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Roche Cobas C111 - User manual

1. A 21 Daily operation A 22 Overview A 22 Reagent and diluent handling A 25 Calibration A 26 Calibration type A 27 Calibration sequence A 28 Calibration status of a set A 28 Calibration result storage A 28 Validating calibration results A 29 Calibration procedures A 29 Quality control QC A 30 Sample handling
2. D 35 lt R 2 2s D 35 gt Reag Rng D 36 lt Reag Rng D 36 gt Repl Dev D 36 gt RR D 37 lt RR D 37 In this chapter Chapter 10 Roche Diagnostics D 24 Operator s Manual Version 3 0 10 Result flags cobas c111 Table of contents gt Std Dev D 37 gt Test Rng D 38 lt Test Rng D 38 Roche Diagnostics Operator s Manual Version 3 0 D 25 cobas c111
3. A 84 Sample overview A 86 Orders A 87 STAT A 89 Tests A 90 Log off A 92 Prepare A 92 End shift A 92 Cuvette status A 92 In this chapter Chapter 5 Roche Diagnostics A 70 Operator s Manual Version 3 0 5 Software cobas c111 Table of contents Disk and reagent status A 93 ISE status A 94 System status
4. D 30 Ep Unstab D 30 High Abs D 31 High Act D 31 lt Kin Read D 32 Low Act D 32 Non Linear D 33 Non Mono D 33 Out of Rng D 34 QC D 34 R 1 2 5s D 34 R 1 3s D 35 gt R 2 2s
5. B 38 Defining routine orders B 39 Defining STAT orders B 41 Making changes to an order B 42 Starting the run B 44 In this chapter Chapter 6 Roche Diagnostics B 4 Operator s Manual Version 3 0 6 Daily operation cobas c111 Table of contents Monitoring the analysis progress B 44 Checking the sample tube status B 44 Checking the instrument status buttons B 46 Checking for alarm messages B 48 Acoustic signal B 48 Stopping and restarting a run B 49 Removing sample tubes B 50 Validating sample results
6. B 135 Changing values B 135 Applications B 137 Installing applications B 137 Activating and deactivating applications B 139 Preparing applications B 140 Uninstalling applications B 143 Deleting applications B 144 Defining the processing order B 145 Defining ratio applications B 146 Profiles B 148 Defining profiles B 148 Adding tests to a profile B 148 Removing
7. B 51 Repeating tests B 55 Rerunning tests B 56 Accepting results B 57 Printing sample results B 58 Performing calibrations B 59 Safety information B 59 Short guide B 60 Process of performing calibrations B 61 Deleting ordered calibrations B 63 Validating calibration results B 64 Performing QC B 68 Safety information
8. A 95 Workplace tab A 97 Orders A 98 Result list A 99 QC status list A 101 QC history A 102 Calibrations list A 104 Lot data A 105 Lot list A 106 Loadlist A 107 Worklist A 107 Utilities tab A 108 Configuration
9. D 8 Confirming alarm messages D 9 Exporting the alarm message log D 9 List of alarm messages D 10 In this chapter Chapter 9 Roche Diagnostics D 4 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 Table of contents Roche Diagnostics Operator s Manual Version 3 0 D 5 cobas c111 9 Messages and alarms About messages About messages The system performs numerous checks When a certain event has occurred or when an irregularity is detected a message is generated Messages are displayed in two ways o Immediate feedback on user actions is displayed in a pop up message screen o Information concerning a problem that occurred during operation is reported as alarm messages in the alarm monitor Alarm messages are stored in a log file which you can export e See Exporting the alarm message log on page D 9 Message screen Message screens are displayed automatically as soon as the message is generated Read the message and press to close the screen Figure D 1 Message screen Roche Diagnostics D 6 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 Acoustic signals Acoust
10. A 74 Working with the user interface A 75 Adjusting the touchscreen A 75 Scrolling A 75 Expanding and collapsing lists A 76 Typing text A 76 Using the filter function A 78 Printing information A 80 Using online Help A 81 Messages A 82 Message screen A 82 Alarm monitor A 82 Key screens A 84 Overview tab
11. A 55 Cuvette segments A 55 Handling cuvettes A 56 Reagent handling A 56 Rotor A 57 Reagent disk A 58 Reagent disk container A 59 Reagent cooler A 59 Cuvette ring A 60 Barcode scanner A 61 Printer A 62 In this chapter Chapter 3 Roche Diagnostics A 38 Operator s Manual Version 3 0 3 Hardware cobas c111 Table of contents Absorbance photometer
12. A 10 License notices A 11 Legal liability A 11 In this chapter Chapter 1 Roche Diagnostics A 4 Operator s Manual Version 3 0 1 Safety cobas c111 Table of contents Disposal recommendation A 12 Disposal label A 12 Disposal of external components A 12 Disposal of the instrument A 12 Constraint A 12 Safety labels A 13 Roche Diagnostics Operator s Manual Version 3 0 A 5 cobas c111 1 Safety Safety classification Safety classification Before you attempt to use the cobas c111 instrument you must be fully familiar with the following symbols and their meanings Safety information Before operating the cobas c111 instru
13. E 74 No Isecal E 74 Out of Rng E 75 QC E 75 R 1 2 5s E 76 R 1 3s E 76 gt R 2 2s E 76 lt R 2 2s E 77 gt RR E 77 lt RR E 77 Seg Fluid E 77 Seg Isecal E 78 In this chapter Chapter 15 Roche Diag
14. A 121 Color interpretation for LEDs A 122 Buttons A 124 Roche Diagnostics Operator s Manual Version 3 0 A 71 cobas c111 5 Software Introduction Introduction To operate the cobas c111 instrument you use its touchscreen The design and functional concept of the touchscreen support you in the way you work The following table lists the major items and characteristics of a cobas c111 screen and describes their impact on the operation of the instrument Screen item Impact on operation Screen types Distinct screen types make it easy for you to find your way around the user interface For example you immediately know whether you are on a main screen or whether you are reading a message Screen layout The consistent layout allows you to quickly find the required information and to locate the various display items Buttons Press a button to open and close a screen or to start a func tion Colors The color of an item on the screen points to its own status or that of the item it represents The traffic light color scheme is used o Green Everything is OK o Yellow The system is working but you need to intervene for it to continue to do so o Red This item does not work you need to intervene
15. D 42 Reacting to messages D 44 Detailed procedures D 46 Checking the printer status D 46 Clearing a paper jam D 46 Changing the mains fuses D 47 Changing the low voltage fuses D 49 Realigning the reagent disk D 50 Exporting diagnostics screens to USB D 51 In this chapter Chapter 11 Roche Diagnostics D 40 Operator s Manual Version 3 0 11 Troubleshooting cobas c111 Table of contents Roche Diagnostics Operator s Manual Version 3 0 D 41 cobas c111 11 Troubleshooting Introduction Introduction Effective troubleshooting requires a good understanding of all basic operating procedures for the cobas c111 instrument and the system software Preventive maintenance You can avoid most unforeseen situations if you observe the recommended procedures at
16. B 68 Short guide B 69 Performing Default QC B 70 Performing interval QC measurements B 71 Validating QC results B 72 Interpreting the QC history B 74 Performing reagent mixing B 76 Finishing the shift B 77 Safety information B 77 Short guide B 78 Checking for unfinished tasks B 80 Checking for unfinished orders B 80 Checking for not accepted sample results B 80 Checking the transmission of results
17. C 23 Replace photometer lamp C 24 Contact service representative C 27 Perform an air water calibration C 28 Initialize degasser fluid sensor C 30 Clean rotor and heating channel C 32 In this chapter Chapter 8 Roche Diagnostics C 4 Operator s Manual Version 3 0 8 General maintenance cobas c111 Table of contents Roche Diagnostics Operator s Manual Version 3 0 C 5 cobas c111 8 General maintenance Overview Overview Completing maintenance actions correctly and on time helps to ensure smooth and uninterrupted operation of your instrument Maintenance scheduling The cobas c111 instrument facilitates performing the maintenance actions in bundles at the times that suit your laboratory work processes To that purpose you can define in the configuration settings one day of the week as your maintenance day e For information on scheduling maintenance actions see Scheduling maintenance actions on page B 158 All maintenance actions can be performed any time Interval For most maintenance actions a fixed maintenance interval is de
18. E 54 Replace ISE unit tubing E 57 Deactivating the ISE unit E 64 In this chapter Chapter 14 Roche Diagnostics E 40 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 Table of contents Roche Diagnostics Operator s Manual Version 3 0 E 41 cobas c111 14 ISE maintenance Introduction Introduction The maintenance actions of the ISE unit are integrated in the maintenance actions of the main instrument e For general information on performing maintenance actions see Overview on page C 5 This chapter describes the ISE specific maintenance actions ISE maintenance actions and their intervals The following table lists the ISE maintenance actions and shows how frequently they need to be performed Every effort has been made to ensure that all the information contained in this table is cor rect at the time of publication However Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development Maintenance actions with no defined interval need to be performed in particular situations for example during troubleshooting Interval Maintenance action None Initiated by other maintenance action Activate Electrodes None Initiated by other maintenanc
19. E 20 Starting the Prepare wizard E 21 Checking the status of the external fluid containers E 21 Checking the ISE status E 21 Performing maintenance actions E 22 Completing the preparation tasks E 23 Performing calibrations E 23 Defining orders E 23 Monitoring the progress E 24 Validating sample results E 25 Main calibration E 26 Performing QC E 26 Finishing the shift E 27 Short guide E 28 Repla
20. E 8 Hardware E 9 Panels E 9 ISE LED E 10 Main components E 10 Fluid containers E 11 Basic operation E 12 Samples E 12 Calibration E 12 ISE Standby E 12 Maintenance actions E 13 Technical specifications E 13 In this chapter Chapter 12 Roche Diagnostics E 4 Operator s Manual Version 3 0 12 ISE de
21. B 164 Workflow definitions B 164 Host definitions B 165 Result handling B 167 Calibration B 167 QC B 167 System B 168 Date and time B 169 Maintenance B 169 Abs adjustment B 169 Defining extra wash cycles B 170 Activating deactivating and deleting extra wash cycles B 171 Short guide to extra wash cycle definitions B 172 Extra wash cycle definitions B 172 Short guid
22. A 31 Order handling A 32 Results A 34 Maintenance A 34 System status A 35 In this chapter Chapter 2 Roche Diagnostics A 16 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Table of contents Roche Diagnostics Operator s Manual Version 3 0 A 17 cobas c111 2 Introduction to the instrument Overview Overview The cobas c111 instrument is a continuous random access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum plasma urine or whole blood HbA1c It is optimized for small throughput workloads of approximately samples per day utilizing photometric analysis and an optional unit for ion selective electrodes ISE Only trained personnel working in a professional laboratory environment may operate the cobas c111 instrument Features As part of the cobas family of instruments the cobas c111 instrument offers small laboratories the following advantages o High analytical performance The same
23. A 7 Reagents and other working solutions A 7 Installation A 7 Environmental conditions A 7 Power interruption A 8 Electromagnetic devices A 8 Approved parts A 8 Third party software A 8 Operator qualification A 9 Operation over an extended period of time A 9 Cross contamination of sample A 9 Insoluble contaminants in sample A 9 Spillage A 9 Data security
24. B 114 Importing certificates B 115 Importing automatic mixing and extra wash cycle definitions B 116 Preparing a new disk B 116 Assigning tests to test tabs B 119 Deleting bottle sets from the Inventory list B 120 Refilling printer paper B 122 Removing condensation water from the reagent cooler B 124 In this chapter Chapter 6 Roche Diagnostics B 92 Operator s Manual Version 3 0 6 Special operations cobas c111 Table of contents Replacing the probe B 125 Connecting and disconnecting the external fluid containers B 127 Adjusting the touchscreen B 130 Cleaning the touchscreen B 131 Roche Diagnostics Operator s Manual Version 3 0 B 93 cobas c111 6 S
25. H USB 2 connector for troubleshooting I Water connector J Cleaner connector K Waste connector Figure A 32 Connectors B C A D A E F G H I J K Roche Diagnostics Operator s Manual Version 3 0 A 65 cobas c111 3 Hardware Hardware overview Fuses The mains fuses are situated at the rear of the instrument above the power connector the internal fuses are situated on the right side of the instrument at the top of the connector panel e See To change the mains fuses on page D 47 See To change a low voltage fuse on page D 49 WARNING Electrical shock by electronic equipment Do not attempt to work in any electronic compartment Installation service and repair must only be performed by authorized and qualified personnel A Power connector with T6 3 A H 250 V fuse B Low voltage fuses T3 15 A F1 Heating system F2 Motors F3 Cooling assembly F4 Photometer unit and LEDs Figure A 33 Fuses A B Roche Diagnostics A 66 Operator s Manual Version 3 0 4 cobas c111 Technical specifications Technical specifications Physical dimension Power requirements Power requirements ISE unit optional unit Measurement principles Environmental conditions Throughput Samples NOTICE Every effort has been made to ensure that all the information contained in these specifica tions is correct at the time of printing However Roche Diagn
26. Roche Diagnostics B 82 Operator s Manual Version 3 0 6 Daily operation cobas c111 Finishing the shift Performing the daily backup The cobas c111 instrument can store orders and result data for one working day It is therefore necessary to export to an external medium all data that you need to keep During a database export the full content of the database is copied to the USB stick The database data can be restored to the instrument if required Utilities gt Import gt Database e For information on restoring the database see Importing a database on page B 114 a To perform the daily backup 1 Press A screen is displayed asking you to insert the USB stick 2 Insert the USB stick A screen is displayed showing the directory structure of the USB stick 3 Select the directory where you want the backup file to be copied 4 Press to confirm the selection The data are copied to the stick Database files names have the following name format dba_yyyymmddhhmmss tgz 5 Press to proceed to the next stage in the End Shift wizard A screen is displayed for deleting sample results When performing backup without using the End Shift wizard Choose Utilities gt Export gt Database Roche Diagnostics Operator s Manual Version 3 0 B 83 cobas c111 6 Daily operation Finishing the shift Exporting the result data When exporting results the full result data are exported
27. sample tubes B 50 repeating tests B 55 Replace ISE pump tubing maintenance action E 54 Replace ISE unit tubing maintenance action E 57 Replace photometer lamp maintenance action C 24 Replace water inlet filter maintenance action C 19 Roche Diagnostics Operator s Manual Version 3 0 F 19 cobas c111 Index replacing cleaner bottle B 18 cuvettes B 29 B 85 electrodes E 32 ISE bottles E 22 E 30 printer paper B 122 probe B 125 reagents B 25 water container B 16 B 86 rerunning tests B 56 restarting the system A 121 restoring database B 114 result conversion B 156 result handling definitions B 167 overview A 34 result list screen A 99 results calibration B 65 checking for not accepted sample results B 80 checking for transmission B 81 cleaning up at end of shift B 84 deleting of calibration B 95 deleting of QC B 96 deleting of samples B 94 exporting B 83 B 105 flags D 23 handling A 34 introduction to handling A 34 list A 99 printing of samples B 58 samples B 51 samples if sample on board B 52 samples if sample removed B 53 validating for QC B 72 validating of samples B 51 revision history 2 rotor cleaning C 10 overview A 57 S safety A 3 approv
28. 3 Do one of the following The results are deleted You cannot retrieve them any more from the system a To delete QC results from the QC History 1 Choose Workplace gt QC History 2 Press A screen for selecting results is displayed 3 Do one of the following The results are deleted You cannot retrieve them any more from the system If Do this You want to delete all QC results 1 Choose All 2 Press to confirm the deletion You want to delete all accepted QC results 1 Choose All Accepted 2 Press to confirm the deletion You want to delete the selected result 1 Choose Selected If Do this You want to delete all results in the list If a filter was applied this list would contain only the results that fulfill the filter criterion and the filter criterion would be part of the button name 1 Choose List 2 Press to confirm the deletion You want to delete all results that were generated before the first day of the previous month 1 Choose Older than Previous Month 2 Press to confirm the deletion You want to delete the results of the selected control 1 Choose Selected Roche Diagnostics B 98 Operator s Manual Version 3 0 6 Special operations cobas c111 Lot handling Lot handling Both the lot data and its handling depend on what item the lot refers to o Calibrators calibrator lot o Controls QC lot o Reagents d
29. 5 Wait 6 Pipetting the next fluid 7 Wait 8 And so on Calculating the results The test result is calculated on the basis of the photometric measurement results During this process various checks are performed to ensure that the whole measuring process was technically correct If values are above or below predefined limits the test result is flagged The results are stored on the system This includes both the forty measurement results raw data and the calculated test result Sequence of processing For a given sample the tests are processed in the order defined by the time required for their processing number of cycles starting with the one that takes the longest This order can be altered manually by defining a specific process sequence list Status of the measuring process At any stage of the measuring process the user can check its status on the screen Result data management The system provides storage space for the results of one working day For backup purposes the results must be exported to an external storage device once a day Roche Diagnostics A 20 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 User interface User interface The cobas c111 instrument is equipped with a touchscreen an on screen keyboard and four global action buttons LEDs and acoustic signals let you know when it is safe to add or remove samples reagents and other fluids With buttons
30. o Accept o Retransmit Display details of the selected result Delete results You can choose what kind of result should be deleted o List All results in the list If a filter was applied the list would contain only the results that fulfill the filter criterion and the filter criterion would be part of the button name o Selected Apply filter criteria to the results list You can choose one of the following criteria o All o Flagged o STAT o Not Accepted o Not Today o Not Sent to Host o By ID Roche Diagnostics Operator s Manual Version 3 0 A 101 cobas c111 5 Software Key screens QC status list f Workplace gt QC Status The entries are grouped first by test name then by control S column Status The result has not been accepted yet I The result was ignored The result has not been transmitted yet Flag Result column Result if no flag was generated Flag with highest priority if flags were generated Order status if the control measurement has not been performed yet Previous Lot indicates that controls of more than one lot were used Print QC results Validate the QC results You can choose one of the following options o Accept o Ignore o Retransmit Display details of the selected QC result Define a new QC order Delete QC results You can choose what kind of result should be deleted o All o All Accepte
31. 7 Select the tests that should be included in the profile 8 Press to confirm the selection Adding tests to a profile a To add tests to a profile 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select the profile 3 Expand the entry 4 Expand the General entry 5 Select Applications 6 Press A test selection screen is displayed 7 Select the tests 8 Press to confirm the selection e For information on assigning a profile to tabs on the test selection screen see Assigning tests to test tabs on page B 119 Roche Diagnostics Operator s Manual Version 3 0 B 149 cobas c111 7 Configuration Applications Removing tests from a profile a To remove tests from a profile 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select the profile 3 Expand the entry 4 Expand the General entry 5 Select Applications 6 Press A test selection screen is displayed 7 Clear the selection of the tests you want to remove 8 Press to confirm the selection Deleting profiles e See Deleting applications on page B 144 Defining control definitions and lots f Workplace gt Lot Data a To define control definitions and lots Perform the following steps for all controls 1 Choose Workplace gt Lot Data 2 Press Controls A screen is displayed that lists all installed control lots 3 Press A screen is displa
32. A Do not use the screen until the system is in Standby status Roche Diagnostics Operator s Manual Version 3 0 B 11 cobas c111 6 Daily operation Starting the shift Logging on to the system a To log on the system 1 Press Log On A screen is displayed for typing your user name e For information on typing text see Typing text on page A 76 2 Type your user name Use characters of the alphanumeric keyboard upper and lower case As soon as you type the first characters of your user name the system looks for a name that starts with these letters and if it finds one displays the complete name 3 Press A screen is displayed for typing your password 4 Type your password Use characters of the alphanumeric keyboard upper and lower case For security reasons you cannot see the actual characters when typing 5 Press The Overview tab is displayed again User name and password are case sensitive This means that for example User and user are two different names Roche Diagnostics B 12 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing the system Preparing the system Before you can start analyzing samples you need to prepare the system Preparing the system includes both user actions and actions performed automatically by the system such as heating up the cuvette ring or cooling down the reagent cooler The process is designed in such a manne
33. A 44 Fluid system A 45 Probe and syringe A 46 Syringe assembly A 46 Wash station A 47 External fluid connectors A 47 Transfer unit A 48 Fluid containers A 50 Waste containers A 50 Water container A 51 Cleaner bottle A 52 Reagent bottles A 53 Tubes A 54 Cuvettes
34. A screen is displayed asking you to scan the barcode transfer sheet or to type the data manually 4 Define the lot values Do one of the following If Do this The lot data are available from a barcode 1 Scan the barcode The screen is displayed again that lists all installed control lots The new lot is selected You want to type the data manually 1 Press 2 Type the name and press 3 Type the material code and press You find this code in Utilities gt Applications gt select a test gt gt Control 4 Type the Lot ID and press 5 Type the expiration date Use the date format as indicated on the screen 6 Press to confirm the definitions If a lot with the same ID already exists on the system a screen is displayed asking you whether you want to replace the existing lot Press to confirm the definitions 7 Press Add new test 8 Press A screen is displayed that contains all tests that use this control and that have not yet been assigned to this lot 9 Select a test and press 10 Type the value for the mean concentration and press 11 Type the value for the standard deviation 12 Press to confirm the definitions The screen for handling control lot data is displayed again 13 Perform steps 7 through 12 for all tests you want to use Roche Diagnostics Operator s Manual Version 3 0 B 103 cobas c111 6 Special operations Lot handling
35. B 74 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing QC 4 Press to close the screen 5 Press 6 Do one of the following o Press Accept to accept the QC results for the selected test o Press Ignore to exclude the result from further QC result calculations such as QC history statistics When ignoring a result the due status does not change In the QC results tables ignored QC results are marked with I Flags of ignored results are not inherited to dependent results o Press Retransmit to send the result again This option is active if your instrument is connected to a host system Interpreting the QC history The QC history provides on individual screens information on the QC results of the current and the previous calendar month as well as on results that were generated before the previous month A graphic representation of the results provides a convenient way for comparing results over a period of time a To interpret the QC history 1 Choose Workplace gt QC History A screen is displayed that contains one QC result entry for each lot of each test If the QC result is outside the defined range perform the QC again If the results are still outside the range check for other causes If all fails perform a calibration A Test name B Control ID C Date of most recent control measure ment If the control does not belong to the current lot
36. Chimneys are bottle inserts that reduce evaporation For reagents that are especially sensitive to concentration changes Roche recommend using chimneys on the reagent bottles See the package inserts of the tests whether you should use chimneys or not To generally reduce evaporation you may use chimneys on all reagent bottles WARNING Incorrect results due to declining reagent quality If the application definitions see package insert recommend the use of chimneys the corresponding calibration intervals apply to conditions when working with chimneys Roche recommend using chimneys whenever this is recommended on the test insert Roche Diagnostics A 54 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Tubes The cobas c111 instrument can use both primary and secondary tubes cups You can use any type of primary tube as long as their dimensions lay within prescribed limits o Maximum height including secondary tube 102 mm o Minimum height 70 mm o Maximum outside width 16 3 mm o Minimum outside width 11 8 mm The following table lists a few typical tubes that are suitable and it gives the dead volume for each of them Roche recommend using approved cups only The following table lists the approved cups The Hitachi standard and micro cups can be placed on top of 16 x 75 mm tubes WARNING Incorrect results due to insufficient fluid Insufficient fluid may
37. ISE Abbreviation for ion selective electrode ISE Reference Electrode The electrode through which the ISE Reference Solution flows to set the electronic baseline to zero for ISE measurement E F G H I Roche Diagnostics F 6 Operator s Manual Version 3 0 Glossary cobas c111 ISE Reference Solution operator ID ISE Reference Solution A KCl solution pulled through the ISE Reference Electrode to set the electronic baseline to zero for ISE measurement Also known as the REF or reference electrode solution IVD Abbreviation for in vitro diagnostics A diagnostic procedure performed outside the living body with specimen body fluid level detection A check for the availability of sufficient liquid in a container linear barcode A conventional one dimensional barcode with limited data capacity liquid level detection LLD The ability of an analytical instrument to sense liquid by using the probe log file A set of data typically stored in the control unit that traces instrument related or operator related activities such as maintenance log off The procedure of terminating access to a system Also known as log out or logoff The reverse procedure is known as log on or log in Log off button A button used to terminate access to a system See also log off log on The procedure of gaining access to a system by entering a user name and if required a password Also known as log in or logon The revers
38. Importing data 6 Select the database file Typically the file format looks like this dba_yyyymmddhhmmss tgz Press tgz to display cobas c111system files only Press to display all files and directories 7 Press to confirm the selection When the data are imported a message is displayed asking you to restart the system 8 Choose gt Restart to restart the system Importing certificates Certificates are digital records that ensure the authenticity of reagent barcodes On each cobas c111 instrument there must be a certificate installed a To import certificates 1 Choose Utilities gt Import gt Certificate A screen is displayed that lists the currently installed certificates 2 Press A screen is displayed asking you to insert the USB stick 3 Insert the USB stick 4 Press 5 Select the certificate You recognize a certificate by its file extension prm 6 Press to confirm the selection The certificates are installed on the system The screen is displayed again that lists the currently installed certificates After the database installation o Load all bottle sets that are defined using the appropriate software features o Perform Abs Air Water Calibration maintenance action Roche Diagnostics B 116 Operator s Manual Version 3 0 6 Special operations cobas c111 Preparing a new disk Importing automatic mixing and extra wash cycle definitions
39. Preparing the system 6 Open the main cover and remove the bottle 7 Press to confirm the removal The system does not check whether you have actually removed the bottle 8 Do one of the following The screen with the reagent set buttons is displayed again The button for the removed set is no longer present If you did not remove all bottles of the set the reagent set would be disabled its button would be red Adding a reagent set 9 Open the main cover if required 10 Press A screen is displayed asking you to scan the bottle barcode 11 Scan the barcode on the bottle A screen is displayed asking you to place the bottle on the reagent disk If Do this There is another bottle belonging to the set The system moves this bottle to the reagent port A screen is displayed asking you to remove the bottle 1 Remove the bottle 2 Press to confirm the removal 3 Start adding the new reagent set All bottles of the set are removed 1 Start adding the new reagent set When scanning bear this in mind o Scanning its barcode is the only way of identifying a reagent diluent and cleaner bottle o If there are not enough free slots for all bottles of the set a message will inform you o You cannot re insert empty bottles that were previously removed from the system If you scanned such bottle a message would inform you that you cannot do this Roche Diagnostics Operator s Manual
40. o Handle extra wash cycles o Display export and import the mapping table for test IDs of the cobas c111 instrument and the laboratory information system Diagnostics Perform diagnostics actions Inventory Display information on bottle sets that are currently defined on any disk used on the cobas c111 Import Import application data software updates the complete content of a database certificates extra wash cycle definitions reagent mixing rules or a new user interface language Users Define users and manage their user rights Export Export the complete content of the database the full results and log files Figure A 71 Utilities tab Roche Diagnostics Operator s Manual Version 3 0 A 109 cobas c111 5 Software Key screens Configuration f Utilities gt Configuration There are list items of a lower level Select the item marked with and press again to expand the list and display the items The list is expanded Select the item marked with and press again to hide the items Print configuration data You can choose one of the following options o All o Selected Print the settings of the selected configuration group With an item selected configure the selected item With a group title selected expand or collapse the list Figure A 72 Configuration table Roche Diagnostics A 110 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Maintenan
41. 2 Press 3 Press 4 Select a control and place the tube Repeat until there are no controls left on the screen 5 Press Perform a single interval QC measurement 1 Choose Workplace gt QC Status 2 Press 3 Select the test 4 Press 5 Select a control and place the tube Repeat until there are no controls left on the screen 6 Press 2 Validate the results 1 Choose Workplace gt QC Status 2 Press to look at result details Close the details screen 3 Press and press a button to validate the QC result 4 Remove the controls Table B 7 Steps for performing QC Roche Diagnostics B 70 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing QC Performing Default QC Performing Default QC follows a streamlined procedure whereby QC orders are automatically defined as soon as you identify a control An order is defined for all tests for which this control is defined as the Default QC provided the test is currently active on the system a To perform Default QC 1 Choose Overview gt Order 2 Press A screen is displayed that contains a button for each of the controls that are required 3 Prepare the controls 4 Press a control button A screen is displayed asking you to place the selected control 5 Place the control tube on any free position on the sample area The system registers the position and automatically defines an order
42. 21 Press to perform the main calibration 22 When the system is in Standby status remove ISE Solution 1 and ISE Solution 2 from the sample area 23 Press Make sure to place a full bottle You need to perform a main calibration before you can process orders Roche Diagnostics E 32 Operator s Manual Version 3 0 13 ISE operation cobas c111 Replacing electrodes Replacing electrodes There are up to three ion selective electrodes and one ISE Reference Electrode on the ISE unit The replacement procedure is the same for all of them As part of replacing electrodes the Electrode Service maintenance action and a main calibration need to be performed Replacing an electrode takes about 15 minutes Tools and materials required o ISE Calibrator indirect urine on board o ISE Reference Solution on board o ISE Deproteinizer o ISE Etcher o Activator o ISE Solution 1 o ISE Solution 2 o ISE Sodium Electrode if you intend to replace this type of electrode o ISE Potassium Electrode if you intend to replace this type of electrode o ISE Chloride Electrode if you intend to replace this type of electrode o ISE Reference Electrode if you intend to replace this type of electrode o ISE Dummy Electrode if you intend to replace this type of electrode or if you no longer intend to use one of the ion selective electrodes Roche recommend replacing electrodes when their expiration date
43. A 63 Connectors A 64 Fuses A 65 Technical specifications A 66 Roche Diagnostics Operator s Manual Version 3 0 A 39 cobas c111 3 Hardware Covers and panels Covers and panels The following figure shows the removable panels and the lids that can be opened Transfer head cover Provides access to o Transfer mechanism o Probe Switch off the system before you open this cover Left service flap Provides access to o Wash station o Tubing o Internal waste tank o Initialization plate Open this flap as instructed during maintenance actions or switch off the system before you remove it To open the flap press its front towards the instrument and lift A Left side panel B Left service flap C Main cover D Transfer head cover E Rear service flap F Right side panel G Right service flap H Printer panel Figure A 7 The cobas c111 instrument B C D F E G A H Roche Diagnostics A 40 Operator s Manual Version 3 0 3 Hardware cobas c111 Covers and panels Main cover Provides access to o Rotor o Reagent disk o Cuvettes o
44. D 50 Operator s Manual Version 3 0 11 Troubleshooting cobas c111 Detailed procedures Realigning the reagent disk a To realign the reagent disk 1 Insert your fingers in the holes in the reagent disk cover an lift the reagent disk 2 Insert a pencil in the opening in the center of the underside of the reagent disk 3 Turn the reagent disk until the arrows of the reagent disk and the cover face each other CAUTION Spillage through tipping reagent disk When handling the reagent disk make sure not to tilt it A Incorrect position The two arrows do not face each other B Correct position The two arrows face each other Figure D 7 A B Roche Diagnostics Operator s Manual Version 3 0 D 51 cobas c111 11 Troubleshooting Detailed procedures Exporting diagnostics screens to USB When performing diagnostics actions you can export the content of the screen to the USB stick Prerequisites You need Lab Administrator or Administrator user rights to perform diagnostics actions and the system must be in Standby or Stopped status a To export the content of the screen 1 Press to start the diagnostics action 2 Press 3 Press Send to File As screen is displayed asking you to insert the USB stick 4 Insert the USB stick 5 Press 6 Select the directory 7 Press to confirm the selection The data are copied to the USB stick File name format prt_yyyymm
45. E 69 Information about the ISE unit status E 69 Messages E 69 Safety E 70 List of ISE flags E 71 gt E 71 Air Fluid E 71 Air Isecal E 72 Cal E 72 Cal Error E 72 Calc Error E 73 Ise Unstab E 73 No Fluid
46. J Press to validate the results K Press to display result details L Press to display context information of the fluids used to arrive at this result Figure B 23 F B D A C G J L K H I E WARNING Incorrect results when using Use Old Calibrations are performed to compensate for changes over time in reagents and in the measurement systems Failing to perform calibrations when they are due may lead to incorrect results o Roche recommend performing a QC measurement before you continue working with the old calibration results o In the application definitions choose On for QC After Cal Utilities gt Applications gt Laboratory Parameters gt Control gt QC After Cal Roche Diagnostics Operator s Manual Version 3 0 B 67 cobas c111 6 Daily operation Performing calibrations Accepting calibration results Calibration results will be used by the system only when you have accepted them There can be only one unaccepted calibration result for a test If there already exists a not accepted calibration for a test and you place another cali bration order for this test the order will be blocked Roche Diagnostics B 68 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing QC Performing QC QC is performed at regular intervals to check the integrity of the whole measuring system Control A control is a sample that has been measured using all tes
47. QC history results qch_yyyymmddhhmmss csv Calibration results cal_yyyymmddhhmmss csv Process event log pev_yyyymmddhhmmss csv Roche Diagnostics B 106 Operator s Manual Version 3 0 6 Special operations cobas c111 Exporting data Interpreting result data The following tables list for the sample calibration and QC result files the column headings of the spreadsheet and provide information on the kind of information the columns contain res_yyyymmddhhmmss csv Column Title Description Instr Instrument ID always 30 for cobas c111 Msg Message Type 7 Result for sample control or calibration Index 166 ID of the data set used App Application code Date Date when the result was calculated Time Time when the result was calculated SW Version Software version installed on the instrument Serial Serial number of the instrument Test Short name of the application User User name SYS if Auto Accept is on Sample Sample ID Order Time Time when the order was started Result Results of the measurement Unit Defined display unit Flags Flag name Rates Rate value calculated in Abs Last Calculation Point First Calculation Point Raw1 Raw40 Absorbance value of cycle 1 through 40 in Abs one cycle 18 s isSTAT Generated as part of a STAT order Table 33 Explanations on test results Roche Diagnostics Operator s Manual Version 3 0 B 107 cobas c111 6
48. Replacing electrodes 8 Remove the electrode Lift it at the front to disengage then remove it 9 On the screen press the electrode button to confirm that you have removed the electrode You are asked to scan the barcode of the new electrode or to type its ID manually 10 Scan the electrode barcode on the package insert or type the ID manually If you want to install a dummy electrode scan its barcode You are asked to insert the new electrode 11 Insert the new electrode Push it back towards the contacts and press it down until it clicks into place 12 Fasten the tension lever 13 Close the electrode block lid 14 On the screen press the electrode button to confirm that you inserted the electrode If you inserted a dummy electrode press the button of the electrode you replaced with a dummy electrode A screen is displayed that shows detailed information on the electrode 15 Press 16 Close the ISE cover 17 On the ISE status screen press to continue the process A placement list is displayed Fixed electrode positions Always replace an electrode with the same type or with an ISE Dummy Electrode The ISE Reference Electrode must always be replaced with another ISE Reference Elec trode ISE Dummy Electrode is not allowed on this position Keeping the barcode Keep the electrode barcode in a safe place You will need it again in the case of a data base import At this stage if you wa
49. Start the QC measurement 5 Validate the QC results Workplace gt QC Status gt 6 Remove the control Performing all due QC measurements 1 Start the wizard Overview gt Order gt gt 2 Select a control and place the tube Repeat until there are no controls left on the screen n a 3 Start the QC measurement 4 Validate the QC results Workplace gt QC Status gt 5 Remove the controls Task Steps Navigation With wizard As individual steps Table B 1 Overview of the daily operation tasks Roche Diagnostics Operator s Manual Version 3 0 B 9 cobas c111 6 Daily operation Introduction Working with a host system Communication with the instrument is defined during installation e For an overview on working with a host system see Host connectivity on page A 33 9 Finishing the shift 1 Check for unfinished orders Workplace gt Orders Choose gt Not Finished 2 Check for non validated results Workplace gt Result Review Choose gt Not Accepted 3 Check for non transmitted results If working with a host system only Workplace gt Result Review Choose gt Not Sent to Host 4 Start the End Shift wizard Overview gt End Shift 5 Perform the daily backup Utilities gt Export gt Database 6 Export the full results Utilities gt Export gt Results 7 Clean up the database Workplace gt Orders gt Workplace gt Result
50. Version 3 0 5 Software cobas c111 Key screens Applications f Utilities gt Applications gt Laboratory Parameters There are list items of a lower level Select the item marked with and press again to expand the list and display the items The list is expanded Select the item marked with and press again to hide the items Print the application list With an item selected that is preceded by or expand or collapse the list With any other item selected change the selected item Import an application Define a new profile or a ratio Install an application Uninstall an application Delete a profile or uninstalled application Figure A 75 Applications table Roche Diagnostics Operator s Manual Version 3 0 A 113 cobas c111 5 Software Key screens Extra wash cycles f Utilities gt Applications gt Extra Wash Cycles Print the selected or all extra wash cycle definitions With an item selected that is preceded by or expand or collapse the list With any other item selected change the selected item Import a new extra wash cycle Delete the selected extra wash cycle Host codes f Utilities gt Applications gt Host Codes Print the mapping table Import the mapping table Export the mapping table as a text file Use the same test IDs for the cobas c111 instrument and the laboratory information system Figure A 76 Extra wash cycles table Figure A 77
51. Version 3 0 5 Software cobas c111 Working with the user interface 2 Use the scroll bar to display the hidden information e For details on scrolling see Scrolling on page A 75 Messages Messages are displayed in two ways o Immediate feedback on user actions is displayed in a pop up message screen o Information concerning a problem that occurred during operation is reported in the alarm monitor Message screen Message screens are displayed automatically as soon as the message is generated Read the message and press to close the screen Alarm monitor Messages concerning an irregularity that occurred during operation can be viewed in the alarm monitor The alarm LED alerts you when such messages are generated It is turned off when all alarm messages are confirmed The Alarm button is always active even if nobody is logged on the system Alarm button and LED Figure A 45 Message screen A Alarm LED B Alarm button Figure A 46 Alarm LED A B Roche Diagnostics Operator s Manual Version 3 0 A 83 cobas c111 5 Software Working with the user interface Interpreting the alarm LED No color off There are no unconfirmed alarm messages Yellow There is at least one unconfirmed alarm message You need to deal with it as soon as possible Red There is at least one unconfirmed alarm message You need to deal with it immediately processing may not be able to continue unless you d
52. cobas c111 5 Software Key screens Orders f Overview gt Order Press Order to define routine orders The process of defining an order and consequently which screens are displayed depends on how your cobas c111 instrument is integrated in your laboratory infrastructure barcodes host connection Identifying samples f Overview gt Order Order Interval QC Order Default QC Typing the sample ID f Overview gt Order If you work with barcodes additionally press e For information on how to use the keyboard screens see Typing text on page A 76 Order Interval QC Order Default QC Figure A 50 Figure A 51 Roche Diagnostics A 88 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Selecting tests profiles and ratios f Overview gt Order gt identify sample Tabs are used to group information into units that can be displayed on one screen The system administrator can define up to six test tabs name them and assign tests profiles and ratios to them The tests profiles and ratios are sorted alphabetically Profiles and ratios precede the tests and they adopt the color of their tests The test is on board and ready for use The test has already been pipetted The test is blocked A Easy mode test board all tests fit on one screen B Tabs marked with an asterisk contain selected tests C Full mode test board The tests are grouped
53. cobas c111 Index Index A abbreviations 9 abbreviations ISE E 5 aborting the process A 121 Abs air water calibration maintenance action C 28 absorbance adjustment definitions B 169 absorbance measurements process A 19 absorbance photometer A 63 acceptable flags list editing B 162 accepting calibration results B 66 QC results B 74 sample results B 57 acoustic signals A 83 D 6 Activate electrodes maintenance action E 45 adding lots B 101 adjusting touchscreen B 130 air water calibration C 28 alarm button A 82 alarm LED A 82 alarm messages checking A 83 confirming D 9 exporting log D 9 overview A 83 printing D 8 reacting to D 7 D 44 alarm monitor overview A 82 D 6 alarms checking A 83 LED A 82 LED colors A 83 monitor A 82 analyzer See instrument analyzing checking the progress B 44 samples B 34 application codes mapping B 162 applications B 137 activating B 139 calculation definitions B 155 calibration definitions B 153 control definitions B 154 deactivating B 139 definitions B 152 deleting B 144 general definitions B 152 importing B 111 B 137 installing B 112 B 138 preparing B 140 result conversion definitions B 156 screen A 112 un
54. o Remove the locking ring C from the base of the ISE tower by turning it counter clockwise one quarter of a turn and then lifting it over the ISE tower o Lift the ISE tower A Check whether any O ring is stuck to the ISE tower If so remove it and place it back in its position on the ISE tower base o Disconnect the tubing B C A Do not remove the piece of tubing at the underside of the mixing tower It will be changed when a service representative performs periodic maintenance Roche Diagnostics E 60 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions 12 Slide off the lid of the fluid distributor 13 Disconnect the tubing from the electrode block o Open the electrode block lid o Release the tension lever o Lift the connector on the side of the K electrode o Disconnect the tube on the side of the tension lever o Lift the connector to the ISE Reference Electrode and disconnect the tube leading to the ISE Reference Solution bottle 14 Disconnect the tubing connecting to the peristaltic pump Removing the tubing 15 Lift the tubing from its routing follow carefully the individual tubes 16 Dispose of the tubing Treat it as biohazardous waste Installing the new tubing 17 Install and connect the tubing in the order recommended on the illustration on the ISE tubing set cover When installing the single items perform the individual steps in revers
55. 2 min ISE measurements Roche Diagnostics Operator s Manual Version 3 0 A 67 cobas c111 4 Technical specifications Water purity Calibrators Reagent bottles Cuvettes Photometer ISE unit Software data handling Mass storage Interfaces Display Printer Minimum requirements Electrical resistivity M cm 25 C gt 1 Electrical conductivity S cm 25 C lt 1 Silicate SiO2 mg L lt 0 1 Particulate matter size m n a Bacteria CFU mL lt 1000 Whenever the term purified water is used in this document water of at least the quality specified above must be used Roche recommends using Reagent Grade water Roche calibrators See the package inserts of the reagents Reagent bottles 20 mL maximum Identification Barcode Barcode 2 D format PDF417 Number of tests 50 200 tests depending on the test Segments of 10 cuvettes Manual insertion and removal of segments Single use Cuvettes are for single use only Static incubation temperature in cuvette 37 C 0 5 C Absorbance photometer 20 W halogen lamp 12 wavelengths 340 659 nm Sensor Photosensitive diode array Ion selective electrode Indirect measurement Sample volume 15 L Dilution 1 6 1 part sample 5 parts water 3 Electrodes 1 ISE Reference Electrode Na K Cl Operating system o LINUX o VX Works CPUs Intel XScale Memory system o Flash ROM o DRAM o SRAM
56. 3 Start the QC measurement 4 Validate the QC results Workplace gt QC Status gt 5 Remove the controls n a Performing an individual QC measurement 1 Start the wizard Workplace gt QC Status gt 2 Select a test n a 3 Select a control and place the tube Repeat until there are no controls left on the screen n a 4 Start the QC measurement 5 Validate the QC results Workplace gt QC Status gt 6 Remove the control Performing all due QC measurements 1 Start the wizard Overview gt Order gt gt 2 Select a control and place the tube Repeat until there are no controls left on the screen n a 3 Start the QC measurement 4 Validate the QC results Workplace gt QC Status gt 5 Remove the controls 9 Finishing the shift 1 Check for unfinished orders Workplace gt Orders Choose gt Not Finished 2 Check for non validated results Workplace gt Result Review Choose gt Not Accepted 3 Check for non transmitted results If working with a host system only Workplace gt Result Review Choose gt Not Sent to Host 4 Start the End Shift wizard Overview gt End Shift 5 Perform the daily backup Utilities gt Export gt Database 6 Export the full results Utilities gt Export gt Results 7 Clean up the database Workplace gt Orders gt Workplace gt Result Review gt Workplace gt QC Status gt Work
57. C Roche Diagnostics Operator s Manual Version 3 0 A 59 cobas c111 3 Hardware Hardware overview Reagent disk container For storage outside the instrument the reagent disk is placed in a container This reduces evaporation of reagents and prevents their contamination Reagent cooler The reagent cooler holds the reagent disk with its reagent bottles The temperature in the cooler is kept within the range of 6 to 10 C e See maintenance action Clean reagent disk and sample area on page C 14 A Reagent cooler Figure A 27 Reagent cooler A Roche Diagnostics A 60 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Cuvette ring The cuvette ring holds up to 6 cuvette segments each containing 10 cuvettes Cuvettes fit neatly in the cuvette ring without touching the walls when being moved along the ring e See Preparing the reagents on page B 22 See maintenance action Clean reagent disk and sample area on page C 14 A Cuvette ring B Cuvette segment Figure A 28 Cuvette ring A B Roche Diagnostics Operator s Manual Version 3 0 A 61 cobas c111 3 Hardware Hardware overview Barcode scanner A hand held barcode scanner is used for reading barcoded labels e For information on how to use the barcode scanner see Using the barcode scanner on page B 89 The following containers are always supplied with barcodes o Reagent bottles o Dilue
58. Choose Workplace gt Calibrations gt 2 Press to select all tests that currently need calibrating 3 Check and if required print the placement list 4 Prepare and place the calibrators according to the placement list 5 Press Perform all calibrations that will be due within the forecast period 1 Choose Workplace gt Calibrations gt 2 Press to select all tests that will require cal ibrating within the forecast period 3 Check and if required print the placement list 4 Prepare and place the calibrators according to the placement list 5 Press Perform an individual calibra tion 1 Choose Workplace gt Calibrations gt 2 Select the test 3 If there is more than one reagent set on board for this test choose whether to calibrate the cur rent set or to precalibrate a standby set 4 Check and if required print the placement list 5 Prepare and place the calibrators according to the placement list 6 Press 2 Validate the results 1 Choose Workplace gt Calibrations 2 Select the calibration result 3 Press to look at result details 4 Press to validate the calibration 5 Remove the calibrators Table B 5 Steps for performing calibrations Roche Diagnostics Operator s Manual Version 3 0 B 61 cobas c111 6 Daily operation Performing calibrations Process of performing calibrations The process of defining calibration orders depends on wh
59. Define whether QC should be performed after calibration of the test QC After Cal o Define whether the test should have QC performed as part of the Default QC function Default QC is an automated process for performing all QC measurements that are currently due This is the ideal method if you want to perform QC periodically during routine operation On QC will be performed collectively for all tests that use a certain control Off QC has to be ordered manually for each test 18 Press to confirm the definitions Calibration definition changes require subsequent calibration of the tests Roche Diagnostics B 142 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications Ratio Calculation definitions 19 For applications that use a ratio perform the following steps o Expand the Ratio Calculation entry select Coefficient w and press o Define one or two coefficients o Define the formula 20 Press to confirm the definitions Calculation definitions 21 Expand the Calculation entry select Factor and press 22 Change the factor and offset if correlating two different methods 23 Choose whether valuation a reference range should be employed or not If you choose Reference Range you need to define an upper and lower limit and decide which of them should be taken into account or whether both of them 24 Define whether the lower limit is used if required 25 Define whether t
60. Direct contact with cleaning solutions or other working solutions may cause personal injury When handling such solutions exercise the precautions required for handling them observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch moving parts during instrument operation Infection by biohazardous materials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Incorrect results due to build up of contaminants During use contaminants may adhere to the probe As a result traces of analytes or reagents may be carried over to the next Make sure to perform the probe maintenance actions as soon as they are due in order to prevent potentially false results Incorrect results or damage to the analyzer due to dust and soiling The user
61. External USB memory stick Internal Flash ROM USB1 1 2 0 For backing up data or loading data on the system memory stick USB1 1 2 0 Modem 2 x RS232 Host barcode scanner Color touchscreen 5 7 inch active matrix 1 4 VGA 320 x 240 pixels Internal thermal printer Paper width 112 mm Roche Diagnostics A 68 Operator s Manual Version 3 0 4 cobas c111 Technical specifications Roche Diagnostics Operator s Manual Version 3 0 A 69 cobas c111 5 Software Table of contents Software Getting the most out of the instrument In this chapter you will find information on how to operate the instrument by using the touchscreen You will find out about the concept of wizards and you are introduced to the key screens Introduction A 71 Screen layout A 72 Display items A 73 Color concept A 74 Workflows and wizards A 74 Navigation
62. Global action button Abort When the system is in Operating status Stop immediately all processing activities Pipettings that were not finished are considered not pipetted Measurements that have not yet yielded a valid result are considered not measured Recover When the system is in Standby or Stopped status Initialize all systems and modules that are currently not ready Sampling stop Finish the current pipetting action but do not start a new one You can restart processing by pressing Stop printing Stop the current printing task It may take a few moments before printing actually stops Shutdown Shut down the cobas c111 software and the operating system This option is active in Standby status only Restart Shut down the cobas c111 software and automatically restart it This option is active in Standby status only It is used in cases where a configuration change requires restarting the software for it to become effective Figure A 85 Stop options Roche Diagnostics A 122 Operator s Manual Version 3 0 5 Software cobas c111 Color interpretation for LEDs Color interpretation for LEDs The following table lists the LEDs and explains what their colors mean A Sample area LED B Global button LEDs from top Start LED Stop LED Alarm LED C Main cover LED Figure A 86 The cobas c111 instrument LED Color Meaning Main cover LED Off No activities in this area You can open
63. Perform restart 7103 s Adjustment of the ISE Ref bottle or ISE Cal bottle weight sensor failed Repeat the adjustment In lt Diagnostics gt perform lt Adjust ISE Ref Bottle Sensor gt and lt Adjust ISE Cal Bot tle Sensor gt If the error persists call service 7107 s A not specified hardware error d was reported by the ISE Unit Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7108 s A not specified hardware error d was reported by the DC Slave control Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7109 d The sample probe is bent or not properly aligned Check the probe and replace it if necessary Restart the sys tem If the error persists call service 7110 d A timing error occurred while fluid is expelled into a cuvette Probably the error was caused by a previous hardware problem Check for previous errors Restart the system If the error persists call service 7111 d Transfer movement failed due to open cover Keep covers closed while the system is in Operating status ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics Operator s Manual Version 3 0 D 17 cobas c111 9 Messages and alarms List of alarm messages 7112 s The ISE refere
64. Reading reagent bottle barcodes B 89 Reading barcodes from sheets B 90 Reading sample tube barcodes B 90 Roche Diagnostics Operator s Manual Version 3 0 B 5 cobas c111 6 Daily operation Introduction Introduction Daily operation includes the routine tasks that are required to prepare and monitor the system and to analyze samples Safety information Before you start working with the cobas c111 instrument it is essential that you both read and understand the safety information listed below Read carefully all safety notices given in instructions and make sure you understand them The screen representations shown in this chapter and throughout this manual are for illus trative purposes only The screens do not necessarily show valid data WARNING Injury through reagents and other working solutions Direct contact with reagents cleaning solutions or other working solutions may cause personal injury When handling reagents exercise the precautions required for handling laboratory reagents observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions Infection by biohazardous mate
65. Remove the tubing adapters from ISE Calibrator indirect urine and ISE Reference Solution bottles 8 Press to confirm the removal The tubing is drained 9 Remove the tubing from the adapters The two tubing adapters are slightly different but the process of removing the tube is the same o Have a tissue ready o Remove the tubing adapter by lifting it and place it on the clean lint free tissue o Remove the tube from its clips o Remove the nozzle from the tube by pulling it off o Pull through the tube from the top of the adapter Place the adapter together with its nozzle on the tissue Removing the pinch valve caps and clamps 10 Remove the pinch valve caps and clamps of the input B entry C and exit A valve plates A ISE Reference Solution tubing adapter B ISE Calibrator indirect urine tubing adapter Figure E 13 B A B C A Roche Diagnostics Operator s Manual Version 3 0 E 59 cobas c111 14 ISE maintenance ISE maintenance actions To remove a pinch valve cap and clamp o Push the cap horizontally in the direction of the arrow away from the cut out o Lift and put it aside o Lift the valve clamp and put it aside Disconnecting the tubing from ISE tower 11 Disconnect the tubing from the ISE tower o Remove the ISE overflow collector B by pulling it upwards and turning it from side to side as you do so Place the collector behind the wash station
66. Repeat with fresh reagent gt R 2 2s Meaning Two sequential control measurements are above the 2 standard deviation Message ID 29 Priority 26 Possible cause o The controls are not properly prepared o The controls are not properly positioned on the instrument Recommended actions 1 Repeat with fresh control 2 Check that the correct control material has been used 3 If the flag reappears check the calibration and reagent status Repeat with fresh reagent lt R 2 2s Meaning Two sequential control measurements are below the 2 standard deviation Message ID 29 Priority 26 Possible cause o The controls are not properly prepared o The controls are not properly positioned on the instrument Recommended actions 1 Repeat with fresh control 2 Check that the correct control material has been used 3 If the flag reappears check the calibration and reagent status Repeat with fresh reagent Roche Diagnostics D 36 Operator s Manual Version 3 0 10 Result flags cobas c111 List of flags gt Reag Rng Meaning Absorbance above defined reagent range o During calibration the absorbance value of the lowest calibrator is above the upper defined range Message ID 12 Priority 7 Possible cause Deteriorated or outdated calibrator or reagent Recommended actions 1 Check the calibration and reagent expiry dates 2 Repeat with fresh lowest calibrator 3 If the
67. Version 3 0 Roche Diagnostics Operator s Manual Version 3 0 5 cobas c111 Table of contents Document information 2 Contact addresses 3 Table of contents 5 Preface 7 How to use this manual 7 Online Help system 7 Conventions used in this manual 8 System Description Part A 1 Safety Safety classification A 5 Safety information A 5 Data security A 10 License notices A 11 Legal liability A 11 Disposal recommendation A 12 Safety labels A 13 2 Introduction to the instrument Overview A 17 User interface A 20 Wizards A 21 Daily operation A 22 Maintenance A 34 System status A 35 3 Hardware Covers and panels A 39 LEDs A 41 Main components A 43 Hardware overview A 44 Technical specifications A 66 5 Software Introduction A 71 Screen layout A 72 Display items A 73 Workflows and wizards A 74 Working with the user interface A 75 Key screens A 84 Color interpretation for LEDs A 122 Buttons A 124 Operation Part B 6 Daily operation Introduction B 5 Starting the shift B 10 Preparing the system B 12 Analyzing samples B 34 Validating sample results B 51 Performing calibrations B 59 Performing QC B 68 Finishing the shift B 77 Logging off B 88 Switching off the system B 88 Using the barcode scanner B 89 6 Special operations Deleting sample orders B 93 Deleting sample results B 94
68. Version 3 0 5 Software cobas c111 Working with the user interface Expanding and collapsing lists In hierarchically structured lists you initially see only the top level entries List items that contain but hide lower levels of entries are marked with List items that display lower levels of entries are marked with a To expand a list 1 Select a list item marked with 2 Press again or press 3 Use the scrollbar if required to display the items you are interested in a To collapse a list 1 Select a list item marked with 2 Press again or press Typing text There are dedicated screens for typing alphanumeric and numeric characters You can choose from the following screens o Alphanumeric upper case o Alphanumeric lower case o Special characters o Numeric characters Figure A 38 Hierarchically structured list Roche Diagnostics Operator s Manual Version 3 0 A 77 cobas c111 5 Software Working with the user interface Numeric keyboard Delete the last character displayed in the text line A Z Switch to the uppercase alphanumeric keyboard Alphanumeric keyboards Switch to the lowercase keyboard Switch to the uppercase keyboard Delete the last character displayed in the text line Switch to the special characters keyboard Press to insert a space A Typed text Figure A 39 Numeric keyboard screen A A Typed text Figure A 40 U
69. Version 3 0 8 General maintenance cobas c111 Maintenance actions Preparing the instrument 13 Reinsert the sample tray 14 Close the right service flap and the main cover 15 Press The system automatically initializes the instrument A message will inform you when the maintenance action is complete 16 Press 17 Perform an air water calibration You cannot process orders unless you perform this action e See Perform an air water calibration on page C 28 Roche Diagnostics Operator s Manual Version 3 0 C 27 cobas c111 8 General maintenance Maintenance actions Contact service representative f Utilities gt Maintenance gt Call Service Rep To ensure smooth operation of the instrument a service representative periodically needs to perform some preventive maintenance tasks The system displays a message when this maintenance action is due Operator time Approximately 2 minutes A service representative takes about 3 hours to perform preventive maintenance for a system without an ISE unit 4 hours including the ISE unit Prerequisites None a To initiate preventive maintenance 1 A message screen reminds you that you should contact your service representative 2 Select the maintenance action Call Service Rep 3 Press The maintenance definition screen is displayed 4 Press An instructions screen is displayed 5 Contact your service representative to arrange
70. With absorbance tests that require several calibrators the calibrators are placed according to their concentration starting with the highest concentration You can delete a running calibration order After deleting the order the calibration retains the Due status if it was due before Roche Diagnostics Operator s Manual Version 3 0 B 63 cobas c111 6 Daily operation Performing calibrations 8 Validate the calibration results e See Validating calibration results on page B 64 9 Remove the calibrator tubes a To replace the current lot calibration 1 Choose Workplace gt Calibrations A screen is displayed that lists all tests and their currently valid calibration 2 Select the test whose lot calibration want to replace 3 Press to delete the result 4 Press to confirm the deletion 5 Load the new reagent set See Adding a reagent set on page B 26 You can only generate a new lot calibration result when calibrating a new reagent set 6 Choose Workplace gt Calibrations 7 Press 8 Select the test 9 Press If a screen is displayed for selecting the calibration type choose Lot Master 10 Prepare the calibrators 11 Place the calibrators on the sample area positions indicated on the placement list 12 Press to confirm the placement 13 Press to start the calibration Deleting ordered calibrations You can delete a calibration order while it is being processed
71. a To define a calibrator lot 1 Choose Workplace gt Lot Data 2 Press Calibrators A screen is displayed that lists all installed calibrator lots 3 Press A screen is displayed asking you to scan the barcode or to type the data manually 4 Define the lot values Do one of the following If Do this The lot data are available from a bar code 1 Scan the barcode The screen is displayed again that lists all installed calibrator lots The new lot is selected You want to type the data manually 1 Press 2 Type the name up to 10 alphanumeric characters and press 3 Type the material code and press Refer to the package insert 4 Type the lot ID up to nine alphanumeric characters and press 5 Type the expiration date and press Use the date format as indicated on the screen 6 Type the number of calibrators cups you need to place on the instrument Use the information given on the package insert Exclude calibrators that use system water from this number See step 14 7 Press to confirm the definitions 8 Press Add new test 9 Press A screen is displayed that shows all tests that have this calibrator defined for them and that are not yet assigned to this lot 10 Press one of the test buttons 11 Press 12 Define the first calibration value target value 13 Define the next calibration value You can define up to six calibration values and you
72. cobas c111 14 ISE maintenance ISE maintenance actions Initialize ISE unit f Utilities gt Maintenance gt Initialize ISE Unit Initializing the ISE unit uses Activator to condition the electrodes and to adjust the sensors and the pump action This ensures proper transportation of fluids through the ISE tubing Operator time Approximately 3 minutes Prerequisites The system must be in Standby status Tools and materials required m Activator a To initialize the ISE unit 1 Select the maintenance action Initialize ISE Unit 2 Press The maintenance definition screen is displayed 3 Press to start the action A placement list is displayed 4 Place the Activator on the sample area positions indicated on the screen 5 Press to confirm the placement and to start the action A message will inform you when the maintenance action is complete 6 Remove the Activator from the sample area 7 Press Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Infection by biohazardous materials on page E 42 Roche Diagnostics E 54 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Replace ISE pump tubing f Utilities gt Maintenance gt Replace ISE Pump Tubing Replacing the pump tubing ensures proper ISE pump action During the Replace ISE Pump Tubing mai
73. container Used for diluting the samples controls and standard solu tions and for cleaning purposes It is also used during ISE ini tialization Sample Sample area Sample tubes are placed on the sample area of the main instrument and pipetted by the main instrument probe Waste Internal waste tank The waste is first pumped into the internal waste tank of the main instrument and then to the external waste container Table E 1 Solutions used with ISE analysis WARNING Incorrect results due to changes in fluids The chemical composition of ISE fluids changes over time The assigned on board stability is the interval within which the quality of the fluid remains within the prescribed tolerances Using fluids whose interval has expired may lead to incorrect results Always exchange the fluids when an interval has expired Follow the instructions given on the screen Roche Diagnostics Operator s Manual Version 3 0 E 9 cobas c111 12 ISE description Hardware Hardware The ISE unit is designed as an add on unit to the cobas c111 main instrument It will be installed by your service representative Panels The ISE cover has two joints The front cover provides access to the parts you may need to handle during daily operation Opening the back cover as well provides access to the peristaltic pump and its tubing Left side panel Provides access to o ISE power supply o ISE connectors Switch off th
74. d 0001 A fatal system exception software error d occurred Restart the system If the error recurs export the log files while the system stays in the error condition If the error persists call service 0002 An internal software error d occurred while updating the configuration Restart the system If the error recurs export the log files while the system stays in the error condition If the error persists call service 0003 A software error occurred Order d d could not be processed Delete the orders that are not processed yet If the error recurs export the log files while the system stays in the error condition If the error persists call service 0004 A software error occurred The unit is not ready order d rejected Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 0005 A mathematical exception arose Repeat the order If the error recurs export the log files with the system remaining in this error condition If the error persists call service 0006 Last calculation cycle d too short Repeat the order If the error recurs export the log files with the system remaining in this error condition If the error persists call service 0007 Failed to calculate linear regression Repeat the order If the error recurs export the log files with the system remaining in this error condition If the error persists c
75. in tabs Figure A 52 Test selection screens A B C CA Roche Diagnostics Operator s Manual Version 3 0 A 89 cobas c111 5 Software Key screens The expiration date of the test has passed There are only few tests left A QC is due or its result has not been accepted A more recent version of the application has been imported For a development channel An extra wash cycle is missing The test is defined but not on board A required diluent or cleaner is not on board Display a screen that contains information on the status of each test STAT f Overview gt STAT Press STAT to define urgent short turn around time orders The process of defining a STAT short turn around time order is identical to that of defining a routine order The difference lies in the scheduling of the tasks When a STAT order is defined it will be the next order to be processed irrespective of what routine orders already exist Existing STAT orders are finished first Roche Diagnostics A 90 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Tests Displaying the test overview f Overview gt Tests Tabs The tabs are displayed if you work with the order mode Full They represent user defined test panels If you work with the order mode Easy all tests are on one panel and there are no tabs The color of a test button represents its status The test is on board and ready for
76. see Performing calibrations on page B 59 By default all calibrations that are due or will be due within the forecast period are taken into account during the Prepare phase When mixing reagents without using the Prepare wizard Choose Overview gt Press the reagent set button and then The system must be in Standby status Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page B 5 o Infection by biohazardous materials on page B 5 WARNING Skin inflammation caused by reagents Direct contact with reagents may cause skin irritation inflammation or burns When handling reagents be sure to wear protective equipment and observe the cautions given in the package insert Incorrect results due to expired calibration Calibrations are performed to compensate for changes over time in reagents and in the measurement systems Failing to perform calibrations when they are due may lead to incorrect results Make sure to perform calibrations when they are due Incorrect results due to wrong tube placement Be sure to place the calibrators in the specified positions Roche Diagnostics Operator s Manual Version 3 0 B 31 cobas c111 6 Daily operation Preparing the system a To perform the calibrations A screen is displayed that shows all active tests Ch
77. 0 6 Special operations cobas c111 Refilling printer paper Refilling printer paper You can refill the printer paper any time provided printing is not in progress a To check the printer status 1 On the Overview tab press the System status button The printer button is red if the printer is out of paper 2 Scroll to display the Printer entry and read the text a To replace the printer paper 1 Make sure the printer is not currently printing 2 Open the printer panel 3 Lift the empty printer paper roll from its holder 4 Remove the pin from the roll 5 Insert the pin in the new roll 6 Place the new roll on the holder Make sure the paper unrolls at the top and towards you Be sure to press down the release button A firmly before you pull the panel The panel should open without resistance A Roche Diagnostics Operator s Manual Version 3 0 B 123 cobas c111 6 Special operations Refilling printer paper 7 Insert the paper in the slot in the printer panel and pull some through 8 Close the printer panel The system feeds some paper If the system ran out of paper during printing it will resume printing 9 On the Overview tab press the System status button The printer button should now be green and the status description should be OK Roche Diagnostics B 124 Operator s Manual Version 3 0 6 Special operations cobas c111 Removing condensation water
78. 4 Remove the transfer head cover Press the release buttons on both sides and lift 5 Remove the probe with its holder o Remove the tube from at least the first two tubing clips o Press the release button on the side of the probe holder carriage and lift the probe holder with the probe Be careful not to pull the tubing Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 o Incorrect results due to build up of contaminants on page C 8 o Infection by biohazardous materials on page C 8 Roche Diagnostics Operator s Manual Version 3 0 C 13 cobas c111 8 General maintenance Maintenance actions 6 Hold the assembly by the probe holder and clean the probe using a tissue moistened with 70 ethyl alcohol Wipe from top to bottom several times 7 Wipe the side of the probe holder that faces the level detection contact Use a tissue moistened with 70 ethyl alcohol 8 Reinstall the probe holder with the probe Press the release button on the side of the probe holder carriage before you insert the probe holder Release the button when the holder is inserted Push down firmly until the release button latches on 9 Fix the tube to the tubing clips 10 Reinstall the transfer head cover Press down until the release buttons latch on 11 Press The system au
79. 5 Insert the USB stick 6 Press A screen is displayed that shows the file structure on the stick You should see the c111_xx tar file where xx stands for the language abbreviation for example c111_en tar represents the English language file 7 Select the c111_xx tar file 8 Press to confirm the selection The software is installed on the system A message will inform you when the installation is complete 9 When the installation is complete remove the USB stick For the language to become active you need to restart the system 10 Press 11 Press Restart The system will shut down and automatically restart When startup is complete the Overview tab is displayed and the system is in Standby status 12 Wait until the system is in Standby status a To change the user interface language 1 Choose Utilities gt Configuration gt System 2 Expand the list 3 Select Language 4 Press A screen is displayed that contains a button for each of the currently installed languages The buttons are labelled with the two letter language abbreviation e See Table B 20 on page B 158 Roche Diagnostics B 160 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration 5 Press the button for the required language 6 Press For a language to become active you need to restart the system 7 Press 8 Press Restart The system will shut down and automatically
80. A 109 Maintenance A 110 Applications related functions A 111 Applications A 112 Extra wash cycles A 113 Host codes A 113 Reagent mixing A 114 Process sequence A 115 Diagnostics A 116 Inventory A 117 Import A 118 Users A 119 Export A 120 Stopping a run
81. Alarm button The most recently generated alarm message in this list is displayed Which messages are included in this list depends on the filter criteria that are applied to it 3 To limit the number of messages that are contained in the list press A list of filter options is displayed o Select Not confirmed to include in the list all alarm messages that have not yet been confirmed by the user o Select Today s alarms to include in the list all alarm messages that so far have been generated on the current day o Select Complete list to include in the list all alarm messages that are stored in the alarm database No color Off There are no unconfirmed alarm messages Yellow There is at least one unconfirmed alarm message You need to deal with it as soon as possible Red There is at least one unconfirmed alarm message You need to deal with it immediately processing may not be able to continue unless you do so An acoustic signal is sounded when an alarm is generated You can adjust the volume Utilities gt Configuration gt System gt Volume A Alarm ID B Total number of messages in the list C Display the previous alarm message D Problem description and short remedy suggestion E Display the next alarm message F Display additional information G Display the filter options for the alarm list Figure D 3 B D A C E F G The alarm list can contain up to 250 messa
82. B 58 validating B 51 validating if sample on board B 52 validating if sample removed B 53 Roche Diagnostics F 20 Operator s Manual Version 3 0 Index cobas c111 samples analyzing B 34 barcodes A 62 checking the status B 44 handling A 31 introduction to handling A 31 overview B 50 reading barcodes B 90 short guide B 35 specifications A 66 sampling stop A 121 scanners A 61 scheduling calibration B 96 screens alarms A 82 applications A 111 applications list A 112 calibration list A 104 configuration A 109 cuvette status A 92 diagnostics A 116 display items overview A 73 expanding and collapsing lists A 76 export A 120 external bottle status A 96 extra wash cycles A 113 host codes A 113 import A 118 inventory A 117 ISE status A 94 keyboards A 76 layout A 72 Loadlist A 107 lot data A 105 lot list A 106 maintenance A 110 messages A 82 D 5 navigation A 74 orders list A 98 QC history A 102 QC history graph A 103 QC list A 101 QC status A 101 reagent mixing A 114 A 115 reagent status A 93 result list A 99 sample overview A 86 scrolling A 75 stopping processing A 121 sy
83. Calibration B 95 Deleting QC results B 96 Lot handling B 98 Exporting data B 104 Importing data B 111 Preparing a new disk B 116 Assigning tests to test tabs B 119 Deleting bottle sets from the Inventory list B 120 Refilling printer paper B 122 Removing condensation water from the reagent cooler B 124 Replacing the probe B 125 Connecting and disconnecting the external fluid containers B 127 Adjusting the touchscreen B 130 Cleaning the touchscreen B 131 7 Configuration Introduction B 135 Applications B 137 Configuration B 157 Maintenance Part C 8 General maintenance Overview C 5 Maintenance actions C 8 Roche Diagnostics 6 Operator s Manual Version 3 0 cobas c111 Troubleshooting Part D 9 Messages and alarms About messages D 5 Message screen D 5 Acoustic signals D 6 Alarm monitor D 6 List of alarm messages D 10 10 Result flags About flags D 25 Safety D 27 List of flags D 28 11 Troubleshooting Introduction D 41 Dealing with exceptional situations D 42 Reacting to messages D 44 Detailed procedures D 46 ISE Part E 12 ISE description Overview E 5 Hardware E 9 Basic operation E 12 Technical specifications E 13 13 ISE operation Daily operation E 17 Replacing ISE fluid bottles E 30 Replacing electrodes E 32 Cleaning the ISE tower off the instrument E 36 14 ISE maintenance Int
84. Code mapping table Roche Diagnostics A 114 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Reagent mixing f Utilities gt Applications gt Reagent Mixing Print the selected or all mixing rules Delete the selected mixing rule Figure A 78 Reagent mixing rules table Roche Diagnostics Operator s Manual Version 3 0 A 115 cobas c111 5 Software Key screens Process sequence f Utilities gt Applications gt Process Sequence Print the process sequence list In the Priority list move the item up In the Priority list move the item down Move the selected test to the Priority list Move the selected test to the Default list Move all tests from the Priority to the Default list Figure A 79 Processing priority table Roche Diagnostics A 116 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Diagnostics f Utilities gt Diagnostics You can choose one of the following options o All o Selected Print the actions of the selected action group With a topic selected expand or select the list With a diagnostic action selected Perform the selected action Diagnostics actions are designed for use by Roche representatives or when instructed by them to do so Therefore these functions are not described in this manual You need at least Lab Manager user rights to perform diagnostics functions Figure A 80 Diagnostics li
85. Color Meaning for buttons Green The element is OK Yellow Your intervention is required to ensure continuous operation Red Your immediate intervention is required Operation has stopped Blue The item is selected Table A 10 Color concept A Button where you started B Current position in the workflow C Headline Figure A 36 Headline with navigation path B A C Roche Diagnostics Operator s Manual Version 3 0 A 75 cobas c111 5 Software Working with the user interface Working with the user interface Adjusting the touchscreen With a touchscreen it is important that the point where you press the screen corresponds exactly with its hardware equivalent If this were not the case pressing a screen item such as a button might not lead to the expected result e See Adjusting the touchscreen on page B 130 Scrolling If not all text or all list elements fit on one screen or display area use the scrolling function to display the hidden content Scroll to the previous page Select the previous line and scroll if necessary Select the next line and scroll if necessary Scroll to the next page A You are on the first page You can scroll down B There is text both before and after the currently displayed text You can scroll up and down C You are on the last page You can scroll up Figure A 37 Scroll bars C A B Roche Diagnostics A 76 Operator s Manual
86. Diagnostics Operator s Manual Version 3 0 F 21 cobas c111 Index syringe assembly A 46 hardware A 46 system definitions B 168 logging on B 11 preparing B 12 preparing ISE E 20 See also instrument system status overview A 35 screen A 95 systems fluid A 45 See also units assemblies T tabs B 119 assigning tests B 119 Overview A 84 removing tests B 120 Utilities A 108 Workplace A 97 technical specifications A 66 test panels assigning tests B 119 test selection screen A 88 test status screen A 90 tests adding to profile B 148 assigning to tabs B 119 defining profiles B 148 performing B 34 removing from profile B 149 removing from tabs B 120 repeating B 55 rerunning B 56 text typing A 76 third party software A 8 throughput specifications A 66 touchscreen adjusting B 130 trademarks 2 transfer head A 48 transfer unit A 48 transmission checking of results B 81 transport safety A 5 troubleshooting ISE E 67 main instrument D 39 tube bottom detection A 49 tubes A 54 disconnecting from instrument B 129 tubing conditioning E 46 connecting to instrument B 127 disconnecting from instrument B 129 installing for ISE E 61 ISE E 11 replaci
87. Export the log files If the error persists call service 13010 A software error occurred An invalid database entry d for a control was detected Export the log files If the error persists call service 13011 Validation of Development Channels failed The number of installed DC applications does not match the number of available channels d DC applications found d channels installed 13012 Auxiliary reagent d not found Ensure that the reagent bottle has been loaded If the error recurs export the log files with the system remaining in this error condition If the error persists call service 13013 Reagent bottle d not found Ensure that the reagent bottle has been loaded If the error recurs export the log files with the system remaining in this error condition If the error persists call service 13014 Calibrator lot definition for application d inconsistent Check number of standards used with number of calibrator cups and Last Is Water definition 20001 lt Replace Water Inlet Filter gt completed 20002 lt Clean Water and Waste gt completed 20003 lt Replace Photometer Lamp gt completed 20004 lt Clean Probe Manually gt completed 20005 lt Prime Fluid System gt completed 20006 lt Clean Housing gt completed ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics Operator s Manual Version 3 0 D 21 cobas c111 9 Messages and alarms List
88. ISE tower Removing the ISE tower 1 Make sure the system is in Standby status 2 Switch off the instrument 3 Move the transfer head to its rightmost position 4 Open the main cover and the left service flap 5 Remove the ISE overflow collector by pulling it upwards and turning it from side to side as you do so Place the collector behind the wash station Make sure that you have read and understood section Safety information on page E 19 The following warning messages in particular are relevant o Infection by biohazardous materials on page E 19 o Injury through reagents and other working solutions on page E 19 A ISE tower B ISE overflow collector C Locking ring Figure E 7 B C A Roche Diagnostics Operator s Manual Version 3 0 E 37 cobas c111 13 ISE operation Cleaning the ISE tower off the instrument 6 Remove the locking ring from the base of the ISE tower by turning it counter clockwise one quarter of a turn and then lifting it over the ISE tower 7 Lift the ISE tower and carefully disconnect the tubing Check whether any O ring is stuck to the ISE tower If so remove it and place it back in its position on the ISE tower base Cleaning the ISE tower 8 Clean the inside of the ISE tower with a cotton swab to remove any visible clots 9 Pour ISE Deproteinizer in the beaker 10 Soak the ISE tower in the ISE Deproteinizer for about 5 minutes If there are clots in th
89. It is used on the screens for example on the test selection screen or the results list 6 Type the long name and press The long name must be unique on the cobas c111 system and consists of up to 30 alphanumeric characters Use a name that is commonly known in your laboratory environment 7 Select the first application and press You can define between one and four applications 8 Define the other applications if required 9 Type the first coefficient and press You can define between one and four coefficients 10 Define the other coefficients if required 11 Type the formula and press The formula relates the applications with the coefficients You can use the following operands space and application subindex 1 and 2 Roche Diagnostics Operator s Manual Version 3 0 B 147 cobas c111 7 Configuration Applications 12 Type the factor to compensate for differences in measuring methods of different instruments then press 13 Type the offset and press 14 Select whether the offset correlation factor is going to be used or not then press 15 Select the valuation type then press No valuation means that no valuation will be performed Reference range means that the result will be compared with the defined reference ranges 16 Select whether the low range will be used or not then press 17 Select whether the high range will be used or not then press 1
90. Load the missing fluid Roche Diagnostics Operator s Manual Version 3 0 B 25 cobas c111 6 Daily operation Preparing the system Displaying detailed information on a reagent set 3 Press a reagent button A screen is displayed that shows the details of the selected reagent Preparing reagents During preparation you typically replace reagents that are empty or whose expiration date has passed or you add new reagents a To prepare the reagents 1 Choose Overview gt Tests Preparing the reagent set 2 Obtain the reagent sets you want do add or replace When replacing a reagent set try to use one of the same lot as the old one This way if you work with the calibration sequence Each Lot and Interval you avoid having to perform a calibration Removing a reagent set 3 Select the reagent you want to remove 4 Press The system moves the first bottle of the set to the reagent port 5 Wait for the main cover LED to turn green A message is displayed asking you to open the main cover and remove the bottle A Status description Figure B 6 A WARNING Incorrect results due to impurities and carryover Traces of analytes or reagents may be carried over one test to the next when reusing bottle caps Do not remove reagent bottles that are not empty with the purpose of loading them again later Roche Diagnostics B 26 Operator s Manual Version 3 0 6 Daily operation cobas c111
91. Make sure it is unique within your laboratory 4 Press 5 Type the password 6 Press 7 Press the appropriate user level button o Press Operator for users who should perform routine tests o Press Supervisor for users who should perform routine tests as well as calibration and QC o Press Lab Manager for users who should perform all test actions and who should be able to update or add applications and perform diagnostics tasks o Press Administrator to define the administrator of the cobas c111 instrument The administrator can in addition to all Lab Manager actions perform user administration 8 Press Deleting a user a To delete a user 1 Choose Utilities gt Users A screen is displayed that lists all currently defined users 2 Select the user you want to delete 3 Press A confirmation screen is displayed 4 Press to confirm the deletion Roche Diagnostics B 162 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration Editing the acceptable flags list When working with automatic accepting of results results that are not flagged are automatically accepted Results with flags that are marked in an acceptable flags list are accepted as well There is such a list for sample QC and calibration results a To add or remove a flag from an acceptable flags list 1 Choose Utilities gt Configuration gt Result Handling 2 Expand the list 3
92. Mixing and extra wash cycle information is contained in a separate barcode on a barcode transfer sheet a To import mixing and extra wash cycle information 1 Choose Utilities gt Import gt EWC Mixing A screen is displayed asking you to scan the barcode 2 Scan the barcode The data are installed on the system A message will inform you when the installation is complete The screen for importing data is displayed again e For information on defining extra wash cycles see Defining extra wash cycles on page B 170 Preparing a new disk WARNING Injury through reagents and other working solutions Direct contact with reagents cleaning solutions or other working solutions may cause personal injury When handling reagents exercise the precautions required for handling laboratory reagents observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions Infection by biohazardous materials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply dis
93. P All pipetted R Ready S Some blocked T Rerun time out U Unknown blank Done all tests measured and results accepted STAT orders are marked with an asterisk Roche Diagnostics Operator s Manual Version 3 0 A 99 cobas c111 5 Software Key screens Apply filter criteria to the orders list You can choose one of the following criteria o All o Incomplete o STAT o Not Finished o Not Today o By ID Result list f Workplace gt Result Review Reviewing sample results This line contains result information This line contains sample information This line is selected S column Status This result has not yet been accepted Print results You can choose one of the following options o List All results in the list If a filter was applied the list would contain only the results that fulfill the filter criterion and the filter criterion would be part of the button name o Detail of Order All results of the associated order Figure A 62 Result list o STAT orders are marked with an asterisk o The time indication represents the time when the order was defined Roche Diagnostics A 100 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Validate the results You can choose one of the following options o Repeat Perform the same test with identical dilution o Rerun Perform the same test with different dilution
94. Position name highest 2 Position name lot number 3 4 Position name lowest Roche Diagnostics Operator s Manual Version 3 0 B 33 cobas c111 6 Daily operation Preparing the system End of Prepare phase The instrument is now ready for analyzing samples You may want to perform QC before analyzing samples e See Performing QC on page B 68 When performing calibrations without using the Prepare wizard Choose Workplace gt Calibrations gt Roche Diagnostics B 34 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples Analyzing samples Safety information Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Infection by biohazardous materials on page B 5 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page B 5 o Loss of sight on page B 6 WARNING Incorrect results due to inadequate sample preparation Specimen containing clots may obstruct the probe Specimen containing bubbles or foam may cause level detection errors and air pipetting Consequently incorrect results may be generated Take adequate care when preparing the samples Incorrect results due to insufficient fluid Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results Always fill the tubes with enough fluid that
95. Previous Lot is dis played instead of the date Figure B 27 A B C Roche Diagnostics Operator s Manual Version 3 0 B 75 cobas c111 6 Daily operation Performing QC 2 Press A graphic is displayed that shows either the QC results for the current or the previous month or those generated before the previous month A Calibrator change B Reagent set change C QC target value change D 3s E 2 5s F 2s G Mean value H 2s I 2 5s J 3s K Press to print the graphic L Press to display the results in a table M Press to display the results of the previous month N Press to display the results of the current month O Press to display the results that were gen erated before the last month Figure B 28 A D F H I J E G N M L K B C O o The date format in the month selection buttons is always month year o Ignored QC results are not displayed in the graph but they are included in the QC History printout Such results are marked with I at the end o Ignored QC results are not taken into account for QC history statistics Roche Diagnostics B 76 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing QC 3 Press to display the results in a table The results are sorted chronologically An overview is followed by statistical data for all stored results and for the results of the current month If
96. Repeat to re perform the test using the same dilution e See Repeating tests on page B 55 o Press Rerun to re perform the test using a predefined different dilution e See Rerunning tests on page B 56 o Press Accept to accept the result e See Accepting results on page B 57 o Press Retransmit to send the result to the host again Use this function if you suspect that the result has not been stored properly on the host system for example because of a communication problem Roche Diagnostics Operator s Manual Version 3 0 B 55 cobas c111 6 Daily operation Validating sample results Repeating tests Repeat Performing a repeat means reperforming the same test with identical dilution Typically you perform repeats if the result is flagged and you want to confirm the result a To repeat a test 1 Validate the result e If the sample is still on board see To validate sample results of on board samples on page B 52 e If the sample is no longer on board see To validate sample results from the results list on page B 53 2 Press Repeat The system automatically creates a new order and selects the test It then performs the test In the results list the result of the repeat is shown on a separate line WARNING Incorrect results due to insufficient fluid Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results Always fill the tubes with enough fluid that at
97. Restart the system If the error persists call service 7119 d Consequential error caused by a previous hardware or software problem Check previous errors Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7120 s Either a rotor an X transfer or a Z transfer position error occurred Maybe one of these devices has been moved manually by accident Restart the system If the error persists call service 7121 d Consequential error caused by an internal communication problem Check previous errors Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7122 d The Prepare action has been stopped due to an open cover Ensure that all covers are closed while the system is being initialized in the Operating or Maintenance status 7123 Extra wash cycle after reagent pipetting failed Perform lt Deproteinize Probe gt before next run 7124 Analyzer temperature outside the range 7125 s Motion control error in rotor motor Restart the system to correct the problem If the error per sists call service 7126 s Motion control error X transfer motor Restart the system to correct the problem If the error per sists call service 7127 s Motion control error Z transfer motor Restart the system If the error persists call
98. Select one of the following entries o Sample Accept Flags o QC Acceptable Flags o Cal Acceptable Flags 4 Press A list of relevant flags is displayed 5 Press the square to the left of a flag name to select it or to cancel its selection A selected flag shows a check mark l 6 Press Mapping the host codes Applications are delivered with a unique ID called code Laboratories often use their own codes for applications By mapping the codes used by the laboratory host codes to those defined by the application manufacturer the laboratory can work with their own accustomed codes The cobas c111 instrument provides a mapping table that can easily be edited The application profile and ratio codes are also used on the cobas c111 Printer Tool The codes on the cobas c111 system and on the Printer Tool must correspond Editing a mapping table involves the following steps 1 Exporting the mapping table to an USB stick The table is written as a text file 2 Editing the file on a computer and save it as a text file to the stick 3 Importing the file to the cobas c111 instrument a To export the mapping table 1 Choose Utilities gt Applications gt Host Codes 2 Press A screen is displayed asking you to insert the USB stick 3 Insert the USB stick 4 Press 5 Select the directory where you want to save the mapping file Roche Diagnostics Operator s Manual Version 3
99. Serum used to coat ISE electrodes tubing and the sample probe after cleaning procedures The cobas c111 Activator is based on human sample material For further details refer to the Activator package insert alarm A visual or audible operator notification of any system irregularity Alarm button A button used to display the alarm messages alarm level A level that identifies the source and severity of a problem There are two levels warning and alarm alarm message A message that reports a system irregularity It can be viewed in the alarm monitor screen See Alarm button aliquot Portion of sample material pipetted into any secondary cup alphanumeric sorting The listing of information in a printout or on a screen in a pre defined order by letters or numbers analyte The constituent in the sample that is to be determined analytical instrument A device or a combination of devices used to carry out an analytical process analyzer unit Central analyzing unit including cooling assembly heating channel rotor and insulation Does not include the photometer unit application Chemistry and method to determine a parameter See also test assay 1 A specific test 2 The process of measuring a substance backup The saving of data onto supplementary storage media such as disks or tape If such data is required again but is no longer available from the main storage instrument hard disk it can be restored from a backu
100. Special operations Exporting data cal_yyyymmddhhmmss csv Column Title Description Instr Instrument ID always 30 for cobas c111 Msg Message Type 7 Result for sample control or calibration Index 151 Calibration data 152 Std 1 value 153 Std 2 value 154 Std 3 value 155 Std 4 value 156 Std 5 value 157 Std 6 value App Application code Date Date when the result was generated Time Time when the result was calculated SW Version Software version installed on the instrument Serial Serial number of the instrument Cal Std Calibrator ID C f a s 401 and standard number User User name SYS if Auto Accept is on Lot Lot number LS Value Calibration type Target value of corresponding calibrator L Lot calibration S Set calibration Unit Defined display unit Flags Flag name R0 Rate Offset and factor of the calibration curve Kc Raw01 Kc parameter value or absorbance value of cycle 1 in Abs A Raw02 A parameter value or absorbance value of cycle 2 in Abs B Raw03 B parameter value or absorbance value of cycle 3 in Abs C Raw04 C parameter value or absorbance value of cycle 4 in Abs Raw05 Raw40 Absorbance value of cycle 5 through 40 in Abs one cycle 18 s Test Short name of the application Table 34 Explanations on calibration results If the calibration results were accepted using Use Old is displayed as the Date and Time values and the co
101. The Overview tab is your main work area when performing the daily routine tasks Show details about the order for this sample STAT Define STAT orders Order Define routine orders Tests Check the status of the currently installed tests Log off Log on Log off or on the system If somebody is logged on your user name is displayed for example admin if nobody is logged on Log on Prepare Perform the preliminary tasks at the beginning of a shift End Shift Perform the necessary tasks when ending the shift The screen representations shown in this chapter and throughout this manual are for illus trative purposes only The screens do not necessarily show valid data A Tube icons B Status of current order processing C Buttons Figure A 48 Overview tab C A B Roche Diagnostics Operator s Manual Version 3 0 A 85 cobas c111 5 Software Key screens Check the status of the reagent disk The reagents are OK Fewer than 10 of tests are left for a reagent set or its expiration date has passed No or unidentified disk on board A reagent set is not complete or a reagent is empty Check the status of the cuvette segments currently loaded on the rotor More than one segment is available The last available cuvette segment is in use No cuvettes are available System Status The System Status button displays both the icon and the color of one of the buttons of the underlying s
102. The photometer signals were outside the range while performing a photometer initialization or a photometer measurement Restart the system If the error persists call service 6020 s Photometer lamp error Perform lt Clean Rotor and Heating Channel gt If the error persists replace the photometer lamp Perform first the maintenance action lt Replace Photometer Lamp gt and then lt Abs Air Water Calibration gt 6021 s Photometer error The lamp voltage is outside the range Restart the system If the error persists call service 6022 s Photometer error The internal photometer 15 V power supply failed Restart the system If the error persists call service 6023 s Photometer error The lamp current is outside the range Perform first the maintenance action lt Replace Photome ter Lamp gt and then lt Abs Air Water Calibration gt Restart the system If the error persists call service 6024 s Photometer error Either the lamp fan is not running or its speed is not correct Switch off the instrument Open the main cover and check if the lamp fan is jamming or blocked Restart the system If the error persists call service ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics Operator s Manual Version 3 0 D 13 cobas c111 9 Messages and alarms List of alarm messages 6025 s Photometer error Either the dark shutter motor does not work or the shutter me
103. There are salt deposits or there is an obstruction at the adapter of the ISE Reference Solution bottle o The electrodes have not been serviced o The expiration date of the electrode has expired or the electrode is damaged o The electrodes and or the electrode block is not dry o The preamplifier is defective Recommended actions 1 Perform the maintenance action Electrode Service and repeat the measurement 2 Repeat the measurement with a suitable sample where pH gt 5 5 and sample concentration within the test range to establish that the ISE module is OK 3 Check the position and condition of the O rings and replace if necessary 4 Check the adapter of the ISE Reference Solution bottle for salt deposits and obstruction Roche Diagnostics E 74 Operator s Manual Version 3 0 15 ISE troubleshooting cobas c111 List of ISE flags No Fluid Meaning The ISE sample or ISE Reference Solution sensor could not detect any fluid It takes too long for a sample segment to reach the electrodes Message ID 68 Priority 2 Possible cause o The fluid was not pipetted o The ISE tower is clogged o The ISE tubing is blocked or leaking o The ISE sample sensor is defective o The ISE Electrodes are blocked or not properly mounted Recommended actions 1 Repeat the measurement 2 Check the sample tubing for clots 3 Check ISE Electrodes and O Rings for proper mounting 4 Check the ISE to
104. Version 3 0 A 7 cobas c111 1 Safety Safety information Waste Reagents and other working solutions Installation Environmental conditions e For details on the required environmental conditions see Environmental conditions on page A 66 WARNING Infection by waste solution Contact with waste solution may result in infection All materials and mechanical compo nents associated with the waste systems are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician WARNING Injury through reagents and other working solutions Direct contact with reagents cleaning solutions or other working solutions may cause personal injury When handling reagents exercise the precautions required for handling laboratory reagents observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions Skin inflammation caused by reagents Direct contact with reagents may cause skin irritation inflammation or burns When handling reagents be sure to wear protective equipment and observe the
105. WARNING Loss of sight The intense light of the LEDs may severely damage you eyes Do not stare into the LEDs Scanning equipment using LED technology is covered by the international standard IEC 60825 1 LED Safety Class 1 WARNING Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch moving parts during instrument operation WARNING Personal injury or damage to the analyzer due to contact with instrument mechanism Keep all covers closed operate them as instructed on the screen WARNING Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch any parts of the instrument other than those specified During operation and maintenance of the instrument proceed according to the instructions WARNING Infection by biohazardous materials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Roche Diagnostics Operator s Manual
106. Wizards A wizard denotes a predefined sequence of screens steps that represent a certain task for example defining an order By following the suggested sequence of steps you ensure the proper execution of the tasks and functions With some critical tasks you need to follow the wizard exactly right through to the end In other cases you may skip a step and perform it later Table A 8 The major items and characteristics of the touchscreen Roche Diagnostics A 72 Operator s Manual Version 3 0 5 Software cobas c111 Screen layout Screen layout All screens are based on the following layout Depending on the function of a screen some layout items may not be displayed The following is an example of a screen with the full range of display items A Status area B Tabs C Headline D Global action area E Working area F Buttons area Figure A 34 Basic screen layout A D B C E D F The screen representations shown in this chapter and throughout this manual are for illus trative purposes only The screens do not necessarily show valid data A The status line displays the system status B Tabs represent the major work areas You can switch to any of them any time C The headline characterizes the content or function of the screen If the screen is part of a sequence of screens wizard the headline tells you where you are within this sequence D The working area
107. all reagent bottles Reagent set Up to three reagents can be required to perform a certain test These reagents are handled in reagent sets You can define more than one reagent set for a test but only one can be active A reagent set is defined as soon as its first bottle is loaded From this moment on whenever you remove or replace a reagent you do so for all reagents of the set Each diluent or cleaner bottle is treated as a separate reagent set A Reagent disk B Reagent bottle with barcode C Chimney Figure A 4 Equipment for reagent handling A B C Roche Diagnostics A 26 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Daily operation Volume detection For each reagent set the number of available tests is continuously calculated Periodic mixing Reagents may have a mixing interval defined This interval is checked by the system every 30 minutes and mixing is performed without removing the reagent bottles from the reagent disk For a reagent set that contains more than one reagent for which mixing is defined the shortest interval of all reagents of the set is used for all reagents Tests are blocked if any reagent they use requires mixing Diluents Both system water and dedicated diluents are used System water is kept in the external water container dedicated diluents are supplied in reagent bottles and placed on the reagent disk Cleaners Both a system cleaner
108. an external waste container must be connected at all times Therefore when you empty the waste container you immediately replace it with the spare container and then empty the original container The instrument is supplied with a spare waste container There is no active level monitoring for the external waste container but you are notified if the external waste container has not been emptied for more than one day The external waste container is connected by tubing to the internal waste tank e See Connecting and disconnecting the external fluid containers on page B 127 See Checking the status of the external fluid containers on page B 15 See maintenance action Clean the water and waste containers on page C 16 Water container The white water container is positioned on the external fluid rack Attached to the cap is a suction tube which is equipped with a water filter There is no active level monitoring for the water container but you are notified if the water container has not been refilled for more than one day The water container is designed to be washed and refilled The water container is connected by tubing to o Wash pump o Syringe assembly o Probe e See Connecting and disconnecting the external fluid containers on page B 127 See Checking the status of the external fluid containers on page B 15 See maintenance action Clean the water and waste containers on page C 16 See maintenance action Replace water i
109. and dedicated cleaners can be used The system cleaner is kept in the external cleaner bottle dedicated cleaners are supplied in reagent bottles and placed on the reagent disk Calibration Calibration is the process that establishes under specified conditions the relationship between values indicated by the analytical instrument and the corresponding known values of an analyte Periodic calibration is required because the concentration of reagents can change over time Reagents are typically calibrated with a two point calibration measuring the predefined value of a multicalibrator and of system water Some reagents are calibrated using a set of calibrators On the cobas c111 instrument reagents are handled as sets of up to three reagents You always load and unload all reagents of a set As a consequence all reagents bottles of a set are calibrated when performing calibration The system checks when calibration is due When a calibration is due depends mainly on two definitions the calibration type and the calibration sequence Figure A 5 Remaining tests indication Each reagent set must have accepted calibration results to be available for use in tests Roche Diagnostics Operator s Manual Version 3 0 A 27 cobas c111 2 Introduction to the instrument Daily operation Calibration type The calibration types Set and Lot define the manner in which the system determines whether there is a valid calibration
110. and orders to ensure that there is enough space on the system for the next shift a To clean up the database 1 Press The following results will be deleted o Accepted sample results o QC results that were accepted are deleted from the QC Status list they remain in the QC history o QC results that were generated before the first day of the previous month are deleted from the QC history o Obsolete calibration results provided there are more than five obsolete results for the same test Results become obsolete if the empty set was removed or if the set was removed more than 30 days ago 2 Press to confirm the deletion The results are deleted 3 Press to proceed to the next stage in the End Shift wizard A screen for handling cuvettes is displayed By deleting the sample results you delete the corresponding orders as well When deleting results outside the End Shift wizard You can delete accepted sample results calibrations orders and accepted and ignored QC results by pressing in the respective result lists e To delete orders on page B 93 e To delete sample results on page B 94 e To delete a calibration on page B 95 e To delete QC results from the QC Status list on page B 97 e To delete QC results from the QC History on page B 97 Maintenance action Cleanup Database The maintenance action Cleanup Database is intended for situations where the system does not work efficiently any
111. and other display items traffic light color coding is used Green means OK yellow watch out you need to do something and red means that your intervention is required for processing to continue The screens have a clear and consistent layout and are easy to use The topics are divided in the proven work areas Overview for order and fluid handling Workplace for result handling and details on orders and Utilities for administration tasks e For details on the user interface see Chapter 5 Software The following is an example of a screen It contains the full range of display items A The status line displays the system status B Tabs represent the major work areas C The headline characterizes the content or function of the screen If the screen is part of a sequence of screens wizard the headline tells you where you are within this sequence D The working area displays the main content of the screen E The buttons vary depending on the content of the working area and the screen position within a series of steps wizard F The Help button leads to concise information that is relevant to the current screen and situation G The global action buttons represent the functions that are permanently available Start Stop Alarm Line Feed The LEDs next to them point to their status Figure A 3 Example of a screen E G F D C B A Roche Diagnostics Operator s Manua
112. and release the trigger If the reading was successful a screen for selecting tests is displayed For safety reasons the barcode scanner is set to only read barcodes that contain a check sum Roche Diagnostics Operator s Manual Version 3 0 B 91 cobas c111 6 Special operations Table of contents Special operations The tasks you do not perform every day In this chapter you will find information on operator tasks that are not part of the daily routine of analyzing samples Deleting sample orders B 93 Deleting sample results B 94 Calibration B 95 Deleting calibration results B 95 Setting up your calibration schedule B 96 Deleting QC results B 96 Lot handling B 98 Viewing the current lot definitions B 98 Calibrator and QC
113. and understood section Safety information on page B 5 The following warning messages in particular are relevant o Personal injury or damage to the analyzer due to contact with instrument mechanism on page B 5 o Infection by waste solution on page B 5 Icon Meaning Possible actions All cuvettes are used Replace the segment Up to two cuvettes are free to be used More than two cuvettes are free to be used No action is currently required Roche Diagnostics Operator s Manual Version 3 0 B 29 cobas c111 6 Daily operation Preparing the system Replacing cuvette segments 2 Press a segment button A screen is displayed informing you that the system is ready for cuvette handling 3 Wait for the main cover LED to turn green 4 Open the main cover 5 Remove the segment and treat it as biohazardous waste 6 Insert a new cuvette segment 7 Press to confirm the replacement Press if you removed the segment without replacing it 8 Do one of the following 9 When you have finished replacing cuvettes press to proceed to the next stage in the Prepare wizard Performing reagent mixing Reagents that contain Latex granules for example D Dimer require periodic mixing The mixing interval is part of the application definitions and cannot be changed or deleted by the user The system checks every 30 minutes for reagent sets that require mixing Within the Prepare phase a screen is displa
114. are outside the same limit s Standard deviation The value for the standard deviation is defined in the QC lot Off 2s Table B 25 QC definitions Roche Diagnostics B 168 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration System Date and time Item Values Comment Language Language ID according to ISO 639 1 See Table B 20 on page B 158 The language English is always included Choose one of the available languages The first five languages in the alphabetical sequence of the installed languages and English are displayed Date Format dd mm yyyy dd mm yyyy yyyy mm dd yyyy mm dd mm dd yyyy Examples for June 14 2006 o dd mm yyyy 14 06 2006 o mm dd yyyy 06 14 2006 Time Format 24 Hours 12 Hours Screen Saver Wait 0 120 min Time after which the screen saver feature becomes active 0 zero means that the screen saver function is off The screen saver time is linked to the Auto Log off feature For example if you define a Screen Saver Wait time of 5 minutes then after 5 minutes of inactivity the screen saver feature becomes active and the user is automatically logged off provided Auto Log off is on Auto Log off On Off If you work with On the user is automatically logged off after a certain number minutes of inactivity on the instrument This number is defined in the Screen Saver Wait definition Sound Effects On Off Acoustic signals wh
115. be moved smoothly Restart the system If the error persists call service 7135 s Motor Z transfer overheated Switch off the instrument Check if the Z transfer is blocked or jamming Ensure that the Z transfer can be moved smoothly Restart the system If the error persists call service 7136 s Tube bottom detector is blocked or jamming Switch off the instrument Remove the transfer head cover Check the tube bottom detector mechanism Install the transfer head cover Restart the system If the error persists call service 7137 s Na sample measurement unstable Check the expiry date of the Ref and Na electrodes Replace expired electrodes Check the ISE tubing for obstructions and leaks Perform lt Electrode Service gt If the error persists call service 7138 s Cl sample measurement unstable Check the expiry date of the Ref and Cl electrodes Replace expired electrodes Check the ISE tubing for obstructions and leaks Perform lt Electrode Service gt If the error per sists call service 7139 s K sample measurement unstable Check the expiry date of the Ref and K electrodes Replace expired electrodes Check the ISE tubing for obstructions and leaks Perform lt Activate Electrodes gt If the error per sists call service 7140 s Na calibrator measurement unstable Perform lt Electrode Service gt and lt Prime ISE Reference and Calib gt Check ISE Cal and Ref flow Check the ISE tubing for obstr
116. be calibrated Typically found on reagent package inserts calibration type Describes the event that triggers the calibration for example lot change and interval expiration calibrator 1 A material of known composition or properties that can be presented to the analytical instrument for calibration purposes 2 The test portion or test solution used for calibration of an analytical procedure carryover A process by which materials are carried into a reaction mixture where they do not belong check digit A verification number used in barcodes and software check sum The result of a mathematical procedure to validate the integrity of a set of data cleaner A solution used to wash the probe clot detection 1 A device built into the pipetting system to detect clots and to avoid false pipetting 2 The procedure of detecting a clot cobas A modular range of in vitro diagnostics systems from Roche Diagnostics Hitachi High Technologies communication The exchange of data between different computers conditioning The process of letting serum type liquid flow through the flow path before electrolyte measurement consumables A generic term for items that are used during test processing and must be replaced on a regular basis by the operator Examples of consumables include printer paper and cuvette segments control See control material control ID The abbreviated name for a control material Control IDs are used on screen
117. be performed periodically or after certain events To ensure the smooth running of the system you should perform maintenance actions either as part of the preparation or the end of shift activities e For information on scheduling maintenance actions see Scheduling maintenance actions on page B 158 a To perform maintenance actions Checking what maintenance actions are due 1 Check the colors of the maintenance actions The maintenance actions are sorted by the maintenance date by when they should be performed Use these dates for planning the maintenance actions for example for ordering the required materials Interpreting the colors Make sure that you have read and understood section Safety information on page C 8 If you interrupt the performing of a maintenance action that was due its status will remain due and you need to fully re perform the action later A Maintenance action name B Due dates in ascending order C Use the scroll bar to display the mainte nance actions that are currently hidden Figure B 3 C A B The defined maintenance interval has expired Perform this maintenance action now The system may not be able to operate until this action is per formed This maintenance action should be performed on the next major mainte nance day No action is currently required This maintenance action is selected Roche Diagnostics B 20 Operator s Manual Version 3 0 6 Daily ope
118. but do not start a new one You can restart processing by pressing the global action button Stop Printing Stop the current printing task It may take a few moments before printing actually stops Shutdown Shut down the cobas c111 software and the operating system This option can only be performed in Standby status Restart Shut down the cobas c111 software and automatically restart it This option is available in Standby status only It is used in cases where a configuration change requires restarting the software for it to become effective Roche Diagnostics B 50 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples Removing sample tubes You can remove a sample when its tube button is green e See Checking the sample tube status on page B 44 All tests are accepted All tests are pipetted 1 1 If you remove a sample tube before the pipetting is complete the tests that were pipetted will be performed as normal The order remains unfinished You can check the resulting order details in Workplace gt Order gt Roche Diagnostics Operator s Manual Version 3 0 B 51 cobas c111 6 Daily operation Validating sample results Validating sample results The cobas c111 instrument provides several aids for validating results o In the results list results that fall outside predefined technical ranges are flagged o You can display detailed result in
119. c111 Detailed procedures Detailed procedures Checking the printer status a To check the printer status 1 On the Overview tab press the System status button The printer button is red 2 Scroll to display the Printer entry Clearing a paper jam a To clear the paper jam 1 Choose gt Stop Printing if required 2 Open the printer panel 3 Lift the printer paper roll from its holder 4 Remove all loose paper Cut or tear it off 5 Place the roll back on the holder Make sure the paper unrolls at the top and towards you Press down the release button A firmly before you pull the panel The panel should open without resistance A Roche Diagnostics Operator s Manual Version 3 0 D 47 cobas c111 11 Troubleshooting Detailed procedures 6 Insert the paper in the slot in the printer panel and pull some through 7 Close the printer panel The system feeds some paper and then automatically resumes printing 8 Choose Overview gt 9 The printer button should now be green and the status description should be OK Changing the mains fuses a To change the mains fuses 1 Press O on the main toggle switch to switch off the instrument 2 Disconnect the mains cable from the instrument 3 Using a screwdriver disengage the clips on both sides of the fuse box cover Roche Diagnostics D 48 Operator s Manual Version 3 0 11 Troubleshooting cobas c111 Detai
120. carry out operation and maintenance unless you have been trained by Roche Diagnostics o Start all maintenance actions on the screen Do not perform maintenance actions with out the assistance of the user interface o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to trained Roche Technical Support personnel o Follow standard laboratory practices especially when working with biohazard material Roche Diagnostics Operator s Manual Version 3 0 E 71 cobas c111 15 ISE troubleshooting List of ISE flags List of ISE flags This section lists the general and ISE specific flags in alphabetic order and provides information on each of the flags e For information on flags that concern absorbance measurements only see List of flags on page D 28 gt Meaning Result generated by re performing the test with the same running parameters repeated Message ID 120 Priority 32 Possible cause The user initiated the repeat Recommended actions No action required Air Fluid Meaning o The length of the sample segment was too short o The end of the sample segment was not detected It takes too long for a sample segment to reach the electrodes Message ID 19 Priority 4 Possible cause o Air bubbles are present o The ISE tower is clogged o The dosing
121. cautions given in the package insert WARNING Incorrect results or damage to the analyzer due to wrong installation Follow the specified installation instructions carefully WARNING Incorrect results or damage to the analyzer due to heat and humidity Use the instrument indoor only Roche Diagnostics A 8 Operator s Manual Version 3 0 1 Safety cobas c111 Safety information Power interruption Electromagnetic devices Approved parts Third party software NOTICE Data loss or damage to the system due to voltage drop By a power failure or momentary voltage drop the operation unit or software of this system may get damaged or data loss may occur Use only uninterruptible power supply WARNING Malfunction of instrument and incorrect results due to interfering electromagnetic fields Devices that emit electromagnetic waves may cause the instrument to malfunction Do not operate the following devices in the same room where the system is installed o Mobile phone o Transceiver o Cordless phone o Other electrical devices that generate electromagnetic waves NOTICE Instructions for in vitro diagnostic IVD equipment for professional use The IVD equipment complies with the emission and immunity requirements described in the particular requirements for IVD medical equipment of the EN IEC 61326 2 6 standard The electromagnetic environment should be evaluated prior to operation of the device Cla
122. cobas c111 system Operator s Manual Version 3 0 cobas c111 Roche Diagnostics 2 Operator s Manual Version 3 0 Document information Revision history Edition notice The cobas c111 instrument is a continuous random access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum plasma urine or whole blood HbA1c It is optimized for small throughput workloads of approximately samples per day utilizing photometric analysis and an optional unit for ion selective electrodes ISE This manual is for users of the cobas c111 instrument Every effort has been made to ensure that all the information contained in this manual is correct at the time of printing However Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development Any customer modification to the instrument will render the warranty or service agreement null and void Software updates are done by service representatives Intended use The cobas c111 instrument is a continuous random access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum plasma urine or whole blood HbA1c It is important that the operators read this manual thoroughly before using the system Copyrights 2009 Roche Diagnostics GmbH All rights reserved Trademarks The following trademarks are acknowledged
123. cuvette ring The temperature is outside the acceptable range Status of the sample area fan The fan is not running Display information on the fill status of each of the external bottles The color of the underlying buttons is displayed e See Checking the external bottles on page A 96 Figure A 58 System status o Roche strongly recommends to always use extra wash cycles with development chan nel applications and also to always load extra cleaner when tests with extra wash cycles are used o Roche Diagnostics Ltd assumes only limited liability when using the cobasc111 instrument in conjunction with the cobas c111 Development Channel Programming Software For detailed information on this matter refer to the latest version of the Development Channel Registration Form cobas c111 and the cobas c111 Develop ment Channel Operator s Manual Roche Diagnostics A 96 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Display the maintenance actions list The color of the most urgent maintenance action is displayed e See Maintenance on page A 110 Status of the printer paper The printer is out of paper Checking the external bottles f Overview gt gt Water button Press to confirm that you have refilled the external water container The water container was last filled up less than one day ago The water container was last filled up more than one day ago The system does
124. define when calibration becomes due and the system automatically informs you about due calibrations No Interval The system does not inform you about the due status Use this value if the reagent is stable enough over the whole period until it is empty and you replace it Calibration is due whenever a new reagent set is loaded on the instrument Interval only Performed when the reagent interval has expired Each Lot and Interval Performed whenever the first reagent of a new lot is loaded and then each time the interval has expired Each set and Interval Performed whenever a reagent is loaded or when the reagent interval has expired 11 Change the interval number of days hours for ISE applications if required 12 Change the number of replicates if required Possible values 1 2 3 The default value is 2 13 Press to confirm the definitions Control definitions 14 Expand the Control entry select Sequence and press 15 Define the sequence Choose No Interval for cases when for example you intend to perform QC as part of standard sample testing and not as a separate task Choose Interval Only if QC should be performed whenever the reagent interval has expired The system automatically informs you about due QCs 16 Define the interval in hours 17 For each control perform the following steps o Define the material code Unique identifier for the controls Check the package insert of the control o
125. ensure validation of the software in question o Do not use the USB ports to connect other storage devices unless you are instructed to do so by official user documentation or a Roche service representative o 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 cobas c111 o Keep all external storage devices in a secure place and ensure that they can be accessed by authorized persons only Roche Diagnostics Operator s Manual Version 3 0 A 11 cobas c111 1 Safety License notices License notices Legal liability Roche Diagnostics Ltd assumes only limited liability when using the cobas c111 instrument in conjunction with the cobas c111 Development Channel Programming Software For detailed information on this matter refer to the latest version of the Development Channel Registration Form cobas c111 and the cobas c111 Development Channel Operator s Manual WARNING Malfunction of instrument and incorrect results due to software modifications by the customer The cobas c111 instrument uses open source software Among other things the holders of the proprietary rights grant licenses under the terms of the GNU General Public Licence GPL edition 2 or above as well as under the GNU Lesser General Public License LGPL The cobas c111 instrument has been designed to be operated with the unmodified soft
126. error persists call service 7062 s The ISE sample sensor could not detect calibrator Check the filling level of the ISE Cal bottle Check the ISE tubing for obstructions and leaks Perform lt Initialize ISE Unit gt If the error persists call service 7063 s The ISE sample sensor could not detect the end of the calibrator segment Check the ISE tubing for obstructions and leaks Perform lt Initialize ISE Unit gt If the error persists call service 7064 s The ISE sample sensor could not detect Activator during initialization Check the ISE tower and ISE tubing for obstructions and leaks Perform lt Initialize ISE Unit gt If the error persists call service 7065 s Calibration of the ISE reference sensor failed no valid calibration data are available Check the filling level of ISE Ref Perform lt Initialize ISE Reference Sensor gt If the error persists call service 7066 An internal control unit d reported a wrong firmware version Reinstall the system software 7067 An internal control unit d reported a checksum or an attach error Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7068 d Wash aborted due to open cover Close the cover and restart the system 7069 d Transfer initialization failed due to an open main cover Ensure that all covers are closed Restart the system 7070 The
127. flag reappears replace reagent set a reagent may be contaminated lt Reag Rng Meaning Absorbance below defined reagent range o During calibration the absorbance value of the lowest calibrator is below the lower defined range Message ID 12 Priority 7 Possible cause Deteriorated or outdated calibrator or reagent Recommended actions 1 Check the calibration and reagent expiry dates 2 Repeat with fresh lowest calibrator 3 If the flag reappears replace reagent set a reagent may be contaminated gt Repl Dev Meaning Greater than replicate deviation Deviation between replicates exceed programmed limit One or more replicates are erroneous Message ID 13 Priority 12 Possible cause Problems in air water system air bubbles clogged probe Recommended actions 1 Check the calibrators for air bubbles and repeat the calibration 2 If the flag reappears repeat with fresh calibrators 3 Check the probe 4 Check the fluid system Roche Diagnostics Operator s Manual Version 3 0 D 37 cobas c111 10 Result flags List of flags gt RR Meaning Above reference range For patient samples the calculated concentration is greater than the upper limit of the expected value range nnnnn is the actual value that was checked against Message ID 40 Priority 22 Recommended actions No action required lt RR Meaning Below reference range For patient samples t
128. fluid may lead to incorrect results In ambient temperatures of more than 25 C be sure to start processing immediately after placing the sample and defining the order When processing of the order is finished be sure to immediately remove the sample from the sample area WARNING Incorrect results due to insufficient fluid Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results Always fill the tubes with enough fluid that at least the defined dead volume of fluid is left when pipetting is complete e See Tubes on page A 54 Incorrect results due to inappropriate tube and cup placement Inappropriate tube and cup placement may lead to inaccurate pipetting and consequently to incorrect results Make sure that the primary tubes are placed centrally and perfectly vertically in the hold ers in the sample area and that they are inserted firmly Make sure that secondary tubes are placed centrally on the primary tubes and that they rest fully on them NOTICE Probe damage and instrument malfunction due to not removing primary tube caps The probe is not designed to pierce tube caps It can get damaged when trying to pierce tube caps which can lead to instrument malfunction Always remove the caps of primary tubes before placing them on the instrument Roche Diagnostics Operator s Manual Version 3 0 B 39 cobas c111 6 Daily operation Analyzing samples Defining routine orders a T
129. for each test that has this control defined as its Default QC The screen with the control buttons is displayed again The button for the control you just loaded is no longer active 6 Press the next active control button A screen is displayed asking you to place the control 7 Place the control on a free position on the sample area 8 Select and place the remaining controls as described in steps 6 through 7 When all controls are placed the screen for identifying samples is displayed 9 Press to close the screen 10 Press to start processing the control orders Roche Diagnostics Operator s Manual Version 3 0 B 71 cobas c111 6 Daily operation Performing QC Performing interval QC measurements a To define a QC order 1 To define a new order do one of the following o Choose Overview gt Order gt o Choose Workplace gt QC Status gt A a test selection screen is displayed Interpreting the display 2 To select the tests do one of the following o Press to select all tests with due QC This selection also applies to controls of the type QC after Cal o Press a test button 3 Press A screen is displayed that contains a button for each of the controls that are required 4 Prepare the controls A Press to select all tests with due QC Press again to cancel the selection Figure B 24 A The test is blocked for one of the following reasons o Calibr
130. from the sample probes is inaccurate o The ISE tubing is leaking blocked or not conditioned o Mixing is too vigorous Recommended actions o Check the quality of the sample o Check the sample tubes o Check the ISE tower and ISE tubing for leaks and blockages o Repeat the measurement 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 com pleted the previous one Roche Diagnostics E 72 Operator s Manual Version 3 0 15 ISE troubleshooting cobas c111 List of ISE flags Air Isecal Meaning o The length of the calibrator segment was too short o The end of the calibrator segment was not detected It takes too long for a calibrator segment to reach the electrodes Message ID 91 Priority 5 Possible cause o Air bubbles are present o The ISE tubing is leaking or blocked Recommended actions o Ensure that the ISE Calibrator indirect urine on the ISE unit is available and check the level of fluid replace if necessary o Repeat the measurement o Check the ISE tubing for leaks and blockages Cal Meaning A result where its calibration is flagged Message ID 110 Priority 29 Possible cause The calibration was in question and has been flagged however the calibration could be used to calculate the result compare with Cal Error where the calibration
131. gt gt Accept Table B 1 Overview of the daily operation tasks Roche Diagnostics B 8 Operator s Manual Version 3 0 6 Daily operation cobas c111 Introduction 7 Performing calibrations Performing individual calibrations 1 Start the wizard Workplace gt Calibrations gt 2 Select the test n a 3 Prepare and place the calibrators n a 4 Start the calibration 5 Validate the calibration results Workplace gt Calibrations gt 6 Remove the calibrators Performing all due calibrations 1 Start the wizard Workplace gt Calibrations gt 2 Select all tests with due calibrations or Select all tests with calibration due within the forecast period n a 3 Prepare and place the calibrators n a 4 Start the calibration 5 Validate the calibration results Workplace gt Calibrations gt 6 Remove the calibrators 8 Performing controls Performing Default QC 1 Start the wizard Overview gt Order gt 2 Select a control and place the tube Repeat until there are no controls left on the screen n a 3 Start the QC measurement 4 Validate the QC results Workplace gt QC Status gt 5 Remove the controls n a Performing an individual QC measurement 1 Start the wizard Workplace gt QC Status gt 2 Select a test n a 3 Select a control and place the tube Repeat until there are no controls left on the screen n a 4
132. in particular is relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 Roche Diagnostics Operator s Manual Version 3 0 E 65 cobas c111 14 ISE maintenance ISE maintenance actions 12 Open the cover of the peristaltic pump 13 Push the pump towards the back of the instrument 14 Disengage the tube connector plate 15 Remove all pinch valve caps and clamps store them in secure place e See Removing the pinch valve caps and clamps on page E 58 16 Close the ISE cover 17 Switch off instrument 18 Disconnect the ISE power supply from the wall socket 19 Switch on instrument On the Overview tab the ISE icon is deactivated grey A Cover of peristaltic pump Figure E 18 A Connector plate Figure E 19 A A Roche Diagnostics E 66 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Roche Diagnostics Operator s Manual Version 3 0 E 67 cobas c111 15 ISE troubleshooting Table of contents ISE troubleshooting How to deal with exceptional ISE situations In this chapter you will find information on the result flags that may be generated with ISE measurements and also guidance for general troubleshooting procedures and on how to deal with error messages Introduction
133. instrument Overview Principles of operation The cobas c111 main instrument uses absorption photometry for determining the amount of absorbance in a fluid The absorbance is used to calculate the concentration in the solution Loading the sample The operator identifies the sample places it on the instrument and defines the order If you work with a host system the order is defined automatically Measuring process The measuring process for each test consists of forty regular cycles each lasting 18 seconds In each of these cycles a measurement is taken irrespective of what other actions take place during this cycle The application definitions determine what is done in which cycle and they also define which results are taken into account for the result calculation With each cycle a new test can be started The basic process works as follows 1 Checking the cuvette A measurement is taken to check the quality of the cuvette 2 Pipetting reagent R1 to the cuvette After each pipetting action the system performs a wash cycle to minimize carry over During this cycle the probe and tubing are flushed with water and cleaner 3 Wait The fluid needs to reach the prescribed temperature Such a phase can last several cycles During the wait cycles activities for other tests are performed 4 Pipetting the next fluid Typically this would be the sample The details are defined in the application definitions
134. lead to inaccurate pipetting and consequently to incorrect results Always fill the tubes with sufficient fluid that at the end of the pipetting process at least the dead volume of fluid is left e See Tubes on page A 54 Incorrect results due to inappropriate tube and cup placement Inappropriate tube and cup placement may lead to inaccurate pipetting and consequently to incorrect results Make sure that the primary tubes are placed centrally and perfectly vertically in the hold ers in the sample area and that they are inserted firmly Make sure that secondary tubes are placed centrally on the primary tubes and that they rest fully on them NOTICE Probe damage due to not removing primary tube caps The probe is not designed to pierce tube caps It can get damaged when trying to pierce tube caps Always remove the caps of primary tubes before placing them on the instrument Tube name Dead volume 13 x 75 mm 500 L 13 x 100 mm 500 L 16 x 75 mm 700 L 16 x 100 mm 700 L Table A 6 Typical examples of suitable tubes Cup name Dead volume Placement Hitachi standard cup 75 L for 2 L sample volume Directly on sample area Hitachi micro cup 50 L for 2 L sample volume Directly on sample area Roche Diagnostics Standard false bottom tube 75 L for 2 L sample volume Directly on sample area Table A 7 Typical examples of suitable tubes Roche Diagnostics Operator s Manual Version 3 0 A 5
135. 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 com pleted the previous one Roche Diagnostics D 28 Operator s Manual Version 3 0 10 Result flags cobas c111 List of flags List of flags This section lists the general flags and those that concern absorbance measurements only and it provides information on each of the flags e For information on ISE specific flags see List of ISE flags on page E 71 gt Meaning Result generated by re performing the test with the same running parameters repeated Message ID 120 Priority 32 Possible cause The user initiated the repeat Recommended actions No action required V Meaning A rerun result with diluted sample Message ID 121 Priority 33 Possible cause The user initiated the rerun Recommended actions No action required Ag Excess Meaning Antigen excess The sample contains an excess antigen and a valid result cannot be calculated Message ID 6 Priority 19 Recommended actions Rerun the test with postdilution Roche Diagnostics Operator s Manual Version 3 0 D 29 cobas c111 10 Result flags List of flags Cal Meaning A result where its calibration is flagged Message ID 110 Priority 29 Possible cause The calibration was in question and has been flagged however the calibration could be used to calculate the
136. logged on 1 Press the button showing your user name 2 Press Log On Roche Diagnostics B 158 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration Scheduling maintenance actions The cobas c111 instrument facilitates performing the maintenance actions in bundles at times that suit your laboratory work processes To that purpose you can define one day of the week as your maintenance day Concept of the main maintenance day The main maintenance day is the day in the week when you want to perform the majority of the maintenance actions Let us suppose that you chose Monday as your main maintenance day On the Maintenance screen actions that are due on Monday or an earlier day are marked in red actions that will fall due between Tuesday and Sunday will be marked in yellow The idea is to perform on the main maintenance day all red and yellow maintenance actions This way between Tuesday and Sunday you only need to perform maintenance that need to be performed daily a To define the main maintenance day 1 Choose Utilities gt Configuration gt Maintenance 2 Expand the main entry and select Major Maint Day 3 Press A screen is displayed for selecting a day of the week 4 Press one of the weekday buttons 5 Press Handling user interface language You can choose from up to six languages You could install more than six languages but only the first six in the alphabet
137. lots B 98 Reagent lots B 99 Viewing the lot details of fluids that were used B 101 Adding a new lot B 101 Exporting data B 104 Exporting the database B 104 Exporting results B 105 Interpreting result data B 106 Exporting log files B 110 Importing data B 111 Importing applications B 111 Importing software B 113 Importing a database
138. must define them in descending order 14 Select the value for Last is Water Press On if you want to calibrate with system water as zero cali brator In this case no cup needs to be placed on the system See step 7 Press Off if you want to use a special zero calibrator for the cali bration The special zero calibrator needs to be placed on the sample area 15 Press to confirm the definitions Calibration values target values in method sheets may be defined in increasing order of concentration Always define the values in decreasing order on the cobas c111 instrument Roche Diagnostics B 104 Operator s Manual Version 3 0 6 Special operations cobas c111 Exporting data Exporting data f Utilities gt Export Exporting the database The database is normally exported as part of the daily backup during the end of shift activities e See Performing the daily backup on page B 82 During a database export the full content of the database is copied to the USB stick The database data can be restored to the instrument if required e See Importing a database on page B 114 a To export the database 1 Choose Utilities gt Export gt Database A screen is displayed asking you to insert the USB stick 2 Insert the USB stick 3 Press 4 Select the directory 5 Press to confirm the selection The data are copied to the USB stick Database files names have the following name f
139. o Condition ISE Tubing o Initialize ISE Unit Operator time Approximately 15 minutes Prerequisites The system must be in Standby status Tools and materials required m Activator m Roche approved ISE unit tubing set m Tissues a To remove the ISE unit tubing 1 Select the maintenance action Replace ISE Unit Tubing 2 Press The maintenance definition screen is displayed 3 Press to start the action The placement screen is displayed 4 Place the Activator on the sample area position indicated on the screen 5 Press to confirm the placement The tubing is emptied Your are asked to open the covers 6 Open the main cover then the left service flap and the ISE cover Your are asked to remove the tubing adapters from the ISE solution bottles Always replace the ISE tubing with the help of the Replace ISE Unit Tubing maintenance action Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 o Infection by waste solution on page E 43 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page E 42 Roche Diagnostics E 58 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Disconnecting the ISE solution bottles 7
140. of the environment you need to empty the waste at the end of your shift a To empty the waste container 1 Remove the tubing adapter from the yellow waste container and insert it in the spare container 2 Remove the bottle from the rack and place it on a firm and even surface 3 Place the spare container on the rack 4 Follow the instructions given in To check the waste container on page B 17 Refilling the external water bottle a To refill the external water container 1 Remove the tubing adapter from the white water container and place it on a clean surface 2 Follow the instructions given in To check the water container on page B 16 Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page B 5 o Infection by biohazardous materials on page B 5 o Infection by waste solution on page B 5 Roche recommend to refill the water container whenever you empty the waste container When emptying the waste without using the End Shift wizard Choose Overview gt gt WARNING Danger of poor measurement quality due to inadequate water quality Inadequate water quality may lead to incorrect results Always use purified water of the quality specified in section Technical specifications Roche recommend to empty the waste container whenever you refill the water conta
141. one calibration is flagged o Repeat the calibration If successive calibrations are flagged o Check whether the ISE Calibrator indirect urine is in the correct position o Check whether the ISE Calibrator indirect urine has expired o Check whether the ISE Solution 1 has expired o Perform the maintenance action Clean ISE Tower Automatically o Perform the maintenance action Activate Electrodes o Perform the maintenance action Deproteinize Probe o Perform the maintenance action Prime ISE Calibrator amp Reference o Check whether the electrode expiration date has passed Replace the expired electrode if necessary and perform the maintenance action Electrode Service o Check the ISE unit tubing for leaks and blockages o Contact your service representative Roche Diagnostics Operator s Manual Version 3 0 E 79 cobas c111 15 ISE troubleshooting List of ISE flags gt Test Rng Meaning PANIC value over upper Technical Limit The result is higher than the upper limit for the test Message ID 26 Priority 20 lt Test Rng Meaning PANIC value below lower Technical Limit The result is lower than the lowest limit for the test Message ID 27 Priority 21 Roche Diagnostics E 80 Operator s Manual Version 3 0 15 ISE troubleshooting cobas c111 Reacting to error messages Reacting to error messages For general information on error messages and troublesho
142. one of the test buttons 11 Press 12 Define the first calibration value target value 13 Define the next calibration value You can define up to six calibration values and you must define them in descending order 14 Select the value for Last is Water Press On if you want to calibrate with system water as zero cali brator In this case no cup needs to be placed on the system See step 7 Press Off if you want to use a special zero calibrator for the cali bration The special zero calibrator needs to be placed on the sample area 15 Press to confirm the definitions Calibration values target values in method sheets may be defined in increasing order of concentration Always define the values in decreasing order on the cobas c111 instrument Roche Diagnostics B 152 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications Short guide to application definitions Version The version uniquely identifies a particular set of application definitions Code The Roche application code identifies the application If you work with a LIS you may need to map the Roche application code with your own code All applications profiles and ratios must be identified with an application code For profiles and ratios use a number between 910 and 930 for these codes e See Mapping the host codes on page B 162 This code is also used on the cobas c111 Printer Tool The codes on the cobas c111
143. operation cobas c111 Preparing the system a To check the cleaner bottle 1 Check the cleaner button 2 Replace the cleaner bottle if required o Remove the tubing adapter from the cleaner bottle and place it on a clean noncorrosive surface o Dispose of the bottle o Remove the cap from the new bottle o Place the new bottle on the rack o Insert the tubing adapter and press it down firmly 3 On the screen that shows the container status press the cleaner button to confirm that you have exchanged the cleaner bottle Level monitoring for the cleaner bottle is based on the number of cleaning and pipetting actions that were performed The counter is reset when you press the cleaner button Make sure you only press the button when you actually have replaced the bottle 4 Press to proceed to the next stage in the Prepare wizard A fluid sensor detected that there is no cleaner in the instrument tubing You need to replace the cleaner bottle now No new tests can be processed started tests may have to be restarted after replacing the bottle The cleaner level is down to 10 or lower See the indication No action is required When replacing the cleaner bottle without using the Prepare wizard Choose Overview gt gt Roche Diagnostics Operator s Manual Version 3 0 B 19 cobas c111 6 Daily operation Preparing the system Performing maintenance actions Maintenance actions need to
144. or not properly connected Check that the LAN cable is properly connected 1 Switch off the instrument 2 If the cable was not connected connect it If the cable was connected remove it at both ends and reconnect it 3 Start the instrument Electronic problem If the above measures are not successful contact your service representative Figure D 5 Troubleshooting with the help of messages Roche Diagnostics Operator s Manual Version 3 0 D 45 cobas c111 11 Troubleshooting Reacting to messages 1 xxx 73 Level detection error conductivity Level detection o Poor water quality o Contamination with cleaner valve is leaking 1 Make sure you use the correct water quality e See Technical specifications on page A 66 2 Perform the Prime Fluid System mainte nance action e See Prime the fluid system on page C 11 3 If the problem persists contact your service representative 4 xxx 41 through 4 xxx 44 Various texts related to photometer Gc 0166807 Photometer o Lamp defective o Photometer lens soiled Do not attempt to clean the photometer lenses 1 Replace the photometer lamp 2 If the problem persists contact your service representative Message or error code Affected items Possible causes Comments Figure D 5 Troubleshooting with the help of messages Continued Roche Diagnostics D 46 Operator s Manual Version 3 0 11 Troubleshooting cobas
145. order 2 Scan the sample barcode or type the same sample ID as before 3 Reinsert the sample tube Processing continues where it stopped Removing a sample and then placing it again means defining a new order The system does not remember where the sample was placed in the previous order The sample is not identified 1 Remove the sample 2 Scan the sample barcode or type the same sample ID as before 3 Reinsert the sample on any posi tion Removing a sample and then placing it again means defining a new order The system does not remember where the sample was placed in the previous order There is no sample on this position You can place a sample tube on this position Tests are ordered Processing has not yet started You can still cancel ordered tests and add additional tests to the order Tests are ordered Processing has started You can no longer cancel ordered tests but you can add additional tests to the order The sample is identified but no tests were ordered yet If working in Order Query Mode The order could not be obtained from the host This should be a temporary status No action is required Icon Meaning Possible action 1 1 1 1 1 1 1 1 Roche Diagnostics B 46 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples 2 Press the sample tube button A screen is displayed that shows details about the stat
146. reagent bay 12 Press to confirm the insertion If you confirm without placing the bottle the system assumes that the bottle is placed If you press after placing the bottle the position is deemed empty When the first reagent bottle of a set is loaded the reagent set is defined From this moment on the reagents are handled as part of the set You no longer handle them as individual reagents 13 Do one of the following 14 Press 15 On the disk overview screen press to load the next reagent Proceed as described in steps 10 through 15 If Do this There is another bottle belonging to the set A screen is displayed asking you to scan the bottle 1 Scan the bottle 2 Insert the bottle 3 Press to confirm the insertion All bottles of the set are inserted 1 Close the main cover On the screen with the reagent set buttons the button for the new set is now present Roche Diagnostics Operator s Manual Version 3 0 B 119 cobas c111 6 Special operations Assigning tests to test tabs Assigning tests to test tabs The system provides two order modes Easy and Full When working in Easy mode the test selection screen consists of one panel if working in Full mode the screen contains up to six panels each is identified by a tab To make a test available for selection from the test selection screen you need to assign it to a test tab This is done in two steps 1 Naming the tabs if r
147. restart When startup is complete the Overview tab is displayed and the system is in Standby status 9 Wait until the system is in Standby status Uninstalling a language You can uninstall all languages except English Prerequisites o The current user interface language must be English e See To change the user interface language on page B 159 o The system must be in Standby status o The uninstall language file c111_uninstall_languages tar has been copied to a USB stick o You need Lab Manager or Administrator user rights a To uninstall user interface languages 1 Choose Utilities gt Import 2 Press Software A screen is displayed asking you to insert the USB stick Insert the USB stick 3 Press A screen is displayed that shows the file structure on the stick 4 Select the c111_uninstall_languages tar file 5 Press to confirm the selection All languages except English are deleted from the system A message will inform you when uninstalling is complete 6 When the installation is complete remove the USB stick Roche Diagnostics Operator s Manual Version 3 0 B 161 cobas c111 7 Configuration Configuration User management You need Administrator user rights to define or delete a user Defining a user a To define a user 1 Choose Utilities gt Users A screen is displayed that lists all currently defined users 2 Press 3 Type the user name
148. result compare with Cal Error where the calibration did not provide a usable result Recommended actions Check and redo calibration if needed Cal Error Meaning No valid calibration data available Message ID 43 Priority 24 Possible cause Caused by an alarm that occurred during calibration because the calibration could not provide a usable result Recommended actions Check the flags of the calibration and proceed to deal with the calibration first Calc Error Meaning Calculation error o General calculation error o Slope or nonlinear standard curve cannot be calculated due to a calibration error Message ID 16 Priority 13 Possible cause o Calibrator outdated or deteriorated o Misplacement of the calibrator tubes Recommended actions o Repeat calibration with fresh calibrators o If the calibrators were incorrectly positioned replace the calibrators and repeat the calibration Roche Diagnostics D 30 Operator s Manual Version 3 0 10 Result flags cobas c111 List of flags Curv Dir Meaning Curve direction The direction of the calibration curve is incorrect or not as expected Message ID 14 Priority 10 Possible cause Misplacement of calibrator tubes Recommended actions 1 Check the details of the calibration 2 If the calibrators were incorrectly positioned replace the calibrators correctly and rerun the calibration Ep Unstab Meaning End point un
149. s Manual A This label on the electrode block of the ISE unit indicates that there is a danger of hazardous situations arising within the vicinity of this label which may result in death or serious injury The rele vant laboratory procedures on safe use must be observed You will find this label only if an ISE unit is installed B This label on the main cover indicates that there are potential bio hazards within the vicinity of this label which may result in death or serious injury The relevant laboratory procedures on safe use must be observed Figure A 1 Safety labels on the cobas c111 instrument A B Roche Diagnostics A 14 Operator s Manual Version 3 0 1 Safety cobas c111 Safety labels Roche Diagnostics Operator s Manual Version 3 0 A 15 cobas c111 2 Introduction to the instrument Table of contents Introduction to the instrument What you need to know before you start In this chapter you will find basic information on the features that are relevant for working with the cobas c111 instrument Overview A 17 Principles of operation A 19 User interface A 20 Wizards
150. s Manual Version 3 0 B 57 cobas c111 6 Daily operation Validating sample results Accepting results Results must be accepted before they can be printed sent to the host or deleted Automatic acceptance The system can be set up to automatically accept results that are not flagged In addition it can be set up to accept results with flags that are marked in an editable list of flags that should be ignored Utilities gt Configuration gt Result Handling e See Result handling on page B 167 See Editing the acceptable flags list on page B 162 a To accept a result 1 Validate the result e If the sample is still on board see To validate sample results of on board samples on page B 52 e If the sample is no longer on board see To validate sample results from the results list on page B 53 f Press Accept The result list is displayed again Ratio results cannot be manually accepted They are automatically accepted if all their constituent results are accepted Roche Diagnostics B 58 Operator s Manual Version 3 0 6 Daily operation cobas c111 Validating sample results Printing sample results a To print results 1 Do one of the following 2 Press A screen is displayed for selecting which results should be printed 3 Press one of the buttons Press List to print the items currently displayed in the list If a filter was applied the list would contain only the items that fulfi
151. service 7128 s Initialization error X transfer Switch off the instrument Ensure that all covers are closed Check if the X transfer is blocked or jamming Restart the system If the error persists call service 7129 s Initialization error Z transfer Switch off the instrument Check if the Z transfer is blocked or jamming Check the seating of the transfer head cover Restart the system If the error persists call ser vice 7130 s Rotor position error Switch off the instrument and check if the rotor is blocked or jamming If the error recurs call service ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics D 18 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 List of alarm messages 7131 s Position error X transfer Switch off the instrument and check if the X transfer is blocked or jamming If the error recurs call service 7132 s Initialization error Z transfer Switch off the instrument Check if the Z transfer is blocked or jamming Check the seating of the transfer head cover Restart the system If the error persists call ser vice 7133 s Rotor motor overheated Switch off the instrument Check if the rotor is blocked or jamming Restart the system If the error persists call ser vice 7134 s Motor X transfer overheated Switch off the instrument Check if the X transfer is blocked or jamming Ensure that the X transfer can
152. sink temperature sensor does not react anymore Restart the system If the error persists call service 5028 s Error temperature sensor instrument The ambient temperature sensor does not react anymore Restart the system If the error persists call service 5030 s Error wash pump P1 The wash pump could not be started Restart the system If the error persists call service 5032 s Error waste pump P2 The waste pump could not be started Restart the system If the error persists call service 5034 s Error wash valve V1 The valve does not react anymore Restart the system If the error persists call service 5036 s Error cleaner valve V2 The valve does not react anymore Restart the system If the error persists call service 5038 s Error analyzer heating system The heating system does not react anymore Restart the system If the error persists call service 5040 s Error cooling system One of the Peltier elements does not react anymore Restart the system If the error persists call service 5044 s Error main board fan The fan could not be started or the fan speed is not correct Restart the system If the error persists call service 5047 s Error cooling fan The fan could not be started Restart the system If the error persists call service 5049 s Error sample area fan Switch off the instrument Remove the right side panel and check if the fan is jam ming or blocked If poss
153. system and on the Printer Tool must correspond General application definitions The following tables provide reference information on the meaning and use of application definitions the user might want to change Item Values Comment Short Name Up to 5 alphanumeric characters The short name is used on the screens for exam ple on the test selection screen or the results list Long Name Up to 30 alphanu meric characters The long name is a telling description of the test It is particularly useful if the short name is not generally familiar in the laboratory environ ment Active On Off Tests that not active are not available for use You cannot see them on the screens Their applica tion definitions remain on the system Test Tabs See Workflow definitions on page B 164 Choose one or several of the buttons The test will be included in the corresponding test tabs Choose Easy if you work with order mode Easy Clear all selections to prevent the test from being selected in the test selection screens Table B 12 General application definitions Roche Diagnostics Operator s Manual Version 3 0 B 153 cobas c111 7 Configuration Applications Calibration definitions ISE applications do not have calibration definitions Item Values Comment Sequence The sequence values define when calibration becomes due and the sys tem automatically informs you about due calibrations No Interval The sy
154. system is not available for performing tests Diagnostics A diagnostics action is being performed The system is not available for performing tests Operating Processing is in progress Powerup After switching on the system performs initialization and functional test Powerdown Regular shutdown is in progress E Stopped Processing has stopped User intervention is required to allow the system to resume regular operation Table A 3 System statuses Roche Diagnostics A 36 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 System status Roche Diagnostics Operator s Manual Version 3 0 A 37 cobas c111 3 Hardware Table of contents Hardware The parts and how they work In this chapter you will find information on the main hardware components of the cobas c111 instrument Covers and panels A 39 LEDs A 41 Main components A 43 Hardware overview A 44 Sample area
155. than one tab If it is selected in one it will automatically be selected in the others Tabs with selected items are marked with an asterisk 4 Press to confirm your selection 5 Wait for the Sample Area LED to turn green Make sure to keep clear of the sample area while the LED is yellow and blinking A screen is displayed asking you to place the sample on the instrument 6 Place the sample on any free position on the sample area The system registers where you placed the sample and associates this position with the order you just defined The screen for identifying samples is displayed again You can now start defining the next order If there were no free sample positions the screen for selecting the tests would be displayed instead 7 Do one of the following The test is blocked for one of the following reasons o The calibration failed o Initial calibration is required o For the reagent set the number of available tests is 0 or a reagent bottle is missing incomplete reagent set The expiration date of the test has passed There are only few tests left A QC is due or its result has not been accepted A more recent version of the application has been imported For a development channel An extra wash cycle is missing The test is on board and ready for use The test is defined but not on board A required diluent or cleaner is not on board Time limit for placing samples You need
156. the controls and a placement list supports you in preparing and loading them Safety information Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page B 5 o Infection by biohazardous materials on page B 5 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page B 5 WARNING Incorrect results due to inappropriate tube and cup placement Inappropriate tube and cup placement may lead to inaccurate pipetting and consequently to incorrect results Make sure that the primary tubes are placed centrally and perfectly vertically in the hold ers in the sample area and that they are inserted firmly Make sure that secondary tubes are placed centrally on the primary tubes and that they rest fully on them Roche Diagnostics Operator s Manual Version 3 0 B 69 cobas c111 6 Daily operation Performing QC Short guide The following table provides an overview of the steps that make up the QC process Step User action 1 Perform QC Perform Default QC 1 Choose Overview gt Order 2 Press 3 Select a control and place the tube Repeat until there are no controls left on the screen 4 Press Perform all interval QC mea surements that are due 1 Choose Overview gt Order gt or Workplace gt QC Status gt
157. the laboratory temporarily or if you want to relocate the cobas c111 instrument with the ISE unit Tools and materials required m Glass beaker m Deionized water m Tissues a To prepare the ISE data 1 Delete all ISE sample calibration and control results e See Deleting sample results on page B 94 Deleting calibration results on page B 95 Deleting QC results on page B 96 2 Disable all ISE applications e See Activating and deactivating applications on page B 139 3 Delete the ISE lot data e See Lot handling on page B 98 a To deactivate the ISE unit 1 Open the ISE cover 2 Remove the tubing adapters from the ISE solution bottles 3 Place the adapters in a beaker filled with deionized water 4 Remove bottles and screw on their lids 5 Place the beaker in the position where your removed the ISE solution bottles from 6 Choose Utilities gt Maintenance gt Prime ISE Reference and Calib 7 Press The maintenance definition screen is displayed 8 Press to start the action The ISE unit tubing is primed with water A message will inform you when the maintenance action is complete 9 Repeat steps 6 through 8 10 Remove the adapters from the beaker and place them on a lint free tissue 11 Repeat steps 6 through 8 The water is drained from the ISE unit tubing Make sure that you have read and understood section Safety information on page E 42 The following warning message
158. the system Preparing the reagents Reagents are handled in sets A set consists of up to three reagents If for example one reagent bottle of a set is empty all reagents of the set need to be replaced The system only uses reagents of complete sets On the screen each set is represented by a separate button Use reagents of the same lot if possible When replacing a new reagent set try to use one of the same lot as the old one This way you avoid having to perform a calibration Diluent and cleaner bottles An extra diluent or cleaner bottle is considered one set Extra cleaners and diluents are handled in the same type of bottles that are used for reagents Their handling works the same way In the following the process is described for reagents Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page B 5 o Infection by biohazardous materials on page B 5 o Loss of sight on page B 6 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page B 5 WARNING Incorrect results due to declining reagent quality Due to the declining quality of reagents the quality of measurement may decline This may cause incorrect results Make sure to use reagents whose expiration date has not passed yet Incorrect results due to reagent dilution thr
159. there is no other shift Step User action Table B 9 Steps for finishing the shift Roche Diagnostics B 80 Operator s Manual Version 3 0 6 Daily operation cobas c111 Finishing the shift Checking for unfinished tasks Checking for unfinished orders a To check for unfinished orders 1 Choose Workplace gt Orders 2 Choose gt Not Finished 3 Press A screen is displayed that contains all unfinished orders 4 Do whatever is necessary to finish the orders Checking for not accepted sample results a To check for not accepted results 1 Choose Workplace gt Result Review A screen is displayed that contains all sample results of the day 2 Choose gt Not Accepted 3 Press A screen is displayed that contains all sample results that have not been accepted yet 4 Select a result 5 Press to validate the result A screen is displayed for selecting your decision e See Accepting results on page B 57 See Repeating tests on page B 55 See Rerunning tests on page B 56 6 Press one of the buttons 7 Select and validate the remaining results as described in Steps 4 through 6 If you did not accept all results deal with the not accepted ones and check for not accepted results again Results must be accepted before they can be printed or transmitted to the host Roche Diagnostics Operator s Manual Version 3 0 B 81 cobas c111 6 Daily operation Finishi
160. to be performed This action will be performed as part of the Daily Prepare Actions When performing maintenance actions without using the Prepare wizard Choose Utilities gt Maintenance Roche Diagnostics Operator s Manual Version 3 0 E 23 cobas c111 13 ISE operation Daily operation Completing the preparation tasks 1 When you have finished performing maintenance actions press to proceed to the next stage in the Prepare wizard A screen is displayed that shows the status of the reagents on the reagent disk This is not relevant for ISE operation 2 Press A screen is displayed that shows the status of the cuvettes that are on board This is not relevant for ISE operation 3 Press A screen is displayed that shows the tests that need calibrating Because the calibrations have already been performed as part of the Daily Prepare Actions maintenance action this step is not relevant for ISE operation 4 Press The Overview tab is displayed The preparation tasks are completed Performing calibrations The ISE calibrations are integrated in the Daily Prepare Actions maintenance action e See Daily prepare actions on page E 44 Defining orders ISE sample analysis is integrated in the operation of the main instrument The process of defining orders is the same a To define orders 1 Follow the instructions given in Defining orders on page B 38 ISE tests are defined and requested as pr
161. to fit at the underside of the mixing tower It will be required when a service representative performs periodic maintenance A Peristaltic pump block B Upper set of sockets C There are no sharp angles in the tubing D Lower set of sockets Figure E 16 A C D B Roche Diagnostics E 62 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions 9 Install the tubing on the tubing adapters of the ISE Calibrator indirect urine and ISE Reference Solution bottles The two tubing adapters are slightly different but the process of installing the tube is the same o Pull the tube through the hole that aligns with the clips o Insert the nozzle in the tube o At the top of the adapter pull through the tube until the nozzle is flush with the end of the adapter There should be no slack o Fix the tube to the clips With the adapter that offers two clip positions use the inner position o Insert the tubing adapter in the appropriate bottle 10 Close the ISE cover then the left service flap and the main cover 11 Press to confirm completion of the action Conditioning the tubing The system now performs the maintenance action Prime ISE Reference and Calib A message will inform you when the maintenance action is complete The system now performs the maintenance action Initialize ISE Reference Sensor You are asked to remove the tubing adapter from of the ISE
162. to place the sample on the sample area within 10 seconds of confirming the test selection Failing to place the sample tube within 10 seconds cancels the current identification process You will be asked to identify the sample tube again WARNING Incorrect results due to not placing the identified sample The system assumes that the operator places the sample that was just identified Fail ing to do so might lead to wrong results If Do this There is another order to be defined Identify the sample and repeat the order definition process There are no more orders to define Press to close the screen Roche Diagnostics Operator s Manual Version 3 0 B 41 cobas c111 6 Daily operation Analyzing samples 8 Press the global action button to start processing e See Starting the run on page B 44 If you defined the order while the system was processing orders new orders will automatically be processed without pressing Order of processing When you first start processing orders the order of the sample placed on the leftmost position on the sample area is processed first The others follow in sequence from left to right Once processing is in progress the orders are processed according to the sequence in which they were defined Repeats and reruns of routine orders are performed before routine orders e See Repeating tests on page B 55 See Rerunning tests on page B 56 Defining STAT orders Short turn a
163. to spilled liquid Any liquid spilled on the instrument may result in malfunction of the instrument If liquid does spill on the instrument wipe it up immediately and apply disinfectant Make sure you do not tilt the bottle or sample tube when scanning its barcode Roche Diagnostics B 90 Operator s Manual Version 3 0 6 Daily operation cobas c111 Using the barcode scanner Reading barcodes from sheets a To use the barcode scanner for reading barcodes from sheets 1 When a screen is displayed asking you to scan use the barcode scanner and scan the barcode 2 Place the barcode transfer sheet on a flat surface and smooth it out 3 Hold the scanner at a distance of approximately 20 cm 8 in from the barcode pull the trigger on the scanner and point the red light just outside the barcode 4 Move the light slowly across the barcode 5 Wait until you hear a beep and release the trigger If the reading was successful a screen is displayed asking you to place the item Reading sample tube barcodes a To use the barcode scanner for reading sample tube barcodes 1 When a screen is displayed asking you to scan use the barcode scanner and scan the barcode 2 Make sure not to tilt the sample tube while scanning its barcode 3 Hold the scanner at a distance of approximately 20 cm 8 in from the barcode pull the trigger on the scanner and point the red light at the barcode 4 Wait until you hear a noise
164. understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 o Infection by biohazardous materials on page C 8 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page C 8 Roche Diagnostics Operator s Manual Version 3 0 C 25 cobas c111 8 General maintenance Maintenance actions Removing the lamp 6 Unplug the power connector A 7 Lift the photometer lamp housing cover C 8 Unscrew B the lamp assembly and remove it Installing the new lamp 9 Insert the new lamp assembly Hold the assembly by the screw and fit the lamp socket in the guides 10 Fasten the screw of the lamp assembly 11 Close the photometer lamp housing cover 12 Plug the power connector into its socket CAUTION Injury through hot parts Direct contact with hot parts may result in injury Do not touch the lamp assembly with bare hands Let the lamp cool down for about ten minutes before touching any part of the lamp housing A Power connector B Assembly screw C Cover Figure C 3 A B C WARNING Incorrect results through soiled lamp Touching the lamp with bare fingers reduces the life of the bulb and may affect the consistency of measurements made with the absorbance photometer Hold the lamp assembly by its screw Roche Diagnostics C 26 Operator s Manual
165. water to ensure the paths in the fluid system including pipette tubing and probe 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 Operator time Approximately 2 minutes Prerequisites The system must be in Standby status Tools and materials required m Purified water a To prime the fluid system 1 Check the external water and waste containers If required refill the water and empty the waste container 2 Select the maintenance action Prime Fluid System 3 Press The maintenance definition screen is displayed 4 Press The system performs the priming actions automatically A message will inform you when the maintenance action is complete 5 Press Roche Diagnostics C 12 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Clean the probe manually f Utilities gt Maintenance gt Clean Probe Manually You must clean the probe regularly by hand to prevent any build up of deposits that may affect results Operator time Approximately 1 minute Prerequisites The system must be in Standby status Tools and materials required m 70 ethyl alcohol m Tissues a To clean the probe 1 Select the maintenance action Clean Probe Manually 2 Press The maintenance definition screen is displayed 3 Press The system deactivates the transfer motors
166. were incorrectly positioned re place the calibrators correctly and repeat the calibration 3 If flag reoccurs repeat with fresh reagent QC Meaning A result where the quality control measurement is flagged Message ID 111 Priority 30 Possible cause The last QC measurement before this measurement was flagged The dependency is derived from the time sequence Recommended actions Check QC measurement R 1 2 5s Meaning One control value is above 2 5 standard deviation or below 2 5 standard deviation Message ID 36 Priority 28 Possible cause o The reagent has deteriorated linearity of working curve degraded o One control is concentrated or has deteriorated Recommended actions 1 Repeat with fresh control 2 Check that the correct control material has been used 3 If the flag reappears check the calibration and reagent status Repeat with fresh reagent Roche Diagnostics Operator s Manual Version 3 0 D 35 cobas c111 10 Result flags List of flags R 1 3s Meaning One control value is above 3 standard deviation or below 3 standard deviation Message ID 35 Priority 27 Possible cause o Improper control is set o Proper control values mean value standard deviation are not specified Recommended actions 1 Repeat with fresh control 2 Check that the correct control material has been used 3 If the flag reappears check the calibration and reagent status
167. 0 B 163 cobas c111 7 Configuration Configuration 6 Press to confirm the selection The file is exported as a text file of the name format hct_yyyymmddhhmmss txt a To re import the mapping table 1 Choose Utilities gt Host Codes 2 Press A screen is displayed asking you to insert the USB stick 3 Insert the USB stick 4 Press 5 Select the mapping file Typically mapping files have the name format hct_yyyymmddhhmmss txt Press txt to display text files only Press to display all files and directories 6 Press to confirm the selection The file is installed on the system The screen with the mapping table is displayed again a To use the manufacturer s application codes 1 Choose Utilities gt Host Codes 2 Press The host codes are set to values that are identical to the application codes By pressing again you can revert to the original values Roche Diagnostics B 164 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration Short guide to configuration definitions Workflow definitions Item Values Comment Working Mode Defines the way in which you select tests during order definition Manual Use this definition if the cobas c111 instrument is used as a stand alone system During order definition the test selection screen is displayed allowing you to select the tests or to make changes to the selection Host Use thi
168. 10 Result flags About flags About flags Flags are automatically generated with results if during processing certain technical checks were not passed or if the result exceeds or does not reach predefined limits Measurements that did not generate flags can be considered technically correct Flags are displayed and printed with the results a To display flag information 1 Display the result Do one of the following A screen is displayed that lists the results If flags were generated the flag with the highest priority is displayed For ratio results the flag with the highest priority of all constituent test results is displayed 2 Select the flagged result 3 Press to display all flags that were generated for this test A They are sorted according to their priority 4 Look up the flag in section List of flags on page D 28 for detailed information on the flag a To display flag information with the sample still on board 1 Choose Overview gt tube button A screen is displayed that shows the result together with the flag of the highest priority e To view all flags that were possibly generated see To display flag information on page D 25 If Do this You want to look at sample results Choose Workplace gt Result Review You want to look at calibration results Choose Workplace gt Calibrations You want to look at QC results Choose Workplace gt QC Status A Roche Diagnostics D 26 Op
169. 11 licenses A 11 lids ISE E 9 overview A 39 lists Abs flags D 28 alarm messages D 10 expanding and collapsing A 76 ISE flags E 71 lots A 106 orders A 98 loading reagent disk B 21 D 50 reagents B 26 loadlist screen A 107 log files exporting B 110 logging off B 88 logging on B 11 logs alarm messages D 9 lot data screen A 105 lot list A 106 lots adding B 101 defining B 101 defining for calibrators B 150 defining for controls B 149 handling B 98 list A 106 viewing definitions B 98 B 99 viewing details of used fluids B 101 lower case letters A 77 M main calibration E 12 E 26 maintenance instrument C 5 ISE E 39 overview C 5 screen A 110 maintenance actions Abs air water calibration C 28 Activate electrodes E 45 Clean housing C 21 Clean ISE tower automatically E 50 Clean ISE tower manually E 51 Clean probe manually C 12 Clean reagent disk C 14 Clean rotor and heating channel C 10 Clean rotor heating channel C 32 Clean water and waste C 16 Cleanup database C 23 colors of entries B 19 Condition ISE tubing E 46 Contact service representative C 27 Daily prepare actions E 44 Deproteinize probe C 10 Electrode service
170. 111 6 Daily operation Introduction Overview The following table gives an overview of the tasks you might need to perform during daily operation Roche recommend using the sequence of steps in the way given below but you may perform the tasks differently For details on the individual steps see the relevant sections in this chapter Task Steps Navigation With wizard As individual steps 1 Starting the system 1 Switch on the system 2 Logging on the system Overview gt Logon 3 Preparing the system Start the Prepare wizard Overview gt Prepare 1 Check the external fluid containers Overview gt gt 2 Perform the maintenance actions that are due Utilities gt Maintenance 3 Load the reagent disk Overview gt 4 Check the reagents Overview gt 5 Check the cuvettes Overview gt 6 Perform mixing Overview gt gt test gt 7 Perform calibrations that are due Workplace gt Calibrations gt gt 4 Defining orders Start the Orders wizard Overview gt Order or Overview gt STAT 1 Identify the sample n a 2 Select the tests n a 3 Place the sample n a 4 Start the run 5 Monitoring the progress n a Overview 6 Validating results 1 View results n a Workplace gt Result Review 2 Handle flagged results n a Workplace gt Result Review gt gt Repeat gt Rerun 3 Accept results n a Workplace gt Result Review
171. 111 software does not support the handling of patient demographic data NOTICE Probe damage due to not removing primary tube caps The probe is not designed to pierce tube caps It can get damaged when trying to pierce tube caps Always remove the caps of primary tubes before placing them on the instrument Roche Diagnostics Operator s Manual Version 3 0 A 33 cobas c111 2 Introduction to the instrument Daily operation Host connectivity The cobas c111 instrument can be connected to an external laboratory information system LIS a host computer for downloading order information and uploading results or a cobas c111 Printer Tool If the instrument is connected to a host system the following setups can be configured o Downloading order information When you identify a sample using the barcode scanner the appropriate order information is automatically assigned to the order on the system The order information was downloaded previously o Performing host queries When you identify a sample using the barcode scanner a query is sent to the host asking for the order information of the sample in question This information is then downloaded to the cobas c111 instrument and automatically assigned to the sample on the system o Transmitting results You can have results automatically transmitted to the host as soon as they are accepted e For the setup when connecting to a cobas c111 Printer Tool see the cobas
172. 12 Failed to identify the reagent disk This is probably a consequential error Check for previous errors and eliminate the cause Remove the reagent disk and check the ID tabs Reinsert the reagent disk correctly 7013 s Position error X transfer Switch off the instrument Check if the X transfer is blocked or jamming Eliminate the cause Restart the system If the error persists call ser vice ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics D 14 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 List of alarm messages 7014 s s electrode is not stable during sample measurement Perform restart Perform lt Electrode Service gt Check ISE Ref solution tubing for obstructions Replace electrode 7015 s s electrode is not stable during calibrator measurement Perform restart Perform lt Electrode Service gt Check ISE Ref solution tubing for obstructions Replace electrode 7016 s Initialization of the ISE unit failed due to a fluid transport problem Check the ISE tower and the ISE tubing for obstructions and leaks Check the electrodes Perform lt Initialize ISE Unit gt If the error persists call service 7017 s The ISE sample sensor could not detect ISE Etcher Check the ISE tower and the ISE tubing for obstructions and leaks Ensure that the tubing is correctly inserted into the sample sensor If the error persists call service 701
173. 41 ISE maintenance actions and their intervals E 41 ISE maintenance actions E 42 Safety information E 42 Daily prepare actions E 44 Activate electrodes E 45 Condition ISE tubing E 46 Initialize ISE Reference Solution sensor E 47 Prime ISE reference and calibrator E 48 Electrode service E 49 Clean ISE tower automatically E 50 Clean ISE tower manually E 51 Initialize ISE unit E 53 Replace ISE pump tubing
174. 5 cobas c111 3 Hardware Hardware overview Cups with a rim can be placed directly on the sample area whereas cups without rim must be placed on top of primary tubes Cuvettes Cuvette segments Each segment holds 10 cuvettes All optical measurements are made using the same transparent plastic containers called cuvettes Samples are automatically transferred from a sample tube to the cuvettes on the cuvette ring Cuvettes are disposable to eliminate carry over A Segment handle B Cuvette segment holding individual cuvettes C Cuvettes Figure A 20 Cuvette segment A B C Roche Diagnostics A 56 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Handling cuvettes Cuvettes are supplied in boxes containing cuvette sets Each set contains a number of cuvette segments This way the cuvettes can easily be handled without touching them Loading and removing cuvettes is guided by the system software When handling is required the rotor moves the cuvette segments to the cuvette port where you can load or remove them You handle one segment at a time Cuvette segments are placed in the cuvette ring of the rotor e See Preparing cuvettes on page B 28 Reagent handling Loading and removing reagents is guided by the system software When handling is required the rotor moves the bottles to the reagent port where you can load or remove them You handle one reagent bottle at a t
175. 53 d A reagent mixing cycle failed because the probe crashed Switch off the instrument Check if the probe and probe holder are correctly installed Replace a bent probe Restart the system If the error persists call service 7154 d A probe wash cycle failed because the probe crashed Switch off the instrument Check if the probe and probe holder are correctly installed Replace a bent probe Restart the system If the error persists call service 7155 d Initialization of the transfer failed because the probe crashed Switch off the instrument Check if the probe and probe holder are correctly installed Replace a bent probe Restart the system If the error persists call service 7156 d A prime cycle failed because the probe crashed Switch off the instrument Check if the probe and probe holder are correctly installed Replace a bent probe Restart the system If the error persists call service 7157 d Initialization of the Z transfer failed due to a level detection problem Switch off the instrument Check if the probe and probe holder are correctly installed Clean the init plate Restart the system If the error persists call service 7158 d A tube bottom sensor problem was detected Switch off the instrument Check if the tube bottom sen sor mechanism can be moved freely Restart the system If the error persists call service 7159 d Movement stopped because the probe crashed Switch off the instrumen
176. 65 connectivity A 33 definitions B 165 host codes B 162 screen A 113 housing cleaning C 21 Roche Diagnostics Operator s Manual Version 3 0 F 15 cobas c111 Index I ignoring QC results B 74 import screen A 118 importing applications B 111 B 137 certificates B 115 database B 114 extra wash cycles B 116 mixing information B 116 software B 113 Initialize ISE reference sensor maintenance action E 47 Initialize ISE unit maintenance action E 53 installation safety A 7 installing applications B 112 B 138 ISE pump tubing E 54 ISE unit tubing E 61 instrument approvals 3 disposal A 12 features A 17 introduction A 15 main components A 43 overview A 17 switching on B 10 where to use A 7 intended use instrument 7 of operator s manual 2 interface See user interface interfaces specifications A 67 internal waste tank A 50 interpreting QC History B 74 Interval QC overview B 68 performing B 71 intervals ISE maintenance actions E 41 maintenance actions C 7 introduction See overview inventory checking bottle sets B 23 B 100 deleting bottle sets B 120 screen A 117 ISE calibration E 12 calibrator priming E 48 checking status E 21 cleaning tower
177. 8 d The probe is not straight or not properly mounted Check that the probe is properly mounted Perform lt Replace Probe gt 7019 d Transfer initialization failed due to a level detection problem Clean the transfer init plate Ensure that the probe is not bent and installed correctly Restart the system If the error persists call service 7020 d Transfer initialization failed due to an open main cover Ensure that all covers are closed Restart the system 7021 d Instrument failed to initialize due to dirty init plate or probe Perform lt Clean Probe Manually gt and restart the system If the problem persists call service 7022 s Motor d movement impeded Perform restart If the problem persists call service 7033 s Position error Z transfer Switch off the instrument Check if the Z transfer is blocked or jamming Eliminate the problem Restart the system If the error persists call service 7034 s Either a rotor or an X transfer or a Z transfer motion control error occurred Restart the system If the error persists call service 7036 s The level detection frequency is outside the range Clean the probe and probe holder Replace the water inlet filter Ensure that the system water meets the specifica tions Restart the system If the error persists call service 7037 s The level detection frequency is outside the range Clean the probe and probe holder Check the level detec tion ca
178. 8 Type the low limit then press 19 Type the high limit then press 20 Type the standard unit then press 21 Type the laboratory unit then press 22 Type the conversion factor then press 23 Select whether the standard or the laboratory unit will be displayed for the final ratio result then press For the calculation of the individual results the system uses standard units 24 Type how many decimal positions will be used in the displayed results 25 Press WARNING Incorrect results due to inappropriate formula The formula defines how the values of the applications and coefficients are mathemat ically combined to generate a result It is the responsibility of the user to ensure that the formula is appropriate for the appli cation that is being defined Roche Diagnostics B 148 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications Profiles Defining profiles A profile is a set of tests that are frequently ordered in combination When ordering a profile all tests of the profile are performed a To define a profile 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Press 3 Press Add Profile 4 Type the profile code For customer defined profiles use the numbers 910 through 930 5 Type the short name up to 5 characters The short name will appear on the test selection screens 6 Type the long name up to 30 characters
179. 88 Operator s Manual Version 3 0 6 Daily operation cobas c111 Logging off Logging off You should log off the system before you hand it over to another operator Only one person can be logged on at any time You can log off any time even while the system is processing orders a To log off the system 1 Choose Overview gt button with your user name e For configuring automatic logoff see System on page B 168 If there is no other shift you can now switch off the main instrument Switching off the system Preconditions The system must be in Standby status a To switch off the main instrument 1 Press O on the toggle switch Automatic logoff You can configure the system to automatically log off the user after a configurable period of inactivity Utilities gt Configuration gt System gt Screen Saver Wait 0 Utilities gt Configuration gt System gt Auto Log off On Viewing alarms while you are logged off You can view alarms any time even when you are logged off When you switch off the system reagent cooling stops Therefore you need to remove the reagent disk and store it in a cool place before switching off the system Roche Diagnostics Operator s Manual Version 3 0 B 89 cobas c111 6 Daily operation Using the barcode scanner Using the barcode scanner e For information on the barcodes see Barcode scanner on page A 61 Because the barcodes on reagent bottles a
180. B 81 Starting the End Shift wizard B 81 Performing the daily backup B 82 Exporting the result data B 83 Cleaning up the database B 84 Performing maintenance actions B 85 Replacing cuvettes B 85 Dealing with the external fluid bottles B 86 Emptying the waste container B 86 Refilling the external water bottle B 86 Removing the reagent disk B 87 Logging off B 88 Switching off the system B 88 Using the barcode scanner B 89
181. COBAS COBAS C and LIFE NEEDS ANSWERS are trademarks of Roche All other trademarks are the property of their respective owners Manual version Software version Revision date Changes 1 0 July 2006 First publication 2 0 2 0 December 2007 Full mode added Improved calibration concept Additional maintenance and troubleshooting information Additions improvements and corrections 3 0 3 0 June 2009 Inventory processing sequence and ratio functions added Improvements and corrections Layout upgraded Roche Diagnostics Operator s Manual Version 3 0 3 cobas c111 Instrument approvals The cobas c111 instrument meets the protection requirements laid down in IVD Directive 98 79 EC and the European Standard EN 591 Furthermore our instruments are manufactured and tested according to the following international standards o EN IEC 61010 1 2nd Edition o EN IEC 61010 2 101 1st Edition The Operator s manual meets the European Standard EN 591 Regulatory compliance is demonstrated by the following marks Contact addresses Manufacturer Distributor Complies with European Union EU Directive 98 79 EC C US Issued by Underwriters Laboratories Inc UL for Canada and the US Roche Diagnostics Ltd Forrenstrasse CH 6343 Rotkreuz Switzerland Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim Germany cobas c111 Roche Diagnostics 4 Operator s Manual
182. Checking the status of the external fluid containers B 15 Performing maintenance actions B 19 Preparing the reagent disk B 21 Preparing the reagents B 22 Checking the status of reagent sets B 23 Preparing reagents B 25 Preparing cuvettes B 28 Performing reagent mixing B 29 Performing the calibrations Prepare phase B 30 Analyzing samples B 34 Safety information B 34 Short guide B 35 System setup and order definition workflow B 37 Defining orders
183. D 9 database B 104 diagnostics data D 51 log files B 110 results B 83 B 105 external bottle status screen A 96 external waste container A 51 extra wash cycles activating B 171 deactivating B 171 defining B 170 definitions B 172 deleting B 171 importing B 116 screen A 113 F features of instrument A 17 filtering A 78 finishing the shift B 77 flags Abs results D 28 ISE results E 71 overview D 25 priorities D 26 viewing details D 25 flaps instrument A 39 ISE unit E 9 fluid system overview A 45 priming C 11 fluids bottles A 50 bottles for ISE E 11 checking external containers B 15 connecting external cleaner bottle B 128 connecting waste container B 128 connecting water container B 127 external connectors A 47 ISE E 8 replacing ISE bottles E 22 E 30 forecast period A 29 fuses A 65 changing for mains D 47 changing low voltage D 49 G global action buttons A 73 H handling cuvettes A 56 lots B 98 orders A 32 reagents A 25 A 56 results A 34 samples A 31 software data A 67 hardware overview A 37 specifications A 66 heads transfer A 48 heating channel cleaning C 10 host configuration B 1
184. E 49 Initialize ISE reference sensor E 47 Initialize ISE unit E 53 intervals C 7 intervals for ISE E 41 performing C 6 performing during End Shift phase B 85 performing during Prepare phase B 19 Prime fluid system C 11 Prime ISE calibrator and reference E 48 Replace ISE pump tubing E 54 Replace ISE unit tubing E 57 Replace photometer lamp C 24 Replace water inlet filter C 19 maintenance days B 169 manual how to use 7 mapping application codes B 162 measurements specifications A 66 measuring modes ISE E 6 messages alarms A 83 D 10 list D 10 overview A 82 D 5 screen A 82 D 5 mixing motor A 49 mixing reagents B 76 during Prepare phase B 29 mixing rules B 173 definitions B 173 deleting B 174 importing B 116 printing B 173 monitor See alarm monitor monitoring analysis process B 44 ISE status E 24 Roche Diagnostics Operator s Manual Version 3 0 F 17 cobas c111 Index N navigation through screens A 74 O obsolete calibration A 28 online Help using 7 A 81 operation overview B 7 principles A 19 routine B 3 routine ISE E 17 safety A 6 operators qualifications A 9 regular breaks A 9 optical safety A 6 order of processing B 44 B 145 orde
185. I and chloride CL I tests are calibrated with a two point calibration using ISE Solution 1 and 2 For urine the sodium NA U potassium K U and chloride CL U tests are calibrated with a two point calibration using ISE Solution 1 and 2 The main calibration is typically performed during the Prepare phase and if there follows a second shift at the end of a shift It is integrated in the Daily Prepare Actions maintenance action e For details on performing the Daily Prepare Actions maintenance action see Daily prepare actions on page E 44 For details on performing individual calibrations see Process of performing calibrations on page B 61 Performing QC ISE QC handling is integrated in the operation of the main instrument a To perform QC e Follow the instructions given in Performing QC on page B 68 Roche Diagnostics Operator s Manual Version 3 0 E 27 cobas c111 13 ISE operation Daily operation Finishing the shift ISE Standby status If there is no measurement for more than three minutes the ISE unit switches to Standby status In this status ISE Calibrator indirect urine and ISE Reference Solution are pumped into the measuring channel and moved a short distance at regular intervals Also every two hours the ISE tubing is primed with ISE Calibrator indirect urine and ISE Reference Solution This is done to prevent the following o Flow of ISE Reference Solution backwards into the measuring channe
186. Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions 6 Replace the water inlet filter o Remove the retaining ring by pulling it by its tab away from the filter casing A D E o Remove the filter B and replace it with a new one o Place the retaining ring Press it firmly on the filter casing by placing your thumb across it an applying equal pressure all around 7 Reinsert the tubing adapter into the water container Press down firmly 8 Press The maintenance action Prime Fluid System is automatically performed A message will inform you when the maintenance action is complete 9 Press A Removing the retaining ring B Filter C Filter casing D Retaining ring E Tab on retaining ring Figure C 2 A C B E D Roche Diagnostics Operator s Manual Version 3 0 C 21 cobas c111 8 General maintenance Maintenance actions Clean and disinfect housing f Utilities gt Maintenance gt Clean Housing You must clean the housing regularly to ensure that contaminants do not build up and affect the efficiency of the instrument as a measuring system Operator time Approximately 10 minutes Prerequisites Instrument is switched off Tools and materials required m Ethyl alcohol m Tissues a To clean the housing 1 Make sure the system is in Standby status 2 Switch off the system 3 Wipe all the outside of the instrument with alcohol
187. Pull the new tubing set over the pump head with the connector plate facing the electrode block A Cover of peristaltic pump Figure E 10 A Connector plate Figure E 11 A ISE pump tubing set Figure E 12 A A A Roche Diagnostics E 56 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions 12 Align the tubing connector plate with the tube connectors on the ISE unit 13 Carefully close the peristaltic pump lid The tube connector plate is automatically pushed into the tube connectors of the ISE unit 14 Close the ISE cover 15 Press to confirm completion of the action The system first performs the Prime ISE Reference and Calib maintenance action then Initialize ISE Unit A message will inform you when the maintenance actions are complete 16 Remove the Activator from the sample area 17 Press Roche Diagnostics Operator s Manual Version 3 0 E 57 cobas c111 14 ISE maintenance ISE maintenance actions Replace ISE unit tubing f Utilities gt Maintenance gt Replace ISE Unit Tubing Due to the abrasion by the ISE valve action the ISE tubing needs to be replaced periodically Replacing the ISE tubing ensures the proper functioning of the ISE unit During the Replace ISE Unit Tubing maintenance action the following maintenance actions are automatically performed o Prime ISE Reference and Calib o Initialize ISE Reference Sensor
188. RNING Injury through working solutions Direct contact with cleaning solutions or other working solutions may cause personal injury When handling such solutions exercise the precautions required for handling them observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions Infection by biohazardous materials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Injury or damage to the analyzer due to contact with instrument mechanism Do not touch any parts of the instrument other than those specified During operation and maintenance of the instrument proceed according to the instructions Incorrect results or damage to the analyzer due to wrong operation Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not
189. Reagent bottles o Photometer unit You open this cover whenever you need to handle cuvettes reagent bottles or the reagent disk A green LED indicates that you should place an item a yellow LED that you should not open the main cover To open the cover press the release button at the underside of the front of the cover When you should close the cover an acoustic signal is sounded and the system icon on the System Status screen turns red Rear service flap Provides access to o Computer boards o Power supply o Transfer unit o Degasser This flap should be opened by service representatives only Switch off the system before you open this cover and remove the two side panels before opening this flap Right side panel Provides access to o Syringe assembly Remove this panel as instructed during maintenance actions or switch off the system before you remove it Right service flap Provides access to o Photometer unit o Sample area o Touchscreen o Data management computer Open this panel as instructed during maintenance actions or switch off the system before you open it Printer panel Provides access to o Printer paper You can open this flap any time as long as the printer is not printing To open the panel press the release button Roche Diagnostics Operator s Manual Version 3 0 A 41 cobas c111 3 Hardware LEDs LEDs LEDs are placed on key positions on the co
190. Reagent port Figure A 24 Reagent port on the reagent disk A B A Roche Diagnostics A 58 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Reagent disk The reagent disk holds up to 27 reagent bottles It is designed to be handled as one unit including the bottles When not used on the instrument the reagent disk is placed in a container and stored in a refrigerated place e See Preparing the reagent disk on page B 21 Reagent disk ID You can use up to eight different reagent disks on one cobas c111 instrument Each reagent disk is equipped with numbered tabs For automatic disk identification by the instrument one and only one of these tabs is removed The number of this removed tab is the disk ID When you label the disk make sure that the number on the label corresponds to that of the removed tab Figure A 25 Reagent disk NOTICE Damage to the reagent disk The reagent disk is designed to handle reagents while it is loaded on the instrument The cover is equipped with a locking mechanism Always remove and load reagents while the reagent disk is on the instrument and by using the software supported procedures A Reagent disk IDs There are eight possible IDs B Disk label The number must correspond to the reagent disk ID C Identification tabs D The tab has been removed for automatic disk recognition Figure A 26 Reagent disk ID B A A D C
191. Reference Solution bottle 12 Open the ISE cover 13 Remove the tubing adapter from of the ISE Reference Solution bottle o Have a clean lint free tissue ready o Lift the tubing adapter and place it on the tissue 14 Press to confirm completion of the action The system now starts to initialize the ISE Reference Solution sensor You are asked to insert the tubing adapter in the ISE Reference Solution bottle and to close the ISE cover A ISE Reference Solution tubing adapter B ISE Calibrator indirect urine tubing adapter Figure E 17 B A Roche Diagnostics Operator s Manual Version 3 0 E 63 cobas c111 14 ISE maintenance ISE maintenance actions 15 Insert the tubing adapter in the ISE Reference Solution bottle 16 Close the ISE cover 17 Press The system first pumps ISE Reference Solution through the ISE tubing Then it performs the Condition ISE Tubing maintenance action and finally Initialize ISE Unit A message will inform you when the maintenance action is complete 18 Remove the Activator from the sample area 19 Press Roche Diagnostics E 64 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Deactivating the ISE unit If you intend not to use the ISE unit for more than one week you should deactivate it This saves ISE fluids and reduces wear and tear of the tubing This situation may occur for example if you need close
192. Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 13002 A software error occurred The calculated result for the order d could not be stored in the database Export the log files If the error persists call service 13003 A software error occurred Data of the order d could not be retrieved from the database Export the log files If the error persists call service 13004 A software error occurred The required parameters for application d could not be found Export the log files If the error persists call service 13005 A software error occurred The calibration result for order d could not be stored in the database Export the log files If the error persists call service 13006 A software error occurred A required parameter set for a certain application d could not be found Export the log files If the error persists call service 13007 Reagent disc d was replaced by disc d while the system was switched off Ensure that the information provided in lt Disk Status gt corresponds to the actually loaded reagent bottle sets 13008 The import of the database failed The database version does not correspond to the currently installed software version An old database version was provided detected V d expected V d 13009 A software error occurred An invalid database entry d for a control was detected
193. Review gt Workplace gt QC Status gt Workplace gt QC History gt Workplace gt Calibrations gt 8 Perform the maintenance actions that are due Utilities gt Maintenance 9 Replace cuvettes Overview gt 10 Check the external fluid containers Overview gt gt 11 Remove the reagent disk if last shift Overview gt gt 12 Log off the system Overview gt button with your user name 13 Switch off the system if last shift n a n a Task Steps Navigation With wizard As individual steps Table B 1 Overview of the daily operation tasks Roche Diagnostics B 10 Operator s Manual Version 3 0 6 Daily operation cobas c111 Starting the shift Starting the shift Starting the shift includes the tasks from switching on the instrument up to the moment when you are logged on The various tasks are described in the order in which they should be performed Switching on the instrument Preconditions Before you switch on the instrument make sure the following preconditions are met o All covers are closed o The external fluid containers are connected o The sample area is empty a To switch on the instrument 1 Press down I on the power toggle switch A The system performs internal checks and routines The startup phase may take a few minutes During this time a splash screen is displayed When the system is ready to log on the Overview tab is displayed
194. The following results are copied to the USB stick each of the sets is contained in a separate file File format Result data are exported as comma separated value csv files The entries are separated by semicolons e For details on csv definitions see Exporting results on page B 105 These files can be processed with any spreadsheet program that can import csv files a To export the results 1 Press A screen is displayed asking you to insert the USB stick 2 Insert the USB stick A screen is displayed showing the directory structure of the USB stick 3 Select the directory where you want the result files to be copied 4 Press to confirm the selection The data are copied to the stick 5 Press to proceed to the next stage in the End Shift wizard A screen is displayed for deleting sample results Data set File name Sample results res_yyyymmddhhmmss csv QC results qcs_yyyymmddhhmmss csv QC history results qch_yyyymmddhhmmss csv Calibration results cal_yyyymmddhhmmss csv Process event log pev_yyyymmddhhmmss csv When performing backup without using the End Shift wizard Choose Utilities gt Export gt Full Results Roche Diagnostics B 84 Operator s Manual Version 3 0 6 Daily operation cobas c111 Finishing the shift Cleaning up the database The cobas c111 instrument can store orders and results data for one working day It is therefore necessary to delete results
195. Version 3 0 B 27 cobas c111 6 Daily operation Preparing the system 12 Remove the cap from the bottle and place it in the reagent bay 13 Press to confirm the insertion If you confirm without placing the bottle the system assumes that the bottle is placed If you press after placing the bottle the position is deemed empty When the first reagent bottle is loaded the reagent set is defined From this moment on the reagents are handled as part of the set You no longer handle them as individual reagents 14 Do one of the following 15 On the screen with the reagent set buttons press the button for the set you just inserted A screen is displayed that shows details of the set The status description points to the action you need to take If you just inserted a reagent set you may have to perform the initial calibration and QC Time limit for placing reagent bottles o The system assumes that you place the bottle that you just scanned o You need to place the reagent bottle on the reagent disk within 15 seconds of scanning the reagent barcode Failing to confirm the placement within 15 seconds cancels the current identification process You will be asked to scan the bottle again WARNING Incorrect results due to not placing the identified reagent The system assumes that the operator places the reagent that was just identified Fail ing to do so might lead to wrong results If Do this There is another b
196. WARNING Loss of sight The intense light of the LEDs may severely damage you eyes Do not stare into the LEDs Scanning equipment using LED technology is covered by the international standard IEC 60825 1 LED Safety Class 1 Incorrect results or damage to the analyzer due to wrong operation Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics o Start all maintenance actions on the screen Do not perform maintenance actions with out the assistance of the user interface o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to a trained service representative o Follow standard laboratory practices especially when working with biohazard material Incorrect results or damage to the analyzer due to dust and soiling The user can leave the main cover open while the system is in Standby status or while the instrument is shut down This can cause dust and dirt being collected in the cuvette ring which in turn might decrease the quality of the cuvettes Keep all covers closed Open them only to perform operation actions Roche Diagnostics Operator s Manual Version 3 0 B 7 cobas c
197. a To delete an ordered calibration 1 Choose Workplace gt Calibrations 2 Select the order 3 Press A confirmation dialog box is displayed 4 Press to confirm the deletion The processing activities for this order are stopped Measurements that have not yielded a valid result are considered not measured After deleting the order the calibration retains the Due status if it was due before Roche Diagnostics B 64 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing calibrations Validating calibration results For a calibration to become active you need to accept its result Flagged calibration results If flags are generated you must determine their cause and decide whether to accept the result continue working with the old results or to rerun the calibration The effect of flagged calibration results depends on the configuration e See Result handling on page B 167 See Editing the acceptable flags list on page B 162 Configuration setting Effect Cal Auto Accept On Results that do not contain a flag are auto matically accepted Results with flags that are marked in a predefined list of flags that should be ignored are also automatically accepted Cal Auto Accept Off All results need to be manually accepted Cal Acceptable Flags Flags that are marked in this list will be ignored by the system Table B 6 Calibration flag configuration and its effect Roche Dia
198. a QC target value change took place only the results from this date onward are taken into account for both statistics 4 Press to close the screen Performing reagent mixing Reagents that contain Latex granules for example D Dimer require periodic mixing The mixing interval is part of the application definitions and cannot be changed by the user The system checks every 30 minutes for reagent sets that require mixing e For mixing during the Prepare phase see Performing reagent mixing on page B 29 a To perform the mixing 1 Choose Overview gt 2 Press the button of the reagent set you want to mix A screen is displayed that contains details on the set 3 Press This button is available if there is a mixing interval defined for this reagent set Mixing starts A screen is displayed informing you about the progress of the mixing action 4 When mixing is finished press to close the screen Closing the dialog box while mixing is in progress stops the mixing action Mixing would have to be performed anew A Date of QC measurement B Result or event C Flag if generated Figure B 29 A B C Roche Diagnostics Operator s Manual Version 3 0 B 77 cobas c111 6 Daily operation Finishing the shift Finishing the shift The typical end of shift activities are organized in a single wizard By performing the steps as suggested by this wizard you put the instrument in a condition tha
199. agent cooler with a cloth dampened with soapy water 8 Reinsert the reagent disk e For information on inserting the reagent disk see Preparing the reagent disk on page B 21 9 Open the right service flap Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 o Infection by biohazardous materials on page C 8 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page C 8 Roche Diagnostics Operator s Manual Version 3 0 C 15 cobas c111 8 General maintenance Maintenance actions 10 Lift the sample tray from its fixture 11 Wash the sample tray using detergent You can wash the tray in a dish washer 12 Leave the sample tray to dry or dry it using tissues 13 Reinsert the sample tray Make sure to align the guides with the pins Press down firmly 14 Close the right service flap and the main cover 15 Press to confirm that you have performed the maintenance action The system initializes automatically A message will inform you when the maintenance action is complete 16 Press Do not disassemble the sample tray Roche Diagnostics C 16 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Clean the water and waste containers f Utilities gt Maintenance gt Clean W
200. agnostics A 34 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Maintenance Results You can check the results on the screen as soon as they are calculated Units Results are normally given in your lab units The units can be configured Flags Result flags are test specific They indicate that the limit of an internal check was exceeded or not reached System flags point to the status of the result within the process of analysis for example they tell you that the result has not been accepted or that is has not been transmitted to the host successfully Printing results You can print all or selected results on the built in printer Validating results All results need to be validated result accepted test rerun or repeated Result flags help you identify critical results and point to possible actions that need to be taken Each test must have accepted calibration results tests whose associated calibration results are not accepted cannot be performed Ratio results The user can manually define ratios Ratio results are handled like any other sample result with the exception that they cannot be accepted by the user They are automatically accepted if all their constituent results are accepted Repeating and rerunning tests If a result is flagged you may decide to run a test again You can either perform exactly the same test Repeat or perform it with a different predefined dilution R
201. ainers the wash station and the probe It transports all fluids around the instrument including sample reagent calibrator control diluent cleaner system water and waste The fluid system also delivers the correct amounts of fluids to the cuvettes A Wash station B Transfer head with probe C Pumps D Degasser E Syringe assembly F Internal waste tank G Cleaner bottle red cap H Water container white I Waste container yellow Figure A 11 Fluid system A D C E I H G F B NOTICE To prevent overflow of the internal waste tank when the system is in Standby status the waste is periodically pumped to the external waste container Condensation can build up in the cooling assembly while the system is in Standby status Roche Diagnostics A 46 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Probe and syringe The probe is connected by tubing to o The syringe to ensure the pipetting of the required amounts of fluid o The external water container and cleaner bottle to ensure supply of fresh water and cleaner e See maintenance action Clean the probe manually on page C 12 See maintenance action Deproteinize the probe on page C 10 See Replacing the probe on page B 125 Syringe assembly The syringe assembly controls the aspiration and dispensing of fluids It also controls the supply of water and cleaner to clean the probes in the wash
202. alibrations gt 2 Select the test n a 3 Prepare and place the calibrators n a 4 Start the calibration 5 Validate the calibration results Workplace gt Calibrations gt 6 Remove the calibrators Performing all due calibrations 1 Start the wizard Workplace gt Calibrations gt 2 Select all tests with due calibrations or Select all tests with calibration due within the forecast period n a 3 Prepare and place the calibrators n a 4 Start the calibration 5 Validate the calibration results Workplace gt Calibrations gt 6 Remove the calibrators 8 Performing controls Performing Default QC 1 Start the wizard Overview gt Order gt 2 Select a control and place the tube Repeat until there are no controls left on the screen n a 3 Start the QC measurement 4 Validate the QC results Workplace gt QC Status gt 5 Remove the controls n a Performing an individual QC measurement 1 Start the wizard Workplace gt QC Status gt 2 Select a test n a 3 Select a control and place the tube Repeat until there are no controls left on the screen n a 4 Start the QC measurement 5 Validate the QC results Workplace gt QC Status gt 6 Remove the control Performing all due QC measurements 1 Start the wizard Overview gt Order gt gt 2 Select a control and place the tube Repeat until there are no controls l
203. all service 0008 The cycle range d d is not valid Repeat the order If the error recurs export the log files with the system remaining in this error condition If the error persists call service 0010 The reaction direction d is invalid Repeat the order If the error recurs export the log files with the system remaining in this error condition If the error persists call service 0011 An internal communication error occurred The received IPC message d d could not be interpreted Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 0012 A software error occurred The status of an order is invalid d d Delete and redefine the order If the error recurs export the log files with the system remaining in this error condi tion If the error persists call service 0017 The installed language version is out of date s s Install the language version that belongs to the currently installed system software version If the error persists call service 0018 The current system date and time are invalid Correct the date and time settings in Configuration If the error persists call service 5001 Air detected in the fluid system Water container or cleaner bottle is empty Table D 1 List of alarm messages Roche Diagnostics Operator s Manual Version 3 0 D 11 cobas c111 9 Messages and alarms List of al
204. all times and if the operating environment is effectively controlled by performing all maintenance actions when they become due in the manner described in the Operator s Manual e See Maintenance actions on page C 8 Information about the status of the system The system performs numerous checks When a certain event has occurred or when an irregularity is detected a message is generated Messages are displayed in two ways o Immediate feedback on user actions is displayed in a pop up message screen e See Message screen on page D 5 o Information concerning a problem that occurred during operation is reported as alarm messages in the alarm monitor e See Alarm monitor on page D 6 Roche Diagnostics D 42 Operator s Manual Version 3 0 11 Troubleshooting cobas c111 Dealing with exceptional situations Dealing with exceptional situations The following table list possible exceptional situations provides information on the possible causes and suggests ways of remedying the situation Subsequent sections contain detailed procedures for selected remedies Situation Affected items Possible causes Comments Measuring whole blood Tube bottom detection Use of unsuitable tubes With whole blood samples pipetting is always per formed from near the tube bottom of the tube To ensure proper pipetting only use primary tubes With other tubes the bottom detector might register and pipetting would stop T
205. ample reagent calibrator control diluent cleaner system water and waste Syringe assembly Performs the aspiration and dispensing of fluids This includes the supply of water and cleaner to clean the probes in the wash station after every pipetting action which prevents carry over between tests Degasser Removes possible air bubbles from the system water Sample area Eight positions for holding sample tubes This area is also used for placing calibrators controls and auxiliary fluids Display The touchscreen provides the user interface for controlling and managing the cobas c111 instrument Front USB port This port is used for the USB stick when backing up data or loading data on the system Hardware overview Sample area The sample area provides eight positions for placing sample tubes You can place primary and secondary tubes e See Tubes on page A 54 Place the samples when instructed by the system to do so For calibrators the system tells you on which position to place them with the other fluids you can choose any free position A The LED indicates that the transfer tower is approaching or that you should place a sample tube Figure A 10 Sample area with sample tubes A Roche Diagnostics Operator s Manual Version 3 0 A 45 cobas c111 3 Hardware Hardware overview Fluid system The fluid system consists of all the valves pumps tubing syringe fluid sensors water and waste cont
206. anges and values that determine the correct functioning of the instrument This is typically done both for the normal and the pathological analyte concentration When QC is due With regards to when it needs to be performed QC is divided in the following types o QC After Cal The QC measurement is due after calibration of the test o Interval QC QC is due whenever its interval has expired QC measurements of this type are performed in a batch typically once or twice a day o Default QC QC is performed at certain times during routine operation This is done to fit in with laboratory processes and procedures Ways of performing QC With regards to how QC is performed the following methods are provided o Default QC Default QC is an automated process for performing multiple QC measurements at the time when you define the QC orders This is the ideal method if you want to perform QC at certain times and days This method only applies to tests whose controls are defined to be performed as part of Default QC Therefore if you intend to work with the Default QC function you need to configure the tests accordingly Default QC follows a streamlined procedure where the necessary QC orders are automatically defined as soon as you identify a control An order is defined for each test for which this control is defined provided the test is currently active on the system A wizard helps you select the controls and a placement list su
207. annot be changed by the operator password A form of authentication that uses secret data to control access to a resource photometer A device that measures the intensity of light photometer unit Complete photometer assembly including optical components power supply preamplifyer and absorbance controller pipette to The process of aspirating and dispensing sample and reagents performed by an appropriate probe pop up screen A screen that contains additional information or additional options required for making entries or decisions potentiometric assay An assay in which analytes for example Na K or Cl are measured by ion selective electrodes precision The closeness of agreement between independent test results obtained under prescribed conditions pre dilution A dilution step performed before samples are analytically processed on the analyzer preventive maintenance A series of actions suggested by the system that the operator should perform to ensure smooth and uninterrupted operation of the instrument for example emptying the waste container or replenishing reagents primary tube The original tube containing the sample that has been drawn from the patient See sample tube prime The process of flushing a system for example the tubing with ISE Calibrator indirect urine and water to clear it of possible obstacles traces of fluid and of air bubbles profile A user defined set of tests protoc
208. arcode of the item and you define them by scanning the barcode With the exception of reagent and diluent lots they can be defined by scanning their barcodes only all lots can also be defined manually You would for example define the lot data manually if you cannot read the barcode for some reason or in the case where you work with lab specific controls or third party controls that do not include barcode transfer sheets for lot data If Do this You want to check the context information of a sample result 1 Choose Workplace gt Result Overview 2 Select a result 3 Choose gt You want to check the context information of a QC result 1 Choose Workplace gt QC Status 2 Select a result 3 Choose gt You want to check the context information of a calibration result 1 Choose Workplace gt Calibrations 2 Select a result 3 Choose gt Defining lots manually requires utmost diligence During lot definition you need to type data that are directly relevant to result generation Roche Diagnostics B 102 Operator s Manual Version 3 0 6 Special operations cobas c111 Lot handling Preparation tasks Make sure that the controls and calibrators are assigned to the application e See Preparing applications on page B 140 a To define a control lot 1 Choose Workplace gt Lot Data 2 Press Controls A screen is displayed that lists all installed control lots 3 Press
209. arm messages 5002 d Air detected in the fluid system Refill the water container Check the filling level of the cleaner bottle Replace the cleaner bottle if required Per form lt Prime Fluid System gt If the error persists call ser vice 5003 s An internal software error occurred A parameter is not valid Restart the system If the error persists call service 5004 s Error syringe motor The syringe motor could not be started Restart the system If the error persists call service 5010 s Initialization of syringe failed Switch off instrument Remove right side panel Check for syringe mechanism jamming or blockage Ensure correct syringe installation Restart the system If the error persists call service 5013 s Error mixer motor The mixer motor could not be started Restart the system If the error persists call service 5019 s Initialization of the mixer motor failed Switch off the instrument Remove the transfer head cover Check if the mixing mechanism is jamming or blocked Restart the system If the error persists call service 5022 s Error temperature sensor analyzer heating system The sensor does not react anymore Restart the system If the error persists call service 5024 s Error temperature sensor analyzer cooling system The sensor does not react anymore Restart the system If the error persists call service 5026 s Error temperature sensor cooling system The heat
210. at least the defined dead volume of fluid is left when pipetting is complete e See Tubes on page A 54 Time limit for placing samples The system assumes that you place the sample tube that you just identified You need to place the sample on the sample area within 10 seconds of confirming the test selection Failing to place the sample tube within 10 seconds cancels the current identifi cation process You will be asked to identify the sample tube again Roche Diagnostics Operator s Manual Version 3 0 B 35 cobas c111 6 Daily operation Analyzing samples Short guide The following table gives an overview of the tasks you typically perform when analyzing samples Step User action 1 Identify the sample If working with sample barcodes 1 Scan the barcode using the barcode scanner If working without sample barcodes type the sample ID by using the screen keyboards 1 Press 2 Type the ID 3 Press 2 Select the tests ratios and profiles This step is not required if the workflow setting Working Mode is Host Utilities gt Configura tion gt Workflow 1 Press a tab to select the test panel if required 2 Press an active test ratio or profile to select it Press a selected item to cancel its selection 3 Press 3 Place the sample 1 Place the sample on any free position on the sample area You need to place the sample within 10 seconds of pressing Failing to p
211. at you want to achieve o Calibrating all tests that need calibrating o Calibrating all tests that will need calibrating during the forecast period o Calibrating individual tests O Calibrating the current set O Pre calibrating a standby set e For information on performing calibrations in the Prepare phase see Performing the calibrations Prepare phase on page B 30 a To perform calibrations 1 Choose Workplace gt Calibrations A screen is displayed that lists all tests and their currently valid calibration 2 Press A screen is displayed that shows all active tests Interpreting the colors A Press to select all tests that now need calibrating B Press to select all tests that need calibration within the forecast period Figure B 20 A B Color Meaning Possible actions Calibration is due Perform the calibration Calibration failed Check the result flag to find out why the calibration failed Repeat the cali bration if necessary The calibration was successfully per formed but its result has not been accepted yet Validate the calibration results Not relevant for calibration The calibration is OK Its result has been accepted No action is currently required The calibration is OK It applies to a reagent set that is not active No action is currently required Roche Diagnostics B 62 Operator s Manual Version 3 0 6 Daily operation cobas c111 Perfor
212. ater and Waste You must clean the external water and fluid waste containers to prevent the build up of contaminants which can affect the water quality and therefore the quality of the results produced This maintenance action consists of the following steps o Cleaning the water container o Cleaning the waste container The water and waste containers are placed on the rack next to the cobas c111 instrument Operator time Approximately 10 minutes Prerequisites The system must be in Standby status Tools and materials required m Spare waste container m Purified water m Hypochlorite solution 0 6 m Alcoholic cleansing issues a To clean the water container 1 Select the maintenance action Clean Water and Waste 2 Press The maintenance definition screen is displayed 3 Press 4 Lift the tubing adapter from the white water container 5 Place the tubing adapter on a clean surface Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 o Infection by waste solution on page C 9 o Infection by biohazardous materials on page C 8 Roche Diagnostics Operator s Manual Version 3 0 C 17 cobas c111 8 General maintenance Maintenance actions 6 Dispose of any remaining water 7 Pour 500 mL hypochlorite solution in the water container 8 C
213. ation is required o The calibration failed o For the reagent set the number of available tests is 0 or a reagent bottle is missing incomplete reagent set A QC is due or its result has not yet been accepted The reagent set is on board and ready for use The reagent set is not on board If at this stage the required controls are already loaded on the instrument then the QC orders are automatically created Roche Diagnostics B 72 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing QC 5 Press a control button A screen is displayed asking you to place the selected control 6 Place the control tube on any free position on the sample area The system registers the position and automatically defines an order If there are more controls to place the screen with the control buttons is displayed again The control you just placed is no longer active 7 Select and place the remaining controls as described in steps 5 through 6 When all controls have been selected and placed the Overview tab is displayed 8 Press to start processing the control orders Validating QC results Flagged QC results If flags are generated you must determine their cause and decide whether to accept the result or to ignore it The effect of flagged QC results depends on the configuration e See Result handling on page B 167 See Editing the acceptable flags list on page B 162 Configuration settin
214. atus button displays both the icon and the color of one of the buttons of the underlying system status screen The icons are first prioritized by color first priority being red followed by yellow and green and then according to the sequence in which they are listed below Analyzer main cover Press the button and on the Sys tem Status screen check the text about the status of the main cover Reagent cooler and cuvette ring temperature Press the button and on the Sys tem Status screen check the text about the temperature Sample area ventilation Press the button and on the Sys tem Status screen check the text about the ventilation status External fluid containers Press the button and on the Sys tem Status screen press it again to display the screen for handling the external fluid containers Maintenance Press the button and on the Sys tem Status screen press it again to display the maintenance actions list Printer Press the button and on the Sys tem Status screen check the text about the printer status Roche Diagnostics B 48 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples Checking for alarm messages a To check for problems during processing 1 Observe the Alarm LED 2 Take appropriate action e For details on dealing with alarm messages see Alarm monitor on page D 6 Acoustic signal An acoustic signal informs you of the fact that all tes
215. automatically E 50 cleaning tower manually E 51 cleaning tower off the instrument E 36 conditioning tubing E 46 flags E 71 fluid containers E 11 installing pump tubing E 54 installing tubing E 61 list of flags E 71 main calibration E 26 maintenance E 39 measurement process E 7 measuring modes E 6 monitoring status E 24 operation E 17 overview E 5 preparing system E 20 priming calibrator E 48 principles of measurement E 7 pump tubing E 54 replacing pump tubing E 54 replacing tubing E 57 sensors E 11 solutions E 8 standby E 12 status E 69 tower E 36 E 50 E 51 troubleshooting E 67 tubing E 11 E 61 ISE reference sensor initializing E 47 ISE status screen A 94 ISE tower E 11 cleaning automatically E 50 cleaning manually E 51 cleaning off the instrument E 36 ISE unit E 9 deactivating E 64 main components E 10 specifications A 67 K keyboards A 76 Roche Diagnostics F 16 Operator s Manual Version 3 0 Index cobas c111 L laboratory correlations B 156 language B 158 changing B 159 layout of screens A 72 LEDs alarms A 83 color table A 41 A 122 ISE E 10 overview A 41 level detection A 49 liability A
216. bas c111 instrument They inform you whether you can perform certain actions Interpreting the LED colors A Sample area LED B Global button LEDs from top Start LED Stop LED Alarm LED C Main cover LED Figure A 8 The cobas c111 instrument B A C LED Color Meaning Main cover LED Off No activities in this area You can open the main cover User intervention is required for example you are expected to place or remove a bottle The system is performing some action Do not handle the cover An acoustic signal is sounded when the cover is open while the system is in Operating state You can adjust the volume Utilities gt Configuration gt System gt Volume Sample area LED Off No activities in this area You can remove sample tubes You are expected to place a sample tube Blinking The transfer head is approaching Do not place your hand or any object in the sample area Start LED Off You cannot start the measuring process You can start the measuring process Table A 4 LEDs and their meaning Roche Diagnostics A 42 Operator s Manual Version 3 0 3 Hardware cobas c111 LEDs Stop LED Off Pressing does not have any effect Pressing leads to the various stop options Alarm LED Off There are no unconfirmed alarm messages There is at least one unconfirmed alarm message You need to deal with it as soon as possible There is at least one unconfirmed alarm mes
217. ble for damage Ensure that the cable is connected correctly Restart the system If the error persists call ser vice 7038 s Motor d error overheated Switch off the instrument Check for smooth transfer movements Restart the system If the problem persists call service 7039 s Power supply error One or more internally used voltages are outside the range Switch off the instrument Check the fuses F1 through F4 and replace blown fuses Restart the system If the error persists call service 7042 s Fuse F1 blown Switch off the instrument Check fuse F1 If necessary replace fuse F1 Restart the system If the error persists call service 7043 s Fuse F2 blown Switch off the instrument Check fuse F2 If necessary replace fuse F2 Restart the system If the error persists call service 7044 s Fuse F3 blown Switch off the instrument Check fuse F3 If necessary replace fuse F3 Restart the system If the error persists call service ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics Operator s Manual Version 3 0 D 15 cobas c111 9 Messages and alarms List of alarm messages 7045 s Fuse F4 blown Switch off the instrument Check fuse F4 If necessary replace fuse F4 Restart the system If the error persists call service 7046 s The initialization of the rotor failed Switch off the instrument Check if the rotor is jamming or blocked Clean t
218. bulk reagents 12 wavelength photometer and disposable cuvettes generate results that are highly correlated to other cobas instruments o Efficient operation Cooled exchangeable reagent disks ensure economical reagent use disposable cuvette segments allow for easy cuvette loading and removal o High reliability low maintenance Innovative low impact instrument design and software driven preventive maintenance improves up time and reduces maintenance costs o Adaptable user interface The built in color touchscreen process driven software and reagent and sample barcode entry adapts to users of different skills and access levels o High safety standards Built in safety devices such as level detection tube bottom detection cuvette quality control and ISE clot detection anticipate potential hazards during operation o Flexible sampling Eight on board sample positions accommodate virtually any type of sample carrier and enable continuous sample placing and removal during operation o Data management Bidirectional RS 232 and USB ports on board thermal printer and drivers offer the latest in data management capabilities WARNING Incorrect results or damage to the analyzer due to wrong operation Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not carry out operation and maintenance unless
219. c111 8 General maintenance Maintenance actions Cleaning the rotor 16 Rinse the cuvette ring A under running water 17 Leave the rotor to dry Cleaning the heating channel 18 Clean the heating channel B with a lint free tissue or a cloth moistened with ethyl alcohol Make sure not to touch the photometer lens A Reinstallation 19 With one hand pull the spring loaded bearing away from the rotor position and with the other hand insert the rotor 20 Engage the right rotor bearings and fasten the fixation screws 21 Move the rotor to test its smooth running 22 Hold the spring loaded rotor motor in position lift the retention pin and release the motor gently 23 Move the transfer head to its leftmost position 24 Fit the upper rotor shell 25 Fold down the display and fasten the fixation screw A NOTICE Do not use any cloth to clean or dry the rotor This could leave dust and lint on the Abs inspection holes and so prevent proper measurement B A Roche Diagnostics C 36 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions 26 Install the sample tray Make sure to align the guides with the pins Press down firmly 27 Install and close the right service flap 28 Move the transfer head to its rightmost position 29 Install and close the left service flap and main cover Finishing the maintenance action 30 Switch on the instrument 31 Wait for in
220. c111 Printer Tool Operator s Manual Routine orders Routine orders are normally defined on the Overview tab The software guides you through the process of assigning the tests to the sample and placing the sample tube on the instrument STAT orders STAT short turn around time orders are handled in the same way as routine orders except that their tests are processed next irrespective of the scheduling of routine order tests Defining orders There must be at least one free sample tube position when defining an order You are guided by the software when ordering the tests and placing the samples There can be only one order for each test and sample Modifying orders The process for changing an order is similar to that of defining it You first identify the sample and then change the tests You can change an order as long as its processing has not yet started It is always possible to add a further test to an existing order Deleting orders At the end of a shift you should delete all orders that are defined on the system This is to free storage space for the next shift Deleting the orders is an integral part of the End Shift wizard Deleting an order also deletes the corresponding sample results You can export the data to a USB stick and store them on a computer Controlling the run Controlling the execution of test runs is done via the global action buttons Press to start the run Press to stop the run Roche Di
221. calibrated with a two point calibration using ISE Solution 1 and 2 The main calibration is typically performed during the Prepare phase One point calibration The electrodes are calibrated after each ISE measurement using the on board ISE Calibrator indirect urine This calibration is an integral part of each ISE measurement and is performed automatically ISE Standby If there is no measurement for more than three minutes the ISE unit switches to Standby status In this status ISE Calibrator indirect urine and ISE Reference Solution are pumped into the measuring channel and moved a short distance at regular intervals Also every two hours the ISE tubing is primed with ISE Calibrator indirect urine and ISE Reference Solution This is done to prevent the following problems o Flow of ISE Reference Solution backwards into the measuring channel which can damage the electrodes because of the high ion concentration of the ISE Reference Solution o Crystallization of salts in the tubing causing blockages The ISE unit has a separate power supply Therefore the Standby status is maintained even if the main instrument is switched off NOTICE Damage to electrodes and possible tubing blockage o Do not unplug or switch off the ISE power supply Periodic flow of solutions must be performed at all times o If you intend not to use the ISE unit for more than one week you should deactivate it This saves ISE fluids and reduces wear and
222. can leave the main cover open while the system is in Standby status or while the instrument is shut down This can cause dust and dirt being collected in the heating chan nel which in turn might decrease the quality of the cuvettes Keep all covers closed Open them only to perform operation actions Incorrect results or processing stop due to skipping maintenance actions Not performing maintenance actions that are due may lead to situations where the system cannot continue processing orders or it may lead to incorrect results If at all possible per form the maintenance actions when they are due Roche Diagnostics Operator s Manual Version 3 0 C 9 cobas c111 8 General maintenance Maintenance actions WARNING Incorrect results or damage to the analyzer due to wrong operation Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics o Start all maintenance actions on the screen Do not perform maintenance actions with out the assistance of the user interface o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to a trained service representative o Follow standard laborato
223. cancel a maintenance action any time by pressing If you interrupt the performing of a maintenance action that was due its status will remain due and you need to fully re perform the action later If at all possible complete a maintenance action without interrupting it Roche Diagnostics Operator s Manual Version 3 0 E 43 cobas c111 14 ISE maintenance ISE maintenance actions WARNING Incorrect results or damage to the analyzer due to wrong operation Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics o Start all maintenance actions on the screen Do not perform maintenance actions with out the assistance of the user interface o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to a trained service representative o Follow standard laboratory practices especially when working with biohazard material Danger of poor measurement quality due to inadequate water quality Inadequate water quality may lead to incorrect results Always use purified water of the quality specified in section Technical specifications Infection by waste solution Contact with waste solu
224. ce f Utilities gt Maintenance The maintenance actions are listed according to the urgency with which they need to be performed No action is currently required This maintenance action should be performed on the next major maintenance day The defined maintenance interval has expired Perform this maintenance action now Perform the selected maintenance action A Maintenance action name B Due dates in ascending order C This maintenance action is selected D Use the scroll bar to display the maintenance actions that are currently hidden Figure A 73 Maintenance actions list D B A C If you interrupt the performing of a maintenance action that was due its status will remain due and you need to fully re perform the action later Roche Diagnostics Operator s Manual Version 3 0 A 111 cobas c111 5 Software Key screens Applications related functions f Utilities gt Applications Laboratory Parameters Handle the definitions of the installed applications and import and install new applications Extra Wash Cycles Handle and install extra wash cycles Host Codes Display export and import the mapping table for test IDs of the cobas c111 instrument and the laboratory information system Reagent Mixing Display print and delete mixing rules Process Sequence Prioritize individual tests Figure A 74 Applications functions Roche Diagnostics A 112 Operator s Manual
225. ce action that was due its status will remain due and you need to fully re perform the action later If at all possible complete a maintenance action without interrupting it Every effort has been made to ensure that all the information contained in this table is cor rect at the time of publication However Roche Diagnostics GmbH reserves the right to make any changes necessary without notice as part of ongoing product development Maintenance actions with no defined interval need to be performed in particular situations for example during troubleshooting Interval Maintenance action None Prime Fluid System None Abs Air Water Calibration None Clean Rotor And Heating Channel None Cleanup Database Daily Deproteinize Probe Weekly Clean Probe Manually Monthly Clean Reagent Disk Three monthly Clean Water and Waste Three monthly Replace Water Inlet Filter Six monthly Clean Housing Six monthly Replace Photometer Lamp Yearly Call Service Rep Yearly Initialize Degasser Fluid Sensor Table C 1 Periodicity of maintenance actions Roche Diagnostics C 8 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Maintenance actions The following sections describe the maintenance actions of the main instrument e For ISE specific maintenance actions see ISE maintenance actions on page E 42 Safety information WARNING Injury through working solutions
226. chanism is jamming or blocked Restart the system If the error persists call service 6026 s Photometer error A problem caused by the internal circuitry has been detected Restart the system If the error persists call service 6027 s Photometer error The photometer signals are outside the range while performing a dark measurement Restart the system If the error persists call service 6029 s Photometer error A problem caused by the internal circuitry has been detected Restart the system If the error persists call service 6030 s Initialization of the rotor failed Switch off the instrument Remove the rotor and clean all rotor measurement holes Reinstall the rotor Restart the system If the error persists call service 6031 s Photometer error The photometer dark signal is not stable Restart the system If the error persists call service 7001 d An Instrument Control software exception error occurred Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7002 d A software error occurred Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7004 d An internal communication software error occurred Restart the system If the error recurs export the log files with the system remaining in this error cond
227. che Diagnostics Operator s Manual Version 3 0 F 5 cobas c111 Glossary default QC ISE Reference Electrode default QC An automated process for performing multiple QC measurements at the time when you define the QC orders default value A set value registered in advance initial setting demographics Patient related data such as name date of birth and gender diluent DIL A liquid agent used to reduce the concentration of a sample dilution factor A preset dilution ratio that is used by the analyzer to perform a requested dilution disposable Typically a plastic tip vessel or cuvette that is discarded after a single use dynamic range The reportable range of an assay This range extends from the lower detection limit to the limit of linearity E stopped A status indicating that the system has performed an emergency stop This could be due to hardware failure or because any of the safety devices have requested an emergency stop expected range The pre defined range of test result values expected for a defined group of healthy patients or materials Also known as normal range or reference range expected value A value for a test result that can be considered as a normal result expiration date Also called the expiry date The end of a period until which Roche Diagnostics guarantees product claims for its reagents calibrators and controls extended dynamic range The measuring range for an assay at its h
228. ciently Overview C 5 Performing maintenance actions C 6 Maintenance actions and their intervals C 7 Maintenance actions C 8 Safety information C 8 Deproteinize the probe C 10 Prime the fluid system C 11 Clean the probe manually C 12 Clean reagent disk and sample area C 14 Clean the water and waste containers C 16 Replace water inlet filter C 19 Clean and disinfect housing C 21 Clean up the database
229. cing ISE fluid bottles E 30 Replacing electrodes E 32 Cleaning the ISE tower off the instrument E 36 In this chapter Chapter 13 Roche Diagnostics E 16 Operator s Manual Version 3 0 13 ISE operation cobas c111 Table of contents Roche Diagnostics Operator s Manual Version 3 0 E 17 cobas c111 13 ISE operation Daily operation Daily operation Daily operation of the ISE unit is integrated in the daily operation of the main instrument e See Chapter 6 Daily operation The following table gives an overview of the tasks you might need to perform during daily operation Task Steps Navigation With wizard As individual steps 1 Starting the system 1 Switch on the system 2 Logging on the system Overview gt Logon 3 Preparing the system Start the Prepare wizard Overview gt Prepare 1 Check the external fluid containers Overview gt gt 2 Check the ISE status Overview gt 3 Perform Daily Prepare Actions Utilities gt Maintenance 4 Defining orders Start the Orders wizard Overview gt Order or Overview gt STAT 1 Identify the sample n a 2 Select the tests n a 3 Place the sample n a 4 Start the ru
230. concept A 71 End Shift B 81 introduction A 21 orders B 35 Prepare B 15 workflow definitions B 164 working solutions safety A 7 worklist A 107 Workplace tab A 97 Revisions G Roche Diagnostics Operator s Manual Version 3 0 G 3 cobas c111 18 Revisions Revisions Roche Diagnostics G 4 Operator s Manual Version 3 0 18 Revisions cobas c111
231. control material has been used 3 If the flag reappears check the calibration and reagent status Repeat with fresh reagent R 1 3s Meaning One control value is above 3 standard deviation or below 3 standard deviation Message ID 35 Priority 27 Possible cause o Improper control is set o Proper control values mean value standard deviation are not specified Recommended actions 1 Repeat with fresh control 2 Check that the correct control material has been used 3 If the flag reappears check the calibration and reagent status Repeat with fresh reagent gt R 2 2s Meaning Two sequential control measurements are above the 2 standard deviation Message ID 29 Priority 26 Possible cause o The controls are not properly prepared o The controls are not properly positioned on the instrument Recommended actions 1 Repeat with fresh control 2 Check that the correct control material has been used 3 If the flag reappears check the calibration and reagent status Repeat with fresh reagent Roche Diagnostics Operator s Manual Version 3 0 E 77 cobas c111 15 ISE troubleshooting List of ISE flags lt R 2 2s Meaning Two sequential control measurements are below the 2 standard deviation Message ID 29 Priority 26 Possible cause o The controls are not properly prepared o The controls are not properly positioned on the instrument Recommended actions 1 Re
232. controller firmware o Press to perform standard import A screen is displayed asking you to insert the USB stick 3 Insert the USB stick 4 Press 5 Select the software package You recognize the software packages by their file extension tar 6 Press to confirm the selection The software is installed on the system A message will inform you when the installation is complete The system will automatically reboot When the import is complete the Overview tab is displayed and the system is in Standby status Roche Diagnostics B 114 Operator s Manual Version 3 0 6 Special operations cobas c111 Importing data Importing a database Compatibility o If the version of the imported database is older than the one on the target system the imported database will be converted to the version on the system o If the version of the imported database is more recent than the one on the target system the database cannot be imported Typical situations Importing a database is mainly done in the following situations o You want to restore your existing system to a previous status for example from a backup version of the database that was generated on the same system o You want to install a known system setup on another system cloning The following table illustrates the different effects in the two situations a To import the database 1 Remove all bottles of all bottle sets of all disks d
233. create the master calibration curve standard deviation A statistic used as a measure of the dispersion or variation in a distribution of data Start button A button used to start system operation Operating status and begin the pipetting of samples measurement and the result calculation process STAT Abbreviation for Short Turn Around Time Terminology used by the medical clinical professionals to prioritize the processing of a sample in a laboratory S Roche Diagnostics Operator s Manual Version 3 0 F 9 cobas c111 Glossary status worklist status A general term used to refer to the current status of the system Explicit terminology may be used to address sub parts of the system status such as analyzer status and printer status Stop button A button used to display options for different kinds of processing stop SW Abbreviation for software target range The allowed range of recovery for an analyte in a control material target value The mean of all participant responses after removal of outlying values TAS Abbreviation for Test Application Software TDM Abbreviation for Therapeutic Drug Monitoring test Running an analysis of a specific parameter for a sample See also application test ID The abbreviated name for a test This code is displayed on test buttons shown on screens test sheet A document that lists all the information necessary to perform a specific assay or test on an instrumen
234. ction is displayed Usually this is the maintenance description screen Press if you want to print the instructions before you start A Maintenance action name B Due dates in ascending order C This maintenance action is selected D Use the scroll bar to display the maintenance actions that are currently hidden Figure C 1 D B A C The defined maintenance interval has expired Perform this maintenance action now This maintenance action should be performed on the next major maintenance day No action is currently required This maintenance action is selected Roche Diagnostics Operator s Manual Version 3 0 C 7 cobas c111 8 General maintenance Overview 4 Follow the instructions on the screen A message will inform you when the maintenance action is complete In addition with maintenance actions that take some time an acoustic signal is sounded This allows you to do work away from the instrument while the maintenance action is in progress e For information on how to perform individual maintenance actions see Maintenance actions on page C 8 Maintenance actions and their intervals The following table lists the maintenance actions and shows how frequently they need to be performed WARNING Incorrect results or processing stop due to incomplete maintenance actions You can cancel a maintenance action any time by pressing If you interrupt the performing of a maintenan
235. ctive buttons Roche Diagnostics Operator s Manual Version 3 0 A 125 cobas c111 5 Software Buttons System Status Show the status of the main cover Container Status Show the status of the external fluid containers Handle the external fluid containers Temperature Status Show the status of the reagent cooler and cuvette ring temperature Printer Status Show the printer status Fan Status Show whether the sample area fan is running Maintenance Status Display the maintenance actions list Keyboard Type information manually Exchange Reagent Disk Handle the reagent disk Insert Bottle Place a reagent bottle Remove Bottle Remove a reagent bottle Mixing Perform reagent mixing Replace Cuvette Confirm replacement of the cuvette segment Remove Cuvette Confirm removal of the cuvette segment Due Calibrations Select all tests with due calibration or QC Forecast Calibrations Select all calibrations that are due within the forecast period Default QC Perform Default QC Interval QC Perform Interval QC Related Information Show context information for the result Used fluids together with their lot information Map Host Codes Use identical application codes on host and cobas c111 instrument Exchange ISE Bottle Exchange an ISE fluid bottle Remove ISE Bottle Remove an ISE fluid bottle Remove Electrode Remove an ISE electrode Insert Electrode Insert an ISE e
236. d Tests ready to run Number of tests that could be performed taking into account all disks known to the system The reagent sets have been calibrated and are ready for use Print the test status information Show the fluids that were used for generating this result together with their lot information lt xyz gt A Status description of the test Figure A 54 Details on a test A Profiles are user defined sets of tests They are represented like any other test Roche Diagnostics A 92 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Log off f Overview gt button with your user name Log off the system You can log off any time even while the system is processing orders Prepare f Overview gt Prepare Start the Prepare wizard to perform the preliminary tasks at the beginning of a shift End shift f Overview gt End Shift Start the End Shift wizard to perform the tasks necessary for ending the shift Cuvette status f Overview gt The six cuvette segments are represented by buttons The number in the button indicates how many cuvettes are free to be used Press a segment button to exchange the corresponding segment The segment buttons are color coded All cuvettes are used Up to two cuvettes are free to be used More than two cuvettes are free to be used A Overview of required and available cuvettes Figure A 55 Cuvette status A Roc
237. d You need to replace the bottle now The fluid level in the bottle is low Operation will proceed until one of the sensors detects that there is no fluid The fluid s expiration date has passed You should replace the bottle as soon as possible No action is required Roche Diagnostics Operator s Manual Version 3 0 E 31 cobas c111 13 ISE operation Replacing ISE fluid bottles 5 Press A screen is displayed asking you to scan the bottle barcode or to type it manually 6 Scan the bottle barcode 7 Press 8 Observe the messages on screen and react accordingly If the barcode cannot be read type it manually When the scanning process is finished a message is displayed asking you to replace the bottle 9 Open the ISE cover 10 Remove the tubing adapter by lifting it and placing it on a clean lint free tissue 11 Remove the bottle 12 Remove the cap of the new bottle 13 Place the new bottle 14 Insert the tubing adapter 15 Close the ISE cover 16 On the screen press to confirm the placement The system performs the Prime ISE Reference and Calib maintenance action 17 Press to close the screen for reading barcodes 18 On the ISE status screen press A placement list is displayed telling you where to place ISE Solution 1 and 2 19 Place ISE Solution 1 and ISE Solution 2 on the positions indicated on the screen 20 Press The Overview tab is displayed
238. d o Selected Figure A 63 QC status list Roche Diagnostics A 102 Operator s Manual Version 3 0 5 Software cobas c111 Key screens QC history The QC history provides on individual screens information on the QC results of the current and the previous calendar month as well as on results generated before the previous month A graphic representation of the results provides a convenient way for comparing results over a period of time f Workplace gt QC History The list contains for each test and control the latest QC result The entries are grouped first by test name then by control Last Measurement column Date and time of the most recent result Previous Lot indicates that control was performed after a QC lot change Print QC results Display a graphic representation of the QC results Delete QC results You can choose what kind of result should be deleted o List All results in the list If a filter was applied the list would contain only the results that fulfill the filter criterion and the filter criterion would be part of the button name o Older than Previous Month o Selected Apply filter criteria to the QC results list You can choose one of the following criteria o All o Current Lot o Previous Lot Figure A 64 QC history Roche Diagnostics Operator s Manual Version 3 0 A 103 cobas c111 5 Software Key screens f Workplace gt QC History
239. d m ISE Deproteinizer m Activator m ISE Etcher m ISE Solution 1 m ISE Solution 2 a To perform the daily prepare actions 1 Prepare a tube with ISE Deproteinizer ISE Etcher Activator ISE Solution 1 and ISE Solution 2 each 2 Select the maintenance action Daily Prepare Actions 3 Press The maintenance definition screen is displayed 4 Press A placement list is displayed 5 Place the fluids on the positions indicated on the screen 6 Press to confirm the placing The system performs the maintenance actions 7 When the system is in Standby status remove the tubes 8 Press Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Incorrect results due to build up of contaminants on page E 42 Roche Diagnostics Operator s Manual Version 3 0 E 45 cobas c111 14 ISE maintenance ISE maintenance actions Activate electrodes f Utilities gt Maintenance gt Activate Electrodes The electrode surfaces must be activated with fresh serum so that the correct potentials are measured Electrodes may be damaged if they are deprived of regular contact with serum Operator time Approximately 4 minutes Prerequisites The system must be in Standby status Tools and materials required m Activator a To activate the electrodes 1 Se
240. d or in the Operating or Maintenance status 7147 d The initialization of the ISE Unit has been stopped due to an open cover Ensure that all covers are closed while the system is being initialized or in the Operating or Maintenance status 7148 d Initialization of the ISE Unit has been stopped due to a blocked transfer Switch off the instrument Check if the transfer is blocked or jamming Ensure that all covers are closed Restart the system If the error persists call service 7149 d Initialization of the rotor failed The calculated offset is outside the range Switch off the instrument Check if the rotor is blocked or jamming Restart the system If the error persists call ser vice 7150 d Initialization of the transfer failed due a level detection problem Switch off the system Clean the probe and probe holder and ensure that they are installed correctly Restart the sys tem If the error persists call service 7151 d Dispensing fluid into the ISE tower failed due to an incorrect X transfer or probe position Switch off the instrument Check if the X transfer and Z transfer are blocked or jamming Restart the system If the error persists call service 7152 d A pipetting or dispensing cycle failed due to an incorrect X transfer or probe position Switch off the instrument Check if the X transfer and Z transfer are blocked or jamming Restart the system If the error persists call service 71
241. d again o Press to close the screen If the sample is no longer on the instrument A message is displayed asking you to place the sample o Place the sample on the sample area The orders list is displayed again 4 The system reschedules the order and processes it as normal If the Starting point was Perform these steps Overview gt Order A screen is displayed asking you to scan the sample or to type its ID manually 1 Identify the sample either by scanning its barcode or by typing the sample ID If the same barcode was scanned before during the current day or you use the same sample ID as in the original order the system recognizes the origi nal order and displays its associated information 2 Press A screen for selecting tests is displayed Workplace gt Orders A screen is displayed that lists all orders 1 Select the order you want to change 2 Press A screen for selecting tests is displayed Roche Diagnostics B 44 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples Starting the run a To start processing an order 1 Press the global action button The system checks whether there are enough cuvettes and whether all required reagents are on the reagent disk If any of this is not the case a screen is displayed informing you of what is missing Order of processing When you first start processing orders the order of the sample plac
242. d sample ID are identical For a given sample the same sample ID is used all the time A three digit number is appended and automat ically increased with each new order Examples 789 001 for the first order 789 002 for the second order and so on Table B 21 Workflow definitions Roche Diagnostics Operator s Manual Version 3 0 B 165 cobas c111 7 Configuration Configuration Host definitions Sample ID Separator One alphanumeric character This definition is used in combination with Grouped Sample ID It defines the character that separates the sample ID from the automatically appended number Examples 789 001 789 001 789_001 Auto Order ID On Off If you use On the system automatically increments the order ID number by one whenever you define a new order If you use On choose Off for Order ID Sample ID Auto Print Results On Off If you use On sample results are printed as soon as all results of the order are available and accepted Test Tab 1 6 Name Up to four alphanumeric characters Display name for the test tab 1 6 Test tabs are used to group tests that are usually used together You can assign a test to more than one tab Test Tab 1 6 Visible On Off Use On to make available the tab on the test selection screen Item Values Comment Table B 21 Workflow definitions Item Values Comment Baud Rate Data transmission rate for host interface communica t
243. ddhhmmss txt Roche Diagnostics D 52 Operator s Manual Version 3 0 11 Troubleshooting cobas c111 Detailed procedures 12 ISE description E 3 13 ISE operation E 15 14 ISE maintenance E 39 15 ISE troubleshooting E 67 ISE E Roche Diagnostics Operator s Manual Version 3 0 E 3 cobas c111 12 ISE description Table of contents ISE description Overview of the ISE unit In this chapter you will find a general overview of the cobas c111 ISE unit You also will find a description of the main components and their principle operation Overview E 5 Abbreviations E 5 Measuring modes E 6 Principles of operation E 7 ISE solutions
244. did not provide a usable result Recommended actions Check and redo calibration if needed Cal Error Meaning No valid calibration data available Message ID 43 Priority 24 Possible cause Caused by an alarm that occurred during calibration because the calibration could not provide a usable result Recommended actions Check the flags of the calibration and proceed to deal with the calibration first Roche Diagnostics Operator s Manual Version 3 0 E 73 cobas c111 15 ISE troubleshooting List of ISE flags Calc Error Meaning Calculation error o General calculation error o Slope or nonlinear standard curve cannot be calculated due to a calibration error Message ID 16 Priority 13 Possible cause o Calibrator outdated or deteriorated o Misplacement of the calibrator tubes Recommended actions o Repeat calibration with fresh calibrators o If the calibrators were incorrectly positioned replace the calibrators and repeat the calibration Ise Unstab Meaning The signal from the electrode s was not stable during the measurement Message ID 18 Priority 6 Possible cause o There are air bubbles in the measuring segment o The concentration of sample is too low for example dialyzed samples o The ISE Reference Solution tubing is blocked or leaking o The pH of the sample is too low for example pH lt 5 5 o One or more O rings are missing or damaged o
245. disk overview screen is displayed 5 Press A screen is displayed asking you to insert the disk 6 Open the main cover 7 Place the reagent disk in the reagent cooler Make sure the reagent port faces the front and align the cut outs with their counterparts on the reagent cooler The system automatically detects that a disk was inserted A screen is displayed asking you to close the main cover NOTICE Damage to the reagent disk The reagent disk is designed to handle reagents while it is loaded on the instrument The cover is equipped with a locking mechanism Remove or insert bottles only when the reagent disk is loaded on the instrument and always use the software functions to perform these tasks A Reagent disk IDs There are eight possible IDs B Disk label The number must correspond to the reagent disk ID C Identification tabs D The tab has been removed for automatic disk recognition Figure B 38 Reagent disk ID B A A D C C Roche Diagnostics B 118 Operator s Manual Version 3 0 6 Special operations cobas c111 Preparing a new disk 8 Close the main cover At this stage the system identifies the disk A screen is displayed that shows the status of the reagent sets Loading reagent sets 9 Press A screen is displayed asking you to scan the bottle barcode 10 Scan the barcode on the bottle 11 Remove the cap from the bottle and place it in the
246. displays the main content of the screen E The buttons vary depending on the content of the working area and the screen position within a series of steps wizard F The Help button leads to concise information that is relevant to the current screen and sit uation G The global action buttons represent the func tions that are permanently available Start Stop Alarm Line Feed The LEDs next to them point to their status Figure A 35 Example of a screen G F D E C B A Roche Diagnostics Operator s Manual Version 3 0 A 73 cobas c111 5 Software Display items Display items The cobas c111 screens are made up of text areas and various kinds of display items such as tabs and buttons The following table lists the major display items and describes their use Display item Use Button Press a button to start a function In addition many buttons also either open a new screen or close the current screen A triangle in the top right corner of a button tells you that a new screen will be displayed when you press the button a triangle in the bottom left corner that the current screen will be closed Global action button The global action buttons are positioned on the right side next to the screen The LED next to each of the buttons indicates whether the button is active or not List Press a list item to select it Its color turns blue Use the scroll buttons to disp
247. dous materials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Roche Diagnostics B 126 Operator s Manual Version 3 0 6 Special operations cobas c111 Replacing the probe 5 Remove the sensor tubing adapter A 6 Remove the probe holder D from the carriage Press the release button on the side of the probe holder carriage and lift the probe holder with the probe 7 Unscrew the probe from its holder and remove it from it 8 Place the probe in the beaker and the probe holder on a clean surface 9 Unscrew the tubing from the distribution block E 10 Lift the tubing and wait until all fluid has run into the beaker 11 Dispose of the probe assembly Treat it as biohazardous waste a To install the new probe 1 Carefully insert the probe in the probe holder and fasten the screw that fixes the tubing to the holder C 2 Reinstall the probe holder with the probe Press the release button on t
248. e SYS if Auto Accept is on Lot Lot ID Mean Mean value Result Result value Unit Defined display unit Flags Flag name SD Standard deviation Test Short name of the application Ignored I if the QC result was ignored Table 36 Explanations on QC history results Roche Diagnostics Operator s Manual Version 3 0 B 109 cobas c111 6 Special operations Exporting data pev_yyyymmddhhmmss csv The following figure is an example of a test result file that was opened in a spreadsheet tool Rows 11 and 12 represent the raw data of a development channel application with the short name DCBLG Column Title Description Instr Instrument ID always 30 for cobas c111 Msg Message Type 9 Process event Index 191 Reagent usage changed 192 Calibrator assigned valued changed 193 QC assigned valued changed 199 Other process event App Application code Date Date when the event took place Time Time when the event took place SW Version Software version installed on the instrument Serial Serial number of the instrument Event Description of the event User User name SYS system user if nobody is logged in Test Short name of the application Table 37 Explanations on process events Figure 3 Example of spreadsheet representation of a test result raw data file Roche Diagnostics B 110 Operator s Manual Version 3 0 6 Special operations cobas c111 Exp
249. e new application Situation Explanation and possible actions No crypto module is installed A message is displayed informing the operator of this fact The system does not import the application The maximum number of devel opment channel applications is already installed A message is displayed informing the operator of this fact 1 Uninstall and then delete a development channel application 2 Start the import process again Roche Diagnostics Operator s Manual Version 3 0 B 139 cobas c111 7 Configuration Applications 4 Choose Install Application The system checks whether there is already an application installed on the system with identical application code or short name In the applications list the application name is displayed without brackets and in the profile details the short name is displayed The profiles that use this application are included in the test selection screen provided that all applications of the profiles are installed 5 Prepare the applications e See Preparing applications on page B 140 Activating and deactivating applications When an application is installed on the system it is automatically activated e Installing applications on page B 137 You can deactivate an application to temporarily make unavailable the test on the test panel All associated fluids and data remain unchanged You can activate the application later again and continue using the tes
250. e action Condition ISE Tubing None Initiated by other maintenance action Initialize ISE Reference Sensor None Initiated by other maintenance action Prime ISE Reference and Calib Daily Daily Prepare Actions Daily Electrode Service Weekly Clean ISE Tower Automatically Monthly Clean ISE Tower Manually Monthly Initialize ISE Unit Six monthly Replace ISE Unit Tubing Six monthly Replace ISE Pump Tubing Table E 6 Periodicity of maintenance actions For the expiration dates of electrodes see their package inserts Roche Diagnostics E 42 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions ISE maintenance actions Safety information WARNING Injury through working solutions Direct contact with cleaning solutions or other working solutions may cause personal injury When handling such solutions exercise the precautions required for handling them observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch moving parts during instrument operation Infection by biohazardous materials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially bi
251. e and a bottle with a red label for ISE Reference Solution are located on the ISE unit The procedure for exchanging these bottles is the same a To replace an on board ISE fluid bottle 1 Follow the instructions given in Replacing ISE fluid bottles on page E 30 2 When you have finished replacing electrodes and ISE fluid bottles press to proceed to the next stage in the Prepare wizard A screen is displayed that lists the maintenance actions Performing maintenance actions The routine maintenance actions that are relevant for working with the ISE unit are integrated in one single maintenance action Daily Prepare Actions e For general information on performing maintenance actions see Performing maintenance actions on page B 19 For details on how to perform individual ISE maintenance actions see ISE maintenance actions on page E 42 a To perform maintenance actions 1 Select Daily Prepare Actions 2 Press The maintenance definition screen is displayed 3 Follow the instructions given on the screen e See Daily prepare actions on page E 44 4 Perform the non routine ISE maintenance actions Follow the instructions given on the screen o After replacing an ISE fluid bottle the Prime ISE Reference and Calib mainte nance action needs to be performed This action will be performed as part of the maintenance procedure of the Prepare wizard o After replacing an ISE fluid bottle a main calibration needs
252. e colors of buttons tell you whether you need to intervene You can check the meaning of a button and its color using the Online Help o Buttons on the Overview tab lead to detailed information on the status of selected processes and hardware items o Messages on the screen provide information on individual tasks and events o The text in the Status line provides information on the status and activities of the analyzer unit o Flags with results from samples calibrations and controls are automatically generated if during processing certain technical checks were not passed or if the result exceeds or does not reach predefined limits Messages The system performs numerous checks When an irregularity is detected an alarm message is generated Alarm messages are displayed in two ways o Immediate feedback on user actions is displayed in a pop up message screen o Information concerning a problem that occurred during operation is reported in the Alarm Monitor e For details on alarm messages see Alarm monitor on page D 6 For details on instrument messages see Message screen on page D 5 Roche Diagnostics E 70 Operator s Manual Version 3 0 15 ISE troubleshooting cobas c111 Safety Safety Before you start troubleshooting it is essential that you both read and understand the safety information listed below Read carefully all safety notices given in instructions and make sure you understand them WA
253. e instrument before you open this cover ISE cover Provides access to o Electrodes o ISE unit tubing o ISE fluid bottles Do not open this cover when the system is in Operating status A ISE cover B ISE LED Figure E 2 ISE cover A B Roche Diagnostics E 10 Operator s Manual Version 3 0 12 ISE description cobas c111 Hardware Left service flap Provides access to o ISE tower Remove this flap as instructed during maintenance actions or switch off the instrument before you remove it ISE LED The ISE LED is color coded Main components Peristaltic pump A fluid pump that draws the solutions through the electrode block and then pumps it to the internal waste tank Power off e g power supply disconnected The ISE unit is OK and ready for use Blinking The fluid level in the ISE Reference or ISE Calibrator indirect urine bottle is low Error processing stopped A Electrode block with ISE Sodium Potassium Chloride and Reference Electrode B ISE Reference Solution sensor C ISE tower D Input valve plate E ISE Reference Solution bottle red label F ISE Calibrator indirect urine bottle blue label G Peristaltic pump with pump tubing H Exit valve plate I Measuring channel J ISE sample sensor K Entry valve plate with tubing Figure E 3 Main components of the ISE unit G C D F E H I K J B A Roche Diagnostics O
254. e order of removing the items A Lid of fluid distributor Figure E 14 A Tension lever Figure E 15 A A Roche Diagnostics Operator s Manual Version 3 0 E 61 cobas c111 14 ISE maintenance ISE maintenance actions a To install the new ISE unit tubing 1 Remove the new tubing set from its packaging 2 Place the tubing roughly in position on the ISE unit Refer to the illustration on the ISE tubing set cover Take care not cut the tubing avoid any sharp objects 3 Press the tubes into their routing Take care not to compress the tubes or to kink them Make sure to press the tubing firmly in its routing around the ISE Reference Solution sensor 4 Connect the tubing to the ISE tower and then install the tower 5 After connecting the tubing to the electrode block make sure the electrodes are properly mounted when closing the tension lever Close the electrode block cover 6 When connecting the tubing to the peristaltic pump connector block take care not to introduce sharp angles in the tubing Sharp angles may lead to flow problems Always insert the tubing connectors in the lower set of holes in the pump connector block and make sure to fully insert the tubing in the connectors 7 Install all clamps and pinch valve caps Be sure to place the clamps in the correct position covering the tubing 8 Install the lid of the fluid distributor Make sure to keep the piece of tubing designed
255. e procedure is known as log off or log out Log on button A button used to gain access to a system See also log on lot calibration A mandatory calibration when a new lot of reagents is introduced to an analytical instrument main calibration Two point calibration of the ISE tests with ISE Solution 1 and 2 As opposed to the calibration with ISE Calibrator indirect urine which is part of each ISE measurement maintenance action A maintenance procedure performed by the system or the operator and that must be performed on a regular basis for example daily weekly or monthly to secure reliable operation of the analyzer maintenance procedure See maintenance action manual dilution An off system pre analytical step performed by laboratory staff to reduce the analyte concentration in a sample mean The sum of values divided by the number of values measure point Time at which absorbance reading is taken and used to calculate results measuring range See reportable range message In computing a defined set of alphanumeric data that transfers information from computer to computer or from an analytical instrument to the operator Microcup A secondary sample cup made by Hitachi with a small dead residual volume minimum sample volume The amount of residual sample material plus the volume required for assaying all requested tests to ensure faultless sample aspiration monochromatic Absorbance measurement at one pr
256. e shows which container is used for which fluid Waste containers Internal waste tank The internal waste tank collects the waste from the wash station and the ISE unit if this is used It also collects the condensation from the cooling assembly in the rotor The internal waste tank is connected by tubing to o External waste container o Wash station o Reagent cooler condensation o ISE unit if installed Fluid Container s Position Sample Tube Sample area Control Tube Sample area Calibrator Tube Sample area Diluent Reagent bottle Reagent disk System cleaner External cleaner bottle External fluid rack Cleaner Reagent bottle Reagent disk Reagent Reagent bottle Reagent disk Water Bottle External fluid rack Waste Bottle External fluid rack Table A 5 Fluid containers what they are used for and where The term tube includes all kinds of tubes as long as their dimensions lay within prescribed limits It also includes secondary tubes cups See Tubes on page A 54 A Tubing adapter B External waste container C Internal waste tank Figure A 17 Waste container B A C Roche Diagnostics Operator s Manual Version 3 0 A 51 cobas c111 3 Hardware Hardware overview External waste container The yellow external waste container is placed on the external fluid rack It is designed to be washed and reused Because the system periodically performs wash actions
257. e to reagent mixing rules B 173 Reagent mixing rule definitions B 173 Printing mixing rules B 173 Deleting mixing rules B 174 Roche Diagnostics Operator s Manual Version 3 0 B 135 cobas c111 7 Configuration Introduction Introduction The process for viewing and changing configuration and application values is the same The following procedures use the example of a calibration value Viewing values a To view values 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Expand the list o Select a list item marked with o Press o Select a sublist item marked with o Press o Use the scrollbar if required to display the items you are interested in The definition items and their current values are displayed Changing values If the change of a value results in one or several other values needing to be changed a wizard is started when you change the first value You recognize a wizard by the presence of the and buttons a To change a value 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Expand the list to display the items and their values 3 Sel
258. e tower you can extend the soaking time to 30 minutes 11 Rinse the ISE tower with deionized water and leave it to dry Reinstalling the ISE tower 12 Reconnect the tubing to the ISE tower 13 Make sure that both O rings are present and seated on the tower base 14 Place the ISE tower on its base Align the two pins on the base with the two holes in the ISE tower 15 Reinstall the locking ring Make sure it is properly engaged and turn it firmly clockwise 16 Reinstall the overflow collector 17 Close the left service flap and the main cover A O ring positions Figure E 8 A A Alignment pins Figure E 9 A A Roche Diagnostics E 38 Operator s Manual Version 3 0 13 ISE operation cobas c111 Cleaning the ISE tower off the instrument Finishing the task 18 Switch on the instrument 19 Wait for initialization to finish 20 Log on to the system 21 Perform the maintenance action Clean ISE Tower Automatically e See Clean ISE tower automatically on page E 50 Roche Diagnostics Operator s Manual Version 3 0 E 39 cobas c111 14 ISE maintenance Table of contents ISE maintenance In this chapter you will find step by step instructions of the ISE specific maintenance actions that you must perform to keep the instrument running smoothly and efficiently Introduction E
259. e where exactly a small red square pixel is displayed The red square should be exactly where you pressed 7 Do one of the following If Do this The red square is exactly where you pressed 1 Press The red square is some distance from where you pressed 1 Press 2 Repeat the whole procedure make sure that you press exactly in the center of the crosses Roche Diagnostics Operator s Manual Version 3 0 B 131 cobas c111 6 Special operations Cleaning the touchscreen Cleaning the touchscreen Because the touchscreen gets easily soiled you should clean it regularly Tools and materials required m 70 ethyl alcohol m Tissues m Protective gloves a To clean the touchscreen 1 Pour or spray some alcoholic solution on a tissue 2 Wipe the screen Exert as little pressure as possible 3 Wipe the screen with a clean tissue Roche Diagnostics B 132 Operator s Manual Version 3 0 6 Special operations cobas c111 Cleaning the touchscreen Roche Diagnostics Operator s Manual Version 3 0 B 133 cobas c111 7 Configuration Table of contents Configuration Integrating the system in your environment In this chapter you will find information on how to define the way you work with the cobas c111 instrument Introduction B 135 Viewing values
260. eagent disk on page B 21 To move a test from one tab to another delete it from the original tab and assign it to the new tab o Before you can delete a bottle set from the Inventory list you need to remove it from the disk o Bottle sets that have been removed from the disk and whose expiration date had passed more than 30 days ago are automatically deleted from the Inventory list pro vided there is still a valid set for the same fluid on board If this were not the case the set that was loaded last would remain in the inventory Roche Diagnostics Operator s Manual Version 3 0 B 121 cobas c111 6 Special operations Deleting bottle sets from the Inventory list Deleting the bottle set 2 Choose Utilities gt Inventory The Bottle sets list is displayed It contains all bottle sets that are defined on any of the disks used on this cobas c111 instrument including sets that were removed from the disk as long as they were not empty or their expiration date has not passed yet In the D column removed bottle sets are marked with R A 3 Select the bottle set you want to delete 4 Press A confirmation dialog box is displayed If the set cannot be deleted a message will inform you 5 Press to confirm the deletion Figure B 39 A It is not possible to place a bottle set on a reagent disk again once it was deleted from the Bottle sets list Roche Diagnostics B 122 Operator s Manual Version 3
261. ecking which calibrations are due 1 Check the colors of the test buttons Interpreting the colors Modifying selections By default all tests whose calibration is due or will be due within the forecast period are automatically selected You can cancel these selections by pressing or a test button If you do not perform a calibration that is due the affected test is blocked you cannot perform this test A Press to cancel the selection of all tests that need calibrating B Press to cancel the selection of all tests that need calibrating within the forecast period Figure B 8 B A Color Meaning Possible actions No sample tests can be measured Possible reasons Initial calibration is required Perform the calibration The calibration failed Check the flag to find out why the cal ibration failed Repeat the calibration if necessary The calibration was successfully per formed but its results have not been accepted yet Validate the calibration results QC is due Perform QC as soon as possible The calibration is OK Its results have been accepted No action is currently required The calibration is OK It applies to a reagent set that is not active No action is currently required Roche Diagnostics B 32 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing the system Performing calibrations 2 On the screen that shows the tests press A screen is d
262. ect an item that shows a value Roche Diagnostics B 136 Operator s Manual Version 3 0 7 Configuration cobas c111 Introduction 4 Press A screen is displayed where you either can type a new value or select one by pressing its corresponding button 5 Type the new value or press a value button 6 Do one of the following If Do this You are in a wizard and want to change a further value 1 Press A screen is displayed for changing the value 2 Type the new value or press a value button 3 Continue with step 6 4 When is no longer active press to confirm the changes This was the only value you want to change 1 Press to confirm the changes Roche Diagnostics Operator s Manual Version 3 0 B 137 cobas c111 7 Configuration Applications Applications Installing applications To make available a new application on a cobas c111 instrument you need to perform the following steps 1 Import the data to the instrument by reading its barcode or by reading them from a USB stick This step saves the data on the instrument It is possible to import a new version of an application with identical application code but you cannot install it e To import application data on page B 137 2 Install the application This step activates the application on the instrument and so makes it available for use e Installing applications on page B 137 3 Prepare the application Thi
263. ed Timeout 10 300 s Period of time the system will wait for a response from the host when working in Order Query Mode This definition applies to routine STAT and rerun sample tests Send Result Mode Off The results are sent to the host manually Complete The results are automatically sent to the host when all results of the order are available and accepted Immediate Each result is automatically sent to the host as soon as it has been accepted Send Raw Data On Off Raw data include all measurement results made dur ing the measuring cycles not just the calculated test results Trace On Off The Trace function records the content of the com munication with the host in a trace file This is a troubleshooting function Do not work with it during normal daily operation The trace file can be exported as a log file Utilities gt Export gt Log Files file format htryyyymmddh hmmss log System Device ID Up to 10 alphanumeric characters The ID is used on reports and for communication between the cobas c111 instrument and the host Host Device ID Up to 10 alphanumeric characters The ID is used on reports and for communication between the cobas c111 instrument and the host Item Values Comment Table B 22 Host definitions Roche Diagnostics Operator s Manual Version 3 0 B 167 cobas c111 7 Configuration Configuration Result handling Calibration QC Item Values Co
264. ed intervals are performed whenever necessary or they are triggered by another maintenance action Due date The due date is the last possible maintenance day This is the date you see when you check the status of maintenance actions Ensuring smooth operation Performing all due maintenance actions during the daily Prepare or End Shift phase ensures that routine operation does not have to be interrupted for performing maintenance actions System status The cobas c111 instrument provides several means of indicating the status of the various parts and processes o Color coded LEDs on the instrument inform you when and when not to open covers or place sample tubes e See Color interpretation for LEDs on page A 122 o The colors of buttons inform you whether you need to intervene e See Color concept on page A 74 You can check the meaning of a button using the online Help o Buttons on the Overview tab lead to detailed information on the status of selected processes and hardware items o Messages on the screen provide information on individual tasks and events o The text in the Status line provides information on the status and activities of the analyzer and photometer unit The following system statuses are defined Status Comment Standby The user and host interfaces remain active as do the reagent cooling system fluid system and the cuvette heating Maintenance A maintenance action is being performed The
265. ed on the leftmost position on the sample area is processed first The others follow in sequence from left to right Once processing is in progress the orders are processed according to sequence in which they were defined Repeats and reruns of routine orders are performed before routine orders Monitoring the analysis progress During operation you should regularly check the following items o The status of the buttons on the Overview tab o The Alarm Monitor LED Checking the sample tube status a To check the sample status 1 Press the Overview tab Interpreting the sample tube buttons A Sample tube buttons B Information on tests that are associated with defined orders C Information on results that are associated with defined orders D Alarm Monitor LED Figure B 12 C B A D Icon Meaning Possible action 1 The number in the button denotes the position on the sample area n a A sample tube button with a wide edge symbolizes a STAT order n a Roche Diagnostics Operator s Manual Version 3 0 B 45 cobas c111 6 Daily operation Analyzing samples All tests are accepted You can remove the sample tube All tests are pipetted You can remove the sample tube All tests are completed but not yet accepted Validate the results All remaining tests are blocked because There is not enough sample fluid 1 Remove the sample tube and add fluid Do not delete the old
266. ed parts A 8 biohazardous materials A 6 calibration B 59 classification A 5 cross contamination A 9 data security A 10 disposal of instrument A 12 during End of Shift phase B 77 during Prepare phase B 12 during routine operation B 5 electrical A 5 electromagnetic devices A 8 insoluble contaminants A 9 installation A 7 instrument covers A 6 ISE operation E 19 operation and maintenance A 6 operator breaks A 9 operator qualifications A 9 optical A 6 performing ISE maintenance E 42 performing QC B 68 power supply A 8 reagents and working solutions A 7 spillages A 9 third party software A 8 transport A 5 waste A 7 when analyzing samples B 34 when exchanging external bottles B 15 when handling cuvettes B 28 when handling external bottles B 15 when handling reagents B 22 when removing reagent disk B 87 when troubleshooting ISE E 70 when using the barcode scanner B 89 with flags D 27 with maintenance actions C 8 sample area cleaning C 14 overview A 44 sample handling overview A 31 sample ID A 32 sample overview screen A 86 sample results accepting B 57 auto accept B 51 checking for not accepted B 80 deleting B 94 printing
267. eed with deleting the application There is one entry for the application in the list and the application is currently not installed in brackets Confirm to proceed with deleting the appli cation There is a second entry for the application in the list The selected application is installed not in brackets Confirm to proceed with deleting the appli cation Note You can only delete the installed application The selected item is a profile Confirm to proceed with deleting the pro file There are still associated reagents on one of the disks Remove the associated reagent set from the disk The disk may be off board and you might need to load it in order to remove the reagents Roche Diagnostics Operator s Manual Version 3 0 B 145 cobas c111 7 Configuration Applications 4 Press The application data are deleted Defining the processing order For a given sample the tests are processed in the order defined by the time required to perform the tests number of cycles starting with the one that takes the longest This order can be altered manually by defining a specific process sequence list a To define the processing sequence 1 Choose Utilities gt Applications gt Process Sequence 2 In the Default list select a test you want to be processed with high priority 3 Press to move it to the Priority list The tests are processed in the order displayed in this list When t
268. eep clear of the sample area Figure A 6 Sample area with sample tubes A WARNING Incorrect results due to inadequate sample preparation Specimen containing clots may obstruct the probe Specimen containing bubbles or foam may cause level detection errors and air pipetting Consequently incorrect results may be generated Take adequate care when preparing the samples Incorrect results due to insufficient fluid Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results Always fill the tubes with enough fluid that at least the defined dead volume of fluid is left when pipetting is complete e See Tubes on page A 54 Roche Diagnostics A 32 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Daily operation Sample tubes The cobas c111 instrument can use both primary and secondary tubes cups You can use any type of primary tube as long as their dimensions lay within prescribed limits Roche recommend using approved cups only e See Tubes on page A 54 Sample ID The sample ID is an identifier of up to 23 alphanumeric characters that is unique within a whole organization for example the hospital It identifies the sample and is also used for host communication Sample IDs are defined either by scanning a barcode or by typing them manually Because there is limited space when displaying lists on screens Roche recommend to limit the ID to 13 charac
269. efined on the target system using the appropriate software features e See Preparing the reagents on page B 22 2 Choose Utilities gt Import gt Database A confirmation screen is displayed informing you about the major effects of the import e For details see Table B 11 on page B 114 3 Press A screen is displayed asking you to insert the USB stick 4 Insert the USB stick 5 Press Data item Identical source and target system Different source and target systems Installed applications Overwrite Write overwrite if present System configuration Overwrite Write overwrite if present Bottle set inventory Overwrite Write overwrite if present Bottle sets Mark as removed Mark as removed Lot information for calibra tors and controls Overwrite Write overwrite if present Sample orders and results Overwrite Delete if present QC orders and results Overwrite Delete if present QC history results Overwrite Delete if present Calibration orders and results Overwrite Delete if present Abs Air Water Calibration Delete Delete if present Administrator password Reset to default value Reset to default value Electrode definitions Delete Delete if present ISE fluid bottle definitions Delete Delete if present Table B 11 Effects on existing data when importing a database Roche Diagnostics Operator s Manual Version 3 0 B 115 cobas c111 6 Special operations
270. eft on the screen n a 3 Start the QC measurement 4 Validate the QC results Workplace gt QC Status gt 5 Remove the controls Task Steps Navigation With wizard As individual steps Table A 1 Overview of the daily operation tasks Roche Diagnostics A 24 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Daily operation 9 Finishing the shift 1 Check for unfinished orders Workplace gt Orders Choose gt Not Finished 2 Check for non validated results Workplace gt Result Review Choose gt Not Accepted 3 Check for non transmitted results If working with a host system only Workplace gt Result Review Choose gt Not Sent to Host 4 Start the End Shift wizard Overview gt End Shift 5 Perform the daily backup Utilities gt Export gt Database 6 Export the full results Utilities gt Export gt Results 7 Clean up the database Workplace gt Orders gt Workplace gt Result Review gt Workplace gt QC Status gt Workplace gt QC History gt Workplace gt Calibrations gt 8 Perform the maintenance actions that are due Utilities gt Maintenance 9 Replace cuvettes Overview gt 10 Check the external fluid containers Overview gt gt 11 Remove the reagent disk if last shift Overview gt gt 12 Log off the system Overview gt button with your user name 13 Switch off the
271. en handling instrument items e g clicking sound when typing Does not affect the acoustic signals for alarms and warnings Volume 0 100 Volume of any acoustic signal generated by the instrument including alarm and warning signals 0 zero means silent Host Server On The host interface of the instrument is enabled allowing it to communicate with a host Off The host interface of the instrument is disabled Communication with a host computer is not possible Host definitions have no effect Table B 26 System definitions Item Values Comment Date Format dd mm yyyy Date that is used for time records for example with results Example 17 02 2006 for February 2 2006 This format is for entry purposes only It does not influence the format of displayed dates Time Format hh mm Time that is used for time records for example with results Example 08 32 This format is for entry pur poses only It does not influence the format of dis played times Table B 27 Date and time definitions Roche Diagnostics Operator s Manual Version 3 0 B 169 cobas c111 7 Configuration Configuration Maintenance Abs adjustment The absorbance adjustment values cannot be changed Item Values Comment Major Maint Day Day in the week when you usually perform mainte nance actions Minor Maint Day This definition has currently no effect Table B 28 Maintenance definitions Item Values Com
272. ent port STAT reagent port Section of the analyzer unit where reagent bottles are inserted and removed reference electrode See ISE Reference Electrode reference range See expected range reference solution See ISE Reference Solution repeat The performance of the same test on a sample again with identical dilution reportable range The range of results that can be reported for the assay It stretches from the lower detection limit to the high end of the calibration curve request See order rerun The performance of the same test on a sample again with a different dilution result The value reported by an analytical device during or after the assay of a sample or control ROM Abbreviation for read only memory Semiconductor memory devices used in computers ROM content remains when a computer is switched off rotor Assembly consisting of cuvette ring and plastic frame sample area Area on the instrument where sample tubes are placed sample cup A small container that is used for samples and also for calibrator and control material A sample cup can be placed either directly on the sample area or on sample tubes Compared to a sample tube a sample cup allows the use of smaller liquid volumes and so reduces the dead volume sample ID A set of alphanumeric data that unmistakably identifies a particular sample within a whole organization for example the hospital It is used on barcodes and is the unique identifier
273. equired 2 Assigning the tests to the tabs Assignment when importing applications When you import applications the tests are assigned to the tabs as follows o If you work in Easy mode the tests are added to the Easy panel If the panel is full they will not be displayed o If you work in Full mode the tests are added to the Easy panel if there is space and to the first Full mode tab If there is not enough space on the first Full mode tab the test is added to the next tab that has space available a To name a test tab 1 Choose Utilities gt Configuration gt Workflow 2 Expand the Workflow entry scroll down and select Test Tab 1 6 Name 3 Press A screen for typing text is displayed e For details on typing text see Typing text on page A 76 4 Type up to four characters This is the name of the tab on the screen for assigning tests 5 Press The tab name is now available on the screen for assigning tests See below a To assign a test to a tab 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select the test you want to assign to a tab 3 Press 4 Select General and expand the entry 5 Select Test Tabs 6 Press A screen is displayed that provides a button for each of the possible tabs The Easy button is always available It is the standard panel for working in Easy order mode You cannot rename it You need Lab Manager or Administrator r
274. erator s Manual Version 3 0 10 Result flags cobas c111 About flags Flags and error messages Some flags trigger error messages if they appear in consecutive measurements Each flag has its own counter If one measurement does not generate the flag the counter is reset to zero Flag priority If the conditions in the cobas c111 instrument are such that multiple flags were generated for a single measurement only the flag with the highest priority is displayed in the results lists Flags and user actions With each flag description contained in this chapter the recommended user actions are given e See List of flags on page D 28 Roche Diagnostics Operator s Manual Version 3 0 D 27 cobas c111 10 Result flags Safety Safety Before you start troubleshooting it is essential that you both read and understand the safety information listed below Read carefully all safety notices given in instructions and make sure you understand them WARNING Injury through working solutions Direct contact with cleaning solutions or other working solutions may cause personal injury When handling such solutions exercise the precautions required for handling them observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions Infection by biohazardous materials Contact with samples containing material of human origin may re
275. erform QC as part of standard sample testing and not as a sep arate task and if QC should be handled by a host computer Note that an accepted QC result is required for a test before it can be used Interval Only Due whenever the reagent interval has expired The system automatically informs you about due QCs Interval Number of days hours for ISE applications Use 0 zero if the Sequence is set to No Interval For each of the controls Mat Code 0 999 Unique identification of the control material Numbers 801 through 999 are reserved for non Roche controls You need to define this initially for every applica tion QC After Cal On Off QC needs to be performed after each calibration of the test Default QC On Off Mark the test to have QC performed as part of the Default QC function Default QC is an automated process for per forming all QC measurements that are currently due This is the ideal method if you want to per form QC periodically during routine operation Table B 14 Control definitions Roche Diagnostics Operator s Manual Version 3 0 B 155 cobas c111 7 Configuration Applications Calculation definitions Calculation definitions ratio applications Item Values Comment Factor Used for sample and control results Final result result Factor Offset The correlation factor is used to compensate for differences in measuring methods of different instrument
276. erun Storing results The cobas c111 instrument is designed to hold the sample results of one day s analyzing Therefore you need to back up the data regularly to an external medium Backing up results is an integral part of the End Shift wizard The QC results of the previous and the current months are stored on the system Up to five calibration results are stored on the system for each test Maintenance Completing maintenance actions correctly and on time helps to ensure smooth and uninterrupted operation of your instrument Maintenance scheduling The cobas c111 instrument facilitates performing the maintenance actions in bundles at the times that suit your laboratory work processes To that purpose you can define in the configuration settings one day of the week as your maintenance day e For information on scheduling maintenance actions see Scheduling maintenance actions on page B 158 All maintenance actions can be performed any time Roche Diagnostics Operator s Manual Version 3 0 A 35 cobas c111 2 Introduction to the instrument System status Interval For most maintenance actions a fixed maintenance interval is defined You cannot change this interval This is the basis upon which the system calculates the date when the actions need to be performed The interval timers and counters are reset whenever you confirm that the maintenance action has been performed Maintenance actions without predefin
277. erview ISE solutions The ISE unit requires several specific solutions for performing the analyses and maintaining the system They are listed in the following table Solution summary Fluid stability For information on the stability of fluids see the package insert of the fluid in question Solution Location Use ISE Solution 1 Sample area Used in the two point calibration of sodium chloride and potassium ISE Solution 2 Sample area Used in the two point calibration of sodium chloride and potassium ISE Calibrator indirect urine ISE unit Used in the one point calibration after each measurement It is also used during ISE initialization and standby and for maintenance purposes ISE Reference Solution ISE unit Used in all ISE measurements of sodium potassium and chloride Also used during ISE standby ISE Etcher Sample area Used as a cleaning solution for cleaning the ISE Sodium Elec trode during ISE maintenance ISE Deproteinizer Sample area Used as a cleaning solution for cleaning the probe ion selec tive electrodes ISE tower and tubing during ISE maintenance Activator Sample area Activates the electrodes tubing and the ISE tower during ISE maintenance It is also used for the initialization of the ISE unit and for activating the probe Roche recommend using their Activator on the cobas c111 instrument For details see the package insert of the Activa tor Water External water
278. essages Roche Diagnostics Operator s Manual Version 3 0 D 23 cobas c111 10 Result flags Table of contents Result flags In this chapter you will find a list of the flags generated by the cobas c111 instrument their associated error messages and the possible user actions About flags D 25 Safety D 27 List of flags D 28 gt D 28 V D 28 Ag Excess D 28 Cal D 29 Cal Error D 29 Calc Error D 29 Curv Dir
279. est selected Delete the lot values of the test With a value selected Not active A Calibrator name Asterisk The lot data were changed by the operator Not installed The associated application is not installed B Calibrator lot C Expiration date D Associated test E Lot values Figure A 68 Calibrator lot data A B C D E Roche Diagnostics Operator s Manual Version 3 0 A 107 cobas c111 5 Software Key screens Loadlist List of tests that are ready to be performed f Workplace gt Loadlist Print the loadlist Worklist The worklist shows all tubes currently placed on the sample area f Workplace gt Worklist Print the worklist A Number of due pipettings B Number of available pipettings Figure A 69 Loadlist A B A Position on sample area B Fluid type A Activator C Calibrator D Diluent E ISE Etcher P ISE Deproteinizer Q Control S Sample U Unknown Figure A 70 Worklist A B Roche Diagnostics A 108 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Utilities tab Use the Utilities tab to perform tasks that are not normally part of the routine analysis workflow Typically these are administration and maintenance tasks Configuration View and change configuration values Maintenance Select and perform maintenance actions Applications o Handle applications and their definitions
280. esults outside the normal daily routine e For deleting calibration results at the end of a shift see Cleaning up the database on page B 84 a To delete a calibration 1 Choose Workplace gt Calibrations 2 Select the calibration entry 3 Press A confirmation screen is displayed 4 Press The order and the results are deleted You cannot retrieve them any more from the system Roche Diagnostics B 96 Operator s Manual Version 3 0 6 Special operations cobas c111 Deleting QC results Setting up your calibration schedule The cobas c111 instrument provides convenient software supported procedures for the following major calibration scenarios o Performing all calibrations that are currently due o Performing all calibrations that fall due within a configurable forecast period o Performing individual calibrations Performing calibration as part of the Prepare wizard includes performing all calibrations that are due and that will fall due during the forecast period The following table lists the configurable definitions and describes their effect Deleting QC results Accepted QC results are normally deleted from the QC Status list as part of the daily end of shift activities at the same time results that were generated before the first day of the previous month are deleted from the QC History list This section describes how to proceed if you need to delete QC results outside the normal da
281. et been assigned to this lot 9 Select a test and press 10 Type the value for the mean concentration and press 11 Type the value for the standard deviation 12 Press to confirm the definitions The screen for handling control lot data is displayed again 13 Perform steps 7 through 12 for all tests you want to use Roche Diagnostics Operator s Manual Version 3 0 B 151 cobas c111 7 Configuration Applications 4 Define the lot values Do one of the following If Do this The lot data are available from a bar code 1 Scan the barcode The screen is displayed again that lists all installed calibrator lots The new lot is selected You want to type the data manually 1 Press 2 Type the name up to 10 alphanumeric characters and press 3 Type the material code and press Refer to the package insert 4 Type the lot ID up to nine alphanumeric characters and press 5 Type the expiration date and press Use the date format as indicated on the screen 6 Type the number of calibrators cups you need to place on the instrument Use the information given on the package insert Exclude calibrators that use system water from this number See step 14 7 Press to confirm the definitions 8 Press Add new test 9 Press A screen is displayed that shows all tests that have this calibrator defined for them and that are not yet assigned to this lot 10 Press
282. fined You cannot change this interval This is the basis upon which the system calculates the date when the actions need to be performed The interval timers and counters are reset whenever you confirm that the maintenance action has been performed Maintenance actions without predefined intervals are performed whenever necessary or they are triggered by another maintenance action Due date The due date is the last possible maintenance day This is the date you see when you check the status of maintenance actions Ensuring smooth operation Performing all due maintenance actions during the daily Prepare or End Shift phase ensures that routine operation does not have to be interrupted for performing maintenance actions Roche Diagnostics C 6 Operator s Manual Version 3 0 8 General maintenance cobas c111 Overview Performing maintenance actions a To perform maintenance actions Checking when maintenance actions are due 1 Choose Utilities gt Maintenance Interpreting the colors Preparing the maintenance actions The maintenance actions are sorted according to the date by when they should be performed Use these dates for planning the maintenance actions for example for ordering the required materials Performing the maintenance action 2 Select the maintenance action you want to perform The selected line turns blue 3 Press The first screen of the wizard for performing the selected maintenance a
283. for preventive maintenance 6 Press Roche Diagnostics C 28 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Perform an air water calibration f Utilities gt Maintenance gt Abs Air Water Calibration The absorbance photometer calibration determines the air water correction values that are needed for result calculation In addition the obtained absorbance values for an empty cuvette at each wavelength are used as a reference for the cuvette blank check Operator time Approximately 5 minutes Prerequisites The system must be in Standby status Tools and materials required m 2 cuvette segments with empty cuvettes a To perform an air water calibration 1 Choose Utilities gt Maintenance gt Abs Air Water Calibration 2 Press Your are asked to insert a cuvette segment with empty cuvettes 3 Open the main cover 4 If there is a segment in the cuvette ring remove it and check whether there are used cuvettes If all cuvettes of this segment are empty you can reinsert it 5 Place a cuvette segment with empty cuvettes on the cuvette ring 6 Press Your are asked to insert a second cuvette segment with empty cuvettes 7 If there is a segment on in the cuvette ring remove it and check whether there are used cuvettes If all cuvettes of this segment are empty you can reinsert it 8 Place the cuvette segment with empty cuvettes on the cuvette r
284. formation that allows you to make a considered decision o Non flagged results can be accepted automatically o You can print the results o You can export the results and process them on an external computer The following ways of dealing with results are available o Accept the result o Re perform the identical test Repeat o Re perform the test using a predefined different dilution Rerun Results must be accepted before they can be transmitted to a host or before they can be automatically printed The effect of flagged results depends on the configuration Utilities gt Configuration gt Result Handling The following table shows how e See Editing the acceptable flags list on page B 162 There are two main approaches to validating results o To validate sample results of an order whose sample is still on board press the tube button on the Overview tab o In all other situations choose Workplace gt Result Review Results must be accepted before they can be transmitted to a host or before they can be automatically printed Ratio results cannot be manually accepted They are automatically accepted if their con stituent results are accepted Configuration setting Effect Sample Auto Accept On Results that do not contain a flag are auto matically accepted Results with flags that are marked in a predefined list of flags that should be ignored are accepted as well Sample Auto Accept Off Al
285. from the reagent cooler Removing condensation water from the reagent cooler a To remove water from the reagent cooler 1 Make sure the system is in Standby status 2 Choose Overview gt gt 3 Open the main cover 4 Remove the reagent disk Be sure not to tilt it and place it on an even surface 5 Wipe the inside of the reagent cooler with a cloth or paper to remove the water 6 Insert the reagent disk 7 Close the cover Roche Diagnostics Operator s Manual Version 3 0 B 125 cobas c111 6 Special operations Replacing the probe Replacing the probe If the probe is bent broken or corroded you need to replace it Tools and materials required o Probe and tubing set o Tube with ISE Deproteinizer o Tube with Activator o Glass beaker a To remove the probe 1 Make sure the system is in Standby status 2 Switch off the system 3 Remove the transfer head cover Press the release buttons on both sides and lift 4 Release the tube leading to the probe from all tubing clips WARNING Injury through working solutions Direct contact with cleaning solutions or other working solutions may cause personal injury When handling such solutions exercise the precautions required for handling them observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions Infection by biohazar
286. g Effect QC Auto Accept On Results that do not contain a flag are auto matically accepted Results with flags that are marked in a predefined list of flags that should be ignored are also automatically accepted QC Auto Accept Off All results need to be manually accepted QC Acceptable Flags Flags that are marked in this list will be ignored by the system Table B 8 QC flag configuration and its effect Roche Diagnostics Operator s Manual Version 3 0 B 73 cobas c111 6 Daily operation Performing QC a To validate the QC results 1 Choose Workplace gt QC Status A screen is displayed that lists the most recent QC results for each test that is installed on the system 2 Select a result 3 Press to look at result details A Status The result has not been accepted yet I The result was ignored The result has not been transmitted yet B Test name C Control ID D Result if no flag was generated Flag with highest priority if a flag was generated Order status if the control measurement has not been performed yet Figure B 25 A Test name B Control name C Accepted by User name SYS means automatically accepted D Result E Calculation date and time F Time when accepted G Press to display context information of the fluids used to perform QC for this test Figure B 26 A B C D A B D C G E F Roche Diagnostics
287. ges When this number is reached the old est message is automatically deleted when a new one is generated Roche Diagnostics D 8 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 Alarm monitor 4 Select the message you are interested in Use and to display the previous and next message respectively 5 Do one of the following o Press to display more detailed information If this button is not available there is no additional information o Press to print alarm messages o Press to export the log file e See Exporting the alarm message log on page D 9 6 When you have dealt with the issue press to confirm that you have dealt with the issue The message is deleted from the Not confirmed list but it remains in the other lists and the alarm messages log which you can export e See Confirming alarm messages on page D 9 Printing alarm messages When you print alarm messages their details are included in the printout a To print alarm messages 1 Press 2 Press A screen is displayed for defining which alarm messages should be printed 3 Do one of the following o Press All to print all messages that have not been dealt with o Press Selected to print the current message Roche Diagnostics Operator s Manual Version 3 0 D 9 cobas c111 9 Messages and alarms Alarm monitor Confirming alarm messages Confirming a message means that you have dealt
288. ggers performance of the extra wash cycle If you use the pipetting type Sample it defines the bottle whose fluid will be prevented from being car ried over to the sample by using the extra wash cycle Pipetting Type Reagent 1 Reagent 2 Start Reagent Sample Defines the individual bottle bottle of the set or a sample tube whose pipetting triggers performance of the extra wash cycle Cleaner Bottle Code 0 999 Material code of the cleaner Volume L Amount of cleaner that will be pipetted during the extra wash cycle Table B 30 Extra wash cycle definitions Roche Diagnostics Operator s Manual Version 3 0 B 173 cobas c111 7 Configuration Configuration Short guide to reagent mixing rules f Utilities gt Applications gt Reagent Mixing gt e For importing reagent mixing rules see Importing automatic mixing and extra wash cycle definitions on page B 116 Reagent mixing rule definitions You cannot change these definitions Printing mixing rules You can print mixing rules a To print mixing rules 1 Choose Utilities gt Applications gt Reagent Mixing 2 Select the mixing rule you want to print 3 Press A printing screen is displayed 4 Select whether you want to print the selected rule set or all defined rule sets The rules are printed on the built in printer You can import and delete mixing rules but cannot change them Item Values Comment Active Defi
289. gnostics B 24 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing the system a To check the status of individual reagent sets 1 Choose Overview gt 2 Check the colors of the reagent set buttons Interpreting the colors A Press to add a reagent set B Press to display the disk content in a table Figure B 5 A B Color Meaning Possible actions No tests can be performed with this reagent set The number of available tests is 0 Replace the reagent set The set is incomplete Add the missing reagent The test needs calibrating Perform calibration There are fewer than 10 of tests left for this set Load a new reagent set as soon as pos sible The expiration date has passed A QC is due or its result has not been accepted Perform QC as soon as possible or accept the result A more recent version of the applica tion has been imported Install the new version of the applica tion to start working with it This development channel test is run without extra wash cycles Activate the extra wash cycle Roche strongly recommends to always use extra wash cycles with develop ment channel applications and also to always load extra cleaner when tests with extra wash cycles are used Ready for use No action is currently required There is no application that uses this reagent set Add the missing application A required diluent or cleaner is not on board
290. gnostics Operator s Manual Version 3 0 B 65 cobas c111 6 Daily operation Performing calibrations a To validate the calibration results 1 Choose Workplace gt Calibrations A screen is displayed that lists all tests and their currently valid calibration Interpreting the screen e For details on calibration types see Calibration type on page A 27 2 Select the result A Test ID B Calibration use C Calibration type D Status indication E Press to validate the result F Press to define a new calibration order G Press to delete the selected calibration and its results H Press to display all or only the current results Figure B 22 A E F G H B C D Item Value Interpretation U Use CU Current The calibration results of this set are currently used SB Standby The calibration results of this set are not currently used An identical set is currently in use or the set was removed and is not empty OB Obsolete The calibration results of this set are no longer used The set was empty and removed or it was removed more than 30 days ago T Type L Lot calibration first calibration of a lot also applies to sub sequent sets of the lot S Set calibration applies to calibrated set only Status The date indicates when the results were accepted If flags were generated for the result the flag with the highest pri ority is displayed In al
291. gt Print the graphic Display the results in a table The results are sorted chronologically relevant events QC lot change reagent set change QC target value change precede the results Month button Display the results of the month indicated on the button Old Display the results generated before the beginning of the previous month A Calibrator lot change B Reagent set change C QC target value change D 3s E 2 5s F 2s G Mean value H 2s I 2 5s J 3s Figure A 65 QC history graphic A D F H I J E G B C Roche Diagnostics A 104 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Calibrations list f Workplace gt Calibrations U column Use of calibration CU Current calibration SB Standby calibration OB Obsolete calibration T column Calibration type L Lot calibration S Set calibration Status column The date indicates when the results were accepted If flags were generated for the result the flag with the highest priority is displayed In all other cases the order status is displayed Print calibration results You can choose one of the following options o List If a filter was applied the list would contain only the results that fulfill the filter criterion and the filter criterion would be part of the button name o Detail of Calibration Display details of the selected calibration Valida
292. guration cobas c111 Applications Laboratory correlations ratio applications Reference range definitions ratio applications Result conversion definitions Item Values Comment Factor Used for sample and control results Final result result Factor Offset The correlation factor is used to compensate for differences in measuring methods of different instruments By applying a factor the final results of the different instruments can be directly compared Offset The offset is used to compensate for differences in measuring methods of different instruments By adding the offset the final results of the dif ferent instruments can be directly compared Used On Off Choose On to ensure that the defined factor and offset are applied the final ratio result Table B 17 Laboratory correlation definitions for ratio applications Item Values Comment Valuation No Valuation No valuation is performed by the system Reference Range Use the limits defined as Low Limit and High Limit Low Used On Off Refers to Low Limit High Used On Off Refers to High Limit Low Limit Values in standard units Results that are outside the limit are flagged High Limit Values in standard units Results that are outside the limit are flagged Table B 18 Reference range definitions for ratio applications Item Values Comment Standard Unit Laboratory Unit Alphanumeric characters Type the unit Fact
293. he Diagnostics Operator s Manual Version 3 0 A 93 cobas c111 5 Software Key screens Disk and reagent status f Overview gt The color of a reagent set button represents the status of the set The reagent set is on board but it is blocked for one of the following reasons o The number of available tests is 0 o The set is incomplete o The test needs calibrating o There is no application that uses this reagent set There are fewer than 10 of tests are left for this set The expiration date has passed The reagent set is on board and ready for use Display detailed information on the status of this test Load a reagent set Display a list with all tests on board together with information on their status On the list the following abbreviations are used to indicate the status of the reagent set o C Calibration missing o E Empty o I Incomplete o N Not used o L Low o X Expired Handle the reagent disk A A plus indicates that there is already an active identical reagent set on board This icon is displayed as soon as the first bottle of the set is loaded Figure A 56 Reagent sets loaded on the reagent disk A lt xyz gt Roche Diagnostics A 94 Operator s Manual Version 3 0 5 Software cobas c111 Key screens ISE status f Overview gt Na K Cl Ref Display detailed information on the status of the electrode The expirati
294. he calculated concentration is less than the lower limit of the expected value range nnnnn is the actual value that was checked against Message ID 41 Priority 23 Recommended actions No action required gt Std Dev Meaning Greater than standard deviation A point in the calibration fell outside the defined limits Message ID 17 Priority 17 Recommended actions 1 Check calibration curve 2 Repeat with fresh calibrators 3 If the calibrators were incorrectly positioned replace the calibrators correctly Roche Diagnostics D 38 Operator s Manual Version 3 0 10 Result flags cobas c111 List of flags gt Test Rng Meaning PANIC value over upper Technical Limit The result is higher than the upper limit for the test Message ID 26 Priority 20 lt Test Rng Meaning PANIC value below lower Technical Limit The result is lower than the lowest limit for the test Message ID 27 Priority 21 Roche Diagnostics Operator s Manual Version 3 0 D 39 cobas c111 11 Troubleshooting Table of contents Troubleshooting Dealing with exceptional situations In this chapter you will find information on how to deal with selected exceptional situations Introduction D 41 Dealing with exceptional situations
295. he control Repeat with fresh control TEST 1 Rerun with dilution Roche Diagnostics Operator s Manual Version 3 0 D 33 cobas c111 10 Result flags List of flags Non Linear Meaning Abnormal linearity Message ID 11 Priority 11 Possible cause o The slope changes between the first and last parts of the reaction curve Recommended actions CAL 1 Check reaction plot 2 Repeat with fresh calibrator CNTL 1 Check reaction plot 2 Repeat with fresh control TEST 1 Check reaction plot 2 Rerun with dilution or concentration if necessary Non Mono Meaning Curve not monotonic No calibration curve could be calculated because the rates of the calibrators were non monotonic Message ID 80 Priority 14 Possible cause Misplacement of a series of calibrators automatic dilution series failed Recommended actions 1 If the calibrators were incorrectly positioned re place the calibrators correctly and rerun the calibration 2 Check the fluid system 3 Repeat the calibration Roche Diagnostics D 34 Operator s Manual Version 3 0 10 Result flags cobas c111 List of flags Out of Rng Meaning Curve out of range The calibration curve is outside the acceptable programmed range Message ID 84 Priority 16 Possible cause Deteriorated or outdated calibrator or reagent Recommended actions 1 Repeat with fresh calibrators 2 If the calibrators
296. he fluid connectors need to be disconnected from the instrument External fluid connectors o Moving the instrument to another location o Removing blockages To get easier access to the release clamps on the connec tors remove the side panel before removing the connec tors e See To disconnect a tube from the instrument on page B 129 A service representative asks you to perform diag nostics tasks Diagnostics features These features are usually used at the request of a service repre sentative Follow the instructions given by the service representa tive e See Exporting diagnostics screens to USB on page D 51 The system does not work or does not switch on and the power switch light is off Instrument No electricity 1 Check that the instrument is connected to the mains power supply 2 If the instrument is properly connected replace the mains fuses e See Changing the mains fuses on page D 47 No printing Printer Printer is out of paper Load printer paper e Refilling printer paper on page B 122 Printer jam e To clear the paper jam on page D 46 Reagent disk cannot be inserted in the reagent cooler Reagent disk The bottle storage assembly in the reagent disk was moved while the latter was outside the instrument The reagent disk is designed to handle reagents while it is loaded on the instrument The cover is equipped with a locking mechanism Always remove and load
297. he following situations o The set was removed and it is empty o The set was removed and it is not empty It was removed more than 30 days ago SB standby indicates that the set s calibration results are not currently used This status applies for example to the following situations o A new set was loaded and calibrated while an identical set was still in use pre calibration o The set was removed not more than 30 days ago and it is not empty Calibration result storage The current and up to five obsolete calibration results are stored on the system If there are more than five obsolete calibration results the oldest obsolete calibration results are automatically deleted as part of the daily end of shift activities Roche recommend not to change the calibration sequence Roche Diagnostics Operator s Manual Version 3 0 A 29 cobas c111 2 Introduction to the instrument Daily operation Validating calibration results Applications define checks for ranges and limits If these are exceeded the results are flagged Each new calibration result has to be validated If flags were generated you must determine their cause and decide whether to accept the result rerun the calibration or continue using the old calibration results You can automatically accept unflagged results and results with flags that are contained in a specific list of flags that should be ignored e See Editing the acceptable flags l
298. he higher limit is used if required 26 Change the lower limit value if required 27 Change the higher limit value if required 28 Define for each control whether sample results should be flagged that were generated using a test whose QC results were marked with a flag 29 Press to confirm the definitions Result Conversion definitions 30 Expand the Result Conversion entry select Laboratory Unit and press 31 Change the laboratory unit if you intend to work with units that are different from the currently specified units 32 Type the conversion factor if required This factor is required if lab units were defined 33 Choose whether values should be displayed in standard or laboratory units This definition affects displays on screens as well as printouts 34 Change the decimal position if required This value corresponds to the number of digits after the decimal point that are displayed on the screens 35 Press to confirm the definitions WARNING Incorrect results due to inappropriate formula The formula defines how the values of the applications and coefficients are mathemat ically combined to generate a result It is the responsibility of the user to ensure that the formula is appropriate for the appli cation that is being defined Roche Diagnostics Operator s Manual Version 3 0 B 143 cobas c111 7 Configuration Applications Uninstalling applications Uninstalling an application
299. he rotor initialization light barrier Restart the system If the error persists call service 7051 s Error rotor motor The motor could not be started Restart the system If the error persists call service 7052 s Error motor X transfer The motor could not be started Restart the system If the error persists call service 7053 s Error motor Z transfer The motor could not be started Restart the system If the error persists call service 7057 s The ISE sample sensor is not calibrated or no calibration data is available Perform lt Initialize ISE Unit gt If the error persists call ser vice 7058 s ISE sample sensor could not detect fluid Check the ISE tower and the ISE tubing for obstructions and leaks Ensure that the electrodes are installed cor rectly If the error persists call service 7059 s The ISE sample sensor could not detect the end of the transported fluid segment Check the ISE tower and the ISE tubing for obstructions and leaks If the error persists call service 7060 s The calibration of the ISE sample sensor failed Check the filling level of the ISE Cal bottle Check the ISE tubing for obstructions and leaks Perform lt Initialize ISE Unit gt If the error persists call service 7061 s The calibration of the ISE sample sensor failed Check the filling level of the ISE Cal bottle Check the ISE tubing for obstructions and leaks Perform lt Initialize ISE Unit gt If the
300. he side of the probe holder carriage while you insert the probe holder Release the button when the holder is inserted Push the holder firmly down until the release button latches on 3 Reinstall the sensor tubing adapter Push down until the clips engage 4 Screw the tubing to the distributor block 5 Fix the tube to all tubing clips Start near the probe holder A Sensor tubing adapter B Example of tubing clip C Tube fixation screw on holder D Probe holder E Tube fixation screw on distribution block Figure B 40 A D E B C Roche Diagnostics Operator s Manual Version 3 0 B 127 cobas c111 6 Special operations Connecting and disconnecting the external fluid containers 6 Install the transfer head cover Push down until the release buttons latch on 7 Switch on the system The system performs internal checks and routines The startup phase may take a few minutes When the instrument is ready for use the Overview tab is displayed and its status is Standby 8 Log on the system 9 Perform the Deproteinize Probe maintenance action e See Deproteinize the probe on page C 10 Connecting and disconnecting the external fluid containers Before switching on the system make sure that all external fluid containers are placed on the rack and properly connected a To connect the water container 1 Place the white full water container on the tray Always use purified wa
301. he steps that make up the preparation process e For non ISE specific tasks see Preparing the system on page B 12 Step User action 1 Start the Prepare wizard 1 On the Overview tab press Prepare 2 Check the status of the external containers 1 Refill the water container if required and con firm by pressing the water button If you refill the water empty the waste as well 2 Empty the waste container if required and confirm by pressing the waste button 3 Replace the cleaner bottle if required and con firm by pressing the cleaner button 4 Press to proceed to the next stage in the Prepare wizard 3 Check the onboard ISE fluids 1 Replace the ISE fluid bottles if required 2 Replace the electrodes if required 3 Press to proceed to the next stage in the Prepare wizard 4 Perform the maintenance actions that are due 1 Perform the Daily Prepare Actions mainte nance action 2 Perform the other ISE maintenance actions that are due Perform at least all red maintenance actions Table E 4 Steps for preparing the system Roche Diagnostics Operator s Manual Version 3 0 E 21 cobas c111 13 ISE operation Daily operation Starting the Prepare wizard a To start the preparation process 1 Choose Overview gt Prepare Checking the status of the external fluid containers a To check the status of the external fluid containers 1 Follow the instructions given in Chec
302. he tests contained in this list are processed the rest of the tests are processed in the normal order 4 Perform steps 2 and 3 to move the other tests you want to process with high priority 5 To move a test from the Priority to the Default list select the test in the Priority list and press To move all tests to the Default lists press 6 In the Priority list select a test and use and to move it up and down in the list 7 Press to save the processing sequence The processing sequence defined in the Priority list applies to all tests performed on the current cobas c111 instrument Roche Diagnostics B 146 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications Defining ratio applications The user can manually define ratio applications Such applications yield results that are mathematically arrived at and are based on test results that were generated using up to four different applications In the results list both the results of the test or tests as well as the calculated ratio result will be displayed a To define a ratio application 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Press 3 Press Add Ratio 4 Type the code and press The code is a number between 910 and 930 and identifies the application 5 Type the short name and press The short name must be unique on the cobas c111 system and consists of up to 5 alphanumeric characters
303. his does not help change the Last Is Water value to On Calibration for this test does not work with a spe cial zero calibrator 1 Choose Workplace gt Lot Data gt Calibrators 2 Select the entry for the test and expand the entry 3 Select the Last Is Water entry and press 4 Press On 5 Press 6 Delete the current calibration order and redefine it A hardware error had occurred Some hardware conditions prevent the system from per forming tests 1 Press to check the alarm messages 2 Follow the advise given in the messages 3 Choose gt Restart to restart the system Situation Affected items Possible causes Comments Figure D 4 Troubleshooting overview Continued Roche Diagnostics D 44 Operator s Manual Version 3 0 11 Troubleshooting cobas c111 Reacting to messages Reacting to messages A cobas c111 error message starts with a message ID which consists of a number followed by the date and time for example 7009 19 19 32 1402 25 08 2006 8 53 Providing information to service representatives Whenever you are asked to provide message information to a service representative provide the error codes contained in the explanatory text not the message ID of the first line If there are no error codes in the text supply the complete message text Also keep in mind that an event may trigger several messages therefore it is important to provide the information for all message
304. hnical specifications When refilling the water without using the Prepare wizard Choose Overview gt gt Roche Diagnostics Operator s Manual Version 3 0 B 17 cobas c111 6 Daily operation Preparing the system a To check the waste container 1 Check the waste button 2 Empty the waste container if required o Have the spare waste container ready The system periodically performs wash actions Therefore an external waste container must be connected at all times o Remove the tubing adapter from the yellow waste container and insert it in the spare container o Remove the bottle from the rack and place it on a firm and even surface o Place the spare container on the rack o Check that the tubing adapter is properly inserted o Empty the removed waste container Treat the fluid as biohazardous waste o Rinse the container with water and leave it to dry 3 On the screen that shows the container status press the waste button to confirm that you have emptied the container The waste container was last emptied more than one day ago You should check the waste level and empty if required No action is required The system does not monitor the filling level It is up to the operator to empty the waste container regularly When emptying the waste without using the Prepare wizard Choose Overview gt gt Roche Diagnostics B 18 Operator s Manual Version 3 0 6 Daily
305. ialog boxes and on how to perform particular tasks o Keep this Operator s Manual in a safe place to ensure that it is not damaged and remains available for use o This Operator s Manual should be easily accessible at all times cobas c111 Roche Diagnostics 8 Operator s Manual Version 3 0 Conventions used in this manual Visual cues are used to help locate and interpret information in this manual quickly This section explains the formatting conventions used in this manual Symbols The following symbols are used Buttons When used for identification purposes a generic form of the buttons is used without color or navigation indicators Screenshots The screen representations shown in this publication are for illustrative purposes only The screens do not necessarily show valid data Symbol Used for a Start of procedure o List item e Cross reference h Call up software navigation path Color of display item on the screen Tip Safety alert Electrical and electronic equipment marked with this symbol are covered by the European directive WEEE The symbol denotes that the equipment must not be disposed of in the municipal waste system Roche Diagnostics Operator s Manual Version 3 0 9 cobas c111 Abbreviations The following abbreviations are used Abbreviation Definition C Cfas Calibrator for automated systems D DIL Diluent DM Data management DRAM Dyna
306. ible eliminate the problem Restart the system If the error persists call service 5052 s Error cooling system The cooling heat sink overheated Ensure unrestricted cooling air circulation Check the cooling fan and make sure the external vent is not blocked Restart the system If the error persists call service 5054 s The analyzer heating system overheated Switch off the instrument and wait 15 minutes to let cool down the analyzer Restart the system If the error persists call service ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics D 12 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 List of alarm messages 5055 s The analyzer temperature is outside the range Restart the system If the error persists call service 5056 s The calibration of the transfer head fluid sensor failed Ensure that the sample probe tube is correctly installed Ensure that the syringe is correctly installed Restart the system If the error persists call service 5058 s Error fluid sensor transfer head The sensor does not react anymore Restart the system If the problem persists call service 5060 s A not specified hardware error d was reported by the Multi Slave control Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 5061 d Air detected in the f
307. ic cleansing tissues 4 Open the main cover and the right service flap 5 Wipe all the inside of the cover and flap with alcoholic cleansing tissues 6 Close the right service flap and then the main cover 7 Push the transfer head to the rightmost position 8 Open the main cover and the left service flap 9 Wipe all the inside of the flap with alcoholic cleansing tissues 10 Close the left service flap and the main cover 11 Push the transfer head to its home position 12 Remove the transfer head cover Press the release buttons on both sides and lift 13 Wipe all the inside of the cover with alcoholic cleansing tissues 14 Reinstall the transfer head cover Push down until the release buttons latch on 15 Remove the left and right side panels 16 Wipe the panels with alcoholic cleansing tissues 17 Reinstall the left and right side panels Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 o Infection by biohazardous materials on page C 8 o To find out what steps are required you can choose Utilities gt Maintenance gt Clean Housing and then press The maintenance definition screen is displayed o Do not press at this stage You do this only when you have completed the mainte nance action Instead press to close the screen Roche Diagnost
308. ic sequence are available for selection In the software and the user interface the languages are identified by their two letter abbreviation ISO 639 1 The following languages are available The definition of the minor maintenance day has currently no practical influence on the maintenance scheduling because there are no maintenance actions with intervals of between two and six days Abbreviation Language Abbreviation Language DE German EL Greek EN English ES Spanish FI Finnish FR French HU Hungarian ID Indonesian KO Korean PL Polish PT Portuguese TR Turkish ZH Chinese Table B 20 Abbreviations for user interface languages Roche Diagnostics Operator s Manual Version 3 0 B 159 cobas c111 7 Configuration Configuration Prerequisites o Make sure that there are no pending or unfinished orders o The system must be in Standby status o You need Lab Manager or Administrator user rights a To install a new language 1 Copy the language file c111_xx tar where xx is the language code to the Root directory of a USB stick 2 Choose Utilities gt Import 3 Press Software A screen is displayed asking you whether you want forced download of controller software that is whether you want to overwrite the current controller firmware irrespective of its current status 4 Press to perform standard import A screen is displayed asking you to insert the USB stick
309. ic signals The operator is alerted to certain events by an acoustic signal The following events trigger an acoustic signal o An alarm was generated o The Main cover is open while the system is in Operating status o A run is finished The system status has changed from Operating to Standby o A maintenance action is complete provided it is a longer maintenance action where no user intervention is required You can adjust the volume of all generated acoustic signals Utilities gt Configuration gt System gt Volume You can also turn on and off acoustic signals o Choose Utilities gt Configuration gt System gt Sound Effects to turn on and off the acoustic signals other than alarm and warning signals o Choose Utilities gt Configuration gt System gt Volume and set the value to zero to turn off all acoustic signals e System on page B 168 Alarm monitor Messages concerning an irregularity that occurred during operation can be viewed in the alarm monitor The alarm LED alerts you when such messages are generated Alarm button and LED The alarm button is always active even if you are not logged on the system A Alarm LED B Alarm button Figure D 2 Alarm LED A B Roche Diagnostics Operator s Manual Version 3 0 D 7 cobas c111 9 Messages and alarms Alarm monitor Reacting to alarm messages a To react to an alarm message 1 Observe the alarm LED 2 Press the
310. ications Deleting an application means removing the data from the system The process of removing an application from the system consists of the following steps 1 Delete all associated sample results e See Deleting sample results on page B 94 2 Delete all associated QC results both from the QC Status list and the QC History e See Deleting QC results on page B 96 3 Uninstall the application This process makes the application unavailable for use in testing e See Uninstalling applications on page B 143 4 Remove all associated reagent sets from any of the reagent disks The disk may be off board and you might need to load it in order to remove the reagents e See To load the reagent disk on page B 21 See Removing a reagent set on page B 25 5 Delete the application This process removes the application data from the system a To delete an application 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select the application 3 Press The following table lists possible situations and how they affect the process of deleting A confirmation screen is displayed Situation Proceed as follows There is one entry for the application in the list and the application is currently installed not in brackets 1 Confirm to proceed with uninstalling 2 In the applications list select the unin stalled application it is now contained in brackets 3 Press 4 Confirm to proc
311. ics A 124 Operator s Manual Version 3 0 5 Software cobas c111 Buttons Buttons The following tables list the buttons used in cobas c111 screens and describe their use The buttons are grouped according to the kind of function they represent General functions Interactive functions Icon Name Use Help Display concise information that is relevant to the current screen and situation Start Start processing orders Stop Display Stop options Alarm Look at alarms Paper Feed Advance the printer paper Table A 12 Global action buttons Icon Name Use Add Add or define an item Delete Delete the selected item Cancel Abort the operation Close Close the screen Print Print the content of the current screen s working area List Display the content of the current screen s working area in a table OK Confirm the operation save the data and close the screen Save Detail Show detailed information on the selected item Filter Apply filter criteria to the current view Edit Modify the selected item Perform Perform the selected action Export Export data Import Import data Disk Status Handle the reagent disk and its reagents Show the status of the reagents Cuvette Status Show the status of the cuvette segments Handle cuvette segments ISE Status Show the status of ISE electrodes and fluids Exchange ISE electrodes and fluids Table A 13 Intera
312. ics C 22 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions 18 Switch on the system The system performs internal checks and routines The startup phase may take a few minutes When the instrument is ready for use the Overview tab is displayed and its status is Standby 19 Log on the system 20 Choose Utilities gt Maintenance gt Clean Housing 21 Press The maintenance definition screen is displayed 22 Press A detailed maintenance definition screen is displayed 23 Press to confirm the completion of the maintenance action Roche Diagnostics Operator s Manual Version 3 0 C 23 cobas c111 8 General maintenance Maintenance actions Clean up the database f Utilities gt Maintenance gt Cleanup Database This maintenance action restores the database to the condition where the instrument can work at its optimum You typically use this action when you think that the instrument suddenly works slow for example when displaying information on the screen takes long or when it takes long until an action starts after you have initiated it Operator time Approximately 10 minutes Prerequisites The system must be in Standby status Tools and materials required None a To clean up the database 1 Select the maintenance action Cleanup Database 2 Press The maintenance definition screen is displayed 3 Press An instructions screen
313. ighest dilution filter A process that sorts data for viewing documenting or printing according to pre defined criteria flag An identifier used to call an operator s attention to a result global action button See global button global button A button that allows access to the global software screens and that can be used at any time For example lt Start gt lt Stop gt or lt Alarm gt home position The position to which a certain part of the instrument returns on reset The start position of a mechanism host computer 1 A computer used for overall management and control of the computer network 2 A clinical laboratory computer that stores and processes patient requests and results A host is able to communicate with analytical instruments host communication Data exchange with a clinical laboratory information system LIS host interface protocol A technical description that defines data transfer between a host computer and an analytical system Initialization Also known as Initializing The operational mode of an analyzer that occurs immediately after power on and during which the instrument prepares itself for operation installing applications Process of making the application available for testing as opposed to importing the application data which just saves the data on the system interval QC A streamlined process of performing all due QC measurements for QC that needs to be performed periodically
314. ights for assigning tests to tabs Roche Diagnostics B 120 Operator s Manual Version 3 0 6 Special operations cobas c111 Deleting bottle sets from the Inventory list 7 Select the buttons for all the tabs where the test should be displayed 8 Press The tests are now available on the corresponding tabs on the test selection screen a To remove a test from a tab 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select the test you want to remove 3 Press 4 Select General and expand the entry 5 Select Test Tabs 6 Press 7 Cancel the selection of the button of the tab to which the test is assigned to 8 Press The test is no longer available from the corresponding tab on the test selection screen Deleting bottle sets from the Inventory list The Inventory list serves to gain an overview on the status of all bottle sets that are defined on any of the reagent disks used on the cobas c111 instrument You can delete bottle sets from the list this would be appropriate if you removed a set from the disk and did not intend to use it again a To delete a bottle set from the Inventory list Removing the bottle set 1 Remove the bottle set from the disk e Removing a reagent set on page B 25 If the bottle set that you want to delete is not on the currently installed disk you need to change the disk first e Removing the reagent disk on page B 87 Preparing the r
315. iluents reagent lot Viewing the current lot definitions Calibrator and QC lots a To view calibrator or lot data 1 Choose Workplace gt Lot Data 2 Press either Controls or Calibrators A screen is displayed that lists all installed lots 3 Select the calibrator and expand the entry The following description shows an example of viewing a calibrator lot A Calibrator name Asterisk The lot data were changed by the operator not installed The associated applica tion is not installed B Lot ID C Expiration date Figure B 30 A B C Roche Diagnostics Operator s Manual Version 3 0 B 99 cobas c111 6 Special operations Lot handling 4 Select a test and expand the entry Calibrators that were defined or changed manually are marked with an asterisk Reagent lots You can view the lot number in the reagent set details a To check the status of an individual reagent set 1 Choose Overview gt 2 Press a reagent set icon A screen is displayed that contains information on the selected reagent set including its lot number A Calibrator name Asterisk The lot data were changed by the operator not installed The associated applica tion is not installed B Associated test C Lot values Figure B 31 B C A Roche Diagnostics B 100 Operator s Manual Version 3 0 6 Special operations cobas c111 Lot handling a To gain a gene
316. ily routine e For deleting QC results at the end of a shift see Cleaning up the database on page B 84 Definition item Configuration path Effect Forecast Hours Utilities gt Configuration gt Calibration Period of time starting with the current date within which calibration falls due Defining a forecast period value other than zero allows to concentrate calibration per formance to specific days Cal Auto Accept Utilities gt Configuration gt Result Handling If on results that are not flagged are auto matically accepted Results with flags that are marked in a pre defined list of acceptable flags would also be automatically accepted Cal Acceptable Flags Utilities gt Configuration gt Result Handling List of calibration relevant flags Flags that are marked are automatically accepted if Cal Auto Accept is on Table B 10 Calibration definitions and their effect o QC results are displayed in the QC Status list as soon as they are generated A copy of the results is also placed in the QC History list This list keeps the results of the previ ous and the current months o Deleting QC results deletes the associated orders as well Roche Diagnostics Operator s Manual Version 3 0 B 97 cobas c111 6 Special operations Deleting QC results a To delete QC results from the QC Status list 1 Choose Workplace gt QC Status 2 Press A screen for selecting results is displayed
317. imary wavelength multi wavelength spectrophotometer A spectrophotometer in which detectors are placed at multi wavelength positions to enable simultaneous light reception on board 1 A technical device or function that is part of the analytical instrument and can be used by the instrument at any time 2 The availability of reagents and consumables on an analytical instrument for use at any time online help On screen documentation that a user can request in a context sensitive manner operating system A software program that controls all basic functions of a computer for example Windows Linux and Palm OS operator The person who uses and controls the analytical instrument or a computer system See also user operator ID An alphanumeric ID that a system uses to identify a particular operator L M O Roche Diagnostics Operator s Manual Version 3 0 F 7 cobas c111 Glossary order reagent disk position order Collection of all tests that are defined to be performed for a particular sample order ID A set of alphanumeric data that unmistakably identifies a particular sample order in the lab and is often manually written on the sample label parameters A set of criteria or definitions used to establish how an assay is performed Examples of parameters include sample and reagent volumes and incubation times and temperatures Such information is typically contained in the application definitions and c
318. ime Reagent bottles are placed on the reagent disk e See Preparing the reagents on page B 22 WARNING Incorrect results due to scratched or soiled cuvettes Scratches and impurities on the cuvettes distort the measurements Do not touch the cuvettes and make sure they do not touch other items when handling them A Hold the segment by its handle Make sure not to touch the cuvettes Figure A 21 Handling a cuvette segment A Figure A 22 Handling a reagent bottle Roche Diagnostics Operator s Manual Version 3 0 A 57 cobas c111 3 Hardware Hardware overview Rotor The rotor provides the following features o Space for up to 27 reagent bottles on the reagent disk o Space for up to 60 cuvettes in the cuvette ring o A cooled environment for reagents reagent cooler o A temperature controlled environment for samples cuvette ring o A synchronized transport mechanism to move reagent bottles and cuvettes to the pipetting loading and measuring positions Rotational movement The bottles and cuvettes are positioned in a manner that they can be moved to the various positions by a rotational movement There are positions for loading and removal reagent and cuvette ports pipetting and measuring A Reagent disk B Reagent cooler C Temperature controlled cuvette ring not visible D Cuvette segment Figure A 23 Main rotor elements A D C B A Pipetting positions B
319. iner When refilling the water without using the End Shift wizard Choose Overview gt gt Roche Diagnostics Operator s Manual Version 3 0 B 87 cobas c111 6 Daily operation Finishing the shift Removing the reagent disk During periods when you do not perform tests the disk should be stored in a clean refrigerated place at temperatures in the range of 2 to 8 C a To remove the reagent disk 1 Choose Overview gt gt A screen is displayed asking you to remove the reagent disk 2 Open the main cover 3 Remove the reagent disk 4 Place the reagent disk in the reagent disk container 5 Close the main cover 6 Store the reagent disk container in a refrigerated place Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page B 5 o Infection by biohazardous materials on page B 5 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page B 5 CAUTION Spillage through tipping reagent disk The reagent disk container can slip off or tip over if it is not placed on an even horizontal surface When storing the reagent disk container make sure to place it on a firm even horizontal surface that is easily accessible When handling the reagent disk make sure not to tilt it Roche Diagnostics B
320. iner white C Waste container yellow Figure B 1 External fluid bottles Figure B 2 C B A Roche Diagnostics B 16 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing the system a To check the water container 1 Check the water button 2 Refill the water if required o Remove the tubing adapter from the white water container and place it on a clean surface o Refill the bottle with purified water o Insert the tubing adapter Press down firmly 3 On the screen that shows the container status press the water button to confirm that you have refilled the water 4 Roche recommend to empty the waste container whenever you refill the water container e See To check the waste container on page B 17 There is no water left A fluid sensor detected that there is no water coming from the water container You need to refill the water now No new tests can be processed started tests may have to be restarted after refill The water container was last filled up more than one day ago You should check the water level and refill if required No action is required The system does not monitor the filling level It is up to the operator to fill up the water container regularly WARNING Danger of poor measurement quality due to inadequate water quality Inadequate water quality may lead to incorrect results Always use purified water of the quality specified in section Tec
321. iner s Position Samples Tube Sample area Controls Tube Sample area ISE Solution 1 and 2 Tube Sample area Cleaner External cleaner bottle External fluid rack ISE Deproteinizer Tube Sample area Activator Tube Sample area ISE Etcher Tube Sample area ISE Reference Solution Bottle ISE unit ISE Calibrator indirect urine Bottle ISE unit Water External water container External fluid rack Waste External waste container External fluid rack Table E 2 Fluids containers and where they are used The term tube includes all kinds of tubes as long as their dimensions lay within prescribed limits It also includes secondary tubes cups See Tubes on page A 54 Roche Diagnostics E 12 Operator s Manual Version 3 0 12 ISE description cobas c111 Basic operation Basic operation Operation of the ISE unit is integrated in the operation of the main instrument The following sections contain some ISE specific information on operation related issues e For general information on operating the main instrument see the corresponding sections in Chapter 2 Introduction to the instrument and Chapter 6 Daily operation For ISE specific tasks see Chapter 13 ISE operation Samples The sample tubes are placed on the sample area of the main instrument Calibration The ISE unit requires frequent calibration to ensure the accuracy of the test results obtained Main calibration The electrodes are
322. infectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Personal injury or damage to the analyzer due to contact with instrument mechanism Contact with moving parts of the instrument may cause personal injuries stop the instru ment from processing and cause damage to instrument parts o Do not touch moving parts during instrument operation o Keep all covers closed operate them as instructed on the screen Roche Diagnostics Operator s Manual Version 3 0 B 117 cobas c111 6 Special operations Preparing a new disk You can use up to eight different reagent disks on one cobas c111 instrument Each reagent disk is equipped with numbered tabs For automatic disk identification by the instrument one and only one of these tabs is removed The number of this removed tab is the disk ID When you label the disk make sure that the number on the label corresponds to that of the removed tab a To prepare a new reagent disk Defining the disk ID 1 Be sure to select an ID that is not used by any other reagent disk you intend to use on this cobas c111 instrument You can choose a number between one and eight 2 Print the number on a label and stick the label on the disk A 3 Using pliers break off the ID tab C D with the same number as the one printed on the label Loading the disk 4 On the system choose Overview gt A
323. ing 9 Close the main cover 10 Press The system performs the calibration measurements It first measures all cuvettes empty pipettes water in the cuvettes and measures them again A message will inform you when the measurements are complete 11 Scroll to display the results if required 12 Check the Outlier statistics Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 o Infection by biohazardous materials on page C 8 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page C 8 Roche Diagnostics Operator s Manual Version 3 0 C 29 cobas c111 8 General maintenance Maintenance actions 13 Press to accept the results 14 Remove the used cuvettes or replace them with empty ones If at this stage you press the results are not stored and the maintenance action is deemed not performed Roche Diagnostics C 30 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Initialize degasser fluid sensor f Utilities gt Maintenance gt Initialize Degasser Fluid Sensor The degasser fluid sensor checks whether there is air in the water supply to the syringe assembly Air in the water supply may lead to inaccurate pipetting and ultimately to incorrect results Therefore the sen
324. ing routine tasks In this chapter you will find information on performing the routine tasks that are required for processing orders and keeping the system running Introduction B 5 Safety information B 5 Overview B 7 Working with a host system B 9 Starting the shift B 10 Switching on the instrument B 10 Preconditions B 10 Logging on to the system B 11 Preparing the system B 12 Short guide B 13 Starting the Prepare wizard B 15
325. installing B 143 applications screen A 111 approvals 3 approved parts A 8 assemblies syringe A 46 auto accept QC results B 64 B 72 sample results B 51 B backup B 82 barcode scanner A 61 B 89 barcode sheets reading B 90 barcodes reading from reagent bottles B 89 reading from sample tubes B 90 reading from sheets B 90 reagent bottles A 61 samples A 62 scanner A 61 biohazardous materials safety A 6 bottle sets See reagent sets bottles cleaner A 52 external cleaner B 18 external fluid containers B 15 external waste container B 17 external water container B 16 B 86 ISE fluids E 11 reagents A 53 reagents specifications A 67 replacing ISE E 22 E 30 bottom detection A 49 buttons alarms A 82 global action A 73 overview A 124 Roche Diagnostics F 12 Operator s Manual Version 3 0 Index cobas c111 C calculation B 155 ratios B 155 calibration checking if due B 31 definitions B 153 B 167 deleting orders B 63 deleting results B 95 during Prepare phase B 30 forecast period A 29 introduction A 26 ISE E 12 E 26 main ISE calibration E 12 overview A 26 performing B 59 reserve A 29 schedule B 96 selecting tests B 62
326. ion Select one of the predefined values Handshake Off An exchange of signals between two devices when communication begins in order to ensure synchroni zation Hardware XON XOFF Line Mode Number of bits and stop bits used during data trans mission Select one of the predefined values Parity Check On Off An error detection technique that tests the integrity of digital data in memory or on disk Communication Mode Off Download to the cobas c111instrument is possible but upload to host is not Batch Only manual upload to the host is possible Realtime Results and queries are sent during processing Checksum On Off A value used to ensure that data are stored or trans mitted without error It is stored with the data When the data are retrieved from memory or received at the other end of a network a new checksum is computed and matched against the existing checksum A non match indicates an error Table B 22 Host definitions Roche Diagnostics B 166 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration Order Query Mode Query mode allows real time communication during order definition of regular rerun and repeated tests Off No queries are sent Test orders have to be defined either manually or by downloading them from the host Once A query is sent only when the sample is identified the first time Always A query is sent every time the sample is identifi
327. ipe the waste inlet with a tissue 14 Reinsert the tubing adapter into the waste container Press down firmly 15 Press The maintenance action Prime Fluid System is automatically performed A message will inform you when the maintenance action is complete 16 Press Roche Diagnostics Operator s Manual Version 3 0 C 19 cobas c111 8 General maintenance Maintenance actions Replace water inlet filter f Utilities gt Maintenance gt Replace Water Inlet Filter The water inlet filter in the external water container removes particulate matter from the water supply You must replace this filter according to the maintenance action schedule The water container is placed on the rack next to the cobas c111 instrument Operator time Approximately 10 minutes Prerequisites None Tools and materials required m Purified water m Hypochlorite solution 0 6 m Tissues m Water inlet filter a To replace the water inlet filter 1 Select the maintenance action Replace Water Inlet Filter 2 Press The maintenance definition screen is displayed 3 Press 4 Remove the tubing adapter from the water container 5 Place the tubing adapter on a clean surface Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 Roche Diagnostics C 20 Operator s
328. is complete 6 Remove the Activator ISE Deproteinizer and ISE Etcher from the sample area 7 Press Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 You need to perform a main calibration before you can process orders Roche Diagnostics E 50 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Clean ISE tower automatically f Utilities gt Maintenance gt Clean ISE Tower Automatically The ISE tower must be cleaned regularly to ensure the proper functioning of the ISE unit Cleaning includes deproteinizing and activating the ISE tower Operator time Approximately 3 minutes Prerequisites The system must be in Standby status Tools and materials required m Activator m ISE Deproteinizer a To clean the ISE tower automatically 1 Select the maintenance action Clean ISE Tower Automatically 2 Press The maintenance definition screen is displayed 3 Press to start the action A placement list is displayed 4 Place the Activator and the ISE Deproteinizer on the sample area positions indicated on the screen 5 Press to confirm the placement and to start the action A message will inform you when the maintenance action is complete 6 Remove the Act
329. is displayed while the database cleanup is performed 4 When the maintenance action is complete press to confirm the completion Roche Diagnostics C 24 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Replace photometer lamp f Utilities gt Maintenance gt Replace Photometer Lamp It is essential that the photometer lamp maintains a constant intensity in successive absorbance measurements After a certain time of use the intensity of the light emitted by the lamp deteriorates and the accuracy of the measurements may no longer meet the required standards Therefore the lamp must be periodically replaced The system alerts you when the lamp should be replaced by changing the maintenance action status to due entry turns red Operator time Approximately 20 minutes Prerequisites The system must be in Standby status Tools and materials required m Paper tissue m Photometer lamp assembly Lamp socket and cable are pre assembled m Cuvette segments m Clean cloth a To replace the photometer lamp 1 Select the maintenance action Replace Photometer Lamp 2 Press The maintenance definition screen is displayed 3 Press The system switches off the lamp and the transfer head moves to the home position Preparing the instrument 4 Open the main cover and the right service flap 5 Remove the sample tray by lifting it Make sure that you have read and
330. is reached For information on the stability of the electrodes see their package inserts Make sure that you have read and understood section Safety information on page E 19 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page E 19 o Injury through reagents and other working solutions on page E 19 Roche Diagnostics Operator s Manual Version 3 0 E 33 cobas c111 13 ISE operation Replacing electrodes a To replace an electrode 1 Check that the system is in Standby status 2 Choose Overview gt The ISE status is displayed 3 Press the button of the electrode you want to replace Details of the electrode status are displayed 4 Press to start the exchange wizard The system rinses the electrodes with ISE Calibrator indirect urine to remove any sample residue and then drains all electrodes You are asked to remove the electrode Make sure to remove the electrode that is marked on the screen 5 Open the ISE cover 6 Open the electrode block lid 7 Release the tension lever A Turning the tension lever releases the electrodes You may have to push the anchoring piece towards the tension lever to create enough space for removing the electrodes A Electrode buttons Figure E 5 A Tension lever Figure E 6 A A Roche Diagnostics E 34 Operator s Manual Version 3 0 13 ISE operation cobas c111
331. isplayed that lists all required calibrators and it shows on which position to place them Calibrators with several concentrations are listed according to their concentration starting with the one with the highest concentration They are displayed as follows 3 Prepare the calibrators 4 Place the calibrators on the sample area positions indicated on the placement list 5 Press to confirm the placement 6 Press to start the calibration 7 Choose Workplace gt Calibrations to check the status of the calibrations Validating the results 8 Validate the results e See Validating calibration results on page B 64 A Position on the sample area where to place the calibrator B Lot number C Calibrator with highest concentration D There are not enough empty positions the system suggests using occupied positions E Calibrator with lowest concentration Figure B 9 A C E B D o The system first uses the free positions if there are not enough free positions occupied positions are suggested For these you would have to replace the cur rently loaded tubes with calibrator tubes o With absorbance tests that require several calibrators the calibrators are placed according to their concentration starting with the highest concentration Number of calibrators Displayed information 1 Position name lot number 2 1 Position name highest 2 Position name lot number More than 2 1
332. ist on page B 162 Calibration procedures There are three basic procedures for performing calibration o Calibrating all reagent sets that need calibrating o Calibrating all reagent sets that will need calibrating during the forecast period o Calibrating individual reagent sets Forecast period The forecast period is a configurable period of time Calibrations that fall due within this period will be performed collectively e See Calibration on page B 167 Typically you would set this period to fit your shift length for example 8 hours This would enable you to prepare the instrument before the work shift starts and so avoid having to interrupt sample processing for performing calibrations Precalibration At any given time there is only one accepted calibration result for each test You can however install and precalibrate one reserve reagent set This is done for example to ensure continuous sample processing lt xyz gt Roche Diagnostics A 30 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Daily operation Quality control QC QC is performed at regular intervals to check the integrity of the whole measuring system For each test up to three controls are defined The results are compared against predefined ranges or values and then interpreted accordingly Control A control is a sample that has been measured using all tests it is associated with in order to define the r
333. ith system water 1 6 1 5 The dilution and mixing are performed automatically in the ISE tower Pipetting volumes Sample 15 L Diluent H2O 75 L ISE measurements ISE measurements and photometric measurements can be carried out at the same time and are independent of each other ISE measurements do not use cuvettes the reagent rotor or the photometer All requested ISE measurements on a specific sample control or standard solution are performed in parallel that is measurements are made at each electrode at the same time Roche Diagnostics Operator s Manual Version 3 0 E 7 cobas c111 12 ISE description Overview Principles of operation The ISE unit uses flow through ion selective electrodes and a reference electrode with an open liquid junction Each electrode has a membrane that is sensitive to a particular type of ion Measuring process 1 The ISE maintenance and standard solutions ISE Deproteinizer ISE Etcher Activator and ISE Solution 1 and 2 are pipetted from sample tubes on the sample area to the ISE tower as required 2 The sample is pipetted from the sample tube located on the sample area into the ISE tower 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 3 The sample is divided into segments with the aid of a special arrangement of valves The first shorter segment
334. itialization to finish 32 Log on to the system 33 Insert the reagent disk e See Preparing the reagent disk on page B 21 w 9 Messages and alarms D 3 10 Result flags D 23 11 Troubleshooting D 39 Troubleshooting D Roche Diagnostics Operator s Manual Version 3 0 D 3 cobas c111 9 Messages and alarms Table of contents Messages and alarms How to make the most of the available information In this chapter you will find information on messages generated by the cobas c111 instrument and on how to use them and react to them About messages D 5 Message screen D 5 Acoustic signals D 6 Alarm monitor D 6 Reacting to alarm messages D 7 Printing alarm messages
335. ition If the error persists call service 7006 s A not specified hardware error d was reported Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7007 d An internal communication error d occurred A control unit could not be connected Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7008 d A software error occurred that was caused by an unexpected system situation Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7009 The LAN connection to the IC software failed Check the external Ethernet cable Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7010 Instrument initialization failed Check for previous errors Switch off instr Check transfer mechanism Restart system If error recurs export the log files with the system remaining in this error condition If the error persists call service 7011 Failed to aspirate sample from tube on position d Ensure that there is enough sample present For mainte nance tasks ensure to provide enough Activator ISE Deproteinizer and ISE Etcher If the error persists call ser vice 70
336. ivator and ISE Deproteinizer from the sample area 7 Press Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 Roche Diagnostics Operator s Manual Version 3 0 E 51 cobas c111 14 ISE maintenance ISE maintenance actions Clean ISE tower manually f Utilities gt Maintenance gt Clean ISE Tower Manually Operator time Approximately 6 minutes Prerequisites The system must be in Standby status Tools and materials required m ISE Deproteinizer m Activator m Cotton swabs a To clean the ISE tower 1 Select the maintenance action Clean ISE Tower Manually 2 Press The maintenance definition screen is displayed 3 Press to start the action A placement list is displayed 4 Place the Activator and ISE Deproteinizer on the sample area positions indicated on the screen 5 Press to confirm the placement and to start the action The ISE tower is first washed The transfer head moves to the right side of the instrument You are asked to clean the ISE tower 6 Open the main cover and then the left service flap When the ISE tower is blocked perform first the Clean ISE Tower Automatically mainte nance action See Clean ISE tower automatically on page E 50 If this does not help per f
337. k that the electrodes are mounted prop erly o Check that the pinch valve caps and clamps are properly installed o Check that the peristaltic pump cover is properly closed e See Replace ISE unit tubing on page E 57 Figure E 20 ISE troubleshooting with the help of messages Glossary F 3 Index F 11 Glossary and Index F Roche Diagnostics Operator s Manual Version 3 0 F 3 cobas c111 Glossary 2 dimensional barcode button Glossary This glossary is a compendium in which to look up the meaning of technical terms used in conjunction with the cobas c111 instrument 2 dimensional barcode A type of barcode on reagent bottles calibrators and control barcode sheets These matrix barcodes which use PDF417 symbology contain more information than traditional linear barcodes absorbance photometer A device used to make absorbance photometry measurements It consists of a halogen light source optical groupings a monochromator diffraction grating a preamplifier filters and a diode array See also photometer accuracy The absolute deviation of a result from a pre defined target value in percent or absolute units activate The process of conditioning electrodes with fresh serum so that the correct potentials are measured Activator
338. king the status of the external fluid containers on page B 15 2 When you have finished with the fluid containers press to proceed to the next stage in the Prepare wizard A screen is displayed that shows the status of the electrodes and the on board ISE fluids Checking the ISE status Replacing electrodes a To replace an electrode 1 Follow the instructions given in Replacing electrodes on page E 32 When checking external fluid containers without using the Prepare wizard Choose Overview gt gt WARNING Injury through working solutions Direct contact with cleaning solutions or other working solutions may cause personal injury When handling such solutions exercise the precautions required for handling them observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions o After replacing an electrode the Electrode Service maintenance action needs to be performed This action will be performed as part of the maintenance procedure of the Prepare wizard o After replacing an electrode a main calibration needs to be performed This action will be performed as part of the Daily Prepare Actions maintenance action Roche Diagnostics E 22 Operator s Manual Version 3 0 13 ISE operation cobas c111 Daily operation Replacing ISE fluid bottles A bottle with a blue label for ISE Calibrator indirect urin
339. l Version 3 0 A 21 cobas c111 2 Introduction to the instrument Wizards Wizards Screens help you perform your tasks If not all steps of a task can be performed from one screen the workflow is realized as a sequence of screens a so called wizard cobas c111 wizards do not usually force you to perform a task at a certain stage they just make your work easier e For details on workflows see Workflows and wizards on page A 74 When intervention is required On the screen there are several methods of telling when your intervention is required o Buttons and texts are color coded o Screens can contain instructions For example the text may ask you to place the sample on the sample area or to remove a reagent bottle from the reagent disk o Messages inform you about the status of current actions o A permanent alarm monitor alerts you to events you should know about Wizards There are three major wizards Prepare wizard Orders wizard and End Shift wizard With most tasks that involve more than one step such as exchanging reagent or other fluid bottles you are supported by wizards Prepare wizard The Prepare wizard guides you through the tasks that need to be performed at the beginning of a shift When this wizard is done the system is ready for processing orders Orders wizard The Orders wizard guides you through the process of creating and changing orders End Shift wizard The End Shift wizard guides you thro
340. l which can damage the electrodes because of the high ion concentration of the ISE Reference Solution o Crystallization of salts in the tubing which can cause blockages The ISE unit has a separate power supply Therefore the Standby status is maintained even if the main instrument is switched off End Shift wizard The end of shift activities are organized in a single wizard By performing the steps as suggested by this wizard you put the system in a condition that allows you to hand over operation to another operator or to switch off the instrument The following table provides an overview on the steps that make up the end of shift process e For details on performing the individual tasks see the instructions in Finishing the shift on page B 77 NOTICE Damage to electrodes and possible tubing blockage Do not unplug or switch off the ISE power supply Periodic flow of solutions must be per formed at all times Roche Diagnostics E 28 Operator s Manual Version 3 0 13 ISE operation cobas c111 Daily operation Short guide Step User action 1 Check for unfinished tasks 1 Check for unfinished orders 2 Check for nonvalidated results 3 Check for results that were not transmitted 2 Start the End Shift wizard 1 On the Overview tab press the End Shift but ton 3 Perform data backup 1 Press 2 Insert the USB stick 3 Press 4 Select the directory 5 Press 6 Press to
341. l other cases the order status is dis played Roche Diagnostics B 66 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing calibrations 3 Press to display information on the selected calibration and its results 4 Press A screen is displayed for selecting your decision 5 Do one of the following o Press Accept Set to accept the set calibration results for the selected test o Press Accept Lot to accept the lot calibration results for the selected test This button is only active if the calibration sequence Each Lot and Interval is defined for the application and if no flags were generated for the result e For information on lot and set calibration see Calibration type on page A 27 o Press Repeat to have the calibration performed again o Press Use Old to discard the new result reset the calibration due date and to continue using the old calibration results This possibility is available if you selected an accepted result When you press Use Old a copy of the old result is made and a new entry is displayed in the calibration results list Note that the intervals are reset as if a new calibration result were generated A Test ID B Calibration use C Calibration type D Calibration status E Calculation date and time F Calibrator lot expiration date G Accepted by User name SYS means automatically accepted H Flags I Calibration results
342. l results need to be manually accepted Sample Accept Flags Flags that are marked in this list will be ignored by the system Table B 4 Sample flag configuration and its effect Roche Diagnostics B 52 Operator s Manual Version 3 0 6 Daily operation cobas c111 Validating sample results a To validate sample results of on board samples 1 On the Overview tab press the sample button A screen is displayed that lists the results of the order that is associated with the sample 2 Select the result if there is more than one test 3 Continue with Validating the results on page B 53 A Status The result has not been accepted yet The result has not been transmitted yet B Test name gt Repeated C Results D Press to validate the results E Press to add more tests to the order F Press to delete the order and its results Figure B 16 D E F A B C Roche Diagnostics Operator s Manual Version 3 0 B 53 cobas c111 6 Daily operation Validating sample results a To validate sample results from the results list 1 Choose Workplace gt Result Review A screen is displayed that lists the results Interpreting flags e For detailed information on the flags see List of flags on page D 28 Displaying details of a result 2 Select the result 3 Press to display detailed information on the selected result 4 Press to close the screen The screen
343. lace gt Orders STAT orders are marked with an asterisk Making changes to an order You can make changes to orders that either have not yet been processed or that are fully processed You can add further tests to an order any time The process of changing an order depends on whether the sample tube is still on the instrument or not Making a change to an order when the sample tube is no longer on the sample area is basically the same as defining a new order a To change an order 1 Identify the sample If the sample is still on the instrument o On the Overview tab press the sample tube button of the order you want to change A screen is displayed that shows details on the order and the sample o Press A screen for selecting tests is displayed Figure B 11 Example of STAT order icon Roche Diagnostics Operator s Manual Version 3 0 B 43 cobas c111 6 Daily operation Analyzing samples If the sample is no longer on the instrument o Do one of the following 2 Select the tests o Press an available test to select it o Press a selected test to cancel its selection Tests that are already scheduled to be performed cannot be cancelled 3 Press to confirm your selection If the sample is still on the instrument A message is displayed showing the position the sample is placed on o Press to confirm the position The screen with details on the order and the sample is displaye
344. lace the sample tube within 10 seconds cancels the current iden tification process You will again be asked to identify the sample tube 4 Start processing Press Table B 3 Steps for analyzing samples Roche Diagnostics B 36 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples 5 Validate the results 1 Choose Workplace gt Results 2 Validate the result You can accept the result or perform the test again 6 Remove the samples 1 Press the Overview tab 2 Check the status of the sample tube button that corresponds to the sample you want to remove 3 If the sample tube button is green remove the tube Step User action Table B 3 Steps for analyzing samples Roche Diagnostics Operator s Manual Version 3 0 B 37 cobas c111 6 Daily operation Analyzing samples System setup and order definition workflow The workflow for defining orders depends on a few configuration settings f Utilities gt Configuration gt Workflow Working Mode The Working Mode defines the way you select tests when defining orders o Use Manual if you use the cobas c111 instrument as a stand alone system During order definition the test selection screen is displayed allowing you to select the tests or to make changes to the selection o Use Host if the cobas c111 instrument is connected to a host computer or to a computer running the cobas c111 Printer Tool The orde
345. lay the items that are not visible Text Text usually provides information or instructions It can be color coded to indicate its importance level Tab Tabs are used to group information into units that can be displayed on one screen Table A 9 Major display items 1 Roche Diagnostics A 74 Operator s Manual Version 3 0 5 Software cobas c111 Workflows and wizards Color concept The color of buttons and other display items tells you about the status of the display item or the item it represents The cobas c111 instrument uses the familiar traffic light color scheme e For details on the meaning of LED colors see Color interpretation for LEDs on page A 122 e For details on the meaning of button colors see the explanations in the relevant operation instructions Workflows and wizards Screens and sequences of screens help you perform your tasks If not all steps of a task can be performed from one screen the workflow is realized as a sequence of screens a so called wizard cobas c111 wizards do not usually force you to perform a task at a certain stage they just make your work easier Navigation Moving from screen to screen You move from screen to screen with the help of buttons Knowing where you are Screens on which you perform tasks provide a headline that displays the navigation path of the current screen e For an overview of the navigation buttons see Navigation functions on page A 126
346. lean the water container with a brush 9 Dispose of the solution 10 Clean the interior of the water container manually using tissues Remove any residue 11 Rinse the water container with tap water at least four times 12 Rinse the water container with purified water 13 Wipe the suction pipe with a tissue 14 Fill the water container with purified water 15 Reinsert the tubing adapter into the water container Press down firmly a To clean the waste container 1 Have the spare waste container ready The system periodically performs wash actions Therefore an external waste container must be connected at all times 2 Remove the tubing adapter from the yellow waste container and insert it in the spare container 3 Remove the bottle from the rack and place it on a firm and even surface 4 Place the spare container on the rack 5 Check that the tubing adapter is properly inserted 6 Empty the removed waste container Treat the fluid as biohazardous waste 7 Pour 500 mL hypochlorite solution in the waste container 8 Clean the container with a brush 9 Dispose of the fluid Treat it as biohazardous waste 10 Clean the interior of the waste container manually using tissues Remove any residue 11 Rinse the waste container with tap water 12 Empty the container completely Roche Diagnostics C 18 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions 13 W
347. least the defined dead volume of fluid is left when pipetting is complete e See Tubes on page A 54 A First result B Repeat result gt Figure B 18 A B Roche Diagnostics B 56 Operator s Manual Version 3 0 6 Daily operation cobas c111 Validating sample results Rerunning tests Rerun Performing a rerun means reperforming the same test with a different predefined dilution Typically you perform reruns if the result is outside the test range a To rerun a test 1 Validate the result e If the sample is still on board see To validate sample results of on board samples on page B 52 e If the sample is no longer on board see To validate sample results from the results list on page B 53 2 Press Rerun The system automatically creates a new order and selects the test The dilution factor is part of the test definition and therefore automatically selected It cannot be changed It then performs the test In the results list the result of the rerun is shown on a separate line WARNING Incorrect results due to insufficient fluid Insufficient fluid may lead to inaccurate pipetting and consequently to incorrect results Always fill the tubes with enough fluid that at least the defined dead volume of fluid is left when pipetting is complete e See Tubes on page A 54 A First measurement B Rerun result v Rerun with dilution Figure B 19 B A Roche Diagnostics Operator
348. lect the maintenance action Activate Electrodes 2 Press The maintenance definition screen is displayed 3 Press to start the action A placement list is displayed 4 Place the Activator on the sample area position indicated on the screen 5 Press to confirm the placement and to start the action A message will inform you when the maintenance action is complete 6 Remove the Activator from the sample area 7 Press Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 Roche Diagnostics E 46 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Condition ISE tubing f Utilities gt Maintenance gt Condition ISE Tubing Conditioning the tubing with Activator ensures the proper flow of fluids Operator time Approximately 3 minutes Prerequisites The system must be in Standby status Tools and materials required m Activator a To condition the ISE tubing 1 Select the maintenance action Condition ISE Tubing 2 Press The maintenance definition screen is displayed 3 Press to start the action A placement list is displayed 4 Place the Activator on the sample area position indicated on the screen 5 Press to confirm the placement and to s
349. lectrode Icon Name Use Table A 13 Interactive buttons Continued Roche Diagnostics A 126 Operator s Manual Version 3 0 5 Software cobas c111 Buttons Navigation functions Element moving functions Icon Name Use Line Up Move one line up Select the previous line Line Down Move one line down Select the next line Page Up Move one page up Page Down Move one page down To Top Select the first item in a list To Bottom Select the last item in a list Forward Open the next screen in a wizard Next Step Back Open the previous screen in a wizard Previous Step Table A 14 Navigation buttons Icon Name Use Move Up Move selected element one line up Move Down Move selected element one line down Move Right Move selected element to the list on the right Move Left Move selected element to the list on the left Move All Left Move all elements in the list to the list on the left Table A 15 Element moving buttons 6 Daily operation B 3 6 Special operations B 91 7 Configuration B 133 Operation B Roche Diagnostics Operator s Manual Version 3 0 B 3 cobas c111 6 Daily operation Table of contents Daily operation Perform
350. led procedures 4 Remove the holder 5 Remove the two fuses from the holder 6 Replace both fuses 7 Insert the fuse holder in the fuse box Press it in firmly until the clips engage 8 Connect the mains cable to the instrument 9 The instrument switch should be illuminated Damage to the analyzer due to use of wrong fuses Always replace fuses with new ones of the same type and specifications See Technical specifications on page A 66 Roche Diagnostics Operator s Manual Version 3 0 D 49 cobas c111 11 Troubleshooting Detailed procedures Changing the low voltage fuses a To change a low voltage fuse 1 Switch off the instrument 2 Using a screwdriver size 2 or 3 remove the fuse indicated in the alarm message o Insert the screwdriver in the slot and turn anticlockwise until the holder disengages o Remove the holder with the fuse 3 Remove the fuse from its holder 4 Insert the new fuse in the holder 5 Insert the holder in the socket 6 Using the screwdriver lock the holder in position by pressing it in and turning the screwdriver clockwise until the slot is vertical 7 Switch on the instrument A Low voltage fuses B Slot in low voltage fuse holder Figure D 6 A B NOTICE Damage to the analyzer due to use of wrong fuses Always replace fuses with new ones of the same type and specifications See Technical specifications on page A 66 Roche Diagnostics
351. lications B 152 degasser A 44 deleting applications B 144 bottle sets B 120 calibration orders B 63 calibration results B 95 mixing rules B 174 orders B 93 profiles B 149 QC results B 96 results at end of shift B 84 sample results B 94 users B 161 demographics patients A 32 Deproteinize probe maintenance action C 10 detection fluid levels A 49 tube bottom A 49 diagnostics data exporting D 51 diagnostics screen A 116 dilutions A 32 dimensions specifications A 66 disconnecting tubes from instrument B 129 disinfecting housing C 21 display items A 73 disposing instrument A 12 waste B 86 document information 2 Roche Diagnostics F 14 Operator s Manual Version 3 0 Index cobas c111 E edition notice 2 electrical safety A 5 electrode block E 11 Electrode service maintenance action E 49 electrodes activating E 45 maintenance E 49 position in block E 34 replacing E 32 electromagnetic devices safety A 8 emptying waste container B 17 B 86 End of Shift short guide B 78 environment specifications A 66 error messages reacting to D 44 E 80 exceptional situations ISE unit E 80 main instrument D 42 exchanging reagents B 25 expanding lists A 76 export screen A 120 exporting alarm message log
352. ll the filter criterion and the filter criterion would be part of the button name Press Detail of Order to print all results of the associated order For repeated or rerun orders all results of this order are printed including those that were accepted earlier Automatic printing You can set up the system to automatically print results as soon as all results of an order are accepted Configuration gt Workflow gt Auto Print Results If Do this You want to print all results of an order Choose Workplace gt Orders You want to print individual results Choose Workplace gt Result Review Choose gt to terminate the printing task if required Roche Diagnostics Operator s Manual Version 3 0 B 59 cobas c111 6 Daily operation Performing calibrations Performing calibrations e For an overview on calibration concepts see Calibration on page A 26 For performing calibrations in the Prepare phase see Performing the calibrations Prepare phase on page B 30 For information on configuring calibration see Defining calibrator definitions and lots on page B 150 Tests with a due calibration are blocked e For validating calibration results see Validating calibration results on page B 64 Safety information Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions
353. lled liquid Any liquid spilled on the instrument may result in malfunction of the instrument If liquid does spill on the instrument wipe it up immediately and apply disinfectant Roche Diagnostics A 10 Operator s Manual Version 3 0 1 Safety cobas c111 Data security Data security e For further information contact your Roche service representative CAUTION Unauthorized access and data loss due to malicious software and hacker attacks Portable storage media can be infected with and transmit computer malware which may be used to gain unauthorized access to data or cause unwanted changes to software The cobas c111 is not protected against malicious software and hacker attacks The customers are responsible for IT security of their IT infrastructure and for protecting it against malicious software and hacker attacks Failure to do so may result in data loss or render the cobas c111 unusable Roche recommends the following precautions o Allow connection to authorized external devices only o Ensure that all external devices are protected by appropriate security software o Ensure that access to all external devices is protected by appropriate security equip ment o Do not copy or install any software on the cobas c111 unless it is part of the system software or you are instructed to do so by a Roche service representative o If additional software is required contact your Roche service representative to
354. lowing possible exceptional situations The applications list Utilities gt Applications gt Laboratory Parameters is displayed The application name is displayed in square brackets for example GLU2 to indicate that the application is not installed yet To make the application available for performing tests you now need to install it a To install an application 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select an application whose name is in square brackets 3 Press If This happens Both the application code and the short name exist The laboratory parameters for example the short name are retained from the existing application The application definitions are replaced on the system by the new ones The application code exists and the short name does not exist for any application on the system The laboratory parameters of the new application are used for example the short name The application definitions are replaced on the system by the new ones The short name exists but the application code does not A screen is displayed for changing the short name to a unique short name If you do not change the short name the application is not imported If you want to replace both the laboratory parameters and the application definitions you first need to uninstall and delete the existing application and then to import the new application Situation Explanation and
355. luid system Refill the water container Check the filling level of the cleaner bottle Replace the cleaner bottle if required Per form lt Prime Fluid System gt If the error persists call ser vice 5062 The degasser fluid sensor is not initialized Perform lt Initialize Degasser Fluid Sensor gt Follow the instructions provided on the display If the error persists call service 5063 s Error sample area fan Switch off the instrument Remove the right side panel and check if the fan is jamming or blocked If possible eliminate the problem Restart the system If the error per sists call service 5064 s Error fluid sensor degasser The sensor does not react anymore Restart the system If the error persists call service 6001 s Photometer error Signal is invalid or unstable Switch off the instrument Remove and clean the rotor In case of a recurrence perform lt Replace Photometer Lamp gt and lt Abs Air Water Calibration gt If the error per sists call service 6002 s Photometer error The photometer has a wrong status because initialization has not been successfully performed yet Restart the system If the error persists call service 6018 s A not specified photometer hardware error d was reported by the photometer Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 6019 s Photometer error
356. m Description A Roche Diagnostics Operator s Manual Version 3 0 A 3 cobas c111 1 Safety Table of contents Safety Protecting yourself and the environment In this chapter you will find information on the safe operation of the cobas c111 instrument Safety classification A 5 Safety information A 5 Transport A 5 Electrical safety A 5 Optical safety A 6 Mechanical safety A 6 Instrument covers A 6 Operation and maintenance A 6 Biohazardous materials A 6 Waste
357. means making the application unavailable for use in testing You can reinstall an uninstalled application e See Installing applications on page B 137 Before you can uninstall an application you need to perform some preparation tasks a To prepare uninstalling an application 1 Delete all associated sample results e See Deleting sample results on page B 94 2 Delete all associated QC results both from the QC Status list and the QC History e See Deleting QC results on page B 96 a To uninstall an application 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select the application 3 Press A confirmation screen is displayed 4 Press to confirm the action All associated calibration results and lot data are deleted In the applications list the application name is enclosed in square brackets for example GLU2 and in the profile details instead of the short name its application code is displayed The profiles that use this application are removed from the test selection screen If you still want to use these profiles you need to remove the application from them e See Removing tests from a profile on page B 149 Select an application that is not in square brackets for example ALTL Brackets indi cate that the application is not currently installed Roche Diagnostics B 144 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications Deleting appl
358. ment Adjustment Valid On Off H2O Signal For each wave length the adjustment value for the cuvette filled with water is given H2O Cuv Signal For each wave length the adjustment value for the empty cuvette is given Table B 29 Absorbance adjustment definitions Roche Diagnostics B 170 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration Defining extra wash cycles Extra wash cycles are used to minimize carry over You can define an extra wash cycle either by reading a barcode or by defining the values manually a To define an extra wash cycle 1 Choose Utilities gt Applications gt Extra Wash Cycles A screen is displayed that lists the currently defined extra wash cycles 2 Select Add new rule 3 Press 4 Do one of the following The new wash cycle is listed in the Extra Wash Cycles list Its name is made up of the action the short name of the trigger bottle and the pipetting type If Do this The definitions are available on a barcode 1 Read the barcode The definitions will be installed on the system You want to define the values manually 1 Press 2 Choose when in relation to the pipetting action from the bottle defined in Trigger Bottle Code and Pipetting Type the extra wash cycle should be performed action then press 3 Type the trigger bottle code and press The trigger bottle code is the reagent set code You find it o
359. ment 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 Transport Electrical safety WARNING Warning Indicates a hazardous situation which if not avoided could result in death or serious injury CAUTION Caution Indicates a hazardous situation which if not avoided may result in minor or moderate injury NOTICE Notice Indicates a hazardous situation which if not avoided may result in property damage WARNING Injury from heavy loads You may injure your hands fingers or back when putting the analyzer in place Carry the analyzer according to the transport instructions WARNING Electrical shock by electronic equipment Do not attempt to work in any electronic compartment Installation service and repair must only be performed by authorized and qualified personnel Electrical safety Connect the analyzer to grounded power outlets only IEC protection class 1 All periph eral devices that are connected to the cobas c111 instrument must comply with safety standard IEC 60950 for information technology equipment or with IEC 61010 1 UL 61010 1 for laboratory use instruments Roche Diagnostics A 6 Operator s Manual Version 3 0 1 Safety cobas c111 Safety information Optical safety Mechanical safety Instrument covers Operation and maintenance Biohazardous materials
360. mic random access memory E e g Exempli gratia for example EMC Electromagnetic compatibility EN European standard I i e Id est that is to say IEC International Electrical Commission ISE Ion selective electrode L LED Light emitting diode LIS Laboratory information system LLD Liquid level detection N n a Not applicable Q QC Quality control R REF Reference solution for ISE unit ROM Read only memory S SD Standard deviation SRAM Static random access memory cobas c111 Roche Diagnostics 10 Operator s Manual Version 3 0 Units Abbreviation Description C degree centigrade L microliter m micrometer A amp re cm centimeter h hour Hz hertz LB pound weight in inch kg kilogram kVA kilo volt ampere L liter m meter MB megabytes min minute mL milliliter mm millimeter nm nanometer s second V volt VA volt amp re V AC volt alternating current V DC volt direct current W watt 1 Safety A 3 2 Introduction to the instrument A 15 3 Hardware A 37 5 Software A 69 Syste
361. ming calibrations 3 To select the tests do one of the following A screen is displayed that lists the calibrators that are required for the ordered calibrations and it shows on which sample position to place them 4 Prepare the calibrators 5 Place the calibrators on the sample area positions indicated on the placement list 6 Press to confirm the placement 7 Press to start the calibration If Do this You want to perform all due calibrations 1 Press All tests with due calibrations are selected The cur rently active lots and sets are used for the calibration 2 Press You want to perform all calibrations that fall due during the forecast period 1 Press All tests are selected whose calibration will be due within the forecast period The currently active lots and sets are used for the calibration 2 Press You want to calibrate the current set 1 Select the test 2 Press A Position on the sample area where to place the calibrator B Lot number C Calibrator with highest concentration D There are not enough empty positions the system suggests using occupied positions E Calibrator with lowest concentration Figure B 21 A C E B D o The system first uses the free positions if there are not enough free positions occupied positions are suggested For these you would have to replace the cur rently loaded tubes with calibrator tubes o
362. mment Sample Auto Accept On Off Results that do not contain a flag are automatically accepted Results with flags that are marked in a list of acceptable flags are accepted as well Sample Accept Flags List of possible flags Results with marked flags are automatically accepted if Sample Auto Accept is on QC Auto Accept On Off Results that do not contain a flag are automatically accepted Results with flags that are marked in a list of acceptable flags are accepted as well QC Acceptable Flags List of possible flags Results with marked flags are automatically accepted if QC Auto Accept is on Cal Auto Accept On Off Results that do not contain a flag are automatically accepted Results with flags that are marked in a list of acceptable flags are accepted as well Cal Acceptable Flags List of possible flags Results with marked flags are automatically accepted if Cal Auto Accept is on Table B 23 Result handling definitions Item Values Comment Forecast Hours 0 999 h Calibrations that fall due within this period will be performed collectively 0 means working without this feature The default value is 8 Table B 24 Calibration definitions Item Values Comment Rule 1 Rule A flag is generated if one result is outside a limit s Standard deviation The value for the standard deviation is defined in the QC lot Off 2 5s 3s Rule 2 Rule A flag is generated if two consecutive results
363. more it is not intended to clear up the data at the end of a shift Roche Diagnostics Operator s Manual Version 3 0 B 85 cobas c111 6 Daily operation Finishing the shift Performing maintenance actions To ensure the smooth running of the system you should perform all due maintenance actions Performing these actions as part of the end of shift activities ensures that at the beginning of the next shift when there might be many tests to be performed the system is ready for processing quickly a To perform maintenance actions 1 Follow the instructions given in To perform maintenance actions on page B 19 2 Press to proceed to the next stage in the End Shift wizard A screen is displayed that shows the status of the cuvettes Replacing cuvettes a To replace cuvettes 1 Follow the instructions given in To prepare the cuvettes on page B 28 2 Press to proceed to the next stage in the End Shift wizard A screen is displayed that shows the status of the external fluid bottles When performing maintenance actions without using the End Shift wizard Choose Utilities gt Maintenance When replacing cuvettes without using the End Shift wizard Choose Overview gt Roche Diagnostics B 86 Operator s Manual Version 3 0 6 Daily operation cobas c111 Finishing the shift Dealing with the external fluid bottles Emptying the waste container To prevent unpleasant smells and contamination
364. mple and order IDs Make sure this ID is unique within the cobas c111 instrument o Use Order ID Sample ID to have the system automatically define the order ID identical to the sample ID o Use Independent IDs to define the sample and order IDs independently of each other o Use Grouped Sample ID to use identical order and sample IDs as a constant part of any order for a give sample and to let the system automatically append a running number to the ID for each order Because there is limited space when displaying lists on screen Roche recommend to limit the IDs to 13 characters Roche Diagnostics B 38 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples Auto Order ID Use On to automatically increment the order ID number by one whenever you define a new order You only need to define the number of the first order of your shift If you use On for this feature use Off for Order ID Sample ID Defining orders Preconditions o All preparation tasks are complete o The required tests are installed on the system and ready for use calibration and QC performed o The system status is either Standby or Operating o At least one sample position on the sample area is free o There can be only one order per test and sample o Possible post dilution is predefined in the application definition WARNING Incorrect results due to declining sample quality Evaporation of sample
365. mport f Utilities gt Import Application Import application data Software Import software updates Database Import the complete content of the database Certificate Import certificates that authenticate reagent barcodes EWC Mixing Import extra wash cycle or mixing information for a particular application Figure A 82 Importing data Roche Diagnostics Operator s Manual Version 3 0 A 119 cobas c111 5 Software Key screens Users f Utilities gt Users There are list items of a lower level Select the item marked with and press again to expand the list and display the items The list is expanded Select the item marked with and press again to hide the items Print the user data of the selected user With an item selected change the selected item With any other item selected expand or collapse the list Define a new user Delete the user You cannot delete your own user data Figure A 83 User administration Roche Diagnostics A 120 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Export f Utilities gt Export Database Export the complete content of the database Full Results Export the full result data Log Files Export the system messages alarm logs and possibly trace logs Figure A 84 Exporting data Roche Diagnostics Operator s Manual Version 3 0 A 121 cobas c111 5 Software Key screens Stopping a run f
366. n 5 Monitoring the progress n a Overview 6 Validating results 1 View results n a Workplace gt Result Review 2 Handle flagged results n a Workplace gt Result Review gt gt Repeat gt Rerun 3 Accept results n a Workplace gt Result Review gt gt Accept 7 Performing calibrations Performing individual calibrations 1 Start the wizard Workplace gt Calibrations gt 2 Select the test n a 3 Prepare and place the calibrators n a 4 Start the calibration 5 Validate the calibration results Workplace gt Calibrations gt 6 Remove the calibrators Performing all due calibrations 1 Start the wizard Workplace gt Calibrations gt 2 Select all tests with due calibrations or Select all tests with calibration due within the forecast period n a 3 Prepare and place the calibrators n a 4 Start the calibration 5 Validate the calibration results Workplace gt Calibrations gt 6 Remove the calibrators Table E 3 Overview of the daily operation tasks Roche Diagnostics E 18 Operator s Manual Version 3 0 13 ISE operation cobas c111 Daily operation The following sections describe the ISE specific operation tasks 8 Performing controls Performing Default QC 1 Start the wizard Overview gt Order gt 2 Select a control and place the tube Repeat until there are no controls left on the screen n a
367. n This step activates the application on the instrument and so makes it available for use a To import application data 1 Do one of the following o Choose Utilities gt Applications gt Laboratory Parameters then continue with step 2 o Choose Utilities gt Import gt Application then continue with step 4 2 Press 3 Press Import Application A screen is displayed asking you to scan the barcode or to import the data from the USB stick 4 Do one of the following The system checks whether there is already an application on the system with identical application code and short name If Do this You intend to scan the barcode 1 Scan the barcode from the barcode sheet You intend to import from the USB stick 1 Press 2 Insert the USB stick 3 Press 4 Select the directory that contains the application file You recognize the application pack ages by their file extension tsb 5 Press to confirm the selection Roche Diagnostics B 112 Operator s Manual Version 3 0 6 Special operations cobas c111 Importing data The following table lists the basic situations e For detailed information on possible conflicts when importing applications see the section on installing and configuring development channel applications in the cobas c111 Development Channel Operator s Manual If the application you are importing is a development channel application note the fol
368. n page C 8 o Infection by biohazardous materials on page C 8 Roche Diagnostics Operator s Manual Version 3 0 C 33 cobas c111 8 General maintenance Maintenance actions 7 Open and remove the right service flap 8 Remove the sample tray Removing the rotor 9 Loosen the display fixation screw A 10 Tilt forward the display 11 Move transfer head to its rightmost position 12 Remove the upper rotor shell A Roche Diagnostics C 34 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions 13 For each of the two rotor bearings to the right loosen slightly one of the fixation screws and completely unscrew the other Use a screw driver to loosen the screws if required Then pull away from the rotor the side of the bearing that you completely unscrewed 14 From the rotor motor slightly lift the retention pin move the motor away from the rotor and engage the pin to fix the motor in the removed position Make sure to use the hole nearer to the front of the instrument for arresting the bearing with the pin 15 With one hand release the spring loaded bearing from the rotor and with the other hand lift the rotor A Retention pin of motor B Spring loaded rotor bearing C Rotor motor D Fixed rotor bearings E Photometer lens not shown Figure C 4 A C B D E D Roche Diagnostics Operator s Manual Version 3 0 C 35 cobas
369. n the barcode sheet 4 Choose the pipetting type This defines the individual bottle bottle of the set or the sample tube whose pipetting triggers performance of the extra wash cycle 5 Define whether the wash cycle should be active or not 6 Type the cleaner bottle code to define which cleaner should be used 7 Type the volume of cleaner in L that will be pipetted 8 Press to confirm the definitions Roche Diagnostics Operator s Manual Version 3 0 B 171 cobas c111 7 Configuration Configuration Activating deactivating and deleting extra wash cycles You can deactivate an extra wash cycle if you do not want to use it The definitions remain on the system You can activate the extra wash cycle later again a To activate or deactivate an extra wash cycle 1 Choose Utilities gt Applications gt Extra Wash Cycles A screen is displayed that lists the currently defined extra wash cycles 2 Select and expand the extra wash cycle entry 3 Press 4 Choose On to activate the extra wash cycle Choose Off to deactivate the extra wash cycle 5 Press A screen is displayed for entering your password 6 Type your password and confirm by pressing a To delete an extra wash cycle 1 Choose Utilities gt Applications gt Extra Wash Cycles A screen is displayed that lists the currently defined extra wash cycles 2 Select the extra wash cycle entry 3 Press A screen is di
370. nance actions Deproteinize the probe f Utilities gt Maintenance gt Deproteinize Probe To maintain the efficiency of the instrument you must clean and deproteinize the probe regularly to prevent the build up of contaminants Operator time Approximately 5 minutes Prerequisites The system must be in Standby status Tools and materials required m ISE Deproteinizer m Activator a To deproteinize the probe 1 Prepare one tube with ISE Deproteinizer and one with Activator 2 Select the maintenance action Deproteinize Probe 3 Press The maintenance definition screen is displayed 4 Press A placement list is displayed 5 Place the ISE Deproteinizer and Activator on the positions indicated on the screen 6 Press to confirm the placing The system first deproteinizes and then activates the probe A message will inform you when the maintenance action is complete 7 Remove the tubes 8 Press Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions on page C 8 o Incorrect results due to build up of contaminants on page C 8 Roche Diagnostics Operator s Manual Version 3 0 C 11 cobas c111 8 General maintenance Maintenance actions Prime the fluid system f Utilities gt Maintenance gt Prime Fluid System Priming flushes the fluid system with
371. nce sensor detected air when ISE Ref solution was transported Check the ISE Ref bottle filling level Perform lt Prime ISE Reference and Calib gt and check the fluid flow If the error persists call service 7113 d A prime cycle failed due to an open cover Ensure that all covers are closed while the system is being initialized in the Operating or Maintenance status 7114 d An initialization error occurred The X transfer zero positions are invalid Check the X transfer for obstructions Ensure that all cov ers are closed Restart the system If the error persists call service 7115 d Dispensing into the ISE tower stopped because the ISE tower was not empty Check the ISE tower waste tubing Check the ISE tower outlet for obstructions Check the pinch valves If the error persists call service 7116 d The needle crashed while the system was trying to dispense fluid Switch off the instrument Check if the transfer or probe movement is obstructed Restart the system If the error persists call service 7117 d Consequential error caused by a previous hardware or software problem Check previous errors Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7118 s Rotor initialization error The light barrier did not react Switch off the instrument Remove the rotor and clean the light barrier Reinstall the rotor
372. nd con firm by pressing the water button If you refill the water empty the waste as well 2 Empty the waste container if required and confirm by pressing the waste button 3 Replace the cleaner bottle if required and con firm by pressing the cleaner button 4 Press to proceed to the next stage in the Prepare wizard 3 Perform the maintenance actions that are due 1 Check which maintenance actions are due 2 Perform the maintenance actions Perform at least all red maintenance actions 3 Press to proceed to the next stage in the Prepare wizard 4 Prepare the reagent disk 1 Open the main cover 2 Remove the disk from its container 3 Place the disk on the instrument 4 Close the main cover A screen is displayed showing the reagent sta tus Table B 2 Steps for preparing the system Roche Diagnostics B 14 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing the system 5 Prepare the reagents Deal with at least all red and yellow buttons 1 Press a reagent button to check the details Replace the empty reagents 2 Press 3 Open the main cover 4 Remove the bottle 5 Press to confirm 6 Remove the remaining bottles of the set 7 Press 8 Place the new bottle 9 Press to confirm 10 Load the remaining bottles of the set 11 Press to proceed to the next stage in the Prepare wizard 6 Prepare the cuvettes Replace all red c
373. nd sample tubes are different you use the barcode scanner in a different way The various procedures are described in the following sections Reading reagent bottle barcodes a To use the barcode scanner for reading reagent bottle barcodes 1 When a screen is displayed asking you to scan use the barcode scanner and scan the barcode 2 Make sure not to tilt the bottle while scanning its barcode 3 Hold the scanner at a distance of approximately 20 cm 8 in from the barcode pull the trigger on the scanner and point the red light just outside the barcode 4 Move the light slowly across the barcode 5 Wait until you hear a beep and release the trigger If the reading was successful a screen is displayed asking you to place the bottle on the reagent disk WARNING Loss of sight The intense light of the LEDs may severely damage you eyes Do not stare into the LEDs Scanning equipment using LED technology is covered by the international standard IEC 60825 1 LED Safety Class 1 Injury through reagents and other working solutions Direct contact with reagents cleaning solutions or other working solutions may cause personal injury When handling reagents exercise the precautions required for handling laboratory reagents observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions CAUTION Malfunction due
374. nes whether this rule can be applied to an appli cation or not Initial Mixing Time Defines the duration of the mixing for the first mix ing Mixing Interval Defines the time after which mixing must be per formed again Periodic Mixing Time Defines the duration of the mixing for the second or subsequent mixing Relaxing Time Defines the time after mixing before the reagent can be used Table B 31 Reagent mixing rule definitions Roche Diagnostics B 174 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration Deleting mixing rules Prerequisites You need Lab Manager or Administrator user rights to perform this task a To delete a mixing rule 1 Choose Utilities gt Applications gt Reagent Mixing A screen is displayed that lists the currently defined mixing rules 2 Select the mixing rule 3 Press A screen is displayed for entering your password 4 Type your password and confirm by pressing The mixing rule definitions are deleted 8 General maintenance C 3 Maintenance C Roche Diagnostics Operator s Manual Version 3 0 C 3 cobas c111 8 General maintenance Table of contents General maintenance Keeping the instrument going In this chapter you will find step by step instructions of the maintenance actions that you must perform to keep the instrument running smoothly and effi
375. ng of ISE E 57 replacing of ISE pump E 54 typing password B 11 text A 76 user name B 11 U unfinished orders B 80 uninstalling applications B 143 units ISE E 9 laboratory B 156 transfer A 48 updating software B 114 upper case letters A 77 user interface language B 158 changing B 159 installing B 159 uninstalling B 160 user interface overview A 20 A 71 user name typing B 11 users defining B 161 deleting B 161 screen A 119 using manual 7 online Help 7 A 81 Utilities tab A 108 V validating calibration results B 64 QC results B 72 sample results B 51 viewing cal and QC lot definitions B 98 configuration values B 135 flag details D 25 lot details of used fluids B 101 reagent lot definitions B 99 Roche Diagnostics F 22 Operator s Manual Version 3 0 Index cobas c111 W wash cycles See extra wash cycles wash station A 47 waste checking external B 17 cleaning container C 17 emptying B 17 B 86 external container A 51 internal tank A 50 safety A 7 water checking external B 16 B 86 cleaning container C 16 container A 51 refilling B 16 B 86 specifications A 67 water filter changing C 19 wavelengths A 63 wizards
376. ng the shift Checking the transmission of results This step is only relevant if you work with a host system Before deleting the results you must make sure they were properly transmitted to the host a To check for results that were not transmitted 1 Choose Workplace gt Result Review A screen is displayed that contains all sample results of the day 2 Choose gt Not Sent to Host 3 Press A screen is displayed that contains the sample results that have not been successfully transmitted to the host 4 Select a result 5 Press A screen for validating results is displayed 6 Press Retransmit The list with the results that were not transmitted successfully is displayed again The result you just retransmitted should no longer be present 7 Select and retransmit the remaining results as described in Steps 4 through 6 8 Choose gt Not sent to Host The list should now be empty 9 If the results were not successfully transmitted contact the administrator of the host computer Starting the End Shift wizard The easiest way of performing the end of shift tasks is by following the End Shift wizard a To start the End Shift wizard 1 Choose Overview gt End Shift A screen is displayed for performing daily backup Results must be accepted before they can be transmitted to the host See also the information on Result handling on page B 167 in particular on the Auto Accept settings
377. nlet filter on page C 19 A Tubing B Container C Water inlet filter Figure A 18 Water container C A B Roche Diagnostics A 52 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Cleaner bottle The cleaner bottle is positioned on the external fluid rack It is designed to be replaced when empty Level monitoring for the cleaner bottle is based on the number of cleaning and pipetting actions that were performed When delivered the bottle has a white cap During installation this is replaced by a red cap with tubing attached to it tubing adapter The cleaner bottle is connected by tubing to o Syringe assembly o Probe e See Connecting and disconnecting the external fluid containers on page B 127 See Checking the status of the external fluid containers on page B 15 A Tubing adapter B Cleaner bottle Figure A 19 Cleaner bottle A B Roche Diagnostics Operator s Manual Version 3 0 A 53 cobas c111 3 Hardware Hardware overview Reagent bottles Chimneys The cobas c111 instrument works exclusively with reagent bottles that are equipped with a two dimensional barcode Each bottle holds up to 20 mL of fluid The actual volume depends on the test Place the bottles on the reagent disk as instructed by the software Reagents are handled in reagent sets A set consists of up to three reagents You always load and replace all bottles of a set
378. nostics E 68 Operator s Manual Version 3 0 15 ISE troubleshooting cobas c111 Table of contents Sol1 F Dev E 78 gt Test Rng E 79 lt Test Rng E 79 Reacting to error messages E 80 Roche Diagnostics Operator s Manual Version 3 0 E 69 cobas c111 15 ISE troubleshooting Introduction Introduction Effective troubleshooting on the ISE unit requires a good understanding of all basic operating procedures However you can avoid most of the common problems if you observe the recommended procedures at all times and if the operating environment is effectively controlled e For information on ISE maintenance see ISE maintenance actions on page E 42 Information about the ISE unit status The user interface keeps you informed about the status of the ISE unit as a whole and about particular hardware software and chemistry events as they arise It does this in the following ways o Color coded LEDs on the instrument inform you when to open covers or place sample tubes e See Color concept on page A 74 o Th
379. not monitor the filling level It is up to the operator to fill up the water container regularly A fluid sensor detected that there is no water in the instrument tubing No new tests can be processed started tests may have to be restarted after refill Waste button Press to confirm that you have emptied the external waste container The waste container was last emptied less than one day ago The waste container was last emptied more than one day ago The system does not monitor the filling level It is up to the operator to empty the waste container regularly Figure A 59 Status of external containers Roche Diagnostics Operator s Manual Version 3 0 A 97 cobas c111 5 Software Key screens Cleaner button Press to confirm that you have exchanged the external cleaner bottle The cleaner is OK The cleaner level is down to 10 or lower See the indication A fluid sensor detected that there is no cleaner in the instrument tubing No new tests can be processed started tests may have to be restarted after replacing the bottle Workplace tab The Workplace tab leads to information on orders and the corresponding results Orders View and handle orders Result Review View and validate sample results QC Status View and validate active QC results QC History View QC results on individual screens of the current or the previous calendar month or those generated before the previous month Calibrati
380. nt bottles o Auxiliary fluids diluents cleaners etc Sample tubes can be used with or without barcoded labels Reagent bottle barcode On the reagent bottles barcode of the PDF417 format is used The barcode contains the following information o Part ID o Lot number o Expiration date o Reagent volume o Serial number of bottle o Test data WARNING Loss of sight The intense light of the LEDs may severely damage you eyes Do not stare into the LEDs Scanning equipment using LED technology is covered by the international standard IEC 60825 1 LED Safety Class 1 A Barcode scanner B Scanner connector on the instrument Figure A 29 Hand held barcode scanner A B Connect to the lower COM2 port Always connect the barcode scanner to the lower of the two serial communication con nectors B Roche Diagnostics A 62 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Sample barcode The following barcode types are supported for sample tube identification o Codabar o Codabar 2 of 7 o Code 3 of 9 o Code 128 o EAN o Interleaved 2 of 5 o UPC A E Printer The cobas c111 instrument has a built in thermal printer with a 112 mm paper roll The printer is used for example for printing placement lists results maintenance action instructions and status information on various items such as the loaded tests e See maintenance action Refilling p
381. nt sets o To get a general overview of the status of all reagents that are defined on any disk use Utilities gt Inventory e For information on deleting reagent sets from the Inventory list see Deleting bottle sets from the Inventory list on page B 120 o To check the status of individual reagent sets use Overview gt Tests gt test icon a To gain a general overview of the currently defined reagent sets 1 Choose Utilities gt Inventory The Bottle sets list is displayed It contains all bottle sets that are defined on any of the disks used on this cobas c111 instrument including sets that were removed from the disk as long as they were not empty or their expiration date has not passed yet 2 Select a set and press A dialog box is displayed that contains detailed set information 3 Press A dialog box is displayed that contains set calibration and QC information 4 Press to close the dialog boxes until the Utilities tab is displayed NOTICE Damage to the reagent disk The reagent disk is designed to handle reagents while it is loaded on the instrument The cover is equipped with a locking mechanism Always remove and load reagents while the reagent disk is on the instrument and by using the software supported procedures A Number of tests left B ID of reagent disk on which the set is defined C R indicates that the set was removed from the disk Figure B 4 A B C Roche Dia
382. nt to replace another electrode press its button and continue with step 7 Roche Diagnostics Operator s Manual Version 3 0 E 35 cobas c111 13 ISE operation Replacing electrodes 18 Place the Activator ISE Deproteinizer ISE Etcher ISE Solution 1 and ISE Solution 2 on the sample area positions indicated on the screen 19 Press to confirm the placement and to start the action The system performs the Electrode Service maintenance action 20 Press to perform the main calibration A message will inform you when the action is complete 21 When the system is in Standby status remove the Activator ISE Deproteinizer ISE Etcher ISE Solution 1 and ISE Solution 2 from the sample area 22 Press Roche Diagnostics E 36 Operator s Manual Version 3 0 13 ISE operation cobas c111 Cleaning the ISE tower off the instrument Cleaning the ISE tower off the instrument If performing the Clean ISE Tower Manually maintenance action did not lead to the desired results you need to remove the ISE tower to clean it Cleaning the ISE tower off the instrument consists of the following steps 1 Removing the ISE tower 2 Soaking the ISE tower in ISE Deproteinizer 3 Cleaning and drying the ISE tower 4 Installing the ISE tower 5 Performing the maintenance action Clean ISE Tower Automatically Tools and materials required o Cotton swabs o ISE Deproteinizer o Small glass beaker a To clean the
383. ntenance action the following maintenance actions are automatically performed o Prime ISE Reference and Calib o Initialize ISE Unit Operator time Approximately 10 minutes Prerequisites The system must be in Standby status Tools and materials required m Activator m Roche approved ISE pump tubing set a To replace the ISE pump tubing 1 Select the maintenance action Replace ISE Pump Tubing 2 Press The maintenance definition screen is displayed 3 Press to start the action The placement screen is displayed 4 Place the Activator on the sample area position indicated on the screen 5 Press to confirm the placement The tubing is emptied Your are asked to remove the tubing 6 Open the ISE cover Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 o Infection by waste solution on page E 43 Roche Diagnostics Operator s Manual Version 3 0 E 55 cobas c111 14 ISE maintenance ISE maintenance actions Removing the tubing 7 Open the cover of the peristaltic pump 8 Push the pump towards the back of the instrument 9 Disengage the tube connector plate 10 Remove the ISE pump tubing set Installing the tubing Install the tubing in the reverse order of removing it 11
384. o define an order 1 Choose Overview gt Order A screen is displayed asking you to identify the sample 2 Identify the sample Do one of the following A screen is displayed that shows all active tests profiles and ratios Note that all applications of a profile or ratio must be installed for it to be active If the workflow setting Working Mode is Host this screen will not be displayed Utilities gt Configuration gt Workflow If Do this You work with sample barcodes Use the barcode scanner to scan the bar code You do not work with sample barcodes or if the barcode could not be read for some rea son 1 Press 2 Type the sample ID then press 3 Type the order ID then press Note This step is only required if the configuration setting Order ID Sam ple ID is not selected A Easy mode test board all tests fit on one screen B Tabs marked with an asterisk contain selected tests C Full mode test board The tests are distributed across several panels tabs Figure B 10 A B C Roche Diagnostics B 40 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples Interpreting the colors The tests are sorted alphabetically Profiles precede the tests Profiles display the color of their tests 3 Select one or several of the tests profiles and ratios You can select items from more than one tab An item can be contained in more
385. o so Acoustic signal An acoustic signal is sounded when an alarm is generated You can adjust the volume Utilities gt Configuration gt System gt Volume a To display alarm messages 1 Press 2 Use to limit the number of messages that are contained in the list 3 Select the message you are interested in Alarm message 4 Press to display the detailed message Detailed alarm message e For details on handling alarm messages see Reacting to alarm messages on page D 7 A Alarm ID B Total number of messages in the list C Display the previous alarm message D Problem description and short remedy suggestion E Display the next alarm message Figure A 47 B D A C E Roche Diagnostics A 84 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Key screens The main screen is divided into tabs These tabs represent distinct work areas f The Overview tab is your main work area when performing the daily routine tasks o Use the Workplace to gain information on orders and the corresponding results You can also start the lot handling functions from this tab o Use the Utilities tab to perform tasks that are not normally part of the routine analysis workflow Typically these would be administration and maintenance tasks The following sections describe the key screens of these tabs and point out the main tasks you can perform on them Overview tab
386. of alarm messages 20007 lt Deproteinize Probe gt completed 20008 lt Clean Reagent Disk gt completed 20009 lt Database Backup gt completed 20010 lt Call Service Rep gt completed 20011 lt Clean ISE Tower Manually gt completed 20012 lt Replace ISE Unit Tubing gt completed 20013 lt Replace ISE Pump Tubing gt completed 20014 lt Replace ISE s Electrode gt completed 20015 lt Initialize ISE Reference Sensor gt completed 20016 lt Clean ISE Tower Automatically gt completed 20017 lt Initialize ISE Unit gt completed 20019 lt Electrode Service gt completed 20020 lt Activate Electrodes gt completed 20021 lt Prime ISE Reference and Calibrator gt completed 20022 lt Condition ISE Tubing gt completed 20023 An unknown action d was completed successfully 20024 Installation completed The intervals of the maintenance actions were reset successfully except daily maintenance actions 20025 lt Abs Air Water Calibration gt completed 20026 The external water reservoir was refilled 20027 The external waste container was emptied 20028 lt Daily Prepare Actions gt completed 20029 Database cleanup completed 20030 lt Initialize Degaser Fluid Sensor gt completed ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics D 22 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 List of alarm m
387. ofiles There is hardly ever the need for elec trolytic measurements of just one electrode Roche Diagnostics E 24 Operator s Manual Version 3 0 13 ISE operation cobas c111 Daily operation Monitoring the progress a To monitor the progress 1 Follow the instructions given in Monitoring the analysis progress on page B 44 a To check the instrument status 1 Press the Overview tab Interpreting the instrument status buttons A Relevant instrument status buttons Figure E 4 A Icon Meaning Possible action The ISE unit is in standby No action is required The expiration date of an electrode has passed or an on board ISE fluid level is low 1 Check the details on the dedi cated System Status screen 2 Replace the electrode or ISE fluid bottle as soon as possible The ISE unit is blocked 1 Check the details on the dedi cated ISE status screen 2 Act accordingly Roche Diagnostics Operator s Manual Version 3 0 E 25 cobas c111 13 ISE operation Daily operation Acoustic signal An acoustic signal informs you of the fact that all tests are finished and the system status has changed to Standby Validating sample results ISE result handling is integrated in the operation of the main instrument The process of reviewing results is the same a To validate sample results 1 Follow the instructions given in Validating sample results on page B 51 e For information
388. ohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Incorrect results due to build up of contaminants During use contaminants may adhere to the probe As a result traces of analytes or reagents may be carried over to the next Make sure to perform the probe maintenance actions as soon as they are due in order to prevent potentially false results Incorrect results or damage to the analyzer due to dust and soiling The user can leave the main cover open while the system is in Standby status or while the instrument is shut down This can cause dust and dirt being collected in the heating chan nel which in turn might decrease the quality of the cuvettes Keep all covers closed Open them only to perform operation actions Incorrect results or processing stop due to skipping maintenance actions Not performing maintenance actions that are due may lead to situations where the system cannot continue processing orders or it may lead to incorrect results If at all possible per form the maintenance actions when they are due Incorrect results or processing stop due to incomplete maintenance actions You can
389. ol 1 A convention or standard that controls or enables the connection communication and data transfer between two computing end points Protocols can be implemented by hardware software or a combination of the two 2 A set of rules that guides how an activity should be performed QC Abbreviation for quality control The operational techniques and activities that are used to fulfill requirements for quality QC measurement The process of performing a test with control material query download A communication process between instrument PC and LIS by which a pre defined data set is transmitted upon request of the analytical instrument RAM Abbreviation for random access memory Semiconductor memory devices used in computers RAM content is lost when a computer is switched off ratio A test result calculated from different individual analytical methods with a given formula such as A B raw data The unprocessed values obtained during the analytical process on an instrument for example mVolt or absorbance reagent A composition of chemicals used to determine the concentration of substances in body fluid reagent bottle Standard plastic bottle for photometric reagents reagent disk The removable device into which the reagent bottles are placed reagent disk position One of the multiple positions on the reagent disk P Q R Roche Diagnostics F 8 Operator s Manual Version 3 0 Glossary cobas c111 reag
390. omplete you will be asked to insert the tubing adapter 9 Insert the tubing adapter in the water container 10 Press The fluid system is primed A message will inform you when the maintenance action is complete 11 Press A Roche Diagnostics C 32 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Clean rotor and heating channel Perform this maintenance action whenever a message asks you to do so Operator time Approximately 15 minutes Tools and materials required m 95 ethyl alcohol m Lint free tissues a To clean the rotor and heating channel 1 Remove the reagent disk o Choose Overview gt gt A screen is displayed asking you to remove the reagent disk o Open the main cover o Remove the reagent disk o Close the main cover 2 Remove all cuvettes o Choose Overview gt o Open the main cover o Press a segment button o Remove the segment o Press to confirm the removal Remove all segments as described above o Close the main cover 3 Switch off the instrument 4 Move the transfer head to the sample area 5 Open and remove the main cover and left service flap 6 Move the transfer head to its leftmost position Make sure that you have read and understood section Safety information on page C 8 The following warning messages in particular are relevant o Injury through working solutions o
391. on ISE flags see List of ISE flags on page E 71 System Status The System Status button displays both the icon and the color of one of the buttons of the underlying System Status screen The icons are first prioritized by color first priority being red followed by yellow and green and then according to the sequence in which they are listed below Analyzer main cover Press the button and on the System Status screen check the text about the status of the main cover Reagent cooler and cuvette ring temperature Press the button and on the System Status screen check the text about the temperature Sample area ventilation Press the button and on the System Status screen check the text about the ventilation status External fluid containers Press the button and on the System Status press it again to display the screen for handling the external fluid containers Maintenance Press the button and on the System Status press it again to display the maintenance actions list Printer Press the button and on the System Status screen check the text about the printer status Icon Meaning Possible action Roche Diagnostics E 26 Operator s Manual Version 3 0 13 ISE operation cobas c111 Daily operation Main calibration The main calibration of the electrodes must be performed periodically It also needs to be performed after certain maintenance actions For the indirect method the sodium NA I potassium K
392. on board stability of a reagent One of the following sequences applies to each reagent set No Interval You perform calibration whenever you think fit Use this value if you are sure that the reagent is stable until it is empty and you replace it with a new one Calibration is due whenever a new reagent set is loaded on the instrument Interval Only You perform calibration only when the interval has expired Each Lot and Interval You perform calibration whenever the fist reagent of a new lot is loaded and then each time the interval has expired In this case the interval is related to the date when the lot calibration was generated and it re starts whenever you calibrate a reagent set as a result of interval expiry or starting a new lot You can turn off the interval check by defining its duration as 0 zero Each Set and Interval You perform calibration whenever a new reagent is loaded and when the interval has expired The interval starts again whenever you calibrate a reagent set because the interval had expired or a new lot was started You can turn off the interval check by defining its duration as 0 zero Calibration status of a set Each reagent set has one of the following calibration statuses CU current denotes that the set is on board and that its calibration results are currently used OB obsolete denotes that the set s calibration results are no longer used This status applies for example to t
393. on date of an electrode has passed The electrode is ready for use Calibration required Does not apply to the reference electrode After installing a new electrode the Electrode Service maintenance action is due Cal Ref Display detailed information on the status of the ISE fluid bottle No fluid registered by a sensor Operation has stopped Calibration required The fluid level in the bottle is low Operation will proceed until one of the sensors detects that there is no fluid There is sufficient fluid Display the placement list for actions that are due for example calibration or electrode service This button is only active if your instrument is equipped with an ISE unit Figure A 57 ISE status Roche Diagnostics Operator s Manual Version 3 0 A 95 cobas c111 5 Software Key screens System status f Overview gt or or or or or The system status button on the Overview tab displays both the color and the icon of one of buttons of the system status screen The icons are first prioritized by color first priority being red followed by yellow and green and then according to the sequence in which they appear on the screen Check the texts for the status of hardware items and on IDs of installed software Status of the instrument The main cover is open A development channel application is run without using extra wash cycles Temperature status for reagent cooler and
394. on page B 5 o Infection by biohazardous materials on page B 5 WARNING Skin inflammation caused by reagents Direct contact with reagents may cause skin irritation inflammation or burns When handling reagents be sure to wear protective equipment and observe the cautions given in the package insert Incorrect results due to expired calibration Calibrations are performed to compensate for changes over time in reagents and in the measurement systems Failing to perform calibrations when they are due may lead to incorrect results Make sure to perform calibrations when they are due Incorrect results due to wrong tube placement Be sure to place the calibrators in the specified positions Incorrect results due to inappropriate tube and cup placement Inappropriate tube and cup placement may lead to inaccurate pipetting and consequently to incorrect results Make sure that the primary tubes are placed centrally and perfectly vertically in the hold ers in the sample area and that they are inserted firmly Make sure that secondary tubes are placed centrally on the primary tubes and that they rest fully on them Roche Diagnostics B 60 Operator s Manual Version 3 0 6 Daily operation cobas c111 Performing calibrations Short guide The following table provides an overview on the steps that make up the calibration process Step User action 1 Perform the calibrations Perform all due calibrations 1
395. ons View validate and delete calibration results Lot Data Define and change calibration and QC lot data by reading barcodes or typing the values Loadlist List of tests that are ready to be performed Worklist Information on tubes currently placed on the sample area Figure A 60 Workplace tab Roche Diagnostics A 98 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Orders f Workplace gt Orders St column Status Dn column Number of tests done for this order column Total number of tests required for this order Print the content of the orders list You can choose one of the following options o List All orders in the list with their results If a filter was applied the list would contain only the results that fulfill the filter criterion and the filter criterion would be part of the button name o Detail of Order The currently selected order with its results Change the selected order Define a new order Delete orders You can choose what kind of orders should be deleted o List All orders in the list If a filter was applied the list would contain only the orders that fulfill the filter criterion and the filter criterion would be part of the button name o Selected Delete the selected order with its results Figure A 61 Orders list A Accepted B All blocked C Created D Deleted F All calculated N No test order O Order time out
396. or Conversion factor for converting results from one unit to another for example from mg dL to mmol L Displayed Unit Standard Unit Laboratory Unit Dec Position 0 4 Number of digits after decimal point that are displayed on the screens Table B 19 Result conversion definitions Roche Diagnostics Operator s Manual Version 3 0 B 157 cobas c111 7 Configuration Configuration Configuration Changing your password a To change you password 1 Do one of the following 2 Type your user name As soon as you type the first characters of your user name the system looks for a name that starts with these letters and if it finds one displays the complete name 3 Press 4 Press Change Password 5 Type your old password 6 Press 7 Type the new password 8 Press 9 Type the new password a second time 10 Press NOTICE Damage to data and programs due to unauthorized access to the cobas c111 instrument User access to the cobas c111 instrument is controlled by a login name and password Users are administered by a system administrator Roche recommend to periodically change the password of the system administrator and to store the current password in a safe place with adequate access control User name and password are case sensitive This means that for example Admin and admin are two different names If Do this You are logged off 1 Press Log On You are
397. orm the Clean ISE Tower Manually maintenance action If the ISE tower is still blocked clean the ISE tower off the instrument See Cleaning the ISE tower off the instrument on page E 36 Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 Roche Diagnostics E 52 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions 7 Clean the inside of the ISE tower with a cotton swab to remove any residual of ISE Deproteinizer 8 Close the left service flap and then the main cover 9 Press to confirm the cleaning of the ISE tower The ISE tower is first washed The transfer head moves to the right side of the instrument You are asked to clean the ISE tower 10 Open the main cover and then the left service flap 11 Clean the inside of the ISE tower with a cotton swab to remove any residual water 12 Close the left service flap and then the main cover 13 Press to confirm the cleaning of the ISE tower The ISE tower is first washed and dried and then conditioned with Activator A message will inform you when the maintenance action is complete 14 Remove the Activator and ISE Deproteinizer from the sample area 15 Press Roche Diagnostics Operator s Manual Version 3 0 E 53
398. ormat dba_yyyymmddhhmmss tgz Roche Diagnostics Operator s Manual Version 3 0 B 105 cobas c111 6 Special operations Exporting data Exporting results When exporting results the full result data are copied into an archive on the USB stick The archive has the name format csv_yyyymmddhhmmss tgz and it contains the following files File format Result data are exported as line oriented comma separated value csv files The following definitions apply o Character set ISO1LATIN1 ANSI ISO8859 1 ISO Latin 1 Western o Separator Semicolon o Element qualifier Quote ASCII Code 34 0x22 o Empty element Two quotes ASCII Code 34 0x22 o Line terminator Standard Win Style CRLF ASCII Code 13 10 0x0D 0x0A These files can be processed with any spreadsheet program that can import csv files a To export the support data 1 Choose Utilities gt Export gt Full Results A screen is displayed asking you to insert the USB stick 2 Insert the USB stick 3 Press 4 Select the directory A screen is displayed for selecting a directory Press lt csv gt to archive files only Press lt gt to display all files and directories 5 Press to confirm the selection The data are copied to the USB stick The screen for exporting data is displayed again Data set File name Sample results res_yyyymmddhhmmss csv QC results qcs_yyyymmddhhmmss csv
399. orting data Exporting log files During troubleshooting you may be asked to export the log files and to send them to by the service representative for examination The log files contain the alarm messages and system logs a To export the log files 1 Choose Utilities gt Export gt Log Files A screen is displayed asking you to insert the USB stick 2 Insert the USB stick 3 Press to confirm the insertion A screen is displayed for selecting a directory Press tgz to display cobas c111system files only Press to display all files and directories 4 Select the directory 5 Press to confirm the definitions The data are copied to the USB stick The screen for exporting data is displayed again Roche Diagnostics Operator s Manual Version 3 0 B 111 cobas c111 6 Special operations Importing data Importing data f Utilities gt Import You can import the following kinds of data o Application data application definitions o Software software updates o Database as exported using Utilities gt Export gt Database o Certificates digital records that ensure the authenticity of reagent barcodes o Extra wash cycle and mixing rule definitions Importing applications Importing an application consists of two steps 1 Importing the data to the instrument by reading a barcode or a data file This step stores the data on the instrument 2 Installing the applicatio
400. ostics reserves the right to make any changes necessary without notice as part of ongoing product development Width with ISE unit 590 mm 720 mm Depth with ISE unit 550 mm 550 mm Height with ISE unit 480 mm 480 mm Weight with ISE unit Approximately 32 kg 35 kg Line voltage 100 125 V and 200 240 V 15 10 Line frequency 50 Hz 5 and 60 Hz 5 Power consumption 250 VA Insulation coordination Installation category II IEC 61010 1 Main fuse T6 3 A H 250 V Low voltage fuses T3 15 A L 250 V Battery Lithium 3 6 V 2 3 Ah SL 360 S Line voltage 100 240 V 10 Line frequency 50 Hz 5 and 60 Hz 5 Supply voltage 19 24 V DC Min 2A Power consumption 70 VA Insulation coordination Installation category II IEC 61010 1 Absorbance photometry enzymes substrates drugs of abuse Potentiometry ISE ion selective electrodes Na K Cl Temperature Running conditions 15 32 C Transport and storage 25 to 60 C Humidity Running conditions 30 80 at 15 32 C non condensing Transport and storage 10 95 non condensing Pollution Degree 2 IEC 61010 1 Altitude Max 2000 m above sea level Photometric 85 tests h max 60 tests h consolidated with typical test panel ISE 180 tests h max 60 100 tests h consolidated photometric and ISE mixed Sample handling Manually by operator Time to first result 5 10 min photometric measurements
401. oting see Reacting to messages on page D 44 The following table lists selected messages and provides more detailed information on how to react to them Message or error code Affected items Possible causes Comments 8 xxx 56 The ISE reference sensor has detected too much air during ISE Reference Solu tion transport ISE unit ISE Reference Solution is empty Replace the ISE Reference Solution bottle e See Replacing ISE fluid bottles on page E 30 Leakage in the tubing or at elec trodes o Check that the ISE unit tubing is properly connected o Check the ISE unit tubing for leakages and blockages e See Replace ISE unit tubing on page E 57 o Check that the electrodes are mounted prop erly e See Replacing electrodes on page E 32 The cover of the peristaltic pump is open or not properly closed Close the cover The tubing around the ISE Ref erence Solution sensor is not properly installed Make sure that the tubing is properly pressed into the groves and that the tubing itself is not compressed 109000567 code raised by IC software caused by an unexpected handling or sys tem situation ISE unit This is a flow problem within the ISE unit the ISE tower is not empty The system checks whether the tower is empty before dispensing Perform the following checks o Check that the ISE unit tubing is properly connected o Check the ISE unit tubing for leakages and blockages o Chec
402. ottle belonging to the set A screen is displayed asking you to scan the bottle 1 Scan the bottle 2 Insert the bottle 3 Press to confirm the insertion All bottles of the set are inserted 1 Close the main cover On the screen with the reagent set buttons the button for the new set is now present A Status description Figure B 7 A Roche Diagnostics B 28 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing the system 16 Press 17 When you have finished adding and replacing reagent sets press to proceed to the next stage in the Prepare wizard Preparing cuvettes Cuvettes are supplied and handled in cuvette segments Each segment contains ten cuvettes The segments are placed on the cuvette ring of the rotor e For information on cuvette segments see Cuvette segments on page A 55 For information on the cuvette ring see Cuvette ring on page A 60 Each segment on the cuvette ring is represented by a button on the screen a To prepare the cuvettes Checking the cuvette status 1 Check the color of the cuvette segment buttons You can refresh the cuvette screen by pressing If there were pending orders this would also start their processing Interpreting the screen The number in the button indicates how many cuvettes are free to be used When handling the reagent sets without using the Prepare wizard Choose Overview gt Make sure that you have read
403. ough condensation In ambient conditions of high temperature and humidity condensation can build up inside the reagent bottles This leads to dilution of the reagent In such conditions and when not performing tests especially if you observe condensation on the reagent disk or in the reagent cooler be sure to remove the reagent disk from the instrument and place it in the reagent disk container Close the container with its lid and place it in a refrigerator Incorrect results due to condensation in the reagent cooler In ambient conditions of high temperature and humidity condensation can build up in the reagent cooler Water can spill on the analyzer unit and get into the cuvettes when remov ing the reagent disk In ambient conditions of high temperature and humidity be sure to periodically wipe up the condensation water in the reagent cooler Incorrect results due to inappropriate reagent handling Removing and loading reagents while the reagent disk is outside the instrument may lead to inconsistencies between the recorded and the physically loaded reagents and conse quently to incorrect results Always remove and load reagents while the reagent disk is on the instrument and by using the software supported procedures Roche Diagnostics Operator s Manual Version 3 0 B 23 cobas c111 6 Daily operation Preparing the system Checking the status of reagent sets There are two main ways of checking the status of reage
404. p copy barcode A numeric or alphanumeric code used on sample tubes and reagent bottles to identify the samples and reagents Different barcode standards are available See also barcode type barcode scan The process of reading barcode information into the memory of an instrument barcode scanner The device that reads the code from sample or reagent barcode labels barcode transfer sheet BTS A sheet bearing a barcode that encodes test related or calibrator or control information for an analytical instrument barcode type Typical sample barcode types used in the IVD industry are Code39 NW7 Codabar ITF and Code 128 biohazardous A classification used to identify material that poses a health threat for example something contaminated with biological material button A button is found on a screen or pop up window It can be touched either to initiate an action or to move to a different screen Numbers A B Roche Diagnostics F 4 Operator s Manual Version 3 0 Glossary cobas c111 calculated result dead volume calculated result A test result calculated from different individual analytical methods with a given formula such as ratio A B calibration The set of operations that establish under specified conditions the relationship between values indicated by the analytical instrument and the corresponding known values of an analyte calibration interval A specified interval at which an assay should
405. peat with fresh control 2 Check that the correct control material has been used 3 If the flag reappears check the calibration and reagent status Repeat with fresh reagent gt RR Meaning Above reference range For patient samples the calculated concentration is greater than the upper limit of the expected value range nnnnn is the actual value that was checked against Message ID 40 Priority 22 Recommended actions No action required lt RR Meaning Below reference range For patient samples the calculated concentration is less than the lower limit of the expected value range nnnnn is the actual value that was checked against Message ID 41 Priority 23 Recommended actions No action required Seg Fluid e See Air Fluid Roche Diagnostics E 78 Operator s Manual Version 3 0 15 ISE troubleshooting cobas c111 List of ISE flags Seg Isecal e See Air Isecal Sol1 F Dev Meaning The ISE Solution 1 factor was not within the expected range Message ID 22 Priority 18 Possible cause This flag occurs with calibrations because o The dosing from the sample probe is not accurate o The ISE tower is blocked or the mixing was not sufficient o There may be problems with the ISE unit tubing the electrodes or the ISE unit was not serviced properly o The ISE Calibrator indirect urine has expired o ISE Solution 1 has expired Recommended actions If only
406. pecial operations Deleting sample orders Deleting sample orders Sample orders are normally deleted as part of the daily end of shift activities This section describes how to proceed if you need to delete sample orders outside the normal daily routine e For deleting orders at the end of a shift see Cleaning up the database on page B 84 Preconditions for deleting The orders should be fully processed before you delete them a To delete orders 1 Choose Workplace gt Orders A screen is displayed that lists all currently defined sample orders 2 Do one of the following The orders are deleted You cannot retrieve them any more from the system If Do this You want to delete an individual order 1 Select the order entry in the list 2 Press 3 Press Selected You want to delete all or a specific group of orders 1 Press 2 Press the appropriate filter button 3 Press to confirm the selection 4 Press 5 Press List filter criterion o By deleting a sample order you delete the associated results as well o You can delete a running order After deleting the order cuvettes and reagents that were not used are released again for future use Roche Diagnostics B 94 Operator s Manual Version 3 0 6 Special operations cobas c111 Deleting sample results Deleting sample results Sample results are normally deleted as part of the daily end of shift activities This section desc
407. perator s Manual Version 3 0 E 11 cobas c111 12 ISE description Hardware Input valve plate A set of valves to create cleaning segments and to control the flow of waste fluids Entry valve plate A set of valves to control and monitor the flow of fluids Exit valve plate A set of valves to control the aspiration action of the peristaltic pump Electrode block A block that contains the electrodes ISE tower A hollow transparent cylinder with multiple inlets and outlets for air and solutions In the ISE tower samples and diluents are mixed using an air stream Tubing Tubing is used for transporting the fluids It connects the ISE unit with the water and waste system and also with the ISE Reference Solution and ISE Calibrator indirect urine bottles which are placed on the ISE unit Sensors The ISE sample sensor detects the presence of liquid sample control standard solution or ISE Calibrator indirect urine or air and enables the correct placing of segments for measurement and cleaning The ISE Reference Solution sensor detects the presence of ISE Reference Solution ISE fluid bottles Two bottles are placed on the ISE unit o ISE Calibrator indirect urine bottle blue label o ISE Reference Solution bottle red label Level monitoring is performed on the basis of weight the bottles are placed on scales Fluid containers The following table shows which container is used for which fluid Fluid Conta
408. place gt QC History gt Workplace gt Calibrations gt 8 Perform the maintenance actions that are due Utilities gt Maintenance 9 Check the external fluid containers Overview gt gt 10 Log off the system Overview gt button with your user name 11 Switch off the system if last shift n a n a Task Steps Navigation With wizard As individual steps Table E 3 Overview of the daily operation tasks Roche Diagnostics Operator s Manual Version 3 0 E 19 cobas c111 13 ISE operation Daily operation Safety information WARNING Injury through reagents and other working solutions Direct contact with reagents cleaning solutions or other working solutions may cause personal injury When handling reagents exercise the precautions required for handling laboratory reagents observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning solutions Infection by biohazardous materials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immedia
409. plications B 156 Reference range definitions ratio applications B 156 Result conversion definitions B 156 Configuration B 157 Changing your password B 157 Scheduling maintenance actions B 158 Handling user interface language B 158 Uninstalling a language B 160 User management B 161 Defining a user B 161 Deleting a user B 161 Editing the acceptable flags list B 162 Mapping the host codes B 162 Short guide to configuration definitions
410. possible actions No crypto module is installed A message is displayed informing the operator of this fact The system does not import the application The maximum number of devel opment channel applications is already installed A message is displayed informing the operator of this fact 1 Uninstall and then delete a development channel application 2 Start the import process again Roche Diagnostics Operator s Manual Version 3 0 B 113 cobas c111 6 Special operations Importing data 4 Choose Install Application The system checks whether there is already an application installed on the system with identical application code or short name In the applications list the application name is displayed without brackets and in the profile details the short name is displayed The profiles that use this application are included in the test selection screen provided that all applications of the profiles are installed 5 Prepare the application e See Preparing applications on page B 140 Importing software This function is usually used for installing software updates a To import system software 1 Choose Utilities gt Import gt Software A screen is displayed asking you whether you want forced download of controller software that is whether you want to overwrite the current controller firmware irrespective of its current status 2 Do one of the following o Press to overwrite the
411. pper and lowercase alphanumeric keyboard screens A A Roche Diagnostics A 78 Operator s Manual Version 3 0 5 Software cobas c111 Working with the user interface Special characters keyboard Switch to the lowercase alphanumeric keyboard A Z Switch to the uppercase alphanumeric keyboard Delete the last character displayed in the text line Press to insert a space Using the filter function In many lists you can apply a filter that is you can select predefined criteria for generating a selection of entries The way to apply a filter is the same in all screens where a filter is available Here is an example a To apply a filter to a list 1 Display the list A Typed text Figure A 41 Special characters keyboard screen A Roche Diagnostics Operator s Manual Version 3 0 A 79 cobas c111 5 Software Working with the user interface 2 Press A screen is displayed for selecting the filter criterion 3 Choose one of the filter options 4 Press The list is displayed again It now contains only the entries that comply with the criterion you just applied by pressing its button A In the status line the screen is indicated where you pressed A After you have applied a filter the criterion name will appear as part of the List button for example on screens for deleting data If you used the Not Accepted filter criterion the List button would be called Li
412. pports you in preparing and loading the controls o Interval QC This method applies to tests whose controls have an interval defined Interval QC is a process that is suitable both for performing a single QC measurement and for performing all QC measurements that are due You can select all tests that require QC simply by pressing a button This selection also reflects QC of the type QC After Cal A wizard helps you select the controls and a placement list supports you in preparing and loading them Roche Diagnostics Operator s Manual Version 3 0 A 31 cobas c111 2 Introduction to the instrument Daily operation Validating QC results Each new QC result has to be validated If flags were generated you must determine their cause and decide whether to accept or ignore the result You can automatically accept unflagged results and results with flags that are contained in a specific list of flags that should be ignored e See Editing the acceptable flags list on page B 162 If you ignore a QC result you exclude the result from further QC result calculations such as QC History statistics Sample handling You can place up to eight sample tubes on the sample area Sample types The cobas c111 instrument can process the following sample fluids o Serum o Plasma o Urine o Whole blood for HbA1c A Sample area LED A green LED indicates that you should place a tube a blinking yellow LED that you should k
413. probe crashed or the reagent bottle set s became unexpectedly empty Check if the probe is obstructed Check the filling level of the associated reagent bottle 7071 Photometer error Signal is invalid or unstable Switch off the instrument Remove and clean the rotor If the error recurs perform lt Replace Photometer Lamp gt and lt Abs Air Water Calibration gt If the error persists call service ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics D 16 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 List of alarm messages 7072 d The reagent mixing failed due to a level detection problem Check if the probe is obstructed Check the filling level of the associated reagent bottle If the error persists call ser vice 7073 s Peristaltic pump speed is outside the range Check ISE tubing for obstructions and leaks Ensure that the electrode tension lever and the peristaltic pump cover are closed Perform lt Initialize ISE Unit gt If the error per sists call service 7074 s The detected sample or calibrator segment is too short Check the ISE tubing for obstructions and leaks Ensure that the electrodes are installed correctly If the error per sists call service 7075 s A timeout error occurred while performing an ISE measurement Restart the system and repeat the measurement If the error persists call service 7076 s Initialization of
414. proceed to the next stage in the End Shift wizard 4 Export support data 1 Press 2 Insert the USB stick if you have removed it 3 Press 4 Select the directory 5 Press 6 Remove the USB stick 7 Press to proceed to the next stage in the End Shift wizard 5 Clean up the database 1 Press 2 Press to confirm the deletion 3 Press to proceed to the next stage in the End Shift wizard Table E 5 Steps for finishing the shift Roche Diagnostics Operator s Manual Version 3 0 E 29 cobas c111 13 ISE operation Daily operation 6 Perform maintenance actions 1 Check which maintenance actions are due 2 Perform the maintenance actions Perform at least all red maintenance actions 3 Press to proceed to the next stage in the End Shift wizard 7 Check the cuvette status Not relevant for ISE operation 1 Press to proceed to the next stage in the End Shift wizard 8 Empty the waste container 1 Empty the waste container 2 Press the Waste button to confirm 3 Refill the water container 4 Press the Water button to confirm 9 Remove the reagent disk Not relevant for ISE operation 10 Finish your shift 1 Log off the system 2 Switch off the main instrument If there is no other shift Step User action Table E 5 Steps for finishing the shift If you intend not to use the ISE unit for more than one week you should deactivate it Thi
415. r that user intervention is mainly required at the beginning and at the end of the Prepare phase This way the operator does not have to stand by the instrument the whole time The easiest way of performing the daily preparation tasks is to follow the Prepare wizard Preventing intervention during sample processing Performing conscientiously all preparation steps reduces considerably the chances of you having to intervene during routine operation Follow the steps suggested by the wizard You are guided through the preparation process by the Prepare wizard This sequence of screens shows you which actions you should perform and in which order Skipping a step You may skip a step Before you do so remind yourself of the consequences In many cases skipping a step simply means postponing the task to a more convenient time In other cases skipping a step could prevent the system from performing an analysis for example if you chose not to replace a reagent that is low a test that uses this reagent may not have enough reagent Roche Diagnostics Operator s Manual Version 3 0 B 13 cobas c111 6 Daily operation Preparing the system Short guide The following table provides an overview of the steps that make up the preparation process Step User action 1 Start the Prepare wizard 1 On the Overview tab press Prepare 2 Check the status of the external containers 1 Refill the water container if required a
416. ral overview of the currently defined reagent sets 1 Choose Utilities gt Inventory The Bottle sets list is displayed It contains all bottle sets that are defined on any of the disks used on this cobas c111 instrument including sets that were removed from the disk as long as they were not empty or their expiration date has not passed yet 2 Select a set and press A dialog box is displayed that contains detailed set information 3 Press A dialog box is displayed that contains set calibration and QC information 4 Press to close the dialog boxes until the Utilities tab is displayed A Number of tests left B ID of reagent disk on which the set is defined C R indicates that the set was removed from the disk Figure B 32 A B C Roche Diagnostics Operator s Manual Version 3 0 B 101 cobas c111 6 Special operations Lot handling Viewing the lot details of fluids that were used For sample calibration and QC results you can check to which lot the used fluids belong reagents calibrators controls a To check context information of a result 1 Do one of the following A screen is displayed that lists the lot IDs for the used reagent set calibrators and controls The following figure shows an example of sample result lot data 2 Scroll to display the information if required 3 Press to close the screen Adding a new lot Lot data are usually contained in the b
417. ration A 29 Prepare phase short guide B 13 Prepare wizard B 15 preparing applications B 140 ISE unit E 20 new reagent disks B 116 reagents B 22 B 25 system B 12 Prime ISE reference and calibrator maintenance action E 48 Prime the fluid system maintenance action C 11 principles absorbance measurements A 19 calibration A 26 ISE measurements E 7 specifications A 66 printer clearing paper jam D 46 overview A 62 refilling paper B 122 specifications A 67 printer status checking D 46 Printer Tool B 37 Roche Diagnostics F 18 Operator s Manual Version 3 0 Index cobas c111 printing alarm messages D 8 mixing rules B 173 overview A 80 sample results B 58 stopping A 80 B 58 priority flags D 26 probe cleaning manually C 12 deproteinizing C 10 description A 49 hardware A 46 replacing B 125 process sequence screen A 115 processing defining sequence B 145 processing stop B 49 profiles B 148 adding tests B 148 B 149 deleting B 149 removing tests B 149 pumps ISE E 10 Q QC Default QC B 68 definitions B 167 interpreting history B 74 Interval QC B 68 list A 101 overview A 30 performing B 68 performing Default QC B 70 pe
418. ration cobas c111 Preparing the system Performing the maintenance actions 2 Select the maintenance action you want to perform The selected line turns blue 3 Press The maintenance definition screen is displayed e For information on how to perform individual maintenance actions see Chapter 8 General maintenance 4 Press to start the action 5 Follow the instructions on the screen 6 Perform the next maintenance action that is due 7 When you have finished performing maintenance actions press to proceed to the next stage in the wizard WARNING Incorrect results or processing stop due to skipping maintenance actions Not performing maintenance actions that are due may lead to situations where the sys tem cannot continue processing orders or it may lead to incorrect results If at all pos sible perform the maintenance actions when they are due When performing maintenance actions without using the Prepare wizard Choose Utilities gt Maintenance Roche Diagnostics Operator s Manual Version 3 0 B 21 cobas c111 6 Daily operation Preparing the system Preparing the reagent disk The reagent disk holds the reagent and diluent bottles During periods when you are not performing tests for example at night or during holidays the disk is placed in a reagent disk container and stored in a refrigerated place Reagents should be stored at temperatures in the range of 2 to 8 C a To load
419. rators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to trained service representatives o Follow standard laboratory practices especially when working with biohazard material CAUTION Fatigue due to long hours of operation Looking at the monitor screen over an extended period of time may lead to fatigue of your eyes or body Take a rest for 10 to 15 minutes every hour to relax Avoid spending more than 6 hours per day looking at the monitor screen WARNING Incorrect results due to carryover Traces of analytes or reagents may be carried over one test to the next Take adequate measures e g sample aliquoting to safeguard additional testing and to avoid potentially false results WARNING Incorrect results and interruption of analysis due to contaminated samples Insoluble contaminants in samples may cause clogging or pipetting volume shortage and deterioration in measurement accuracy When loading samples on the instrument make sure that samples contain no insoluble contaminants such as fibrin or dust NOTICE Malfunction due to spi
420. reagents while the reagent disk is on the instrument and by using the software sup ported procedures 1 Align the bottle storage assembly in the reagent disk e See Realigning the reagent disk on page D 50 2 Insert the reagent disk in the cooler Figure D 4 Troubleshooting overview Roche Diagnostics Operator s Manual Version 3 0 D 43 cobas c111 11 Troubleshooting Dealing with exceptional situations The system does not go to Operating status System status There are not enough free cuvettes on the instrument Load empty cuvette segments e See Preparing cuvettes on page B 28 Air water calibration is required Perform Abs Air Water Calibration maintenance action e See Perform an air water calibration on page C 28 In the corresponding calibrator lot definitions of at least one of the tests you want to perform the value for Last Is Water is Off The Last Is Water definition defines what is used as the zero calibrator It is either system water On or a stan dard usually water Off which would be placed in a tube like any other calibrator With some tests calibration does not work with special zero calibrators they need the Last Is Water definition on Possible remedies 1 Delete the current calibration order and redefine it 2 If the Last Is Water definition is Off make sure to place a special zero calibrator on the instrument when calibrating This is usually water If t
421. ree tissue ready o Lift the tubing adapter and place it on the tissue 6 Press to confirm completion of the action The system now starts to initialize the ISE Reference Solution sensor You are asked to insert the tubing adapter in the ISE Reference Solution bottle and to close the ISE cover 7 Insert the tubing adapter in the ISE Reference Solution bottle 8 Close the ISE cover 9 Press The instrument pumps ISE Reference Solution through the ISE tubing A message will inform you when the maintenance action is complete 10 Press Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 Roche Diagnostics E 48 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Prime ISE reference and calibrator f Utilities gt Maintenance gt Prime ISE Reference and Calib This maintenance action ensures that no traces of a previous ISE Calibrator indirect urine and ISE Reference Solution are left in the tubing and so prevents drift in the results Operator time Approximately 1 minute Prerequisites The system must be in Standby status Tools and materials required None Hazards and precautions None a To prime the ISE calibrator and ISE Reference Solution 1 Select
422. result for a particular reagent set Set calibration Set calibration results are valid for the calibrated set only They can be generated from any reagent set Lot calibration Lot calibration results are valid for the reagent set they were calibrated with and for all subsequent reagent sets of the same lot Usually lot calibrations are generated by calibrating the first reagent set of a new lot There can only be one accepted lot calibration result for the reagents of a given lot Let us suppose that you place the first reagent set of a new lot and calibrate it straight away Let us further assume that subsequent control measurements suggest that a new calibration is required Within the first 24 hours of placing a set on the system you can recalibrate it and possibly existing lot calibration results of this set are superseded When this period has elapsed you can no longer change the lot calibration results To generate new lot calibration results you would have to delete the existing results and then calibrate a new reagent set The following table illustrates the two calibration types in an example Assumptions o Sequence Each Lot and Interval o Interval 5 days Note that the interval re starts when a set is calibrated as a result of the interval expiring or a new lot being started Lot calibration is relevant if you work with the calibration sequence Each Lot and Interval Day Trigger Event Task Result used Se
423. rforming Interval QC B 71 short guide B 69 status list A 101 when due A 30 QC history graph B 75 interpreting B 74 screen A 102 QC history graph screen A 103 QC results auto accept B 72 deleting B 96 validating B 72 QC status list screen A 101 qualifications of operators A 9 quality control See QC R ratios calculation definitions B 155 defining B 146 reagent bottles A 53 reading barcodes B 89 specifications A 67 reagent cooler removing condensation B 124 reagent disks cleaning C 14 ID A 58 loading B 21 overview A 58 preparing B 116 realigning D 50 removing B 87 storage container A 59 reagent handling overview A 25 reagent lots viewing B 99 reagent mixing screen A 114 reagent sets A 25 checking status B 23 deleting from inventory B 120 reagent status screen A 93 reagents barcodes A 61 bottles A 53 cooling A 59 exchanging B 25 handling A 56 introduction to handling A 25 loading B 26 preparing B 22 B 25 removing B 25 replacing B 25 safety A 7 sets A 25 reference ranges ratios B 156 refilling printer paper B 122 water container B 16 B 86 removing B 50 reagent disk B 87 reagents B 25
424. rials Contact with samples containing material of human origin may result in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Infection by waste solution Contact with waste solution may result in infection All materials and mechanical compo nents associated with the waste systems are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch moving parts during instrument operation Keep all covers closed operate them as instructed on the screen Roche Diagnostics B 6 Operator s Manual Version 3 0 6 Daily operation cobas c111 Introduction
425. ribes how to proceed if you need to delete sample results outside the normal daily routine e For deleting results at the end of a shift see Cleaning up the database on page B 84 Preconditions for deleting Sample results should be accepted and printed or sent to the host before deleting a To delete sample results 1 Choose Workplace gt Result Review A screen is displayed that lists all results 2 Do one of the following The results are deleted You cannot retrieve them any more from the system If Do this You want to delete an individual sample result 1 Select the result entry in the list 2 Press 3 Press Selected You want to delete all or a specific group of sample results 1 Press 2 Press the appropriate filter button 3 Press to confirm the selection 4 Press 5 Press List filter criterion By deleting all sample results of an order you delete the corresponding order as well Roche Diagnostics Operator s Manual Version 3 0 B 95 cobas c111 6 Special operations Calibration Calibration Deleting calibration results Obsolete calibration results are automatically deleted as part of the daily end of shift activities if there are more than five obsolete calibration results for the test Calibration results become obsolete when the empty set is removed or if it was removed more than 30 days ago This section describes how to proceed if you need to delete r
426. rinter paper on page B 122 See To clear the paper jam on page D 46 A sample barcode must include a checksum at the end A Panel release button B Paper slot C Printer panel Figure A 30 Printer A B C Roche Diagnostics Operator s Manual Version 3 0 A 63 cobas c111 3 Hardware Hardware overview Absorbance photometer The cobas c111 main instrument uses the absorbance photometry measuring method Absorbance photometer The measurements are taken without removing the cuvette from the rotor Halogen lamp The Halogen lamp is mounted on a holder for easy replacement The system informs you when you need to replace the lamp e See maintenance action Replace photometer lamp on page C 24 Wavelengths for the absorbance photometer For each cuvette the absorbance photometer measures light intensity at 12 different wavelengths Measurement principles e See Principles of operation on page A 19 A Photometer unit Figure A 31 Photometer unit A 340 nm 449 nm 520 nm 629 nm 378 nm 480 nm 552 nm 652 nm 409 nm 512 nm 583 nm 659 nm Roche Diagnostics A 64 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Connectors A Power supply B Data and communication connectors C Fluid connectors D Front USB port not shown E Serial communication connector F Barcode scanner connector G Maintenance connectors Do not remove the cable
427. rnal cleaner bottle B 128 external waste container B 128 external water container B 127 connectivity host A 33 connectors fluids A 47 overview A 64 contact addresses 3 Contact service representative maintenance action C 27 containers fluids A 50 reagent disks A 59 waste A 50 water A 51 control lot defining B 102 controls definitions B 154 placing B 70 conventions used in manual 8 cooling reagents A 59 copyrights 2 correlations B 156 covers ISE E 9 overview A 39 cross contamination A 9 csv files B 83 cups A 54 cuvette ring A 60 cuvette status screen A 92 cuvettes A 55 checking the status B 28 handling A 56 replacing B 29 B 85 ring A 60 segments A 55 specifications A 67 D daily backup B 82 daily operation B 3 introduction A 22 overview table A 22 Daily prepare actions maintenance action E 44 data security A 10 database cleaning up C 23 exporting B 104 importing B 114 restoring B 114 date and time definitions B 169 deactivating ISE unit E 64 Default QC overview B 68 performing B 70 defining calibrator lots B 103 B 150 control lot B 102 control lots B 149 lots B 101 orders B 38 ratios B 146 users B 161 definitions app
428. roduction E 41 ISE maintenance actions E 42 15 ISE troubleshooting Introduction E 69 Safety E 70 List of ISE flags E 71 Reacting to error messages E 80 Glossary and Index Part F Glossary F 3 Index F 11 Revisions Part G 18 Revisions Roche Diagnostics Operator s Manual Version 3 0 7 cobas c111 Preface The cobas c111 instrument is a continuous random access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum plasma urine or whole blood HbA1c It is optimized for small throughput workloads of approximately samples per day utilizing photometric analysis and an optional unit for ion selective electrodes ISE This manual describes the cobas c111 features and general operational concepts and it provides operating maintenance and emergency procedures How to use this manual To help you find information quickly there is a table of contents at the beginning of the manual and each chapter In addition a complete index can be found at the end Online Help system The cobas c111 instrument has a context sensitive online Help feature to aid in its operating Context sensitive means that wherever you are located within the cobas c111 software choosing Help displays Help text relating to that area of the software The online Help offers a quick and convenient way of finding information such as explanations of screens and d
429. round time STAT orders are defined in the same way as routine orders a To define a STAT order 1 On the Overview tab press STAT 2 Continue as if defining a routine order e See Defining routine orders on page B 39 Order of processing When you have defined a STAT order and started the run the system reacts as follows o Existing STAT orders are finished first o Started tests of routine orders are finished o Repeats and reruns of STAT orders are treated as normal STAT orders The order that was defined first will be performed first o Repeats and reruns of routine orders are performed before routine orders o Roche strongly recommends to always load extra cleaner when tests with extra wash cycles are used o Roche Diagnostics Ltd assumes only limited liability when using the cobasc111 instrument in conjunction with the cobas c111 Development Channel Programming Software For detailed information on this matter refer to the latest version of the Development Channel Registration Form cobas c111 and the cobas c111 Develop ment Channel Operator s Manual If there is no space on the sample area Remove any sample whose tube button is green Roche Diagnostics B 42 Operator s Manual Version 3 0 6 Daily operation cobas c111 Analyzing samples Recognizing STAT orders on the screens On the Overview tab the sample buttons for STAT orders are marked with a wide edge In the orders list Workp
430. rresponding values for Raw1 Raw40 are missing Roche Diagnostics B 108 Operator s Manual Version 3 0 6 Special operations cobas c111 Exporting data qcs_yyyymmddhhmmss csv qch_yyyymmddhhmmss csv Column Title Description Instr Instrument ID always 30 for cobas c111 Msg Message Type 7 Result for sample control or calibration Index 161 Data values App Application code Date Date when the result was generated Time Time when the result was calculated SW Version Software version installed on the instrument Serial Serial number of the instrument Ctrl Control ID User User name SYS if Auto Accept is on Lot Lot ID Mean Mean value Result Result value Unit Defined display unit Flags Flag name Rate Rate value calculated in Abs First Calculation Point Last Calculation Point Raw1 Raw40 Absorbance value of cycle 1 through 40 in Abs one cycle 18 s Test Short name of the application Ignored I if the QC result was ignored Table 35 Explanations on QC results Column Title Description Instr Instrument ID always 30 for cobas c111 Msg Message Type 8 QC history result Index 151 Data values App Application code Date Date when the result was calculated Time Time when the result was calculated SW Version Software version installed on the instrument Serial Serial number of the instrument Ctrl Control ID User User nam
431. rs changing B 42 changing with sample on board B 42 checking for unfinished B 80 defining B 38 B 39 defining profiles B 148 deleting B 93 handling A 32 IDs A 32 introduction to handling A 32 list A 98 order of processing B 44 overview A 32 STAT B 41 workflow setup B 37 overview buttons A 124 calibration A 26 daily operation A 22 flags D 25 instrument A 15 A 17 ISE E 5 ISE operation E 17 maintenance C 5 messages A 82 D 5 order handling A 32 reagent handling A 25 result handling A 34 routine operation B 7 sample handling A 31 user interface A 20 A 71 wizards A 21 Overview tab A 84 P panels ISE E 9 overview A 39 See also test panels paper jam clearing D 46 paper refilling B 122 password changing B 157 typing B 11 performing calibration B 59 calibration during Prepare phase B 30 Default QC B 70 Interval QC B 71 maintenance actions C 6 QC B 68 reagent mixing B 76 reagent mixing during Prepare phase B 29 tests B 34 peristaltic pump E 10 photometer overview A 63 specifications A 67 photometer lamp replacing C 24 power interruption A 8 requirements A 66 precalib
432. rs are automatically defined the test selection screen is not displayed After identifying the sample you are asked to place the sample Sample Barcode Use On if you exclusively work with barcoded sample tubes When defining orders the screen for typing the sample ID manually is skipped Order Mode The order mode reflects the way in which you organize the tests on the test selection screen Use Easy if the reagents fit on one or two reagent disks and you work with one test panel on the screen You can fit up to 25 tests and profiles on this panel Use Full if you distribute the reagents across several up to eight reagent disks and if you predominantly work with specific groups of tests for example for emergency situations or for testing diabetes You can define up to 20 tests and profiles on each panel tab e See Assigning tests to test tabs on page B 119 Sample ID Handling The sample ID is an identifier of up to 23 alphanumeric characters that is unique within a whole organization for example the hospital It cannot be changed once the order is saved This ID is used for communication with a laboratory information system The order ID is an identifier of up to 23 alphanumeric characters that is unique within the laboratory In practice this could for example be an autonumber followed by the patient name If you work with one ID only the sample ID is used as the order ID as well There exists a fixed relation between the sa
433. ry practices especially when working with biohazard material Incorrect results or processing stop due to incomplete maintenance actions You can cancel a maintenance action any time by pressing If you interrupt the performing of a maintenance action that was due its status will remain due and you need to fully re perform the action later If at all possible complete a maintenance action without interrupting it Danger of poor measurement quality due to inadequate water quality Inadequate water quality may lead to incorrect results Always use purified water of the quality specified in section Technical specifications Infection by waste solution Contact with waste solution may result in infection All materials and mechanical compo nents associated with the waste systems are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Whenever the term purified water is used in this document water of at least the quality specified in chapter Technical specifications must be used Roche Diagnostics C 10 Operator s Manual Version 3 0 8 General maintenance cobas c111 Mainte
434. s By applying a factor the final results of the different instruments can be directly compared Offset The offset is used to compensate for differences in measuring methods of different instruments By adding the offset the final results of the dif ferent instruments can be directly compared Valuation No Valuation Reference Range Use the limits defined as Low Limit and High Limit Low Used On Off Refers to Low Limit High Used On Off Refers to High Limit Low Limit Results that are outside the limit are flagged High Limit Results that are outside the limit are flagged 1 3 Flag QC Fail On Off Choose On to ensure that all sample results are flagged that were generated using a test whose QC results were marked with a flag The initial number refers to the control that was used for performing the QC See also Control definitions Table B 15 Calculation definitions Item Values Comment Application A through D Up to 5 alphanumeric characters Short names of the installed applications Coefficient w through z 000 999 Numeric variable for use in the formula Formula Defined application and coefficient letters Operands and space The formula relates the defined applications with the coefficients For example A w B A B Table B 16 Calculation definitions for ratio applications Roche Diagnostics B 156 Operator s Manual Version 3 0 7 Confi
435. s saves ISE fluids and reduces wear and tear of the tubing See Deactivating the ISE unit on page E 64 Roche Diagnostics E 30 Operator s Manual Version 3 0 13 ISE operation cobas c111 Replacing ISE fluid bottles Replacing ISE fluid bottles ISE fluid bottles are supplied with a barcode that contains information on their expiration date which is monitored by the system Tools and materials required o ISE Calibrator indirect urine or ISE Reference Solution bottle o Tissues a To replace an on board ISE fluid bottle 1 Check that the system is in Standby status 2 Choose Overview gt 3 Check the status of the ISE bottles A Interpreting the bottle status screen 4 Press Cal or Ref A screen is displayed that shows details about the bottle status Roche recommend replacing ISE fluid bottles as soon as their expiration date has passed Their icon on the screen turns yellow For information on the stability of fluids see their package inserts WARNING Injury through working solutions Direct contact with cleaning solutions or other working solutions may cause personal injury When handling such solutions exercise the precautions required for handling them observe the cautions given in the package insert and observe the information given in the Safety Data Sheets available for Roche Diagnostics cleaning solutions A No fluid registered by an ISE fluid sensor Operation has stoppe
436. s a development channel application note the following possible exceptional situations The applications list Utilities gt Applications gt Laboratory Parameters is displayed The application name is displayed in square brackets for example GLU2 to indicate that the application is not installed yet To make the application available for performing tests you now need to install it a To install an application 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Select an application whose name is in square brackets 3 Press If This happens Both the application code and the short name exist The laboratory parameters for example the short name are retained from the existing application The application definitions are replaced on the system by the new ones The application code exists and the short name does not exist for any application on the system The laboratory parameters of the new application are used for example the short name The application definitions are replaced on the system by the new ones The short name exists but the application code does not A screen is displayed for changing the short name to a unique short name If you do not change the short name the application is not imported If you want to replace both the laboratory parameters and the application definitions you first need to uninstall and delete the existing application and then to import th
437. s are used for cleaning these are followed by a longer segment on which the measurements are made 4 The sample is passed to the ion selective electrodes by the action of the peristaltic pump The exact positioning of segments is ensured by the ISE sample sensor 5 In the meantime the ISE tower is washed with distilled water and dried 6 ISE Reference Solution is passed through the ISE Reference Electrode and into the measuring channel downstream of the electrodes The ISE Reference Solution completes the electrical circuits for each electrode so that measurements can be made While the measurements are made the sample and ISE Reference Solution are stationary 7 A one point calibration is performed after each sample measurement using the ISE Calibrator indirect urine which is located on ISE unit 8 The electrolyte concentration of the sample is calculated A ISE Reference Electrode B ISE Reference Solution sensor C ISE tower D Samples controls ISE Solution 1 and 2 Activator ISE Etcher and ISE Deproteinizer E ISE Reference Solution F ISE Calibrator indirect urine G Peristaltic pump H Measuring channel I Ion selective electrodes J Electrode block K ISE sample sensor Figure E 1 Main parts of the ISE measuring system K Ref Cl Na B G C I D E F K A J H Roche Diagnostics E 8 Operator s Manual Version 3 0 12 ISE description cobas c111 Ov
438. s definition if the cobas c111 instrument is connected to a host computer or to a computer run ning the cobas c111 Printer Tool The orders are automatically defined the test selec tion screen is not displayed After identifying the sam ple you are asked to place the sample Sample Barcode On Off You can work with or without barcodes on sample tubes Use Off only if you exclusively work without barcodes If you use On during order definition the option to type the sample ID manually is skipped Order Mode Easy You work with one test panel on the test selection screen containing up to 25 tests Typical situation for this mode You work with one or two reagent disks manual order identification iden tical sample and order IDs possibly but not necessar ily with host connection Full You can work with up to six test tabs on the test selec tion screen each containing up to 20 tests Typical situation for this mode You distribute the reagents across several up to eight reagent disks and you predominantly work with specific groups of tests for example for emergency situations or for testing diabetes You also work with a host connection with automatic order identification and result upload Sample ID Handling Order ID Sample ID The order ID is automatically defined when you iden tify the sample Independent IDs You define the sample ID and order ID independently of each other Grouped Sample ID Order an
439. s step associates the application with lot data and auxiliary fluids such as calibrators and controls e To prepare an application on page B 140 a To import application data 1 Do one of the following o Choose Utilities gt Applications gt Laboratory Parameters then continue with step 2 o Choose Utilities gt Import gt Application then continue with step 4 2 Press 3 Press Import Application A screen is displayed asking you to scan the barcode or to import the data from the USB stick 4 Do one of the following The system checks whether there is already an application on the system with identical application code and short name If Do this You intend to scan the barcode 1 Scan the barcode from the barcode sheet You intend to import from the USB stick 1 Press 2 Insert the USB stick 3 Press 4 Select the directory that contains the application file You recognize the application pack ages by their file extension tsb 5 Press to confirm the selection Roche Diagnostics B 138 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications The following table lists the basic situations e For detailed information on possible conflicts when importing applications see the section on installing and configuring development channel applications in the cobas c111 Development Channel Operator s Manual If the application you are importing i
440. s that were generated within about one minute Basically there are three kinds of error message texts o Messages that contain text only o Messages that contain an error code of the format a bbb xxx for example 3 000 121 o Messages that contain a nine digit error code for example 104000551 The following table lists selected messages and provides more detailed information on how to react to them In the Message or error code column of the following table the most relevant informa tion is the number the texts may be different on the actual instrument Message or error code Affected items Possible causes Comments 1 xxx 81 1 xxx 82 1 xxx 84 Instrument Fuse F1 F2 or F4 is defective Replace the low voltage fuse that is mentioned in the alarm message e See Changing the low voltage fuses on page D 49 109000572 code raised by IC software caused by an unexpected handling or sys tem situation Instrument The probe is bent or the trans fer head is poorly adjusted 1 Check that the probe is mounted properly and replace it if necessary e See Replacing the probe on page B 125 2 If the problem persists contact your service representative No connection to Instrument Control Instrument Fuse F3 is defective Check the LED of fuse F3 Replace the fuse if nec essary If the fuse has blown the LED is off e See Changing the low voltage fuses on page D 49 The LAN cable is not
441. s where limited space prevents the use of longer names control material A material used to assess the performance of an analytical procedure or part of an analytical procedure Also called the control sample control name The name of a control material for example PreciControl Universal CPU The Central Processing Unit of the system or computer CSF Abbreviation for cerebral spinal fluid A sample type for clinical analysis cup See sample cup cup on tube The placement of a smaller secondary sample container for example a Hitachi Cup on top of a primary sample tube cuvette Disposable plastic container into which sample reagents diluent and water is pipetted and where the sample pre dilution and reaction takes place cuvette port Section of the analyzer unit where cuvette segments are inserted and removed cuvette segment Cuvette holder containing 10 cuvettes cycle The instrument time interval during which pipetting or measurement can be carried out DAT Abbreviation for Drugs of Abuse Testing The abbreviation DAU is also used database A defined section of the computer memory where all instrument assay and patient relevant data are processed and stored DAU Drug of Abuse in Urine The old term for DAT or Drugs of Abuse Testing DB Abbreviation for database DBMS Abbreviation for database management system dead volume The amount of residual sample material in a sample tube or cup C D Ro
442. sage You need to deal with it immediately processing may not be able to continue unless you do so An acoustic signal is sounded when an alarm is generated You can adjust the volume Utilities gt Configuration gt System gt Volume LED Color Meaning Table A 4 LEDs and their meaning Roche Diagnostics Operator s Manual Version 3 0 A 43 cobas c111 3 Hardware Main components Main components The following figure illustrates the main components of the cobas c111 instrument Rotor Provides a cooled area for reagents cooling assembly and a heated channel for cuvettes It moves the containers to the correct position for loading removal pipetting and measuring Transfer unit Pipettes sample reagent and other fluids from their source to target containers such as cuvettes or the wash station Photometer unit Contains the absorbance photometer used for making absorbance measurements PCB main board Controls the instrument hardware A Rotor B Transfer unit C Photometer unit D PCB main board E Degasser F Sample area G Display H Syringe assembly I Front USB port J External fluid rack K Printer Figure A 9 Main hardware components J K A B C D E F I G H Roche Diagnostics A 44 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Fluid system not shown Transports all fluids around the instrument including s
443. scription cobas c111 Table of contents Roche Diagnostics Operator s Manual Version 3 0 E 5 cobas c111 12 ISE description Overview Overview The Ion Selective Electrode ISE module is a measurement system for electrolytes that runs independently of the main instrument The ISE unit uses the same samples and sample tubes that are used for photometric measurements and the samples are transferred using the same probe The ISE unit uses specific solutions some of which are kept in bottles on the ISE unit itself the others are transferred to sample tubes and placed on the sample area Abbreviations The following ISE specific abbreviations are used Abbreviation Definition CL I Chloride indirect CL U Chloride urine F Solution 1 factor K I Potassium indirect K U Potassium urine mV Measured voltage in millivolt NA I Sodium indirect NA U Sodium urine S Slope in mV dec Std 1 1 First measurement of ISE Solution 1 Std 1 2 Second measurement of ISE Solution 1 Std 2 Measurement of ISE Solution 2 Roche Diagnostics E 6 Operator s Manual Version 3 0 12 ISE description cobas c111 Overview Measuring modes The ISE unit makes in serum plasma and urine quantitative determinations of the following electrolytes o Sodium Na o Potassium K o Chloride Cl Measurements are done using indirect mode The samples controls and standard solutions are diluted w
444. short guide B 60 validating results B 64 B 65 calibration list screen A 104 calibration results auto accept B 64 obsolete A 28 calibrator lot defining B 103 calibrators placing B 32 B 62 B 63 specifications A 67 certificates importing B 115 changing configuration values B 135 low voltage fuses D 49 mains fuses D 47 orders B 42 password B 157 user definitions B 161 user interface language B 158 characters special A 78 checking alarm messages B 48 bottle sets B 23 B 100 cleaner B 18 external fluid containers B 15 instrument status B 46 ISE status E 21 printer status D 46 sample status B 44 waste B 17 water B 16 B 86 classification of safety notices A 5 Clean and disinfect housing maintenance action C 21 Clean ISE tower automatically maintenance action E 50 Clean ISE tower manually maintenance action E 51 Clean probe manually maintenance action C 12 Clean reagent disk and sample area maintenance action C 14 Clean rotor and heating channel maintenance action C 10 Clean the water and waste containers maintenance action C 16 cleaner checking external bottle B 18 replacing bottle B 18 cleaner bottle A 52 cleaning ISE tower off the instrument E 36 ISE tower on the instrument E 51 was
445. sor needs to be initialized to ensure its proper functioning Operator time Approximately 5 minutes Prerequisites The system must be in Standby status All covers must be closed Tools and materials required m Full external water container m Clean cloth a To initialize the degasser fluid sensor 1 Make sure that all covers on the instrument are closed 2 Choose Utilities gt Maintenance gt Initialize Degasser Fluid Sensor An instructions screen is displayed 3 Press The maintenance definition screen is displayed 4 Check whether the tube connecting the external water container with the instrument is full of water or contains air bubbles 5 Do one of the following If Do this You cannot see any air bub bles 1 Continue with step 6 You can see air bubbles or the tube is empty 1 Press to abort this maintenance action 2 Perform the maintenance action Prime Fluid System 3 Restart the maintenance action Initialize Degasser Fluid Sensor Roche Diagnostics Operator s Manual Version 3 0 C 31 cobas c111 8 General maintenance Maintenance actions 6 Lift the tubing adapter from the white water container 7 Place the tubing adapter on a clean surface Make sure the filter A is not obstructed and air can get to it 8 Press to initialize the fluid sensor The system aspirates air through the tubing adapter and initializes the fluid sensor When initialization is c
446. splayed for entering your password 4 Type your password and confirm by pressing The extra wash cycle definitions are deleted To ensure the highest effectiveness of probe cleaning extra wash cycles are performed automatically by the cobas c111 instrument when using development channel applica tions Roche strongly recommends to always use extra wash cycles with development channel applications and also to always load extra cleaner when tests with extra wash cycles are used Roche Diagnostics Ltd assumes only limited liability when using the cobas c111 instru ment in conjunction with the cobas c111 Development Channel Programming Software For detailed information on this matter refer to the latest version of the Development Chan nel Registration Form cobas c111 and the cobas c111 Development Channel Operator s Manual Roche Diagnostics B 172 Operator s Manual Version 3 0 7 Configuration cobas c111 Configuration Short guide to extra wash cycle definitions f Utilities gt Applications gt Extra Wash Cycles gt Extra wash cycle definitions Item Values Comment Active On Off Defines whether the extra wash cycle can be applied or not Action None Before After Defines when in relation to the pipetting action from the bottle defined in Trigger Bottle Code and Pipet ting Type the extra wash cycle should be performed Trigger Bottle Code 0 999 Bottle set code of the fluid that tri
447. ss B FCC rule compliance 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 reason able protection against harmful interferences when the equipment is operated in a resi dential area However this equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the present manual may cause harmful interference to radio communications The electromagnetic environment should be evaluated prior to operation of the device WARNING Malfunction of instrument and incorrect results due to nonapproved parts Use of nonapproved parts or devices may result in malfunction of the instrument and may render the warranty null and void Only use parts and devices approved by Roche Diag nostics WARNING Malfunction of instrument and incorrect results due to third party software Installation of any third party software that is not approved by Roche Diagnostics may result in incorrect behavior of the system Do not install any nonapproved software Roche Diagnostics Operator s Manual Version 3 0 A 9 cobas c111 1 Safety Safety information Operator qualification Operation over an extended period of time Cross contamination of sample Insoluble contaminants in sample Spillage WARNING Incorrect results or damage to the analyzer due to wrong operation Ope
448. ssage ID 56 Priority 9 Recommended actions CAL 1 Check if the correct calibrators are placed on the instrument 2 Repeat with fresh calibrators CNTL 1 Check control Repeat with fresh control TEST 1 Rerun with dilution Roche Diagnostics D 32 Operator s Manual Version 3 0 10 Result flags cobas c111 List of flags lt Kin Read Meaning Insufficient kinetic reading points Message ID 11 Priority 11 Possible cause o Not enough kinetic readings o Insufficient absorbance readings were found in the linear part of the reaction to be able to calculate a rate o Not enough readings in kinetic range for calc mode Kinetic Recommended actions CAL 1 Check reaction plot 2 Repeat with fresh calibrator CNTL 1 Check reaction plot 2 Repeat with fresh control TEST 1 Check reaction plot 2 Rerun with dilution or concentration if necessary Low Act Meaning Low activity This check is used to identify zero pipetting for samples and reagents o The absorbance change during measurement is below the accepted limit i e the reaction has taken off too slowly Possibility of substrate exhaustion o The absorbance change during the measurement is lower than the defined limit Message ID 56 Priority 9 Recommended actions CAL 1 Check if the correct calibrators are placed on the calibrator rack 2 Repeat with fresh calibrators CNTL 1 Check t
449. st At the end of performing a diagnostics action system status transition from Diagnostics to Ready the system checks that all modules are initialized if they are not initialization is performed Roche Diagnostics Operator s Manual Version 3 0 A 117 cobas c111 5 Software Key screens Inventory The inventory displays information on all bottle sets that are defined on any of the disks used on this cobas c111 instrument including sets that were removed from the disk as long as they were not empty or their expiration date had not passed yet Bottle sets that have been removed from the disk and whose expiration date had passed more than 30 days ago are automatically deleted from the Inventory list provided there is still a valid set for the same fluid on board If this were not the case the set that was loaded last would remain in the inventory f Utilities gt Inventory Print the bottle set list You can choose one of the following options o List o Detail of Bottle Set Display details on the selected bottle set Delete the selected bottle set from the list Bottle sets must be removed from the disk before you can delete them from the list Apply filter criteria to the Inventory list You can choose one of the following criteria o All o By ID Figure A 81 Bottle set inventory Roche Diagnostics A 118 Operator s Manual Version 3 0 5 Software cobas c111 Key screens I
450. st Not Accepted Figure A 42 List button names Roche Diagnostics A 80 Operator s Manual Version 3 0 5 Software cobas c111 Working with the user interface Printing information On many screens you can print the contents of the working area on the built in printer In many cases a screen is first displayed for selecting the kind of data you want to print In these cases the print button is marked with a triangle in the top right corner a To print information 1 Press If filter criteria are available a screen is displayed for selecting what data you want to print For example 2 Choose one of the print options The appropriate data is automatically selected and printed A In the status line the screen is indicated where you pressed A Choose gt to terminate the printing task if required Roche Diagnostics Operator s Manual Version 3 0 A 81 cobas c111 5 Software Working with the user interface Using online Help The Help button is a permanent feature of all screens a To display the Online Help 1 Press A The Help button is always in the top right corner of the screen Figure A 43 Permanent Help button A A The Legend tab describes the buttons and their colors B The Workflow tab provides additional information on items on the screen or on actions you can perform Figure A 44 A B Roche Diagnostics A 82 Operator s Manual
451. stable The absorbance values near the endpoint show unacceptable fluctuation Message ID 9 Priority 8 Recommended actions CAL 1 Repeat with fresh calibrators if only calibration is flagged 2 If the flag is on control sample or on calibration repeat results replace the reagent set CNTL 1 If only one control is flagged repeat with fresh control 2 If more than one control and sample result is flagged replace the reagent set TEST 1 Rerun diluted 2 If only one sample result is flagged repeat with fresh sample 3 If more than one sample result is flagged or a repeat result replace the reagent set 4 If a serum protein test result is flagged repeat with dilution Roche Diagnostics Operator s Manual Version 3 0 D 31 cobas c111 10 Result flags List of flags High Abs Meaning Excessive absorbance The absorbance value to be used for calculation and checks is gt 2 0 Abs Message ID 5 Priority 1 Recommended actions CAL o Repeat with fresh calibrator CNTL o If a single control is flagged rerun with a fresh control o If more than one control is flagged perform a calibration TEST o If a single sample result is flagged rerun with dilution o If the problem persists replace the reagent set High Act Meaning High activity o The absorbance change during measurement is above the accepted limit i e the reaction has taken off too fast Me
452. station after every pipetting action which prevents carry over between tests A Fluid sensor B Probe C Syringe Figure A 12 Probe and syringe B A C Roche Diagnostics Operator s Manual Version 3 0 A 47 cobas c111 3 Hardware Hardware overview Wash station The probe is washed after each pipetting It is lowered in the wash station and then cleaner is pumped through the probe to wash it in and outside Next water is pumped through the probe to flush away the cleaner The wash station is connected by tubing to the internal waste container External fluid connectors The three external fluid containers must be properly connected before you switch on the cobas c111 instrument Figure A 13 Wash station A Water connector B Cleaner connector C Waste connector Figure A 14 External fluid connectors A B C Roche Diagnostics A 48 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Transfer unit The transfer unit moves the probe to the correct positions for all pipetting and cleaning actions The following figure shows the major parts of the transfer unit Transfer head The transfer head moves horizontally along the X axis the probe moves up and down Z axis and it performs a rotational movement for mixing the cuvette and reagent bottle content Transfer head arrest When the transfer head is obstructed in its horizontal movement it immediatel
453. stem does not inform you about the due status Use this value if the reagent is stable enough over the whole period until it is empty and you replace it Calibration is due whenever a new reagent set is loaded on the instrument Interval Only Due whenever the reagent interval has expired Each Set and Interval Due whenever a new reagent is loaded and when the interval has expired The interval starts again whenever you place a new reagent set You can turn off the interval check by defining its duration as 0 zero Each Lot and Interval Due whenever the fist reagent of a new lot is loaded and then each time the interval has expired The interval re starts whenever you calibrate a reagent set You can turn off the interval check by defining its duration as 0 zero If you install a reagent set of the same lot no cal ibration is required The system uses the Lot calibration result as the Set calibration result of the new reagent set Interval Number of days For ISE 1 day fixed Use 0 zero if the Sequence is set to No Interval Replicates 1 2 Number of times each measurement should be repeated Table B 13 Calibration definitions Roche Diagnostics B 154 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications Control definitions Item Values Comment Sequence No Interval The system does not inform you about the due status Use this value if you intend to p
454. stem status A 95 test selection A 88 test status A 90 users A 119 worklist A 107 scrolling A 75 segments of cuvettes A 55 selecting groups of list items See filtering selecting tests to be calibrated B 62 sensors ISE E 11 sequence of processing B 145 service representative contacting C 27 setting up order definition B 37 sheets barcodes B 90 shift finishing B 77 starting B 10 short guides analyzing samples B 35 calibration B 60 End of Shift B 78 ISE Prepare phase E 20 Prepare phase B 13 QC B 69 shutting down the system end of shift B 88 stop option A 121 software importing B 113 updating B 114 software data handling specifications A 67 solutions ISE E 8 special characters A 78 specifications technical A 66 spillages safety A 9 standby ISE status E 12 starting a run B 44 processing B 44 shift B 10 STAT orders B 41 status cuvettes B 28 instrument B 46 ISE unit E 69 reagent sets B 23 sample tubes B 44 standby for ISE E 12 system A 35 stop screen A 121 stopping printing A 80 B 58 processing B 49 run B 49 storage facilities specifications A 67 switching between upper and lower case A 77 off B 88 on B 10 symbols 8 Roche
455. sult in infection All materials and mechanical components associated with samples of human origin are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch moving parts during instrument operation Incorrect results or damage to the analyzer due to wrong operation Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics o Start all maintenance actions on the screen Do not perform maintenance actions with out the assistance of the user interface o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to trained service representatives o Follow standard laboratory practices especially when working with biohazard material Where a flag description gives a
456. system External components such as the scanner and the ISE power supply which are marked with the crossed out wheeled bin symbol are covered by the European Directive 2002 96 EC WEEE These items must be disposed of via designated collection facilities appointed by govern ment or local authorities For more information about disposal of your old products contact your city office waste disposal service or your local service representative WARNING The instrument must be treated as biologically contaminated hazardous waste Final dis posal must be organized in a way that does not endanger waste handlers As a rule such equipment must be sterile before it is passed on for final disposal For more information contact your local service representative Roche Diagnostics Operator s Manual Version 3 0 A 13 cobas c111 1 Safety Safety labels Safety labels Read all safety labels on the instrument and equipment The following illustration shows where on the instrument labels are displayed In addition to safety labels on the instrument there are safety notes in the corresponding parts of the Operator s Manual These safety notes give more detailed information about potentially hazardous situations that may arise during daily operation or when carrying out maintenance procedures When working with the instrument be sure to observe both the safety labels on the instrument and the safety notes in the Operator
457. system if last shift n a n a Task Steps Navigation With wizard As individual steps Table A 1 Overview of the daily operation tasks Roche Diagnostics Operator s Manual Version 3 0 A 25 cobas c111 2 Introduction to the instrument Daily operation Reagent and diluent handling Reagent disk On the instrument the reagents are stored on a reagent disk It provides space for 27 bottles allowing up to 14 reagent sets to be installed on the disk assuming that most tests need two reagents Extra diluents and cleaners are also loaded on the reagent disk You can work with up to eight different reagent disks on one cobas c111 instrument You always load and remove bottles while the disk is on the instrument The system needs to know exactly what is loaded on the disk When you finished running tests you can remove the whole reagent disk place it in a reagent disk container and store it in a refrigerator Bottles cobas c111 reagents diluents and extra cleaners are provided in uniform bottles They are supplied with two dimensional barcodes and placed on the reagent disk with their cap removed Chimneys Chimneys are bottle inserts that reduce evaporation For reagents that are especially sensitive to concentration changes Roche recommend using chimneys on the reagent bottles See the package inserts of the tests whether you should use chimneys or not To generally reduce evaporation you may use chimneys on
458. t a To activate or deactivate an application 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Expand the application entry 3 Expand the General entry 4 Select Active 5 Press 6 Choose On if you want to use the application Choose Off if you do not want to use the application 7 Press Roche Diagnostics B 140 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications Preparing applications Perform following steps for each new application Use the wizards to make the definitions e For the general procedure of making changes to definitions see To change a value on page B 135 a To prepare an application 1 Choose Utilities gt Applications gt Laboratory Parameters 2 Expand the application entry Code The Roche application code identifies the application It is used for host communication If you work with a different code for a particular application you need to map the Roche application code to your own code e See Mapping the host codes on page B 162 This code is also used on the cobas c111 Printer Tool The codes on the cobas c111 system and on the Printer Tool must correspond Version The version uniquely identifies a particular set of application definitions The version number increases whenever there is a change to the application definitions for example from version 1 0 to 1 1 General definitions 3 Expand the General en
459. t touchscreen An input device that allows the user to interact with the computer by touching the display screen turn around time 1 The time between the decision to perform a test and the time when the doctor receives the result and can act on it 2 Inside the laboratory Lab TAT Time between receiving a sample and sending out the validated result unit A chosen reference quantity of an analyte used to compare quantities of the same dimension for example mol L g L or U L user The person who operates and controls the analytical instrument or a computer system See also operator user interface The part of a system exposed to a user In a computer system the user typically interacts with an operating system or with application software With these the user interacts by using menus icons keystrokes mouse clicks and similar means validation The process of checking results or data against defined rules or ranges in clinical laboratories Validation can be against technical or clinical criteria waste Anything discarded by the analyzer waste can be liquid or solid worklist A report generated by an analytical instrument A worklist aids a user by listing calibrators controls and samples currently loaded on the sample area T U V W Roche Diagnostics F 10 Operator s Manual Version 3 0 Glossary cobas c111 worklist worklist Roche Diagnostics Operator s Manual Version 3 0 F 11
460. t Cal type Cal Usage 1 NA 1 Place first reagent set of new lot 2 Calibrate set L1 1 Result 1 L1 1 Lot Current 2 Reagent empty 1 Remove set L1 1 2 Place new set L1 2 Result 1 L1 2 L1 1 Set Lot Current Reagent empty Replace set whenever it is empty Result 1 Set Current 5 Interval expired Calibrate current set L1 n Result 2 L1 n L1 n 1 Set Set Current Obsolete 6 Reagent empty Place new set L1 n 1 Result 1 L1 n 1 L1 n Set Set Current Obsolete 8 Reagent empty New lot 1 Remove set L1 n 1 2 Place new set which is the first set of a new lot 3 Calibrate set L2 1 Result 3 L2 1 L1 1 L1 n 1 Lot Lot Set Current Obsolete Obsolete Reagent empty Place new set L2 2 Result 3 L2 2 L2 1 Set Lot Current 10 Interval expired Calibrate current set L2 n Result 4 L2 n L2 n 1 Set Set Current Obsolete 11 Reagent empty Place new set L2 n 1 Result 3 L2 n 1 L2 n Set Set Current Obsolete Table A 2 Example for set change and calibration types Roche Diagnostics A 28 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Daily operation Calibration sequence The calibration sequence is an application definition It defines the manner in which the system determines when a calibration is due The calibration interval defines the
461. t Check if the probe and probe holder are correctly installed Replace a bent probe Check the magnetic slider Restart the system If the error persists call service 12001 The host computer did not answer the order query for sample s within the time limit Check the communication and existing orders on the host 12002 The communication port is not accessible Communication to the host server is not possible Check the Host Settings and compare them with the host server settings 12003 Sending a message to the host computer failed Enable the host trace file in the Host Settings in order to record HIF communication activities 12004 Receiving or processing a message from the host computer failed Enable the host trace file in the Host Settings in order to record HIF communication activities ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics D 20 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 List of alarm messages 12005 Host server could not send message to the host Select result and perform Retransmit If the problem recurs enable the host trace file in the Host Settings Retransmit again and export the log files If the error per sists call service 12006 Changes of the host communication settings could not be applied Restart the system If the error persists call service 13001 A software error d occurred The database could not be opened
462. t allows you to hand over operation to another operator or to switch off the instrument Safety information Make sure that you have read and understood section Safety information on page B 5 The following safety messages in particular are relevant Warning messages o Injury through reagents and other working solutions on page B 5 o Infection by biohazardous materials on page B 5 o Injury through reagents and other working solutions on page B 5 WARNING Skin inflammation caused by reagents Direct contact with reagents may cause skin irritation inflammation or burns When handling reagents be sure to wear protective equipment and observe the cautions given in the package insert Roche Diagnostics B 78 Operator s Manual Version 3 0 6 Daily operation cobas c111 Finishing the shift Short guide The following table provides an overview of the steps that make up the end of shift process Step User action 1 Check for unfinished tasks 1 Check for unfinished orders 2 Check for nonvalidated results 3 Check for results that were not transmitted 2 Start the End Shift wizard 1 On the Overview tab press the End Shift but ton 3 Perform data backup 1 Press 2 Insert the USB stick 3 Press 4 Select the directory 5 Press 6 Press to proceed to the next stage in the End Shift wizard 4 Export support data 1 Press 2 Insert the USB stick if you have remo
463. tart the action A message will inform you when the maintenance action is complete 6 Remove the Activator from the sample area 7 Press Make sure that you have read and understood section Safety information on page E 42 The following warning messages in particular are relevant o Injury through working solutions on page E 42 o Infection by biohazardous materials on page E 42 Roche Diagnostics Operator s Manual Version 3 0 E 47 cobas c111 14 ISE maintenance ISE maintenance actions Initialize ISE Reference Solution sensor f Utilities gt Maintenance gt Initialize ISE Reference Sensor Initializing the ISE Reference Solution sensor ensures proper detection of possible air in the ISE tubing This maintenance action forms part of the Replace ISE Unit Tubing maintenance action Operator time Approximately 1 minute Prerequisites The system must be in Standby status Tools and materials required m Tissues a To initialize the ISE Reference Solution sensor 1 Select the maintenance action Initialize ISE Reference Sensor 2 Press The maintenance definition screen is displayed 3 Press to start the action The instrument pumps ISE Reference Solution through the ISE tubing You are asked to remove the tubing adapter from the ISE Reference Solution bottle 4 Open the ISE cover 5 Remove the tubing adapter from of the ISE Reference Solution bottle o Have a clean lint f
464. te container C 17 water container C 16 cleaning up database C 23 results B 84 Cleanup database maintenance action C 23 clearing paper jam D 46 collapsing lists A 76 colors alarm LED A 83 B 48 cleaner button B 18 concept A 71 A 74 cuvette buttons B 28 instrument buttons B 47 ISE bottle buttons E 30 ISE LED E 10 LEDs A 41 A 122 maintenance actions B 19 reagent buttons B 25 sample buttons B 44 test buttons B 31 waste button B 17 water button B 16 components disposal A 12 instrument A 43 ISE unit E 10 concepts calibration A 26 colors in screens A 71 A 74 wizards A 71 condensation removing from the reagent cooler B 124 Condition ISE tubing maintenance action E 46 Roche Diagnostics Operator s Manual Version 3 0 F 13 cobas c111 Index configuration B 133 B 157 Abs adjustment B 169 calibration definitions B 167 changing values B 135 date and time B 169 extra wash definitions B 170 B 171 B 172 B 173 host definitions B 165 maintenance days B 169 QC definitions B 167 result handling B 167 screen A 109 system definitions B 168 viewing values B 135 workflow definitions B 164 confirming alarm messages D 9 connecting exte
465. te the calibration You can choose one of the following options o Accept Set o Accept Lot o Repeat o Use Old Use Use Old to override and reset the calibration due date and to continue using the old calibration results Define a new calibration order Figure A 66 Calibrations list Roche Diagnostics Operator s Manual Version 3 0 A 105 cobas c111 5 Software Key screens Delete the selected calibration result Apply filter criteria to the calibration results list You can choose one of the following criteria o All o Current Lot data f Workplace gt Lot Data Choose the kind of material for which you want to handle lot data Controls Handle control lots Calibrators Handle calibrator lots Figure A 67 Select lot type Roche Diagnostics A 106 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Lot list f Workplace gt Lot Data then choose a lot type The content of this list depends on the selected lot type The following screen is an example of calibrator lot data Print lot data With a calibrator selected Expand or collapse the list With a test selected Expand or collapse the list With a value selected Change the value With a calibrator selected Add a lot With a test selected Assign a test to the lot With a value selected Not active With a calibrator selected Delete the lot values of the calibrator With a t
466. tear of the tubing See Deactivating the ISE unit on page E 64 Roche Diagnostics Operator s Manual Version 3 0 E 13 cobas c111 12 ISE description Technical specifications Maintenance actions Maintenance of the ISE unit is integrated in the maintenance of the main instrument The system software guides you through the maintenance procedures Maintenance actions are performed after a certain event or after a defined interval has expired e For ISE specific maintenance actions see Chapter 14 ISE maintenance Technical specifications e See Technical specifications on page A 66 Roche Diagnostics E 14 Operator s Manual Version 3 0 12 ISE description cobas c111 Technical specifications Roche Diagnostics Operator s Manual Version 3 0 E 15 cobas c111 13 ISE operation Table of contents ISE operation In this chapter you will find information on performing the routine tasks that are required for processing tests using the ISE unit Daily operation E 17 Safety information E 19 Preparing the system E 20 Short guide
467. tely and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Personal injury or damage to the analyzer due to contact with instrument mechanism Do not touch any parts of the instrument other than those specified During operation and maintenance of the instrument proceed according to the instructions Keep all covers closed operate them as instructed on the screen Incorrect results or damage to the analyzer due to wrong operation Operators are required to have a profound knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator s Manual o Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics o Start all maintenance actions on the screen Do not perform maintenance actions with out the assistance of the user interface o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to trained Roche support representative personnel o Follow standard laboratory practices especially when working with biohazard material Roche Diagnostics E 20 Operator s Manual Version 3 0 13 ISE operation cobas c111 Daily operation Preparing the system Short guide The following table provides an overview on t
468. ter of the quality specified in section Technical specifications 2 Connect the water tubing to the connector on the instrument by pushing the plug firmly in the socket 3 Insert the tubing adapter in the container and push it down firmly A Water container B Tubing adapter C Water connector Figure B 41 A B C Roche Diagnostics B 128 Operator s Manual Version 3 0 6 Special operations cobas c111 Connecting and disconnecting the external fluid containers a To connect the waste container 1 Place the empty yellow waste container on the tray 2 Connect the waste tubing by pushing the plug firmly in the socket 3 Insert the tubing adapter in the container and push it down firmly a To connect the cleaner bottle 1 Place the bottle on the tray 2 Screw the cleaner tubing to the connector on the instrument Do not fasten the screw too tight 3 Insert the tubing adapter in the container and push it down firmly A Waste container B Tubing adapter C Waste connector Figure B 42 A B C A Cleaner bottle B Tubing adapter C Cleaner connector Figure B 43 A B C Roche Diagnostics Operator s Manual Version 3 0 B 129 cobas c111 6 Special operations Connecting and disconnecting the external fluid containers a To disconnect a tube from the instrument 1 Remove the right side panel 2 Do one of the following If Do this You want to disconnect
469. ters Sample barcode You can use sample tubes with or without barcode Dilution Pre dilution is used when performing calibration Post dilution is used when measuring samples The dilution factor is part of the application definition and therefore does not need to be defined by the operator Removing sample tubes You can remove sample tubes as soon as pipetting is complete Order handling Order Mode The order mode reflects the way in which you organize the tests on the test selection screen Choose Easy if the reagents fit on one or two reagent disks and you work with one test panel on the screen You can fit up to 25 tests and profiles on this panel Choose Full if you distribute the reagents across several up to eight reagent disks and if you predominantly work with specific groups of tests for example for emergency situations or for testing diabetes You can assign up to 20 tests and profiles to each panel tab Order ID The order ID is an identifier of up to 23 alphanumeric characters that is unique within the laboratory The order ID identifies the order and links it to the sample Order and sample IDs are often identical Using separate IDs makes sense when working with a host system Order IDs are defined either by scanning a barcode or by typing them manually Because there is limited space when displaying lists on screens Roche recommend to limit the ID to 13 characters Patient demographics The cobas c
470. tests from a profile B 149 Deleting profiles B 149 Defining control definitions and lots B 149 Defining calibrator definitions and lots B 150 Short guide to application definitions B 152 Version B 152 Code B 152 General application definitions B 152 Calibration definitions B 153 Control definitions B 154 Calculation definitions B 155 Calculation definitions ratio applications B 155 In this chapter Chapter 7 Roche Diagnostics B 134 Operator s Manual Version 3 0 7 Configuration cobas c111 Table of contents Laboratory correlations ratio ap
471. the ISE unit failed due to a fluid transport problem Check the ISE tower and the ISE tubing for obstructions and leaks Check the electrodes Perform lt Initialize ISE Unit gt If the error persists call service 7083 s The ISE bypass tubing is blocked Perform lt Replace ISE Unit Tubing gt Follow the instruc tions in the Operator s Manual If the error persists call service 7084 s An ISE pinch valve is probably defective Restart the system If the error persists call service 7086 s The ISE air pressure is outside the range Check the air tubing underneath the ISE tower for obstructions If the error persists call service 7087 s ISE air pressure sensor detected that the pressure is too low Restart the system If the problem persists call service 7088 s A failure of the internal ISE power supply has been detected Restart the system If the error persists call service 7099 s Weight sensors of the ISE Ref and ISE Cal bottle are not calibrated correctly In lt Diagnostics gt perform lt Adjust ISE Ref Bottle Sensor gt and lt Adjust ISE Cal Bottle Sensor gt If the error persists call service 7100 A power fail has been detected and an automatic system restart was performed 7101 s Rotor position error Switch off the instrument Check if the rotor is blocked or jamming Eliminate the cause Restart the system If the error persists call service 7102 s Transfer bumper init failed
472. the main cover User intervention is required for example you are expected to place or remove a bottle The system is performing some action Do not handle the cover An acoustic signal is sounded when the cover is open while the system is in Operating state You can adjust the volume Utilities gt Configuration gt System gt Volume Sample area LED Off No activities in this area You can remove sample tubes You are expected to place a sample tube Blinking The transfer head is approaching Do not place your hand or any object in the sample area Start LED Off You cannot start the measuring process You can start the measuring process Table A 11 LEDs and their meaning B A C Roche Diagnostics Operator s Manual Version 3 0 A 123 cobas c111 5 Software Color interpretation for LEDs Stop LED Off Pressing does not have any effect Pressing leads to the various stop options Alarm LED Off There are no unconfirmed alarm messages There is at least one unconfirmed alarm message You need to deal with it as soon as possible There is at least one unconfirmed alarm message You need to deal with it immediately processing may not be able to continue unless you do so An acoustic signal is sounded when an alarm is generated You can adjust the volume Utilities gt Configuration gt System gt Volume LED Color Meaning Table A 11 LEDs and their meaning Roche Diagnost
473. the maintenance action Prime ISE Reference and Calib 2 Press The maintenance definition screen is displayed 3 Press to start the action The instrument pumps first ISE Reference Solution and then ISE Calibrator indirect urine through the ISE tubing and past the electrodes A message will inform you when the maintenance action is complete 4 Press Roche Diagnostics Operator s Manual Version 3 0 E 49 cobas c111 14 ISE maintenance ISE maintenance actions Electrode service f Utilities gt Maintenance gt Electrode Service The electrodes must be cleaned regularly to prevent the buildup of deposits and so to maintain the efficiency of the ISE unit During this action the ISE Sodium Electrode is etched and all electrodes are deproteinized and activated and the tubing is conditioned Operator time Approximately 9 minutes Prerequisites The system must be in Standby status Tools and materials required m ISE Etcher m Activator m ISE Deproteinizer a To perform electrode service 1 Select the maintenance action Electrode Service 2 Press The maintenance definition screen is displayed 3 Press to start the action A placement list is displayed 4 Place the Activator ISE Deproteinizer and ISE Etcher on the sample area positions indicated on the screen 5 Press to confirm the placement and to start the action A message will inform you when the maintenance action
474. the reagent disk 1 Get the reagent disk from the refrigerator and remove it from its container 2 Open the main cover A screen is displayed asking you to insert the disk 3 Place the reagent disk in the reagent cooler Make sure the reagent port faces the front and align the cut outs with their counterparts on the reagent cooler The system automatically detects that a disk was inserted A screen is displayed asking you to close the main cover 4 Close the main cover At this stage the system identifies the disk A screen is displayed that shows the status of the reagent sets Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page B 5 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page B 5 CAUTION Spillage through tipping reagent disk The reagent disk container can slip off or tip over if it is not placed on an even horizontal surface When storing the reagent disk container make sure to place it on a firm even horizontal surface that is easily accessible When handling the reagent disk make sure not to tilt it When handling the reagent disk without using the Prepare wizard Choose Overview gt Roche Diagnostics B 22 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing
475. the water tubing Press down the release clamp A on the connecting socket and pull the connector away from the socket You want to disconnect the diluent tubing Turn the connecting screw B counter clockwise until the connector is released You want to disconnect the waste tubing Press down the release clamp C on the connector and pull the connector away from the socket A Release clamp on water connecting socket B Diluent connector screw C Waste connector release clamp Figure B 44 A B C Roche Diagnostics B 130 Operator s Manual Version 3 0 6 Special operations cobas c111 Adjusting the touchscreen Adjusting the touchscreen With a touchscreen it is important that the point where you press the screen corresponds exactly with its hardware equivalent If this were not the case pressing a screen item such as a button might not lead to the expected result a To adjust the touchscreen 1 Press the global button A screen is displayed that offers several kinds of stopping 2 Press the global button again A screen for adjusting the screen is displayed 3 Press exactly in the center of the black cross The cross turns green and the next cross turns black 4 Press exactly in the center of the black cross The cross turns green and the next cross turns black 5 Press exactly in the center of the black cross All crosses are green 6 Press anywhere in the screen and observ
476. tion may result in infection All materials and mechanical compo nents associated with the waste systems are potentially biohazardous o Be sure to wear protective equipment Take extra care when working with protective gloves these can easily be pierced or cut which can lead to infection o If any biohazardous material is spilled wipe it up immediately and apply disinfectant o If waste solution contacts your skin wash it off immediately with water and apply a dis infectant Consult a physician Whenever the term purified water is used in this document water of at least the quality specified in chapter Technical specifications must be used Roche Diagnostics E 44 Operator s Manual Version 3 0 14 ISE maintenance cobas c111 ISE maintenance actions Daily prepare actions f Utilities gt Maintenance gt Daily Prepare Actions To make it easier and more efficient for the operator some daily maintenance actions that may take quite some time are grouped into one maintenance action This way the operator does not have to remain near the instrument while the actions are performed The following maintenance actions are included if due o Initialize ISE Unit o Electrode Service o Clean ISE Tower Automatically o Deproteinize Probe In addition a main calibration is performed Operator time Approximately 25 minutes Prerequisites The system must be in Standby status Tools and materials require
477. to perform during daily operation Task Steps Navigation With wizard As individual steps 1 Starting the system 1 Switch on the system 2 Logging on the system Overview gt Logon 3 Preparing the system Start the Prepare wizard Overview gt Prepare 1 Check the external fluid containers Overview gt gt 2 Perform the maintenance actions that are due Utilities gt Maintenance 3 Load the reagent disk Overview gt 4 Check the reagents Overview gt 5 Check the cuvettes Overview gt 6 Perform mixing Overview gt gt test gt 7 Perform calibrations that are due Workplace gt Calibrations gt gt 4 Defining orders Start the Orders wizard Overview gt Order or Overview gt STAT 1 Identify the sample n a 2 Select the tests n a 3 Place the sample n a 4 Start the run 5 Monitoring the progress n a Overview 6 Validating results 1 View results n a Workplace gt Result Review 2 Handle flagged results n a Workplace gt Result Review gt gt Repeat gt Rerun 3 Accept results n a Workplace gt Result Review gt gt Accept Table A 1 Overview of the daily operation tasks Roche Diagnostics Operator s Manual Version 3 0 A 23 cobas c111 2 Introduction to the instrument Daily operation 7 Performing calibrations Performing individual calibrations 1 Start the wizard Workplace gt C
478. tomatically initializes the transfer head and performs the Prime Fluid System maintenance action A message will inform you when the maintenance action is complete 12 Press NOTICE Probe damage and instrument malfunction due to inappropriate probe handling Applying unilateral side pressure on the probe can lead to its deformation and conse quently to instrument malfunction Make sure to apply equal pressure on both sides and to move exactly in the direction of the probe when wiping it Roche Diagnostics C 14 Operator s Manual Version 3 0 8 General maintenance cobas c111 Maintenance actions Clean reagent disk and sample area f Utilities gt Maintenance gt Clean Reagent Disk To remove possible spillages you must clean the reagent disk and sample area regularly This maintenance action involves the following steps o Cleaning the reagent disk o Cleaning the sample area Operator time Approximately 10 minutes Prerequisites The system must be in Standby status Tools and materials required m Alcoholic cleansing tissues m Tissues m Commercial nonabrasive detergent a To clean the reagent disk 1 Select the maintenance action Clean Reagent Disk 2 Press The maintenance definition screen is displayed 3 Press 4 Open the main cover 5 Remove the reagent disk 6 Remove spillages and stains on the disk with alcoholic cleansing tissues 7 Wipe the inside of the re
479. try select Short Name and press 4 Change the short name up to 5 alphanumeric characters if required The short name affects the display of the test name in the user interface for example test buttons or test names in the orders and results lists and in all printouts 5 Press and change the long name up to 30 alphanumeric characters of the test if required The long name is a telling description of the test It is particularly useful if the short name is not generally familiar in the laboratory environment 6 Press and then On to activate the application If an application is not active its associated tests are not available for use You cannot select them on the test selection screen The application definitions remain on the system 7 Press and select the buttons of the tabs the test should be available from e For details see Assigning tests to test tabs on page B 119 8 Press to confirm the definitions Calibration definitions For Roche calibrators recommended definitions are automatically defined for each application You can change the sequence interval and the replicate value if required 9 Expand the Calibration entry select Sequence and press Roche recommend not to change the calibration definitions of Roche reagents Roche Diagnostics Operator s Manual Version 3 0 B 141 cobas c111 7 Configuration Applications 10 Change the sequence if required The sequence values
480. ts are finished and the system status has changed to Standby LED Meaning Possible action No color off There are no unconfirmed alarm messages No action is required Yellow There is at least one unconfirmed alarm message User intervention is required as soon as possible Processing can continue for the time being Check the details of the message Red There is at least one unconfirmed alarm message Immediate user intervention is required Processing may not be able to continue without it Check the details of the message An acoustic signal is sounded when an alarm is created You can adjust the volume Utilities gt Configuration gt System gt Volume Roche Diagnostics Operator s Manual Version 3 0 B 49 cobas c111 6 Daily operation Analyzing samples Stopping and restarting a run a To stop a run 1 Press the global action button A screen is displayed that offers several kinds of stopping each of them representing a certain level of interrupt Interpreting the screen Figure B 15 Abort When the system is in Operating status Stop immediately all pro cessing activities Pipettings that were not finished are considered not pipetted Measurements that have not yielded a valid result are considered not measured Recover When in Standby or Stopped status Initialize all systems and mod ules that are currently not ready Sampling stop Finish the current pipetting action
481. ts it is associated with in order to define the ranges and values that determine the correct functioning of the instrument This is typically done both for the normal and the pathological analyte concentration e For an overview on QC see Quality control QC on page A 30 For information on QC configuration see Defining control definitions and lots on page B 149 There are two basic ways of performing QC on the cobas c111 instrument Default QC Default QC is an automated process for performing QC measurements in one request This is the ideal method if you want to perform QC on certain days or at certain times This process only applies to tests whose controls are defined to be performed as part of Default QC Therefore if you intend to work with Default QC you need to configure the tests accordingly e See Defining control definitions and lots on page B 149 Performing Default QC follows a streamlined procedure whereby QC orders are automatically defined as soon as you identify a control An order is defined for all tests for which this control is defined as the Default QC provided the test is currently active on the system Interval QC Interval QC is a process that is suitable both for performing a single QC measurement and for performing all QC measurements that are due You can select all tests that require QC simply by pressing a button This selection also reflects QC of the type QC after Cal A wizard helps you select
482. uctions If the error persists call service 7141 s Cl calibrator measurement unstable Perform lt Electrode Service gt and lt Prime ISE Reference and Calib gt Check ISE Cal and Ref flow Check the ISE tubing for obstructions If the error persists call service 7142 s K calibrator measurement unstable Perform lt Electrode Service gt and lt Prime ISE Reference and Calib gt Check ISE Cal and Ref flow Check the ISE tubing for obstructions If the error persists call service 7143 d An internal software problem d occurred The access to the internal EEPROM failed Restart the system If the error recurs export the log files with the system remaining in this error condition If the error persists call service 7144 d The instrument battery is low or not connected The date and time may no longer be valid A replacement of the battery is probably required Call service 7145 d The action lt Clean ISE gt has been stopped due to an open cover Ensure that all covers are closed while the system is being initialized or in the Operating or Maintenance status ID Message Comment Table D 1 List of alarm messages Continued Roche Diagnostics Operator s Manual Version 3 0 D 19 cobas c111 9 Messages and alarms List of alarm messages 7146 d The initialization of the system has been stopped due to an open cover Ensure that all covers are closed while the system is being initialize
483. ugh the tasks that need to be performed at the end of the day or to prepare the instrument for handing over to another operator Everything is fine To ensure smooth operation you need to perform some task The current process or action has not started yet or stopped You need to do something for it to start or continue Individual tasks can be performed outside the wizards Most tasks that make up a workflow can be performed without using a wizard If you perform a task independently you first need to navigate to the appropriate screen and then start the task from there whereas if you use a wizard the appropriate screen is displayed automatically Using the wizards also ensures that all necessary steps are performed and in the right order Roche Diagnostics A 22 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Daily operation Daily operation Overview Daily operation includes the routine tasks that are required to prepare and monitor the system and to analyze samples When you switch on the system it performs several checks to make sure that all preconditions are met for example that all covers are closed or that there are cuvettes available It then performs self tests to ensure that all modules function properly At the end of the startup phase the screen is updated to display the current status of the system The following table gives an overview of the tasks you might need
484. us of the sample tube 3 Take appropriate action Checking the instrument status buttons a To check the instrument status 1 Press the Overview tab A Test name B Press to validate the results C Press to add tests to the order D Press to delete the order Figure B 13 B C D A After deleting a running order cuvettes and reagents that were not used are released again for future use A Instrument status buttons Figure B 14 A Roche Diagnostics Operator s Manual Version 3 0 B 47 cobas c111 6 Daily operation Analyzing samples Interpreting the instrument status buttons Icon Meaning Possible action The reagents are OK No action is required There is no disk on board Load a disk Fewer than 10 of tests are left for a reagent set or its expiration date has passed Load a new reagent set A reagent set is not complete or a reagent is empty Complete the reagent set or replace it A reagent set is blocked because it requires calibration or mixing Perform calibration or mixing The disk could not be identified Remove the disk and make sure that one and only one ID tab is removed Reinsert the disk There is more than one segment available No action is required The last available segment is in use Replace the used cuvette segments as soon as possible There are no empty cuvettes avail able Replace the cuvette segments System Status The system st
485. use The test is blocked for one of the following reasons o The calibration is due or failed o For the reagent set the number of available tests is 0 or a reagent bottle is missing incomplete reagent set o Initial calibration is required The expiration date of the test has passed There are only few tests left A QC is due or its result has not been accepted A more recent version of the application has been imported For a development channel An extra wash cycle is missing A Test selection screen in order mode Easy B Test selection screen in order mode Full Figure A 53 Test selection screen A B Roche Diagnostics Operator s Manual Version 3 0 A 91 cobas c111 5 Software Key screens The test is not on board A required diluent or cleaner is not on board Display detailed information on the status of this test Display a list of all defined tests together with information on their status Handle the reagent disk that is currently on board Displaying test details f Overview gt Tests gt test button The color of the text indicates whether you need to react to the information and if so with which urgency you need to deal with the issue Calibration Information on the calibration status Quality control Information on the QC status Tests on disk Total number of tests that are currently available There might be more than one reagent set for this test on boar
486. used to communicate with a laboratory information system sample splitting The act of making one or more aliquots from a primary or secondary specimen sample tube A glass or plastic container for liquid samples to be used with the system It may or may not have a bar code label which may be used for positive sample identification A sample tube contains sample of one specific specimen sample type sample type A type of sample that can be analyzed serum plasma whole blood or urine sampling stop An alarm level that indicates a problem with the sampling system See also S Stop scan See barcode scan scroll The action of moving through text or graphics up down left or right to see parts of the file or list that cannot fit on the screen scroll arrow An arrow on either end of a scroll bar that you use to scroll through the contents of the screen or list box scroll bar A bar that appears at the bottom or right edge of a screen whose contents are not entirely visible SD Abbreviation for standard deviation secondary tube A sample container of variable size into which aliquots are transferred shutdown The process of powering off an instrument software A computer operated program that processes data in a defined manner Software is usually intellectual property of the software supplier or its licensee specimen Generic term for a calibrator control and sample standard Traceable reference material used to
487. utions 1 and 2 and check visually the correct flow of all ISE solutions and the ISE Reference Solution If successive calibrations are flagged 1 Repeat the calibration with fresh ISE Solutions 1 and 2 and check visually the correct flow of all ISE solutions and the ISE Reference Solution 2 Check whether the electrode expiration date has expired Replace the electrodes if necessary 3 Perform the maintenance action Electrode Service 4 Perform the maintenance action Deproteinize Probes 5 Check ISE Reference Solution tubing for leaks and blockages 6 If the slopes of all electrodes are zero replace the ISE Reference Electrode 7 Contact your service representative QC Meaning A result where the quality control measurement is flagged Message ID 111 Priority 30 Possible cause The last QC measurement before this measurement was flagged The dependency is derived from the time sequence Recommended actions Check QC measurement Roche Diagnostics E 76 Operator s Manual Version 3 0 15 ISE troubleshooting cobas c111 List of ISE flags R 1 2 5s Meaning One control value is above 2 5 standard deviation or below 2 5 standard deviation Message ID 36 Priority 28 Possible cause o The reagent has deteriorated linearity of working curve degraded o One control is concentrated or has deteriorated Recommended actions 1 Repeat with fresh control 2 Check that the correct
488. uvette segments 1 Press the cuvette button 2 Open the main cover 3 Replace the cuvette segment 4 Press to confirm the replacement 5 Replace the remaining segments that need replacing 6 Press to proceed to the next stage in the Prepare wizard 7 Perform reagent mixing 1 Select the test s 2 Press 8 Perform calibrations Perform the calibrations 1 Check the test selection 2 Press 3 Place the calibrators 4 On the placement screen press 5 Press 6 Validate the results Step User action Table B 2 Steps for preparing the system Roche Diagnostics Operator s Manual Version 3 0 B 15 cobas c111 6 Daily operation Preparing the system Starting the Prepare wizard a To start the preparation process 1 Choose Overview gt Prepare Checking the status of the external fluid containers The external fluid containers are placed on a rack The status of all three containers is displayed on the same screen Make sure that you have read and understood section Safety information on page B 5 The following warning messages in particular are relevant o Injury through reagents and other working solutions on page B 5 o Infection by biohazardous materials on page B 5 o Infection by waste solution on page B 5 o Personal injury or damage to the analyzer due to contact with instrument mechanism on page B 5 A Cleaner bottle red cap B Water conta
489. ved it 3 Press 4 Select the directory 5 Press 6 Remove the USB stick 7 Press to proceed to the next stage in the End Shift wizard 5 Clean up the database 1 Press 2 Press to confirm the deletion 3 Press to proceed to the next stage in the End Shift wizard Table B 9 Steps for finishing the shift Roche Diagnostics Operator s Manual Version 3 0 B 79 cobas c111 6 Daily operation Finishing the shift 6 Perform maintenance actions 1 Check which maintenance actions are due 2 Perform the maintenance actions Perform at least all red maintenance actions 3 Press to proceed to the next stage in the End Shift wizard 7 Check the cuvette status Replace at least all red cuvette segments 1 Press the cuvette button 2 Open the main cover 3 Replace the cuvette segments 4 Close the main cover 5 Press to proceed to the next stage in the End Shift wizard 8 Empty the waste container 1 Empty the waste container 2 Press the Waste button to confirm 3 Refill the water container 4 Press the Water button to confirm 9 Remove the reagent disk 1 Choose Overview gt 2 Press 1 Open the main cover 2 Lift the disk from the instrument 3 Place the disk in its container 4 Press 5 Close the main cover 6 Store the reagent disk in a cool place 10 Finish your shift 1 Log off the system 2 Switch off the main instrument If
490. ware as shipped The user assumes full responsibility for changing any part of the open source software which excludes any liability of Roche Diagnostics Ltd This program is distributed without any warranty without even the implied warranty of merchantability or fitness for a particular purpose See the GNU General Public License for more details www gnu org copyleft gpl html The source code of the used open source software is part of MIKRAPs CPUX255LCDNET board support package and may be obtained from SYSGO http www sysgo com prod ucts board support packages Roche Diagnostics A 12 Operator s Manual Version 3 0 1 Safety cobas c111 Disposal recommendation Disposal recommendation 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 label Disposal of external components Disposal of the instrument Constraint It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not If contaminated treat in the same way as the instrument Electrical and electronic equipment marked with this symbol are covered by the European directive on waste electrical and electronic equipment WEEE 2002 96 EC The symbol denotes that the equipment must not be disposed of in the municipal waste
491. wer and ISE tubing for leaks and blockages 5 Ensure that the ISE bottles on the ISE unit are available and check the level of fluid replace if necessary No Isecal Meaning The ISE sample sensor could not detect any calibrator It takes too long for a calibrator segment to reach the electrodes Message ID 90 Priority 3 Possible cause o ISE Calibrator indirect urine bottle is not available o The ISE tubing is leaking or blocked o The ISE sample sensor is defect Recommended actions 1 Repeat the measurement 2 Ensure that the ISE Calibrator indirect urine on the ISE unit is available and check the level of fluid replace if necessary Roche Diagnostics Operator s Manual Version 3 0 E 75 cobas c111 15 ISE troubleshooting List of ISE flags Out of Rng Meaning Slope out of range The slope for the specified electrode is outside the acceptable programmed range Message ID 20 Priority 15 Possible cause This flag appears with calibrations because o There are problems with the ISE solutions on the instrument o There are problems with the electrodes or the ISE unit was not properly serviced o The ISE Reference Solution tubing is blocked or leaking o The dosing from the sample probe is not accurate o The preamplifier is not working properly Recommended actions If only one calibration is flagged 1 Repeat the calibration 2 Repeat the calibration with fresh ISE Sol
492. with the issue mentioned in it a To confirm a message 1 Press 2 Select the message Use and to display the previous and next message respectively 3 Press A confirmation dialog box is displayed o Press All to remove all messages from the list o Press Selected to remove the currently displayed message The message or messages are removed from the Not confirmed list but they remain in the other lists and the alarm messages log which you can export When all messages are confirmed the Alarm LED is turned off not lit Exporting the alarm message log a To export the message log file 1 Press 2 Press A screen is displayed asking you to insert a USB stick 3 Insert the USB stick 4 Press to confirm the insertion A screen is displayed for selecting a directory Press tgz to display log files only Press to display all files and directories 5 Select a directory for the error log 6 Press to confirm the selection All log files are added to a file with the name format log_yyyymmddhhmmss tgz and copied to the stick The error log file has the name format err_yyyymmddhhmmss log Roche Diagnostics D 10 Operator s Manual Version 3 0 9 Messages and alarms cobas c111 List of alarm messages List of alarm messages In the following table the variables s and d are used they represent text and numbers ID Message Comment 0000 Unknown message id
493. with the result list is displayed again 5 Select a result Validating the results The system can be set up to automatically accept results that are not flagged In addition it can be set up to accept results with flags that are marked in an editable list of flags that should be ignored which is particularly suitable if the flags are assessed on the host system anyway e See Result handling on page B 167 See Editing the acceptable flags list on page B 162 6 Press A screen is displayed for selecting your reaction A Order number B Status The result has not been accepted yet The result has not been transmitted yet C Test name D Results E Time when the order was defined F This test was performed again gt Repeated v Rerun with dilution G Press to validate the selected result H Press to display certain kinds of results only filter Figure B 17 B E G H C A F D o To check when the result was generated press o For results that were not generated on the current day only their date of genera tion is displayed You can look at the results by pressing o To display context information of the fluids used to arrive at this result press then on the detail screen press Roche Diagnostics B 54 Operator s Manual Version 3 0 6 Daily operation cobas c111 Validating sample results 7 Do one of the following o Press
494. y stops All pipetting and processing actions stop A Transfer head B Probe holder carriage C Transfer X guide rail Figure A 15 Major elements of the robotic transfer unit A C B Roche Diagnostics Operator s Manual Version 3 0 A 49 cobas c111 3 Hardware Hardware overview Mixing motor The mixing motor is mounted on the carriage When running it generates a circular movement of the probe This movement is used for mixing the content of cuvettes and reagent bottles Probe The probe has a flat tip This is required for tube bottom detection Because such a probe cannot pierce a bottle cap all bottles must be placed on the instrument with their caps removed Level detection A sensor detects when the probe enters a fluid On the basis of this level the system establishes whether there is enough fluid to perform the scheduled pipetting action Tube Bottom detection A physical sensor is activated as soon as the probe touches the bottom of a sample tube This mechanism also works when the probe touches an object outside the tube In both cases probe action stops and an appropriate alarm message is generated A Mixing motor B Transfer Z motor C Probe holder D Probe E Mixer movement axis Figure A 16 Transfer head A B D E C Roche Diagnostics A 50 Operator s Manual Version 3 0 3 Hardware cobas c111 Hardware overview Fluid containers The following tabl
495. yed asking you to scan the barcode transfer sheet or to type the data manually Roche Diagnostics B 150 Operator s Manual Version 3 0 7 Configuration cobas c111 Applications 4 Define the lot values Do one of the following Defining calibrator definitions and lots You need to perform the definitions for all calibrators a To define a calibrator lot 1 Choose Workplace gt Lot Data 2 Press Calibrators A screen is displayed that lists all installed calibrator lots 3 Press A screen is displayed asking you to scan the barcode or to type the data manually If Do this The lot data are available from a barcode 1 Scan the barcode The screen is displayed again that lists all installed control lots The new lot is selected You want to type the data manually 1 Press 2 Type the name and press 3 Type the material code and press You find this code in Utilities gt Applications gt select a test gt gt Control 4 Type the Lot ID and press 5 Type the expiration date Use the date format as indicated on the screen 6 Press to confirm the definitions If a lot with the same ID already exists on the system a screen is displayed asking you whether you want to replace the existing lot Press to confirm the definitions 7 Press Add new test 8 Press A screen is displayed that contains all tests that use this control and that have not y
496. yed that lists all reagent sets for which a mixing interval is defined a To perform the mixing 1 Select the reagent sets you want to mix If working with the Prepare wizard the reagent sets that need mixing are automatically selected 2 Press Mixing starts A screen is displayed informing you about the progress of the mixing action If there is more than one bottle in the set with a mixing interval defined it will be mixed as well irrespective of being due or not WARNING Incorrect results due to scratched or soiled cuvettes Scratches and impurities on the cuvettes distort the measurements Do not touch the cuvettes and make sure they do not touch other items when handling them If Do this You want to exchange another segment Perform steps 2 through 7 This was the last segment you wanted to exchange Close the main cover When handling cuvette segments without using the Prepare wizard Choose Overview gt The system must be in Standby status Roche Diagnostics B 30 Operator s Manual Version 3 0 6 Daily operation cobas c111 Preparing the system 3 When mixing is finished press to close the screen 4 Press to proceed to the next stage in the Prepare wizard Performing the calibrations Prepare phase At this stage the system checks for all calibrations that are due e For an overview on calibration see Calibration on page A 26 For performing individual calibrations
497. you have been trained by Roche Diagnostics o Carefully follow the procedures specified in the Operator s Manual for the operation and maintenance of the system o Leave maintenance that is not described in the Operator s Manual to trained service representatives o Follow standard laboratory practices especially when working with biohazard material Roche Diagnostics A 18 Operator s Manual Version 3 0 2 Introduction to the instrument cobas c111 Overview Measuring principles Measurements are performed by means of an absorbance photometer and optionally an ISE ion selective electrode module that uses ion selective potentiometry A first look at the instrument A Left service flap covers wash station ISE tower tubing B Main cover covers rotor reagents cuvettes photometer unit C Main switch D Transfer head holds probe E Rear service flap covers computer boards power supply degasser F Sample area LED G Sample area space for 8 sample tubes H Touchscreen I Fluid connectors J Right service flap covers photometer unit sample area K Printer panel L Main cover LED M Paper slot N Release button for printer panel O USB connector not shown Figure A 2 The cobas c111 instrument A L N M B D I F E G H O J K C Roche Diagnostics Operator s Manual Version 3 0 A 19 cobas c111 2 Introduction to the
498. ystem status screen see System status on page A 95 The icons are first prioritized by color first priority being red followed by yellow and green and then according to the sequence in which they are listed below This button can show either of the following icons Analyzer main cover Reagent cooler and cuvette ring temperature Sample area ventilation External fluid containers Maintenance Printer Roche Diagnostics A 86 Operator s Manual Version 3 0 5 Software cobas c111 Key screens Sample overview The number in the button indicates the position on the sample area A sample tube button with a wide edge symbolizes a STAT order All tests are completed and their results are accepted All tests are pipetted All tests are completed but not yet accepted All remaining tests are blocked for one of the following reasons o There is not enough sample fluid o The sample is not identified There is no sample on this position Tests are ordered Processing has not yet started Tests are ordered processing has started The sample is identified but no tests were ordered yet If working in Order Query Mode The order could not be obtained from the host A Sample tube buttons B Open orders C Results Figure A 49 Sample tube status on the Overview tab C B A 1 1 1 1 1 1 1 1 1 Roche Diagnostics Operator s Manual Version 3 0 A 87

Roche Cobas C111 - User manual

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