Power off Initializing Turn the power on by using the main switch e on the front of the instrument green Initializing This transition is automatic that is when the O 9 amp o gt 5 5 S D 5 D s S a 2 A o E lt a ml Q oO D oS icp os feb a o lt z 2 e 5 S g gt Q icp A D o lt a Ma 3 5 o Wes 3 a 3 Maes lt go i E F Q 5 lt S a T lt Operating green Standby E am gray n leeping blue Initializing green ervi Nn O D green Standby E gray Auto service green system has finished initializing it goes into Standby This takes a few minutes to complete This transition is automatic if Autostart is enabled Configuration General System Alternatively press F11 or click Start to start processing tests You can force the system into Standby by pressing F12 or clicking Stop Alternatively the system automatically goes into Standby either after a user specified period of inactivity or at a specific time You can force a system to go from Standby into Sleeping by pressing F12 or clicking Stop Alternatively the system automatically goes into Sleeping after user specified period The system automatically initializes when a rack is inserted or when it is time for the Begin of Day actions Alternatively you can
487. te Click Print Tip Select Final Report in Configuration Database Automatic Actions to print the Final Report automatically as soon as the last result of an order is accepted Printing the Final Report on page B 53 Operator s Manual Version 1 2 B 21 5 Daily workflow Daily routine with sample barcode and with host Cedex Bio HT Daily routine with sample barcode and with host Keep your system running Loading samples on board 2 p Start processing gt To load samples on board 1 Place the sample tubes and cups on the appropriate racks 2 Insert the rack into one of the slots in the sample area Tips e You can use only one tube type per rack e If you use tubes that are not defined on your system you may damage the probes e Before you move a rack wait until the status light above the rack is green gt Loading samples on page B 38 To start processing e Ifthe system is in Standby press F11 or click Start on the navigation bar e Ifthe system is in Sleeping press F11 or click Start on the navigation bar As soon as the system is in Standby press F11 again Tip If you work with Auto Start Configuration General System the system starts processing automatically as soon as you insert a rack provided there are orders that need to be processed Monitoring scheduled orders gt To identify blocked tests or samples that are not on board 1 Check the Validate
488. te arrow H on the rotor cover must correspond with the white arrow on the workstation cover 16 Restart the instrument at the main switch and wait until initialization is completed Operator s Manual Version 1 2 D 45 14 Service actions Prime the fluid system Cedex Bio HT Prime the fluid system Overview Duration Interval Tools and materials Hazards and precautions Further information gt This is an automatic service action that does not require manual intervention Priming flushes the fluid system with water to ensure the paths in the fluid system including pipettes tubing and probes are filled with fluid and are free of air bubbles If air bubbles are present in the fluid system your test results will be inaccurate Priming the fluid system is an automatic step in several service actions You can also prime the fluid system automatically as a Begin of Day action or at any time by selecting the action from the All tab in the Service work area 2 minutes Daily BOD action and if instrument is in Standby or Sleeping for more than 4 hours None None e Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software To prime the fluid system _ Select Prime fluid system in the Service work area Click Perform N The Service Actions dialo
489. te tab respectively in the Results work area e Press F1 to display Help for this tab lt gt For more information see Chapter 11 Quality controls B 94 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Creating an order Creating an order To run tests on samples you must create an order with a unique order ID The order specifies which tests are to be run and other optional information about the order and the sample You can create a new order or you can add tests to an existing order When you create an order manually you have to work through a series of substeps 1 Specify an order ID mandatory and demographics 2 Select tests for the order and save 3 Ifthere are no barcodes on the tubes and you work without a host system you must assign the samples to rack positions This can be done either automatically or manually See Assigning samples to racks on page B 96 These and other step by step procedures related to the Orders work area are described in this section Some procedures may differ depending on the lab setup you are working with The main criteria are whether or not you work with barcodes and whether or not you work with a host system The procedures describing the various steps of creating an order apply to working without barcodes and without host system unless otherwise indicated For information on the procedures when working with a specific lab setup see the Daily ro
490. ted results are displayed All All results are displayed Results that have been accepted are marked with an asterisk If you choose Unaccepted the filter icon Y is displayed on the tab label B 118 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Sample tab Sample tab Use the Sample tab to review result information of all orders on the system This z includes accepted and unaccepted results The functions on this tab are similar to those on the Validate tab Validate tab on page B 117 File Edit View Tools Window Help 7ai2 4leaX b Al zj Validate Y Sample Calibration Quality Contra A p Order Date Order ID E S 21 03 2012 Test Result Unit Flags Action Ref Range S E 15 03 2012 GLU 716g iL v B azo Gluc lt 0 20 g L lt TEST RNG S F11 476 02 KD gt 30 00 mmol L gt TEST RNG oy F11 476_03 LAC Soig ov E F11 476 04 NA D gt 250 0 mmol L gt TEST RNG oy F11 476_05 E F11 476_Al E F12 113_141HSu E F12 113_142HrFL oy F12 114_141HSu E F12 114_142HrFL E F12 115_141HSu E F12 116_141HSu S Gluc_check my 14 03 2012 ig 12 03 2012 fy 05 03 2012 I admin 27 03 2012 20 27 A Change the display in this column by clicking the column header B The Orders amp Samples list contains orders with unaccepted and accepted results C The Results list contains all results for the selected order Tips The Samples amp
491. ted when you click the Due tab The items that are not highlighted are almost due B Shows the time it takes to perform the service action C gt gt isa service action with user intervention gt is an automatic service action without user intervention D Shows whether the service action is almost due less then 100 due 100 or overdue more than 100 E Click Perform to perform the highlighted service action The dialog box that lists the instructions for performing the service action is displayed F Click Done if you do not intend to perform the service action but wish to reset the counters to zero The service action is removed from the Due tab Tips e Display the details for a particular service action by Double clicking the item in the list o Right clicking the item then choosing Detail e Choose View gt Notes to see a list of user actions and service actions that have been performed The paper clip indicates the presence of a Service note Service notes on page D 13 e Press F1 to display Help for this tab Operator s Manual Version 1 2 D 7 13 Service action software Cedex Bio HT All tab All tab The All tab lists all of the service actions It tells you how long the service action will lA take to perform whether it is partially or fully automatic and whether it is due Service Eile Edit View Tools Window Help ela alal N Begin of Day Beas Cle
492. teinize probes service action 23 deproteinizer See ISE solutions deproteinizing probes 23 Detail toolbar button 52 details displaying 80 messages 9 diagnostics remote 45 dialog boxes Calculated Results Definitions 13 Configuration Cassette Definitions 15 Configuration Cleaner Definitions 16 Configuration Diluent Definitions 16 Configuration General 20 Custom Query 123 Details 125 Find Orders 103 principle of 50 Sample Handling 99 Service Counters 15 Service Notes 13 Test Counters 18 View Message 6 DIL xii diluent definitions viewing 16 diluents blocked 69 contained on ISE rack 7 ISE tower 6 loading 40 position of 70 position on ISE rack 11 User Manual Version 2 7 Index INTEGRA 400 plus diluting in ISE measuring modes 4 dilution factor 107 dilutions automatic 112 requesting 107 when rerunning a result 129 dimensions of instrument 4 direct mode ISE 4 disabled ISE module 24 disabling ISE electrode 82 ISE module 82 tests 82 disk drives 73 disk space 66 displaying general Help window 67 item details 80 online Help 57 specific samples and orders 123 distribution block location 5 part ISE module 6 sage pipettes 21 replacing 61 replacing plunger tip 57 drag and drop 54 dripping
493. tem When a clot is detected a message is displayed The tube or cup indicated may contain clotted sample material There will be no further pipetting from this cup Make sure no clots are contained in the sample cup Depending on the kind of specimen centrifuging or filtering may solve the problem Operator s Manual Version 1 2 E 29 16 Troubleshooting Hardware Clotted transfer Cedex Bio HT No sample pipetting possible due to previous sample cup clot error Remove the clot physically from the sample Pressure sensors are fitted to detect clots during aspiration of samples during washing of probes or when initializing the system When a clot is detected a message is displayed Clot detection for the transfer arm Attempting to resume operation 1 Look for other messages which may indicate the source of the clot 2 Ifthe next wash operation succeeds the system will continue to operate normally Clot error after sample probe washing Pressure sensors are fitted to detect clots during aspiration of samples during washing of probes or when initializing the system When a clot is detected a message is displayed Extensive clots have been detected in a sample probe which could not be removed automatically The system will be stopped and some scheduled tests may need to be repeated Look for other messages which may indicate the source of the clot Wait until the system is in Standby Apply the cleaning procedure fo
494. tentially infectious material For additional information on hazardous substances refer to the instruction for use of respective reagent kit used on the relevant instrument System principle e Random and continuous access sample selective instrument e Integration of four measuring principles with capacity of up to 36 tests on board e Separate instrument and data station Measurement principles e Absorbance photometry Enzymes substrates chemicals e Fluorescence polarimetry Hormones special substances e Turbidimetry Specific proteins e Potentiometry Nat Kt CI Lit Throughput e Up to 400 tests per hour e Up to 260 tests per hour consolidated Urgent analyses STAT interrupt e STAT samples prioritized and performed immediately H 6 Operator s Manual Version 1 2 Cedex Bio HT 21 Appendix Samples Technical specifications e Sample tubes and cups e Sample volumes e Sample types e Sample loading capacity e Sample handling e Sample barcode Primary or secondary tubes 16 x 100 mm 13 x 100 mm 16 x 75 mm 13 x 75 mm Cups Eppendorf cup 1 5 mL Cup on tube Micro Cups 0 5 mL or Sample Cups 1 5 mL on Adapter Cups or on primary or secondary tubes 16 x 100 mm 16 x 75 mm Typically 2 10 pL per test ISE 20 uL indirect mode 97 uL direct mode Aqueous solutions free of solids Up to 90 samples on board Rack system for samples calibrators and controls Up to s
495. ter explains how to identify and interpret messages and suggests ways of reacting to these messages In this chapter Chapter 15 About imessages iA Ar araa AA A EAA ANE aN Messages button New Messages tab Message Log tab oaar E AA R A A A NAN E A N a Options 1 o PA EE EEEE E E E Working With messages siys istri resi rss S r REE EErEE EEE N S ERENS Confirming MESSAGES Es siussesscaseasssscnsscuscssstastossssnsees evsshesesopssunsecsstusssagsvecassbisenscssesustapent Displaying message details Printing MESSAGES os sc0ssnssceyeusssderesssisetassscesievesdceteessdestestdesbansddcetesnddestansadestanssdsebeosseves Putting the system into Standby isisisi iiras esnai aeii a eai Stopping and restarting the system s ssssssssssssssssssssssssssstesssssssssststtesssssssnnrsretteesessssss E 13 SUOP PFOCESSING siiin keni ai eioi aena a aaa iea a aian a iaia E 13 Shutting down the system errre aa E R EEE E EEE E 15 Operator s Manual Version 1 2 E 3 15 Messages About messages Cedex Bio HT About messages Messages button Messages inform you about errors or other events that have occurred on the system The icon displayed on the message dialog box reflects the severity of the problem Symbol Meaning i Information message Often a prompt to ask you if you really want to do lt 7 something Warning Alerts you to some condition or consequence but the system as a whole can keep running Some
496. th a cotton swab to remove any visible clots 10 Soak the ISE tower in ISE Deproteinizer for about 5 minutes Extend the soaking time to 30 minutes if there are any clots in the ISE tower 11 Rinse the ISE tower in deionized water and leave Operator s Manual Version 1 2 F 23 18 ISE service actions Cedex Bio HT Clean ISE tower manually to dry 12 Reinstall the ISE tower Ensure that all three sealing rings G between the ISE tower and the mounting are positioned correctly 13 Reinstall the tubing Ensure that the tubing is placed in the corresponding tubing guide 14 Reinstall the locking bolt and the overflow collector 15 Release the spring catch and slide the ISE module back until it clicks into place 16 Click next 17 Electrodes are activated twice with Activator automatic step 18 ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes 19 When all steps are complete click Finish in the Service work area Tips e You must connect the tubing to the ISE tower correctly otherwise it may be damaged during initialization e Ifyou replace one or more sealing rings you must ensure that the replacements are exactly the same type as the originals F 24 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Replace ISE module tubing Replace ISE module tubing Overview Duration Interval Begin
497. th a photomultiplier tube and take two seconds for each component e Assays are based on the competitive binding principle e The average throughput is up to 170 tests per hour The system contains two computer systems one the circuit boards in the instrument for controlling the automatic operations of the instrument the other the computer of the data station for processing data and managing the user interface The data station computer runs under Windows XP This system includes e Color monitor e Standard US keyboard e Mouse e 3 5 inch disk drive no longer included for data station model rp5800 DS and later e DVD drive R W e Two hard disks e 2 serial interfaces e Parallel printer port e Analog modem connector e LAN connector e USB Ports e 2ndLAN connector A 40 Operator s Manual Version 1 2 Cedex Bio HT 2 System description Functional systems l The 2nd LAN connector must only be used for Roche remote service connectivity If a remote service connection is established over an unsecure network via an AXEDA client the device must be installed behind either a Roche connect 2 device or a cobas link gateway The use of an AXEDA client is the only approved and supported remote service solution Other non intended usage of the LAN connectors could lead to unauthorized database access resulting in possible disclosure or modification of sensitive data Warning Processing data
498. th the calibrator G The Calibrator Test Summary lists all current requests for calibrations H Click Save to save the calibration request Tips e When you request a calibration for a test that has more than one cassette on board the Calibrate dialog box is displayed Select the cassette that you want to use To postpone a calibration right click the test that now requires a calibration and choose Postpone Calibration from the context menu e To review completed calibrations use the Calibration tab in the Results work area e To review flagged calibrations use the Validate tab in the Results work area e Press F1 to display Help for this tab lt gt For more information see Chapter 10 Calibration Operator s Manual Version 1 2 B 93 8 Orders Cedex Bio HT Quality Control tab Quality Control tab Use the Quality Control tab to create modify review or delete requests for quality Fi control measurements You can select individual tests or a profile containing several tests All pending controls whether requested manually or scheduled automatically by the system are listed Z A Eio Eat Tanie yanina Laky ja ela 7 B ACES Worklist Sample Calibration Quality Control r Tests amp Profiles r Control Test Summary Bae B Fact att rs aca zj Control Tube Position Lot fa AMM AB COBAS cup 1024 168078 Stop c Saer AMM N COBAS cup 102 3
499. th the instrument Query Command to find and display the entries in the work areas according to customized search criteria Rack Carrier holding containers used on specific systems Rack Number A number that identifies a particular rack This number is assigned when the rack is defined to the system Rack Status Display Consists of a set of lights that show the status of the racks The icon on each light indicates the type of rack The color and whether the light is flashing or steady indicates the rack status Random Access Analysis Ability to run analyses flexibly in any order as opposed to in batches Rate Absorbance difference between first and last measurement cycle A A or change in absorbance per minute AA min A Letter buttons Click to jump to the items beginning with this letter B Glossary term C Definition of the term Operator s Manual Version 1 2 A 71 4 Online Help Cedex Bio HT Glossary A 72 Operator s Manual Version 1 2 Operation Part B gives you a detailed description of the user interface and how you use it in your everyday tasks It provides sample daily workflows and step by step information about common procedures that you need to perform as part of your daily workflow It also provides information about results on samples calibrations and controls Cedex Bio HT 5 Daily workflow Table of contents Daily workflow Use the system efficiently This c
500. that keep the instrument running properly In some service actions all the steps are performed automatically others have some steps that you must perform manually If the button color is Do this Grey No action is required Yellow Perform the due service action as soon as possible Red Take immediate action As a first step back up the database immediately Then perform the due service action s gt To perform due service actions Check the Service button on the navigation bar If its background is yellow A 1 Click Service on the navigation bar 2 Select one or more service actions from the list 3 Click Perform 4 Perform the service actions according to the on screen instructions Click Help for full details Tip e Should you have chosen to not perform the Backup database service action automatically at BOD Service gt View Counters Service Intervals then if the Backup database service action is due perform it at the end of the day This service action may take about 5 minutes Database backup must be performed in regular intervals otherwise the accumulated data will fill all available space on the hard disk and the system will be blocked Caution Chapter 13 Service action software Chapter 14 Service actions B 50 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Checking the Memo Pad Checking the Memo Pad The Memo Pad may contain messages from other users
501. the Cedex Bio HT software Permissible Deviation The maximum acceptable deviation of the control results from the assigned value of the accuracy controls Photometry Analyzer Consists of workstations the rotor the Fluorescence Polarization FP Photometer and the Absorbance ABS Photometer Postaction Definable pipetting action that can be either dilution or concentration It is triggered by appearance of several flags e g gt test range antigen excess Postpone Calibration Overruling of a due calibration by the user All results of a test with a postponed calibration are flagged Power up The instrument is designed to be left switched on For maintenance or long breaks the system may have to be switched off shutdown and on power up again Precision Control Precision controls are run to detect random errors see also Accuracy Control Precontrol and Quality Control Precontrol Before a control material can be included as a precision control see Precision Control it should be tested along with the samples The results from the precontrol period the assigned mean and the standard deviation are used to automatically establish a precision control Primary Wavelength Main wavelength for signal detection in bichromatic ABS measurements See Absorbance Photometry Profile Set of tests frequently ordered in combination Purge Command to clear all completed orders and results from the work areas Quality Cont
502. the Delete Orders after box in Configuration Database Automatic Actions You can save results on the system for future reference You cannot reload archived results onto the system you can only review them To archive results Click Results on the navigation bar Choose File gt Archive The Archive Results dialog box is displayed Select the type of results to archive and optionally a date range Click Archive The Archive Result File dialog box is displayed Select the F disk drive and specify a folder file type and file name for the archive Click OK B 132 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Working with results Note This is not a backup facility Reviewing archived You can use the review facility to browse the archived results results gt To review archived results Click Results on the navigation bar 2 Choose File gt Review The Review File dialog box is displayed 3 Select the folder file type and filename from where the results should be read 4 Click OK The Review Results dialog box is displayed 5 Use Find to locate a specific test Click Close Operator s Manual Version 1 2 B 133 9 Results Cedex Bio HT Working with results B 134 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Calibration Working with calibrators and calibration results This chapter tells you how to load set up request and analyze results for
503. the Order ID box and press Enter Tip Type asterisk in the Order ID box and press Enter to use the lookup function The Lookup dialog box is displayed with a list of all order IDs stored on the system Specifying an order ID on page B 95 amp To select tests and save the order 1 Click the buttons for the required profiles and tests 2 Click STAT for a high priority order 3 Click Save B 12 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Daily routine without sample barcode and without host Tips The samples are automatically assigned to appropriate rack positions These positions can be modified if required on the Sample Handling dialog box which is displayed after the order is saved By default the sample type Automatic is displayed The Position boxes for rack number and position are disabled Change the test group in the Group box to limit or expand the display of test and profile buttons Select General to display all available test and profile buttons If you want Then do this To limit or expand the display Select the appropriate Group in the Test amp Profiles group of test and profile buttons in the Test amp Profiles group To delete a test from the Right click the test in the Test Summary group and choose Sample Calibration or QC Delete from the context menu Alternatively click the test tab button To request a dilution for a Right click th
504. the electrodes if necessary Perform the service action Electrode service Perform the service action Deproteinize probes Check ISE Reference Electrolyte tubing for leaks or blockages Check the floater of the ISE Reference Electrolyte bottle for leaks or blockages If the slopes of all electrodes are zero replace the reference electrode On OW F Ww Contact Roche Service The end of the fluid segment was not detected 14 3248 08 012 xxx The end of the sample segment was not detected It takes too long for a sample segment to reach the electrodes because e The ISE tower is clogged e The ISE module tubing is leaking or blocked Recommended actions If only one result is flagged 1 Repeat the measurement If the error message is displayed 1 Perform the service action Activate electrodes 2 Replace the ISE tower use the service action Clean ISE tower manually 3 Check the ISE module tubing for leaks or blockages 4 Replace the ISE module tubing if necessary Use the service action Replace ISE F 46 Operator s Manual Version 1 2 Cedex Bio HT 19 ISE flags and troubleshooting SEG ISECAL Meaning Message ID Possible cause Recommended actions SOL 1 F DEV Meaning Message ID Possible cause Recommended actions Flag descriptions module tubing 5 Contact Roche Service The end of the calibrator segment was not detected 14 3248 08 028 xxx The end of the calibrator segment was not detected I
505. tion about performing a service action see Chapter 13 Service action software To replace probe B or C Select Replace probe B or C in the Service work area Click Perform The Service Actions dialog box is displayed follow the online instructions The transfer head is positioned in the sample area automatic step Open the main front cover A to access the probes D 54 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace probe B or C 5 Remove the transfer head cover B AL yi eS 6 Disconnect the probe tubing from the transfer head fluid distributor C 7 Remove the probe and sample loop holder a Press and hold down the button D b Push the probe upwards E until it disengages from the housing 8 Disassemble the probe and sample loop structure a Push the sample loop off the bracket F b Unscrew the probe G D 55 Operator s Manual Version 1 2 14 Service actions Cedex Bio HT Replace probe B or C c Lift the probe out of the bracket 9 Reassemble the structure using a new probe and sample loop Make sure to hold the screw thread of the probe in line with the probe holder to avoid damaging the screw thread 10 Install the new probe and sample loop on the transfer head 11 Reinstall the transfer head cover 12 Click Next 13 The transfer
506. tion and See above bottle label ISE Reference Electrolyte Red x ISE Calibrator Direct Gray y ISE Calibrator Indirect Blue Zz Operator s Manual Version 1 2 F 35 18 ISE service actions Cedex Bio HT Replace ISE tower Replace ISE tower Overview This is a general procedure not a service action The ISE module cannot operate if the ISE tower is blocked Flags or messages will be generated if you need to clean or replace the ISE tower You can replace the ISE tower if cleaning it manually does not have the required effect gt To replace the ISE tower 1 Perform the service action Clean ISE tower manually 2 Exchange the existing ISE tower with a replacement at the appropriate step F 36 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions ISE Performance Check ISE Performance Check Overview Duration Interval Begin of Day System state Tools and materials Hazards and precautions gt This is a general procedure not a service action This procedure needs to be performed on request for ISE troubleshooting It checks the performance of each electrode by measuring 10 times ISE Calibrator Direct and ISE Calibrator Indirect respectively 10 minutes None No Standby e ISE Calibrator Direct Bio HT e ISE Calibrator Indirect Bio HT ISE Reference Electrolyte Bio HT See General safety precautions on page F 16 To check the ISE performance Select ISE Performan
507. tion on the manual dilution factor e Roche recommends not to use manual dilution for ISE tests The test range of all ISE tests direct and indirect covers all physiological ranges and therefore there is no need to measure electrolytes from off line diluted samples e The sample is run using an automatic dilution factor if the result flag demands it This depends on the configuration of your system and overrides any dilution that you have requested For some tests dilution by the system is not allowed In these cases Roche has set Automatic Dilutions to Disabled in Configuration Test Dilutions You cannot change this setting You can set Automatic Dilutions to Off in Configuration Test Dilutions and then specify a Specific Factor e Define dilution factors for a test in Configuration Tests Dilutions Deleting tests You can delete tests from an order or you can delete the whole order amp To delete atest F 1 Click Orders on the navigation bar HE 2 Click the Sample tab B 108 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Working with Orders 3 Type the order ID in the ID box and press Tab 4 Inthe Sample Test Summary group right click the test to be deleted and choose Delete from the context menu 5 Click Save Tips e Ifthe order has not yet been saved click Clear to remove all tests e You cannot delete finished tests with results that have not been accepted yet Purging and
508. tions ceessessessessesesesseseeseeseeseescsesucescsscsucsesseaeeaeeneeneeneess H 5 Water requirements ezsivsccesctysccisteeceedcieansesstetacidetvencetetpuecctstvenesistrccssaredesteceveredseupuentesties H 5 Plumbing requirements isiscscsssisccnsscsscvecnsscsotessnesesoessenvoedsavenesesssusesapevesnssnesensssverusstasens H 5 Waste Handling siorse aose EE EE ER EE REES E SE Eal H 6 System Princ plen ar a E E E RRE H 6 Measuremient principles sess scssssssssisesscssassoscocsyesveesapssssssapecnssespiooeusbecudeaepestssapesnasivves H 6 Through putes siiis eia ahaaa ei eaa H 6 Urgent analyses STAT interr pt iniisiseisisirisosiseisssisnieoniserisiiceiiseeiiasiceni reias H 6 Samples issii A A H 7 Calibration enikankan ia aE RE AE EREEREER hn H 7 Reagent Cassettes seene pia E a E E E E E R E E E icees te H 8 CUVETTES rio iiao E S R A R KER EREE R A E RRR E amen aes H 8 Photometry analyzer euss esrara R R ERER ERR H 8 Absorbancemod l sysrrs an an EE S EE E eased H 8 FP photometer bis ya a sii sas ISE module siiceccneencantvietn ce acacia neater Pipetting Systems seoesssscsiesevececccesestecevectetaeccateee stares ee ety aac oe ees Software and data handling Safetyapprovals ic 62 2 0 25 GN A RL ad Fluidisystenischematic c c2 cidiinndnindc Ganka E a E Menu StrUctUte nsostni eeren roren easar iEn ia ier E NR oS iR Eies N esT Operator s Manual Version 1 2 21 Appendix Technical specifications Tech
509. tions 14 at Begin of Day 13 due 50 5 ISE 10 ISE See also ISE service actions nearly due 5 performing 11 safety 5 6 states 14 status 14 Service button color 50 red 5 yellow 5 service counters printing 58 Service Counters dialog box 15 service intervals printing 58 service notes printing 58 Service Notes dialog box 13 I 26 User Manual Version 2 7 Index INTEGRA 400 plus Service work area 6 All tab 8 Begin of Day tab 9 Due tab 7 menu structure 15 sessions remote diagnostics 46 shortcut keys 13 to access work areas 49 Windows 53 shutting down system 35 13 Sleeping system state 44 slopes out of range ISE 50 software specifications 10 software messages reacting to 34 SOL 1 F DEV flag 47 solids in samples xv solution 1 2 and 3 See ISE solutions solutions replacing ISE 32 34 ISE on the module 6 Sounds icon 22 Sounds Like function 104 specifications pipetting system 9 technical 4 spiral feeder 26 splash guard 37 cleaning 24 Spline calibration mode 137 Standby ISE mode 10 putting system into 11 system state 44 start arun 37 instrument 32 online Help 57 processing 14 19 22 system 12 Start button 42 48 37 startup daily 8 STAT xii 10 STAT
510. tions are context sensitive that is certain options are only available in certain a situations Therefore some of the options displayed on the following figures may not be available on your system For reasons of readability the attempt was made to show as many options in active state as possible Status menus Ele Vew Tools Window Help Print Report gt Demographics gt mun Messages Shift F5 General Help Print Preview Detail F2 v Status F5 Status Print Fg Test Counters Orders Fe Ss About Archive Results Purge Orders Results F7 Review Results Purge Results Service F8 SS Retransmit All Data Configuration Shift F8 Shut Down Alt F4 Execute Begin Of Day MemoPad Shift F7 Export Raw Data Load TAS Diskette Log on off Shift F3 Worklist Refresh All Loadlist Place Items Results Test Calibrations Missing amp Blocked Begin of Day Order Final Report Orders menus Ele Edt View Toole Window Heb Print Report gt Find F3 Demographics gt J rete Messages Shift F5 General Help oe Preview s Copy Ctrl C Sample Handing Test Counters a Bees Eint Paste Ctrl V Multiple Tests v tanh 3 About Archive Results Paste Multiple Dilutions Purge Orders gesus Review Results Purge Results Service Fe ane a Clear Retransmit All Data Configuration Shift F8 Rown i Delete Execute Begin Of Day Memo Pad _ ShilteF Reset Export Raw Data Save Load TAS Diskette
511. tions such as o Adjusting the display font size Defining whether the Help window should always remain visible on your screen o Printing the contents of the topic Choose Options gt Display History Window to display a window that contains the topic titles of the topics you previously visited Double click a title to redisplay the topic Operator s Manual Version 1 2 A 61 4 Online Help Cedex Bio HT Finding information Finding information Use the tabs in the navigation pane to access Help information in the way that suits you best In addition you can click buttons in the button bar to find related topics and to browse through topics The following sections describe these various methods Contents tab The Contents tab displays the Help contents in a directory tree Click H to open a book and display its content click H to close the book Click an entry to display the content of the topic in the topic area w Toc Index Search Ej How to Flags Ej Troubleshooting and messages EQ Service About service actions B About service actions 2 Performing a service action Service action states Adding service notes and use B Counters and timers Ej Service actions E About ISE service actions nj ISE service actions Managing data Ej Software reference information Messages a Online books Ej Glossary 4 E Index tab The Index tab displays the index en
512. tly In this chapter Chapter EI Operator s Manual Version 1 2 A first look atthe user interface cssccenetsleees aaah ends dance aay A 46 Work AP CAS rinira hii lat eet iat iat aa E seit aa Gast A 47 Working with the tser intertace scistssccscsssvsvcisrscevcbssossvensoneorussussevetiganses ornesvesiavawcssaenvsdeets A 49 Tapssanid techni Ques sszcescicasaasviet vende dssseiud sa E a voted RN A 51 A 47 3 User interface Cedex Bio HT A first look at the user interface A first look at the user interface When you have logged on the Status work area is displayed Logging onto the system on page B 33 The following picture shows the main features of a work area A B M File View Tools window Help H c HEERS D Missing amp Blocked Samples Cassettes TestStatus Analyzer ISE a l Pessettes Samples a m Empty Blocked o E E B Not on Board Co ear QC Cleaners Diluents ISE 4 iy Expired iy Blocked By Not on Board Oy Q 1 oe Printthe seen ADIN T 1354 E F G A Menu bar Click any item to display the corresponding menu B Work area name Name of the current work area C Toolbar Click a button to run the corresponding command D Tab name Change the tab displayed by clicking another tab for example Cassettes E Status bar Short text for messages and expanded tooltips are displayed here F U
513. to confirm Switch off the computer Switch off the instrument at the main switch Wait for the power down to complete on oo oO Open the controller rack cover and using a small screwdriver turn the fuse holder counter clockwise 9 Replace the failed fuse with a fuse of the same type 10 Re insert the fuse 11 Switch on the instrument at the main switch 12 Switch on the computer 13 If the problem occurs again contact Roche Service E 43 Operator s Manual Version 1 2 16 Troubleshooting Cedex Bio HT Contacting Roche Service Contacting Roche Service Roche Service can help you solve many problems that you are unable to solve for yourself However before you contact Roche Service 1 Check this chapter to see if your particular problem is described If it is follow the recommended procedures 2 Search the online Help for the information you require You can perform a full text search to help you find this information 3 Ifthis fails contact your system supervisor for further advice 4 Ifyou still cannot solve the problem make a note of any special conditions that you think might be relevant 5 Create a problem report See Creating a problem report on page E 44 6 Contact Roche Service In the first instance contact the Roche remote diagnostics support service This service allows a Roche service engineer to log on and control the system remotely See Remote diagnostics on page E 4
514. to the host computer E 38 Operator s Manual Version 1 2 Cedex Bio HT 16 Troubleshooting External connectors Modem connection Check that the modem on the computer Line is not connected to the telephone socket Do not use this connection for remote diagnostics 2nd LAN connection This port can be used for remote diagnostics I The 2nd LAN connector must only be used for Roche remote service connectivity If a remote service connection is established over an unsecure network via an AXEDA client the device must be installed behind either a Roche connect 2 device or a cobas link gateway The use of an AXEDA client is the only approved and supported remote service solution Other non intended usage of the LAN connectors could lead to unauthorized database access resulting in possible disclosure or modification of sensitive data Warning Monitor connections Check that the connection from the 15 pin VGA connector on the computer is made to the monitor e Check that the monitor power cable is plugged in at both ends Printer connections Check that the printer cable is connected from the LPT1 25 pin connector on optional the computer to the Centronics type connector on the printer itself e Check that the printer power cable is properly connected at both ends Barcode pen connections Check that the keyboard cable is connected to the female plug of the barcode pen optional Check t
515. tomatic step ISE Deproteinizer is pipetted into the ISE tower automatic step The pipetted ISE Deproteinizer is drawn through the tubing automatic step On oO a Fw Steps 6 and 7 are repeated three times 9 The ISE tower and tubing are rinsed with system water automatic step 10 ISE module tubing is conditioned twice with Activator automatic step 11 Electrodes are rinsed with ISE Calibrator Direct automatic step 12 Electrodes are activated twice with Activator automatic step 13 ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes Operator s Manual Version 1 2 F 21 18 ISE service actions Cedex Bio HT Clean ISE tower manually Clean ISE tower manually Overview You must clean the ISE tower manually to ensure the proper functioning of the ISE module The tower must be exchanged if it is blocked Duration 6 minutes Interval Every 30 days Begin of Day No System state Standby Tools and materials Activator e ISE Calibrator Direct Bio HT e ISE Deproteinizer Bio HT ISE Reference Electrolyte Bio HT e Cotton swab e Deionized water e Protective gloves e Small glass beaker Hazards The ISE module including the tower fluid waste tubing and electrodes is potentially infectious e Sample material is potentially infectious e There is a danger of cauterization and poisoning through skin contact with the reagents Precaution
516. tomatically assign samples to rack positions Then use the Sample Handling dialog box to confirm the position or change it You can also use the Place Items function to manually assign samples to rack positions Q Use only tube and cup types that are defined on your system in Configuration Lab Sample Tubes To load samples 1 Load the samples in primary tubes secondary tubes A or in cups B on adapters C B c i The tubes may have barcodes D i s G o gt vime en cal 2 Place the sample tubes or cups into the rack E Ensure that barcodes if used face to the right when you insert the rack and that the grid level corresponds with that defined for the tube type Configuration Lab Racks B 38 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks 3 4 5 6 7 8 Handling test materials Open the rack area access panel F Insert the rack into one of the five slots labeled J K L M or N in the sample area Push the rack a short way about 2 cm into the slot until you feel the resistance of the stop pin Look at the rack status panel above the slot you are inserting the rack into When the LED changes from red to green push the rack all the way into the slot Rack status panel LEDs Red Rack in use do not remove Red blinking Rack cannot be identified Orange blinking Rack has not been properly inserted
517. tor s Manual Version 1 2 Configuration Part G describes the Configuration work area and gives step by step procedures for some common configuration tasks You must have the required user access level to perform these tasks Cedex Bio HT 20 Configuration Configuration Modifying your system configuration This chapter provides an overview of common configuration procedures for the Cedex Bio HT analyzer In this chapter Chapter EJ Configuration OVeTViEW giie aa e E AE E EAR G 4 About the Definitions gropion eii E E E EO G 6 Aboutitest definitions arora ae ETORO G 7 Loading and modifying test definitions ssssssssssssssssssssssssssssssssssssrsetteeessssssreeeee G 7 Creating and modifying test groups sequences and Classes 0 G 10 About profile definitions ceeesseessesesseessessessesssesesssessessnsssessessssssssessesseesess G 12 Creating and modifying profile definitions sesseesesseessessesseessesseesesseesees G 12 About Calculated Result definitions eeessesssesesssessesstessessesstesesseesessesseess G 13 Creating and modifying calculated result definitions ee eeeseeseeseeeeeeeeee G 14 About calibrator and control definitions ssessssssssssssssssssssssssesssssssrsesresesssssssssesee G 16 About Cassette definitions sescscsscvessssseissssssevsssssssvessassesnssnoctsstssaresstosssenescsossestuseveostsns G 16 Viewing and modifying cassette definitions eessesesseesessesseesesseesesseeseess
518. tries each topic may have multiple entries gt To find a topic with the help of the index Click the Index tab 2 Inthe text box A type the first few characters of a keyword you associate with the information you are looking for 3 Select an item from the list B to display the topic in the topic area If there is more than one topic for this item a list is displayed Select one topic from the list C to display it in the topic area A 62 Operator s Manual Version 1 2 Cedex Bio HT 4 Online Help Search tab A Tip buttons See also A Iso gt E Related topics St Q Contents Index E Search Initialize ISE service action 2 button bar on Help windows a buttons Back Close Glossary Help Topics Messages next topic on Help windows preceding topic Print cflag cables detached or damage CALC ERROR flag Calculated Result Definitions dialo Evaluation tab Formula tab i ID tah Z Display Finding information To select all existing text in the box click and then right click in the box A and choose Select All from the context menu The Search function lists all occurrences of a particular word This is useful if you do not know the topic heading or if your Index search was not successful The first time you use the search facility the system has to build the word list Follow the online instructions to create the list and then type the word on which
519. trol or sample type E Control name With quality control orders the control name is displayed F Calibrator name With calibration orders the calibrator name is displayed The Orders list may contain the following folders and information Folder Contents Blocked Orders with at least one test with the Blocked status Not On Board Orders for which there are still tests to be performed and for which the sample is not on board the system Without Orders Samples without orders Calculated Orders with calculated results New Orders with tests that still need to be performed Running Orders with tests that are currently being performed Tips e Only folders that contain entries are displayed in the Orders list e STAT orders are displayed in bold print e To follow the logical job sequence work through the entries in the list from top to bottom B 90 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Sample tab Sample tab Use the Sample tab to create modify review or delete an order for tests You can Fi select individual tests or a profile containing several tests kx File Edit View Tools Window Help CYA PAETE ERY Worklist Sample Calibration Quality Contral gna PTT SS SS SSS SSS SS SSS TTS SESS STS SST SSS SSS STIS TS SST SS TSS ST SSS est tss v i A i Order jio 5 z Comment a r Stop eae na nanan eee eee nena nea een new ac nanan nanan ena aaa aa a
520. ts Definitions dialog box 13 Calculator toolbar button 52 calibration intervals ISE module 9 Calibration tab Orders work area 93 Results work area 120 Calibration work area 135 User Manual Version 2 7 Index INTEGRA 400 plus calibrations blocked 19 checking when due 140 curve parameters 136 due date 74 flags 3 history 120 151 intervals 156 ISE module 9 linear 136 main ISE 9 modes 136 137 modifying details 8 multi calibrator set 137 non linear 136 one point ISE 9 overview 11 performing 136 points 136 postponing 147 rate information 153 requesting 145 results 149 reviewing details 152 specifications 7 tasks by work area and tab 138 tasks in the Configuration work area 139 validating 136 149 calibrator direct See ISE solutions calibrator indirect See ISE solutions calibrators 135 blocked 140 definitions 15 definitions missing 140 deleting definitions 159 empty 140 expired 140 ISE calibrator direct See ISE solutions ISE calibrator indirect See ISE solutions ISE module 5 ISE solutions replacing 34 ISE priming 20 loading 11 40 143 loading definitions 158 lot number 136 missing 142 not on board 140 position of 70 problems with 140 reviewing status 140 setting up
521. ts on the right side of the tab e Double click any item in either of the lists to display more details for that item e Right click an order and choose Demographics gt Order to display the order demographics for the selected order The reference range for the test is shown by the parentheses The asterisk shows the position of the result compared with the reference range Graphic Meaning _ Result less than the reference range lt Result much less than reference range Result inside the reference range gt Result much greater than reference range Result greater than the reference range e Press F1 to display Help for this tab To display Help on a blocked test select the test on the Results Detail dialog box and press F1 Factors affecting the information you see here The information displayed depends on how your system has been set up The settings in Configuration Results Handling determine which results are automatically accepted and which must be manually validated here Typically results without flags are accepted automatically orders are listed only if they contain one or more flagged result Accepted orders are displayed in the Sample tab The units displayed depend on the lab units defined for your system in Configuration Tests Laboratory e There are two options in the filter list on the toolbar Unaccepted Only unaccep
522. ttes on the rack 7 Re insert the rack into the cassette area Checking resources The background color of the Status button tells you whether you need to take action or not Button Background color Take action Red Fatal error Immediately Yellow Soon when convenient Green or gray None The icon on the Status button also changes depending on the resource status For example if cuvettes are running low you see the cuvette icon on a yellow background Status Resource User action Button 3 Cleaner Replace cleaner eS Cuvettes Add cuvettes to cuvette reservoir Water Check water supply connections If supplied from an external reservoir check the level Cuvette Waste Empty the cuvette waste reservoir Waste Drain If waste is put into an external reservoir check the level Temperature Check all ventilation filters and passages Check the fuses m ISE Solutions Check the ISE tab in the Status work area UL for more information Tip You can check all system resources on the Analyzer tab of the Status work area Checking resources on page B 42 B 10 Operator s Manual Version 1 2 Cedex Bio HT 5 Daily workflow Daily start up Performing service actions Caution gt To perform service actions 1 a AON Tip Check the printed Begin of Day report for service actions that need to be performed Prepare all required tools and materials Click
523. ual Version 1 2 1 System overview Cedex Bio HT Basic principles Basic principles This section provides a quick introduction to some of the key features of the instrument and how you use it Sample handling Samples can be placed in 5 5 5 7 7 5 or 10 mL primary tubes Cups and Cup on Tube can be used for smaller volumes of rare samples Figure 0 7 Sample rack Sample racks allow continuous access to samples as tests are completed and new samples arrive Samples can be barcoded to allow the positive identification of samples by the system You can add or remove the racks as necessary When you insert a rack the sample barcodes are read automatically The samples on the left most rack rack in slot with lowest position letter are measured first followed by those on the rack next to it on the right STATs are automatically given priority to speed up the delivery of results while the routine workflow remains uninterrupted Cassettes and reagents All tests use the same reagent cassette design A large number of reagent cassettes specifically tailored to the Cedex Bio HT systems are available in an easy to use easy to store design Figure 0 8 Cassette rack A 10 Operator s Manual Version 1 2 Cedex Bio HT 1 System overview Basic principles You put cassettes onto a cassette rack which you can load or remove while the system is running Cassette labels are barcoded for fast accurate and secure entry of reag
524. ual Version 1 2 B 81 7 Status Cedex Bio HT Selected tasks Selected tasks To review the status of tests on the system Click Status on the navigation bar Click the Test Status tab Folders such as Blocked and Disabled are displayed Click the test l A OON The information for the selected test is displayed on the right Tip You can display detailed information on the selected test by double clicking an entry in the Cassettes Calibrators controls or Diluents group This displays the detail box for the item selected gt To enable or disable a test Click Status on the navigation bar 2 Click the Test Status tab 3 Click the test The information for the selected test is displayed on the right 4 Select or clear the Enable Test check box to disable the test Tip You cannot process a sample using a disabled test You can however run calibrations and quality controls even if the test is disabled gt To enable or disable the ISE module 1 Click Status on the navigation bar 2 Click the ISE tab 3 Select or clear the Enable ISE Module check box Tip If you disable the ISE module you must still place bottles of deproteinizer and activator on the ISE rack You can use the other positions for diluents gt To enable or disable ISE electrodes 1 Click Status on the navigation bar 2 Click the ISE tab 3 Select or clear the check box to the right of each electrode to enable or disable it gt To re
525. uch as editing and validating The Worklist tab provides maximum support to users who work without barcodes and who are not connected to a host system The tab is divided into two horizontally adjustable areas The area on the left the Orders list contains the folder view of the sample calibration and control orders The area on the right the samples and tests list displays detailed information on the item that is selected in the Orders list Eil Fie Edit view Tools Window Help CACACE Worklist Sampie Calibration Quality Control men E S Not on Board 1 Position Order ID 1 Sample Ep Sample Manual Dilution Factor a Calculated 21 Cup on Tube a Stop S F11476_01 Sample Test Online Dilution Status Blocked Status Text oy F11 476_02 Sample S F11 476_03 Sample an a i Oy F11 476_04 Sample ko New S F11 476_06 Sample HS New B F11 476_Al Sample LDH Naw S F12 113 Sample Oy F12 113 Flask Sample Oy F12 113_141HSu Sample Fi Gij F12 113_142HrFL Sample oy F12 114 Sample oy F12 114 flask Sample E E F12 114_141HSu Sample E E F12 114_142HFL Sample eh oy F12 115 Sample Oy F12 115_141HSu Sample 1D iy F12 116 Sample i 4 E F12 116_141HSu Sample Fresh Media Sample E Gluc_check Sample E E SAMPLE a DUU Sample _ admin 27 03 2012 19 12 Orders list see section below Adjust the width of the Order list to display all information Click Find to
526. uid 21 with air bubbles or foam 27 with Fibrin clots 27 without orders 69 77 Samples tab color coding 71 Status work area 70 sampling stopping 37 re starting 37 Save toolbar button 52 scanner for barcodes 35 scroll bars 51 sealing rings 24 search criteria 102 Search tab on Help windows 63 searching orders 102 samples 102 topics in Help 62 secondary tubes 38 See also Help button 59 70 SEG FLUID flag 46 SEG ISECAL flag 47 INTEGRA 400 plus selecting specific samples and orders 123 serial communication instrument 38 serial number of instrument 76 Service system state 44 service action See also ISE service actions Backup database 48 Clean and lubricate the rotor 43 Clean external water reservoir and fluid waste reservoir 33 Clean instrument 36 Clean internal water reservoir 27 Clean probes and splash guard 24 Clean the waste box fitting 42 Clean wash station 30 Deproteinize probes 23 Prime the fluid system 46 Replace Abs halogen lamp 51 Replace dosage pipette B or C 61 Replace external water reservoir filter 64 Replace plunger tip dosage pipette B or C 57 Replace probe B or C 54 Replace ventilation filters 49 Roche service 47 service action software 3 service actions 21 about 5 adding notes 14 adding user ac
527. ulated Results icon in the Definitions group Creating and modifying calculated result definitions You can create and modify calculated result definitions using the different tabs in the dialog box To create a calculated result definition Click the ID tab Click New 3 Type in the Short Name Long Name and the Calc Result No These definitions are mandatory 4 Select the Common Cuvette box This is necessary to make sure that the calculated result is correct For example when using predilution it is necessary that all tests required for a calculated result are prediluted from the same cuvette The Common Cuvette feature is currently required for HbA1cWB only The Common Cuvette box is selected by default 5 Define formula calculated result unit and reference ranges for the new calculated result definition as required 6 Click Save Tips e Short Name consists of up to eight alphanumeric characters e Long Name consists of up to 30 alphanumeric characters e The calculated result number is in the range of 1 through 999 and is unique for tests profiles and calculated results e Calculated result numbers 910 930 are for customer defined calculated results e When creating formulas up to four tests A D and up to four factors w z can be defined e You can use the standard mathematical operations and as well as the brackets and The syntax is checked by the sy
528. uld also have the following additional information available Item Lot number Cassette Calibrator Control Diluent You may also need the following O The last calibration and control results O A printout of the cassette status O A printout of the raw data of the specific test s E 46 Operator s Manual Version 1 2 ISE measurements Part F describes the operational principles of the ISE module and how to use it It shows you step by step how to perform ISE service actions routine maintenance procedures and other related procedures The troubleshooting section suggests user actions to solve problems with ISE measurements Cedex Bio HT 17 ISE module ISE module An overview of the ISE module This chapter provides a description and general overview of the Cedex Bio HT ISE module It describes the main components of the ISE module and how it operates It also describes in general terms how to make ISE measurements and is supported by an ISE solutions summary In this chapter Chapter 17 OVE EW rris r ii t t eE KATETE AEREE REE Measuring Modes sincciatscessteis cksecasststanssstatucevccsvesnustadevesse bcextavssvesnernnrsenscssesuustedeiaraes Parts of the ISE mod le zsruri neie se iE EEKE e ISE racki E ea ee ee ee ee How the ISE module works Principles Of Operation siiri a A E VE R R Calibrations siei e ES EEEE E A E SE ARENE STAT orders Electrode service TSE Stai
529. ull out the sample area ventilation filter housing D and replace the filter E 8 Reinstall the filter housing 9 Reinstall the left bottom panel 10 Click Finish Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Replace Abs halogen lamp Replace Abs halogen lamp Overview Duration Interval Tools and materials Hazards Precautions Further information The absorbance photometer uses a halogen lamp as its light source It is essential that this lamp maintains a constant intensity in successive absorbance measurements You must replace the lamp according to the service action schedule 26 minutes After 800 hours in Running or Standby e Paper tissues e Absorbance photometer halogen lamp The lamp and surrounding components may be hot e Do not touch the bulb surface This reduces the life of the bulb and may affect the consistency of measurements made with the absorbance photometer e Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software To replace the absorbance halogen lamp Select Replace Abs halogen lamp in the Service work area 2 Click Perform The Service Actions dialog box is displayed follow the online instructions 3 The absorbance halogen lamp is switched off automatic step Wait 2 3 minutes for the lamp to c
530. ults the following information is deleted Results Calculated results that were derived from purgeable results Test orders Order IDs To make sure that the relevant calibration results are always available while processing orders as long as the cassette is not empty the following calibration results are kept when purging calibration results The most recent calibration result for each test even if it falls within the specified date range Additional results are kept depending on the calibration interval o Ifcalibration is due with each new cassette a calibration result is kept for each started cassette o Ifcalibration is due when a new lot is started one calibration result is kept for all cassettes of that lot To purge results 1 2 3 4 Choose Tools gt Purge Results on any work area The Purge Results dialog box is displayed x Caution The system must be in Standby or Sleeping Do not add or remove racks during the operation m Purge Results M Calibration M Quality Control M Samples To 19 04 2012 Select or clear the Calibration Quality Control and Samples check box to choose the kind of test results you want do delete In the To box type the date up to which you want to delete the results All results older than that date will be deleted Click Purge A status window is displayed while the results are being purged The purging action may take quite some tim
531. upply unit When the instrument is module switched off at the main switch this standby power supply continues feeding the ISE module to perform continuous maintenance This is necessary to prevent damage to the electrodes and the build up of blockages in the tubing ISE Standby on page F 10 Do not switch off the ISE standby power supply If for some special reason you need to switch off this power supply make sure you use the Roche Diagnostic software and perform this task under the guidance of Roche Service Caution personnel only A On Off switch for the ISE standby power supply unit left side of the instrument B 36 Operator s Manual Version 1 2 Cedex Bio HT 6 Routine tasks Re Starting and stopping a run Re Starting and stopping a run Start Start Stop Stop a gt The Start button serves to start or restart a run When the system is in the Stopped AutoService or Operating status the text of the Start button changes to Restart Tips e Clicking Restart causes the system to perform a re scheduling of all tasks For example clicking Restart after inserting a new rack into the system while in Operating status causes the system to start pipetting on the sample rack that is positioned furthest to the left e In terms of system states clicking Start changes the state from Sleeping to Initializing or from Standby to Operating The Stop button serves to interrupt sampling or to stop sam
532. uration Lab Reserve Positions When you click the button to indicate the ISE Solutions that you have replaced the counters are reset to zero The amount of remaining ISE Etcher and ISE Deproteinizer is calculated from the number of pipette actions that have been performed The remaining amount of Activator and ISE Solution 1 2 and 3 is determined by level detection After replacement and confirmation of the ISE solution and or diluent bottle on the ISE rack the appropriate bottle volume is assigned to the defined ISE rack position for the correct volume management Operator s Manual Version 1 2 F 33 18 ISE service actions Cedex Bio HT Replace bottles on ISE module Replace bottles on ISE module Overview Warning Tools and materials Hazards Precautions This is a general procedure not a service action The ISE tab in the Status work area gives information about the status of the solutions on the ISE module They must be replaced before the bottle is empty The ISE module must be in Standby but the instrument can be running non ISE tests You must perform the service action Prime ISE calibrators after replacing solutions on the ISE module This ensures that no traces of the previous calibrator remain in the tubing and therefore prevents drift in the results e ISE Calibrator Direct Bio HT e ISE Calibrator Indirect Bio HT ISE Reference Electrolyte Bio HT e Protective gloves The ISE
533. urements do not use cuvettes the analyzer rotor or photometers In addition all requested ISE measurements on a specific sample or calibrator are performed in parallel that is measurements are made at each electrode at the same time F 4 Operator s Manual Version 1 2 Cedex Bio HT 17 ISE module Overview Parts of the ISE module The ISE module is located behind the ISE access panel The ISE rack see page F 6 is on the sample rack platform A ISE access panel B SE rack accessed through the rack area panel Figure C 1 Main features of the ISE module A Electrode block D Distribution block G SE Calibrator Direct B SE module tubing E SE tower H _ SE Reference Electrolyte C Peristaltic pump F ISE Calibrator Indirect Operator s Manual Version 1 2 F 5 17 ISE module Overview ISE solutions on the ISE rack module Cedex Bio HT The main parts of the ISE module are as follows ISE module part Description Electrode block A metal block that contains the electrodes shielding them from electromagnetic interference Peristaltic pump A fluid pump that draws the solutions through the electrode block and then into the sample waste ISE tower A hollow transparent cylinder with multiple inlets and outlets for air and solutions When the ISE tower is blocked the user can remove and clean it In the ISE tower samples and diluents for ind
534. utine sections in Chapter 5 Daily workflow Some of the most common problems in connection with creating orders are dealt with in What if on page B 101 Specifying an order ID You can enable the automatic order numbering facility in Configuration Database Automatic Actions If it is enabled the order ID increases automatically when you open the Sample tab in the Orders work area This ensures that you always have a unique order ID You can accept the order ID or type over it The automatic order numbering facility is not available for alphanumeric order IDs To specify an order ID Click Orders on the navigation bar Click the Sample tab Type a valid order ID in the ID box or use the proposed order ID Click the Order button A ON The Order Demographics dialog box is displayed ol Add information as required Click OK Tips e Step 3 A valid order ID has up to 15 alphanumeric characters e Step 3 Users who work with barcodes first insert the sample rack into the system All samples without test orders are then available in the ID drop down list Select an entry from this list Operator s Manual Version 1 2 B 95 8 Orders Cedex Bio HT Creating an order e Your system can be set up to automatically purge order IDs at BOD You can then reuse order IDs each day gt Purging and deleting orders on page B 109 e Step 5 Comments in the Order Demographics dialog box are defined in
535. ution for the selected test On the Worklist tab access the Sample tab to edit the item Request the same test multiple times for the order Operator s Manual Version 1 2 B 87 8 Orders Orders work area Cedex Bio HT Menu item Function Paste Paste Order Paste Multiple Postpone Calibration Reset Sample Handling Select All Undo Use Last Order Validate Paste previously selected text into a box Paste the details of an order into the current order You must have previously saved the details of another order and used Copy Order Create multiple copies of an order You copy tests from an existing order and then use the Paste Multiple dialog box to create a set of orders based on these tests Overrule a system request for calibration and postpone it by a certain period of time or an event Resets the text boxes Review the rack numbers and rack positions for the selected sample Selects all text in a box Revokes the last action Re displays the details of the last order you used On the Worklist tab access the Validate tab on the Results work area to validate the result s of the selected item B 88 Operator s Manual Version 1 2 Cedex Bio HT 8 Orders Worklist tab Worklist tab Use the Worklist tab to get a clear and comprehensive overview of the active orders and tests and to gain easy access to the tasks you perform most frequently on these items s
536. utions on the ISE rack are not fixed but Roche recommends to use the predefined positions Replace ISE solutions on the ISE rack on page F 32 These positions are defined using Configuration Lab Reserve Positions e All ISE solutions on the ISE rack should have caps except for the activator and SDR2 e Ifyou pull out the ISE rack a dialog box is displayed when you replace the rack Use the dialog box to indicate the solutions you have replaced Leave the check boxes cleared for ISE solutions you have not replaced and for special diluents e Press F1 to display Help for this tab B 78 Operator s Manual Version 1 2 Cedex Bio HT 7 Status ISE tab e After replacement and confirmation of the ISE solution and or diluent bottle on the ISE rack the appropriate bottle volume is assigned to the defined ISE rack position for the correct volume management Operator s Manual Version 1 2 B 79 7 Status Displaying item details Cedex Bio HT Displaying item details To display details for an item in the Status work area do one of the following Sample details Rack details e Double click the item e Right click the item and choose Item Detail from the context menu e Select the item and press Space The corresponding details box is displayed The details box looks similar for the various items The actual contents depends on the item for which detailed information is displayed The following are examples for det
537. utton on the navigation bar Click the Print button in the current window or dialog box Click the right mouse button or equivalent on the keyboard Press a key on the keyboard Click the left mouse button or equivalent on the keyboard twice in rapid succession Open the window or dialog box Close the window or dialog box Operator s Manual Version 1 2 Cedex Bio HT Units SI units Systeme International d Unit s are used throughout the manual where appropriate The following units are either non SI or may be unfamiliar to some users Abbreviation Unit BTU cm MQ psi VA VAC uS British thermal unit Centimeters Inches Pounds weight Mega Ohm Pounds per square inch Volt Amperes Volts alternating current Micro Siemens Abbreviations and acronyms The following abbreviations and acronyms are used throughout the documentation Abbreviation Meaning Usage abs absorbance abs measurement BOD Begin of Day BOD service action CAL calibrator legend on graphic DIL diluent legend on graphic FP Fluorescence Polarization FP photometer ID Identification number Order ID Sample ID in internal in water reservoir ISE lon Selective Electrode ISE module LCD Liquid crystal device LCD monitor LED Light emitting diode LED status indicator No number Lot No STAT immediate order Priority samples tests and results TAS Test Application Software Roche default test
538. value s D You can type text into the Comment box or select a predefined comment from the list E For details on the buttons see below Buttons Button name Function Delete Delete this result Print Print a screen shot of this dialog box to the current default printer Rate Info Display rate information for this result Accept Accept the result Rerun Rerun the test For samples The rerun result is recorded in addition to the existing result You can then accept the rerun result The Reactivated status is added to this entry For calibrations The old result is removed from the dialog box For controls The old result is frozen and displayed in grey The Deleted status is added to this entry Close Close this dialog box Any comments you have added while the dialog box was open are saved automatically Help Display Help topic for this dialog box Up Down Arrow Use the arrow buttons to review details of other tests in the same order amp To review rate information for a result Click Results on the navigation bar B 126 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Displaying detailed information Click any tab 3 Select an item in the list to the left to display the results Double click a result in the Results list The Results Detail dialog box is displayed 5 Click Rate Info The Rate Info dialog box is displayed For example x Order I
539. vice Notes from the menu bar The Print dialog box is displayed 3 Click OK Service notes on page D 13 Printing system counters The system counters report contains the information of the System Counters tab on the Service Counters dialog box Service gt View gt Counters gt To print the system counters Click Service on the navigation bar 2 Choose File gt Print Report gt System Counters from the menu bar The Print dialog box is displayed 3 Click OK System Counters tab on page D 17 Printing test counters The service notes report contains the information of the Test Counters dialog box Tools gt Test Counters gt To print the test counters Click either Status Orders Results or Configuration on the navigation bar 2 Choose Tools gt Test Counters from the menu bar The Test Counters dialog box is displayed 3 Use From to set the period for which the test counters should be printed 4 Click Print The Print dialog box is displayed 5 Click OK Test Counters dialog box on page D 18 Operator s Manual Version 1 2 B 59 6 Routine tasks Cedex Bio HT Purging and deleting information and items Purging and deleting information and items Purging Eliminating unneeded information systematically Deleting Erasing orders and results without preconditions Do not delete data from the D disk drive or from the Roche directory on the C drive Caution Deleting raw d
540. vider to the right to reveal the sample type column D These calibration points are flagged Double click for more information A paper clip at the beginning of a line indicates that a comment has been entered in the Details dialog box Tips To view additional details about the calibration double click a calibration line amp Reviewing calibration history on page B 151 Check to see if the flagged result occurs in more than one replicate For a flagged calibration select the calibration then perform these steps Follow the recommended action for each flag Chapter 12 Result flags o Check the assigned lot number of the calibrator against the actual lot number on the package insert If these are different rerun the calibration with the correct calibrator lot o Check the curve parameters against those of existing accepted calibrations for the same test To check individual calibration points double click one of the calibration lines to open the Detail dialog Press F1 to display Help for this tab B 150 Operator s Manual Version 1 2 Cedex Bio HT 10 Calibration Validating calibration results Recommendations e You should run the control measurements after a calibration If the calibration and controls are not flagged you can accept the calibration provided this is not configured to be done automatically anyway e You should not accept a flagged calibration without fu
541. vscuscenesavecutvenuvecsavanssavecaavasowesuysavececvauiguaweatyenvavnscaavareneverseeesiss SKIN READ hirsiset iet RE ERER E EOWAG TS hangee n e a R E R SLOW LIM ivona Gia a R E AR AR LOW SIGNAL IN EU WDD iristea E a a Ea ea spesetduatasetiactey INOASE GALS aaaea ar aeaa a E aa RS NON LINEAR NON MONO isinisisi eaa S Ee E E R OUTLIERS aiora era E E E E E A ENER OUT OFRNG tE E EEEE EO RE EE Operator s Manual Version 1 2 C 3 12 Result flags Cedex Bio HT Peer r r A ERER E R ER RERA E R ER E C 14 1 ROCCO EEA A A E E EE E E E E E ER E E E C 14 POUSE RRytecsscesicesssuetecsestscesesstcceestutecenssstecenenasecesssehscenesanezan cesses ERR C 14 POS value vssccs ccocesssassces setedessenasderstetides wets E E E E eencdes taeda ents C 15 PO STD TIVE ae EEEO EK EEA ERENS C 15 7AA Dret i A EE ET EE T TES C 18 Be Det i AARETE TATEA TA TATEA REEE C 18 a a a NOT UOT C 19 210 PAER AEREA ERARO AEEA EEAS C 19 REAG RNG Sane ea eee nT UEC UO OE OOO oer oF nT OY C 19 TIN apace a eee ela C 19 PIP Ie EN aeee eae eet detonate C 20 SRR Walltie En EE eae esse ese ees aac a C 20 SRR waltie ohscsiavgaa ies Soins occasvavt cased ese es end eaten abe C 20 SEE FII Dooria ieee eee C 20 SEG ISEGCAT eoun e R N EN ORRE C 20 0 TM E D AVA C 20 SSSA N D D SAVA C 20 STEST RN Gunis eee n RR EENES C 21 SEST RNG a a A O ate C 21 SUID TTI E EEE EE A E EEA C 21 TATE TEASE AT EE AA A E E S E AEAT C 22 EAT TAE ATE EEEE E AAE C 22 Pi E E E E E E E
542. w calibrator lot has been used Tips The Test list has a mnemonic search facility click anywhere in the Test list and type the first few characters of the test name to find a test e Press F1 to display Help for this tab D Validating calibration results on page B 149 Reviewing calibration history on page B 151 B 120 Operator s Manual Version 1 2 Cedex Bio HT 9 Results Quality Control tab Quality Control tab B Use the Quality Control tab to review the quality control history of a test The functions on this tab are similar to those on the Validate tab lt Validate tab on page B 117 Understanding control results on page B 176 EJ Fie Edt View Tools Window Help 72 8 4 a b al x From Validate Y Sample Calibration Quality Control Start ByTest Potassium direct mPNom PPath jy GLN Date amp Time mmol l Sse0 cole isms E Flags Action a amp GLU 15Mar201213 29 3 71 i Di j s i Gluc 15 Mar 201213 29 6 45 ioei i Te Calibration parameter i IGGHB changed H i IGGLB 12Mar20121429 624 i h jO R1 2s EE JKD 12 Mar 2012 14 29 3 61 H p ot H R 4s i LAC i i pau iy NA D m NHB Fi Statistics Precision C Accuracy C Limit admin 27 03 2012 20 37 A The Test list shows all the tests on the system and their associated controls B The Results list shows control results
543. ween adjacent points only Number of calibration points 3 6 Curve parameters None lt Logit log 4 Calibration curve A curve characterized by the logit log 4 formula which has four calculated parameters Number of calibration points 4 6 Curve parameters Rg Kc A B N Logit log 5 Calibration curve A curve characterized by the logit log 5 formula which has five calculated parameters Number of calibration points 5 6 Curve parameters Ro Kc A B C Calibration curve A curve characterized by a smooth polynomial function that is piecewise defined Minimum number of calibration points 3 Curve parameters None DMD Operator s Manual Version 1 2 B 137 10 Calibration Calibrations at a glance Calibrations at a glance Cedex Bio HT Use the following table to locate specific tasks by work area and tab Work area Tab Tasks Status Orders Fi Missing amp Blocked Samples Test Status Calibration Worklist Validate Calibration Review calibrators that cannot currently be used by the system for example because they are not on board expired or some additional item such as a diluent is missing View calibrators on board color shows the status Click a position to display the details for the selected calibrator Review test with calibrator intervals rack position Review calibration Request a calibration Postpone a calibration
544. wer fluid waste tubing and electrodes is potentially infectious e Sample material is potentially infectious e There is a danger of cauterization and poisoning through skin contact with the reagents e Make sure you read all the warning labels on the cassettes e Use protective gloves to avoid direct contact with sample material e Remove any spillage of sample material immediately To clean the waste box fitting Select Clean waste box fitting in the Service work area 2 Click Perform The Service Actions dialog box is displayed Follow the online instructions 3 Remove the cuvette waste box Make sure shaking is not performed while you remove the box 4 Clean the Plexiglas protection of the waste box fitting with a paper tissue moistened with water Reinsert the cuvette waste box 6 When all steps are complete click Finish to reset the instrument service counters e Double click the service action in the Due All or Begin of Day tab e Click Help in the dialog box e For general information about performing a service action see Chapter 13 Service action software D 42 Operator s Manual Version 1 2 Cedex Bio HT 14 Service actions Clean and lubricate the rotor Clean and lubricate the rotor Overview Duration Interval Tools and materials Hazards N Q Precautions gt This action improves the cuvette positioning on the rotor The positioning may affect the reproducibility
545. x Bio HT ix 4 P flag 13 p flag 13 panels 16 parameters concerning system states 45 parts of the ISE module 5 Passed service action status 14 password user 33 35 Paste toolbar button 52 paste function 53 User Manual Version 2 7 I 21 Index Paste Multiple function 106 peristaltic pump location 5 photometers absorbance 39 FP 40 photometric measurements 38 physical dimensions ofinstrument 4 pipette module 20 pipettes dosage 21 dripping 31 for washing 21 replacing 61 replacing plunger tip 57 with air bubbles 31 pipetting error 26 incorrect volumes 28 samples and reagents 37 pipetting system specifications 9 pistons worn out 31 Place Items toolbar button 52 using for assigning samples 98 platforms 27 plumbing requirements specifications 5 POL ERR flag 14 poor accuracy ISE 49 pop up window in Help 60 POS flag 14 POSITIVE flag 14 postponing calibration 147 posts for initializing 38 power connectors 37 laboratory 18 mains connector 18 power requirements of computer 4 ofinstrument 4 precautions for ISE 16 Precision control mode 162 precision controls 175 reviewing 177 preconditions for purging results 130 INTEGRA 400 plus preventative maintenance 3 21 17 Prime ISE calibrators service action 20 Prime the fluid
546. y automatic step oar wns ISE Calibrator Direct ISE Calibrator Indirect and ISE Reference Electrolyte are pumped through the ISE module tubing automatic step 7 ISE Calibrator Direct is pumped into the measuring channel and transported slowly through the system every three minutes A calibration is run before any new samples or controls are processed automatic step F 20 Operator s Manual Version 1 2 Cedex Bio HT 18 ISE service actions Clean ISE tower automatically Clean ISE tower automatically Overview Duration Interval Begin of Day System state Tools and materials Hazards and precautions gt This is an automatic service action that does not require manual intervention The ISE tower must be cleaned regularly to ensure the proper functioning of the ISE module 11 minutes e Weekly e Daily if more than 50 plasma samples are processed per day Yes Standby e Activator e ISE Calibrator Direct Bio HT e ISE Deproteinizer Bio HT ISE Reference Electrolyte Bio HT See General safety precautions on page F 16 To clean the ISE tower automatically Select Clean ISE tower automatically in the Service work area Click Perform The Service Actions dialog box is displayed follow the online prompts as required Transfer arm is initialized if necessary automatic step Fluid system is initialized if necessary automatic step ISE module is initialized if necessary au
547. y after a definable period of inactivity default value is 10 minutes or at a defined time Then after a defined interval by default Sleeping Mode after is set to 10 minutes the system goes into Sleeping You can configure the system to start processing automatically otherwise click Start or press F11 to start processing and click Stop or press F12 to stop processing Configure Auto Start BOD time End of Sequence and Sleeping mode in Configuration General System To log on you must use the password and user ID that were created for you by your system supervisor The software uses the ID of the person who is logged on to record their actions gt To logon 1 Use one of the following methods to open the dialog box e Press Shift F3 e Double click the user ID A in the status bar T 25 04 2000 16 22 A Operator s Manual Version 1 2 B 33 6 Routine tasks Cedex Bio HT Starting up and logging on to the system What if My password is rejected Another user is logged on e Choose Tools gt Log on off in any work area File View Window Help Add Patients Journal Test Counters Purge Orders Purge Results Retransmit All Data Execute Begin Of Day Export Raw Data Log on off Shift F3 Refresh All Place Items Test Calibrations 2 Type your user ID and password a User Log On x User ID tevens Password Zz Logon oon 3 Click Log On
548. y water sea You do not need to perform this task if your system is connected directly to a supply pressure drops below the required value Operator s Manual Version 1 2 B 45 6 Routine tasks Managing resources Location Tools and materials Precautions Warning Cedex Bio HT When the water supply icon turns yellow in Status Analyzer or on the Status button you must refill the external water reservoir When the icon is red the system stops The system cannot operate without a water supply but you can disconnect it temporarily while the system runs from the internal water reservoir When the internal water reservoir becomes empty the system stops The external water reservoir is usually located underneath the instrument The reservoir is a 10 L white plastic reservoir labeled Reservoir e 10Lof reagent grade type 1 water e 1000 mL beaker Always use water that meets the required purity standards Failure to do this can affect result accuracy and cause general maintenance problems To refill the external water reservoir 1 Remove the tubing adapter A from the reservoir and put it temporarily into a clean empty 1000 mL beaker 2 Refill the reservoir with reagent grade type 1 water 3 Insert the tubing adapter into the reservoir Tips The system can run off the internal water reservoir for a short time If you perform this task promptly you can avoid having the system shut down due to l

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