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Microlab F.A.M.E. - Frank`s Hospital Workshop

1. 127 11 9 2 Abortirig a RUM ceci en tee 127 11 10 Finishing a Run eee 128 P N 610520 02 05 01 11 105 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 1 Overview Daily Work Routine The daily work routine consists of all the day to day operation of the Microlab FA M E Included in this are O System Start up J Defining and Editing Stack Types O Defining and Editing Work Lists O Fluid Handling O Scheduling and Un scheduling Work Lists J Starting the Test Run O Plate Processing O System Shut down These are the main elements that make up the daily work routine Although there are other necessary procedures i e maintenance etc these are explained in separate sections 11 1 1 Elements of a Test Run To execute a test run a work list defining the work load i e num ber of plates and methods to use must first be created Below are the elements associated with executing a test run O Stack Types are the basic building blocks with which the work load is made up A stack type is an electronically stored list containing reference information for up to four plates and the methods associated with them This list corresponds directly to a physical entry stack to be loaded with this quantity of plates and requiring the specified methods This is the basic loading unit for the system Stack types can be made up of various me
2. 83 11 Daily Work Routine ese 105 12 Test Results amp ML FA M E 129 13 ML EA M E Functions amp Requirements 137 14 ML 147 15 ML FA M E Maintenance 169 16 Technical 183 17 Troubleshooting amp Error Handling 199 Appendices A1 to A8 A1 Error amp Trace Codes 213 A2 Glossary Re aeree ed tee EE HR DER Een 237 Frequently Asked Questions sse 247 PA Anomalies 23H 249 Ab uen te ee eee tie de eed ers 251 News Lotars ncssa 261 A7 User Manual Update Information 263 A8 Index ind see nm b eite 265 Microlab F A M E User Manual V2 0 Master Table of Contents P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter P N 610520 02 05 01 1 ML F A M E Overview Table of Contents 1 1 About the Microlab E A M E 2 1 1 1 gt Basic Goncepts tis anreisen 2 1 2 Using This Manual sse 3 1 2 1 U
3. esee 169 16 Technical Specifications sse 183 17 Troubleshooting amp Error Handling 199 Reference Guide Microlab F A M E User Manual V2 0 Reference Guide 9 80 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Reference Guide Introduction Chapter 9 Reference Guide Introduction The purpose of this reference guide is to give support to the step by step guide Cook Book of the Microlab F A M E user software version 2 0 further referred to as ML F A M E 2 0 A certain amount of end user basic computer understanding will be assumed throughout this manual and the assumption is that a valid user with the necessary access rights is logged in to the ML F A M E workstation P N 610520 02 05 01 9 81 Microlab F A M E User Manual V2 0 Reference Guide Reference Guide Introduction 9 82 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter 10 P N 610520 02 05 01 ML F A M E Methods Table of Contents TREES ule 84 10 1 1 Method Access 84 10 1 2 General Method Definition Limitations 84 10 2 Method nennt 84 10 2 1 Method Information Dialog Box 86 10 2 2 Plate Layout Ed
4. Appendix 5 253 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 5 Forms Appendix 5 254 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 5 Forms Problem Report Form Error number for internal use only Date Company Name User software version OS 2 version PC processor PC RAM PC Hard drive size free space Time problem occurred Brief description Symptom User software hangs System error Abort System error Continue Exit J Database error CJ Installation fault CJ Initialization fault J Maintenance fault Verification fault Processing fault CJ Window dialog box fault J Print fault Instrument hangs un EEE Module fault Iu acer DVD Detailed description of problem Attached C System trace J Test trace C Well trace J Other Please sign and return to your instrument supplier Date Signed P N 610520 02 05 01 Appendix 5 255 Microlab F A M E User Manual V2 0 Appendix 5 Forms Appendix 5 256 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 5 Forms Software Installation Record Computer Serial No Instrument Serial No Original OS 2 Version Original DB2 2 Version User Software Version Installed by
5. 133 12 2 3 Storing Results niinen auian 133 12 2 4 Archiving Test 134 12 2 5 The ASTM File esses ene 134 12 3 Trace Reports iscsi cee 135 12 3 1 Tr ce Priority erect ere e 135 12 3 2 System Trace 135 12 9 3 Test TACQ cope eene eee b oe e cp edes 136 12 3 4 Well Trace 2 22H Br rn 136 P N 610520 02 05 01 12 129 Microlab F A M E User Manual V2 0 Reference Guide Test Results amp ML F A M E Traces 12 1 Overview Once a test has been processed by the system all test results operations are undertaken from within the following two windows dialog boxes O Test Results window see Cook Book Section 5 1 1 on page 56 This window displays all tests that have been processed and therefore have information stored in the ML FA M E data base ECCLE zug File View Tests Method Plate Barcode Load Load Run Error Test N2 Date Tine Status Status Example ELISA TestPlate 188 1997 83 86 16 28 03 Processed TestPlate 181 1997 83 86 16 44 43 Processed TestPlate 182 1997 83 86 17 81 23 Processed TestPlate 183 1997 83 86 17 18 83 Processed TestPlate 184 1997 83 86 17 34 43 Processed TestPlate 185 1997 83 86 17 51 23 Processed 186 Documented Example ELISA Example ELISA xa 3 Documented Figure 12 1 Test Results Window Test Results Report dialog box see Cook Book Section 5
6. Figure 10 11 Test Processing Editor SRAM dialog box The following filter data can be specified for each step O Type of measurement either single wavelength measure ment mode or reference measurement mode O Photometer filter wavelength s for one or in case of refer NOTE ence measurement mode two filters The range check will happen real time during the run However it The following range check data can be specified for each step will have no influence on a T test s processing Any well O Select well type s By selecting the Well push button it is errors will be recorded in the possible to specify which well types will be used in the range trace entry check O Absolute Minimum and Absolute Maximum entry fields allow the ML F A M E operator to define the check range within which the OD s are valid O Deviation From Median check button the ML F A M E oper ator can set the percentage from the median at which the well is then interpreted as correctly dispensed This is an additional step performed after the range check O Blank Correction Before Range Check check box will when selected perform a blank correction before starting the range check The mean of all valid wells defined as Blank will be subtracted for the value of all other wells If the blank correction option is selected Blank wells may not be included in the range check P N 610520 02 05 01 10 99 Microlab F A M E Use
7. DIALOG ID MESSAGE TRP900 1 Exit Lift not functioning Move the Exit Lift manually into upper position Press OK if manual intervention was successful else press Ignore TRP901 1 Main Shuttle not functioning Move the Main Shuttle manually into a collision free position outside of the Entry Lift or Exit Lift Press OK if manual intervention was successful else press Ignore 902 1 Main Shuttle not functioning Move the Main Shuttle manually into a collision free position outside of the Entry Lift or Exit Lift Press OK if manual intervention was successful else press Ignore TRP903 1 Exit Lift not functioning Move the Exit Lift manually into upper position Press OK if your manual intervention was successful else press Ignore C0 810 1 The cover of the instrument has been opened Only the main transport has stopped Other functions of the instrument are still running Danger of moving parts and contamination Do not change the position of plates on the instrument Close the cover as soon as possible to ensure proper processing of a running work list Plates may be aborted if the cover is open too long 05811 1 The pause button of the instrument has been pressed All functions of the instrument have stopped Danger of contamination Do not change the position of plates on the instrument Press CONTINUE as soon as possible to ensure proper processing of a running work list Plates may be aborted if the p
8. A receptacle placed under the manifold during its removal and fitting Resides in the container stack door See Stack Type An entry stack configuration consisting of between 1 and 4 tests method and kit lot The basic loading unit from which a work list is defined Type of reagent used to interrupt the color development of the substrate reaction Term also used Blocking Solution Electrical plug which plugs into the washer dispenser module instead of the waste cap cable when this is not being used The Summit Processor instrument together with the PC running the Summit Processor software ML F A M E workstation and the serial cable connecting the two together Person responsible for administration of the user software A file containing all system related messages and actions related to the Summit Processor i e ML F A M E software tests and wells A maximum of one MTP with an associated method on the Summit Processor System Several tests with the same documentation format which are sent to the same device printer host etc General Information in a test result report giving method kit lot test no etc A package containing all necessary components for one or several assays of a kind The action of temporarily blocking user access to a test if actions are planned or being undertaken on it A unique sequential number which identifies a test can be part of a barcode A report displayed on the computer sc
9. HAMILTON endeavors to provide prompt and satisfactory service P N 610520 02 05 01 Microlab F A M E User Manual V2 0 ML F A M E Overview 1 4 2 Ordering Information Instruments Part No Description 146 000 Microlab F A M E 16 20 146 001 Microlab F A M E 16 30 146 002 Microlab F A M E 24 20 146 003 Microlab F A M E 24 30 Disposables for Microlab F A M E Part No Description 147 624 Wash Fluid Container 147 930 Reagent Container Set 8 pcs 147 931 Disposable Syringe Set 8 pcs 147 933 Reagent Barcode Label Set 52 pcs 281 110 Manifold Plug 281 153 Sterile Filter 281 242 Microlab Detergent amp Disinfectant Kit 281 243 Microlab Disinfectant Spray Kit 281 245 Microlab Disinfectant Starter Kit P N 610520 02 05 01 1 13 Microlab F A M E User Manual V2 0 ML F A M E Overview Accessories for Microlab F A M E Part No Description 281 107 Waste Container 147 660 Entry Stack 147 179 Reagent Container Carousel 148 309 Washer Manifold complete 235 524 Filter Strip 147 256 Filter Case 147 936 Manifold Cleaning Set 148 333 Spillage Tray 230 005 Check Plates for Cold Start Maintenance 146 373 Substitute Plug 146 385 Computer Cable 255 634 Reagent Labels Drawer 255 653 Label Warning PC 148 417 External Water Separator 148 335 Waste Cap 610 520 User Manual English 230 006 Upgrade Kit V2 0 for 16 20 or 16 30 230 007 Upgrade Kit V2 0 for 24 20 or
10. O Use a replica number consistent with the pipetting procedure defined in Sunrise Sunplus e g replica number 2 means two wells per sample O Ensure that the replica direction corresponds with the Sunrise Sunplus definition CJ Wells which are never pipetted by the Microlab AT ML ATplus 2 should be defined as Keep Empty Test Processing Editor The Test Processing Editor allows the user to define all the pro cessing steps for a method Each step incubation duration and temperature wash procedure and photometer settings etc can be defined using this window and its dialog boxes In addition to these steps the Fluids menu allows reagents and wash fluids to be defined and edited Test Processing Editor Example ELISA Eu E File Edit Steps Fluids 1 Prepare plate Plate preparation time is 10min 2 Sample and reagent addition monitoring in normal mode with 450nm measuring filter 3 Incubate at 37 1 deg C heating up fast for 30 5min 4 Wash wash mode plate wash wash solution xODSI 01 wash dispense volume 370pl number of cycles 5 soak time 20sec aspiration height 0 3mm bottom sweep is off Figure 10 9 Test Processing Editor Window 10 94 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 10 2 3 1 10 2 3 2 NOTE The default first processing step is set to 0 zero meaning that the ML F A M E operator must define it manually otherwise an error is retu
11. Start maintenance From the Services menu in the Main procedures ML F A M E window select the Maintenance menu choice The Maintenance window is displayed allowing the ML F A M E operator to view the maintenance status of each ML FA M E module see Reference Guide Section 15 1 3 on page 171 3 From the Procedure menu select the desired maintenance routine 4 The ML EA M E software will then issue on screen instructions detailing all procedures required to perform the selected maintenance procedure For general information on running maintenance procedures see Reference Guide Section 15 1 on page 170 8 70 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Maintenance A ATTENTION Wear protective gloves when handling the washer manifold as it may be contaminated Manifold needles could puncture protective gloves 8 1 2 Washer Manifold The washer manifold must be removed from the ML F A M E monthly for service or maintenance cleaning The following out lines this procedure Table 8 1 2 1 Remove Wash and Install Washer Manifold Do This To NOTE Manifold removal is a part of the Remove the monthly maintenance process washer manifold and is initiated independently from any menu commands d a 00 f a ae P Knurled screw arf Manifold plugs A ATTENTION Do not use water hotter than 50 C to clean the manif
12. ATTENTION Please ensure that the correct kit lot data is defined in the kit lot editor A ATTENTION Please ensure that the default users are deleted and the correct lab specific users and access rights are defined P N 610520 02 05 01 ML F A M E Overview Plate Access On With this option selected the ML F A M E software will allow the ML F A M E operator to process plates when no pipetting infor mation is found Options include retry or searching for the bar code information along a path using an editor to include or exclude wells or to enter the well barcodes after plate loading Active Kit Lot Check With this option selected the master kit lot number included in the plate barcode or in the pipetting file will be checked against the defined one The kit lot file must be provided by the higher system no access is given to the editor Kit Lot Documentation With this option selected the ML F A M E operator will have access to the Kit Lot Editor allowing editing or creating of kit lot information file However the defined kit lot will be documented but no check is made of the loaded lot User Access Editor Off Disables the User Access Editor User Access Editor On Enables the User Access Editor where it is possible to estab lish a list of ML F A M E operators and their security level Microlab F A M E User Manual V2 0 1 4 1 4 1 ML F A M E Overview General Information W
13. Under certain circumstances the ML F A M E operator must use the hand held barcode scanner or double blind entry procedure These circumstances include Plate barcode not readable O To verify a component lot number Correlate wash fluid Table 4 1 7 1 Double Blind Entry To Do This Manually enter When required by the ML FA M E barcode software or selected by the ML F A M E information operator a dialog box is displayed where barcode correlation is required P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine Table 4 1 7 1 Double Blind Entry To Do This 2 TheMLEA M E operator must enter the required barcode in the entry field via the keyboard 3 When entered press the Tab keyboard key The entered barcode will disappear 4 Enter the barcode again and press the Tab key the ML FA M E software will check that the two entered barcodes are identical If so the barcode correlation is complete P N 610520 02 05 01 4 53 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine 4 54 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter P N 610520 02 05 01 5 Test Results amp ML F A M E Traces Table of Contents 5 1 Test Results Overview ceeneessnsnnnssnnnnennnennennnnnennnennennann 56 5 1 1 The Test Results 56
14. ERROR RUN Dispensing finished with error location s Error Status Error loc s NOTE RUN Mixing started intensity s duration u sec location 5 loc 96s int 96c sec 96d ERROR RUN Mixing start failed reason s location 5 Error Status Error loc s NOTE RUN Mixing finished successfully location s loc s ERROR RUN Mixing finished with error location s Error Status Error loc s Appendix 1 231 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages 32032 NOTE RUN Photometer reading started mode s filter d ref filter d 32033 phot c meas d ref d 32036 NOTE RUN Photometer reading finished successfully 32038 ERROR RUN Photometer reading finished with error Error Status Error 32040 NOTE RUN SRAM passed blank corr s abs limits 4 3f 4 3f median s dev limits s s 32041 bcorr s abslim 4 31 4 3f median s devlim s s 32042 WARNING RUN SRAM passed with warnings blank corr s abs limits 4 3f 4 3f median s dev limits s s Error Status Trace 32043 bcorr s abslim 4 3f 4 3f median s devlim s s 32044 WARNING RUN SRAM failed for one or more wells blank corr s abs limits 4 3f 4 3f median s dev limits s s Error Status Trace 32045 bcorr s abslim 4 3f 4 3f median s devlim s s 32046 ERROR RUN SRAM failed reason no
15. INC373 1 Could not deposit Plate in the Incubator Slot d of the Front Tower FRONT Is there still a Plate on the Module Transport Press Yes if a Plate is still present else press No INC373_1 Could not deposit Plate in the Incubator Slot d of the Rear Tower REAR Is there still a Plate on the Module Transport Press Yes if a Plate is still present else press No INC380 1 Module Transport step lost Could not get plate from Incubator Slot Move the Module Transport manually into a collision free position Press OK after successful manual intervention INC381 1 Front Tower Lift step lost Could not get Plate from Incubator Slot Move the Front Tower manually into a collision free position Press OK after successful manual intervention INC382 1 Rear Tower Lift step lost Could not get Plate from Incubator Slot Move the Rear Tower manually into a collision free position Press OK after successful manual intervention INC383 1 Could not get Plate from the Incubator Slot 96d of the Front Tower FRONT Is there still a Plate in the Incubator Slot d of the Front Tower Press Yes if a Plate is still present else press No INC383_1 Could not get Plate from the Incubator Slot d of the Rear Tower REAR Is there still a Plate in the Incubator Slot 96d of the Front Tower Press Yes if a Plate is still present else press No INC403 1 Module Transport step lost Could not read Plate Barcode Check the Plate on the
16. O Rinse Sol 1 O Rinse Sol 2 Reserved barcodes are not displayed in the Assignment editor and cannot be changed 11 117 Microlab F A M E User Manual V2 0 11 7 Starting a Run 11 7 1 NOTE Do not load unstable reagents into the reagent drawers until requested by an Operator Action dialog box NOTE When a fluid is defined with the Verify Fluid option on it is criti cal to the schedule that when the ML F A M E operator is prompted to perform this verifi cation it is carried out as soon and as quickly as possible NOTE While unneeded fluids may be removed from the ML F A M E when prompted by the ML F A M E software this may not be done if a dispensing step is scheduled for the next 5 min utes ATTENTION It is important that the ML F A M E operators ensure that correct fluids are placed in the correct labeled container 11 118 After fluid assignment work list definition or loading and schedul ing the Plan window will be the active window If any of the fluids used in the run are not included in the fluid assignment table they must be assigned container barcodes prior to starting or during the run This is done via the Actions Assign fluids pull down menu option in the Plan window Here the ML F A M E operator may overrule any definitions which have been automatically included by the scheduler from the assignment table see Cook Book Section Table 4 1 6 1 on page 51 Aft
17. an associated set of acceptance criteria The user is responsible O Photometer for taking corrective action whenever a verification result is O plate positioning f range ibili out of range accuracy and short term reproducibility for measuring channels A to H and reference channel O stray light O short term drift infrared blocking O Dispensers O accuracy O precision O Washer s O average residual volume O maximum residual volume O aspirating precision and accuracy O Incubators O temperature variations 14 148 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 14 1 2 14 1 3 Reference Guide ML F A M E Verification Verification Statuses O Required ML FA M E non functional Some verification pro cedures must be run O Completed ML F A M E Functional Modules verified and cri teria matched O Open Module not present in current configuration and after first installation all modules will have the status open When are they Verified 1 Photometer O Upon initial instrument installation O Quarterly every 90 days O After repair or service of the module O If liquid spillage occurred in the end module O When a filter is exchanged O When the end module is exchanged O Dispenser Upon initial instrument installation O Quarterly every 90 days per dispenser O After repair or service of the module O When the module is exchanged O
18. authorization from Hamilton and OCD is required for blood banks in specific territories Please contact the Product Manager at Hamilton Bonaduz to obtain the special disk set A ATTENTION For further information on installation please see the separate Installation Guide It is the responsibility of the laboratory manager which installation options are selected 1 3 2 4 A ATTENTION With this option on it is possible to operate an un verified instrument ML F A M E Overview The ML F A M E Software The ML FA M E software is an application with various access rights assigned to the various levels of ML FA M E operator giving them software control on a need to use basis Main features of the software include O Full operations tracing ML FA M E operator ML F A M E soft ware and ML F A M E functions and actions Full sample tracing from entire plates to individual wells Temporary storage of processed plates data Method definition and editing Scheduling with re scheduling options Graphical representation of daily work routine Extensive error handling and recovery routines du 00 OU UO QO Complete instrument maintenance and verification procedures Installation Options During the installation procedure for the ML F A M E software a number of features exist allowing the customizing of the installa tion The installation options are as follows CJ Verification Res
19. communication error to Dispenser error code d location s 14542 ERROR CTRL WAS412 no parallel function with Module Transport of Dispenser error code d location 5 16602 NOTE TEST Recovery detected plate location 5 16604 NOTE TEST Plate moved to s 16606 NOTE TEST Test created Test id d 16608 NOTE USER Plate removed manually from instrument 16610 NOTE TEST Run state set to 5 16612 NOTE TEST Error state set to s 16614 NOTE TEST Well data have been written 16616 NOTE TEST Photo data have been written 16618 NOTE TEST Sram data have been written 16620 ERROR START Instrument startup while test running Run Status Processed Error Status Aborted 16624 WARNING TEST Plate position not set Position is occupied by test d location s 16632 NOTE TEST Methode s Created s s M Code ld 16634 NOTE TEST Usersoftware version s 16636 NOTE TEST DB version s 16638 NOTE TEST Currently logged in user s 16640 NOTE TEST New user logged in s 17000 ERROR CTRL TRP300 Main Shuttle step lost error code d location 5 17002 ERROR CTRL TRP301 Main Shuttle wrong position parameter detected 96s error code d location s 17004 ERROR CTRL TRP310 Exit Lift step lost error code d location 5 17006 ERROR CTRL TRP320 bad stacking of Plate error code d location 5 17008 ERROR CTRL TRP330 still holding Plate on Manipulation Position cou
20. mation file can result in the detection of errors occurring during the sample pipetting or a mismatch of the well definitions between the pipetting information file and the method definition In these cases and if an incomplete plate is detected an error message is displayed explaining the discrepancies 11 8 Changing a Run NOTE It is not possible to change a plan It is generally possible to change a run during its processing There when it is processed Any diffi are three possibilities as follows culties experienced during the run i e delays of the process O Abort Test ing of test steps are brought to the attention of the operator but O Un scheduling of stacks a rescheduling of a running work list will never be carried 1 Re scheduling of a work list out by the system automatically This avoids any situations To change a run during processing the ML F A M E operator must where the operator is not aware switch from the Plan window to the Work List window of any changes of the plan A 11 8 1 Un schedule ATTENTION The Un schedule option is Select the stack type to be changed or deleted or at which position only applicable to a stack which you may wish to insert a stack and select the Un schedule menu has the status planned stack choice from the Actions menu All stacks including the selected types which are not planned and the following stacks in the work list are then removed from the processed aborted
21. Book Section 4 1 4 on page 45 for information on work list handling O Stack Types allows access to sub menu choices relating to the definition of new edit existing deleting or printing stack types see Cook Book Section 4 2 1 on page 43 O Assignment Editor allows the allocation of barcodes to flu ids and specifying fluid locations see page 116 for general information and see Cook Book Section 4 1 6 on page 50 for information on fluid handling NOTE This option is only available if the O Kit Lot Editor allows the creation of new editing of existing Kit Lot Documentation installa kit lot files in the defined path Kit lots for existing methods or tion option was selected global fluids can be created edited or deleted P N 610520 02 05 01 11 107 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 2 Kit Lot Editor NOTE This option is only available if the The Kit Lot Editor window displays a list of methods and global Kit Lot Documentation installa fluids indicated with a preceding asterisk with the following asso tion option was selected ciated information W Kit Lot Editor 1 File Edit Method Global Fluid Component name Lot no Expiration date OD HCV 3 0 short raw MKL11 1998 04 21 Conjugate KL17 Substrate KL18 OD HIV 1 2 raw MKL12 1998 04 21 Conjugate KL19 Substrate KL20 OD HTLY IZII raw MKL13 1998 04 21 Conjugate KL21 Substrate Solution KL
22. Cook Book 25 3 ML EA M E Methods cccccccccecesesseceeecesesssaeeeeeeseaeaeeeeeesaes 27 4 Daily Work Routine eeseeeeen meme 41 5 Test Results amp ML FA M E 55 6 Instrument 63 7 ML E A M E 65 8 ML EA M E Maintenance 69 P N 610520 02 05 01 2 23 Microlab F A M E User Manual V2 0 CookBook 2 24 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter P N 610520 02 05 01 2 Cook Book Introduction The purpose of the cook book is to give a step by step guide to the day to day operation of the ML FA M E and the ML F A M E soft ware version 2 0 Each section consists of an introduction explaining the basic prin ciples being covered then a step by step guide to each task in a tabulated two column format O Column 1 The Task FJ Column 2 The Procedure Any additional information for the operator s attention is displayed in the left margin as either a Note or an Attention A certain amount of basic computer understanding will be assumed throughout these examples and most will assume that a valid ML F A M E operator with the necessary access rights is logged in to the ML
23. Copy Rename Delete Backup amp Restore Methods functions The following table explains these procedures As most of the dialog boxes for these procedures are identical the process will be explained once in entirety then again for each fur ther command using reference to the common elements Table 3 1 3 1 Save As Copy Rename Delete Backup Restore and Print a Method To Do This From the Methods menu in the main ML F A M E window select the Manage sub menu then the Save as menu choice Saveas 1 2 A dialog box is displayed allowing the ML F A M E operator to enter a new name for the method Copy 3 If a method is open for editing the ML F A M E operator is prompted for the new method name However when no method is open a dialog box is displayed listing all methods available to the ML F A M E operator on the ML F A M E database allowing the selection of the method to be copied and an entry field for its new name P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods Table 3 1 3 1 Save As Copy Rename Delete Backup Restore and Print a Method Conrveo To Do This Rename 4 Select the method from the list in the displayed dialog box and enter the new name Delete 5 To delete a method select the method from the displayed list and use the delete push button The method will be removed from the ML FA M E databa
24. Update Version Installed by Date Initials Supervisor Check P N 610520 02 05 01 Appendix 5 257 Microlab F A M E User Manual V2 0 Appendix 5 Forms Appendix 5 258 P N 610520 02 05 01 Appendix 5 Forms Microlab F A M E User Manual V2 0 Firmware Installation Record Computer Serial sss Instrument Serial Firmware Version sss Installed by sess Date uiniususeiauihetnuieu Update Version Installed by Date Initials Supervisor Check P N 610520 02 05 01 Appendix 5 259 Microlab F A M E User Manual V2 0 Appendix 5 Forms Appendix 5 260 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 6 News Letters 6 News Letters A6 1 Introduction The purpose of this appendix is to collect the periodic news letters which give information to ML F A M E operators concerning many aspects of using the ML F A M E These news letters are very importent to the operation of the ML FA M E and ML F A M E soft ware and must be stored here P N 610520 02 05 01 Appendix 6 261 Microlab F A M E User Manual V2 0 Appendix 6 News Letters Appendix 6 262 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 7 P N 610520 02 05 01 Appendix 7 User Manua
25. corresponding loading step has been started by the system Any unstable reagent must be at least stable until the start of the dispensing step 11 7 6 Wash Container Stand A ATTENTION It is possible some liquid may leak through the thread of the cap due to the vent P N 610520 02 05 01 Reference Guide Daily Work Routine J Fluid assignment verification flag OFF and non unique component lot numbers Finally for those reagents which do not require a verification verifi cation flag OFF but for which several component numbers exist The drop down lists in the Selected Component Lot No field lists all registered component lot numbers of this reagent The ML E A M E operator must select the one that you are actually using Loading of Unstable Reagents Reagents which have been defined within the method as unstable can only be loaded during their preparation and or loading time The above procedures for assignment and verification of stable reagents can also be preformed for unstable reagents however this must be started after the reagents preparation time has begun Loading of Wash Solutions General Remarks O Prepare the wash and rinse fluids at the times specified in the Plan window O When decanting wash rinse fluid into a wash fluid container place the wash fluid container on the wash container stand supplied with instrument This allows it to be placed on its side with the cap facing
26. only by an authorized technician and then reinstalled in the new work place 19 The instrument weighs in excess of 220 kg Necessary precau tions should be taken when carrying individual modules and when transporting the instrument 20 After repair service module exchange the instrument should be verified using the verification kit 21 For reasons of data security and integrity it is recommend to use the system with an uninterruptable power supply UPS since a loss of power may cause data to be lost or corrupted Electrical Safety Precautions Severe damage will occur to an instrument set to 115V which is connected to a 230V mains electricity supply Before removing a mechanical or electrical component the instru ment must first be switched off and disconnected from the mains electricity supply and PC P N 610520 02 05 01 Microlab F A M E User Manual V2 0 ML F A M E Overview 1 4 4 3 Hazards Location of warning and attention labels and general location infor A mation Warning N Warning Warning AN Do not swap plates after loading Biohazard inside transparent cover Moving Parts inside transparent cover ri mm UBER Power sna Jn on left side and Instrument Serial Number on back side Warning Laser Beam Do not stare into beam Class 2 Laser Warning N Do not overfill reagent container Close the reagent drawer gently to prevent spillage A Pause Warning N Inst
27. optional PC requirements 196 PC requirements 196 photometer 190 plate barcode label dimensions 192 symbology 192 plate barcodes code density tolerance 193 length of information 193 positioning on plate 192 print contrast 193 print quality 192 power supply 184 reagent container barcodes 193 positioning of 194 uninterruptable power supply 184 UPS 184 washer dispenser module 188 washer 188 Spillage Tray 180 243 P N 610520 02 05 01 Appendix 8 273 Microlab F A M E User Manual V2 0 Appendix 8 274 Appendix 8 Index Stack 243 Stack Type 243 Steps Menu 95 Stop Solution 243 Strip Direction 92 Strip Wash 96 Substitute Plug 243 Summit Processor 16 20 241 Summit Processor 16 30 241 Summit Processor 24 20 241 Summit Processor 24 30 241 Summit Processor Database 241 Syringe volume of 189 System Manager 243 System Trace 135 243 Technical Specifications 183 Test 243 Test Data managing of 133 Test Documentation Batch 243 Test Documentation Jobs 102 Test Header 243 Test Kit 243 Test Kit Package Insert 28 Test Locking 243 Test No 243 Test Processing Editor 85 94 steps menu 95 Test Processing Steps dispense 98 incubate 95 incubation temperature 95 incubation time 96 incubation tolerance time 96 mix 100 prepare plate 95 read 100 wash 96 Test Report 243 Test Result Report Dialog Box 130 Test Results 129 archiving of 134 documenting a batch 133 edit status 132 overview 130 storage of 133 test s
28. or non plan processable can only be deleted from the work lst After applying the Un schedule option in the Work List window and making the changes in the run by using the options of the Edit pull down menu in the Work List window schedule the altered work list again by selecting the Schedule option from the Action menu Whenever the Un schedule option is applied to a running work list the Plan window is accordingly updated i e all plates and fluids which are no longer used in the changed work list or are not yet used i e their preparation time has not started are removed from the plan The same is true after the schedule of an altered work list 11 8 2 Reschedule Rescheduling a running plan is basically the procedure described in the section above During the processing of a run delays may occur either based on delayed operator activities or any problems encountered during the run that delayed certain process steps 11 126 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine Whenever the system detects that the run might be endangered it forwards information to the operator and suggests a re scheduling of the work list Recalculation of reagent volume and containers during reschedule O The loaded reagent volumes will be taken into consideration e g the unused reagent from aborted plates O The above is also true for reagents with already started prepara ti
29. window after successful scheduling It is also possible to open existing work lists using the Open menu choice in the File pull down menu and then start the sched uling process as described above The scheduler will calculate different plate stay times however the plate hold time defined in the method will never be exceeded The scheduler will organise the plate order to minimize the plate stay time on any stack P N 610520 02 05 01 11 111 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 4 The Plan Window The Plan window is a graphical representation of a scheduled work list It displays information about the run and operator interactions etc The Plan window is displayed whenever the scheduling of a work list was successful Plan Example work List Planned File View Actions Method Plate Location Example ELISA gas Test Window Time Bar Container Fluid Window Figure 11 3 Plan window The Plan window is separated into three sections rows as follows O The upper part of the Plan window is the Test window O The bar across the middle is the Time bar O The lower part is the Fluid window 11 4 1 Menu Choices O File Menu NOTE All times referred to in the printed O Print prints an action list on the OS 2 default printer action list are not accurate until O Close shuts down the Plan Window the ML F A M E oper the work
30. 0 NOTE Each individual Method s state is checked to ensure it is error free and that the corresponding Kit Lot is correct for the method and the expiry date has not been reached NOTE It is not possible to perform any actions on a work list or indi vidual stack in the list that has a status of planned or running In order to edit the properties of a stack the planned work list must be un scheduled see Table 4 1 4 3 Scheduling and Un scheduling a Work List on page 47 Therefore running work lists and their stack types cannot be edited NOTE The ML E A M E software allows two way of defining the earliest starting time for a stacks processing either time of day i e the ML operator defines an actual time for the start or as an offset to the previous stacks start time When the first stack uses the offset time the start time is off set from the time the stack is planned 4 46 Cook Book Daily Work Routine Table 4 1 4 1 Define a New Work List To Do This Remove a stack from a work list Define the earliest start time Change the kit lot Print the work list 5 Select the required stack type name i e Example Stack Type from the list and click on the Insert push button 6 After a moment the stack will appear in the Work List Manager window For further information on the contents of the Work List Manager window see Reference Gui
31. 0 Cook Book ML F A M E Maintenance Chapter 8 ML E A M E Maintenance Table of Contents 8 1 Maintenance Overview cesser eene 70 8 1 1 Maintenance Procedures 70 8 1 2 Washer Manifold seen ennen nerne nerne 71 8 1 3 Manual Maintenance Procedures 74 P N 610520 02 05 01 8 69 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Maintenance 8 1 Maintenance Overview While most of the procedures required to perform ML F A M E maintenance are guided by the ML F A M E software some manual actions are still required by the ML F A M E operator This chapter gives a step by step guide to the initiation of these maintenance tasks and to the aforementioned manual ML FA M E operator actions 8 1 1 Maintenance Procedures O Cold Start must be run after the first ML F A M E initialization of the day or after every 24 hours of operation NOTE If the ML F A M E operator O Daily before ML F A M E shut down if it has not been run for declines to run either weekly or one day monthly maintenance before shut down upon the next initial O Weekly before ML F A M E shut down if it has not been run for ization these routines must be one week run O Monthly before ML F A M E shut down if it has not been run for one month Table 8 1 1 1 Accessing the Maintenance Procedures To Do This
32. 01 Appendix 1 213 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages A1 1 Error Messages Introduction The tables in this section list the errors and warnings that may occur while running the instrument These have an Error ID and then a description of the actual error then This is given as a refer ence A1 1 1 Explanation of Formatted Strings Some formatted text strings may appear in some messages in the tables These are explained below 96s In the actual error dialog these characters will be replaced by a text string d In the actual error dialog these characters will be replaced by a decimal integer 96 3 In the actual error dialog these characters will be replaced by a real number with three digits after the radix For example the message Insufficient unstable Reagent Replace Container with Barcode s at rotor position d immedi ately and close Reagent Drawer 3f ml required for next dis pense Pressing Not OK will abort Plate might appear on the screen as Insufficient unstable Reagent Replace Container with Barcode REAGENT 23 00 at rotor position 3 immediately and close Reagent Drawer 19 950 ml required for next dispense Pressing Not OK will abort Plate Appendix 1 214 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages A1 1 2 General Errors DIALOG ID MES
33. 1 Starting a Run To Do This Starta run From the Actions menu select the Start Run menu option 2 The work list will now start processing using the ML FA M E software defined schedule ML EA M E 3 The ML F A M E operator will be operator actions prompted when action is required 4 Prepare plate s The ML FA M E operator is prompted to start the plate preparation given the time specified in the prepared plate step of the method definition 5 Load stack The ML F A M E operator is prompted to load the appropriate stack then press the instrument s Load button NOTE This option is only available if the Edit plate barcode 6 When a plate is loaded a search is Plate Access On installation information made to find the plate s barcode data If option was selected this search can not find any information the Pipetting Information Error dialog box is displayed By selecting Retry or Search In Path another search is made N to find the pipetting information With in this dialog box it is then possible to select the Edit Plate push button displaying the Edit Plate dialog box ATTENTION Selecting Retry or Search in path must be carried out within two minutes Here it is possible to include or exclude If any samples must be samples and to edit a wells barcode excluded or included this must be done prior to the first 8 Load Unstable Fluid s aspirate wash or SRAM step If Table 4 1 6 2 A
34. 1 Introduction This section contains a list of questions frequently ask of the tech nical support department and training course instructors As these issues have no particular place in the main text of this manual they have been collected into this appendix While these questions and answers address specific issues they are not an absolute cause of a problem it is possible for example that the cause of the problem could be different to the explanation listed Therefore it is recommended to first try the solutions listed in the following text and ifthis does not help proceed with normal technical support A3 1 1 Updates From time to time an update of this appendix will be issued If received the updates should replace the entire appendix section of the user manual P N 610520 02 05 01 Appendix 3 247 Microlab F A M E User Manual V2 0 Appendix 3 Frequently Asked Questions A3 2 Frequently Asked Questions Appendix 3 248 FAQ 1 Question Answer Global fluids can not be deleted from the database An error message indicates that they are associated with an existing method but no method can be found How do I find this method For all test results there is an entry in the data base for the method used and that method s security code even if the method has been changed or deleted These methods will not be visible when the list of methods is displayed in the Delete method selection
35. 24 30 1 14 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 ML F A M E Overview Barcodes for Wash System Part No Description 255 734 External Pump Station Washer 1 255 735 External Pump Station Washer 2 255 736 Ortho Specific Wash Fluids Washer 1 255 737 Ortho Specific Wash Fluids Washer 2 255 738 Maintenance Fluids Washer 1 255 739 Maintenance Fluids Washer 2 255 740 Generic Wash Fluids Verification Kit Part No Description 148 381 Verification Kit 148 383 Washer Dispenser Verification Kit 148 405 Incubator Check Plate Modules Part No Description 148 301 Expansion 16 20 to 16 30 configuration 148 302 Expansion 16 20 to 24 20 configuration 148 303 Expansion 16 20 to 24 30 configuration 148 304 Expansion 16 30 to 24 30 configuration 148 320 Expansion 24 20 to 24 30 configuration P N 610520 02 05 01 1 15 Microlab F A M E User Manual V2 0 ML F A M E Overview Photometer Filters for Microlab F A M E Part No Description 235 511 340 nm 235 504 405 nm 235 505 450 nm 235 506 492 nm 235 509 620 nm Optional Filters for Microlab F A M E Part No Description 235 521 570 nm 235 525 610 nm 235 510 690 nm Other filters available on request Microlab F A M E Software Part No Description 910 034 User Software English including firmware 1 16 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610
36. 610520 02 05 01 Appendix 2 Glossary Microlab F A M E User Manual V2 0 RW SAMPLE SAMPLE AND REAGENT ADDITION MONITORING SRAM SERVICE CONTAINER SERVICE POSITION SERVICE TECHNICIAN SHIPPING KIT SLOT DooR SOAK TIME SPILLAGE TRAY STACK STACK TYPE STOP SOLUTION SUBSTITUTE PLUG THE SYSTEM SYSTEM MANAGER SYSTEM TRACE TEST TEST DOCUMENTATION BATCH TEST HEADER Kir TEST LOCKING No TEST RESULT REPORT TEST RUN P N 610520 02 05 01 Appendix 2 Glossary The optical density OD of a well measured by the photometer using the reference wavelength Specimen to be analyzed A procedure used to determine the correct dispensing of samples or reagents when reagents or samples are pre treated with dye using a photometric read step The resulting data can be checked when processing is completed A reagent container without a syringe used for performing special maintenance and error handling procedures i e automatic syringe deposit A recess in the top of a reagent container into which the cap is placed before the container is placed in the reagent drawer Trained and authorized service engineer Package that contains all necessary instrument accessories Flap on the front of an incubation slot which closes off the slot during incubation of an MTP Parameter of a wash cycle The time wash solution remains in the wells before the plate is emptied
37. Breaker Ratings P N 610520 02 05 01 Primary Circuit Breakers Mains Four 5 A thermal circuit breakers Both live and neutral lines pro tected All circuit breakers are located behind the panel on the left side of the instrument near the mains switch Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications 16 1 5 Operating Environment Operating temperature range 15 to 35 C Humidity up to 85 Indoor use only Altitude 2000m max 16 1 6 Compliance with EU Directives The ML FA M E is in conformity with the requirements of the EMC directive EN 50081 1 and EN 50082 2 and low voltage directive EN 61010 1 of the European Community CE label Please note that this instrument has been designed and tested to meet the requirements of residential environments 16 186 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 16 2 16 2 1 16 2 1 1 16 2 1 2 16 2 2 16 2 2 1 Module Specifications Reference Guide Technical Specifications Entry Module Entry Stack Capacity Up to 4 plates MTP identification by barcode Incubator Towers Front Tower 5 slots ambient temperature Rear Tower 5 individually temperature controlled slots Temperature range In steps of One temperature can be assigned per tower ambient to 45 C active control starting at 5 above
38. E User Manual V2 0 Reference Guide ML F A M E Maintenance 15 1 6 Maintenance Procedures For instructions on accessing the maintenance routines see Cook Book Section 8 1 1 on page 70 15 1 6 1 Every Day Approx Duration 13 25 minutes O Cold Start Maintenance O Approx duration 5 minutes Must be carried out in the morning prior to any ML F A M E test processing Checks the functions of and rinses the Washer s O Renew Defective Syringes see Cook Book Section Table 8 1 3 1 on page 74 O Approx duration 1 3 minutes O Check syringes for tightness i e formation of air bubbles water in reagent container O Replace if applicable O Daily Maintenance Routine O Approx duration 5 10 minutes O Must be carried out at the end of each working day prior to system shut down O Rinses the washer system fills the wash shell and immerses the needles of the manifold in fluid to prevent crystallization O Clean Waste Container see Cook Book section Waste con tainers and waste caps on page 8 76 O Approx duration 2 minutes O Decontaminate the waste with a suitable decontamination fluid empty the container rinse with tap water and leave to dry O Clean Syringes see Cook Book section Clean dispose of syringes on page 8 74 O Approx duration 5 10 minutes O Fill syringe with deionized water O Stand the syringe upright in the reagent container overnight P N 610520 02
39. MCN AW NER E m IC FT D A EN X Ra mcam an ON vit N yp EN a SS d N 7 UN 8200 cio CI00 8250 ET ME ER f in EC X m E ON SZ ee RFS F AN f OW ECTS GE SEF OS AEN 7 DN EIS RP FF eT Ee s Ae EEE G FE Es FIN EN EN 7 oF N d E CN Pd YS dp OF NF RI IP ART RT 87 WEILE ES HN if p We os 7 VES N N N b j Ju yd EDEN EEE SEEN N B200 200 ul check solution B used as reference wells C100 100 pl check solution C checks residual volume B250 250 ul check solution B checks aspirating accuracy and precision Figure 14 3 Plate Layout for Washer Check The OD value of these wells are measured with the photometer and used as reference values The verification procedure is then as fol lows Residual Volume The wells to be tested rows 4 to 9 are filled with 100 ul of a con centrated dye solution check solution C The wells are then aspirated 200 ul of colorless solution check solution D is then dispensed into the aspirated wells The absorbance of the wells is then measured with the photometer 14 155 Microlab F A M E User Manual V2 0 14 156 Reference Guide ML F A M E Verification By comparison with the values of the reference wells and the known concentrations of the check solutions the residual volume can be calculated Aspirating Accuracy and Precision The wells to be
40. ML F A M E Verification Chapter 7 ML EA M E Verification Table of Contents yes 66 7 1 1 Pre verification sss 66 7 1 2 Verifying an Instrument 68 P N 610520 02 05 01 7 65 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Verification 1 1 Overview NOTE Verification is an in built self checking system of the functionality of A warning dialog box will be dis the ML FA M E All physical modules of the instrument are tested played giving 14 days notice of against predefined values using a verification kit with tested known any required verification proce values dures These checks must be performed at a regular interval to ensure reliable operation of the ML FA M E This chapter explains step by step each verification procedure For further technical information see Reference Guide Section 14 on page 147 1 1 1 Pre verification ATTENTION Photometer filters 620 and 405 Before the verification process can be started it is necessary to nm must be present to perform supply the ML E A M E software with validation data for the verifica verification tion kit Three criteria exist and are explained below Table 7 1 1 1 Photometer Verification Validation To Do This Validate the Before the photometer verification the photometer ML E A M E software requires reference data Supplied with the ve
41. Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 10 Finishing a Run A run is finished when the processing of all plates in the work list is finished Then close the Plan window by selecting the Close option from the File pull down menu in the Plan window This returns focus to the Work List window close the work list manager that has been scheduled and processed A new run is started by the ML F A M E operator opening or creat ing a new work list After the test s processing depending on the documentation jobs defined for the methods used the test results must either be realesed manually in the Test Results window or it if defined this will be done automatically Test results may be viewed in the Test Results window 11 128 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Test Results amp ML F A M E Traces Chapter 12 Test Results amp ML F A M E Traces Table of Contents 12 4 Overview Run 130 12 1 1 The Test Results 131 12 1 2 Well Flag ae ea en 132 12 1 3 Photometer Overflow and Underflow 132 12 2 Managing Test Data 133 12 2 1 Releasing Test 133 12 2 2 Documenting a Batch of Tests
42. Module Transport for correct positioning Press OK if the Plate is in correct position INC407 1 Main Shuttle step lost Could not read Plate Barcode Check the Plate on the Main Shuttle for correct positioning Press OK if the Plate is in correct position INC420 1 Entry Lift movement interrupted by user Continue movement of the Entry Lift Press YES to continue NO will abort the loading INC421 1 Entry Lift step lost Could not execute Plate presence check on the Entry Stack Check the Plates on the Entry Stack for correct positioning Press OK if the Plates are in correct position INC422 1 Stack has not been loaded To continue Plate loading press YES NO will abort this function INC425 1 Entry Lift movement interrupted by user Continue movement of the Entry Lift Press YES to continue NO will abort the loading INC510 1 State of Entry Stack is reserved Do not press Load Button while LED is yellow blinking INC800 1 Power interruption detected Please inform your instrument supplier and include the system trace Program will continue INC801 1 Power failure in ventilation system Please inform your instrument supplier and include the system trace Program will continue P N 610520 02 05 01 Appendix 1 223 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages DiALOG ID MESSAGE INC900 1 Module Transport not functioning Move the Module Tr
43. On With this option the plate is moved back wards and forwards during washing to minimize the wash solution left in the wells This option is only possible when using plates with flat bottom wells Pump Power The following data must be specified Aspirate Power either low medium or high Dispensing Power either low medium or high Aspirate Power During Dispensing either low medium or high 10 97 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods Number indicates order of washing strips 7 ist cycle 1 2 istcycle 1 3 5 3 4 2nd cyce 2 4 6 8 2n dcycde 5 6 7 8 OQOOOOOOOOQOOOQ OQOOOOOOOQOOOQ OOOOOOOOOQOO00 OQOOOOOOOOQOOO0 QOOOOOOOQOOOOQ OQOOOOOOOOOOOQ OOOOOOOOOOO00 OQOOOOOOOOOO00 QOOOOOOOOOOQOQ OQOOOOOOOOQOOOQ OOOOOOOOQOOOQ OOOOOOOOQOOQO OOOOOOOOOOO0 OOOOOOOOOOO0 Strip Wash Plate Wash Washer Manifold Aspiration diagram not to scale Figure 10 10 Explanation of Strip Wash and Plate Wash 2 cycle wash and aspiration height O Dispense this step defines the criteria for reagent dispens ing The following data must be specified O Reagent name O Into which well types PC NC etc O Dispense volume O Dispense speed either very slow slow medium or fast O Aspirate speed either very slow slow medium or fast O Sample and Reagent Addition Monitorin
44. Processing saves the Plate Layout Editor information defined and opens the Test Processing Edi tor O Print prints on the default printer a graphical representation of the Plate Layout as defined for the current method O Close Editor shuts down the Plate Layout Editor O Exit Method Editor shuts down all method related editors and related dialog boxes 10 90 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods 10 2 2 2 Edit Menu The Edit menu allows the user to work with well types NOTE Well type names can consist of O Edit Well Types this menu choice displays the Edit Well only two alpha characters No Types dialog box allowing the user to define new and delete numerics are allowed existing well types the plate layout can also be checked Here is an example of possible well types O NC default Negative Control type O PC default Positive Control type NOTE Itis not possible to define individ O SA default SAmple type ual wells as samples default Keep Empty This indicates that wells of this type serve abbreviation SA as all wells no function in a test and no reagents should be dispensed otherwise not defined are inter into them preted as sample containing wells and automatically filled as If other well types are required they must be defined manually per the defined criteria See Cook Book page 28 O Clear Layout clears the plate of all definition
45. Reference Guide ML F A M E Functions amp Requirements O Incubator 1 dialog box allowing the temperature of the front and rear towers of this module to be set Incubator 2 as above O Simulated Instrument Menu using the simulated instrument allows the user to run simulated scheduling of work lists The options in this menu allow the user to define different configura tions to achieve these simulated schedules and are virtually the same as the connected instrument options 13 2 5 Software Presettings Services Software Presettings Global settings Name of laboratory Example Laboratory AG Plate movement time 12074 sec J Always start documentation Mi Audible alarm Sound type Sound on off Default settings for external interface Trace path C FAMENTRACES Method backup path AN Method restore path PAN User access file CNFAMENDATANUSERACCDAT Kit Lot file C FAMENDATANKITLOT DAT Plate acknowledge C FAME HOSTCMD PLATEACK CMD Error recovery C FAME HOSTCMD ERRRECOV CMD Time synchronization C FAME HOSTCMD TIMESYNQ CMD Automatic documentation C FAME HOSTCMD AUTODOC CMD Figure 13 4 The Software Presettings Dialog Box This dialog box allows ML F A M E operators with sufficient access rights to change the settings of the ML F A M E software O Global Settings Name of laboratory this name will be displayed on all infor mation printed from
46. Results Report dialog box is displayed giving detailed information about the selected test see Reference Guide Section 12 1 on page 130 View 4 Select the desired well from the individual well s graphical display then select the Well details Details push button The Well Details dialog box gives full well details NOTE Once a well has been excluded it Exclude a well 5 From the Well Details dialog box select is not possible to re include the the Exclude Well push button well The ML FA M E opera tor who excluded the well and Attach a message 6 From the Well Details dialog box select the time and date of exclusion to a well the Insert Well Comment push button are noted in the trace file A dialog box is displayed where the ML F A M E operator can attach a short message to the selected well View well data ina 8 Select the Table View push button in tabulated format the Test Results Report dialog box 9 The Test Results Report Table View dialog box is displayed 10 The Sort push button allows the user to specify the listing order of the data View the test 11 Select the Test Trace push button to trace view any information attached to the results of the selected test 12 A comment may also be attached by the ML F A M E operator NOTE It is only possible to document Manually release 13 Selectthe Document push button in the tests with the status Processed the documentation Te
47. Test Results window display either select the Refresh Now menu choice from the View menu or use the NOTE F5 keyboard key A user needs the necessary access rights to delete data Delete tests 6 There are three ways to delete tests Ensure that any tests to be from the ML FA M E database Each is deleted have been documented explained in the following section Tests deleted from the ML F A M E database cannot be recovered Delete a Single T To delete an individual test from the ML Test F A M E database select the desired test then from the Tests menu select the Delete Selected Test s menu choice 8 Confirm this action and the test will be erased 5 56 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Test Results amp ML F A M E Traces Table 5 1 1 1 Test Results Window Procedures conrmveo To Do This Deleting multiple tests Enable multiple test Selection Delete tests by criteria Batch documentation 12 16 17 18 19 9 To delete multiple tests it is first necessary to enable multiple test selection 10 Select the Enable Multiple Test Selection menu choice from the Tests menu 11 It is now possible to select more than one test at a time To deselect a selected test just click on the test Select the desired tests to be deleted then the Delete Selected Test s menu choice 13 Confirm this action
48. Washer Upon initial instrument installation O Quarterly every 90 days per washer O After repair or service of the module O When a manifold is exchanged O When the module is exchanged O Incubator O All slots upon initial instrument installation O All slots twice a year every 180 days O After repair or service of the incubator module O After a slot is locked due to a temperature error O When the incubator module is exchanged After ML F A M E initialization a number of checks are made one of these is to determine the verification interval statuses The ML F A M E operator will be prompted if any verification procedures are required 14 149 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 1 4 Whatis in a Verification Kit The complete Verification Kit consists of the following items O Incubator Photometer Verification Kit containing O Incubator Check Plate O Photometer Check Plate Diskette containing Photometer reference data NOTE The Washer Dispenser Verifica O Washer Dispenser Verification Kit containing all consumable tion Kit can be ordered as a sep items required for the dispenser and washer verification proce arate item Additional Incubator dures Check Plates may also be ordered O Four Dye Solutions Check Solutions A B C and D suffi cient to verify 3 Washers and 3 Dispensers or combinations of O Washer and Dispenser Check Plates O Reag
49. a new method has been new one must be carried out to ensure that the processing and created with the method editor data evaluation of both methods produce equal results a verification run should be performed Deionized water containing 0 9 NaCl should be used as a substitute for all reagents and wash solutions The entire test should be visually overseen by the method pro grammer to ensure that all steps are executed correctly and that the right values for wash volumes and reagent volumes have been specified It is also advisable to check for errors in the program ming of the order of processing steps Wrong parameters may result in fluid being spilled from plates onto the instrument s trans port system 10 104 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine Chapter 11 Daily Work Routine Table of Contents 11 1 Overview Daily Work 106 11 1 1 Elements of a Test Run see 106 11 1 2 Work Moris 107 11 2 Kit Lot Editor eicere 108 11 2 1 Menu Choices 108 11 3 Work List 109 11 3 1 Menu Choices ssssssseeeeeneneennenennes 110 11 3 2 Scheduling a Work List sess 111 11 4 The Plan 112 11 4 1 Menu Choices urs
50. a suitable disinfectant leave to blowers to dry the instrument soak as recommended by the Flammable liquids are used for manufacturer cleaning 2 Empty the container rinse thoroughly Wear gloves when cleaning the with water and leave to dry instrument and removing the washer manifold External water 3 the same for the external water separator separator Waste cap 4 Clean the outside of the waste cap with N a cloth soaked in Microlab Disinfectant Spray ATTENTION Do not use water hotter than 50 Reagent 5 Remove the barcode label from the to clean reagent containers and containers reagent container do not dry or store at CO temperatures gt 50 C Cold deionized water is recommended Make sure that the conductive 6 Immerse the reagent containers in deionized water Note that the lids of the reagent containers can be removed if necessary insert is still in place after Washing a reagent container Alternatively clean the reagent containers in a laboratory washing PA machine NOTE E Research has shown that b d 8 Empty and leave to dry syringes can be used for a max 2 imum period of one 1 week if Clean dispose of 9 Fill the syringe manually once with an appropriate cleaning proce syringes deionized water dure is applied The decision to reuse lies with the operator and 10 Leave the filled syringe free of air should be made in accordance bubb
51. all important events and data throughout the entire system and includes ML F A M E operator actions ML F A M E software functions ML F A M E procedures and also important test trace information P N 610520 02 05 01 5 59 Microlab F A M E User Manual V2 0 Cook Book Test Results amp ML F A M E Traces 5 2 1 The Trace Window The following section gives a step by step guide to working with these traces Table 5 2 1 1 The Trace Window To Do This Open the Trace From the Services menu in the Main window ML F A M E window select the Trace menu choice The Trace window is displayed listing the available trace information stored on the ML FA M E database as per the defined view criteria Print the trace 3 From the File menu select the Print information menu choice The displayed information is printed on the default OS 2 printer Store the trace 4 From the File menu select the Save As information menu choice 5 A dialog box will then ask the ML F A M E operator to enter a file name The trace information is recorded in this file Attaching 6 The ML EA M E operator can insert messages messages to any of the three types of traces Well messages T From the Edit menu select the Insert Well Comment menu choice A dialog box is displayed where the ML FA M E operator must select the test containing the required well 8 Once a test has been selected the ML F A M E operator
52. ambient 1 C Incubator Module Incubator Towers Front Tower Temperature range In steps of 5 individually temperature controlled slots One temperature can be assigned per tower ambient to 70 C active control starting at 5 above ambient 1 C Rear Tower Identical to front tower Maximum temperature difference between front and rear towers 25 C Incubator Slot Temperature Variation temperature controlled incubation Temperature Variation at target temperature Up to 45 C lt 1 C 46 70 C lt 2 C a This specification Is valid under the following test conditions Type of MTP Incubator Check Plate Test Method Verification Test Temperature 37 C 16 187 Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications 16 2 3 Washer Dispenser Module 16 2 3 1 Washer 24 channel manifold 8 x 3 array with liquid level detection on each needle Wash volume 50 400 ul In steps of 10 ul Residual volume after Mean lt 10 ul well washing Typically lt 5 ul well Number of wash cycles 1 9 Wash modes Dispense only Strip Wash Plate Wash Soak time Plate Wash 20 300 s Strip Wash 0 605 Wash options Continuous wash Bottom wash Bottom sweep Number of wash containers 3 per washer Number of rinse containers 1 per washer Wash Rinse container 3 litres capacity Wast
53. and rear Device with 5 incubation slots either all at ambient temperature or all temperature controlled A functional element of the instrument e g dispenser washer photometer main shuttle incubator slot Different instrument configurations contain different numbers of instrument functions Package into which all modules the chassis and the shipping kit are packed A controlled stepwise closing of the ML F A M E instrument including optional maintenance macros The RS232 connector for connecting the computer to the ML F A M E instrument A well in a plate that serves no function in a test i e no reagents are dispensed into it and no measurements made on it Keyboard memory Production batch number of a test kit Local Area Network Any computer instrument connected to the LAN Rules for placement of controls standards samples blanks etc in the MTP Appendix 2 239 Microlab F A M E User Manual V2 0 LLD LOAD BUTTON LOADING LOADING ORDER LOCKING DEVICE Lock STATUS LOGIN LOGOUT Lor No MAINS CONNECTOR MAIN SHUTTLE MAIN SHUTTLE RAIL MAINS SWITCH MANIFOLD MANIFOLD HOLDER MANIPULATION POSITION M CODE MENU BAR METHOD MIXER MODULE MODULE TRANSPORT MTP MTP BARCODE MTP BARCODE READER MTP TRANSPORTER Appendix 2 240 Liquid level detection A button on the instrument the pressing of which will initiate the processing of a single MTP or an e
54. and the selected tests will be erased 14 From the Tests menu select the Delete Test by Criteria menu choice 15 Three radio button options are available in the displayed dialog box a All Existing Tests this will delete all test result data from the ML F A M E database b Documented Tests Only this will delete all tests whose documentation has been released c Aborted Tests Only this will delete all tests whose error status is marked as aborted see Reference Guide Section 12 1 1 on page 131 lt With the multiple test selection option active select the tests to be documented From the Tests menu select the Documentation Tests Batch menu choice A dialog box will display the currently available documentation format options See Cook Book page 37 and destination devices Select the desired options and then the Document push button All defined criteria will be followed for the selected tests P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Test Results amp ML F A M E Traces 5 1 2 The Test Result Report Dialog Box Table 5 1 2 1 Test Result Reports To Do This View a test results From the displayed list select the report required test s results line Then from the Tests menu select the Show Test Results Report menu choice or double click with the pointer placed over the required line 3 The Test
55. aspiration height 0 3mm bottom sweep off mm m M 2 stt Nd v i Example ELSA Barcode Mask Documenti Documentation formats Devices RBHHHHHHHTTTTDReK SS ad Start documentation by user Dm am Figure 10 1 Method Editors Process Flow P N 610520 02 05 01 10 85 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods 10 86 10 2 1 Method Information Dialog Box The Method Information dialog box is the first step in the method definition process and is used to define the general information for the method and to display the processing status of the method i e if the method has been checked and is processible Method Information Example ELISA Created by JOHN O FARRELL Date 1997 03 12 Modified by JOHN O FARRELL Date 1997 08 26 Version V07 M Code 074834 Method information Access levels Manufacturer Example Parameter Hepatitis Read access 2 0 6 Test processing information Plate hold time Pipetting delay First processing step 30 min 5 2 State Comment Method OK Information OK Layout OK Test processing OK Check Print Cancel Figure 10 2 Method Information Dialog Box O Created by This is the name of the user logged in when the method was created Directly across the dialog box from this entry is the associated c
56. checking 10 2 6 2 Backup The Backup menu choice allows a method definition to be archived onto another device such as a floppy disk or any other drive LAN etc The method to be backed up has to be selected and the backup path specified As default the backup directory defined in the Software Presettings dialog box is displayed Methods can only be backed up individually i e one method at a time 10 2 6 3 Restore NOTE The Restore menu item allows an archived method definition to Only one method can be restored be re loaded from a device such as a floppy disk or any LAN drive at a time using the Restore into the database The path of the archived method has to be spec function i e it is not possible to ified As default the default directory as defined in the Software specify a batch of methods to Presettings dialog box is displayed restore Any restored method should also be verified before being used for real tests see section 10 2 7 on page 10 104 If the restored method s barcode mask is not unique within the methods currently stored on the instrument s database a message is displayed in which a new barcode mask must be assigned P N 610520 02 05 01 10 103 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods 10 2 7 Method Verification Before using any newly created method for routine test purposes a ATTENTION comparison study between the method previously used and the After
57. dialog box All test results for the particular method must be deleted before these global fluids can be deleted P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 4 Anomalies Appendix 4 Anomalies Table of Contents A4 1 Introduction 250 A4 2 Anomalies during Run ernennen nennen 250 A4 3 Anomalies without Instrument Running 250 P N 610520 02 05 01 Appendix 4 249 Microlab F A M E User Manual V2 0 A4 1 Introduction This appendix lists the known anomalies which still exist in the ML F A M E User Software and have not yet been eliminated A4 2 Anomalies during Run temperature and dialog verification required within 14 days is displayed the user selects reset of instrument status and the instrument is switched off A system error causes software shutdown ANOMALY ID DESCRIPTION WORK AROUND SOLUTION 887 The user ignores a waiting load plate dialog It Do not click in the dialog box more than once starts to beep and the title bar is highlighted red If the screen is left as it is the user timeout occurs The user clicks on the dialog box with the mouse and the loading procedure for the expected plate will to silence the sound This user action also resets be aborted the timeout for the dialog If the user continues to silence the sound in this way the dial
58. documentation jobs Documentation jobs are method specific and can be defined in various ways including or excluding different information These are called documentation formats and are global i e they can be used by multiple methods by being included in the method specific documentation job Table 3 1 2 1 Documentation Jobs To Do This Working with From the Methods menu select the Edit documentation Globals menu choice then the Formats formats sub menu choice Create a new or change an existing documentation format Assigning a documentation format to a doc job and then a method New P N 610520 02 05 01 2 4 5 6 7 The Documentation Formats dialog box is displayed allowing the ML F A M E operator to create new documentation formats and change or delete existing ones The Documentation Formats dialog box allows the ML F A M E operator to enter a name and comment for the documentation format then specify the various information to be contained in the documentation job including trace information OD values and plate information From the Methods menu select the Edit menu choice then the Documentation sub menu choice A dialog box is displayed listing all documentation jobs available for use This includes the documentation format used and the destination device of that information Select the New push button and in the dialog box a list of documentation formats and possi
59. drive or host system An important part of this command file is its confirmation to the ML FA M E of success or failure of delivery of this ASTM file This is done using an executable file called FAM RTC EXE which is used to confirm the transfer This file must be called in the command file defined in the Automatic documenta tion entry field in the software presettings dialog box Parameters of FAM RTC EXE Parameter 1 result file name to be confirmed without path Parameter 2 0 for positive confirmation 1 for negative confirmation 13 143 Microlab F A M E User Manual V2 0 13 144 REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM REM Reference Guide ML F A M E Functions amp Requirements Example FAM RTC 22133517 0 for positive confirmation If the transmission is not confirmed within the result file trans mission time out time the user software considers the trans mission as not successful The test status is not set to documented Example of a File Link Command The file link command myhost cmd will be called by the user software as defined in the Device Presettings dialog box or in the AUTODOC CMD file with two additional parameters OSJ 2 file link command script KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK Filename MyHost cmd kkkkxkxkxkxkxkkkkkkkkxkxkxkkkkkxkx
60. due to dispenser module transport failure Error Status Error ERROR RUN ITP032 Washer locked due to an error during priming location s Error Status Error ERROR RUN ITP040 Plate transport failure plate still on instrument location s ERROR RUN ITPO40 Plate transport failure plate no longer instrument ERROR RUN ITP500 Incubation time not within tolerance location s Error Status Error loc s tow c slot d ERROR RUN ITP500 End of incubation undefined location s Error Status Error loc 96s tow 96c slot 96d ERROR RUN ITP500 Start of incubation undefined location 5 Error Status Error loc s tow c slot d ERROR RUN ITP501 No incubator slot available Error Status Error ERROR RUN ITP510 Plate no longer on instrument Error Status Error ERROR RUN ITP511 Plate barcode could not be read during reidentification Error Status Error ERROR RUN ITP512 Wrong plate detected during reidentify barcode read s Error Status Error be s ERROR RUN ITP520 Plate hold time exceeded Error Status Error ERROR RUN ITP530 Plate not loaded load time exceeded Error Status Error ERROR RUN ITP800 Incubation temperature exceeded safety tolerance band or sensor defective location s Error Status Error loc s tow c slot d ERROR RUN ITP801 Incubation temperature exceeded limits defined in method location s Error Status Error Appendix 1 2
61. function can then be processed If the fault persists the function will be locked again O When the instrument is initialized In this case all correctly func tioning instrument functions will be unlocked 17 208 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 2 Troubleshooting Tables The following troubleshooting tables may help to remedy certain problems which may be encounter when using the system 17 2 1 User Software 08 2 and PC Related Problems Symptom Possible Cause Corrective Action PC 05 2 does not boot Non system disk in 31 3 drive of PC Remove disk from 31 5 drive of PC and re boot User software does not start up PC was not shut down after user software Shut down and re boot PC and try starting installation user software again Cannot get connection to Computer cable connected to wrong PC Check that computer cable is connected to instrument serial port or not connected at all instrument and to correct PC serial port Computer cable faulty Check continuity of computer cable and renew if necessary Unable to print to the 05 2 default Printer not connected to LPT1 parallel Check printer connection printer port Printer off line Check that printer is on line Physical name not correct Check in device presettings that physical name is correct 17 2 2 Module Specific Problems Below is a descript
62. head the recovery procedure is as follows 1 Try if possible to abort the run by selecting from the Abort menu in the Work List Manager Window either Test or Run This should stop all test processing Switch off the instrument Shut down the ML F A M E software Shut down the operating system OS 2 a Rw nm Restart the instrument the operating system and user software in this order All syringes will then be parked and all plates in the instrument will be transported to the exit stack Check if the lens block of the pho tometer is clean before the instrument is re used 17 200 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 1 4 User Actions which Can Adversely Affect a Run AN 17 1 4 1 Switching the Instrument On Off ATTENTION The instrument should not be switched off during a run The following notes should be If the instrument is switched off wait at least 20 seconds before read carefully They contain switching it on again important information which can reduce the occurrence of errors in the system If the instrument is switched off and then immediately on again it is possible that only the message relating to the latest change of instrument state will be displayed on the computer screen i e the message that the instrument has been switched on during a run and not off 17 1 4 2 Shutting Down the User Software PC The PC should not be
63. in the abbreviation entry field Blank in the Used as entry field and an optional comment Confirm the definition with the OK push button Delete any well types that will not be required for the test From the Edit menu select the Edit Well Types menu choice Select the well types to be deleted and select the Delete push button Choose a well type from the Select Well Type drop down list The cursor icon will change from an arrow to a Pencil P indicating well edit mode then select a well to allocate its selected well type as per the desired layout Select the Arrange Samples menu choice from the Samples menu to automatically complete the plate layout assigning all remaining empty wells as sample wells This is always the last action in laying out a plate Finally select the Check Layout menu choice from the File menu to automatically check the plate layout for errors Activate the Test Processing Editor by double clicking on its icon This is carried out external to the ML F A M E and the ML F A M E operator only needs to define the approximate time required to fill the plate with samples in this example 10 minutes 3 31 Microlab F A M E User Manual V2 0 Table 3 1 1 1 Method Definition Process contmueo To Do This NOTE Sample and Reagent Addition Monitoring is used to check dis pensing and can be used at any time in a test run for further information on the SRAM step and
64. is excluded The causing error could have occurred either during sample pipetting by using the Microlab AT ATplus2 during processing in the instrument or the well was manually excluded by the operator The well trace gives more details about the cause of the exclusion 12 1 3 Photometer Overflow and Underflow If a photometer overflow or underflow occurs during a well mea surement the result is handled in two different ways O Display of OD values O A photometer overflow is indicated by an OD value of 3 000 in the test result report display O A photometer underflow is indicated by an OD value of 0 101 in the test result report display O Documentation of OD values in the ASTM result file O A photometer overflow is indicated by an OD value of 9 999 in the test result report ASTM file O A photometer underflow is indicated by an OD value of 8 888 in the test result report ASTM file 12 132 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Test Results amp ML F A M E Traces 12 2 Managing Test Data 12 2 1 Releasing Test Documentation Below are listed the ways to handle the method specific documen tation of a test s results O Start by user When the Start documentation by the user check box is selected the OSP operator must manually start the documentation see Cook Book Section Table 5 1 2 1 on page 58 J Autostart When the Start documentation by the user check box is not ch
65. is not possible to verify a module without registering this data O Load Photometer Reference Data When selected the ML FA M E operator will be prompted to insert the Photometer Reference Data Diskette Predefined data will be loaded into the ML F A M E database and used as the criteria for verification 14 166 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification O Dispenser Displays a dialog box where the ML F A M E operator must enter information about the hand pipetting device used to establish the check volumes by which the dispenser is veri peu fied Washer Displays a dialog box where the user must enter the serial number of th h ifold i i TONNES Emm G ber of the washer manifold in the instrument being veri Serial Number 010 _ O Incubator UN Displays a dialog box where the ML F A M E operator must ION enter information about the Incubator check plate being en used for the verification P N 610520 02 05 01 14 167 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 168 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter 15 P N 610520 02 05 01 ML F A M E Maintenance Table of Contents 15 1 OVerview i ete pner dee Pea cune n
66. manifold cap Quantity 1 smaller needle Quantity 1 IEEE p Contents of Manifold Cleaning Set 15 179 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance The spillage tray locates on the two lugs on the transport fork The transport fork is moved to the correct position in the module automatically SS Correct location of spillage tray in washer dispenser module Figure 15 3 Spillage Tray and its Position in Module 15 1 8 Washer Decontamination NOTE Decontamination takes about 40 Recommended interval minutes O Every month Specific Items Required N Instrument Item required configuration ATTENTION Empty waste container s before 16 20 and 16 30 Wash fluid container containing starting washer minimum 2 of a suitable disinfectant decontamination Dispose of solution see section 15 1 2 for waste liquid using Good recommendations Laboratory Practice Wear gloves during the washer decontamination procedure Wash fluid container containing 1 5 N deionized water ATTENTION If not working with the waste cap clamp the waste tubing to prevent liquid spillage Wash fluid container with 1 5 deionized water containing 0 5 g l NaCl 15 180 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance General Description of Decontamination Procedure Du
67. methods from the stack type Save and exit 4 2 3 4 5 From the Main ML F A M E window select the Work menu then the Stack Type menu choice then the New sub menu choice The New Stack Type dialog box is then displayed enter the desired unique name for the new stack type i e Example Stack Type From the Method list box select the method to be added to the stack type i e Example ELISA then click the Add push button The selected method will be placed in the Stack Type list box Continue this process until the desired stack type is achieved To remove a method from the stack type select the method name in the Stack Type list box and click on the Remove push button When all required methods are in the stack type contents list box click the Save Next push button and then either exit the dialog box using the Cancel push button or repeat the above process to define another stack type 4 43 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine Table 4 1 2 2 Edit a Stack Type To Do This Edit a stacktype 1 From the Main ML F A M E window select the Work menu then the Stack Type menu choice then the Edit sub menu choice The Stack Type Select dialog box is then displayed select the desired stack type from the list box 3 Follow the procedures in the above table to edit and save the stack type Table 4 1 2 3 Print or Delete a Stack
68. nine different processing steps available for use with the ML FA M E Prepare Plate O The approximate plate preparation time This information is necessary for scheduling The operator can then be instructed when to start preparing the plates Sample prepa ration has to be carried out externally to the system O Incubate This option is used to define the incubation step O Type of incubation This can be either ambient or temperature controlled 10 95 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods For ambient incubation Ambient temperature upper and lower limits These define the allowable temperature range for ambient incubation required for the assay O For temperature controlled incubation Temperature Required temperature Temperature tolerance The permissible variation in incuba tion temperature NOTE For short incubation times Heating up either slow medium or fast of the incubator approx 30 minutes or for slot The heating up rate is the speed at which an incubation heating up characteristics simi slot is raised to its preset temperature after a plate has been lar to a water bath use fast inserted an incubation slot loses temperature when its door heating up is opened O Incubation time Duration of Incubation O Tolerance time The permissible variation in the incubation time CJ Wash This option is used to define how the plate is to be washed Th
69. obstruction in dispenser x drive movement Press OK if manual intervention was successful otherwise press IGNORE DIS391 1 Dispenser z drive step lost Check for any obstruction in dispenser z drive movement Press OK if manual intervention was successful otherwise press IGNORE DIS400 1 Dispenser x drive step lost Move dispenser x drive manually to the drop position Press OK if manual intervention was successful otherwise press IGNORE DIS402 1 Dispenser x drive step lost Move dispenser x drive manually to the drop position Press OK if manual intervention was successful otherwise press IGNORE DIS420 1 Operation interrupted due to an open reagent drawer Do not change the position of the container with barcode lt s gt at position d and close reagent drawer immediately DIS421 1 Initialization interrupted due to an open reagent drawer Close reagent drawer immediately DIS422 1 Operation interrupted due to an open reagent drawer Close the reagent drawer immediately DIS501 1 Operation can not proceed due to an open reagent drawer Close the reagent drawer immediately DIS502 1 Reagent containers inaccessible Check the container s at position s for parked syringe and that the cap is in service position Close reagent drawer after checking DIS504 1 Syringe cannot be parked Check the container at position d for no parked syringe and that the cap is in service position Close reagent drawer
70. of the washer manifold One lowers the manifold for removal the other raises it back into its rest position after reinstallation In the 24 20 and 24 30 instrument configurations there are two mani folds to clean For a step by step guide to the various procedures involved in washer manifold maintenance see Cook Book Section 8 1 2 on page 71 Recommended cleaning intervals O Every month this is done during monthly maintenance O When a manifold needle becomes blocked an error message is displayed when this happens 15 178 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 Reference Guide ML F A M E Maintenance Specific Items Required Spare plug for manifold Quantity 6 Small stopper for plugging waste tube and venting tube during module transportation Quantity 2 Large stopper for plugging manifold coupling during module transportation Quantity 2 Spare O ring for manifold coupling Quantity 2 Stopper for plugging dispense tube during module transportation Quantity 1 Figure 15 2 FJ Wash fluid container containing deionized water CJ Manifold cleaning set see Figure 15 2 O Spillage tray supplied with instrument see Figure 15 3 O Ultrasonic bath optional FD Brush for cleaning manifold 4 bores Quantity 1 LLL Cleaning stick for aspirating larger needle Quantity 1 Cleaning stick for dispensing Spare
71. on methods see Reference Guide Section 10 1 on page 84 3 1 1 Method Definition The following section defines the creation of a method as described in a Test Kit Manufacturer s Package Insert Even though it is not generally possible to create or edit in any way this is explained to clarify the structure of the methods Example Information Required To Program A Method Method Name Example ELISA Manufacturer Example Company Parameter Hepatitis B Antigen NOTE Only wash solutions that are Test Kit The Test Kit contains all necessary reagents specified as suitable by the test except wash and stop solution which is kits manufacturer should be available separately Note that the substrate used solution should be used within 60 mins of preparation Ambient Temperature Conditions 15 30 C NOTE Plate Plate dimensions are not nor Dimensions Plate Length 127 5 mm mally included in the package insert and must be measured by Plate Height 14 5 mm hand with the vernier caliper This is to prevent possible spill age contamination or errors during wash and dispense steps The dimensions shown Well Shape Flat are given as an example only Well Diameter 6 6 mm Well Depth 11 4 mm Strip Direction A H Sample Filling Direction A H Assay 1 Dispense 50 ul of conjugate solution into Procedure each well of the plate except the blank 3 28 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Example I
72. order to be detected as identical wash fluids If several identical wash fluid containers are present the sys tem ensures that the one that was loaded at the earliest time is ini tially used 11 122 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 7 7 Plate Preparation and Sample Pipetting Information Sample pipetting into the wells of a plate is an external task and cannot be controlled by the system However assistance is pro vided to the operator in form of the definition of the plate prepara tion time in the method definition This time is taken into account during scheduling and is also displayed in the Plan window to inform the ML FA M E operator that a plate s pipetting is due Since the system cannot monitor the sample pipetting procedure it does not know which well of a plate was pipetted For this reason additional sample pipetting information must be provided to the system at the time a plate is loaded onto the instrument This infor mation must be provided in a specific form The directory into which this file is written can be set by using the Device Presettings menu choice from the Services menu in the Main ML E A M E win dow NOTE 11 7 8 Plate Loading It is possible to load stacks prior to the expected loading time but only if the green light is on see Figure 11 6 If the stack type consists of only one plate the plate may be placed directly Place
73. plate is sent to the manipulation position allowing it to be removed It is not then possible to continue with the method after removing the plate Fluids The Fluids menu allows the definition of all fluids which are required to process a test of this method Fluids can be wash solu tions or reagents Two options are given in this menu CJ Edit Method specific P N 610520 02 05 01 Microlab F A M E User Manual V2 0 NOTE Verification of fluids is possi ble only in installation mode Active Kit Lot Check 10 2 4 10 2 4 1 NOTE A documentation format is non method specific One docu mentation format can included in a documentation job and be used across many different methods P N 610520 02 05 01 Reference Guide ML F A M E Methods O This option displays a dialog box allowing the user to select and change already defined add new or delete existing method specific fluids When the Change or Add options are selected the Edit Method Specific Fluid dialog box is displayed here the type of fluid is defined with the fluids name dual components if applicable i e for a fluid that uses two compo nents mixed together whether the fluid must be verified i e matching the fluid with the registered components for that fluid the preparation time the fluids stability state and stability duration there is also a comment field O Edit Global O This option accesses a dialog box allowing th
74. processed Aborted This test was aborted during processing Not loaded This test was expected but was not loaded less plates than expected in the stack Kit lot not assigned A valid kit lot has not been assigned to the method Kit lot invalid Test cannot be processed since no valid kit lot is defined Method invalid Method is not checked i e method was newly created or edited without method check No resource Test cannot be processed since not all required resources are available e g photometer filter missing defined incubator temperature not available etc Non processable Scheduling did not find a solution for this test Stack was reduced by this test Table 11 4 6 2 Stack Processing Statuses Processing Status Description Not planned This stack has at least one test with the processing status Not planned Planned No test of this stack is Not planned or Running at least one test of the stack is Planned Running At least one test of this stack is Running or Aborting P N 610520 02 05 01 11 115 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine Table 11 4 6 2 Stack Processing Statuses Processing Status Description NOTE Processed All tests of this stack are Processed Aborted An invalid status is not an actual Not loaded or Invalid However not all test ML F A M E state butis a are allowed to be Aborted general name for a test with one of the
75. reagent Do not open a drawer and remove or add reagent containers while drawer as specified in the Fluid the dispenser is active or while the reagent container carousel is Loading dialog box rotating Ensure that all reagent container caps are pressed firmly into their recesses caps in open position and that the syringe plungers are fully down so that they do not foul on the module chassis when the drawer is closed 11 7 4 Fluid Handling for Stable Reagents NOTE In the schedule the loading step is included and planned to ensure Stable fluids may be loaded prior a safe execution of the fluid loading All fluids that are planned to to their preparation time during be loaded at this time a Loading dialog box is displayed their preparation time during a loading step or after the loading step For safety reasons it is The effect of pressing the Ignore button is that the loading of the fluids which have not been assigned by the operator will be post recommended to load fluids only during their loading time When the Assign push button is pressed the Assignment dia The main reason is that for all log box for the selected fluid is displayed The reagent container other times no instrument barcode has to be entered in the Assign Container Barcode entry resources are reserved for fluid field If container barcodes have been reserved for this reagent in loading i e the fluid s loading the fluid assignment ta
76. run is started ator is prompted that this action will destroy the schedule O View Menu O Details gives information on the selected element of the plan i e if a fluid is selected information is displayed about that fluid O Current Time returns the window to the current time line 11 112 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine O Work List switches to the Work List Manager O Actions Menu O Assign Fluid allows the ML F A M E operator to assign a fluids position and associated barcode O Start Run initiates processing of current work list s plan NOTE This option is only available if the O Edit Plate allows the ML F A M E operator to access a Plate Access On installation plate s sample barcode information after the plate has been option was selected loaded and accepted For further information and a step by step guide to working with the above functions see Cook Book Section 4 1 5 on page 49 11 4 2 Test Window The Test window provides a real time view of the processing steps for the various tests in the work list in the order arranged by the Scheduler Test Information is displayed in columns as follows O Method displays the method used by the test O Plate Barcode for plates that have been loaded onto the instrument i e whose barcode has been identified O Test Action graphically displays the status of each test Differ en
77. specific items required 180 Washer in Washer Disp Module 1 244 Washer in Washer Disp Module 2 244 Washer Lift 244 Washer Manifold cleaning of 178 recommended cleaning intervals 178 Washer Manifold Cleaning specific items required 179 Waste Cap 244 Waste Container 7 244 Water Separator 244 Weekly Maintenance specific items required for 176 177 178 Well 244 Well Depth 91 Well Diameter 91 Well Flag 244 Well Group 245 Well Trace 135 136 245 Well Type 245 Well Type Used As 245 Well Types keep empty 91 NC 91 PC 91 SA 91 Work List 106 245 Write Right 245 P N 610520 02 05 01
78. specification instru ment is possible in the field Entry Module The main functions of the Entry Module are O Loading of the plates O Plate barcode reading positive plate identification Incubation The Entry Module consists of the following components Entry Section The entry platform is used to load plates onto the instrument All plates are placed manually onto the entry platform There are two ways of loading plates 1 Place a single plate directly onto the entry platform 2 Place an entry stack which accommodates up to 4 plates onto the entry platform Plate Barcode Reader The function of the plate barcode reader is to identify barcodes on the plates Barcode information is also used to select the test method and or kit lot to be used After reading the plate is transported automatically according to the selected method to the defined modules for processing e g incubator washer etc Microlab F A M E User Manual V2 0 1 3 1 2 3 NOTE Slots within the same incubator tower cannot be individually programmed However each slot is individually temperature controlled 1 3 1 2 4 1 3 1 3 NOTE Slots within the same incubator tower cannot be individually pro grammed However each slot is individually temperature con trolled 1 3 1 4 1 3 1 4 1 ML F A M E Overview Incubators The Entry Module contains two incubator towers each with 5 incu bation slots The fro
79. temperature ditto 15 to 30 C P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 3 Disposal of Consumable Items Consumable items used for verification e g check plates syringes reagent containers waste fluid must be disposed of in accordance with the rules of Good Laboratory Practice 14 3 1 Verification Kit Maintenance In order to produce valid verification results the following mainte nance procedures have to be carried out at the specified intervals CJ Referencing of the photometer check plate see section 14 3 2 O Incubator check plate calibration see section 14 3 3 O Re calibration of the hand pipette s as recommended by man ufacturer 14 3 2 Referencing the Photometer Check Plate Required interval Once a year before the date given on the declaration of quality expires The photometer check plate must be returned to the dealer at the specified interval for referencing This is necessary because the characteristics of the filters can drift with time The newly referenced plate will then be returned with a diskette containing the new reference values The new reference values must then be loaded into the computer 14 3 3 Incubator Check Plate Calibration Required interval Once a year before the date given on the declaration of quality expires The incubator check plate must be returned to the dealer at the specified int
80. tested rows 10 11 amp 12 are pipetted with 250 ul of check solution B using the dispenser The manifold height is set such that the aspirating needles are at the 200 ul liquid level and the wells are then aspirated The absorbance of each well is then measured with the photometer and the mean calculated By comparing the mean of the reference wells with the mean of the wells being tested the aspirating accuracy is measured The aspirating precision is calculated by measuring the variation in absorbance of the tested wells The table below summarizes the parameters measured Parameter Description Average residual Using a dilution the mean of the ODs volume of the tested wells is compared with that of the reference wells Units ul Maximum residual Using a dilution the maximum OD of volume the tested wells is compared with the mean of the reference wells Units ul Aspirating accuracy Compares the mean liquid level of the wells being tested with those of the reference wells Units 96 Aspirating precision Calculates the variation in liquid levels of the tested wells Units CV 96 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 2 4 Incubator The incubator check plate has been referenced at the manufac turer s site and is supplied with a temperature offset value which must be entered into the system via a dialog box carried out y
81. the ML E A M E software O Plate movement time defines the laboratory specific time span which is required to transport the plate from the pipet ting device to the ML F A M E O Always start documentation test documentation will be released automatically O Audible alarm toggles audio prompts on or off checked on when off the other sound options are non selectable grayed O Sound type Sounds on off this spin button allows the selection of individual sounds and the push button will dis able the selected sound 13 142 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 A ATTENTION When the time synchronization has been defined it is not allowed to run work lists when the switch to and from daylight saving time is made Drive A or B must not be defined as the path for time synchronization ATTENTION The following explanation of the results file transfer is for advanced users only and command or system related files should never be edited The example given in the following pages is only a guide line Due to various network system configuration options it is the responsibility of the ML F A M E operator and system administrator to validate any such data transfer process P N 610520 02 05 01 Reference Guide ML F A M E Functions amp Requirements External Interface Settings Trace path specifies the path to where the trace files store
82. the user software The needle which aspirates fluid from the well during the wash procedure The longer needles in the washer manifold Standardized file format used for host result reports ASTM American Society for Testing and Materials Definition of the basic format of a plate barcode Can consist of fixed characters which appear on every barcode and wildcards for test no kit lot no and other data Hand held barcode scanner See also MTP BARCODE READER A reference point used in a work list relative to which stack loading times are defined Special type of assay using antigen and control antigen coated wells for each control and sample for individual well blank correction Component of ML F A M E instrument onto which modules are mounted holding them in position Allows the addition of a further module to each side of the chassis General term for an MTP sized device used to test certain instrument functions An instrument initialisation procedure which is executed by the user software at start up after a shutdown has previously been executed or at start up after a certain time has elapsed since the last connection to the instrument A test in which a specific antibody being tested for in a sample is in competition with the same specific antibody however conjugated with an enzyme contained in a reagent Enzyme linked antibody used in an assay Frame which holds up to two external pump stations A samp
83. used for plates with removable strips and defines in which direc tion the strips run O CAg Ag Coating defines whether the strips are alternately Control Antigen Antigen CAg Ag coated This feature is gener ally used only in very specialized applications 10 92 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 10 2 2 4 NOTE The replica number applies only to sample well types Control and blank wells can only be replicated manually Reference Guide ML F A M E Methods Samples Menu The Samples menu is used to define the following O Arrange Samples once all control well types and layout defini tions are completed use this command to fill the remainder of the plate with samples O Sample Filling Direction either left to right horizontal or top to bottom vertical O Sample Replica Number O Replica Direction either left to right horizontal or top to bot tom vertical This menu is also used to automatically rearrange the sample lay out w m e o c m N TTT TETEE ED C o ene ED EQ ED ED CO Q0 En E ED E ED EL ES dC C C C ento E KENNEN EE DOC EE EAE JJ C ento E E EX EE E ES a Ce Ge Ge at ee dO DK OKT Go OE EDEN EXER ODOM BABS oD GIS EXE En ED EGGS gs fee G Strip Directio
84. used on the plates For further information on Plate hold time and Pipetting delay see Reference Guide Section 10 2 1 on page 86 A ATTENTION The plate dimensions specified in the plate configuration must correspond to dimensions of the plate otherwise contamination spillage or errors may occur during wash and dispense steps 3 30 The following table defines step by step how to create this method as per the above method programming information Table 3 1 1 1 Method Definition Process To Do This Create a method Method 2 identification information 3 Layout editor 4 Plate 5 configuration 6 Arranging sample T well types 8 Select the New menu choice from the Methods pull down menu The Method New dialog box is then displayed Enter the name Example ELISA The Method information dialog box see Reference Guide Section 10 2 1 on page 86 is displayed enter the Manufacturer Example Company Parameter Hepatitis B Antigen Barcode Mask Plate Hold Time 30 mins Pipetting Delay 5 mins Read Access 2 Write Access 6 Confirm the Method Information dialog box definition by selecting the OK push button The Layout editor allows the ML F A M E operator to define what goes where in the plate From the Configuration menu select the Set Plate Dimensions menu choice Enter the plate s dimensions in the appropriate entry fields First s
85. valid blank available Error Status Trace 32048 WARNING RUN Blank correction evaluated with only d valid blank s out of d Error Status Trace 32062 NOTE RUN Priming started location s 32063 loc s 32064 ERROR RUN Priming start failed reason s location s Error Status Error 32065 loc s 32066 NOTE RUN Priming finished successfully wash solution s barcode s comp lot nr 1 s comp lot nr 2 s location s 32067 loc s fluid s be s loti s lot2 s 32068 ERROR RUN Priming finished with error location s S Error Status Error 32069 loc s 32070 NOTE RUN Incubation started time s slot temperature s C location s 32071 loc s tow c slot d time 96s temp 96s 32072 ERROR RUN Incubation start failed location s Error Status Error 32073 loc 96s tow 96c slot 96d 32074 NOTE RUN Incubation finished time s slot temperature s C location s 32075 loc s tow c slot d time s temp s 32076 ERROR RUN Incubation finished with error location s Error Status Error 32077 loc s tow c slot d 32078 ERROR RUN Test information from sampler Run interrupted Error Status Error 32080 WARNING RUN Pipetting errors reported from sampler Error Status Trace 32082 NOTE RUN Barcode file read successfully filename 5 32083 file s 32084 NOTE RUN Plate barcode verified at reidentification barcode read 96s 32085 be s 32086 WARNING RUN Plate barcode not
86. 05 01 15 173 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance 15 1 6 2 Every Week Approx Duration 40 50 minutes For instructions on accessing the maintenance routines see Cook Book Section 8 1 1 on page 70 O Clean Wash System see Cook Book section Table 8 1 3 2 Manual Cleaning Weekly Maintenance on page 8 75 O Approx duration 20 minutes O Must be carried out on the last working day of the week prior to ML EA M E system shut down O Rinses all wash channels and tubings with a solution of Dis infectant and then rinses them with NaCl solution and deion ized water O This procedure will solute any wash system obstructions O Clean the ML FA M E see Cook Book section Clean instru ment housing entry lift entry stack and plate transport system on page 8 75 O Approx duration 5 minutes O Clean all ML FA M E surfaces with Microlab Disinfectant Spray Photometer lens block should always be cleaned with a lint free cloth soaked in 7096 ethanol NOTE Each time the wash containers O Clean Wash Fluid Containers see Cook Book section Wash are cleaned check for any fluid containers on page 8 76 growth or bacterial build up If found replace wash containers O Approx duration 5 10 minutes with new ones O Rinse containers with deionized water O Leave containers to dry over weekend O Clean Reagent Containers see Cook Book section Reagent contain
87. 1 2 on page 58 displays the results of an individual test zril SERIE Test Results Report Instrument Instrument on queue Status ET Method Example ELISA Processed Exd Kit lot MKL500 Hone Ea Test Ne 100 Ex Loaded 1997 03 06 16 28 03 Plate Barcode TestPlate 100 B es pu 819 819 819 819 slo 8 8 B Bi 8 Es Well details Table view Test trace Display OD values Print Display barcodes Document Figure 12 2 Test Results Report Dialog Box 12 130 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Test Results amp ML F A M E Traces 12 1 1 The Test Results Window The following is an explanation of the contents of the Test Results Window For further information on the workings of this window see Cook Book Section Table 5 1 2 1 on page 58 The window is in a table format with the rows representing individ ual tests and the columns information on these tests O Method the method used for the test FJ Plate Barcode the barcode assigned to the test s plate O Load Date recorded date of the plates entry onto the ML FA M E CJ Load Time recorded time of the plates entry onto the ML FA M E O Run Status can be one of the following O Processed indicates that the test has been processed and is awaiting the documentation O Documented indicates that the te
88. 16 4 2 Optional PC 196 16 4 3 User Software Specifications 197 P N 610520 02 05 01 16 183 Microlab F A M E User Manual V2 0 16 1 16 1 1 NOTE This applies only to the instru ment The computer specifica tions may vary 16 184 Reference Guide Technical Specifications General Instrument Specifications Power Supply Electrical Supply 115 230 V 60 50 Hz 10 5 A Details Mains Voltage 90 132V 180 264 V Mains Frequency 45 66 Hz Power Consumtion 900 VA 675 W Installation Category II according to IEC 1010 1 Pollution Degree 2 Power Supply Interruption The instrument will run undisturbed during power supply interrup tions from the nominal mains voltage 15 of less than 100 ms For interruptions exceeding this limit a UPS uninterruptable power supply is recommended Recommendations for UPS To provide disturbance free service with all mains electricity sup plies it is recommended to use the instrument and computer with an uninterruptable power supply UPS A UPS will provide power to the system for power supply interruptions The UPS is used as a battery during power supply interruptions The UPS status information currently cannot be monitored by the user software The software supplied with the UPS should be installed on the PC and
89. 166 and select the Save push button 4 Only after this data is supplied is it possible to verify the washer module Table 7 1 1 4 Incubator Verification Validation To Do This Validate the incubator check plate must be incubator registered with the ML F A M E software to establish temperature offset and a validity date From the Validation menu select the Incubator menu choice 3 Inthe displayed dialog box enter the incubator check plate serial number the predefined temperature tolerance and its validity date then select the Save push button P N 610520 02 05 01 7 67 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Verification 7 1 2 Verifying an Instrument Module The ML F A M E operator will be prompted when verification is required The instrument verification procedure is a predefined pro cess with step by step instructions displayed on screen at the appropriate times However to access these procedures at other times use the following Table 7 1 2 1 Starting Verification Manually To Do This Access verification 1 Fromthe Services menu in the main ML window F A M E window select the Verification menu choice 2 From the Procedure menu all verification options are listed For further information on the Verification window see Reference Guide Section 14 4 on page 165 7 68 P N 610520 02 05 01 Microlab F A M E User Manual V2
90. 22 OD HTLY rp21e raw ri 14 1998 04 21 Conjugate KL23 Substrate KL24 SO HBsAg raw ses MKL 15 1998 04 21 Conjugate KL25 Substrate KL26 xBE WS 1998 04 21 WS KL38 xCB WS AE sas 1998 04 21 Figure 11 1 The Kit Lot Editor window O Component name lists the components of the kit lot or in the case of a global fluid the fluid name O Lot no lists the lot numbers for in the case of a method the master lot number then the component lot number or in the case of a global fluid the fluids lot number Expiration date lists the defined date when the kit lot will be unusable by the ML F A M E 11 2 1 Menu Choices O File Menu O Save stores any changes made to the kit lot file to the path defined in the Device Presettings dialog box O Print prints the contents of the Kit Lot Editor on the OS 2 default printer O Close shuts down the Kit Lot Editor 11 108 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine P N 610520 02 05 01 O Edit Menu O Insert Kit Lot allows the manual definition of kit lots and their components see Cook Book Section Table 4 1 3 1 on page 44 O Insert Global Fluid allows the manual definition of the kit lot of global fluids see Cook Book Section Table 4 1 3 1 on page 44 O Change allows the ML F A M E operator to edit a kit lot and its components O Delete removes the selected kit lot from t
91. 33 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages 32141 loc s tow c slot d 32142 ERROR RUN ITP531 Barcode file not accessible due to corrupted Regneu inf Error Status Error 32144 ERROR RUN ITP532 Barcode file not found filename s Error Status Error 32145 file 5 32146 ERROR RUN ITP533 Barcode directory is locked directory s Error Status Error 32147 dir 96s 32148 ERROR RUN ITP534 Barcode file corrupt filename s Error Status Error 32149 file 965 32150 ERROR RUN ITP540 No plate at required position for washing or dispensing location 5 Error Status Error 32151 loc 96s 32152 ERROR RUN ITP541 Fluid stability time exceeded fluid s barcode s comp lot nr 1 s comp lot nr 2 s Error Status Error 32153 loc 96s fluid 96s bc 96s lot1 96s lot2 965 32154 ERROR RUN ITP803 Step not started due to wrong instrument state step 5 location 5 32156 ERROR RUN ITP535 Plate not loaded aborted by user Error Status Error 32158 ERROR RUN ITP536 Plate loading finished test abort requested by user Error Status Error 32160 NOTE RUN ITP537 Plate loading finished edit plate requested by user 32162 ERROR RUN ITP538 Plate loading finished with error Error Status Error 32164 ERROR RUN ITP539 No pipetting information found Error Status Error 32166 NOTE RUN Plate loading started 96s 96s k
92. 5 1 2 The Test Result Report Dialog 58 5 2 ML EA M E Traces Overview seeren renerne 59 5 2 1 The Trace 60 Cook Book Test Results amp ML F A M E Traces 5 55 Microlab F A M E User Manual V2 0 Cook Book Test Results amp ML F A M E Traces 5 1 Test Results Overview Once a test has been processed by the system all resulting data can be accessed from the Test Results Window 5 1 1 The Test Results Window After the processing of a test whether successfully completed or not the results are stored on the ML F A M E database The follow ing tables give a step by step guide to working with these results Table 5 1 1 1 Test Results Window Procedures To Do This Open the test 1 From the Results menu in the Main ML results window F A M E window select the Test Results menu choice 2 The Test Results window is displayed listing the available test results stored on the ML F A M E database Select viewing 3 From the View menu select the List options Tests by Run Status menu choice 4 Inthe displayed dialog box two check boxes allow the ML F A M E operator to select a Processed when checked will display all tests with the run status Processed b Documented when checked will display all tests with the run status Documented Refresh the 5 To update the
93. 520 02 05 01 1 4 3 1 4 4 IN 1441 ML F A M E Overview Definition of Terms The terms Microplate and MTP are the same and will otherwise be referred to as plate The term ML F A M E refers to the Microlab FA M E instrument The term ML F A M E software refers to the Microlab FA M E user software The term ML F A M E database refers to the Microlab FA M E data base The term ML F A M E workstation refers to the PC running the ML F A M E software and the cable connecting this to the ML F A M E The term ML F A M E operator refers to the person who operates the ML FA M E and ML F A M E software The term Test Kit refers to the package containing all necessary components for one or several assays of a kind Safety Precautions and Hazards Read the following safety notices very carefully before using the ML FA M E General Precautions 1 When using the ML FA M E good laboratory working practices should be observed Suitable protective clothing safety glasses and protective gloves should be worn particularly when dealing with a malfunction of the instrument where the risk of contami nation from spilled liquids exists 2 Onlycertified technicians are authorized to perform mechanical maintenance on the ML F A M E 3 While extensive efforts have been made to ensure error free test processing and general system security any manual manipula tion of ML F A M E data files or other information p
94. 6 AEo AV4 96 Volume Sources of Variation Acceptance Criteria 50 ul Photometer precision edge effects lt 5 with small volumes meniscus 100 ul as above 596 200 ul as above 596 14 161 Microlab F A M E User Manual V2 0 14 162 14 2 9 3 Washer Reference Guide ML F A M E Verification Parameter Sources of Variation Acceptance Criteria Average Dilution meniscus 10 ul residual inhomogenity edge effects volume with small volumes 25 ul dispenser accuracy at 200 ul Maximum as above no well gt 20 ul residual volume Aspirating Meniscus edge effects with lt 20 accuracy small volumes lt 200 yl dispenser accuracy at 200 ul manifold aspirating height plate height slant Aspirating Meniscus edge effects with lt 1596 precision small volumes lt 200 yl manifold aspirating height plate height slant 14 2 9 4 Incubator Precision of incubator check plate 0 3 C Temperature controlled incubator 35 to 45 C Parameter Sources of Acceptance Variation Criteria Temperature deviation Precision of lt 1 0 C of target temperature incubator check check plate plate temperature Temperature deviation ditto t1 0 C of reported temperature check plate temperature Ambient incubator 15 to 30 Parameter Sources of Acceptance Variation Criteria Check plate Precision of 15 to 30 C temperature incubator check plate Reported
95. 690 nm 0 265 0 460 0 95 1 5 Accuracy The acceptance criteria are assigned per wavelength and are listed in the table below units m OD Filter Row 4 Row 5 Row 6 Row 7 Row 8 340 nm lt 50 405 nm lt 9 lt 15 lt 50 lt 120 450 nm lt 16 lt 25 lt 60 lt 120 492 nm t9 lt 15 lt 25 lt 100 570 lt 10 lt 15 lt 25 lt 100 610 lt 10 lt 15 lt 25 lt 100 620 lt 7 lt 15 lt 25 lt 100 690 nm lt 16 lt 25 lt 60 lt 120 Plate Positioning Row 1 amp 12 lt 10 mOD measured at 405 nm Short Term Reproducibility Row 6 lt 0 3 CV measured at all filter wavelengths gt 400 nm P N 610520 02 05 01 Microlab F A M E User Manual V2 0 14 2 9 2 P N 610520 02 05 01 Stray Light Checker board configuration row 2 and 3 3 OD for blocking positions 10 mOD for holes measured at 620 nm Infrared Blocking Row 9 2 3 OD measured at 620 nm Short Term Drift Reference Guide ML F A M E Verification Row 6 lt 10 mOD measured at all filter wavelengths gt 400 nm Dispenser Accuracy AVo 96 AE4 96 Volume Sources of Variation Acceptance Criteria 50 ul Photometer accuracy dilution t 596 meniscus edge effects with small volumes hand pipette accuracy 100 ul as above t 596 200 ul as above t 5 Precision AV 9
96. 8 measuring channels 8 reference channel 8 Photometer filter wavelength s 99 Plan 107 Plate 241 Plate Barcode 241 label dimensions 192 symbology 192 Plate Barcodes 191 code density tolerance 193 length of information 193 positioning on plate 192 print contrast 193 print quality 192 Plate Configuration CAg Ag coating 92 strip direction 92 Plate Dimensions length 91 plate height 91 well depth 91 well diameter 91 Plate Fork 241 Plate Height 91 Plate Layout 28 84 arranging samples filling direction 30 replica direction 93 replica number 30 sample filling direction 93 sample replica number 93 Plate Layout Definition 90 Plate Layout Editor 90 Plate Layout Window samples menu 93 Plate Length 91 Plate Loading Window 109 Plate Wash 96 Plunger 242 Power Supply 6 Power Supply Specifications 184 Prepare for Service 139 Prepare Plate Menu 95 Preparing Reagents 119 Processed 131 Processing Status 242 Processing Steps 28 84 95 Pump Power 97 Appendix 8 271 Microlab F A M E User Manual V2 0 Appendix 8 Index R Raw Data 242 Read Menu 100 Read Right 242 Read Step measuring filter wavelength 100 reference filter wavelength 100 Reagent 242 stability time 33 Reagent Barcode Label 242 Reagent Barcode Label Set 242 Reagent Barcode Reader 242 Reagent Carousels inserting of 120 Reagent Container 242 Reagent Container Barcodes 193 positioning of 194 Reagent Container Cap 242 Reagent Container Capacity 189 R
97. A M E Verification Table of Contents 14 1 QVerview is ecce ve Fe de Fe nh re e ne ieee 148 14 1 1 What is Verified sse 148 14 1 2 Verification Statuses 149 14 1 3 When are they 149 14 1 4 What is in a Verification 150 14 1 5 Pr cautlOns eerte gres 150 14 1 6 Archiving Verification Results 150 14 1 7 Order of Verification 151 14 2 Principles of nennen 152 14 2 1 1 enne aai 152 14 2 2 DISPENSE n i iens oen 154 14 2 3 Washers aan Reden rides 155 14 2 4 Incubatot rere en ein 157 14 2 5 Statistical Definitions Used for Verification 158 14 2 6 Absorbance Calculation E 158 14 2 7 Volume Calculation V eese 159 14 2 8 General Calculation 159 14 2 9 Acceptance 160 14 8 Disposal of Consumable Items sees 163 14 3 1 Verification Kit Maintenance 163 14 3 2 Referencing the Photometer Ch
98. Check for any obstruction in module transport movement Press OK if manual intervention was successful otherwise press IGNORE DIS302 1 Module transport step lost Check for any obstruction in module transport movement Press OK if manual intervention was successful otherwise press IGNORE DIS312 1 Reagent rotor drive step lost Check for any obstruction in rotor movement Close drawer if manual intervention was successful otherwise press IGNORE DIS322 1 Reagent rotor drive step lost Check for any obstruction in rotor movement Do not change the position of any container and close drawer if manual intervention was successful otherwise press IGNORE DIS360 1 Syringe pickup failed Dispensing drive step lost Check syringe in container lt s gt at position d and change syringe if defective Do not change the position of any container Close drawer if manual intervention was successful otherwise press IGNORE DIS361 1 Syringe pickup failed Dispenser rotor drive step lost Check syringe in container lt s gt at position d and change syringe if defective Do not change the position of any container Close drawer if manual intervention was successful otherwise press IGNORE DIS362 1 Syringe pickup failed Dispenser z drive step lost Check syringe in container lt s gt at position d and change syringe if defective Do not change the position of any container Close drawer if manual intervention was successful other
99. Close menu choice from the File menu The fluid will be displayed in the Assignment Editor window with the specified information P N 610520 02 05 01 4 51 Microlab F A M E User Manual V2 0 NOTE When the Load Fluid Container dialog box is displayed the first column of which will indicate whether the fluid has been veri fied A marker i e gt beside the fluid entry means the fluid is verified 4 1 7 4 52 Cook Book Daily Work Routine O After Scheduling Unstable Fluids After a successful work list scheduling the data defined in the Assignment Editor can be overruled in the Plan window For further information on the contents of the Plan Window see Reference Guide Section 11 4 on page 112 Table 4 1 6 2 Assigning Fluids in the Plan Window To Do This Select a fluid 1 Select the desired fluid in the Fluid column of the Plan window From the Actions menu select the Assign Fluids menu choice or use the F4 keyboard key Barcode entry 3 The Assign Fluids dialog box is displayed Then enter the container barcode Fluid verification 4 When the component lot number has been entered either using the barcode scanner or manually using double blind entry and is correct select the OK push button The fluid is now assigned and ready for loading The normal procedure for fluid barcode assignment is by manual entry of the barcode Barcode Scanner or Double Blind Entry
100. Defective syringe Plunger drive faulty Renew syringe Execute Init Cold Start If problem persists call service technician X direction step lost Mechanical problem If problem persists call service technician Z direction step lost Mechanical problem See section 17 1 8 Execute Init Cold Start General If there are problems in the end module with dispenser check if the lens block of the photometer is clean 17 2 2 3 Incubator Problems Error Message Problem Possible Cause Corrective Action Incubator temperatures too high Device presettings incubator temperatures changed Switch off instrument open incubator slots check device presettings shut down user software wait approx 15 minutes Incubator slots locked Heating defect Temperature too high from previous run Call service technician Wait until slots have cooled down then restart System Temperature out of range Room temperature outside of operating range for instrument see specifications Lower room temperature air conditioning 17 2 2 4 Photometer Problems Symptom Possible Cause Corrective Action Module transport of end module locked or general photometer error Dirty lens block Barcode labels blocking out photometer Bottom of plate wet Module transport dirty Clean photometer area Check that barcode labels are cor
101. Detection Sensor for manipulation platform on Exit Stack Check whether space between Plate Sensors of the Exit Stack is blocked Press OK if manual intervention was successful else press Ignore TRP300 1 Main Shuttle step lost Could not transport Main Shuttle to target position Move the Main Shuttle manually to a collision free position Press OK if manual intervention was successful else press Ignore TRP310 1 Exit Lift step lost Could not transport Exit Lift to target position Move the Exit Lift manually into a collision free position Press OK if manual intervention was successful else press Ignore TRP320 1 Exit Stack error Could not deposit Plate in Exit Stack because Exit Stack is full or cannot hold Plate Remove all Plates from Exit Stack and Manipulation Position Press OK after removal of all Plates else press Ignore TRP330 1 Could not transport Exit Lift to target position Manipulation Position still occupied by Plate Remove Plate from Manipulation Position Press OK after removal of Plate from Manipulation Position TRP500 1 Exit Stack almost full Next Plate deposit step might fail Remove all Plates from Exit Stack 502 1 Exit Stack full Can not deposit more Plates in Exit Stack Remove all Plates from Exit Stack Pressing Ignore will abort function P N 610520 02 05 01 Appendix 1 215 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages
102. Device 237 Device Presettings 141 Dispense aspirate speed 34 35 dispense speed 34 35 dispense volume 34 35 wells 35 Dispense Menu 98 Dispense Only 96 Dispense Speed 98 Dispense Step aspirate speed 98 dispense speed 98 dispense volume 98 reagent name 98 Dispense Volume 34 35 98 189 Dispenser 237 Dispenser End Module 237 Dispenser Washer Disp Module 1 238 Dispenser Washer Disp Module 2 238 Dispensing Needle 238 Display Priority 238 Disposable Syringe 238 parked position 119 Disposable Tip Barrel 238 Document Test 238 Documentation 101 Documentation Definition 238 Documentation Editor 85 101 Documentation Format 238 Documentation Job 102 238 Documentation Jobs 28 84 Download 140 Drop down List 238 E Edit Status 132 Appendix 8 266 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 Editor 238 ELISA 238 End Module 8 dispenser 8 exit stack 9 mixer 8 photometer 8 Entry Lift 238 Green light 124 Orange light 124 Signal Lights 124 Entry Module main functions of 5 power supply 6 Entry Module Specifications 187 Entry Platform 238 Entry Section 238 Entry Stack 238 Error 131 Error Handling collision free position 205 Error status 131 Evaluation Editor 85 101 documentation 101 documentation jobs 102 test documentation jobs 102 Exit Lift 238 Exit Plate 100 Exit Stack 9 238 External Interface Settings 143 External Pump Station 238 External Water Separator 7 238 Extra Sl
103. FA M E workstation In trying to avoid long winded explanations and examples com mon information i e explanations of common fields push buttons etc of a repetitive nature has been omitted unless applicable and is explained in the Reference Guide section of this document set Special information directly related to the task being explained but not a step in the procedure like warnings and notes being brought to the attention of the user are displayed in the left margin of this document to avoid breaking the flow of the examples Cook Book Cook Book Introduction 2 25 Microlab F A M E User Manual V2 0 Cook Book Cook Book Introduction 2 26 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods Chapter 3 ML E A M E Methods Table of Contents 9 15 OVerviBW nto t tr ie cioe cei Pee eva 28 3 1 1 Method Definitions srair 28 3 1 2 Documenting a Test Run eene 37 3 1 3 Method Management sse 38 P N 610520 02 05 01 3 27 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods 3 1 Overview A method is a structured group of definitions stored electronically which enables an Immunoassay test to be performed on the ML F A M E and includes plate layout information processing step definitions and documentation criteria for the test For further information
104. Front tower Slot 4 completed 1998 06 25 14 37 02 OAS9 Front tower Slot 5 completed 1998 06 25 14 37 48 OASY Rear tower Slot 1 completed 1998 06 25 15 14 39 OAS9 Rear tower Slot 2 completed 1998 06 25 15 15 18 OASY Rear tower Slot 3 completed 1998 06 25 15 16 29 OASY Rear tower Slot 4 completed 1998 06 25 15 17 20 OASY mi arno e ac un an aana Figure 14 4 Verification Window View 1 View 1 shows the current verification status of each instrument module and is the default view View 2 shows the current verification kit elements and data status and their expiry dates EEE File View Procedure Evaluation Validation Instrument Instrument on COM1 Serial Number 2104 Validation Status Valid until Photometer reference data 1933 84 28 Dispenser Hand pipette calibration 50 ul valid 1998 18 28 Hand pipette calibration 100 ul valid 1998 18 28 Hand pipette calibration 200 pl valid 1998 18 28 Washer Manifold registration valid Incubator Temperature offset Check Plate 1 valid 1999 03 03 Temperature offset Check Plate 2 valid 1999 03 03 Temperature offset Check Plate 3 valid 1999 03 03 Temperature offset Check Plate 4 valid 1999 93 03 Temperature offset Check Plate 5 valid 1999 03 03 Figure 14 5 Verification Window View 2 P N 610520 02 05 01 14 165 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 4 1 Menu Ch
105. KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK if the copy failed one could retry until copy is successful If all retries failed confirm to the Summit Processor software that the transmission P N 610520 02 05 01 Microlab F A M E User Manual V2 0 REM REM REM REM REM REM REM REM REM NOTE To use this function the time syn failed KK KK KK ck ck ck kk KR ck cock RR RR HK HH HH HH KH KH KH HK HK HK HH KH A KH A KK nosuccess fam rtc 2 1 KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK Delete the t drive resource logoff from the network if login was performed within this file link command KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK delres net use t d zend TK KK ck ck ck kk ck ck ck ck ck ck ck kk KKK KK RR HH HK HK HH HH KH KH KH HK HK HH HH KH KK A KK End of example Kock cock ck ck ck kk ck ck ck ck ck ck ck kk KK OK KK KK KK KKK KKK 13 2 6 Set System Time Reference Guide ML F A M E Functions amp Requirements The ML F A M E software allows two ways of setting the system time chronization entry in the Soft the time from a higher level system ware Presettings dialog box See section 13 2 5 on page 13 142 must be deleted and the dialog box saved dow Also it is only possible to use this function if the instrument status is either No instrument or Idle P N 610520 02 05 01 13 3 Access Rig
106. L F A M E Maintenance Table 8 1 2 1 Remove Wash and Install Washer Manifold To Do This Ultrasonic bath 12 Clean the manifold needles by placing method the manifold in an ultrasonic bath containing Microlab Detergent and Disinfectant solution for 5 minutes Do not immerse the connector board After the above procedures rinse all items with pipe water and deionized water Washer manifold Examine each manifold plug for assembly scratches or any signs of damage If signs of scratching or damage are Cap must be _ firmly seated all apparent replace with a new plug around 15 lt Reinsert the plugs into the manifold The plugs must be completely flush with N N the sides of the manifold and the cap must be firmly seated all around i T When reinserting plugs must N SS be completely flush with sides of manifold 16 lt Replace the cap on the manifold Clean wash shell 17 gt The wash shell is the white plastic molding which sits under the washer manifold when it is raised It pivots down and back when the manifold is lowered 18 The wash shell should not removed from the instrument for cleaning Swing it down to clean its vertical position and clean it with a cloth soaked in Microlab Disinfectant Spray wearing protective gloves Reinstall washer 19 From the Extras menu in the ma
107. ML F A M E Maintenance This procedure prepares the selected washer manifold for removal from the ML E A M E for maintenance replacement etc by lowering the manifold to an accessible position Insert Manifold Washer 1 Washer 2 Washer 1 amp 2 This procedure prepares the ML F A M E to accept the selected washer manifold for reinsertion after maintenance replacement etc then raises the manifold to its operational position Decontaminate Washer 1 Washer 2 Washer 1 amp 2 When one of these choices is selected the ML F A M E oper ator will be guided through a decontamination procedure by various on screen action prompts Incubators When this choice is selected all incubator slots are raised or lowered to an accessible position and their doors opened to allow access for decontamination O Load Cold Start Plate Installs the cold start plate to its operational position in Incu bator 2 s storage position situated on top of the incubator 15 1 5 Maintenance Statuses Three maintenance statuses exist Required maintenance procedure is overdue or carried out unsuc cessfully Completed maintenance procedure carried out successfully Open after first installation of ML F A M E software if the serial number of the instrument has changed if a work list is active and if the ML F A M E operator has insufficient access rights 15 172 P N 610520 02 05 01 Microlab F A M
108. Microlab F A M E USER MANUAL Version 2 0 P N 610520 02 05 01 Important Notice This manual may not be used or reproduced in any way whatsoever without the express written consent of Hamilton Bonaduz AG Copyright 1995 1996 1997 1998 1999 Hamilton Bonaduz AG All Rights Reserved Microlab is a registered trade mark of Hamilton Bonaduz AG IBM OS 2 DATABASE 2 and DB2 are registered trademarks of International Business Machines Corporation MICROTITER is a registered trademark of Dynatech Laboratories Microlab F A M E User Manual V2 0 P N 610520 02 05 01 Master Table of Contents Master Table of Contents 1 ML EA M E Overview eeennnnnnene nennen nenas 1 Cook Book Chapter 2 to 8 2 Cook Book Introduction esses 25 3 ML EA M E Methods cccccccccceceeesseceeecesesseaeeeeeessseaeeeeeesees 27 4 Daily Work 41 5 Test Results amp ML FA M E 55 6 Instrument 63 7 ML Verification nnssessesseseeeneneenenenennnnnnenenenenenen 65 8 ML EA M E Maintenance 69 Reference Guide Chapter 9 to 17 9 Reference Guide 81 10 ML EA M E Methods
109. Plate cannot be removed automatically Open cover remove plate at position s by hand and close cover again Have you removed the plate from instrument TPL001_1 The following test cannot be deleted because it is still located in the instrument Reinitialize the instrument and delete the test again Appendix 1 218 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages A1 1 3 Dispenser Errors DiALOG ID MESSAGE DIS101 1 Could not initialize dispenser z drive Check for any obstruction in dispenser z drive movement Press OK if manual intervention was successful otherwise press IGNORE DIS103 1 Could not initialize module transport Check for any obstruction in module transport movement Press OK if manual intervention was successful otherwise press IGNORE DIS105 1 Could not initialize dispensing drive Check for any obstruction in dispensing drive movement Press OK if manual intervention was successful otherwise press IGNORE DIS106 1 Could not initialize dispenser rotor drive Check for any obstruction in rotor movement and close reagent drawer Press OK if manual intervention was successful otherwise press IGNORE DIS107 1 Could not initialize dispenser x drive Check for any obstruction in dispenser x drive movement Press OK if manual intervention was successful otherwise press IGNORE DIS301 1 Module transport step lost
110. Print prints the contents of the current work list on the OS 2 default printer O Close shuts down the Work List Manager CJ Edit Menu for further information on the operations of these commands see Cook Book Section 4 2 1 on page 43 O Insert Stack displays a dialog box allowing the ML F A M E operator to choose a pre defined Stack to include above the highlighted line in the current work list O Delete Stack deletes the selected Stack from the current work list O Set Earliest Start Time allows the ML F A M E operator to specify the method of defining the starting time of a work list and set the time properties O Change Kit Lot allows the ML F A M E operator to specify the kit lot to be used by the selected method within the cur rent work list O View Menu O View Plan allows the ML F A M E operator to switch to the Plan window also use the F7 keyboard key Actions Menu O Schedule the schedule option will analysis the stacks and their methods in the current work list and optimize the pro cessing order within the stacks returning an action list viewed with the Plan window Un schedule will sequentially un schedule stacks from the selected stack down O Abort Menu O Selected Test after scheduling cancels the processing of the selected test O Entire Run after scheduling cancels the processing of the entire work list 11 110 P N 610520 02 05 01 Microlab F A M E User Ma
111. SAGE RAD500_1 Communication to the instrument failed Please switch on instrument again or verify connection cable RAD501 1 Cannot get connection to the instrument Please switch on instrument or verify connection cable RAD503 1 Cannot get connection to the instrument Module s are not connected or are in download mode Call a service technician RAD510 1 System time was manipulated This session must terminate Please contact your dealer RAD511 1 Cannot open device to selected instrument The device is possibly already in use i e serial port in use This session must terminate RAD512 1 Could not execute time synchronize Call a service technician TRP100 1 Could not pre initialize the Exit Lift Move the Exit Lift manually into a collision free position Press OK if manual intervention was successful else press Ignore TRP110 1 Could not initialize the Exit Lift Move the Exit Lift manually into a collision free position Press OK if manual intervention was successful else press Ignore TRP120 1 Could not initialize the Main Shuttle Move the Main Shuttle manually into a collision free position Press OK if manual intervention was successful else press Ignore TRP130 1 Could not calibrate the Plate Detection Sensor for full Exit Stack Check whether space between Plate Sensors of the Exit Stack is blocked Press OK if manual intervention was successful else press Ignore TRP140 1 Could not calibrate the Plate
112. Status File View Instrument Change lock status Lock status overview Instrument Function Incubator 1 Incubator 2 Washer Dispenser 1 Washer Dispenser 2 Dispenser End Transport P N 610520 02 05 01 Lock Status Since Reason Code unlocked unlocked unlocked unlocked unlocked unlocked Figure 13 2 The Instrument Status Window Lock Status Mode In both window modes the menu choices remain the same These are File Menu O Close O View Menu O Temperature Toggles the window to Temperature mode O Lock Status Toggles the window to Lock Status mode O Refresh Now O Instrument Menu Initialize Runs a full instrument initialization connecting or reconnecting the ML F A M E software to the ML FA M E O Prepare for Service Will disconnect the ML F A M E soft ware from the ML F A M E allowing the user to update the ML F A M E settings without influencing with the actual instrument settings It is also not possible to affect some set tings while connected to the ML F A M E Necessary activity prior to downloading firmware CJ Change Lock Status Menu see Cook Book Section on page 64 Each instrument function available with the current configuration is displayed with their current lock status 13 139 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Functions amp Requirements Within each function a number of subsidiary functi
113. TTENTION Do not switch off instrument 5 open drawers or transparent cover touch load button or any moving parts during initialization 6 ATTENTION No other programs or applications should be started while the ML F A M E software is running 8 ATTENTION It is very important that the ML Shut down the ML 9 F A M E operator waits until EA M E prompted by the ML F A M E workstation before turning off 10 the power supply This is due to the closing of the ML F A M E database and misuse can result in ML F A M E database 11 corruption The ML F A M E software will then run a maintenance status check to establish the maintenance routines required 4 42 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 4 2 1 NOTE The List of Stack types push button displays a list of all exist ing stack types The order in which methods are placed in a stack type does not define the order in which plates are processed in a run The scheduler decides the optimum processing order P N 610520 02 05 01 Stack Types Below is a step by step guide to working with stack types For a general description of and further technical information on stack types see Reference Guide Section 11 1 1 on page 106 Table 4 1 2 1 Define a New Stack Type Cook Book Daily Work Routine To Do This Define a new stack type Name the stack type Add methods to the stack type Remove
114. Type To Do This Print or delete From the Main ML F A M E window stack type select the Work menu then the Stack Type menu choice then the Delete or Print sub menu choice 2 The Stack Type Delete or Print dialog box is then displayed select the desired stack type from the list box 3 Click the Delete or Print push button and the selected stack type is erased from the ML FA M E database or printed to the OS 2 default printer 4 1 3 Kit Lot Editor The Kit Lot Editor is only available if the Kit Lot Documentation option was selected during the installation procedure When using the Kit Lot Editor the defined kit lot will be documented and any kit lot information provided in the plate barcode or in the barcode file will be ignored If this installation option is not selected then the ML F A M E soft ware will perform an active kit lot check and compare the loaded kit lot elements with the defined elements Table 4 1 3 1 Working with the Kit Lot Editor To Do This Define a new kit lot From the Main ML F A M E window select the Work menu then the Kit Lot Editor menu choice 4 44 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine Table 4 1 3 1 Working with the Kit Lot Editor To Do This 2 The Kit Lot Editor is displayed and lists all currently stored kit lot data on the system in the path defined in the software preset
115. Un scheduling a Work List To Do This Work list status 4 When a work list has been successfully scheduled the stack and individual methods status will change from Not Planned to Planned All time lines defined for the stacks are now active and no further options can be defined for this work list NOTE Un scheduling is a sequential Un schedule 5 Once a work list has been scheduled process i e itis not possible to planned work list and the ML E A M E software has un schedule an individual stack switched focus to the Plan window positioned in the middle of a select the Work List menu choice from work list selecting an individual the View menu or use the F7 key to stack like this to un schedule change the focus back to the Work List will un schedule the selected Manager stack and all following stacks in the work list 6 Select the required stack see Note and then from the Actions menu the Un schedule menu choice 4 48 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine 4 1 5 Executing and Aborting a Run After successfully scheduling a work list the Plan window is dis played for further information on the Plan Window and its con tents see Reference Guide Section 11 4 on page 112 At this stage the ML FA M E operator should load all stable fluids please see section section 4 1 6 Fluids for a step by step guide to working with fluids Table 4 1 5
116. a window that displays all the menus available in that window A compendium of all necessary definitions layout test processing for a test execution and documentation Function that shakes the MTP horizontally in a lengthwise direction performed by the module transport Functional unit of the Summit Processor instrument Part which moves an MTP from the main shuttle into the module Microplate See Plate Barcode The barcode scanner that reads the barcode on the MTP for identification purposes Device that carries the MTP along the main shuttle P N 610520 02 05 01 Appendix 2 Glossary Microlab F A M E User Manual V2 0 MW 0D Summit Processor 16 20 Summit Processor 16 30 Summit Processor 24 20 Summit Processor 24 30 ML F A M E ML F A M E DATABASE ML F A M E OPERATOR ML F A M E SOFTWARE ML F A M E WORKSTATION PARAMETER PARKED POSITION PAUSE BUTTON PC PHOTOMETER PHOTOMETER CHECK PLATE PLAN WINDOW PLATE PLATE BARCODE PLATE BARCODE READER PLATE FORK P N 610520 02 05 01 Appendix 2 Glossary The optical density OD of a well measured by the photometer using the measurement wavelength Optical density absorbance Instrument configuration consisting of 16 reagent positions 20 incubation slots 4 modules Instrument configuration consisting of 16 reagent positions 30 incubation slots 5 modules Instrument configuration consist
117. ach reagent liquid Liquid Level Detection is used during the reagent s distribution pro cess Reagent Container System Each Reagent Container System consists of O A reagent container O A dedicated disposable syringe O A barcode label In total 8 reagent container systems can be positioned in seg ments on the reagent container carousel The carousel is then placed into the reagent drawer Several reagent container carousels can be utilized Single reagent container systems or complete reagent container carousels can be exchanged and kept in a refrigerator Microlab F A M E User Manual V2 0 1 3 1 4 6 1 3 1 4 7 1 3 1 5 1 3 1 5 1 1 3 1 5 2 1 3 1 5 3 ML F A M E Overview Reagent Container Identification Each reagent container is identified by a clear text label and a bar code A barcode reader located in each reagent drawer identifies the reagents Barcodes are supplied for containers You may use other barcode labels providing that they comply with ML F A M E specifications see Reference Guide Section 16 3 2 on page 193 Mixer The mixer is used for horizontal shaking of the plate in the length wise direction The mix intensity and the mix time are programma ble End Module The main functions of the End Module are O Reagent dispensing Photometric measurement O Mixing shaking of the plate The Exit Stack is also located in this module allowing plates to be remove
118. additional functions see Reference Guide Section 10 2 3 3 on page 95 SRAM Incubate NOTE For incubation times of 30 min utes and less fast heating up is recommended Wash Define global fluid NOTE Global Fluids are designated by a preceding asterisk in their name 3 32 30 91 18 From the Steps menu select the Sample and Reagent Addition Monitoring menu choice 19 In the displayed dialog box select a Measuring Filter of 450 nm an optional Reference Measurement Filter and range check criteria 20 From the Steps menu select the Incubate menu choice 21 In the displayed dialog box select the Temperature controlled incubation radio button 22 Enter a temperature of 37 C default setting 23 An operating temperature tolerance must be set defining the maximum variation in temperature between 1 C and 5 C 24 Select the Fast option from the Heating up drop down list 25 Enter the required incubation and tolerance times in this example 30 minutes and 5 minutes 26 From the Steps menu select the Wash menu choice 27 Select the Plate wash option 28 Before the wash step can be used a wash solution must be defined 29 From the Test Processing Editor Wash dialog box select the Edit Global push button then in the displayed dialog box select the New push button The Edit Global Fluid dialog box is displayed Enter the Wash Fluid
119. after checking DIS505 1 Containers at positions s have the same barcode Remove all duplicate containers and close reagent drawer 018506 1 Service containers inaccessible Check the service container s at position s for no parked syringe and that the cap is in service position Close reagent drawer after checking DIS507 1 No access to an empty service container for syringe check Place an empty service container without syringe and close reagent drawer Initialization will continue DIS508 1 Container of the used syringe is removed Place the container with the barcode lt s gt and close reagent drawer DIS512 1 Container at position d with barcode lt s gt is overfilled Comply with reagent levels in the action list during next loading 018521 1 No access to an empty service container for parking syringe Place an empty service container without syringe and close reagent drawer Initialization will continue 018522 1 Syringe parked during initialization in container with barcode lt s gt at position 96d To prevent contamination remove container Appendix 1 220 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages DIALOG ID MESSAGE 018523 1 Operation can not proceed due to an open reagent drawer Close the reagent drawer immediately DIS541_1 Dispense failed due to defective syringe or foam in reagent container Rep
120. an incubation slot in case of power fail Appendix 2 241 Microlab F A M E User Manual V2 0 PLUNGER P N PROCESSING STATUS RAW DATA READ RIGHT REAGENT REAGENT BARCODE LABEL REAGENT BARCODE LABEL SET REAGENT BARCODE READER REAGENT CONTAINER REAGENT CONTAINER CAP REAGENT CONTAINER CAROUSEL REAGENT CONTAINER SYSTEM REAGENT DRAWER END MODULE REAGENT DRAWER WASHER DISP MODULE 1 REAGENT DRAWER WASHER DISP MODULE 2 REAR TOWER REDOCUMENT REGISTRATION PRIORITY RELEASE RELEASE SwiTCH REPLICA RESIDUAL VOLUME RESULT FILE RESULT FILE FORMAT RINSE FLUID RUN Run STATUS Appendix 2 242 The inner part of the disposable syringe Moves up and down inside the disposable tip barrel Part Number Short form Test Status A flag that indicates at which point in the processing sequence a test is e g Processed Aborted etc Raw OD values from a test An access right which allows a user to view specific data in the user software Conjugate substrate or stop solution used in the reagent container A barcode label designed to fit in the barcode recess of a reagent container Set of 52 reagent barcode labels supplied with instrument The barcode scanner which reads the reagent container barcodes Vessel which holds the reagent liquid Lid which closes the reagent container when not in the instrument Removable device to which up to 8 reagent containers can be attached Reagent container b
121. and pipetted B200 H 200 ul Check Solution B hand pipetted A50 50 ul Check Solution A pipetted by dispenser A100 100 ul Check Solution A pipetted by dispenser B200 200 ul Check Solution B pipetted by dispenser The wells in columns 1 to 4 and 7 to 10 are then filled by the dispenser with check solution D to give a total dispensed volume of 200 ul per well Figure 14 2 Plate Layout for Dispenser Check Since the absorbance is proportional to the volume of liquid in the well the dispensing accuracy can be determined using a simple calculation The dispensing precision is also indirectly calculated from the vari ation in absorbance The following parameters are calculated 14 154 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 Reference Guide ML F A M E Verification Parameter Description Accuracy 50 100 ul 200 ul Compares the volumes dispensed by the dispenser with the volumes of the hand pipetted wells Measured as a percentage of the nominal dispensed volume Precision 50 ul 100 ul 200 ul Measures the variation in dispensed volume Units CV 96 14 2 3 Washer 200 ul of check solution B is pipetted into 24 wells of the wash check plate rows 1 2 amp 3 i 3 4 5 6 7 ATR ME NONE NN D P CIF 29 22 EEE B s FR FOS FR EN FEN RS ON EN KEN gu A SVS SSS E E E HC X CS S OW X OW AY NY ON M
122. ansport manually into a collision free position Press OK if manual intervention was successful else press Ignore INC901 1 Front Tower Lift not functioning Move the Front Tower manually into the lowest position Press OK if manual intervention was successful else press Ignore INC903 1 Entry Lift not functioning Move the Entry Lift manually into the upper position Press OK if manual intervention was successful else press Ignore A1 1 5 Washer Errors DiALOG ID MESSAGE WAS332 1 Water Separator overflow Check whether Waste Tubing and Waste Container are connected and correct manually if necessary Press OK if your manual intervention was successful else press Ignore WAS333 1 Water Separator overflow Check whether Waste Tubing and Waste Container are connected and correct manually if necessary Press OK if your manual intervention was successful else press Ignore WAS340 1 DO NOT OPEN Fluid Connector while rinse procedure running Connect Fluid Container d to wash horizontal position and Fluid Connector 96d to rinse vertical position Pressing Ignore will abort function WAS344 1 Dispense Pump OVERLOAD during rinse procedure Check Wash Fluid Tubing for bends or kinks and correct if necessary Press OK if your manual intervention was successful else press Ignore WAS346 1 Vacuum Pump OVERLOAD Check Waste Tubing for bends or kinks and adjust if necessary Press OK if your manual i
123. arcode has been identi fied 7 Fluid Action graphically displays the status of each fluid Dif ferent colors represent various ML FA M E operator and ML F A M E actions O A schematic plan of the test steps in which the fluid is used this includes preparation times and loading times O Container Location the container location i e in which mod ule O Container Volume for reagent containers only initially the cal culated volume is displayed and after the first dispensing from the reagent container the volume required for the next steps Changing a Work List The scheduling of a work list may not meet all requirements or the user may want to add or delete certain stack types from the work list prior to the start of the run for information on work lists see Cook Book Section 4 1 4 on page 45 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 4 6 Test Processing Statuses Once a work list has been scheduled i e after a plan exists the statuses of the stacks and test change The following tables provide an overview of the statuses of the stacks and tests in the work list Table 11 4 6 1 Test Processing Statuses Processing Status Description Running The processing of this test has already started but not yet finished Processed Successfully processed test Aborting immediate abort of this test was started the abort is not yet been
124. arcode label and disposable syringe together Short form Drawer End or End Drawer in the end module containing a reagent carousel with max 8 reagent containers Short form Drawer 1 Drawer in the washer disp module 1containing a reagent carousel with max 8 reagent containers Short form Drawer 2 Drawer in the washer disp module 2 which contains a reagent carousel with max 8 reagent containers Exists only in 24 20 and 24 30 instrument configurations Incubator with 5 temperature controlled slots Located in the rear of the module The action of repeating all documentation jobs associated with a test i e after a test has already been documented A precedence level that determines which priority of trace message is recorded The action of releasing a processed test for documentation Electrical switch which detects the presence of a user s hand on the reagent drawer handle Number of repeats of samples The volume of fluid in the bottom of a reagent container that cannot be aspirated A temporary store of test result data An ASCII file in which test results are stored after documentation Definition of the ASCII format of a result file with respect to the user programmable parts documentation format Fluid used to clean the tubings and manifold of the washer normally distilled water Execution of an ML F A M E work list Gives information on the status of a test i e Running Processed and Documented P N
125. arranty HAMILTON warrants this product to be free of defects in material and workmanship for a period of 12 months from the date of deliv ery HAMILTON or an authorized HAMILTON representative will repair or replace at its option and free of charge any product that under proper and normal use proves to be defective during the warranty period HAMILTON shall in no event be liable or responsible for any inci dental or consequential damage either direct or contingent HAMILTON consumable products such as syringes valves tubing disposable tips etc are warranted to be free of defects in material and workmanship at the time of delivery only This warranty shall not apply if 1 the product has not been operated in accordance with the ML F A M E operator manual 2 the product is not regularly and correctly maintained 3 the product is not maintained repaired or modified by a HAMIL TON authorized representative or ML FA M E operator parts other than original HAMILTON parts are used the product and parts thereof have been altered without written authorization from HAMILTON 6 the product is not returned properly packed in the original HAMILTON packaging HAMILTON reserves the right to refuse to accept the return of any product that has been used with radioactive or microbiological substances or any other material that may be deemed hazardous to employees of HAMILTON Such a product has to be properly decontaminated and marked
126. ash Fluid Almost Empty the Fluid Loading dialog box The dialog box is closed by either Warning dialog box or an finishing the last necessary identification or by pressing the Ignore Insufficient Liquid error dialog button to postpone the loading box appears the appropriate wash fluid container should be exchanged refilled immediately The dialog box will then automatically disappear Whenever a wash container is loaded i e when the wash connec tor switch is moved from the vertical position to the horizontal posi tion the wash Container Correlation dialog box is displayed In If all wash containers have not been loaded the dialog box remains open i e the ML F A M E operator must manually close the dialog box NOTE this dialog box the container barcode and the wash channel bar The volume of the wash solution code must be entered by the ML F A M E operator Both entry is monitored by the system but fields follow the double blind entry principle see Cook Book Sec only a warning is given Thus it tion Table 4 1 7 1 on page 52 and can be defined either via key remains with the operator s board or hand held barcode scanner responsibility to ensure that there is sufficient wash solution in the wash container or a suffi cient number of wash contain ers are loaded Identical wash solutions can be loaded to different channels of the wash container stack The different containers must have the iden tical container barcode in
127. ause is activated too long DIA001 1 Cannot request instrument data Check connection to instrument or call service representative DIA001 2 Firmware error Start download procedure DIA002 1 Mismatch in technical data Call service representative DIA003 1 Invalid instrument serial number Call service representative DIA003 2 Different instrument connected Press Continue to use new instrument DIA003 3 Login with higher access rights DIA004 1 No or incompatible firmware loaded Install and or download new firmware DIA004 2 No or incompatible firmware loaded or no connection to External Bumptiousness Call service representative DIA005 1 Instrument not adjusted Call service representative DIA006 1 Different filters in instrument Press Continue to use filters in instrument DIA006 2 Login with higher access rights DIA007 1 Download for up System s aborted Repair error and start download again INIOO1 1 Initialization of instrument failed due to fatal error Call a service representative INIOO2 1 Heating up of incubators failed due to instrument failure Call a service representative Appendix 1 216 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages DIALOG ID MESSAGE 1 020 1 Module Transport of End Module is blocked or general Photometer error Free Module Transport manually and clean Transpo
128. ay using the same check solutions Since the washer and dispenser verification procedures use the same check solutions a syringe dedicated to a specific check solution can be used for both verification procedures 14 151 Microlab F A M E User Manual V2 0 14 2 A 14 2 1 ATTENTION Photometer filters 620 and 405nm must be present to perform verification Reference Guide ML F A M E Verification Principles of Verification Photometer Figure 14 1 explains the purpose of the filters on the photometer check plate The gray scale filters have absorbance values of approximately 0 3 0 6 1 0 and 2 0 OD at wavelengths gt 400 nm Due to variations in the glass each photometer check plate has its own set of reference values which must be loaded into the ML F A M E database In order to compensate for any drift in charac teristics the photometer check plate has to be referenced once a year at the manufacturer s site and the new reference values loaded into the database see section 14 3 2 on page 14 163 Position Checksforstray Gray scale filters 1 0 OD at Infrared A1 light between for checking 340 nm blocking photometer accuracy and _ filter filter channels __ precision 7 KEN Fund A B TOT 0 transmission D LOL 100 E O ARES transmission F O H Checks plate positioning Q
129. ble it is displayed in this field or all if sev may interfere with other pro eral container barcodes have been reserved depending on the cessing steps and may cause nature of the reagent definition one of three dialog boxes is then delays in the run displayed O Fluid assignment definition verification flag OFF A unique component lot number must be present O Fluid assignment definition verification flag ON N For all reagents of this type not only the reagent container bar code but also the component kit lot number s for the reagent ATTENTION or its sub components must be entered Verification flag ON is only In the verification entry fields the component lot number s processable with Installation must be entered as a double blind entry see Cook Book Sec mode Active Kit Lot Check tion Table 4 1 7 1 on page 52 Only if both entries are com pletely identical the entry is accepted The entry can be made either via keyboard or by using a hand held barcode scanner 11 120 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 A ATTENTION The definitions in the fluid Assignment dialog boxes must be complete in order to leave the dialog box Any discrepancies e g incorrect double blind see Cook Book Section Table 4 1 7 1 on page 52 entries etc will result in error messages and the dialog box remains open N 11 7 5 ATTENTION The stability time of unstable reagents starts as soon as the
130. ble device destinations is displayed Select the desired options and the Save push button and the new documentation job is displayed in the Documentation Job dialog box 3 37 Microlab F A M E User Manual V2 0 3 1 3 NOTE When a copy is made of a method the new method will not have a barcode mask as no two methods can use the same bar code mask It is then necessary to open the method define the new barcode mask then check the full method definition For information on barcode mask see Reference Guide Section 10 2 1 on page 86 NOTE An open method s name will not appear in the selection dialog box when Copy Rename or Delete are selected A method cannot be deleted if test results for that method exist on the sys tem 3 38 Table 3 1 2 1 Documentation Jobs Conrwueo Cook Book ML F A M E Methods To Do This Change 8 The Change push button allows the ML EA M E operator to edit an existing Documentation Job s properties see New above Delete 9 To delete an existing Documentation Job select it then select the Delete push button Start 10 With this option selected the test s documentation by information must be released manually user by the ML F A M E operator as opposed to automatically at the end of the run see Reference Guide Section 12 2 1 on page 133 Method Management In general it is only possible for ML F A M E operators to use the Save As
131. bottom of the wells of the plate under the weight of the manifold and manifold coupling A ATTENTION If using bottom sweep specify an aspiration height 2 0 3 mm to prevent the aspirating needles from scratching the bottom of the plates Check for scratching with a verification run see section 10 2 7 on page 104 P N 610520 02 05 01 Reference Guide ML F A M E Methods O Aspiration Height Specifies the distance between the aspira tion needle and the bottom of the well during the aspiration cycle There are three additional wash options as follows Continuous Wash With this option dispensing and aspiration take place simultaneously at the top of the well This option requires the following data to be specified Additional volume The volume of wash fluid to use in addi tion to that specified for a normal wash Since dispensing and aspiration take place simultaneously this can be greater than the well volume Bottom Wash This is the same as continuous wash except that the aspiration needles are positioned near the bottom of the wells This option requires the following data to be speci fied Additional Volume The volume of wash fluid to use in addi tion to that specified for a normal wash Since dispensing and aspiration take place simultaneously this can be greater than the well volume Height The distance between the bottom of the aspirating needle and the bottom of the well Bottom Sweep
132. cr Figure 14 1 Photometer Check Plate 14 152 For each well position on the photometer check plate five mea surements are made using each photometer filter 340 405 450 492 620 nm and if installed 570 610 and 690 nm The mean val ues of the five measurements are used to determine the parame ters in the following table Parameter Rows Description Used Plate 1 amp 12 Checks the positioning of the plate positioning in the optical axis at 405 nm The diameter of the check holes are such that when the plate is correctly positioned only 10 mOD may be absorbed P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification Parameter Rows Description Used Accuracy 4 8 Checks the measured values against the reference values of the check plate Each gray scale filter and filter wavelength has specific tolerance values Short term 6 Calculates the variation in 5 reproducibility consecutive measurements Measured as coefficient of variation CV Tested at wavelengths gt 400 nm Infrared IR 9 This row only lets through infrared blocking light In conjunction with the IR filter in the photometer no light should be detected Tested at 620 nm Stray light 2 amp 3 Checks for cross talk between photometer channels at 620 nm The checker board configuration of the two rows tests whether light from one photometer channel is detec
133. ct the Well push button to define into which well types to dispense The Select Wells dialog box will appear 57 Choose the well types to dispense by selecting them from the Well Types drop down list in this example all well types should be selected The selected wells will appear highlighted in the plate layout 98 Select OK The message All types should appear in the Wells field of the Dispense dialog box 59 Select slow aspiration speed from the drop down list Select a slow dispense speed from the drop down list 60 To enter this step in the test processing definition select the OK push button Mix 61 From the Steps menu select the Mix menu choice 62 Select the medium mix intensity 63 Select a mix time of 10 seconds then click on the OK push button Head 64 Select the Read menu choice from the Steps menu NOTE When specifying a Photometer 65 Select the 492 nm measuring filter Filter for an assay it is important from the drop down list to check that this Photometer Filter is installed P N 610520 02 05 01 3 35 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods Table 3 1 1 1 Method Definition Process contmueo To Do This 66 The method also requires a reference measurement Select the Reference measurement check box and select the 620 nm reference filter Then select the OK push button Check
134. cts the wash fluid container to the external pump station Incubator with 5 slots at ambient temperature in the entry module Incubator with 5 temperature controlled slots at the front of the module Tool allowing manual movement of an incubator tower entry lift or dispenser under power fail conditions Logical device to which the ML F A M E software transmits result files i e one physical host can run two applications one responsible for result archiving the other for reporting If the user software has to send result files to both applications in different ways they will be defined as two hosts say two logical devices Two documentation jobs must be defined one for each logical device Central collection station for all data e g host other PC PC to which test results are sent An MTP not wholly filled with samples Short form Slot A single chamber within an incubator tower which accommodates a single MTP An MTP sized device containing a thermometer used to verify incubator tower temperatures Short form Incubator Entry or Inc Entry Incubator in the entry module with 5 ambient temperature slots front tower and 5 temperature controlled slots rear tower Short form Incubator 1 or Inc 1 Incubator with two 5 slot temperature controlled towers front and rear Exists only in 16 30 and 24 30 instrument configurations Short form Incubator 2 or Inc 2 Incubator with two 5 slot temperature controlled towers front
135. d s in Container d almost empty Refill before next operation on Washer WAS566 1 Wash Channel d locked Load Container on different Channel Pressing Ignore will abort function P N 610520 02 05 01 Appendix 1 225 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages A1 2 Trace Messages The following tables list the messages that can appear in traces A1 2 1 Explanation of Trace Codes Trace messages are grouped together in even and odd pairs For instance the following two entries are associated with the same trace message 32000 NOTE RUN Washing started wash solution s barcode s comp lot nr 1 s comp lot nr 2 s volume u ul soak time u sec location s 32001 loc s fluid s bc 96s lot s lot2 96s vol d sec 96d The first entry is the complete trace message The second entry gives only the parameters if any that vary in the trace message e g module wash volume soak time etc These parameters are intended for evaluation by external applications The special character followed by a format character e g s for string d for decimal etc is used in the trace messages as a placeholder for dynamic entries and will be replaced by different text in the actual trace messages For example the message 32016 NOTE RUN Dispensing started reagent s barcode s comp lot nr 1 s comp lot nr 2 s volume pe
136. d and if applicable the file name Method backup path specifies the path to where backed up methods are stored Method restore path specifies the path to where backed up methods are restored to the ML F A M E database from User access file specifies the path to where and the name of the ML E A M E operator data file Kit Lot file specifies the path to where and the name of the kit lot data file Plate acknowledge specifies the name of the command file which informs the higher level system that the ML F A M E software has identified a plate and processing has begun Error recovery specifies the name of the command file which handles error recovery i e if required common files cannot be opened the ML F A M E software will start this command file as a separate procedure Time synchronization specifies the name of the command file which will ensure the time of the ML F A M E workstation matches that of the higher system O Automatic documentation When the command file is defined an ASTM file is generated in addition to the docu mentation jobs defined in a test s method with the following documentation format options Well trace Test trace Lowest trace priority includes all trace messages This documentation job will be processed independently of the documentation jobs defined for the method The command file is a script that will transfer the ASTM file to a specified location e g a network
137. d from the instrument The End Module comprises the following components Dispenser The function of the dispenser is the same as the one in the Washer Dispenser module Mixer The mixer is identical to the one in the Washer Dispenser module Photometer The photometer has 8 measuring channels i e 8 wells can be measured simultaneously and one additional reference channel There are 5 filters incorporated with the following wavelengths O 340 nm O 405 nm O 450 nm 492 nm 620 nm Up to 8 filters can be used These may have wavelengths ranging from 340 nm to 750 nm P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 1 3 1 5 4 1 3 2 1 3 2 1 1 3 2 2 ML F A M E Overview The following parameters are programmable via the user software O Measurement wavelength O Reference wavelength Exit Stack The exit stack is where the instrument stores finished plates i e plates which have had all processing steps performed on them From here the plates can be removed and disposed of Approximately 10 plates can be stored in the exit stack Bristles hold the plates in place in the exit stack A sensor controls the exit status If the stack is nearly full a warning message is displayed by the user software Plates can be removed at any time without interrupt ing processing The ML F A M E Workstation The ML F A M E Workstation is an IBM compatible persona
138. d with washer 1 channel 4 is used for rinse fluid One of four wash channels associated with washer 2 channel 8 is used for rinse fluid Exists only in 24 20 and 24 30 instrument configurations An MTP used during the checking of the washer Resides in the extra slot of incubator module 2 Lid which closes the wash fluid container air vent is incorporated One of four positions in the external pump station into which a wash fluid container is placed Device which allows a wash fluid container to be stood on its side during filling Device that washes an MTP Part of Washer Disp Module 1 that washes MTPs Part of Washer Disp Module 2 that washes MTPs Device that raises and lowers the washer manifold Fluid specified by or supplied by test kit manufacturer used for washing an MTP in an ELISA test for example Vessel which holds either wash or rinse fluid Tubing that connects between the external pump station and the washer dispenser module A component that sits under the manifold allowing rinsing of the washer Lid which closes the waste container when in use and also allows connection of the waste tube Incorporates LLD measurement Holds waste fluids which have been aspirated by the manifold A reservoir that defoams waste fluids before pumping into waste container Also used as a temporary waste fluid store while the waste container is being changed Washer Dispenser A single cavity an MTP An MTP com
139. de Section 11 3 on page 109 To insert a stack in between two stacks select the lower of the two and use the Insert menu choice from the Edit menu The new stack will be placed above the selected stack 8 Select the stack to be removed from the work list and either select the Delete menu choice from the Edit menu or press the keyboard Del key 9 Repeat this process until the desired work list arrangement is achieved Then select the Close push button to return to the Work List Manager window 10 Select the stack type and then from the Edit menu the Set Earliest Start Time menu choice 11 Set the Time of Day or the Delay to the Previous Stack 12 By selecting an individual method in a stack and the Change Kit Lot menu choice from the Edit menu a dialog box is displayed listing all kit lots available for use with this method also see Table 4 1 3 1 Working with the Kit Lot Editor Select the required kit lot and click the OK push button methods of the type selected will now use the new kit lot 14 From the File menu select the Print menu choice the work list data will be printed on the default OS 2 printer P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine Table 4 1 4 1 Define a New Work List To Do This Save the work list From the File menu select the Save As menu c
140. defined criteria displaying an error and error infor mation where applicable P N 610520 02 05 01 10 89 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods 10 2 2 Plate Layout Editor The Plate Layout Editor allows the definition of the plate layout plate configuration and all plate related values sf Layout Editor Example ELISA ru File Edit Configuration Samples Select Well Type 4 5 BL JE 029 GOOG Je CC EO SD Ent Boe eO ED 3 84 3 3 87 Db E eG XS EAE IDG E36 0 n 5 X5 i Figure 10 5 Layout Editor Window IEDEDEIEIDCEI zo m m co o uU m 5 amp For further information on the Layout Editor see Cook Book Sec tion 3 1 1 on page 28 10 2 2 1 File Menu The File menu allows the user to control the management func tions of the Plate Layout Editor O Check Layout when selected this menu choice checks to make sure all defined well types have been used A dialog box will display an error message if applicable O Save Method saves the method to the ML F A M E database O Switch to Test Processing minimizes the Plate Layout Editor and opens the Test Processing Editor O Method Information opens the Method Information dialog box for the current method CJ Save and Switch to Test
141. e The label must perfectly adhere The surface may be untreated sealed or plastic covered to the surface during the whole of its working life Barcode Symbology The following barcodes are recommended for use with the bar code reader O Code 39 with or without check characters O Interleaved 2 of 5 with or without check characters FJ Codabar O Code 128 O UPC A E 0 JAN EAN 8 16 192 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications Length of Information Maximum 32 characters excluding start stop and check charac ters depending on the code length see label dimensions Print Contrast Signal Minimum contrast between bars and spaces PCS 80 at 632 8 nm Code Density Tolerance Minimum module width including print tolerances 0 0065 0 1651 mm 16 3 2 Reagent Container Barcodes A set of 52 plastic barcode labels is provided with the instrument User defined barcodes must fit on the back of these barcode labels and must meet the following specifications Label Dimensions Maximum dimensions of Dimensions of barcode label 59 x 35 plastic label 65 x 37 3 59 23 1 T 10 e i o v 19 8 Y 036 871 7 00 N _ gt 7 4 gt 7 4 Quiet Zone PT MT Quiet Zone ulet Zone uiet Zone gt 10 1 Text Zone gt 10 1 Dimensi
142. e d location s ERROR CTRL FOT302 error in reply string of measurement data error code d location 5 ERROR CTRL FOT311 measurement request command failed error code d location s NOTE RUN Washing started wash solution s barcode s comp lot nr 1 s comp lot nr 2 s volume u ul soak time sec location 5 loc 96s fluid 96s bc 96s lot1 s lot2 s vol d sec d ERROR RUN Washing start failed reason s location s Error Status Error loc s NOTE RUN Washing finished successfully location s loc s ERROR RUN Washing finished with error location s Error Status Error loc s NOTE RUN Aspirating started location s loc s ERROR RUN Aspirating start failed reason s location s Error Status Error loc s NOTE RUN Aspirating finished successfully reagent s barcode s comp lot nr 1 s comp lot nr 2 s volume u Ll location s loc s fluid s bc s lot1 s lot2 s vol d ERROR RUN Aspirating finished with error location s Error Status Error loc s NOTE RUN Dispensing started reagent s barcode s comp lot nr 1 s comp lot nr 2 s volume per well u ul location s loc 96s fluid 96s bc 96s lot1 s lot2 s vol d ERROR RUN Dispensing start failed reason s location s Error Status Error loc s NOTE RUN Dispensing finished successfully location s loc s
143. e Abort menu use the Selected Test menu choice confirm the action and the test is removed from the schedule 11 The entire run can be aborted at any time by following the above procedure but selecting the Entire Run menu choice Fluids Fluid Loading It is highly recommended that stable fluids which have a close loading time i e are the first fluids to be loaded be loaded together and assigned with a location and barcode prior to starting a run This will reduce the amount of time critical work for the ML F A M E operator during the run and will limit possible problems caused by delays The procedure for this is explained below in the Assignment Editor section Table 4 1 6 1 Assignment Editor on page 51 While stable fluids are loaded before starting the run unstable flu ids must be loaded when the ML F A M E software requests them While unneeded fluids may be removed from the ML F A M E when prompted by the ML F A M E software this may not be done if a dispensing step is scheduled for the next 5 minutes For further information on fluids see Reference Guide Section 11 5 on page 116 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine Fluid Assignment Two procedures are possible for assigning fluids O The Assignment Editor Stable Fluids allows the indepen dent assignment of fluids and their barcodes Not available wh
144. e container capacity 10 litres LLD detection when using waste cap exchangeable during operation External water separator capacity 4 litres a This specification is valid under the following test conditions Type of MTP Check Plate Test Method Photometric Test lemperature 18 26 C Test Medium Aqueous dye solution 16 188 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 16 2 3 2 16 2 3 3 Dispenser Reagent Container Carousel Reference Guide Technical Specifications Capacity 8 reagent containers Reagent Container System Volume of syringe 20 ml Dispense volume per well 20 200 yl In steps of 5 ul Reagent container capacity 100 ml approx Reagent identification By barcode Accuracy and precision not specified for volume ranges of 20 45 pl Dispensing Precision Accuracy Volume Precision 96 CV Accuracy lt 50 1 52 5b 52 5P 100 1 52 5b 52 5P 200 1 02 5b 2 52 5P a This specification is valid Test Method Gravimetric Test Temperature 18 26 C Test Medium Deionized wa er containing 0 05 NaCl under the following test conditions b This specification is valid under the following test conditions Test Method Photometric Test Temperature 18 26 C Test Medium Washer Dispenser verification kit check solutions Mixer See sect
145. e decontaminated Software Precautions The ML F A M E Workstation should not be used for running any other applications programs except those described in 1 3 2 en la p gina 1 9 The ML F A M E Workstation date and time must not be changed while the instrument is running tests or while the user software is running or being started up otherwise trouble free operation can not be guaranteed The operating system OS 2 and database DB2 2 functions are optimized to suit the instrument configuration Changes to the setup can impair the operational reliability and data security of the system Only the ML F A M E software may be used to control the ML FA M E When running the system 24 hours a day shut down and restart the system once a day in order to re calibrate the washer photom eter etc and also carry out cold start maintenance P N 610520 02 05 01 Microlab F A M E User Manual V2 0 ML F A M E Overview The ML F A M E operator is responsible for the security of commu nication between the ML F A M E and any host computer The ML F A M E system creates result files but does not provide the spe cific communication protocols to ensure reliable and safe transmis sion of result files P N 610520 02 05 01 1 21 Microlab F A M E User Manual V2 0 ML F A M E Overview 1 22 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 CookBook Chapter 2 8 Cook Book Cook Book Sections 2
146. e following data must be specified Wash solution name Wash mode Either Strip wash The plate is washed three strips at a time i e if there are 2 wash cycles 3 strips of 8 wells are washed twice then the next 3 strips twice then the next 3 twice etc Plate wash Each wash cycle is completed over the whole plate before the next cycle i e if there are 2 wash cycles the entire plate is washed 3 strips at a time and then immediately again for the second cycle Dispense Only With this mode wash solution is only dis pensed into the wells NOTE When setting the wash volume Wash Disp Volume Specifies the amount of solution to be make allowance for the well vol dispensed during washing ume and do not overfill the wells Avoid creating a convex meniscus If a higher volume is required to wash the well e g O Soak Time Specifies the time the dispensed wash solution 500 ul the option Continuous should be left in the plate before aspiration wash can be used to define the additional volume needed e g specify 300 ul for the Wash Disp volume and 200 ul for the additional volume O Number of Cycles Specifies the number of times the wash cycle should be repeated 10 96 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 NOTE If a negative aspiration height is specified a warning message will appear on the screen A negative aspiration height causes the aspirating needles to come in contact with the
147. e information for the specified well is then displayed Viewing a test 20 From the View menu select the Test trace Trace menu choice A dialog box is displayed where the ML F A M E operator must select the required test 21 The trace information for the specified test is then displayed View the system 22 From the View menu select the System trace Trace menu choice NOTE The ML FA M E database will 23 A dialog box is displayed allowing the store a maximum of 14 individ ML F A M E operator to select the date ual days of system traces for which systems trace information are to be displayed 24 The system trace is then displayed Set the trace 25 From the View menu select the Set display priority Priority menu choice P N 610520 02 05 01 5 61 Microlab F A M E User Manual V2 0 Cook Book Test Results amp ML F A M E Traces Table 5 2 1 1 The Trace Window contmueo To Do This 26 Three options are allowed 1 Note displays all messages 2 Warning displays all messages except Notes 3 Error displays all messages except Notes and Warnings Refresh the 27 From the View menu select the Refresh display menu choice or use the F5 keyboard key 5 62 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Instrument Status Chapter 6 Instrument Status Table of Contents 6 1 Instrument Status Window seerne 64 6 1 1 Unlockin
148. e user to select and change already defined add new fluids or delete exist ing global fluids Change If the global fluid is used by another method s a dialog box will be displayed showing the method s and the user is asked to confirm whether to continue or not Delete It is not possible to delete a global fluid if it is used by another method s stored on the ML F A M E database Documentation A method s documentation is defined in two parts the first con trols the definition of a method s documentation formats the sec ond is the actual way it is handled Test Documentation Formats A test s documentation format determines the information that will appear in the test s final documentation A number of different options can be defined in the Documenta tion Format dialog box These include O Traces well trace and test trace use these check buttons to specify if the documentation format will include individual well information and test trace information 10 101 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods O Priority three priority categories can be set these specify the severity of information to be included in the documenta tion Note all traces are included Warnings trace messages with the severity Error and Warning are included Errors trace messages with severity Error are included O On printouts only specifies which information appears
149. eagent Container Carousel 119 242 Reagent Container System 242 Reagent Containers cleaning of 74 inserting of 119 Reagent Drawer 120 Reagent Drawer End Module 242 Reagent Drawer Washer Disp Module 1 242 Reagent Drawer Washer Disp Module 2 242 Reagent Name 98 Reagents preparing of 119 Rear Tower 242 Redocument 242 Reference Filter 36 Reference Filter Wavelength 100 Reference Wavelength 9 243 Registration Priority 242 Re Identify 100 Release 242 Release Switch 242 Replica 242 Replica Direction 93 Replica Number 30 Residual Volume 242 Result File 242 Rinse Fluid 242 Run 242 RW 243 Appendix 8 272 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 8 Index Sample 243 Sample and reagent addition monitoring 98 Sample Filling Direction 93 Sample Replica Number 93 Samples Menu 93 Secondary Window 243 Service Container 243 Service Position 243 Service Technician 243 Set System Time 145 Shipping Kit 243 Simulated Instrument 142 Slot Door 243 Soak Time 96 243 Software Presettings 142 Specifications barcodes 191 circuit breaker ratings 185 dispenser 189 precision accuracy 189 reagent container carousel 189 reagent container system 189 end module 190 entry module 187 entry stack 187 incubator towers 187 exit stack 190 general instrument specifications 184 incubator module 187 incubator towers 187 instrument dimensions 185 instrument weight 185 mixer 190 operating temperature range 186
150. early The formula for the temperature offset is as follows where T temperature offset of incubator check plate T check plate temperature Tm maximum temperature measured by incubator check plate The incubators should always be verified at their normal operating range in the laboratories daily work Temperature range for verification Ambient to 45 C this can be set in the device presettings window The incubator check plate is loaded into a selected incubator slot and incubated for 30 minutes During verification the following values are determined Check plate temperature The actual temperature which is calculated as follows maximum temperature measured and displayed by the incubator check plate temperature offset of incubator check plate Target temperature ATTENTION The temperature of the incubator Temperature which is defined in the user software for the corre check plate must be lower than sponding incubator device pre settings the target temperature of the slot Reported temperature Between each incubator Temperature measured by the sensor in the incubator slot which is verification the incubator check similar to the reported temperature incubation finished in the test plate must be switched off and trace then on again to clear its memory The acceptance criteria are calculated as follows for further information See section 14 2 9 on page 14 160 O Temperature contro
151. eck Plate 163 14 3 3 Incubator Check Plate Calibration 163 14 3 4 Decontamination 164 14 4 The Verification 165 14 4 1 Menu 166 P N 610520 02 05 01 14 147 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 1 Overview NOTE A warning dialog box will be dis played giving 14 days notice of any required verification Verification is an in built self checking system of the functionality of the ML FA M E All physical modules of the instrument are tested against predefined values using a verification kit with tested known values procedures These checks must be performed at a regular interval to ensure reliable operation of the ML F A M E When the ML F A M E software has been installed with the Verifi cation restrictive installation option if any verification procedures have the status Required the ML F A M E will not perform any tests Also if any ML F A M E modules fail verification the module s sta tus will remain Required and the instrument will be locked How ever individual incubator slots that have failed verification may be locked leaving all others active 14 1 1 What is Verified ATTENTION Each verification procedure has The following instrument functions are verified
152. ecked all defined documentation jobs will be started automatically on completion of processing unless the error status of the test is set to Aborted Always start documentation this is a check box found in the Software Presettings dialog box When it is selected all defined documentation jobs in all processed methods regardless of the error status will be started automatically on completion of pro cessing This setting overrides the Start by user and autostart mode 12 2 2 Documenting a Batch of Tests NOTE The Document test batch The Document Test Batch action allows one or more selected action will not change the test tests to be documented using a selectable documentation format status of the selected tests and the results to be sent to a selectable device independent of the documentation definition specified in the method definition see Cook Book Section Table 5 1 2 1 on page 58 12 2 3 Storing Results The ML F A M E software is able to keep a large amount of test data in the ML F A M E database provided there is enough disk space However it is not recommended to keep more tests in the ML F A M E database than necessary as system performance will decrease Once test results have been documented i e printed and sent to the host and archived they should be deleted from the ML F A M E database It is the responsibility of the ML F A M E operator to ensure that the documentation process was success
153. ection Waste containers on and waste caps page 8 74 External water 15 See section External water separator separator on page 8 74 NOTE Do not remove the tubing from Wash fluid 16 Clean all wash fluid containers the inside of wash fluid contain containers especially those which will not be used ers for a long period and keep them dry If a wash fluid container becomes contaminated with 17 Empty any remaining wash solution bacteria or fungus it must be Partially fill the container with deionized replaced It is recommended to water and replace cap renew the wash fluid container at least once a year 18 With the cap facing upwards shake the container in the lengthwise direction for a few moments Some liquid may leak through the thread of the cap This is because a vent is incorporated in the thread to equalize the pressure in the container 19 Control the position of the internal filter It must be on the same side as the filling opening 20 Empty the container and leave dry 21 Once a month it is necessary to rinse the wash fluid containers with Microlab Detergent and Disinfectant solution then rinse with tap water and deionized water Renew syringes 22 The frequency of renewal of syringes and reagent containers is dependent upon the reagents being used but as a minimum syringes should be renewed weekly Renew reagent 23 Every 4 weeks conta
154. efines the ML F A M E operator related tasks in a step by step guide In each section there is an introduction explaining the task then a table structure defining a question and then an explanation of the procedures needed to achieve this task Where necessary there are Notes and Attention paragraphs to bring certain information to the ML F A M E operator These paragraphs are positioned in the left column to avoid any interruption in the flow of the step by step process O Reference Guide The Reference Guide gives full technical information on all functions of the ML FA M E and is designed to be used as both support for the Cook Book through extensive cross referencing and as a stand alone reference work Notes and Attention paragraphs similar to those used in the Cook Book are also used in the Reference Guide User Manual Symbols A ATTENTION NOTE ATTENTION Any special problems warnings or important informa tion will be accompanied by this symbol Read these carefully as they can easly help to understand particular issues NOTE This is used to give information to the ML F A M E operator that is useful but not essential to the task at hand Read these care fully as they can easly help to understand particular issues Microlab F A M E User Manual V2 0 ML F A M E Overview 1 8 ML F A M E Components The ML F A M E consists of two parts O The ML FA M E Instrument and O The ML EA M E Works
155. elect the filling direction from the Configuration menu either vertical A H or horizontal 1 12 A marker on the menu shows which direction is selected For this example select A H Next select the required Replica Number from the Samples menu to define the number of replicas of each sample a value of 1 gives 1 well per sample A value of 2 gives 2 wells per sample etc In this case a value of 1 is required P N 610520 02 05 01 Cook Book ML F A M E Methods Microlab F A M E User Manual V2 0 Table 3 1 1 1 Method Definition Process contmueo Cook Book ML F A M E Methods To Do This Defining control well lypes Deleting well types Assigning control well types NOTE If there are any unused well types Completing the in the layout they must be layout deleted Remember to rearrange the lay out again if well types have been deleted Checking the layout Test processing editor Prepare plate P N 610520 02 05 01 9 10 11 12 13 14 15 16 17 lt lt For this example the required well types are Positive Control PC Negative Control NC Samples SA and Blank BL Except for Blank well types all the above are ML F A M E software defaults From the Edit menu select the Edit Well Types menu choice Select the Insert push button A new line is created in the table Enter BL
156. em Time sse 145 13 3 ACC8sS Flights aie eedem 145 13 137 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Functions amp Requirements 13 1 Overview This section contains information on the various functions required to perform the upkeep of the ML FA M E 13 2 Services Menu The main access point for these functions is the Services menu in the Main ML F A M E window 13 2 1 Instrument Status Window The Instrument Status window has two main functions the first allows the ML E A M E operator to view the current temperature of each incubator slot in the ML FA M E and the second is used to view the lock status and to unlock any locked instrument functions SU Instrument Status 7 File View Instrument Change lock status E Incubator temperatures Incubator Entry Incubator 1 Incubator 2 Front Tower Planned temperature ambient 40 0 40 0 Slot 5 25 0 25 0 25 0 Slot 4 25 0 25 0 25 0 Slot 3 25 0 25 0 25 0 Slot 2 25 0 25 0 25 0 Slot 1 25 0 25 0 25 0 Rear Tower Planned temperature 37 0 37 0 37 0 Slot 5 25 0 25 0 25 0 Slot 4 25 0 25 0 25 0 Slot 3 25 0 25 0 25 0 Slot 2 25 0 25 0 25 0 Slot 1 25 0 25 0 25 0 Ambient temperature 25 0 25 0 25 0 Figure 13 1 The Instrument Status Window Temperature Mode 13 138 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Functions amp Requirements m Instrument
157. ent Container Set O Disposable Syringe Set The following item is also required but is not included in the Verifi cation Kit O Calibrated hand pipette s 50 100 and 200 ul volume 14 1 5 Precautions As is the case with all operation of the ML F A M E it is recom mended to follow Good Laboratory Practice GLP standard In addition to this standard O Avoid touching the undersides of the photometer dispenser and washer check plates and ensure that they are com pletely clean dry and free from particles O The photometer and incubator check plates are fragile so please handle them with care Take the necessary precau tions when handling the photometer check plate O The photometer and incubator check plates must be decon taminated before they are returned for referencing calibra tion O The washer and dispenser check plates may only be used once and then discarded 14 1 6 Archiving Verification Results A record of all verification runs should be kept for future reference and to aid any possible error tracing Use the print functions described in 14 4 1 on page 14 166 to document the verification run immediately upon completion 14 150 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 14 1 7 Reference Guide ML F A M E Verification Order of Verification Always verify the photometer before the dispenser and then the washer Verify the washer and dispenser on the same d
158. ent on queue Serial number 6666 Maintenance procedure Status Date Time Operator Cold Start 1970 01 01 Daily 1997 07 07 Weekly open 1997 07 07 07 08 09 SIX Monthlu open 1997 87 87 07 08 09 SIX Decontaminate Washer 1 open Decontaminate Washer 2 open Decontaminate Incubators open Load Cold Start plate open Remove Manifold 1 open Remove Manifold 2 open Insert Manifold 1 open Insert Manifold 2 open Figure 15 1 Maintenance Window In this window the ML F A M E operator can view the Maintenance status of each ML F A M E module and access the necessary com mands to perform all maintenance related routines 15 1 4 Menu Choices O File Menu O Print Prints the information displayed in the current view on the OS 2 default printer O Abort Maintenance Procedure Halts all maintenance actions regardless of how they were started O Close It is not possible to close the Maintenance window while a maintenance run is active Select the Abort Maintenance Run choice before selecting this option O Procedure Menu All sub menu choices will initiate the applicable maintenance procedure all maintenance procedures are fully guided by on screen ML F A M E operator instructions for further information See section 15 1 7 1 on page 15 175 P N 610520 02 05 01 15 171 Microlab F A M E User Manual V2 0 O Extras Menu Remove Manifold Washer 1 Washer 2 Washer 1 amp 2 Reference Guide
159. er carousel put the cap in the service position i e in its recess and check that it is firmly seated Locking tab Cap Service position _ recess N Closed position Syringe parked position Conductive insert Barcode label Figure 11 4 Reagent Container Definition of Terms 11 7 2 Inserting the Reagent Containers into the Carousel Insert the prepared reagent containers into the reagent container carousel Note the two grooves in the reagent container which slide into the two tongues in each segment of the reagent container carousel The reagent container is locked in place by the locking tab which clicks into the slot in the carousel P N 610520 02 05 01 11 119 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 7 3 Using Reagent Container Garousels NOTE The reagent drawers should only To insert a reagent container carousel in a drawer open the be opened by their handles The reagent drawer smoothly by the handle handle contains a switch which tells the ML F A M E software that the drawer is open Rotate the reagent container carousel by the knob until it drops Hold the reagent container carousel by the knob in the centre and slide it onto the spindle in the reagent drawer and locks into place Close the reagent drawer gently Slamming the drawer shut may ATTENTION cause reagent spillage Make sure to put the reagent container in the correct
160. er these definitions are complete start the run by selecting the Actions Start run menu option form the Plan window Fluid Handling General Remarks As mentioned earlier fluids are defined as all reagents for dispens ing operations the wash fluids and the rinse fluid Additionally some of the reagents may be unstable Therefore the fluid han dling differs slightly depending on the nature of the fluids Some general principles apply to all fluids O Fluids usually have a preparation time defined in the method this preparation time is taken into account during the schedul ing and is also displayed in the Fluid window of the Plan win dow For each fluid a loading step is planned i e a time span is reserved in the plan to load fluids without any negative conse quences on the run i e delays of other steps etc As many fluid loading steps are combined in one loading step as possi ble Fluid loading steps are also displayed in the Fluid window FJ The loading of fluids may be postponed if the operator has insufficient time during the loading step or wants to postpone the fluid loading for whatever reason Postponed fluid loadings are also displayed in the Fluid window O Any barcode on a fluid container must be unique within a run O Some fluids must be verified i e the component kit lot of the fluid must be checked against the registered kit lot file to see whether it matches or not This check must be done prior
161. ermost position move by hand O Front incubator tower in its lowest position use height mover tool O Entry lift in its highest position use height mover tool 17 1 8 2 Incubator Module CJ Module transport in main shuttle position Figure 17 4 i e fork in outermost position move by hand O Front incubator tower in its lowest position use height mover tool 17 1 8 3 Dispenser O Module transport inside module just clear of main shuttle Fig ure 17 4 move by hand P N 610520 02 05 01 17 205 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling O Dispenser head in uppermost position in drop position Figure 17 3 Move the dispenser head up and down using the height mover tool Move the dispenser head from left to right by hand Syringe tip must be positioned directly above drip well Figure 17 3 Drop Position of Dispenser Head 17 1 8 4 Washer O Manifold in uppermost position move by hand Requires con siderable force 17 1 8 5 Photometer Not applicable 17 206 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 1 8 6 Transport System MTP transporter away from entry lift move by hand Figure 17 4 Exit lift in its lowest position move by hand Apply pressure at the inner most end of lift near the spindle Entry Module Incubator Mod
162. ernneensnnnnnnennnnnnnnnnnnnnnnnnnn nn 112 11 42 Test WindOw oed ee 113 11 4 3 Time Bar a Dec eec meer 113 11 4 4 Fluid Window 114 11 4 5 Changing a Work List eeens 114 11 5 Fluid Flandling iie ens 116 11 6 Assignment 117 11 6 1 Fluid Container Barcode Reservation 117 11 6 2 Reserved Bar Codes 117 11 7 Starting a Run oo eee 118 11 7 1 Fluid Handling General Remarks 118 11 7 2 Inserting the Reagent Containers into the Carousel 119 11 7 3 Using Reagent Container Carousels 120 11 7 4 Fluid Handling for Stable Reagents 120 11 7 5 Loading of Unstable 121 11 7 6 Loading of Wash Solutions 121 11 7 6 1 Wash Solution Loading Dialog 122 11 7 7 Plate Preparation and Sample Pipetting Information 123 11 7 8 Plate Loading eine 123 11 8 Changing a Run sse 126 11 8 1 Un schedule 126 11 8 2 RESCH UIC wit ete ie tectae deed ten 126 11 9 Aborting a Plate or Run sse 127 11 9 1 Aborting
163. ers on page 8 76 O Approx duration 5 10 minutes O Clean with tap water not hotter than 50 or with laboratory washing equipment O Rinse with deionized water empty and leave to dry O Replace All Syringes see Cook Book section Renew syringes on page 8 76 O Approx duration 5 minutes 15 174 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 15 1 6 3 15 1 7 A 15 1 7 1 ATTENTION The Cold Start Plate must be in the extra slot of the rear tower of incubator module 2 to run weekly maintenance otherwise the procedure will abort P N 610520 02 05 01 Reference Guide ML F A M E Maintenance Every Month Approx Duration 1 hour 20 minutes 1 hour 25 minutes For instructions on accessing the maintenance routines see Cook Book Section 8 1 1 on page 70 C Washer Decontamination See section 15 1 8 Washer Decon tamination on page 15 180 Q Approx duration 35 40 minutes O Must be carried out at the end of the working day at the end of every month prior to ML F A M E system shut down O Rinses and soaks all wash channels tubings and the waste extraction system using a solution of a suitable disinfectant and then rinses them with NaCl solution and deionized water O Clean Washer Manifold see Cook Book section 8 1 2 Washer Manifold on page 8 71 O Approx duration 40 minutes O see Cook Book Section 8 1 2 on page 71 O Replace Reagent Containers see Cook Boo
164. ertaining to ML FA M E functions can result in erroneous test results or ML F A M E failure 4 During instrument operation do not place hands in the way of moving parts or microplates Do not touch the incubator towers with bare hands as these may cause burns max temp 70 C 5 Smoking and eating in the vicinity of the instrument and in rooms in which samples or reagents are handled is forbidden see also warning notices and precautionary measures in the test kit pakkage inserts 6 During operation the instrument should be shielded from direct sunlight and intense artificial light 7 Nothing should be attached to a microplate when it is loaded into the instrument except one barcode 8 Each plate barcode must be unique Microlab F A M E User Manual V2 0 1 4 4 2 ATTENTION Before connecting and switching on the instrument check the setting of the voltage selector switch and if necessary switch 1 18 ML F A M E Overview 9 Ensure that barcode labels do not protrude above or below the level of the surface of the microplates 10 Microplates must be placed in the entry stack or on the entry platform such that well A1 is in the front left position 11 Under normal operating conditions microplates should only be loaded into the instrument via the entry platform or entry stack and removed via the exit stack Only when specifically instructed by the ML F A M E software may plates be directly placed in or remo
165. erval for calibration The newly calibrated plate will then be returned with a declaration of quality containing the temperature offset value The new temperature offset value must then be entered into the computer P N 610520 02 05 01 14 163 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 3 4 Decontamination The photometer and incubator check plates must be decontami nated at regular intervals and also before they are returned for ref erencing calibration The procedure for both items is the same Recommended interval After each use Procedure Wipe the surfaces gently with a lint free cloth soaked in ethanol 70 14 164 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 4 The Verification Window J veic O O File View Procedure Evaluation Validation Instrument Instrument on COM1 Serial Number 2104 Verification procedure Status Date Time Operator Dispenser End completed 1998 06 25 11 18 87 OASY Dispenser 1 completed 1998 06 25 11 26 82 OASY Dispenser 2 completed 1998 06 25 13 06 55 DASS Washer 1 completed 1998 06 25 13 32 34 OASY Washer 2 completed 1998 06 25 13 53 46 OASY Incubator Entry completed Front tower Slot 1 completed 1998 06 25 14 34 38 OASY Front tower Slot 2 completed 1998 06 25 14 35 30 OAS9 Front tower Slot 3 completed 1998 06 25 14 36 15 OAS9
166. fold Refill appropriate wash fluid container Call service technician Call service technician Vacuum pump overload Tubing kinked Waste cap or substitute plug not connected Check tubings Check that waste cap plug or substitute plug is connected to instrument If waste cap is used check that it is on waste container Waste container full Dirty sensor rods Empty waste container Clean sensor rods Waste cap not on waste container Electrical problems Substitute plug not inserted Place waste cap on waste container immediately otherwise plates will be aborted Wash container almost empty Refill when green lamp is lit Error 342 Wash shell overflow Dirty manifold Clean manifold 17 210 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 17 2 2 2 Dispenser Problems Reference Guide Troubleshooting amp Error Handling Symptom Possible Cause Corrective Action Insufficient reagent or defective Syringe Not sufficient reagent loaded Bad syringe maintenance Renew syringe Dispensing failed due to air gap foam Defective syringe Renew syringe After next test step incubate check visually if all wells have been filled with reagent Retest samples Insert test trace message Reagent rotor step lost Reagent carousel dirty Clean reagent carousel Dispenser plunger drive step lost
167. following statuses Aborted All test of this stack are Aborted Kit lot invalid Method invalid Non processable All test of this stack are Non processable No resource and When a work list is defined i e all stack types are added to the Non processable work list valid stacks and tests will have the status Not planned After scheduling stacks and tests which could be scheduled will have the status Planned To change a work list prior to a scheduling process simply use the menu options of the Edit pull down menu of the Work List window to delete or insert stacks see Reference Guide Section 11 4 5 on page 114 11 5 Fluid Handling Fluids used by the ML FA M E include O Reagents O Wash Fluids O Rinse Fluids O Maintenance Fluids A O Check Fluids ATTENTION If a method definition is not Certain information for the fluids must be present in order to make complete and or the kit lot and a method processable within a run These are global component registration is missing it is not possible to O Fluid definition All relevant fluids are defined within the corre process these methods sponding method of the ML FA M E database For each method either method specific or global components have been specified O Kit lot and component lot information The kit lot information contains the registration of the method s kit lot these contain the kit lot numbers of method specific components and addi tionally of all global compone
168. ful ITP140 1 Dispenser will be unlocked Free Dispenser manually Successful ITP141 1 Dispenser Module Transport will be unlocked If there is a plate on the Module Transport remove it manually Free Module Transport manually Successful ITP150 1 Photometer will be unlocked If there is a plate on the Module Transport remove it manually Clean Module Transport Transport Plane and Photometer manually Successful ITP160 1 Main Shuttle will be unlocked Remove all plates in collision area of the Main Shuttle manually Free Main Shuttle manually Successful P N 610520 02 05 01 Appendix 1 217 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages DiALOG ID MESSAGE ITP161 1 Exit Lift will be unlocked Remove any plates from the Exit Stack manually Free Exit Stack manually Successful ITP531 1 Barcode file not accessible due to corrupted Regneu inf Test cannot be processed Call a service representative ITP532 1 Barcode file 5 not found Test cannot be processed Call a service representative ITP533 1 Directory or File 5 is locked Test cannot be processed Call a service representative ITP534 1 Corrupted barcode file s Test cannot be processed Call a service representative ITP900_1 Unlocking of s not successful Call a service representative PTM900_1 Remove plate from manipulation position PTM910_1
169. ful as the ML F A M E software will automatically set the status to documented regardless of possible problems such as printer failure etc When 700 test results are stored in the ML F A M E database and a new set of results are generated the oldest existing results are deleted to make room in the ML F A M E database for the new one P N 610520 02 05 01 12 133 Microlab F A M E User Manual V2 0 Reference Guide Test Results amp ML F A M E Traces 12 2 4 Archiving Test Data A The host connection facilities of the ML F A M E software enables ATTENTION archiving of test data in ASTM format on any accessible drive net It is impossible to bring ASTM work drive result files back into the database i e only unidirectional communication with a host computer is possible 12 2 5 The ASTM File An ASTM American Society for Testing and Materials file is a stan dard format used for host reporting All test results from the ML F A M E are stored in this format The ASTM file from the ML F A M E contains O all test trace information except the system trace which is not test specific O the OD values O and general test information i e method used plate bar code kit lot information instrument serial number etc As a rule test archiving is performed by the host or higher system and is not a day to day ML F A M E operator task 12 134 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Gu
170. g SRAM NOTE The inclusion of a Sample and This step starts a photometric reading of the plate and is usually Reagent Addition Monitoring included after a reagent dispense step for assays in which the step within a method should be manufacturer added dyes to the various reagents Evaluation of given some consideration as the photometric results can determine whether the reagent this option can have effects on dispensing was successful or not the instrument s throughput since additional transport and SRAM data evaluation criteria can be defined using the Range photometric read steps will Check section of the SRAM dialog become necessary to process such a step 10 98 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods A sample and reagent addition monitoring step can be included in the Test Processing definition as often as desired and at any time during the processing sequence Test Processing Editor Sample and Reagent Addition Monitoring Filter 1 Reference measurement Measuring filter Reference filter 450 gt 340 750 nm 628 f 1348 738 pm Range check Selected well type s Well All Types Absolute minimum Absolute maximum 1 000 0 100 2 999 O D 1 500 0 100 2 999 O D k 1 Deviation from median Minus Pius i8 18896 i8 18896 1 Blank correction before range check ok Comment Cancet
171. g Instrument Functions 64 P N 610520 02 05 01 6 63 Microlab F A M E User Manual V2 0 6 1 6 1 1 NOTE Unlocking a function can take some time and if the dialog box is reopened a Unlocking mes sage will be displayed for func tions currently being unlocked 6 64 Cook Book Instrument Status Instrument Status Window The Instrument Status window allows the ML F A M E operator to view the incubator temperature status of each incubator slot and also lock and or unlock instrument functions Unlocking Instrument Functions Table 6 1 1 1 Change Lock Status To Do This Access required 1 In the Main ML F A M E window select functions the Instrument Status menu choice from the Services menu 2 The Instrument Status window is displayed Initially the display will be in incubator temperature mode View a function s 3 From the View menu select the Lock lock status Status menu choice The display will change to show all present ML F A M E modules and their lock status Unlock an 4 Select the module containing the locked instrument function from the Change Lock Status function menu 5 All functions related to the selected module are displayed see Reference Guide Section 13 2 1 on page 138 6 Select the check box for the function to be unlocked and the OK push button P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book
172. g box select the Ambient incubation radio button 47 Enter the lower and upper temperature limits for ambient incubation given in the package insert in this case 15 and 30 48 Enter the required Incubation and tolerance times in this example 30 minutes and 2 minutes and select the OK push button Re identify 49 Select the Re identify menu choice from the Steps menu to check that the plate barcode matches the one read at the start of the run Dispense 50 From the Steps menu select the Dispense menu choice 51 Before the dispense step can be used a reagent must be defined This is a global reagent since it is not specific to any one method 92 Select Edit Global The Edit Global Fluid dialog box is displayed 53 Select the New push button The Edit Global Fluid dialog box will appear 3 34 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods Table 3 1 1 1 Method Definition Process contmueo To Do This 54 Enter the name 2 MOL L 2504 in the Name entry field then the time it will take to prepare 10 mins select the OK push button to confirm selection Then select the Close push button to return to the Dispense dialog box 55 Select 2 MOL L H2S04 from the Reagent name drop down list and a dispense volume of 50 ul from the Volume drop down list 56 lt Sele
173. ght Load Button Figure 11 6 Entry Stack Loading Entry Lift Signal Lights The green and orange signal lights next to the entry lift have the fol lowing meanings Green Light When the green light is on a plate stack may be placed on the entry platform Orange Light When the orange light is on a plate stack may not be placed on the entry platform A flashing orange light indicates that a plate stack is in the process of being loaded into the instrument i e the entry lift is moving or will soon move In general a Stack Loading dialog box is dis played whenever plates have not been loaded at the required time or will be moved soon The dialog box graphically displays the ATTENTION stack and all plates according to the stack type definition Do not swap plates on the entry This dialog box is either closed by loading the required stack onto stack after loading the instrument and pressing the Load button on the instrument or by selecting the Abort plate button Pressing the Abort plate but ton will result in the aborting of the next plate required by the instru ment Once a plate has been loaded to the instrument several checks are executed which ensure that everything is alright with the loaded plate These checks are 11 124 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine O Plate detection The number of plates on the entry stack is detected to check whether any pla
174. h Clean using Microlab Disinfectant Spray directly onto all surfaces then wipe clean Open and remove if necessary the transparent cover To remove the cover slide the two locking pins located at each end by the hinges inwards and lift the cover out Spray the cover with Microlab Disinfectant Spray and wipe it dry Clean the exit stack in the same way To refit the transparent cover slide the two locking pins inwards and slide the cover into place Do not spray Microlab Disinfectant Spray directly into the washer dispenser areas as this may damage the instrument Wipe the washer dispenser areas with a cloth soaked in Microlab Disinfectant Spray The green printed circuit board must be completely dry before the instrument can be reused Do not spray Microlab Disinfectant Spray directly on the photometer area as this may damage or impair the performance of the instrument Wipe the photometer area with a lint free cloth lightly soaked in Ethanol 70 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Maintenance Table 8 1 3 2 Manual Cleaning Weekly Maintenance conrwuen To Do This 11 The lens block must be completely dry and free from dust and fibres before the instrument can be reused Reagent drawers 12 See section Reagent containers on page 8 74 Reagent 13 See section Reagent containers on containers page 8 74 Waste containers 14 See s
175. he kit lot file 11 3 Work List Manager A work list is a list of stack types and their earliest expected loading times These loading times can be specified in two ways time of day mode i e an absolute time of the day and a day offset as per the time set in the ML FA M E workstation or the delay to the pre vious stack loading time i e an amount of time relative to the previ ous stack types loading time As work lists consist of stack types therefore it is not possible to define work lists if no stack types exist on the ML F A M E data base Work List Example work List Ao El File Edit View Actions Abort Stack Stack status lEarliest start time Method Test status KIt botuNo Example 4 mit R2 gt Figure 11 2 Work List Manager To access the Work List Manager select the Work List Manager menu choice from the Work pull down menu For a step by step guide to working with stack types work lists and fluids see Cook Book Section 4 on page 41 11 109 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine 11 3 1 Menu Choices O File Menu O New allows the ML F A M E operator to create a new work list Open opens an existing work list Delete deletes an existing work list Save saves the current work list Save As saves the current work list under a new name Comment attaches a comment to the current work list
176. hod in any of the following ways ATTENTION When leaving the method editor Select Exit editing from the Methods menu the user is prompted whether p the method should be checked Select Exit method from the File menu of any of the method edit and verified If the user declines ing windows Plate Layout and Test Processing or if the method does not check To close a specific method editing window select the Close choice out without errors then the from its Window Control menu to display the Window Control method cannot be used on the menu click on the Title Bar Icon for further information on closing ML F A M E windows please refer to the OS 2 documentation supplied with the It is also possible to check the version of OS 2 installed on the ML F A M E workstation method at a later date and then if it checks out without errors it can be used 10 2 6 Method Management Menu Items The method management information supplied below is a techni cal reference For further information on method management see Cook Book Section 3 1 3 on page 38 10 2 6 1 Check The Check menu item performs a verification of the entire method currently open Any errors encountered will be listed in a dialog box Errors such as incomplete definitions will be displayed Only methods which are checked and ok or methods with just warn ings can be used for running tests on the instrument If no method is currently open one can be selected from a list for
177. hoice a dialog box is displayed where the unique work list name is entered i e Example Work List Select the Save push button and the work list is stored in the ML F A M E database There is also a Display List push button that allows the ML F A M E operator to view a list of all available defined work lists Table 4 1 4 2 Edit a Work List To Do This Edit a work list To edit an existing work list select the Open menu choice from the File menu a dialog box is displayed listing all available work lists Select the desired work list and follow the steps in the above table to either add new stacks or delete existing ones Once a work list has been created it is then possible to create a schedule of processing events as follows Table 4 1 4 3 Scheduling and Un scheduling a Work List To Do This Schedule a work 1 To schedule the running of the open list creating a work list select the Schedule menu plan choice from the Actions menu in the Work List Manager window 2 progress indicator is displayed indicating the percentage of the work list scheduling completed 3 When scheduling is completed the Plan window is displayed For further information on the contents of the Plan window see Reference Guide Section 11 4 on page 112 P N 610520 02 05 01 4 47 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine Table 4 1 4 3 Scheduling and
178. hts O By setting the system time using the Set System Time menu choice from the Services menu in the Main ML F A M E win O By using the Time Synchronization macro command file to get Due to the complex nature and flexibility of the ML F A M E soft ware it is necessary to allocate various access rights to the different ML F A M E operators therefore closing off some more complex sections which require extensive training to master and are easily affected by an inexperienced ML F A M E operator 13 145 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Functions amp Requirements 13 3 1 User Access Editor When the installation option User access editor off is selected access rights will be re defined and can not be affected When the installation option User access editor on is selected it is possible to define laboratory specific user names passwords and access rights Access rights are assigned to individual ML F A M E opera tors when they are created Six access levels exist designated 1 6 Level 1 is the lowest level ML F A M E operators with level 1 access rights can carry out only very limited tasks with the ML F A M E Level 6 is the highest level ML F A M E operators with NOTE level 6 access rights have access to all ML F A M E software func It is the responsibility of the sys tions The system manager usually has level 6 access rights The tem manager to create users system manage
179. ide Test Results amp ML F A M E Traces 12 3 Trace Reports A trace report gives a complete history of events which have taken place on the system The following types of trace report are avail able O System Trace tracks all important events and data throughout the entire system and includes ML F A M E operator actions ML F A M E software functions ML F A M E procedures and also all test trace and well trace information O Test Trace tracks all events and data for each and every test CJ Well Trace tracks only exceptional events for the wells in a test and is normally blank NOTE Opening or viewing a trace win For information about working with the Trace window see Cook dow during a run is not recom Book Section Table 5 2 1 1 on page 60 mended 12 3 1 Trace Priority Each trace message carries one of the following priority levels O Level 1 Note O Level 2 Warning O Level 3 Error For information about working with priority levels see Cook Book Section Table 5 2 1 1 on page 60 12 3 2 System Trace The system trace records all important events and data throughout the complete system i e ML F A M E operator actions ML F A M E ML F A M E software events and test information It is used to record the complete process and system changes The system trace can be useful for identifying problems with the instrument and the user software and also for identifying when a particula
180. ile the Work List Manager is active Table 4 1 6 1 Assignment Editor To Do This Insert a fluid Open the Assignment Editor using the Assignment Editor menu choice from the Work menu in the main ML F A M E window From the Edit menu select the Insert Fluid push button or use the Insert key on the keyboard the Insert Fluid dialog box is displayed 3 Two selection fields are displayed a Method lists all methods currently available on the ML F A M E database b Fluid lists all fluids available for the selected method The in the method list indicates global fluids Select global fluids 4 To assign a global fluid select the in the Methods list box Then from the list of fluids displayed in the Fluids list box select the desired fluid name then the OK push button Select method 5 Select the method from the Method list specific Fluids any method specific fluids will be displayed in the Fluid list Select the desired fluid and click the OK push button Assign the fluid 6 After the above steps the Assign dialog box is displayed Here the ML F A M E operator must select the module where the fluid is stored and dispensed from The container barcode information is entered in the Assign Container Barcode entry field Select the Add push button The fluid is now assigned and ready for loading Exiting the 8 When all desired fluids have been assignment editor assigned select the
181. in printouts and includes Table of non samples i e controls and blanks Table of samples Plate oriented information i e graphical representation of a microplate with the test s data displayed in it 10 2 4 2 Test Documentation Jobs A test documentation job determines where a test documentation format for a specific method is sent All test documentation jobs associated with a method are listed in the Documentation Jobs dialog box In Figure 10 12 a job is shown which sends the docu mentation protocol called Example Doc Format to the device called Printer1 In this case the destination is Printer1 but could be a host computer Documentation Jobs Example ELISA Documentation jobs Documentation formats Devices Example Doc Format Printer1 d Documentation Job Change Documentation formats Devices Host 1 for CamDo Test Host 2 for CamDo Test Host 3 for CamDo Test Start documentation by user Mew Change Delete Figure 10 12 Edit Test Documentation Job Dialog Boxes A default feature of the ML F A M E software allows a method inde pendent documentation job to be executed whenever any test of any method type is finished on the Summit Processor for further information see Cook Book Section 3 1 2 on page 37 10 102 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods 10 2 5 Exiting a Method Exit a met
182. in a Well Given the absorbance of a known volume of solution hand pipet ted wells for dispenser verification wells dispensed by dispenser for washer verification and assuming that the same concentration of the same solution is used the absorbance of an unknown well can be measured to determine the volume of liquid contained in it Assuming that all wells in a plate have the same diameter the absorbance will be proportional to volume of solution The follow ing formula therefore applies V E where V the unknown volume E absorbance of the unknown volume V4 the known volume E absorbance of the known volume P N 610520 02 05 01 14 159 Microlab F A M E User Manual V2 0 14 2 9 A 14 2 9 1 ATTENTION The combined tolerances listed as sources of variation area are accounted for in the user verification acceptance criteria 14 160 Acceptance Criteria Photometer The table below lists examples of nominal OD values for the pho tometer check plate using the standard photometer filters The exact reference values are supplied on diskette with the photome ter check plate units OD Reference Guide ML F A M E Verification Filter Row 4 Row 5 Row 6 Row 7 Row 8 340 nm 1 0 405 nm 0 265 0 580 1 2 2 2 450 nm 0 265 0 540 1 1 2 0 492 nm 0 270 0 550 1 0 2 0 570 nm 0 280 0 560 1 1 2 0 610 nm 0 290 0 565 1 1 2 0 620 nm 0 280 0 540 1 0 1 9
183. iners 8 76 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Maintenance Table 8 1 3 2 Manual Cleaning Weekly Maintenance conrwuen A To Do This ATTENTION Wear gloves as any liquid which Renew sterile filter 24 The sterile filter is connected to the is released from the tube or filter external water separator cap with a may be biohazardous a short piece of the venting tube Replace Ensure that the venting tube at AH the sterile filter at least every six months the sterile filter is free from Au P or as needed based on laboratory kinks by cutting itto an accurate x conditions or testing requirements fit ET ST d P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Maintenance 8 78 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter 9 17 P N 610520 02 05 01 Reference Guide Reference Guide Sections 9 Reference Guide 81 10 ML EA M E 83 11 Daily Work Routine esee 105 12 Test Results amp ML F A M E 129 13 ML EA M E Functions amp Requirements 137 14 ML 147 15 ML FA M E Maintenance
184. iners containing minimum 1 5 NaCl solution deionized water 2 wash fluid containers containing minimum 1 5 of deionized water All configurations Cold Start Plate should already be in extra slot of incubator 2 Spillage Tray P N 610520 02 05 01 15 177 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance 15 1 7 4 Monthly Maintenance Requirements For a step by step guide to the various maintenance procedures see Cook Book Section 8 1 1 on page 70 Specific Items Required for Monthly Maintenance Instrument Item required configuration 16 20 and 16 30 Wash fluid container containing minimum 2 of a suitable disinfectant solution see section 15 1 2 for recommendations Wash fluid container containing minimum 2 I NaCl solution deionized water Wash fluid container containing minimum 1 5 I of deionized water 24 20 and 24 30 2 wash fluid container containing minimum 2 of a suitable disinfectant solution see section 15 1 2 for recommendations 2 wash fluid containers containing minimum 1 5 NaCl solution deionized water 2 wash fluid containers containing minimum 1 5 of deionized water All configurations Cold Start Plate should already be in extra slot of incubator 2 Spillage Tray Possible replacement barcode labels 15 1 7 5 Cleaning the Washer Manifold There are two menu options used to aid the removal and reinstalla tion
185. ing of 24 reagent positions 20 incubation slots 5 modules Instrument configuration consisting of 24 reagent positions 30 incubation slots 6 modules Microlab F A M E Refers to the actual instrument The database where all ML F A M E data methods test results device pre settings etc is stored Actual logged in user identical to actual user operating the ML F A M E or ML F A M E Workstation ML F A M E software See also Login General name of the software package General name for the personal computer running the Microlab F A M E software package Substance to be detected Hole in top of reagent container into which a disposable syringe is placed before the container is loaded into the reagent drawer A button which when pressed causes an immediate stop of all moving instrument parts Personal Computer ML F A M E Workstation without software Device which measures the optical density or transmission of MTP wells A special device the same size as an MTP used for checking the photometer The Plan window is displayed after a successful schedule or simulated schedule in the Work List Manager window and displays a graphical representation on the schedule Synonymous for microplate MTP Short form Barcode The barcode attached to the microplate Used for plate and method identification Device which identifies barcodes on the plates Atool allowing an MTP to be manually removed from
186. ion 16 2 4 2 on page 16 190 16 189 Microlab F A M E User Manual V2 0 16 2 4 16 2 4 1 16 2 4 2 16 2 4 3 16 2 4 4 16 190 Reference Guide Technical Specifications End Module Photometer Number of measuring channels 8 8 wells can be measured simultaneously Number of reference channels 1 Filters supplied as standard with instrument 340 nm 5 total 405 nm 450 nm 492 nm 620 nm Maximum possible number of filters in instrument 8 Wavelength range of additional filters 340 750 nm Linear Measurement range 400 750 nm 0 00 2 5 OD Linear Measurement range 340 400 nm 0 00 2 0 OD Indication range 0 0 2 999 OD Linearity above 400 nm 0 0 1 2 OD 0 005 OD or lt 0 596 whichever is greater 1 2 2 5 0D lt 0 7596 Linearity at 340 nm 0 5 2 0 OD lt 2 596 Precision variation over plate of a pooled material above 400 nm in range 0 1 5 OD 2 096 or 0 005 OD whichever is greater Reproducibility repeat reads of same plate above 400 nm and 1 0 OD lt 0 396 Mixer Mix mode Lengthwise shaking of plate with 3 different intensities and programmable mix time Dispenser See section 16 2 3 on page 16 188 Exit Stack Capacity thickness Approx 10 plates dependent on plate P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Technical Specificat
187. ion of some possible problems relating to indi vidual ML F A M E modules P N 610520 02 05 01 17 209 Microlab F A M E User Manual V2 0 17 2 2 1 Washer Problems Reference Guide Troubleshooting amp Error Handling Symptom Possible Cause Corrective Action Plates are not washed at all External pump station tubings incorrectly connected Check for correct connection of external pump station tubing Blocked aspirating needle An aspirating needle in the manifold is blocked Aspirating needles not bevelled old manifold Dripping from dispensing needles valve by manifold not liquid tight Carry out daily maintenance Clean manifold Renew Manifold Call service technician Blocked dispensing needle A dispensing needle in the manifold is blocked crystallization No wash fluid air dispensed Dispense tubing kinked MTP not in washer dispenser module Sensor PCB is wet or dirty Carry out daily maintenance Clean manifold Refill wash fluid container Ensure that dispense tubing is not kinked Clean sensor PCB PCB under MTP Improper wash liquid dispensing Overfilling of wells during washing Fluid connector switched during wash procedure Insufficient wash fluid Incorrect calibration of module transport dispensing needles dispensing next to wells Incorrect calibration of washer Z drive Carry out daily maintenance Clean mani
188. ion on entry stack Load Plate Do Nothing Strip Check etc First Processing Step Pipette Plate Move Plate to OSP OP Plate Movement Plate Wait Time Time Creation time of barcode file Planed Plate loading Time Plate Stay Time must be lt defined plate hold time Time Stamp time of relevant sample processing step written into the barcode file from the sampler software Figure 10 4 Plate Hold Time O Pipetting Delay The time span between pipetting the first and last well of a plate can be rather large especially for complex sample pipetting sequences To compensate for this difference from the first well pipetted to the last an aver age can be set with this command O First Processing Step This specifies which is to be the first step used in the calculation of the end of the plate hold time See section 10 2 3 2 on page 10 95 1 State This is the Check State of the method and includes NOTE A method that returns warnings Information whether the method information has passed the when checked may still be run checking criteria while a method returning errors O Layout whether the plate dimensions and layout have cannot be run passed the checking criteria O Test Processing whether the method s processing steps NOTE SENE h d the check teria Unless a method has a state of Wed LLL e ery pig Soke pos O Check push button This starts a check of all method elements s OUSE Ne EO against a pre
189. ions 16 3 Barcode Specifications 16 3 1 Plate Barcodes The plate barcode must fit on side A or side B of the plate as shown in Figure 16 1 below The barcode label must meet the following specifications Barcode Label 666660600 60000000 NOTE The barcode label must be par allel to edge of plate 036 871 7 RI TN D 9 12 mm NOTE The barcode label must not pro trude above or below the edge of the plate Figure 16 1 Plate Barcode Positioning P N 610520 02 05 01 16 191 Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications Horizontal Position 1 The label can be positioned anywhere along the whole length of side A or side B The optimum position is in the middle a minimum distance of 10 mm from both edges is required The label must be parallel to the plate edge Label Dimensions Figure 16 2 Barcode Label Dimensions Dimension Min Max Label length 66 mm B Code length 60 mm C1 C2 Quiet zone 3mm D Label width 7mm E Code width 7mm F Distance from code to label edge 1mm Print Quality The barcode print must be of a high quality Offset typographic intaglio and flexographic printing are suitable ATTENTION Mechanical dot matrix and thermomatrix printing are not suitabl
190. ispenser from accessing the reagent carousel ATTENTION During a run the reagent drawers A second switch located behind the drawer handle detects when should only be opened to load the operator attempts to open the drawer and remove reagent containers or carousels when instructed by the ML FA M E software or If a reagent drawer is left open its associated dispenser will be when instructed during an error blocked which may cause tests to be aborted handling procedure and should not be opened for longer than absolutely necessary Do not open drawers while the reagent rotor is rotating If a drawer is opened and closed all reagent containers will be reidentified 17 1 4 7 Wash Rinse Solution Loading Each wash channel has a switch that detects low fluid level in the wash fluid container There is also a sensor that detects the position of the fluid connec tor i e whether it is in the horizontal wash position or the vertical rinse position If there is insufficient fluid in a wash fluid container or if the fluid connector is in the wrong position the washer cannot operate A message will appear on the computer screen informing the ML F A M E operator of this If the appropriate action is not taken in time the plate to be washed will be aborted The rinse container s should be filled up before the start of a run 17 1 4 8 Waste Cap The waste cap contains a liquid level sensor that detects when the waste containe
191. it lot s 32167 pa s kit s kitlot s 32168 NOTE RUN Plate loading finished 32170 NOTE RUN Well identification started 32172 NOTE RUN Well identification finished kit lot s time stamp s 32173 kitlot s time s Appendix 1 234 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages A1 2 3 Well Trace Messages Trace ID Message 14490 NOTE USER Well excluded manually user s Well flag ex 14492 NOTE USER Well trace comment entered by user Well flag tr 16702 NOTE TEST Well flag set to s 16704 NOTE TEST Well barcode set to 5 21528 ERROR CTRL DIS400 well not dispensed location 5 Well flag ex 21532 ERROR CTRL DIS401 well not dispensed location 5 Well flag ex 21536 ERROR CTRL DIS402 well unusable location s Well flag ex 21540 ERROR CTRL DIS402 well not dispensed location s Well flag ex 32180 ERROR RUN Pipetting error from sampler code d Well Flag tr 32182 WARNING RUN Pipetting warning from sampler code d Well Flag tr 32184 ERROR RUN Plate layout error barcode not identical with well s Well Flag tr 32186 WARNING USER Operator included well for processing Well Flag tr 32188 WARNING USER Operator excluded well from processing Well Flag ex 32190 WARNING USER Operator changed well barcode previous s new 5 Well Flag tr 32192 ERROR RUN Invalid measurement OD meas s ref 5 Wel
192. ith methods see Cook Book Section 3 1 1 on page 28 10 1 1 Method Access Rights During the method definition process individual read and write access rights can be established for the method For further infor mation on access rights see Reference Guide Section 13 3 on page 145 Regardless of individual user access rights or the predefined access rights of a particular method it is impossible to perform any operations on methods under the following conditions 1 When a method has been included in a work list that has been scheduled 2 When the Plan window is open 3 Ifthe method is currently being used for a test running on the instrument 10 1 2 General Method Definition Limitations NOTE While editing a method it is not O A maximum of 100 methods can be stored in the database possible to change the logged in ML F A M E operator A method cannot exceed 50 processing steps A maximum of 400 fluids including both method specific and global fluids can be defined in the ML FA M E Software The ML F A M E s method definition supports methods which will provide only the OD optical density values for the samples of a test Further result interpretation must to be carried out externally to the system 10 2 Method Editors The method editors are used to work with methods stored on the ML F A M E database and are divided into five main areas as fol lows O Method Information dialog box is used to define ge
193. ith the system J Software and firmware installation records this form is to be used to record of software installed on the ML F A M E worksta tion i e OS 2 DB2 2 and the ML F A M E software P N 610520 02 05 01 Appendix 5 251 Microlab F A M E User Manual V2 0 Appendix 5 Forms Appendix 5 252 P N 610520 02 05 01 Appendix 5 Forms Microlab F A M E User Manual V2 0 Up 7089 uuo seii Josie dns MOIACY jo uone duuoo uodn oyeudoidde y Jegu saueuaw eyy Jole edas Jojem pue Adwa S pjouueuu ueso jueuunijsul UESIO s ousem mojeg eseq ueso s ijeus use ueso soDuu s pJeosiQq sJeurgjuoo jueDeai ueso eise ueejo pue Adug 1UEWNANSUI ueso s Jaysem mojeq 8seq ueso S jeus use ueso soBuu s PIEOSIA sJeurejuoo 1ueDeai veao sueurejuoo asem Adug Amsam soBuu s ueo o SJourgjuoo jueDeai ueso Sueurjuoo jsem ueep pue Adwa Area LE 0 62 82 46 9g S2 ve EZ ce 1 O2 6L 8 ZL OL SL VE ELI CE LE OL 6 8 7 9 S v EL ec I nus Herre TOU feues JUSLUNISUI Heer UOMeINBYUOO 1ueurnursu mre OU EOS PJOHUEN seem reugeu AIOTeJOge
194. itor seen 90 10 2 2 1 File Men enne 90 10 2 252 Edit Menu uite ee he te e drei ot 91 10 2 2 3 Configuration Menu sese 91 10 2 2 4 Samples Menu sse 93 10 2 3 Test Processing 94 10 2 3 1 Fil MenU 2 3 Zen 95 10 2 3 2 Edit Men d erede 95 10 2 3 3 Steps Menu sse 95 10 2 4 Documentation essere 101 10 2 4 1 Test Documentation Formats 101 10 2 4 2 Test Documentation 102 10 2 5 Exiting a Meth aeneae 103 10 2 6 Method Management Menu Items 108 10 2 6 1 Check ne ea 103 10 2 6 2 BACKUP e oa Lea ended eee TAA KERNAN 108 10 2 6 3 Restore nischen 103 10 2 7 Method 104 Reference Guide ML F A M E Methods 10 83 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods 10 1 Overview A method is a structured group of definitions stored electronically which enables an immunoassay test to be performed on the Micro lab FA M E ML F A M E and includes plate layout information pro cessing steps definitions and documentation criteria for the test For information on working w
195. k section Reagent containers on page 8 74 O Approx duration 5 minutes O Barcode Maintenance O All barcodes used with the ML F A M E should be inspected on a regular basis It is recommended that a brief check be made during monthly maintenance to ensure all barcodes are clean and in a good physical condition If they require replacement attach the new barcode label directly over the existing one Maintenance Requirements Cold Start Maintenance Requirements Before any maintenance procedures can be carried out the instru ment must be initialized see Reference Guide Section 13 2 1 on page 138 For a step by step guide to the various maintenance procedures see Cook Book Section 8 1 1 on page 70 An initialization must also be executed if an unrecoverable error occurs in a maintenance procedure 15 175 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance Specific Items Required for Cold Start Instrument Item required configuration NOTE With instruments containing only 16 20 and 16 30 Wash fluid container containing minimum one washer 16 20 and 24 20 1 5 I of Rinse Solution deionized water only half of the check plate is Wash fluid container containing minimum 1 I filled with fluid during cold start NaCl solution deionized water 24 20 and 24 30 2 wash fluid containers containing minimum 1 5 I of Rinse Solution deionized water 2 wash f
196. kxkkxkkkkkkkkxkxkxkxkxkkxkxkkkxkxkxkxkxkxkkkxkkxkxkxkxkxkkkkkkkkxx k Description Send the file path and name passed in with parameter 1 and 2 to a remote network resource utilizing a simple copy command KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK Assume that a user is already logged on to the network If not logon to the network here KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK Open the network resource to use if not automatically assigned during logon KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK net use t hostres if errorlevel 1 goto nosuccess KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK copy the file to the network drive t KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK copy 1 2 t v if errorlevel 1 goto nosuccess KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK confirm successful transmission to FAME software KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK fam_rtc 2 0 KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK Start an application on your Host to tell your Host application that a result file was sent KKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKKK net run t pick_res 2 goto delres KKKKKKKKKKKKKKKKKKKKKKKKKKKK
197. l Flag tr 32194 ERROR RUN Invalid reference OD meas s ref s Well Flag tr 32196 ERROR RUN Absolute OD limit exceeded meas s ref s blank corr s calc OD 4 3f abs limits 4 31 4 3f Well Flag tr 32198 ERROR RUN Deviation from median exceeded meas s ref s blank corr s median s calc OD 96 4 3f dev limits s s Well Flag tr P N 610520 02 05 01 Appendix 1 235 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages Appendix 1 236 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 2 Access LEVEL ACCESS RIGHT ACTION LIST ARCHIVE AsPIRATING NEEDLE ASTM FORMAT BARCODE MASK BARCODE SCANNER BASE TIME CAG AG COATING CHASSIS CHASSIS EXPANSION CHECK PLATE COLD START COMPETITIVE TEST CONJUGATE CONTAINER STACK CONTROL DEVICE DISPENSER DISPENSER END MODULE P N 610520 02 05 01 Appendix 2 Glossary Glossary Right for using different functions of the user software e g reading editing etc The specific access right needed to carry out a certain function with the user software A list of instructions generated by the user software which gives all the steps that the user has to carry out during the execution of a work list this information can only be printed i e it can not be viewed from within the Work List Manager A long term store of test data Will not be done by
198. l Update Information User Manual Update Information A7 1 Modification List Date of Change Revision Description of Change 04 99 02 This user manual is valid for software Version 2 0 or higher until an newer revision is released or informed otherwise Appendix 7 263 Microlab F A M E User Manual V2 0 Appendix 7 User Manual Update Information Appendix 7 264 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 8 Index Appendix 8 Index A Access Level 237 Access Right 237 Access Rights 145 Action List 107 237 Archive 237 Archiving Test Data 134 Aspirate Speed 98 Aspirating Needle 237 Aspiration Height 97 Assigning Control well types 31 ASTM Format 237 Barcode Maintenance 175 Barcode Mask 87 237 forbidden characters 87 number of characters 87 wildcard characters 87 Barcode Specifications 191 Barcodes plate 191 reagent container 193 Base Time 237 Bottom Sweep 97 Bottom Wash 97 CAg Ag Coating 92 CAg Ag Coating 237 Change Lock Status 139 Chassis 237 Chassis Expansion 237 Check Plate 237 Circuit Breaker Ratings 185 Cleaning Reagent Containers 74 Cold Start 237 P N 610520 02 05 01 Appendix 8 265 Microlab F A M E User Manual V2 0 Appendix 8 Index Collision Free Position 205 Competitive Test 237 Conjugate 237 Container Stack 237 Continuous Wash 97 Control 237 Database 133 Decontaminate 172
199. l V2 0 Reference Guide ML F A M E Methods Examples of valid barcodes v HP12222xxxx AB v Examples of invalid plate barcodes X ABC D Wildcard separated by another character X Wildcard separated by wildcard X 50 Contains character not allowed 96 X Consists exclusively of wildcards X ABC and AB Barcode mask not unique E Uer that print their own bar Barcode Mask Barcode Label codes please See section 16 3 on page 16 191 forfurther z 29229 information Z 02581 222222 ABC 567 TII ABC000121 HAM ME PIE Ham 210 HAM THE UT EE 211 VLR VOTE PU HMM xv21211K100 Figure 10 3 Barcode Masks and their Corresponding Barcode Labels Access Levels O Read Access This specifies the access level a user must have to be able to open the method O Write Access This specifies the access level a user must have to be able to edit or modifying the method 10 88 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods O Test Processing Information O Plate Hold Time Maximum time between the time stamp from the barcode file and the First processing step defined in the Method This time frame will be checked by the ML F A M E software and if exceeded the plate will be rejected Prepare Plate and cold incubat
200. l com puter PC to the specification listed in section 1 3 2 1 en la p gina 1 9 running the IBM operating system OS 2 WARP with IBM s DB2 2 and version 2 0 of the ML F A M E software The Computer The specification of the personal computer required for use with the ML FA M E is listed in Reference Guide Section 16 4 on page 196 and it is highly recommended to use a system as similar as possible The Operating System An operating system is a software application allowing the system operator to access installed software and to write and read infor mation to a storage device i e floppy or fixed disk This software application has been designed and created to run with IBM s OS 2 operating system WARP It also utilizes IBM s data storage retrieval system DB2 2 OS 2 is a Graphic User Interface GUI operating environment which means the ML F A M E operator can access the required functions using an object oriented control method i e to access a function the ML F A M E operator will physically select the com mand for that function using a pointing device e g a mouse For further information on using OS 2 and DB2 2 please consult the supplier or the documentation supplied with the product Microlab F A M E User Manual V2 0 1 3 2 3 NOTE The standard Microlab FA M E software does not include the Active Kit Lot Check and Sample and Reagent Addition Monitoring SRAM features If Hamilton users need these features
201. lace syringe in container with barcode lt s gt at position d before next aspiration DIS800 1 Power interruption detected Please inform your instrument supplier and include the system trace Program will continue DIS801 1 Power failure in ventilation system Please inform your instrument supplier and include the system trace Program will continue DIS805 1 Reagent drawer locked due to an operation in dispenser Please wait until operation is finished DIS902 1 Module transport failure Move the module transport manually into the module Press OK if manual intervention was successful otherwise press IGNORE DIS905 1 Syringe stuck in dispenser head Danger Do not try to remove syringe P N 610520 02 05 01 Appendix 1 221 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages A1 1 4 Incubator Errors DiALOG ID MESSAGE INC100 1 Couldn t pre initialize the Front Tower Lift Move the Front Tower manually into a collision free position Press OK after successful manual intervention INC100 2 Could not pre initialize the Front Tower Lift Move the Module Transport manually to the Main Shuttle and lower the Front Tower to the bottom position Press OK if your intervention was successful else press Ignore INC110 1 Couldn t pre initialize or initialize the Rear Tower Lift Move the Rear Tower manually into a collision free position Press OK after succe
202. ld not stack Plate error code d location s 17010 ERROR CTRL TRP330 still holding Plate on Manipulation Position again error code d location 5 17500 NOTE MAINT Cold Start maintenance status 5 17501 maint c 17502 NOTE MAINT Daily maintenance status s 17503 maint c 17504 NOTE MAINT Weekly maintenance status s 17505 maint c 17506 NOTE MAINT Monthly maintenance status s 17507 maint c 19500 ERROR CTRL INC300 Module Transport step lost error code d location s 19502 ERROR CTRL INC310 Front Tower Lift step lost error code d location s 19504 ERROR CTRL INC330 Entry Lift step lost error code d location 5 19506 ERROR CTRL INC350 Module Transport step lost error code d location s 19508 ERROR CTRL INC351 Front Tower Lift step lost error code d location s 19510 ERROR CTRL INC370 Module Transport step lost error code d location s 19512 ERROR CTRL INC371 Front Tower Lift step lost error code d location s 19514 ERROR CTRL INC372 Rear Tower Lift step lost error code d location 5 Appendix 1 228 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 19516 19518 19520 19522 19524 19526 19528 19530 19532 19534 19536 20000 20002 20004 20006 20008 20010 20012 21500 21502 21504 21505 21506 21508 21510 21512 21513 Appendi
203. le like material used for evaluation and validation of qualitative and semi quantitative assays An external piece of equipment used together with the ML F A M E Short form Disp Device which picks up a syringe and dispenses accurate volumes of liquid into an MTP Short form Dispenser End or Disp End Part of the End Module that picks up a syringe and dispenses accurate volumes of liquid into an MTP Appendix 2 237 Microlab F A M E User Manual V2 0 DISPENSER WASHER DiSP MODULE 1 DISPENSER WASHER DiSP MODULE 2 DISPENSING NEEDLE DISPLAY PRIORITY DISPOSABLE SYRINGE DISPOSABLE TIP BARREL DOCUMENTATION DEFINITION DOCUMENTATION FORMAT DOCUMENTATION JOB DOCUMENT TEST DROP DOWN LIST EDITOR ELISA ENTRY LIFT ENTRY PLATFORM ENTRY SECTION ENTRY STACK ERROR STATUS EXIT LIFT Exit STACK EXTERNAL PUMP STATION EXTERNAL WATER SEPARATOR EXTRA SLOT FILE LINK FILTER CASE Appendix 2 238 Short form Dispenser 1 Part of Washer Disp Module 1 that picks up a syringe and dispenses accurate volumes of liquid into an MTP Short form Dispenser 2 Part of Washer Disp Module 2 that picks up a syringe and dispenses accurate volumes of liquid into an MTP The needle that dispenses wash fluid into a well The shorter needle in the washer manifold A precedence level that determines which priority of trace message is displayed printed Syringe used by dispenser for pipetting reagent into well
204. les to stand in an upright position with the guidelines of Good Lab overnight 11 Examine the syringe for the overnight more details refer to your reagent manufacturer for an approved syringe cleaning pro cedure formation of air bubbles gt 1 cm Any such air bubbles indicate a faulty syringe 12 Empty the syringe before reusing ATTENTION Never pull the plunger completely out of the syringe this damages the syringe 8 74 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 NOTE Do not use liquids containing pro pyl alcohol to clean the trans parent cover or exit stack as they will cause stain the sur faces P N 610520 02 05 01 Cook Book ML F A M E Maintenance If syringes are used for more than one run dedicate each syringe to a specific reagent Mark each syringe clearly with the name of the reagent for which it is intended Some reagents may require the use of a new syringe every day Check with the reagent manufacturer s recommendations specific to each assay and reagent Table 8 1 3 2 Manual Cleaning Weekly Maintenance To Do This Washer manifold Clean instrument 2 housing entry lift entry stack and plate transport system Transparent cover 3 and exit stack 4 5 6 Washer dispenser 8 areas 9 Photometer area 10 Remove and clean the washer manifold if the needles are blocked otherwise every mont
205. lled incubation O The temperature deviations of the target temperature or of the reported temperature are compared with the check plate temperature O Ambient incubation O The check plate temperature and the reported temperature are compared with the ambient temperature range P N 610520 02 05 01 14 157 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 2 5 Statistical Definitions Used for Verification Mean x number of values x the if value gt 3 Standard Deviation s number of values the i value where n Xi Precision Coefficient of variation CV CV 100 RII Accuracy R For the washer and dispenser the following formula applies X X R 100 X measured as a percentage 96 where x target value For the photometer the following formula applies R An X measured in O D where Xm measured value X reference value 14 2 6 Absorbance Calculation E E e c d where coefficient of absorbance concentration d distance thickness of medium 14 158 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 2 7 Volume Calculation V Assuming a cylindrical well V nr r h where r well radius h liquid height in this case d in the absorbance for mula 14 2 8 General Calculation Principles Calculating the Volume of Liquid
206. luid containers containing minimum 11 NaCl solution deionized water All configurations Cold Start Plate Barcode Cold Start 0000 should already be in the extra slot of incubator 2 15 1 7 2 Daily Maintenance Requirements NOTE Daily maintenance must be carried out every day before the sys day daily maintenance should be carried out at least once a For a step by step guide to the various maintenance procedures day see Cook Book Section 8 1 1 on page 70 Specific Items Required for Daily Maintenance Instrument Item required configuration 16 20 and 16 30 Wash fluid container containing minimum 1 5 of deionized water 24 20 and 24 30 2 wash fluid containers containing minimum 1 5 I of deionized water 15 176 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance 15 1 7 3 Weekly Maintenance Requirements For a step by step guide to the various maintenance procedures see Cook Book Section on page 70 Specific Items Required for Weekly Maintenance Instrument Item required configuration 16 20 and 16 30 Wash fluid container containing minimum 1 5 Disinfectant at 50 Wash fluid container containing minimum 1 5 NaCl solution deionized water Wash fluid container containing minimum 1 5 of deionized water 24 20 and 24 30 2 wash fluid container containing minimum 1 5 Disinfectant at 50 C 2 wash fluid conta
207. method 67 gt Once the processing definition is completed the method must be checked for errors in the test processing definition 68 Select Check Layout And Processing Definition from the File menu to check the layout and test processing definition NOTE A method that returns warnings 69 If errors were found in the layout or when checked may still be run processing definition the ML F A M E while a method returning errors operator will be prompted as to the will prevent the method being type of error and its location run 70 Once these errors have been corrected re check the method until no errors are returned Defining the first 71 From the Edit menu select the Select processing step First Processing Step menu choice A dialog box will be displayed allowing the ML F A M E operator to select the step number that will be addressed first in the run process which defines the end of the plate hold time Save method 72 From the File menu select the Save menu choice and the method is saved in the data base under the name entered in the beginning of the definition in this case Example ELISA This completes the test processing method definition 3 36 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods 3 1 2 Documenting a Test Run Information generated by a test run can be handled in a number of ways These are called
208. mitations Run Status Processed Error Status Aborted ERROR RUN Test aborted due to plate not loaded by user Run Status Processed Error Status Aborted ERROR CTRL DIS301 module transport step lost error code d location s ERROR CTRL DIS302 module transport step lost error code d location s ERROR CTRL DIS303 shaking time was reduced by ld seconds location s Error Status Error loc s sec ld err d ERROR CTRL DIS303 module transport step lost error code d location s ERROR CTRL DIS371 dispenser z drive step lost error code d location s ERROR CTRL DIS373 dispensing drive step lost error code d location s ERROR CTRL DIS377 aspiration approved as valid by the operator location s Error Status Error loc 96s err 96d Appendix 1 229 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages 21514 ERROR CTRL DIS377 improper aspiration error code d location 5 Error Status Error 21516 ERROR CTRL DIS378 liquid level detection defective error code d location s 21518 ERROR CTRL DIS382 liquid level detection defective error code d location s 21520 ERROR CTRL DIS383 no liquid detected error code d location 5 21522 ERROR CTRL DIS384 dispenser rotor drive step lost error code d location s 21524 ERROR CTRL DIS390 dispenser x drive ste
209. must then select a well from the graphical display then the Insert Well Comment push button 9 A dialog box is displayed allowing the entry of up to 80 characters 10 Select the Save push button to confirm the message Test messages 11 The procedure for inserting a test trace is the same as the well trace but without step 8 above 5 60 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Test Results amp ML F A M E Traces Table 5 2 1 1 The Trace Window To Do This System messages 12 To insert a system trace select the Insert System Comment menu choice from the Edit menu 13 A dialog box is displayed allowing the entry of up to 80 characters 14 Select the Save push button to confirm the message Deleting system 15 From the Edit menu select the Delete Traces System Traces menu choice 16 A dialog box is displayed where the ML F A M E operator is asked to select a date All system traces recorded before this date will be erased from the ML F A M E database gt Viewing a well 17 From the View menu select the Well trace Trace menu choice A dialog box is displayed where the ML F A M E operator must select the Test containing the required well 18 Once a test has been selected the ML F A M E operator must then select a well from the graphical display then the View Well Trace push button 19 The trac
210. n Vertical Strip Direction Vertical Filling Direction Vertical Filling Direction Vertical Replica Number 2 Replica Number 2 Replica Direction Horizontal Replica Direction Vertical PTO ee 1006880868 dO C OEJE EE EE do EE E ED EA EDED EX EXE EYED SD Strip Direction Vertical Strip Direction Horizontal Filling Direction Horizontal Filling Direction Horizontal Replica Number 2 Replica Number 2 Replica Direction Vertical Replica Direction Horizontal Figure 10 8 Example Sample Layouts Before exiting the layout editor all unused well types must be deleted For instance if no NC well types are used in the layout all reference to this well type must be deleted using the delete func tion in the Edit menu P N 610520 02 05 01 10 93 Microlab F A M E User Manual V2 0 NOTE Sample wells that are not pipetted by the Microlab AT Microlab ATplus 2 will be flagged as not pipetted and will not be pro cessed by the ML F A M E 10 2 3 Reference Guide ML F A M E Methods Defining an Error Free Plate Layout Compatible with Microlab AT ATplus 2 If a Microlab AT or Microlab ATplus 2 is being used for plate sample distribution and the barcode files are transferred to the ML FA M E workstation the following points should be considered when defin ing the plate layout CJ Define the location of controls as they are pipetted in the Sun rise Sunplus definition
211. n nena nea en ee 170 15 1 1 When to run Maintenance Procedures 170 15 1 2 What is Required for Maintenance 170 15 1 3 The Maintenance 171 15 1 4 Menu ChoiceS eene 171 15 1 5 Maintenance Statuses 172 15 1 6 Maintenance Procedures 173 15 1 7 Maintenance Requirements 175 15 1 8 Washer Decontamination 180 15 1 9 Incubator Decontamination 181 Reference Guide ML F A M E Maintenance 15 169 Microlab F A M E User Manual V2 0 15 1 15 1 1 NOTE If the ML F A M E operator declines to run either weekly or monthly maintenance before shut down upon the next initial ization these routines must be run If three weekly maintenance procedures have been run in a month the forth can be skipped only if the monthly procedure is run as all required procedures are covered in the monthly maintenance procedure 15 1 2 NOTE Use cleaning disinfecting and decontaminating fluids in accor dance with manufacturers instructions Do not use disinfecting materi als which contain hypochlorite Javelle water Chlorox or bleaching fluids NOTE Prepare disi
212. n not successful due to improper aspiration or dispensing of wash fluid Check Wash Fluid and Waste Fluid Tubing for bends or kinks and adjust if necessary Press OK to continue WAS450 1 No communication RS232 to external Pump Station Check cable to external Pump Station for connection Press OK if your manual intervention was successful else press Ignore WAS500 1 Waste Cap must be on Waste Container Place Waste Cap on Waste Container Pressing Ignore will abort function WAS510 1 Waste Container full Empty Waste Container immediately Pressing Ignore will abort function WAS530 1 Waste Container full while function running Empty Waste Container first function will continue with disconnected waste cap Pressing Ignore will abort function WAS542 1 Insufficient liquid in Fluid Container 96d Refill Fluid Container d immediately Pressing Ignore will abort function WAS552 1 Fluid Connector of Container d not in rinse vertical position Connect Fluid Container d to rinse vertical position Pressing Ignore will abort function WAS554 1 Container with Rinse fluid not on position 96d Load Container with Rinse fluid on position 96d Press OK when Rinse fluid loaded Pressing Ignore will abort function WAS560 1 Waste Container almost full Empty Waste Container WAS562 1 Waste Container full Do not put the Waste Cap on a full Waste Container Empty Waste Container first WAS564 1 Flui
213. name OCD 01 and a preparation time of 10 mins Confirm this with the OK push button and the new fluid will appear in the display of the Edit Global Fluids dialog box P N 610520 02 05 01 Cook Book ML F A M E Methods Microlab F A M E User Manual V2 0 Table 3 1 1 1 Method Definition Process contmueo Cook Book ML F A M E Methods To Do This NOTE In this example no wash options are selected To select a wash option select the Wash Options push button addi tional wash options include Continuous wash Bottom wash Bottom sweep and Pump power see Reference Guide Section 10 2 3 3 on page 95 Dispense Define method specific fluid NOTE For method specific reagents it is recommended to include the method name as part of the reagent name to make barcode assignment easier during a run P N 610520 02 05 01 92 Return to the Test Processing Editor Wash dialog box by selecting the Close push button 33 Select the new wash solution from the drop down list Enter the required wash dispense volume or select it from the drop down list In this example 370 ul then the Number of Cycles 5 in this example Soak Time 20 sec and Aspiration Height 0 3 mm 94 To enter this step in the test process definition select the OK push button 95 From the Steps menu select the Dispense menu choice 96 Before the Dispense step can be
214. nce Guide Troubleshooting amp Error Handling Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 1 Error Handling The user software contains error handling procedures which enable problems to be rectified without necessarily aborting plates If the user software encounters a problem it tries to rectify the problem in one of the following ways A O Automatically without operator intervention ATTENTION Error handling instructions should O By issuing instructions to the operator via an error handling be carried out as quickly as message dialog If the instructions are followed the error can possible to prevent plates from usually be rectified being aborted 17 1 1 Example Error Handling Message Dialog Boxes Typically error dialogs contain the following items O Error ID at top of dialog O Description of the error O The test plate affected O The actions required of the operator to rectify the error O A number of buttons allowing the operator to choose how to continue 17 1 2 Warning Dialog Boxes NOTE Warning dialogs have no associ Warning Dialog Boxes appear before an error occurs If the instruc ated ID number tions given are carried out the error will be prevented 17 1 3 Handling of System Deadlocks If a system deadlock System error Detected occurs during a run and plates are still in the instrument or syringes are held in the dis penser
215. neral method information and is the first step in the method definition 10 84 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods O Layout Editor used to define plate dimensions and sample layout and arrangement O Test Processing Editor used to define test processing steps O Documentation used to define documentation criteria O Barcode Mask dialog box used to establish a barcode mask Method Information Method Information Example ELISA Created by O FARRELL Date 1997 03 12 Modified by JOHN O FARRELL Date 1997 08 26 Versione vor M Code 074834 Method information Access levels Manufacturer Example Company Parameter fps Read access 2 0 6 Barcode mask MOUUHWWWNT xxxx Write access 0 9 Test processing information Plate hold time Pipetting dela First processing step 3 min 5 min 2 State Comment Method Information i Layout J Test processing OK J 2 ox mex Layout Editor Test Processing Editor Layout Editor Example ELISA tle Edi Configuration Samples Plate preparation time is 10min K 25 Sample and reagent addition monitoring normal mode with 450nm measuring filter lt 37 Incubate at 37 1 deg C heating up fast for 30 Smin lt 4 Wash wash mode plate wash wash solution 0051 01 wash dispense volume 370pl
216. nfectant fluids according to their labelling 15 170 Overview The ML F A M E requires a number of periodic maintenance rou tines to be run in order to ensure safe and reliable operation These maintenance routines are mandatory and without their com pletion no tests are processable on the ML E A M E When to run Maintenance Procedures Cold Start must be run after the first ML F A M E initialization of the day or after every 24 hours of operation CJ Daily before ML F A M E shut down if it has not been run for one day O Weekly before ML F A M E shut down if it has not been run for one week O Monthly before ML F A M E shut down if it has not been run for one month When any maintenance routine is required it is not possible to per form tests What is Required for Maintenance Disposable latex gloves Protective glasses Lab coat Paper towels Ethanol 7096 Rinse solution Deionized water NaCl solution Deionized water containing 0 5 9 1 NaCl Ultrasonic bath optional Oo 0 0 0 aua QO Disinfectant Microlab Detergent and Disinfectant or Microcide SQ only available in the USA u Microlab Disinfectant Spray P N 610520 02 05 01 Reference Guide ML F A M E Maintenance Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance 15 1 3 The Maintenance Window Maintenance a 0081 File Procedure Extras Instrument Instrum
217. nformation Required To Program A Method Conr nueo 2 10 11 12 13 P N 610520 02 05 01 Pipette controls and samples as follows A1 Substrate Blank BL B1 C1 amp D1 100 ul Negative Control NC E1 amp F1 100 ul Positive Control PC G1 amp H1 keep empty z Pipette all remaining wells with 100 ul of the SAmples to be tested SRAM measuring filter 450 nm see Reference Guide Section 10 2 3 3 on page 95 for further information on this step Place the plate in the incubator as soon as possible max 30 min after completion of the sample distribution step Incubate at 37 1 C for 30 5 min Wash plate 5 times completely aspirate the liquid from all wells and fill the wells with 370 ul of wash solution The washing solution should be allowed to remain for 20 seconds in the wells before being removed Dispense 200 yl of the substrate solution into each well SRAM measuring filter 450 nm Incubate the plate at room temperature for 30 2 min Reidentify the plate Stop the reaction by adding 50 ul 2 mol l sulphuric acid to each well Shake the plate for 10 seconds Read the optical density at 492 nm with 620 nm as the reference wavelength Cook Book ML F A M E Methods 3 29 Microlab F A M E User Manual V2 0 NOTE The Barcode Mask see Refer ence Guide Section 10 2 1 on page 86 must be unique and must correspond exactly to the barcodes
218. nifold Maintenance window select the Insert Manifold menu choice then the required Washer sub menu choice Follow the on screen instructions for the safe removal of the manifold 8 72 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 NOTE Ensure the connector board at the back of the manifold the nee dles the fluid connections and the bottom edge of the manifold coupling are completely dry before reinstallation Wet the manifold coupling O rings using a paper towel soaked in deion ized water P N 610520 02 05 01 Cook Book ML F A M E Maintenance Table 8 1 2 1 Remove Wash and Install Washer Manifold To Do This 20 Slide the manifold onto its guide rods and tighten the knurled screw until solid resistance is met between 11 and 14 revolutions Location of manifold coupling O rings Xs D ux M Dr 4 Connector board manifold fluid connections and bottom n edge of manifold coupling Manifold must be completely dry before manifold is reinstalled 8 73 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Maintenance 8 1 3 Manual Maintenance Procedures AN Table 8 1 3 1 Manual Cleaning Daily Maintenance ATTENTION Do not clean the instrument in the To Do This vicinity of naked flames or devices which could create Waste containers Fill the contaminated waste container sparks Do not use hot air with
219. ns Connector 240 Mains Switch 240 Maintenance 169 general items required 170 Maintenance Procedures 173 Every Day 173 Every Month 175 Every Week 174 Maintenance Requirements 175 Manifold 240 Manifold Cleaning ultrasonic bath method 72 Manifold Cleaning Set 179 Manifold Holder 240 Manipulation Position 240 Measurement Wavelength 9 Measuring Filter 35 Measuring Filter Wavelength 100 Menu Bar 240 Method 240 Method Information dialog box 84 Method Management 103 backup 103 Appendix 8 Index Appendix 8 269 Microlab F A M E User Manual V2 0 Appendix 8 Index restore 103 Method Security Code M code 86 Method Verification 104 Methods 83 exiting of 103 organization of 84 overview 84 processing steps 95 test processing editor 94 Mix mix time 35 Mix Intensity 100 Mix Menu 100 Mix Step intensity 100 time 100 Mix Time 100 Mixer 240 Modification List 263 Module 240 Module Specifications 187 Module Transport 240 MTP 240 MTP Barcode 240 MTP Barcode Reader 240 MTP Transporter 240 N Number of Wash Cycles 96 0 OD 241 Operating Temperature Range 186 Operator 241 Ordering Information 13 Organization of Methods 84 P P N 242 Parameter 241 Parked Position 24 1 Appendix 8 270 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 Appendix 8 Index Pause Button 241 PC 241 PC Requirements 196 optional requirements 196 Photometer 8 241 filters
220. nt tower is used for ambient temperature incubation only The rear tower is used for ambient temperature or for temperature controlled incubation The temperature can be set between ambient and 45 C A plate can be loaded individually into each slot Power Distribution The power supply for all the modules is built into the Entry Module The mains power connector and the on off switch are located on the left hand side of this module towards the rear The primary and secondary protection switches circuit breakers and the voltage selector switch 230 115V are also located in this area behind the instrument side panel Incubator Module The Incubator Module contains two temperature controlled incuba tor towers each with 5 incubation slots The temperature of both towers is programmable up to 70 C max imum allowed temperature difference between the two towers 25 An individual plate can be loaded into each incubator slot Washer Dispenser Module The main functions of the Washer Dispenser Module are O Plate washing O Dispensing of reagents O Mixing shaking of plates Washer Dispenser Modules consist of the following components Washer The washer comprises a 24 channel manifold consisting of 3 rows of 8 needles Each of the 24 wells is washed simultaneously An adjustment of the manifold liquid level detection system is exe cuted automatically during every cold start of the system Each needle ha
221. ntervention was successful else press Ignore WAS349 1 Vacuum Pump OVERLOAD Check Waste Tubing for bends or kinks and adjust if necessary Check Sterile Filter Press OK if your manual intervention was successful else press Ignore WAS360 1 Water Separator overflow during wash procedure Check Waste Tubing or Waste Container disconnected and correct if necessary Press OK if your manual intervention was successful else press Ignore WAS366 1 DO NOT OPEN Fluid Connector while wash procedure running Connect Fluid Container d to wash horizontal position immediately Press OK if Fluid Connector already on wash position Pressing Ignore will abort wash function WAS368 1 Dispense Pump OVERLOAD during wash procedure Check Wash Fluid Tubing for bends or kinks and adjust if necessary Press OK if your manual intervention was successful else press Ignore WAS370 1 Vacuum Pump OVERLOAD during wash procedure Check Waste Tubing for bends of kinks and adjust if necessary Press OK if your manual intervention was successful else press Ignore WAS372 1 No communication RS232 to external pump station Check cable to external Pump Station for connection Press OK if your manual intervention was successful else press Ignore Appendix 1 224 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages DIALOG ID MESSAGE WAS380 1 Plate wash operatio
222. ntry stack loaded onto the entry lift Refers to the date and time at which an MTP was loaded into the instrument List of expected tests and test series with restrictions given by the operator start times position of wash solutions Device which locks the reagent drawer while the dispensing head is in the reagent drawer The state of availability of an instrument function for use in runs Can be either locked not available for use or unlocked available for use Instrument functions may become locked due to an error or a fault Act of gaining access to the ML F A M E software with the related access rights via user name and password Operator user name Act of departing from the program Production batch number of a test kit or parts thereof An electrical socket on the instrument into which the mains electricity supply is connected Device which moves MTPs from module to module including the possibility to read the MTP barcode Device that guides the main shuttle from module to module An electrical switch on the instrument which connects disconnects the instrument to from the mains electricity supply Removable part of washer that aspirates fluid from the MTP and dispenses the wash fluid into the MTP Component to which the manifold is attached Position in the exit stack allowing the removal of one MTP for further external processing The current method security code of a method An area at the top of
223. nts 11 116 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 NOTE 11 6 11 6 1 Assigning several container bar codes for each fluid will make the daily operation easier P N 610520 02 05 01 11 6 2 Reference Guide Daily Work Routine There are two ways to handle fluids while processing a run O Reservation of fluid container barcodes for the different fluids prior to the run using the Assignment Editor O Assignment of fluid container barcodes during the run during fluid loading steps Assignment Editor The assignment editor is accessible via the Work pull down menu in the Main ML FA M E window This editor is used to reserve con tainer barcodes for predefined methods and modules Fluid Container Barcode Reservation It is possible to define several container barcodes for each fluid however each container barcode must be unique i e it is not pos sible to use identical container barcode assignments for several different fluids In a similar fashion the user can remove previously assigned con tainer barcodes from the assignment table e g when no longer using a particular method Reserved Bar Codes There are 4 barcodes that are reserved by the ML FA M E software for service containers these are Reagent Containers O REAGENT 46 00 O REAGENT 47 00 O REAGENT 48 00 i e three minus signs dashes Wash Container Slots O Cont 1 Cont 2 to Cont 8 Rinse Fluid
224. nual V2 0 Reference Guide Daily Work Routine When a stack type is inserted into the work list the following defaults are applied J Earliest Start Time For The Stack Initially the default start time of a stack is set to the actual time of day 20 minutes If an earliest start time has been previously defined it is used as default for each inserted stack NOTE Kit lot changes are only allowed O Kit Lot If one kit lot has been assigned to the methods of the before scheduling is started An stack this kit lot is used as the default If several kit lots are Error Message will inform the assigned for a method the operator must select the individual ML F A M E operator if method s kit lot If no valid kit lot has been assigned the kit lot changes of the kit lots are not field for the method in the Work List window remains empty allowed A stack type name preceded with x indicates that a method asso ciated with that stack type is unchecked Work lists containing these stack types cannot be executed 11 3 2 Scheduling a Work List When the work list definition has been completed it is then possible to create a schedule of events For a step by step guide to scheduling a work list see Cook Book Section 4 1 4 on page 45 During the calculation a progress indicator will display the status of the calculation If the scheduling was successful the resulting plan is displayed in the Plan Window which becomes the active
225. odes Figure 13 3 The Device Presettings window This window allows ML F A M E operators with sufficient access rights see Reference Guide Section 13 3 on page 145 to create or change the attribute settings of devices used by the ML FA M E O Device Menu O New This menu choice contains sub menu choices allow ing the ML FA M E operator to create new Instruments Printers Host computers and Samplers Attention must be paid when defining new devices to the specific information required e g when defining a new printer the physical name ofthe printer must be entered exactly as it is defined in the OS 2 system environment i e if the name is listed in all upper case letters then it must be defined in the ML F A M E software in the same case O Change The Change menu choice allows the ML F A M E operator to modify the attributes of the device selected in the Device Presettings window O Delete Removes the selected device from the ML F A M E database O Connected Instrument Menu options may vary due to config uration O View Configuration displays the currently connected instru ment s configuration O View Filters displays the currently connected instrument s installed photometric filters O Entry Module dialog box allowing the temperature of the rear tower front tower is always ambient of this module to be set P N 610520 02 05 01 13 141 Microlab F A M E User Manual V2 0
226. og box remains on the screen and the error message plate aborted does not appear However if he does eventually load the plate it may be aborted on entering the instrument as the other time parameters have been exceeded 959 The provided runende at and runende sp program A Contact Hamilton and order the new version switche erroneously during data transfer via LAN E2 5 of runende at runende sp from the AT BARCO 999 file to AT BARCO 000 B Alternatively delete the content of the barcode instead of AT BARCO 001 file directory e g h transfer and copy the The Barcode file 000 can not be read by the following files from the Sunrise directory to host the remote directory register ini regneu ini In the barcode file remote directory rename the copied files as follow register ini gt register inf regneu ini gt regneu inf A4 3 Anomalies without Instrument Running ANOMALY ID DESCRIPTION WORK AROUND SOLUTION 900 While instrument status window is open view Do not switch off the instrument under the above mentioned conditions Appendix 4 250 P N 610520 02 05 01 Appendix 4 Anomalies Microlab F A M E User Manual V2 0 Appendix 5 Forms Appendix 5 Forms This appendix containes the following forms Maintenance log form this is to be used for recording details of maintenance carried out on the ML F A M E CJ Problem report form this form is used to report any problems encountered w
227. oices O File Menu Print View Prints the information displayed in the current view on the OS 2 default printer O Print Details Prints detailed information on the selected module O Print All Details Prints detailed information on all modules O Abort Verification Run Aborts the current Verification runs O Close Alt F4 It is not possible to close the Verification window while a verification run is active Select the Abort Verification Run choice before selecting this option O View Menu O Actual Verification Statuses Displays a list of all verifiable modules their sub modules and their current status O Previous Verification Statuses Displays a list of all verifiable modules their sub modules and their status prior to the most recent verification run O Before Previous Verification Statuses Displays a list of all verifiable modules their sub modules and their status prior to the previous verification run O Validation Statuses Displays the validity status and expiry date of the elements and logged data of the verification kit O Procedure Menu All sub menu choices will initiate the verification procedure for the applicable ML F A M E module O Evaluation Menu All sub menu choices will displays a dialog box giving informa tion on the complete verification run of the applicable module CJ Validation Menu Before any verification procedures can be started the informa tion required here must be entered It
228. old and do not dry or store at temperatures gt 50 C Clean the washer manifold Cleaning Aspirating Dispensing Needle Insert cleaning stick into aspirating needle and slide in and out P N 610520 02 05 01 10 1 From the Extras menu in the Maintenance window select the Remove Manifold menu choice then the required Washer sub menu choice The selected manifold will then be lowered into the removal position 3 Release knurled screw on the front of the manifold 4 Withdraw the manifold from its guide rods 5 Remove the cap from the manifold 6 Remove the plugs from the manifold once a month Use the 3 mm allen Screw driver to push the plugs through the manifold bores 1 Soak the manifold the cap and the plugs in a solution of Microlab Detergent and Disinfectant please see the product data sheet for further information Do not immerse the connector board see left 8 Clean the manifold bores using the brush supplied with the manifold cleaning kit and warm tap water 9 Use the cleaning sticks in the mechanical kit only if needles are totally blocked Using these sticks could damage the inner part of the needles If itis necessary to solute obstructions clean the manifold in an ultrasonic bath 11 After the above procedures rinse all items with deionized water 8 71 Microlab F A M E User Manual V2 0 Cook Book M
229. on 5 ERROR CTRL WAS372 no communication to external Pump Station error code d location 5 ERROR CTRL WAS380 improper Wash Fluid aspirating or dispensing error code d location 5 ERROR CTRL WAS382 blocked Aspirating or Dispensing Needle error code d location s ERROR CTRL WAS383 blocked Dispensing Needle error code d location s ERROR CTRL WAS384 Z Movement Manifold step lost error code d location s ERROR CTRL WAS386 Module Transport of Dispenser step lost error code d location s ERROR CTRL WAS390 Waste or Vacuum Pump not connected error code d location s ERROR CTRL WAS400 Manifold not calibrated error code d location s ERROR CTRL WAS500 waste cap not on waste container error code d location s ERROR CTRL WAS510 waste container full error code d location 5 ERROR CTRL WAS530 waste container full error code d location 5 ERROR CTRL WAS540 missing fluid container error code d location s ERROR CTRL WAS542 missing level in fluid container error code location 5 ERROR CTRL WAS406 Module Transport from Dispenser not initialized error code d location s Appendix 1 227 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages 14538 ERROR CTRL WAS408 syntax error from Dispenser error code d location s 14540 ERROR CTRL WAS410
230. on about the data output protocol is available on request 16 197 Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications 16 198 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter 17 P N 610520 02 05 01 Troubleshooting amp Error Handling Table of Contents 17 1 Error Handling eese 200 17 1 1 Example Error Handling Message Dialog Boxes 200 17 1 2 Warning Dialog 200 17 1 3 Handling of System Deadlocks 200 17 1 4 User Actions which Can Adversely Affect a Run 201 17 1 5 What to Do if an Error Cannot Be Rectified 208 17 1 6 Aborting a Test Run see 208 17 1 7 Tools and Their Usage During Error Handling 203 17 1 8 Collision Free 205 17 1 9 Locking of Instrument 207 17 1 10 Unlocking Instrument Functions 208 17 2 Troubleshooting 209 17 2 1 User Software OS 2 and PC Related Problems 209 17 2 2 Module Specific Problems 209 17 3 Instrument Auto Adjustment sees 212 17 199 Refere
231. on times whether loaded or not O It is not possible to refill containers If more reagent is required new containers must be used 11 9 Aborting a Plate or Run 11 9 1 Aborting Plate Plates can either be aborted by the operator or by the system Any plate that is aborted by the system either as a consequence of a delayed operator response the violation of any of the check proce dures e g during plate loading violation of any of the method defined run steps etc or due to a malfunction of the system i e that certain vital instrument functions are locked due to an error is automatically aborted and the operator is informed about this The operator can also initiate aborting a test by selecting the Abort Abort Test option in the Plan window Any operator initi ated test abort must be confirmed and is also traces in the test trace The confirmation of a test abort results in the transport of the selected test to the manipulation position During the transport the test s run status is set to aborting and after removal from the manip ulation position it is set to aborted 11 9 2 Aborting a Run The operator can decide to abort a complete run i e finish the work list before it is completed by selecting the Abort Abort Run option from the Plan window Aborting a run must be confirmed by the operator and results in the removal of all plates from the instru ment and in finishing the run P N 610520 02 05 01 11 127
232. ons are accessible i e the Incubator Entry instrument function contains Module Transport Front Tower with 5 Slots Rear Tower with 5 Slots Plate Barcode Reader and the Entry Lift These subsidiary functions can be individually locked or unlocked by the system or by the ML E A M E operator independently of the others An icon placed before each function name gives at a glance information i e v Status normal IN Subsidiary function locked x Entire function locked 13 2 2 Trace For information on ML F A M E Traces see Reference Guide Sec tion 12 3 on page 135 13 2 3 Download Download is used for updating the ML F A M E firmware and is not a general ML F A M E operator action 13 140 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Functions amp Requirements 13 2 4 Device Presettings Device Presettings sin File Device Connected Instrument Simulated Instrument Name of Device Tupe of Device Serial No Connection Path Instrument DEMO Instrument None Serial Instrument on COM1 Instrument None Serial ial Instrument on COM2 Instrument None Serial Instrument on queue Instrument 6666 Queue Receive Laser Printer None Laser Printer Printer None HPLaser1 Host 1 for CamDo Test Host None start c c Xfame Host 2 for CamDo Test Host None c fame hostcemd r Host 3 for Cambo Test Host None c fame cam code Test Sampler Sampler None c barc
233. ons in mm Figure 16 3 Reagent Container Barcode Label Dimensions Print Quality Same as plate barcodes see page 192 Print Contrast Signal Same as plate barcodes see page 192 Barcode Symbology Same as plate barcodes see page 192 Length of Information Same as plate barcodes see page 192 P N 610520 02 05 01 16 193 Microlab F A M E User Manual V2 0 NOTE The barcodes REAGENT 46 00 REAGENT 47 00 and REAGENT 48 00 are reserved for service and maintenance purposes The barcodes CHECK SOLUTION A CHECK SOLUTION B CHECK SOLUTION C and CHECK SOLUTION D are also reserved This leaves 45 differ ent barcodes for daily routine use 16 194 Reference Guide Technical Specifications Code Density Tolerance Minimum module width including print tolerances 0 01 0 254 mm Restrictions of Barcode Content The last three characters of any reagent barcode are reserved for instrument control and must always be 00 the other up to 29 characters are freely definable Content of Labels Provided with Instrument The barcode labels supplied with the instrument have the following structure REAGENT XX 00 where XX ranges from 01 to 48 Barcode Positioning Figure 16 4 shows the positioning of the barcode on the reagent container P 2 TTE Barcode Label Figure 16 4 Position of Barcode on Reagent Container Vertical Position The vertical position
234. ors of the Module Transport is blocked Press OK after successful manual intervention INC360 1 Module Transport step lost Could not execute Plate presence check in Incubator Slot Move the Module Transport manually into a collision free position Press OK after successful manual intervention INC361 1 Front Tower Lift step lost Could not execute Plate presence check in Incubator Slot Move the Front Tower manually into a collision free position Press OK after successful manual intervention INC362 1 Rear Tower Lift step lost Could not execute Plate presence check in Incubator Slot Move the Rear Tower manually into a collision free position Press OK after successful manual intervention INC370 1 Module Transport step lost Could not deposit Plate in Incubator Slot Move the Module Transport manually into a collision free position Press OK after successful manual intervention Appendix 1 222 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages DIALOG ID MESSAGE INC371 1 Front Tower Lift step lost Could not deposit Plate in Incubator Slot Move the Front Tower manually into a collision free position Press OK after successful manual intervention INC372 1 Rear Tower Lift step lost Could not deposit Plate in Incubator Slot Move the Rear Tower manually into a collision free position Press OK after successful manual intervention
235. ot 238 File Link 238 Filter measuring 35 reference 36 Filter Case 238 Filter Strip 239 Fluid Connector 122 239 Fluids 100 Front Tower Entry Module 239 Front Tower Inc 239 Appendix 8 Index Appendix 8 267 Microlab F A M E User Manual V2 0 Appendix 8 Index G General Instrument Specifications 184 Global Settings 142 Glossary 237 H Height Mover Tool 239 Host 239 Host Computer 239 Incomplete Plate 239 Incubate Menu 95 Incubation heating up 96 tolerance time 32 34 Incubation Check Plate 239 Incubation Slot 239 Incubation Temperature 95 Incubation Time 96 Incubation Tolerance Time 96 Incubator Decontamination 181 recommended interval 181 Incubator Entry Module 239 Incubator Incubator Module 1 239 Incubator Incubator Module 2 239 Incubator Module 6 Incubator temperature 138 Incubator Tower 239 Initialize 139 Inserting Reagent Carousels 120 Inserting Reagent Containers 119 Instrument Dimensions 185 Instrument Function 239 Instrument Package 239 Instrument Shutdown 239 Instrument Weight 185 Interface Connector 239 Appendix 8 268 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 Keep Empty Wells 239 Kit Lot Number 239 LAN 239 Layout 239 Layout Editor 85 LLD 240 Load Button 240 Loading 240 Loading Order 240 Lock Status 240 Locking Device 240 Login 240 Logout 240 Lot No 240 M M Code 240 Main Shuttle 240 Main Shuttle Rail 240 Mai
236. ot be determined exactly Aborted the test was aborted before the completion of all steps Device which moves MTPs into the exit stack or to the manipulation position Area of instrument from where finished plates may be removed Holds up to 10 MTPs Device that selects a wash fluid and pumps it to the manifold Holds waste fluid which has been expelled from the venting tube A location at the top of a rear incubator tower allowing a check plate to be stored A definition for transferring result files to a host using any valid 05 2 command for transferring files Device in the end module which holds up to 8 filters A sticker identifies its part number and serial number P N 610520 02 05 01 Appendix 2 Glossary Microlab F A M E User Manual V2 0 FILTER STRIP FLUID CONNECTOR FRONT TOWER ENTRY MODULE FRONT TOWER INC HEIGHT MOVER TOOL Host HosT COMPUTER INCOMPLETE PLATE INCUBATION SLOT INCUBATOR CHECK PLATE INCUBATOR ENTRY MODULE INCUBATOR INCUBATOR MODULE 1 INCUBATOR INCUBATOR MODULE 2 INCUBATOR TOWER INSTRUMENT FUNCTION INSTRUMENT PACKAGE INSTRUMENT SHUTDOWN INTERFACE CONNECTOR EMPTY WELLS KEYBOARD BUFFER Kir Lor No LAN LAN STATION LAYOUT P N 610520 02 05 01 Appendix 2 Glossary A device which holds the wavelength filter and a sticker with the wavelength written on it Revolving device on the front of the external pump station which conne
237. p lost error code d location s 21526 ERROR CTRL DIS391 dispenser z drive step lost error code d location s 21530 ERROR CTRL DIS400 dispenser x drive step lost well flags changed error code d location s Error Status Trace 21534 ERROR CTRL DIS401 module transport step lost well flags changed error code d location s Error Status Trace 21538 ERROR CTRL DIS402 dispensing drive step lost well flags changed location s Error Status Trace 21539 loc s err d 21542 ERROR CTRL DIS402 dispensing drive step lost well flags changed error code d location s Error Status Trace 21544 ERROR CTRL DIS411 dispenser z drive step lost error code d location s Error Status Error 21546 ERROR CTRL DIS412 dispenser rotor drive step lost error code d location s Error Status Error 21548 ERROR CTRL DIS413 dispensing drive step lost error code d location s Error Status Error 21549 loc s err d 21550 ERROR CTRL DIS414 dispenser x drive step lost error code d location s Error Status Error 21552 ERROR CTRL DIS511 not enough reagent container volume ld error code d location s 21554 ERROR CTRL DIS513 reagent container missing error code d location s 21556 ERROR CTRL DIS514 could not start aspiration step step timeout error code d location 5 21558 ERROR CTRL DIS541 improper dispensa
238. plate s barcode mask defined in the method definition NOTE Kit lot documentation mode CJ Kit lot check The expected kit lots are defined for each plate in The defined kit lot from the kit the work list The used kit lot number is either part of the plate lot file and the used kit lot if barcode see Reference Guide Section 10 2 1 on page 86 available will be documented which has the higher priority or is part of the pipetting informa but not compared tion When the ML F A M E software has been installed with the Active Kit Lot Check mode then both the expected and the used kit lot numbers must completely match to accept a plate s loading C Reading of time stamp of barcode file The span between this time stamp and the defined first processing step plate stay time must be less than the plate hold time as defined in the method definition else the plate will be aborted at the time when the first processing step of the method is due The oldest plate of a similar method in a stack is given priority O Plate assignment Once all the above have been completed a test number is created the plates barcode is registered and dis played in the Plan window and a loading time assigned P N 610520 02 05 01 11 125 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine CJ Well identification The pipetting information file is inspected when the plate is loaded The inspection of the pipetting infor
239. prises 96 wells A status flag that indicates the status of an individual well in a test P N 610520 02 05 01 Appendix 2 Glossary Microlab F A M E User Manual V2 0 Appendix 2 Glossary WELL GROUP One or more wells addressed together Well groups are defined by specifying well abbreviations CAg Ag coating or by specifying the well type used as parameter WELL TRACE A file containing all messages and actions related to a specific well in a test WELL TYPE Description of a well containing name abbreviation and well type used as definition WELL USED As Synonymous with functional well category Defines well with different functions for evaluation in machine readable form Work LIST MANAGER A window where the ML F A M E operator constructs work lists from predefined stack types Here the work list can be scheduled giving access to the Plan window With this window it is also possible to set the earliest starting time for the stack type assign a kit lot to a stack and abort either an individual test or an entire run WRITE RIGHTS An access right which allows a user to view and edit specific data on the ML FA M E P N 610520 02 05 01 Appendix 2 245 Microlab F A M E User Manual V2 0 Appendix 2 Glossary Appendix 2 246 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 3 Frequently Asked Questions Appendix 3 Frequently Asked Questions A3
240. r Colour monitor supported by 05 2 Keyboard Any keyboard supported by 05 2 Mouse Any mouse supported by 0S 2 Operating system IBM 05 2 V4 0 WARP Database IBM DB2 2 V2 10 Accessories General Barcode scanner to be connected in parallel to the keyboard possible to program pre and postamble Optional PC Requirements Interfaces LAN interface card or serial port for connection to host computer 1 serial port RS232C for use with UPS Uninterruptable Power Supply Additional computers Host computer for archiving results Printer HP Laserjet 5 L and Epson LX850 have been tested and deemed as compatible with the ML F A M E software P N 610520 02 05 01 Reference Guide Technical Specifications Microlab F A M E User Manual V2 0 P N 610520 02 05 01 16 4 3 User Software Specifications 16 4 4 Reference Guide Technical Specifications Maximum number of methods storable in 100 database Maximum number of test results storable in 700 4 database Maximum number of stacks 502 Maximum number of stacks in a work list 100 Maximum number of work lists 30 a Depends on amount of free space on hard disk Data Output Protocol Result files are created and exported in an ASTM protocol format see Reference Guide Section 13 2 5 on page 142 and see Refer ence Guide Section 12 2 5 on page 134 Detailed informati
241. r Manual V2 0 NOTE A mix step should be specified before photometric measure ment Read step or after dispensing reagent into plate NOTE The inclusion of a Re Identify step within a method should be given some consideration as this option can have an effect on the schedule since addi tional transport steps and plate barcode read steps will become necessary to process such a step 10 100 Reference Guide ML F A M E Methods Comment push button allows the ML F A M E operator to add a comment This comment will be displayed in the SRAM Error dialog box O Mix use this step to agitate the plate for a given time The following data must be specified O Mix intensity either low 5 Hz medium 7 Hz or high 11Hz O Mix time O Re Identify This step results in a re identification of the plate barcode during processing and is used to ensure that no plate mix ups occur during processing A re identify step can be included in the test processing definition as often as desired and at any time during the processing sequence CJ Read this step is used for photometric measurement The following data has to be specified O Measuring filter wavelength Whether a reference measurement is required and if so O Reference filter wavelength O Exit Plate This step is used if the plate has to be removed from the instrument for external processing When this step is executed the
242. r can assign different access rights to different ML and assign appropriate individ F A M E operators thus allowing say one ML F A M E operator to ual access rights The table run tests but not edit test data and another to run tests and also below summarizes the access edit test data ML F A M E operators must log in with the defined rights required to carry out dif user name and password before actions can be undertaken with ferent functions with the sys the ML E A M E software The login designates the OPS operator s tem corresponding access rights Description Write ead Device presettings Simulated Instrument Delete method Insert of trace messages by user Test results Verification Routine work Assignment editor Stack definition Maintenance Change lock states Documentation job definition of a method Changing the barcode mask Change System time Edit the documentation formats Restore of methods Trace Deletion of tests Device presettings Instrument status Software presettings Kit Lot Editor View or edit method definitions Backup of methods View or edit global data for methods User Access Editor R 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 3 1 1 1 2 1 1 1 2 Firmware download 1 Oo0000i amp gt 13 146 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification Chapter 14 ML E
243. r event took place For information about working with the Trace window see Cook Book Section Table 5 2 1 1 on page 60 P N 610520 02 05 01 12 135 Microlab F A M E User Manual V2 0 Reference Guide Test Results amp ML F A M E Traces 12 3 3 Test Trace The test trace report gives a complete history of a test The test trace can be useful for identifying problems with a test such as at what stage a test was invalidated and why For information about working with the Trace window see Cook Book Section Table 5 2 1 1 on page 60 12 3 4 Well Trace The well trace report gives a complete history of each individual well in a test The well trace can be useful for identifying persistent problems with a particular well position and hence can help point out instrument problems 12 136 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Chapter 13 P N 610520 02 05 01 Reference Guide ML F A M E Functions amp Requirements ML F A M E Functions amp Requirements Table of Contents IESU 138 13 2 Services 138 13 2 1 Instrument Status Window 138 19 2 2 Ia CO SEE SINA ER SER SENSE ine 140 13 2 3 Download 2 2222 ER e e 140 13 2 4 Device PresettingS u 4444 Henne een nennen nennen 141 13 2 5 Software Presettings ureennnennnnnnnnnnnnnnnnn nn 142 13 2 6 Set Syst
244. r is nearly full A warning dialog then appears on the computer screen requesting it to be emptied It is recommend to emptying the waste container s before each test run or at latest when requested by the user software If the waste container is not changed as requested the washer will be locked and plates may be aborted 17 1 4 9 Removing Plates from Instrument A sensor detects when the exit stack is nearly full 6 7 plates depends on plate height and also when it is completely full 10 11 plates Plates should be removed from the exit stack before it becomes full i e when instructed in the action list If the exit stack remains full it will be blocked and as a result may cause tests to be aborted 17 202 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 1 5 What to Do if an Error Cannot Be Rectified NOTE Trace files can be edited using If an error is encountered with the system which cannot be rectified any ASCII text editor The by the ML F A M E operator print out the system and test traces as appropriate part of the trace can applicable fill in an incident report form and send fax it with the then be extracted saved and traces to HAMILTON See Cook Book page 60 for information on printed out printing traces 17 1 6 Aborting a Test Run Any active error handling must first be completed before a test run can be aborted i e any instruc
245. r well u ul location s 32017 loc s fluid s be s loti s lot2 s vol d might appear on the screen as 32016 NOTE RUN Dispensing started reagent Stop Solution barcode REAGENT 13 00 comp lot nr 1 KL 1 comp lot nr 2 KL 2 volume per well 100 ul location Dispenser 1 32017 loc D1 fluid Stop Soluion bc 2 REAGENT 13 00 lot1 KL 1 lot2 KL 2 vol 100 A1 2 2 Test Trace Messages Trace ID Message 10000 NOTE RUN uP System s firmware version s 10002 NOTE RUN Instrument serial number s 10004 NOTE RUN uP System s serial number s 11592 WARNING VRY Photometer verification required location s Error Status Trace 11593 loc 2 PO 11594 WARNING VRY Dispenser verification required location s Error Status Trace 11595 loc 2 D96d 11596 WARNING VRY Washer verification required location s Error Status Trace 11597 loc W d Appendix 1 226 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 11598 11599 14460 14466 14468 14470 14472 14476 14478 14480 14482 14484 14488 14500 14502 14504 14506 14508 14510 14512 14514 14516 14518 14520 14522 14524 14526 14528 14530 14532 14534 14536 Appendix 1 Error amp Trace Codes Messages WARNING VRY Incubator slot verification required location s Error Status Trace loc s tow f slot c slot c slo
246. re by executing an initialization P N 610520 02 05 01 15 181 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Maintenance 15 182 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications Chapter 16 Technical Specifications Table of Contents 16 1 General Instrument 184 16 1 1 Power isinisi e la 184 16 1 2 Instrument 185 16 1 3 Instrument Weight without packaging 185 16 1 4 Circuit Breaker 185 16 1 5 Operating Environment sse 186 16 2 Module 187 16 2 7 Entry Module e e ee ee 187 16 2 2 Incubator Module 187 16 2 3 Washer Dispenser 188 16 2 4 End Module o nee eade deeds 190 16 3 Barcode Specifications 191 16 3 1 Plate Barcodes eci a aiaiai ia 191 16 3 2 Reagent Container 193 16 4 PC Requirements sse 196 16 4 4 ACCOSSOTIOS ecu i ER HERR REDE Eee x dns 196
247. reation date O Modified by This is the name of the user logged in when the method was last modified Directly across the dialog box from this entry is the associated modification date 1 Version Each time the method is saved this number is increased by one O M Code When a new method is defined it is assigned a unique security code designated M Code Similarly when an existing method is edited a new security code M Code is assigned to it When the results of a test are generated the M Code of the method used at the time of the test is recorded in the test results O Manufacturer This entry is freely definable by the ML F A M E oprator and has no systems relevance Enter the manufac turer s name in this entry field i e Example Company O Parameter Again this entry is freely definable by the ML F A M E oprator and has no systems relevance Enter the type of test here i e Hepatitis B P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods O Barcode Mask The barcode mask defines the basic structure of the plate barcode Two types of character are defined in the NOTE barcode mask It is also possible to assign or edit the barcode mask using the O Barcode Specific Characters the use of barcode specific Method menu Edit sub menu characters will identify each barcode as being of the same Barcode mask method or from the same manufacturer O Barcode Wildcard
248. rectly affixed to plates Dry bottom of plate and photometer area Clean module transport Photometer measurement aborted due to error Filter case drive jamming If error persists call service technician P N 610520 02 05 01 17 211 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 3 Instrument Auto Adjustment Some errors can be rectified by adjusting the instrument An adjustment should only be done by a service technician 17 212 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages Appendix 1 Error amp Trace Codes Messages Table of Contents A1 1 Error Messages Introduction 214 A1 1 1 Explanation of Formatted Strings 214 A1 1 2 General Errors ee aaee enne 215 A1 1 3 Dispenser Errors 219 A1 1 4 Incubator 222 A1 1 5 Washer Errors seen ee 224 A1 2 Trace 226 A1 2 1 Explanation of Trace 226 A1 2 2 Test Trace 226 A1 2 3 Well Trace Messages 235 P N 610520 02 05
249. reen giving the results of a test The same as a run Appendix 2 243 Microlab F A M E User Manual V2 0 TEsT STEP TEST TRACE TRACE PRIORITY TRANSPARENT COVER TRANSPORT SYSTEM User MANUAL Box WARM START WASH CHANNEL 1 4 WASH CHANNEL 5 8 WASH CHECK PLATE WASH CONTAINER CAP WASH CONTAINER SLOT WASH CONTAINER STAND WASHER WASHER IN WASHER DisP MODULE 1 WASHER IN WAsHER DisP MODULE 2 WASHER LIFT WASH FLUID WASH FLUID CONTAINER WASH RINSE TUBING WASH SHELL WASTE CAP WASTE CONTAINER WATER SEPARATOR W D WELL WELL FLAG Appendix 2 244 A single test processing step e g incubate dispense wash of a method test processing definition A file containing all messages and actions related to a specific test A level of precedence which a trace message carries Allows the user to select which priority messages to register display Hinged transparent door on front of instrument that prevents dust and user s hands from entering main shuttle area during operation All parts used to move plates into within and out of the instrument except the module transports e g entry lift main shuttle manipulation position Slot in entry module door for holding user manual An instrument initialization procedure which is executed by the user software at start up when a cold start is not necessary Normally executed under error conditions One of four wash channels associate
250. rification kit is a diskette containing the reference data 3 From the Validation menu select the Load Photometer Reference Data menu choice 4 Insert the supplied diskette into the specified drive and confirm with the Yes push button 5 The predefined reference data is loaded into the ML F A M E database and the Photometer may now be verified Table 7 1 1 2 Dispenser Verification Validation To Do This Validate the To validate the dispenser it is first dispenser necessary to establish three known values for a hand pipette as a reference then supply this information to the ML FA M E software From the Validation menu select the Dispenser menu choice 7 66 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Verification Table 7 1 1 2 Dispenser Verification Validation To Do This 3 Inthe displayed dialog box enter the required data and select the Save push button 4 Only after this data is supplied is it possible to verify the dispenser module Table 7 1 1 3 Washer Verification Validation To Do This Validate the 1 Forthe purposes of traceability it is washer required that the serial number s of the washer manifold s be recorded From the Validation menu select the Washer menu choice 3 In the displayed dialog box enter the required data see Reference Guide Section 14 4 1 on page
251. ring decontamination the following steps are carried out A O The washer s all wash channels and all tubings are rinsed with ATTENTION decontamination fluid When decontaminating with Microlab Foam may be expelled from the Detergent and Disinfectant fill the wash container with 196 solu venting tube into the external tion at 60 water separator during the decontamination process O The waste extraction system is soaked with decontamination fluid for 30 minutes O The washer s all wash channels and all tubings are rinsed with 0 5 9 1 NaCl and deionized water O Empty external water separator after the washer decontamina tion is finished A 15 1 9 Incubator Decontamination ATTENTION The incubators must be Recommended interval decontaminated at or around ambient temperature since O Every month flammable liquids are used er A General Description of Decontamination Procedure O This program raises the rear and front incubator towers in turn allowing each slot to be opened and cleaned A For each bank of towers front and rear do the following ATTENTION Wear gloves when cleaning the Clean each incubator slot with a lint free cloth soaked in Micro incubator slots They may be lab Disinfectant Spray contaminated CJ Leave the incubator slot doors open wait until the slots are dry typically 30 minutes and then click on Continue O Continue by following the instructions that appear O Complete the procedu
252. rned when the method is checked 0 2 3 3 NOTE This step can be defined only once within a method and is always the first step of a method if included P N 610520 02 05 01 Reference Guide ML F A M E Methods File Menu o m m Check Layout and Processing Definition Save Method stores the method in the ML F A M E database Switch to Plate Layout Editor minimizes the Test Processing Editor and opens the Plate Layout Editor Method Information opens the Method Information dialog box for the current method Save and Switch to Plate Layout Editor saves the Test Pro cessing Editor information defined and opens the Plate Lay out Editor Print prints on the default printer test processing information as defined for the current method Close Editor shuts down the Test Processing Editor Exit Method Editors shuts down all method related editors and related dialog boxes Edit Menu m o m The Edit Menu has three choices Change allows the user to change the settings of the selected step Delete allows the user to delete the selected step O Set First Processing Step displays a dialog box allowing the user to define which step in the definition is the first relevant step to be processed on the ML F A M E used to calculate the plate hold time Steps Menu The Steps menu allows the user define the required processing steps for the current method from the
253. rt Plane and Photometer Successful 1 022 1 No plate detected on Module Transport of End Module Check visually if a plate is present on the Module Transport of the End Module Plate present ITP032 1 Washer Lift is blocked or Wash Shell sensor has failed Free the Washer Lift manually or clean and dry Wash Shell and sensor Successful ITP033 1 Washer Lift is blocked or Wash Shell sensor is defect Free the Washer Lift manually or Clean and or dry Wash Shell and sensor Successful ITP100 1 Incubator Module Transport will be unlocked If there is a plate on the Module Transport remove it manually Free Module Transport manually Successful ITP101 1 Incubator Front Tower will be unlocked If there is a plate on the Module Transport remove it manually Free Module Transport and Front Tower manually Successful ITP102 1 Incubator Rear Tower will be unlocked If there is a plate on the Module Transport remove it manually Free Module Transport and Rear Tower manually Successful ITP110 1 Entry Lift will be unlocked Free Entry Stack and Main Shuttle manually Successful ITP120 1 Incubator Barcode Reader will be unlocked If there is a plate on the Module Transport remove it manually Clean MTP Barcode Reader manually Successful ITP130 1 Washer Lift will be unlocked If there is a plate on the Module Transport remove it manually Free Module Transport and Washer Lift manually Success
254. ructed by the user software Rear incubator tower in incubator Front incubator tower in incubator module behind transparent cover module behind transparent cover N Dispenser in _ washer dispenser module PA gy 7 Dispenser in end pu module Front incubator tower in entry module 1 Insert height mover tool into hole so that it locates in the hexagonal socket 2 Wind height mover tool to raise and lower incubator tower SER E ATTENTION Do not wind to the end stops stop just before After removing plates wind the tower to the collision free position 17 204 Figure 17 1 Location of Height Mover Tool Insertion Points Figure 17 2 Use of Height Mover Tool P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 1 8 Collision Free Positions A Under certain error conditions the ML F A M E operator may be ATTENTION asked via an error dialog to manually move an instrument module Do not use excessive force to or function into a collision free position It may also be necessary move mechanical parts to manually remove a plate from the instrument in this situation The following sections explain what is meant by a collision free position 17 1 8 1 Entry Module O Module transport in main shuttle position Figure 17 4 i e fork in out
255. rument pause button Turn carousel untill it drops into locked Before removing the module position Ensure all plungers are pushed decontaminate the instrument unplug all down and caps are properly closed connectors and seal the fluid system as described in the manual Figure 1 2 Warning Labels and general locations Explanation of warning and attention labels Power Connection Connect only to earth grounded outlet 115V A 60Hz 230V A 50Hz P N 610520 02 05 01 Microlab F A M E User Manual V2 0 1 20 N 1 4 4 4 ML F A M E Overview Warning Symbols General Warning Danger High Voltage AN Bio Hazard AN Danger Laser If the instrument becomes contaminated with liquids it should be cleaned in accordance with the maintenance procedures see Ref erence Guide Section 15 1 6 on page 173 Certain parts of the instrument are biohazardous Observe and carry out the maintenance procedures see Reference Guide Sec tion 15 1 6 on page 173 paying particular regard to cleaning and decontamination Do not use disinfecting materials which contain hypochlorite Jav elle water Chlorox or bleaching fluids Failure to observe and carry out the maintenance procedures may impair the reliability and correct functioning of the instrument Wear gloves when exchanging the sterile filter and handling the venting tube as any liquid which is released is biohazardous Any surfaces on which liquid is spilled must b
256. s 10 2 2 3 Configuration Menu N Use the Configuration menu to define the characteristics of the plate being used The following data must be specified ATTENTION The plate dimensions specified in O Set Plate Dimensions enter the plate length plate height well the plate configuration must diameter and well depth in the appropriate entry fields Figure correspond exactly to the 10 6 explains exactly what these dimensions are This step is dimensions of the plate to mandatory ensure error free washing and dispensing Erroneous plate dimensions may cause contamination or spillage during wash and dispense steps P N 610520 02 05 01 10 91 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Methods Well Diameter p 00000 00000 00000 i 009000 38888 809099 Well 29990 Plate Depth Height N Plate N Length outermost dimension M VL NOTE Ifthe plate has flat bottom wells with slightly tapered walls measure the diameter about half way down WEM Figure 10 6 Plate Dimensions AN ___ Dial calliper TI depth gauge ATTENTION Use the dial caliper supplied with the instrument to measure the plate dimensions Figure 10 7 Method for Measuring Plate Height O Strip direction either horizontal or vertical this feature is
257. s The outer part of the disposable syringe Houses the disposable plunger Part of a method definition that defines a list of documentation jobs to be executed as part of the documentation process of a test Whenever a test is released or redocumented it is documented according to this job list Definition of what kind of data from a test has to be included in printouts or result files User programmable parameters for the content of a result file or a print out Part of the documentation definition that determines to where a test result report in a given documentation format is sent e g host computer printer etc The action of documenting a test as specified in the method definition A field in a window or dialog box with a control icon which when opened by clicking on its control icon displays a list of objects items from which one can be selected Part of the ML E A M E software used to manipulate data Enzyme Linked Immuno Sorbent Assay Device which moves the entry stack up and down Part of the entry lift upon which an entry stack or a single MTP may be placed The MTP entry area of the instrument Device for loading MTPs into the instrument Can hold up to 4 MTPs Can also be used as MTP carrier for in laboratory use Gives information on the validity of test results i e None no errors occurred Trace at least one well was flagged Error an error occurred during pipetting or during test processing can n
258. s variables the use of variables or wild NOTE cards that hold information like the test kit lot number plate Each method has to have a number test number etc unique barcode mask i e no two methods may have the Barcode mask criteria are given in the following table same barcode mask Maximum number of characters 34 Forbidden character 96 Wildcard characters Mask character for test number numerics only 9 Mask character for kit lot number alpha numeric Mask character for any other characters which may vary from one barcode to another alpha numeric The following restrictions apply to barcode mask definitions A barcode mask may not be made up of only wildcard char acters O The wildcards and can only appear in one group i e identical wildcards must not be separated by other charac ters The wildcard can be defined in different places of the barcode mask O Barcode masks of identical length must be different in at least one fixed character The complete length of the fixed part of the barcode mask is used for plate identification Valid and invalid masks je These characters 7 characters for kit 5 characters for 4 characters for appear every lot number test number any other barcode HAM7F 7777 3622 3422 0 invalid interdispersed wildcards P N 610520 02 05 01 10 87 Microlab F A M E User Manua
259. s liquid level detection If a well cannot be properly washed the liquid level detector produces an error which is docu mented as a message in a trace file P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 1 3 1 4 2 1 3 1 4 3 1 3 1 4 4 1 3 1 4 5 ML F A M E Overview Three different wash solutions up to 3 liters each and one rinse fluid up to 3 liters can be loaded into the container stack situated next to the End Module All wash fluid containers have liquid level detection All wash functions and liquid definitions are programma ble by the user software in the Method Definition For example O Wash mode O Number of wash cycles O Soak time O Volume of liquid FJ Solution name Waste Container The waste container holds the fluid that is aspirated from the plates during washing and has a capacity of 10 liters A liquid level detec tor is incorporated in the waste cap When the container is full a message appears on the workstation screen Exchanging of waste containers is possible without interrupting instrument operation External Water Separator The external water separator holds fluid that is expelled from the venting tube Dispenser A single channel dispenser using disposable syringes and reagent containers dispenses the required reagents into the plates Carry over is eliminated by the use of Hamilton Reagent Container Systems with dedicated syringes for e
260. se Backup 6 To backup an open method the ML F A M E operator must only enter a path to the desired directory however ifno method is open the ML F A M E operator is asked to first select a method NOTE The default back up path for a method is defined in the Software Presettings dialog box see Refer ence Guide Section 13 2 5 on page 142 Restore T Torestore a backed up method the ML F A M E operator will be prompted for the backup path A list of all methods that have been backed up will then be displayed for selection Print 8 With a method open for editing the print command prints that method however with no method open the ML FA M E operator is prompted to select the method to be printed from a dialog box listing all methods available to that ML F A M E operator P N 610520 02 05 01 3 39 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods 3 40 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine Chapter A Daily Work Routine 4 1 Concept of the Daily Work Routine Below is a flow chart giving the logical flow of the daily work routine for the ML F A M E Each of these steps are explained in greater detail in the following pages Concept of the Daily Work Routine Continued Start OSP System Start Work List Start Up Processing Perform Prepare Verify amp Maintenance Load all Fluids Define or Selec
261. ser Manual Symbols sssssseseeee 3 1 3 ML EA M E Components 4 1 3 1 The ML FA M E Instrument seeeeeene 4 1 3 2 The ML F A M E Workstation eneee 9 1 4 General Information 12 1 41 Warranty iacere nee ee ee aree nee iiir REOR 12 1 4 2 Ordering Information ssseeeenees 13 1 4 3 Definition of 17 1 4 4 Safety Precautions and 17 ML F A M E Overview Microlab F A M E User Manual V2 0 1 1 1 1 1 1 1 1 1 1 1 1 2 ML F A M E Overview About the Microlab F A M E Basic Concepts The Microlab F A M E ML F A M E is a diagnostic instrument used to analyze blood samples for the presence of certain biologi cal elements This analysis is performed using the ELISA Enzyme Linked Immuno Sorbent Assay testing process This process requires samples to be manipulated in various ways i e incubating wash ing dispensing mixing photometric measurement etc The ML FA M E has been developed with a modular design incor porating all functions necessary to perform these sample manipu lations The test process is controlled by a highly developed software pakkage allowing O Simultaneous processing of tests from different manufacturers Easy adaptation of various tests using
262. should be such that the centre of the barcode is 20 mm from the bottom of the reagent container P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications Horizontal Position The horizontal position should be such that the barcode is cen tered on the reagent container L mm Figure 16 5 Optimum Position of Barcode on Reagent Container 16 3 3 Wash Fluid Container and External Pump Station Barcodes Barcodes must be attached to the external pump station and the wash fluid container as per the picture below 5 Attach the barcode labels as in the picture RINSE SOLUTION U LESS Figure 16 6 Wash fluid container and external pump station Barcode label position P N 610520 02 05 01 16 195 Microlab F A M E User Manual V2 0 NOTE 16 4 PC Requirements The PC must be 08 2 compatible Ask the manufacturer supplier for confirmation 16 196 16 4 1 16 4 2 The minimum requirements for the PC i e for a stand alone sys tem without connection to Microlab AT or LAN are given below Microprocessor type Intel Pentium 100 MHz Hard disk 1 0 GB RAM 48 MB Floppy disk drive 1 drive 3 2 Interface ports 1 serial port RS232C for connection to the Summit Processor 1 mouse port either RS232C or dedicated mouse port 1 parallel port for the printer VGA or SVGA monito
263. ssful manual intervention INC120 1 Couldn t pre initialize or initialize the Module Transport Move the Module Transport manually into a collision free position Press OK after successful manual intervention INC120 2 Couldn t pre initialize or initialize the Module Transport Move the Module Transport manually into a collision free position Press OK if your manual intervention was successful else press Ignore INC130 1 Could not pre initialize or initialize the Entry Lift Move the Entry Lift manually into a collision free position Press OK after successful manual intervention INC130 2 Could not pre initialize or initialize the Entry Lift Move the Entry Lift manually into the upper position Press OK if your manual intervention was successful else press Ignore INC140 1 Could not initialize the Front Tower Lift Move the Front Tower manually into a collision free position Press OK after successful manual intervention INC140 2 Could not initialize the Front Tower Lift Move the Front Tower manually into the lowest position Press OK if your manual intervention was successful else press Ignore INC160 1 Could not initialize the Plate Detection Sensor of the Entry Lift Check whether space between Plate Sensors of the Entry Lift is blocked Press OK after successful manual intervention INC170 1 Could not initialize the Plate Detection Sensor of the Module Transport Check whether space between Plate Sens
264. ssigning Fluids in the there is insufficient time for this Plan Window on page 52 itis possible to add an ambient incubation step Well barcodes can be entered until before the start of documentation P N 610520 02 05 01 4 49 Microlab F A M E User Manual V2 0 NOTE Individual test can only be aborted when the plate has actually been loaded onto the instrument Aborted tests will appear grey in the Plan window All aborted plates will be trans ported to the exit module 4 1 6 A ATTENTION It is important that the ML F A M E operator ensures that the correct fluids are placed in the correct labeled container NOTE Please consult with the manufac turer of stable fluids to ascertain the exact stability status of their fluids NOTE It is important that the ML F A M E operator check each barcode while placing it on any ML E A M E part to ensure it is in a serviceable condition NOTE To avoid possible errors during a run due to incorrect loading of fluids please label all fluid con tainers and storage containers 4 50 Cook Book Daily Work Routine Table 4 1 5 1 Starting a Run conrmueo To Do This Abort a test run 9 To abort an individual test or an entire run the ML FA M E operator must Switch to the Work List Manager use the Work List menu choice from the View menu or the F7 keyboard key 10 To abort an individual test select the test and from th
265. st Results Report dialog box or documented for the test 14 All defined documentation criteria for the selected test will be followed see Reference Guide Section 10 2 4 1 on page 101 5 58 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Cook Book Test Results amp ML F A M E Traces Table 5 1 2 1 Test Result Reports conrmueo To Do This Print the test result 15 Select the Print push button in the Test reports for the Results Report dialog box selected test 16 The ML F A M E software will now print on the OS 2 default printer the information as defined in the documentation format see Reference Guide Section 3 1 2 on page 37 a graphical representation of the test s plate containing the OD reading and the well barcode a table containing well ID barcode OD MW RW and the well flag View the well 17 There are two radio buttons in the OD barcode bottom left of the Test Results Report dialog box Select the Display barcodes radio button to display the individual well barcodes 5 2 ML F A M E Traces Overview Virtually all actions of the ML F A M E and ML F A M E software are stored in the Trace section of the ML F A M E database Three types of tracing are recorded CJ Well Trace tracks only exceptional events for the wells in a test and is normally blank O Test Trace tracks all events and data for each and every test O System Trace tracks
266. st has been completed in all respects i e all documentation jobs have completed 1 Error status indicates whether a test s processing was errone ous or not It can have one of the following statuses O None empty this indicates that all test processing steps were completed successfully O Trace indicates that at least one well was marked flagged however the test is still valid and its processing was finished Further information is in the well trace O Error indicates that an error occurred during the test s pro cessing which has effected either the complete plate or indi vidual wells The effected wells cannot be positively identified Further information about the occurred error is included in the test trace O Aborted The test s processing was aborted The reason for this is included in the test trace For information on how a tests status affects the tests documenta tion see section 12 2 1 on page 12 133 P N 610520 02 05 01 12 131 Microlab F A M E User Manual V2 0 Reference Guide Test Results amp ML F A M E Traces 12 1 2 Well Flag Each well in the test result report has an associated well flag which can have one of the following statuses O None empty indicates that there are no entries in the well trace O tr abbreviation for trace indicates that there are errors warn ings or messages in the well trace U ex abbreviation for excluded indicates that this well
267. switched off during a run or while the user software is running The proper OS 2 shutdown procedure should always be followed 17 1 4 3 Pressing the Pause Button The pause button is located at the bottom of the right hand side of the ML FA M E see Figure 1 2 Pressing the pause button halts all actions being carried out on the instrument After the pause button has been pressed a message dialog appears on the computer screen containing a button allowing instrument operations to be continued Pressing the pause button can cause plates to be aborted A 17 1 4 4 ATTENTIGK Opening the Transparent Cover When the transparent cover is A sensor detects when the transparent cover is open opened the main shuttle stops i e the part that moves plates from module to module but all functions within modules The transparent cover should only be opened when instructed dur continue ing maintenance and error handling If the transparent cover is opened during a run the schedule may be lost and plates may be aborted 17 1 4 5 Pressing the Load Button When pressed the load button initiates the loading of plates into the instrument P N 610520 02 05 01 17 201 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 1 4 6 Opening the Reagent Drawers There are two switches associated with a reagent drawer N An internal switch detects when a reagent drawer is open and pre vents the d
268. t c slot c slot c tow r slot c slot c slot c slot c slot C NOTE USER Test documentation started manually user s NOTE DOCU The file link command s to external s was executed successfully Waiting for confirmation from fam rtc ERROR DOCU The file link command s to external s was confirmed by fam rtc as NOT successful ERROR DOCU The file link command 5 to external s was NOT confirmed by fam rtc before timeout was reached NOTE DOCU Documentation jobs finished successfullyRun Status Documented NOTE DOCU The file link command s to external s was confirmed by fam rtc as successful ERROR DOCU A system error occurred during documentation of the test NOTE DOCU The test was documented on the 5 printer ERROR DOCU The documentation job on the 5 printer was not successful WARNING USER Operator excluded one or more wells or inserted one or more well comments Error Status Trace NOTE USER Test trace comment entered by the user ERROR CTRL WAS320 Manifold missing error code d location 5 ERROR CTRL WAS360 Water Separator overflow during procedure running error code d location s ERROR CTRL WAS366 Fluid Connector opened during procedure running error code d location s ERROR CTRL WAS368 overload Dispensing Pump during procedure running error code d location 5 ERROR CTRL WAS370 overload Vacuum Pump during procedure running error code d locati
269. t OSP Processes Stack Type s all Plates Define or Select Perform Work List Maintenance Schedule OSP System Work List Shut Down Continued Concept of the Daily Work Routine Finish P N 610520 02 05 01 4 41 Microlab F A M E User Manual V2 0 Cook Book Daily Work Routine 4 1 1 System Start Up and Shut Down This section details the start up procedure and outlines the tasks necessary before a test run can be started Table 4 2 Starting up and Shutting down the ML F A M E Turn on ML F A M E workstation power supply Turn on ML FA M E instrument power supply Enter ML FA M E operator name Enter password The instrument is then initialized to check whether the instrument and ML F A M E software are in an operable condition The ML FA M E software will then run a maintenance status check to establish the maintenance routines required The ML F A M E operator will be prompted to run cold start maintenance if a The instrument has been initialized for the first time that day b more than 24 hours have passed since the last cold start maintenance was run A check is made to ascertain when the ML FA M E had its last verification check See chapter 7 for further information on verification Exit all windows and editors From the File Menu in the main ML F A M E window select the Exit menu choice To Do This Start up the ML 1 EA M E 2 N 3 A
270. t colors represent various ML F A M E operator and ML F A M E actions If an individual test is aborted the action sec tions for the test will appear in grey in the graphical display O The current time is indicated by a vertical line through the Plan window O Location The plate location i e in which module 11 4 3 Time Bar The Time Bar is located between the Test window and the Fluid window It indicates the current time line using a line across the Plan window A status button in the Time Bar gives the ML E A M E operator a warning when a problem exists with one or more tests after sched uling The status button is gray under normal conditions but will turn red when a test within a stack could not be scheduled The ML F A M E operator must then select this button to confirm recogni tion of the problem The Time Bar is marked with vertical strips of magenta indicating a ML F A M E operator action at that time segment P N 610520 02 05 01 11 113 Microlab F A M E User Manual V2 0 11 114 11 4 4 11 4 5 Reference Guide Daily Work Routine Fluid Window The fluids necessary for the plan s processing are listed with the following information O Fluid Name each individually loaded fluid is displayed on one line exception multiple loadings of an identical wash fluid are combined on one line O Container Barcode for reagent barcodes that have been loaded onto the instrument i e whose b
271. tation including ML FA M E software 1 3 1 The ML FA M E Instrument End Module Dispenser Photoneter MTP Exit 40 mex Figure 1 1 16 20 configuration top view The primary functions of the ML F A M E include CJ Positive plate identification O Incubation temperature controlled or ambient O Washing with liquid level detection O Dispensing including positive reagent identification and liquid level detection O Photometric measurement 1 3 1 1 Configurations All instrument configurations consist of a combination of four differ ent modules 1 4 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 1 3 1 2 1 3 1 2 1 1 3 1 2 2 ML F A M E Overview O Entry Module 10 incubation slots FJ Incubator Module 10 incubation slots O Washer Dispenser Module with External Pump Station O End Module These four basic modules connected to the chassis plus a con tainer stack complete the basic instrument configuration 16 20 16 reagent positions and 20 incubator slots By adding an extra incubator module and or an extra washer dis penser module to the chassis the following three instrument con figurations are also possible O 16 30 2 incubator modules giving 30 incubation slots O 24 20 2 washer dispenser modules giving 24 reagent positions O 24 30 2 incubator modules and 2 washer dispenser modules Upgrade from one configuration to a higher
272. tatus 131 Test Results Window 130 Test Run 243 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 Appendix 8 Index Test Status 131 documented 131 Test Step 244 Test Trace 136 244 The System 243 Trace 131 140 Trace Messages 135 priority levels 135 Trace Priority 244 Trace Priority Levels 135 Trace Reports 135 Transparent Cover 244 Transport System 244 Troubleshooting and Error Handling 199 Type of measurement 99 U Unchecked Methods 111 Uninterruptable Power Supply 184 Unstable Reagents 33 loading of 118 UPS 184 User Manual Box 244 V Verification 148 View Configuration 141 View Filters 141 W W D 244 Warm Start 244 Wash Channel 1 4 244 Wash Channel 5 8 244 Wash Check Plate 244 Wash Container Cap 244 Wash Container Slot 244 Wash Container Stand 121 244 Wash Fluid 244 Wash Fluid Container 121 122 244 Wash Menu 96 Wash Mode 96 Appendix 8 275 Microlab F A M E User Manual V2 0 Appendix 8 276 Appendix 8 Index Wash Options bottom sweep 97 bottom wash 97 continuous wash 97 pump power 977 Wash Shell 244 cleaning of 72 Wash Solution Name 96 Wash Step aspiration height 97 dispense only 96 number of wash cycles 96 plate wash 96 soak time 96 strip wash 96 wash mode 96 wash solution name 96 wash volume 96 Wash Volume 96 Wash Rinse Tubing 244 Washer 244 Washer Decontamination 180 recommended interval 180
273. te has been loaded If no plate has been found the entry stack moves back to the upper most position CJ Plate identification and plate barcode check The plate bar code of each plate detected on the stack is read If no or un readable plate barcodes are detected the operator has the opportunity to enter the plate barcodes as part of the error handling The operator definition of the plate barcode follows the double blind entry principle see Cook Book Section Table 4 1 7 1 on page 52 CJ Plate integrity check At the start of the plates planned loading time displayed as a dark red block in the Plan window an ini tial check is made to find the pipetting information file If no pipetting information file is found an error message is dis played and the plate is not accepted if the ML F A M E software has been installed with the Plate Access On option the ML F A M E operator will get the option to continue processing without pipetting information The barcode on the plate must be unique i e the plate s bar code must not already exist on the ML F A M E database If a non unique plate barcode is detected the operator must repeat the complete loading sequence without the plate with the not unique barcode Plates containing non unique barcodes will never be accepted for loading If no matching plate barcode is detected an error message is displayed to the operator i e if the plate s barcode does not match with the required
274. ted by an adjacent one Short term drift 6 Calculates the variation between the measurements made during the current verification and the measurements from the previous verification Note only calculated if previous verification was performed within 10 days of the current verification Tested at wavelengths gt 400 nm P N 610520 02 05 01 14 153 Microlab F A M E User Manual V2 0 Reference Guide ML F A M E Verification 14 2 2 Dispenser The dispenser check plate is a flat bottom microplate Six rows are hand pipetted the remaining wells are pipetted by the dispenser Figure 14 3 shows the layout The ODs of the hand pipetted wells are measured with the photometer and used as reference values Well A1 These three columns have These columns are pipetted to be manually pipetted by the dispenser 3 4 5 6 7 8 9 10 11 12 SONY NE NE ME ON OM ONL ON ON E Xa N 2 Kw S ae N N N QU am d mM m ONS 22 N F N _ y C Nay Se N Se NA n NS 7 BEN a ae Va NUN p N L P L N N tr 7 D ot SS ee NN am ie E q 2 M CD a M 2 mo anco S ma VIN PAIN i NL e 7 27 Nil u N 7 ON E N A We ES AN JK lt en DD 266 ei ED amra ae d NOS DR WE EEE EINE E AND ON ONS SS STS SVS A50 H 50 ul Check Solution A hand pipetted A100 H 100 ul Check Solution A h
275. the ML FA M E Method Editor FJ Automatic schedule optimization and work list visualization O Full traceability and documentation of sample processing and of individual instrument functions Intended Use The intended use of the ML F A M E is to process microplate based ELISA assays for screening blood and blood products for the presence of any blood borne pathogen primarily in screening centers plasma centers hospitals public health centers and refer ence laboratories ML FA M E Operator Any persons operating the ML FA M E and ML F A M E worksta tion must have attended a certified training course Any departure from the following texts could lead to erroneous results or ML E A M E malfunction P N 610520 02 05 01 Microlab F A M E User Manual V2 0 1 2 1 2 1 P N 610520 02 05 01 ML F A M E Overview Using This Manual This manual has been developed for use with ML F A M E version 2 0 and should not be used with any other software version unless previously announced by the supplier The documentation set has been designed to allow various levels of ML F A M E operator to access the required information as they progress in their knowledge of the environment This has been achieved using a three part structure O ML FA M E Overview The ML F A M E Overview gives general information about the ML F A M E its computer environment functions and intended use O Cook Book The Cook Book d
276. the entry stack on the entry platform when requested by the Place the prepared plates on the entry stack to give the required stack type as specified in the action list Position the plates such that well A1 is at the outer left corner and butt the rear edge against the back of the entry stack on the entry platform without ML F A M E software Ensure that it sits flat and inside the lips of using the entry stack the platform Press the load button to activate the loading sequence The barcodes will be read verified and the plates systematically loaded onto the transport system of the instrument ATTENTION If placing plates directly on the entry platform i e without the entry It is important that plates stay in stack ensure that the rear edge of the plate butt against the ledge the same order on the entry at the back of the entry platform stack after plate barcode identification It is also possible to load a stack that does not containing all of the defined plates for this stack however it must contain the next plate required in the plan P N 610520 02 05 01 11 123 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine OOOOOOOO00000 OOOOOOOOOO0 N2900OOO OF When not using entry stack rear edge of plate must butt against ledge at back of entry platform EN CMS EB Well position A1 p Orange Light Green Li
277. thods and do not have to be of only one type of method these stack types can then be stored on the ML F A M E database O A Work List is a group of stack types and their projected load ing times Only one work list can be scheduled to run on the instrument at any one time 11 106 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine O The Plan window is the next step the routine execution of a test run After scheduling a work list the Plan window displays a graphical representation of the various methods with barcode and location information etc scheduled to run and is updated constantly when events occurred that have impact on the pro cessing of a test run 0 Action List is a document type file generated by the ML F A M E software which provides a timetable of actions and steps required of the ML FA M E operator to execute the test run and is based on the work load defined in the work list This list is created after the work list is scheduled and can only be printed out i e is not displayed on the monitor the action list is not updated for any changes in the work list 11 1 2 Work Menu The Work menu in the Main ML F A M E window allows access to the functions necessary to execute a test run on the Summit Pro cessor Available menu choices include O Work List Manager launches the Work List Manager win dow see page 109 for general information and see Cook
278. tings Define a kit lotfora 3 From the Edit menu select the Insert method Kit Lot menu choice 4 Select a method from the pull down list and then select the OK push button 5 A dialog box is displayed where the new kit lot is assigned to an existing method its expiration date and components with the component lot numbers can be defined Define the kit lot of 6 From the Edit menu select the Insert a global fluid Global Fluid menu choice lt Here the ML F A M E operator may select a global fluid name its expiration date whether it is a single or dual component and the either a single component lot number or two lot numbers if it is a dual component 4 1 4 Work Lists Below is a step by step guide to working with work lists for further information on work lists see Reference Guide Section 11 1 1 on page 106 For the purposes of these examples it is assumed that all method data is correct and kit lots exist and are date validated Table 4 1 4 1 Define a New Work List To Do This Define a new work 1 From the Main ML F A M E window list select the Work menu then the Work List Manager menu choice 2 The Work List Manager window is then displayed Include a stack 3 From the Edit menu select the Insert a work list Stack Type menu choice 4 A dialog box is displayed listing all available stack types P N 610520 02 05 01 4 45 Microlab F A M E User Manual V2
279. tion error code d location 5 Error Status Error 21559 loc s err d 21560 ERROR CTRL DIS551 could not start step dispenser has been locked error code d location s 21562 ERROR CTRL DIS900 dispenser has been locked error code d location s 21564 ERROR CTRL DIS901 dispenser has been locked error code d location s 21566 ERROR CTRL DIS902 module transport has been locked error code d location s 21568 ERROR CTRL DIS905 dispenser has been locked error code d location 5 Appendix 1 230 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 21570 24510 24520 24522 31500 31502 31504 31506 32000 32001 32002 32003 32004 32005 32006 32007 32008 32009 32010 32011 32012 32013 32014 32015 32016 32017 32018 32019 32020 32021 32022 32023 32024 32025 32026 32027 32028 32029 32030 32031 Appendix 1 Error amp Trace Codes Messages ERROR CTRL DIS306 dispensing drive step lost error code d location 5 WARNING CTRL PTM112 occurred plate transport aborted error code d WARNING CTRL PTM500 occurred plate transport aborted reason 5 WARNING CTRL PTM500 occurred plate transport not aborted reason s ERROR CTRL FOT003 command failed while not initialized error code d location s ERROR CTRL FOT300 error in reply string of measurement data error cod
280. tions in an error dialog must first be carried out and the dialog then closed 17 1 7 Tools and Their Usage During Error Handling The ML F A M E comes supplied with a number of tools for use when serious mechanical electrical failures occur 17 1 7 1 Plate Fork The plate fork is used to manually remove plates from incubator slots It should only be used under fatal error conditions when __ plates cannot be removed automatically by the system e g when an incubator tower motor drive fails 17 1 7 2 Height Mover Tool The height mover tool manually raises and lowers the following CJ Incubator towers A 0 Dispensers I Entry lift Figure 17 1 shows where the height mover tool should be inserted to move these items Figure 17 2 shows how and where to use this tool The example given is for the entry module front incubator tower The procedure is identical for the other items P N 610520 02 05 01 17 203 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling NOTE Use the tools only when The height mover tool should only be used under fatal error condi tions when such items cannot be raised and lowered automatically by the system e g due to a motor drive failure or when explicitly dialog or when the instrument is switched off Entry lift gt Rear incubator tower in entry module instructed via an error handling inst
281. to the use of this fluid In the case of unstable fluids this verification must be carried out during the preparation time or at loading The definition whether a fluid must be verified or not is con tained in the method definition O For the fluid s verification a hand held barcode scanner con nected in parallel with the computer s keyboard can be used Fluid verification follows a double blind entry principle see Cook Book Section Table 4 1 7 1 on page 52 P N 610520 02 05 01 Reference Guide Daily Work Routine Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine O All fluids must be correlated i e in addition to the fluid container barcode check and the component lot verification the container must be connected to a certain position on the instrument N either automatically in a certain reagent container carousel posi tion or manually in a defined wash channel position ATTENTION When pouring reagents into the When preparing the reagents observe the following points reagent containers ensure that there is no foam on the surface O Ensure that the conductive insert is in place in the bottom of the of the liquid reagent container O Attach the correct barcode label to the reagent container i e the barcode assigned to the reagent O Place a disposable syringe in the parked position of the reagent container O Before inserting the reagent container into the reagent contain
282. trictive With this option selected the ML F A M E operator will be prompted when trying to start a run if there are verification pro cedures required It is not possible to run ML F A M E if the required verification for any module is not completed The only exception is if the ML FA M E operator is asked whether or not to run verification on an incubator slot and answers no then that slot will be locked although a run can be started O Verification Non restrictive With this option selected the ML F A M E operator will be prompted when trying to start a run if there are verification pro cedures required It is still possible to use ML F A M E modules if the required verification for that module is not completed e g if the ML F A M E operator is asked whether or not to run verifi cation on an incubator slot and answers no then that slot will be not locked however the error status of a test will be set to trace and all test traces will contain a warning indicating the required function was not verified when requested O Plate Access Off With this option selected the ML FA M E software must find the pipetting information on the first try or else the plate will not be accepted for processing No other options are allowed P N 610520 02 05 01 Microlab F A M E User Manual V2 0 A ATTENTION Please ensure that the correct sample barcodes are entered Sample barcodes from the plate barcode file are write protected A
283. ule Washer Dispenser End Module Container Stack Module Dispenser Photometer A A L 7 Collision free positions of Collision free position of Collision free position of transport system entry and incubator module washer dispenser and end transports module transports Diagram not to scale Figure 17 4 Collision Free Positions of Module Transports and Transport System 17 1 9 Locking of Instrument Functions Instrument functions can be locked in two different ways O By the operator if not all functions are needed for a run This should be avoided if possible as locking a function changes the throughput of the instrument and under certain circumstances it will not be possible to start a test run or continue with an exist ing test run O When the user software detects a fault in an instrument function If the user software locks an instrument function during a run a message dialog appears on the computer screen informing the ML F A M E operator of this P N 610520 02 05 01 17 207 Microlab F A M E User Manual V2 0 Reference Guide Troubleshooting amp Error Handling 17 1 10 Unlocking Instrument Functions Instrument functions can be unlocked in two different ways O By the operator see Cook Book Section 6 1 1 on page 64 This should be done when a fault with a function has been recti fied Plates requiring this
284. upwards O Unscrew the wash container cap O Fill the wash container with the wash rinse fluid max 3 1 CJ Replace the wash container cap Make sure it is screwed on tight O Slide the wash container into the appropriate position in the container stack O Wash containers should be clearly labelled in order to distin guish between wash solutions both in and outside the instrument O Never load a wash fluid container when the orange status light is lit see Figure 11 5 O Green light wash channel ready O Orange light wash channel in use O Flashing Green light container empty 11 121 Microlab F A M E User Manual V2 0 Reference Guide Daily Work Routine To connect up the wash fluid container pull out the fluid connector from the rinse position vertical turn and push into the wash con tainer outlet Orange Light Green Rinse position Fluid connector Connected position vertical horizontal A Figure 11 5 Connecting Wash Fluid Container ATTENTION Never leave fluid connectors After a wash solution has been loaded into the instrument the unconnected They must be put Correlation dialog box will automatically appear in which a wash in either the wash position or container barcode has to be assigned to the wash channel bar the rinse position code N 11 7 6 1 Wash Solution Loading Dialog Box ATTENTION The Loading of a wash container is requested by the system using If a W
285. used a reagent must be defined 97 The reagent is specific to this method i e not global select the Edit Method specific push button The Edit Method Specific Fluids dialog box is displayed 38 Select the New push button The Edit Method Specific Fluid dialog box will appear Enter the name SUBSTRATE in the Name entry field then the time it will take to prepare the substrate solution 39 In this case the solution is unstable so select the Reagent Is Unstable check box and enter the stability time in this case 60 minutes 40 Confirm this with the OK push button and the new fluid will appear in the display of the Edit Method Specific Fluid dialog box 41 Select the Close push button and the ML F A M E software returns to the Dispense dialog box 3 33 Microlab F A M E User Manual V2 0 Cook Book ML F A M E Methods Table 3 1 1 1 Method Definition Process contmueo To Do This 42 Select SUBSTRATE from the Reagent name drop down list and a dispense volume of 200 ul from the Volume drop down list Select a Slow aspirate speed from the drop down list Select a Slow dispense speed from the drop down list 43 To enter this step in the test process definition select the OK push button SRAM 44 See Step 3 Item Number 18 Incubate 45 From the Steps menu select the Incubate menu choice 46 In the displayed dialo
286. ved from the instrument 12 Do not swap plates on the entry stack after loading i e after pressing the load button 13 Do not open the transparent cover unless instructed by the user software as processing may be interrupted leading to aborted plates An open transparent cover causes the main shuttle to stop i e the part that moves plates from module to module but all functions within modules continue moving parts 14 The pause button should generally not be pressed unless instructed by the ML F A M E software or in case of an emer gency stop situation as plate processing may be interrupted leading to aborted plates Carefully follow the on screen instruc tions 15 Pay close attention to all instructions and parameters given in test kit package inserts when programming test methods for the ML F A M E and when preparing said test kits for use with a test 16 A newly programmed test method should first be run on the system using deionized water containing 0 9 NaCl in place of all reagents and wash solutions to verify correct test definition and operation prior to the verification validation of the method This run should be overseen by the method programmer 17 Only original ML F A M E specific parts and tools may be used with the ML F A M E i e syringes reagent containers wash containers and waste containers 18 Never lift a fully installed assembled instrument from one place to another It must first be dismantled
287. verified because barcode manually entered at loading 32088 NOTE RUN Plate accepted barcode s identification mode s 32089 be s ident c 32090 WARNING USER Operator included one or more wells Error Status Trace 32092 WARNING USER Operator excluded one or more wells Error Status Trace Appendix 1 232 P N 610520 02 05 01 Microlab F A M E User Manual V2 0 P N 610520 02 05 01 32094 32096 32100 32102 32104 32106 32108 32110 32112 32114 32116 32118 32120 32121 32122 32123 32124 32125 32126 32128 32130 32132 32133 32134 32136 32138 32139 32140 Appendix 1 Error amp Trace Codes Messages WARNING USER Operator changed one or more well barcodes Error Status Trace WARNING RUN Different barcodes found for replicate wells or controls of same type Error Status Trace ERROR RUN ITP002 Step could not be executed Error Status Error ERROR RUN ITPO10 Syringe check failed location s Error Status Error ERROR RUN ITP020 Module transport error during photometric measurement Error Status Error ERROR RUN ITP021 Error in photometer or firmware during photometric measurement Error Status Error ERROR RUN ITP024 Not all wells detected or general photometer failure Error Status Error ERROR RUN ITP022 Plate not detected during photometric measurement Error Status Error ERROR RUN ITP023 Photometer locked
288. when battery low is indicated the system should be shut down P N 610520 02 05 01 Microlab F A M E User Manual V2 0 Reference Guide Technical Specifications One of the following uninterruptable power supplies is recom mended Manufacturer Best Fiskars Siemens Headquarters Best Power Technology Inc Fiskars Power Systems Siemens AG PO Box 280 SF 02921 Postfach 3240 Necedah Espoo D 8520 Wisconsin 54646 Finland Erlangen U S A Germany Output Power 2000 VA 1500 W 2000 VA 1400 W 2000 VA 1400 W Backup Power Time 10 min full power 10 min full power 10 min full power 30 min half power 30 min half power 20 min half power Overload Capacity 12596 10 min 12596 10 min 14096 25 sec 150 1 min 150 1 sec Weight 54 5 kg 68 kg 45 kg Dimensions mm 445 x 205 x 485 440 x 190 x 490 464 x 193 x464 RS 232 Interface yes yes yes Software Support yes yes yes 16 1 2 Instrument Dimensions Length 1 Breadth b Height h 16 20 1260 mm 4 1 680 mm 2 3 810 mm 2 8 16 30 1470 mm 4 10 680 mm 2 3 810 mm 2 8 24 20 1470 mm 4 10 680 mm 2 3 810 mm 2 8 24 30 1680 mm 5 6 680 mm 2 3 810 mm 2 8 16 1 3 Instrument Weight without packaging 16 20 220 kg 485 Ibs 16 30 250 kg 550 Ibs 24 20 272 5 kg 600 Ibs 24 30 302 5 kg 666 Ibs 16 1 4 Circuit
289. wise press IGNORE DIS 363 1 Syringe pickup failed No syringe grabbed Check syringe in container lt s gt at position d and change syringe if defective Do not change the position of any container Close drawer if manual intervention was successful otherwise press IGNORE DIS364 1 Dispenser x drive step lost Check for any obstruction in dispenser x drive movement Press OK if manual intervention was successful otherwise press IGNORE DIS373 1 Aspiration failed due to defective syringe Replace syringe in container lt s gt at position d before next dispense DIS377 1 Aspiration failed due to defective syringe foam or insufficient reagent in container Check syringe for an air gap or foam If completely filled with reagent press YES to start dispensing otherwise press NO to abort plate Do not change the position of any container P N 610520 02 05 01 Appendix 1 219 Microlab F A M E User Manual V2 0 Appendix 1 Error amp Trace Codes Messages DiALOG ID MESSAGE DIS377 2 Defective syringe or insufficient reagent in container Replace syringe or check reagent in container lt s gt at position d before next dispense DIS384 1 Reagent rotor drive step lost Check for any obstruction in rotor movement Do not change the position of any container and close drawer if manual intervention was successful otherwise press IGNORE DIS390 1 Dispenser x drive step lost Check for any
290. x 1 Error amp Trace Codes Messages ERROR CTRL INC373 could not deposit Plate in Incubator Slot error code d location s ERROR CTRL INC380 Module Transport step lost error code d location 5 ERROR CTRL INC381 Front Tower Lift step lost error code d location 5 ERROR CTRL INC382 Rear Tower Lift step lost error code d location 5 ERROR CTRL INC383 could not get Plate from Incubator Slot error code d location s ERROR CTRL INC400 Plate Barcode Reader hardware error error code d location s ERROR CTRL INC402 Plate Barcode not readable error code d location s ERROR CTRL INC403 Module Transport step lost error code d location s ERROR CTRL INC404 Front Tower Lift step lost error code d location s ERROR CTRL INC405 Communication error in Exit System error code d location s ERROR CTRL INC407 Main Shuttle step lost error code d location 5 NOTE RUN Test processing finished Run Status Processed ERROR RUN Test aborted due to processing error Run Status Processed Error Status Aborted ERROR RUN Test aborted by user Run Status Processed Error Status Aborted ERROR RUN Test aborted due to run abort by user Run Status Processed Error Status Aborted ERROR RUN Test aborted due to run abort by system Run Status Processed Error Status Aborted ERROR RUN Test aborted due to schedule li

Microlab F.A.M.E. - Frank`s Hospital Workshop

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