User's Guide. COBAS MIRA Systems

User's Guide COBAS MIRA Systems

COBAS MIRA ad Roche Respose Ceter are trademarks of the Roche Group. All other trademarks are the property of their respective holders. 2001 Roche Diagostics Corporatio This user s guide is published by Roche Diagostics Corporatio Techical Publicatios. Questios or commets regardig cotet of this maual ca be directed to: Roche Diagostics Corporatio Techical Publicatios Departmet 9115 Hague Road P.O. Box 50457 Idiaapolis, IN 46250-0457 1-317-521-2000 011661000-1201

Maual Covetios For the purposes of this user s guide, the followig amig covetios are used. COBAS MIRA Classic Aalyzer = Classic COBAS MIRA S Aalyzer = S COBAS MIRA L Aalyzer = L COBAS MIRA Plus Aalyzer = Plus COBAS MIRA Plus CC Aalyzer = Plus CC ii

Table of Cotets Overview 1 COBAS MIRA Software Versios 3 Daily Startup Summary 5 Calibratio ad Cotrol Classic, S, ad L 7 Quality Cotrol Files 11 Worklist 13 Start ad Stop 15 Deletig Worklists 17 COBAS MIRA Maiteace 19 ISE Maiteace 29 COBAS MIRA Troubleshootig 35 Troubleshootig for the ISE Module 39 Troubleshootig for Probes ad Pipettors 49 Flags ad Messages 51 Error Codes 55 No-Routie Procedures 57 COBAS MIRA Spare Parts List 59 Iterfacig to COBAS MIRA Systems 61 iii

iv Notes

Overview Overview 1. The 40-Character priter is mouted i the upper left side of the chassis o the L, S, ad Plus modules. The Classic priter is located o the cover of the istrumet. 2. Z Needle Carriage Assembly cotais the sample tip, reaget head assembly, ad probe. 3. Trasfer Arm Assembly holds the 100 µl sample pipette, 1,000 µl reaget pipette, ad the Z eedle carriage assembly. 4. The CRT is mouted to the right of the priter. The itesity cotrol is located to the left of the maipower switch. 5. The Aalyzer Assembly cotais six segmet chambers ad the photometer optics. 6. The Automatic Cuvette Chager is oly foud o the S ad the Plus CC. 7. The rack plate Assembly o the S ad Plus CC aalyzer is refrigerated. The Classic, L, ad Plus rack plates are ot refrigerated. COBAS MIRA System User s Guide 1

Overview Notes 2 COBAS MIRA System User s Guide

Software Versios COBAS MIRA Software Versios Classic Software versio 8735 or 8847 S, L Software versio 8847 Plus, Plus CC Software versio 9215 To verify the software versio of the istrumet, press <Program> <6> <6> Istrumet cofiguratio ad view the System Program iformatio. COBAS MIRA System User s Guide 3

Software Versios Notes 4 COBAS MIRA System User s Guide

Daily Startup Daily Startup Summary (For details see COBAS MIRA Maiteace ad ISE Maiteace sectios.) Daily Operatio 1 Switch o the COBAS MIRA aalyzer. 2 Eter Operator Code ad Password if required. 3 Perform daily maiteace (COBAS MIRA System ad ISE) accordig to the maiteace log sheet. (See Maiteace sectio.) 4 Prepare reagets as eeded. Place i appropriate positios o the reaget racks. 5 Prepare CAL-CS rack: replace tip cleaer; replace cotrols. 6 Program worklist (see pages 13-14). 7 Prepare sample cups ad place i appropriate sample rack positio. 8 Place racks o the rack platform. (With rack coolig, place refrigerated reagets to the left ad room temperature reagets to the right). 9 REMOVE ALL REAGENT CAPS. 10 Replace cuvette segmets if ecessary. 11 Press <START>. Daily ISE Module Startup The ISE Module should always be left o. 1 Check Stadards ad Referece Solutios; swirl bottles to remove iside codesatio. Replace the bottles if almost empty. 2 Switch o the COBAS MIRA aalyzer. 3 Prime the ISE module, stadards, ad mixtower. 4 Provide serum o CAL-CS 8 rack for activatio ad fluid adjust. (This rack positio is defied uder <PROG> <6> <1>.) 5 Perform Fluid Adjust. Press <INFO> <6> <6> <4>. Correct if ecessary. 6 Place samples ad cotrols o appropriate racks. Program the worklist. Daily Shutdow Plus, S/L, ad Classic (Software Versio 8847) 1 At the ed of the day, perform a eedle/tube clea with a 1:4 dilutio (25%) of Clorox brad bleach (usceted). Place a full 4 ml cotaier of 25% Clorox i the tip cleaer positio of the Cal/CS 8 rack. Press <INFO> <6> <9> <F1> Start. Set the scree as follows: Number of sequeces: 4 Prime Time: 300 S Reaget: ON Sample: ON This procedure takes approximately 6 1/2 miutes. Press <ESCAPE> whe complete. COBAS MIRA System User s Guide 5

Daily Startup Daily Shutdow Plus, S/L, ad Classic (Software Versio 8847) (cot d) 2 Classic (Software Versio 8735G) 1. Prepare three sample cups with 25% Clorox. 2. Prepare 10 ml reaget cotaier with 25% Clorox. 3. Request o worklist the CLRX test five times o each sample cup. 4. Press <START> (allow to ru). 5. Prime for 5 miutes afterwards. Z-positio DOWN. 6 COBAS MIRA System User s Guide

Calibratio ad Cotrol Calibratio ad Cotrol Classic, S, ad L Calibratio Requests 1 Press <ROUTINE>. I place of sample cup positio, type PC to calibrate without assayig patiets. This orders cotrols at the same time. 2 Select appropriate test(s) to be calibrated ad press <ENTER>. The request leaves the scree ad ca be reviewed uder <INFO> <3> Calibratio Cotrol. Precalibratio requests flash. Cotrol requests flash i <INFO><4> Quality Cotrol. 3 Place calibrator(s) i appropriate positio(s) o calibrator rack. Press <START> whe ready to calibrate. A A Cotrol Requests alterative to the PC request is CA. This form of calibratio request is oly started if patiet requests for the test are o the worklist. Cotrols must be requested by the CS commad below. precalibratio request ca be chaged to a calibratio request (SW>8847.AB). This removes the precalibratio request from the worklist if o patiets are ordered. The PC commad may ot be used for the ISE tests. Perform the followig i place of sample cup positio o the Routie or STAT worklist. 1 Type CS. Cotrols will be assayed if patiet requests for the tests are ordered o the worklist. 2 Select the appropriate test(s). 3 Press <ENTER>. Request leaves the scree ad ca be reviewed uder <INFO> <4> Quality Cotrol. Cotrols requested by this method are displayed as gree letters o a black backgroud. If cotrols are ot defied i the test parameters, ru cotrols as patiets. Defied cotrols ru automatically after each precalibratio request or as programmed. COBAS MIRA System User s Guide 7

Calibratio ad Cotrol Calibratio ad Cotrol Plus Calibratio Requests 1 Press <ROUTINE> <F3> Actio. 2 Type PCA to calibrate without assayig patiets. 3 Select appropriate test(s) to be calibrated ad press <ENTER>. The request leaves the scree ad ca be reviewed uder <INFO> <3> Calibratio Cotrol. Precalibratio requests flash. 4 Place calibrator(s) i appropriate positio(s) o calibrator rack. Press <START> whe ready to calibrate. A A alterative to the PCA request is CA. This form of calibratio request is oly performed if patiet requests for the test are o the worklist. precalibratio request ca be chaged to a calibratio request (SW > 8847.AB). This removes the calibratio request from the worklist if o patiets are ordered. The PCA commad may ot be used for the ISE tests. Cotrol Requests 1 Press <ROUTINE> or <STAT> Worklist. Press <F3> Actio. 2 Type PCS to assay cotrols without patiets. 3 Or type CS to assay cotrols ad patiets. 4 Select the appropriate test(s) for cotrols ad press <ENTER>. The request leaves the scree ad ca be reviewed uder <INFO> <4> Quality Cotrol. Precotrol requests flash. Cotrol requests are ot highlighted. 5 Place cotrols i appropriate positios o calibrator rack. Press <START> to assay. A precotrol request ca be chaged to a cotrol request. This removes the cotrol request from the worklist if o patiets are ordered. If cotrols are ot defied, ru cotrols as patiets. The PCS commad may ot be used for the ISE tests. For all COBAS MIRA Aalyzers: Chagig Calibrator Values 1 Press <PROG> <5> Racks. 2 Select CAL/CS rack. 3 Press <F3> STD. 4 Type positio of the STD to be chaged. Press <ENTER>. 5 Press <F1> Chage STD. 6 Select the desired test key, or press <SPACE> to chage all calibrator values for all tests usig this calibrator. 7 Eter the ew value. Press < > to go to the ext test. 8 Press <ESCAPE> whe all values have bee etered. 8 COBAS MIRA System User s Guide

Calibratio ad Cotrol Chagig Cotrol Values 1 Press <PROG> <5> Racks. 2 Select CAL/CS rack. 3 Press <F2> CS. 4 Type the positio of the cotrol to be chaged. Press <ENTER>. 5 Press < > or < > to fid desired test. 6 Press <F1> Chage Cotrol. Select the appropriate test, or press <SPACE> to chage values for all tests usig the cotrol. 7 Eter ew values. Press < > to advace to the ext test. 8 Press <ESCAPE> whe all rages have bee etered. Namig Calibrators or Cotrols 1 Press <PROG> <5> Racks. 2 Select CAL/CS rack. 3 Press <F1> Chage Name. 4 Type the cup positio of the calibrator or cotrol. 5 Press <ENTER>. 6 Type i the ame. 7 Press <ENTER>. 8 Type i the lot umber. 9 Press <ESCAPE> whe fiished. Chagig Date ad Time 1 Press <PROG> <6> System Parameters. 2 Press <5> Set-up Parameters. 3 Press <F1> Modify. 4 Chage Date. Press <ENTER>. 5 Chage Moth. Press <ENTER>. 6 Chage Year. Press <ENTER>. 7 Type i Hour (24-hour clock). Press <ENTER>. 8 Type i Miutes. Press <ENTER>. 9 Press <F2> Time Set to store ew time. COBAS MIRA System User s Guide 9

Calibratio ad Cotrol Notes 10 COBAS MIRA System User s Guide

Quality Cotrol Files Quality Cotrol Files Closig QC Files Close the QUALITY CONTROL files o a regular basis to esure adequate storage capacity for TEST RESULTS, PATIENT FILE, ad CALIBRATION CONTROL. The data stored i QUALITY CONTROL may be deleted selectively by test or i its etirety. Closig QUALITY CONTROL causes the automatic pritout as defied i OUTPUT MODE, <PROGRAM> <6> <3>. The Mothly Report Parameter uder <PROGRAM> <6> <5> must be set to ON. The QC Auto Mode parameter uder <PROGRAM> <6> <3> determies the pritouts that are geerated. STATIST prits statistics oly. PLOT prits statistics ad plot the data. VALUES prits statistics, a plot, ad the daily mea values. All cotrol levels for the specified test are closed. Esure that there is a adequate supply of paper o the istrumet. CLOSE QUALITY may be selected from the followig areas: QUALITY CONTROL assigmet table for closig ALL tests. Press <INFO><4> ad <F2> CLOSE QUALITY. Cofirm by pressig ENTER. DAILY or MONTHLY REPORT for closig SINGLE tests. Press <INFO> <4>, select the appropriate test key ad press <F4> CLOSE QUALITY. Cofirm by pressig ENTER. <PROGRAM> <5> <RACKS> CAL-CS 8/30 for closig either all or selective tests. Chage of Cotrol The chage cotrol fuctio is oly accessible with a operator priority level 4 defied uder <PROGRAM> <6> <4>. For tests with existig MONTHLY QC REPORT, the test file caot be accessed to chage cotrol rages without first closig the QUALITY CONTROL. Istead, the cotrol rages may be modified usig the CAL-CS 8/30 RACK program sectio. This updates the rages i the test file automatically. Procedure Press <PROG> <5>, ad the scree displays the differet types of racks. Press the correspodig umber of the desired rack type (CAL-CS 8/30). The scree chages to show the CAL-CS 8/30 assigmet table. Press <ENTER> or < > to move to the followig pages or < > to review precedig pages. Programmed ames ad lot umbers for the calibrators/stadards ad cotrols are listed ext to the correspodig cup positio. Press <F2> CS ad the CONTROL POSITION prompt appears. Type i the desired cup positio ad press <ENTER>. The tests usig this cotrol with the assiged values is displayed. Press <ENTER> or <4> to move to the followig pages or <1> to review precedig pages. To chage a cotrol rage, press <F1> CHANGE CONTROL ad the TEST prompt appears. COBAS MIRA System User s Guide 11

Quality Cotrol Files Chage of Cotrol (cot d) Chagig oly oe test: Select the desired test key (with test level if required). The test ad the assiged value is displayed. The value is chaged by eterig a ew cocetratio. Press <ENTER> to update the correspodig test file. Chagig more tha oe test: Press <SPACE> ALL. The first test ad the assiged value are displayed. Type i the ew values followed by <ENTER> to the test. Press < > ad the display chages to show the ext test. Repeat util all the tests have bee chaged. If some tests are ot goig to be chaged, press < > util the required test is displayed. Press <ESCAPE> ad the CAL-CS 8/30 assigmet table appears. 12 COBAS MIRA System User s Guide

Worklist Worklist Programmig a Worklist with Patiet ID OFF (Classic, S, L) 1 Press <ROUTINE>. 2 Type the cup positio where the sample is placed. 3 Press <ENTER>. 4 Select appropriate test(s). Use <F4> Test Level to select tests, profiles, or ratios from differet levels. 5 Press <ENTER>. 6 Repeat steps for each patiet. Use <F2> To for groups of patiets with the same test(s). STAT requests are programmed usig the <STAT> key. Remember to press the <START> key after orderig a STAT or addig to the ROUTINE worklist. Programmig a Worklist with Patiet ID ON (Classic, S, L oly) 1 Press <ROUTINE>. 2 Type the cup positio where the sample is placed. 3 Press <ENTER>. 4 Type the patiet idetifier. 5 Press <ENTER>. 6 Select appropriate test(s). Use <F4> Test Level to select sigle tests (Levels 1-4), profiles (Level 5), or ratios (Level 6) from differet levels. 7 Press <ENTER>. 8 Repeat process for each patiet. Use <F2> Copy Last for test selectio if the patiet beig programmed has the exact test request as the previous oe. STAT requests are programmed usig the <STAT> key. Remember to press the <START> key after orderig a STAT or addig to the ROUTINE worklist. Programmig a Worklist with Sample ID OFF, Barcode OFF (Plus, CC) 1 Press <ROUTINE>. Type the sample positio, ad press <ENTER>. The patiet is idetified oly by the sample rack positio. Positio #1 o the first Sample 30 rack is 1. Positio #1 o the first 16A rack is 601. Positio #1 o the first 16B rack is 1101. 2 Select tests/profiles/ratios. Choices are displayed at the bottom of the scree. Press <F4> Next Set for more choices. Switch to a differet level by pressig the level umber. Levels 1-4 cotai sigle tests; Level 5 cotais profiles, ad Level 6 cotais ratios. The scree remais at the last level selected. 3 Press <ENTER> to store the sample ID ad test requests. The sample positio automatically advaces to the ext available sample positio. <F2> To is available for orderig tests o a series of samples. COBAS MIRA System User s Guide 13

Worklist Programmig a Worklist with Sample ID ON, Barcode OFF 1 Eter Sample ID. 2 Eter sample positio. Positio #1 o the Sample 30 rack is 1. Positio #1 o the first 16A rack is 601. Positio #1 o the first 16 B rack is 1101. 3 Select test/profile/ratio. Choices are displayed at the bottom of the scree. Press <F4> Next Set for more choices. Switch to a differet level by pressig the level umber. Levels 1-4 cotai sigle tests; Level 5 cotais profiles, ad Level 6 cotais ratios. 4 Press <ENTER> to store the sample ID ad test requests. The Sample positio automatically advaces to the ext cosecutive umber if defied as umeric (PROG 6 5). 5 Repeat 1-4 for the ext patiet. Copy previous test request(s) with <F3> Copy Last. 6 To review the worklist, press <F1> Display. Programmig a Worklist with Sample ID ON, Barcode ON 1 Place the barcode label o the primary tube. 2 Select the correspodig worklist by scaig the istructio ROUT or STAT o the barcode table. The CRT displays the worklist. 3 The IDENTIFICATION prompt appears. Usig the barcode pe, sca the barcode label o the primary tube to idetify the sample. 4 The prompt TESTS appears o the scree. Sca the barcode o the table correspodig to the test, profile, or ratio you wish to ru. Complete the request by scaig ENTER. 5 Cotrols ad Calibratios (PC, CAL, PCS, ad CS) may also be selected usig the barcode table ad pe. Sca the actio request followed by the tests ad ENTER. The O Request optios are executed whe the <START> key is pressed. The Copy Last fuctio may be used by first scaig the primary tube barcode followed by the Copy Last istructio. 6 Press <F1> Display to view the worklist. **** refers to o-idetified sample positios. Whe <START> is pressed, the barcode reader located i the trasfer arm reads all of the primary tubes i the 16A ad 16B racks ad assig the sample positios. Sample positios ca be etered maually for samples without barcode labels, with labels that are difficult to read, or specimes i sample cups o a Sample 30 rack. 1 Idetify the patiet. 2 Press <F2> Sample positio. Eter the positio usig the barcode table or maually through the keyboard. Positio #1 o the first Sample 30 rack is 1. Positio #1 o the first 16A rack is 601. Positio #1 o the first 16B rack is 1101. 3 Select the test(s) ad press <ENTER>. 14 COBAS MIRA System User s Guide

Start ad Stop Start ad Stop START ad STOP Fuctios Begiig a ru provide samples, reagets (remove the caps), cuvettes, ad press <STATUS> ad <START>. Iterruptig a ru use if racks eed to be chaged, or reagets or samples added. Press <STOP> ad wait for trasfer to go ito stadby o the status scree before hadlig racks. Press <START> to reiitiate trasfer. Startig a STAT program i STAT worklist; press <STOP>. Wait for trasfer to go ito stadby o the status scree before hadlig racks. Press <START> to reiitiate trasfer ad the STAT processig. Termiatig the ru Press <STOP> ad the <F1> Abort to termiate the trasfer ad aalysis ru. Requests will be retured to their respective worklists ad be repeated the ext time <START> is pressed. COBAS MIRA System User s Guide 15

Start ad Stop Notes 16 COBAS MIRA System User s Guide

Deletig Worklists Deletig Worklists To Delete a Complete Worklist 1 Press <INFO>. 2 Press <2> Patiet Report. Press <F1> Iterim Report. 3 Press <F1> STAT to delete from the STAT worklist. Press <F1> Iterim Report. 4 Press <F4> Delete. 5 Select the specific cup umber or press <ENTER> to delete all cups. Select the specific test to be deleted or press <SPACE> for all tests. If samples remai, press <PRINT> to obtai the tests that have ot bee ru. To Delete a Icomplete Worklist 1 Press <ROUTINE> (or <STAT>). For the Plus, press <F1> Display. 2 Press <F3> Delete. 3 Select the specific cup umber or press <ENTER> to delete all samples. 4 Select specific test to be deleted or press <SPACE> to delete all icomplete tests. Status Text Highlighter To Be Doe Gree Noe I-Process Black Bright Gree Completed Bright Gree Dim Gree COBAS MIRA System User s Guide 17

Deletig Worklists Notes 18 COBAS MIRA System User s Guide

COBAS MIRA Maiteace COBAS MIRA Maiteace Daily Maiteace 1 Dispose of ay water remaiig i the water reservoir ad fill with reaget grade type 1 water. 2 Empty the waste cotaier. Add 300 ml of Clorox bleach to the waste cotaier. Replace both cotaiers o the istrumet. 3 Check for a adequate supply of paper o the priter. Chage if ecessary. Procedure: Remove old roll: 1. Remove paper cover from top of istrumet. 2. Pull up o old roll ad tear off roll with spidle. 3. Remove plastic spidle ad save. 4. Press <PAPER> util the rest of paper from the old roll comes out the frot of the priter. DO NOT PULL PAPER THROUGH THE PRINTER. 5. Release paper lever o right-had side, ad pull out remaider of paper. Feed i ew roll: 1. Put plastic spidle through the ew roll. 2. Cut a poited arrow head at the ed of paper by cuttig the corers at a agle. Remove all paper glue ad jagged edges. 3. Release the priter lever. 4. Had feed the agled edge through the opeig at the top of the priter. 5. Whe edge of paper comes out of the frot of the priter, check to see that the paper is straight. 6. Close the paper lever to hold the paper i place. 7. Press <PAPER> to feed. 8. Test paper by pressig <PRINT>. The priter uses thermal paper which is heat sesitive o oly oe side. The prit o this type of paper fades over time. Photocopy all pritouts to be kept for permaet records. 4 Ispect sample eedle ad reaget probe. $ Use care whe hadlig sharp sample eedle. 1. Remove the eedle cover. 2. O Plus aalyzer, lower the sample eedle ad reaget probe so they ca be easily see. 3. Visually ispect for beds ad discoloratio. 4. Check for burrs i the sample eedle by wipig the tip with a dry cotto swab. If ay of the cotto threads become attached to the eedle, replace it. COBAS MIRA System User s Guide 19

COBAS MIRA Maiteace Daily Maiteace (cot d) 5. If ay wear or damage is oticed, replace the eedle or probe. O the Plus aalyzer, replacemet of the eedle or probe requires a Trasfer Adjust. CLASSIC ONLY: Visually ispect the seatig ad color of the sample tubig loop. You may wat to remove the plastic cover. Acceptable Tubig: 1. Tubig must be colorless ad fitted ito the groove above the sample eedle. 2. Tubig should be replaced mothly or if discoloratio is oticed (refer to page 24). 5 Prime the reaget probe ad sample eedle. Procedure: For Plus aalyzer: sample ad reaget primes are doe i TWO separate steps: 1. Press <INFO>, <6> SYSTEM CHECKS, <1> PRIME. 2. Select Z-POSITION: UP-SAMP ad PIPETS: ON. 3. Press <F1> START. 4. Ispect the sample syrige ad water stream comig out of the sample eedle. There should be o air bubbles ad the stream should be steady. 5. Press <F1> STOP whe you have fiished observig the prime. 6. Select Z-POSITION: UP, REAG ad PIPETS:ON to check the water stream o the reaget side. 7. Press <F1> START. 8. Ispect the reaget syrige ad water stream comig out of the reaget probe. There should be o air bubbles ad the steam should be steady. 9. Press <F1> STOP whe you have fiished observig the prime. If air bubbles exist after primig, prime with the PIPETS: OFF. If bubbles persist it is ecessary to remove the syrige ad refill it with water. It may also be ecessary to replace the syrige tip or glass barrel. For other COBAS MIRA systems: sample ad reaget primes are combied i oe step: 1. Press <INFO>, <6> SYSTEM CHECKS, <1> PRIME. 2. Check the scree to make sure that it looks like the oe below. 3. Press <F1> START. 4. Ispect the syriges ad water streams comig out of the probes. There should be o air bubbles ad the water stream should be steady. 5. Press <F1> STOP whe you have fiished observig the prime. If air bubbles exist after primig, prime with PIPETS: OFF. If bubbles persist, it is ecessary to remove the syrige ad refill it with water. It may also be ecessary to replace the syrige tip or glass barrel. 20 COBAS MIRA System User s Guide

COBAS MIRA Maiteace Daily Maiteace (cot d) 6 Replace tip cleaer. 1. Empty the tip cleaer from its reaget cotaier ad refill half-way with fresh solutio. 2. Place the ew tip cleaer i the CL positio o the CAL-CS 8 rack. 3. Oce a week, replace the cotaier with a ew oe. 7 Check cuvette supply. Procedure: 1. Esure cuvette segmet supply is adequate for the aticipated umber of tests. Each segmet ca hold 12 tests. 2. Remove ew cuvettes from their protective plastic coverigs ad hadle at the top. Do ot touch the optical pathway. 3. If o cuvette chager is preset, lift aalyzer turtable cover, remove used cuvette segmets ad replace with ew segmets. Segmets click ito place whe properly loaded. 4. If the cuvette chager optio is preset, fill the left side of the chager with uused cuvettes. Remove used cuvette segmets from the right side. 5. Discard all used cuvettes i a biohazard cotaier. Roche cuvettes are iteded for a sigle use oly. Do ot wash or reuse cuvettes. 8 Ed of day sample ad reaget eedle tube cleaig. Software versios 8847 ad 9215: Procedure: 1. Place 4 ml of 25% Clorox solutio i the CL positio o the CAL-CS 8 rack. 2. Press <INFO>, <6> SYSTEM CHECKS, <9> NEEDLE/TUBE CLEANING 3. Check the scree to make sure that it looks like the scree displayed below. 4. Press <F1> START to begi the cleaig process. DO NOT lift aalyzer cover durig this process. 5. This procedure lasts for approximately 6 1/2 miutes. The eedle/tube cleaig is completed whe the probes rise out of the washtower ad the drai pump stops pumpig. 6. Remove ad discard the Clorox whe completed. Software versio 8735 (Classic oly) 1. Prepare three sample cups with 25% Clorox. 2. Prepare a 10 ml reaget cotaier with 25% Clorox ad place it o the programmed rack positio. 3. Request that the CLRX test five times for each sample cup. 4. Press Start. Allow to ru. 5. Prime for 5 miutes afterward. COBAS MIRA System User s Guide 21

COBAS MIRA Maiteace Weekly Maiteace 1 Clea the tube holder/stepper foot. (Plus ad Plus CC) Procedure: $ Use care whe workig ear the sharp sample eedle. 1. Remove all racks from the rack platform. 2. Move trasfer arm ito ceter of platform. 3. Dip a cotto swab i isopropyl alcohol ad clea bottom ad top of tube holder/stepper foot. DO NOT pull o the stepper foot. 4. Discard swab i a biohazard cotaier. 2 Clea the exteral water reservoir. Procedure: 1. Empty water from exteral water reservoir. 2. Pour 300 ml of Clorox bleach ito the reservoir. 3. Empty the Clorox ad rise the reservoir thoroughly with tap water. 4. Rise the cotaier with Reaget Grade, Type 1 water. 5. Fill the Reaget Grade, Type 1 water. 3 Perform P150/P250 precisio tests. Acceptable Results: The test measures precisio by CV% (coefficiet of variatio) of the replicates of two differet dye cocetratios. Acceptable CV% P150 = <1.5% P250 = <2.5% Procedure: 1. Fill the sample cups: Place 30 empty sample cups o the Sample 30 rack #1. Add 5 drops of P150 precisio dye to cups i positios #1-15. Close the lids. Add 5 drops of P250 precisio dye to cups i positios #16-30. Close the lids. 2. Fill a reaget cotaier: Fill a 10 ml reaget cotaier with Reaget Grade, Type 1 water. Add 2 drops of Tip Cleaer, ad place it i the positio assiged to P150/250 o the reaget rack. 3. Delete all worklists. 4. Power Patiet ID off: Press <PROG><6> SYSTEM PARAMETERS <5> SET UP PARAMETERS. Use the dow arrow key to fid the page with PATIENT at the top. Press <F1> MODIFY. Use the dow arrow to move the cursor to: ID of SAMPLE for Plus. Press <2> OFF. PATIENT ID for other aalyzers. Press <2> OFF. 22 COBAS MIRA System User s Guide

COBAS MIRA Maiteace Weekly Maiteace (cot d) 5. Create the worklist: Press <ROUTINE>. The scree displays sample positio #1. Press <1>, <F2>, TO, <15>, <ENTER> Select P150, <ENTER>. Cups 1-15 will ow have P150 ordered o the worklist. Press <16>, <F2> TO, <30>, <ENTER> Select P250, <ENTER>. Cups 16-30 will ow have P250 ordered o the worklist. Press <F1> DISPLAY. Press <PRINT>. 6. Press <STATUS> ad the <START>. 7. Obtai ad review the statistics from the ru: Press <INFO>, <1> TEST RESULTS, <F1> DATA, <F2> STATISTICS. For test, choose P150. Press <PRINT>. Repeat these steps ad choose P250 for test. Is your CV% acceptable? Remember: Acceptable CV%: P150 = < 1.5% P250 = < 2.5% 8. If CV% is too high: Check absorbace readigs for outliers that may have bee caused by air bubbles i the cuvette. Repeat precisio ru. Replace syrige tips. Repeat precisio ru. Replace syriges (oly if precisio does ot improve after replacig tips). Repeat precisio ru. Before repeatig the precisio ru, power off ad the power o aalyzer to clear the <INFO>, <1> TEST RESULTS file. 9. Whe completed, delete the worklist ad tur o the Patiet ID. Record CV% ad mea absorbace from the rus o the maiteace log. Attach the precisio pritouts to your maiteace log. COBAS MIRA System User s Guide 23

COBAS MIRA Maiteace Mothly Maiteace 1 Replace the reaget probe Procedure: $ Use care whe workig ear the sharp sample eedle. 1. Remove old probe: Power the system off. Remove all racks from the platform. Move the trasfer arm ito the middle above the rack platform. Remove the probe cover. Pull the reaget probe sprig-lock holder to the right, away from the probe. Pull the probe straight dow. 2. Put o ew probe Hold the sprig-lock out. Positio the ew probe with cut-out facig to the right. Push the ew probe up ito positio ad release the sprig-lock to hold the probe i place. Replace the probe cover. 3. Switch o system power. 4. Plus oly: Perform trasfer adjust <INFO> <6> <7> <1> 5. Prime the system <INFO> <6> <1> 6. Perform P150 ad P250 Precisio Tests. 2 Replace the syrige pluger tip Procedure: 1. Switch off system power. 2. Remove the trasfer arm cover by looseig the thumb screw located at the back left side of the trasfer arm ad the pull the cover straight out. 3. Loose the black kurled kob o the syrige (tur to left). 4. Hold the syrige o the silver collar ad tur to left to loose ad the remove the syrige. 5. Pull the syrige pluger out of the glass barrel. 6. Remove the old tip. You may eed pliers. 7. For reaget syrige pluger oly: Place a black O-rig o the tip of the pluger. The sample syrige pluger does ot have a O-rig. 8. Place a ew syrige tip ito the tip replacemet tool, ope ed facig up. 9. Getly push the pluger straight dow ito the ew tip. There should be a figerail s gap betwee the ed of the pluger ad the ew tip. 10. Fill the syrige with water. Elimiate bubbles. 11. Place syrige back o the trasfer arm. Tur to the right to tighte the syrige ad kurled kob. 12. Replace trasfer arm cover. 13. Power o ad prime usig INFO <6> <1>. (Make sure there are NO AIR BUBBLES!) 14. Perform P150 ad P250 Precisio tests. 24 COBAS MIRA System User s Guide

COBAS MIRA Maiteace Mothly Maiteace (cot d) 3 Plus oly replace the washtower foam Procedure: 1. Switch off system power. 2. Move the trasfer arm to the right ed of the rack platform. 3. Use tweezers to remove the old washtower spoge. 4. Discard spoge i biohazard cotaier. 5. Isert a ew spoge ito the wash tower. The cut edge should be facig the back of the tower. Getly push the spoge to the bottom of the wash tower. 4 Classic oly: replace sample eedle/tubig Procedure: $ Use care whe hadlig the sharp sample eedle. 1. Remove the old tubig ad eedle: Switch off system power. Remove all racks from the rack platform. Discoect the tubig from top fittig. Pull tubig out of its curved track. Pull up o brass collar. Tubig with collar should be discoected from the probe ow. Pull back (to the right) o the sprig-lock holder. Pull dow o the sample eedle. Discard the probe i a pucture-proof biohazard cotaier. 2. Attach ew tubig to the brass collar: Remove the brass collar from the old piece of tygo tubig. SAVE THE COLLAR. Cut a ew piece of tygo tubig 11 iches log. Cut oe ed of the tubig to form a log agle (approx. 1 ich) Feed the agled ed of the tubig through the arrow ed of the brass collar. Pull the tubig through util the agle is completely through the collar. Cut off the agled ed so that there is a straight edge eve with the brass collar. Trim the tubig to equal 8 5/8 iches (22 cm). 3. Attach the tubig ad sample eedle to Classic: If a stylet is preset, remove it. Attach the sample probe to the sprig-lock holder. Attach brass collar ed of the tubig to fittig o top of the sample eedle. Press the tubig ito its groove. Attach ed of tubig o top fittig. Replace plastic cover. COBAS MIRA System User s Guide 25

COBAS MIRA Maiteace Mothly Maiteace (cot d) 4. Prime the system <INFO> <6> <6> <1> Switch o system power. 5. Perform P150 ad P250 Precisio tests. Six Moth Maiteace 1 Replace the sample eedle (S, L, Plus) Procedure: Plus aalyzer: 1. Remove the old eedle: Switch off system power. Remove all racks from the rack platform. Move the trasfer arm to the frot ad middle of the rack platform. Move trasfer head forward. Remove metal eedle cover by pullig straight up. Uscrew black kurled kobs at both eds of the sample tubig. (Loose B first, allow residual water to drai out the bottom of the eedle, uscrew B completely, the uscrew A.) Lift eedle straight up. Discard sample eedle i biohazard sharps cotaier. 2. Put o ew eedle. Isert a ew eedle ito the opeig. Screw ito place both eds, A the B. Adjust the tubig height usig the loop so that it is approximately 5 mm below the white level detectio cable. (See diagram below.) Replace eedle cover. 3. Switch o system power. 4. Prime the system <INFO><6><1>. 5. Perform trasfer adjust <INFO> <6> <7> <1>. 6. Perform P150 ad P250 Precisio tests. 26 COBAS MIRA System User s Guide

COBAS MIRA Maiteace Six Moth Maiteace (cot d) L, S aalyzers: $ Use cautio, the sample eedle is very sharp! 1. Remove the old eedle: Switch off system power. Remove all racks from the rack platform. Move the trasfer arm to the frot ad middle of the rack platform. Remove plastic eedle cover. Uscrew silver screw at the top of the eedle assembly. Pull dow o sample cassette. Discard sample cassette i biohazard sharps cotaier. 2. Put o ew eedle: Lie up ew cassette with pi. Tighte top screw. Replace eedle cover. 3. Power o system. 4. Prime the system <INFO> <6> <1>: 5. Perform P150 ad P250 Precisio tests. 2 Ispect the back of the istrumet for dust. 1. Use damp paper towels to clea off the air itake scree o the back pael of aalyzer. 2. Vacuum the air itake scree o the back pael of aalyzer. 3 Replace the diluet filter. 1. Locate the diluet filter o the white tubig leadig from the exteral water reservoir to the back of the aalyzer. 2. Remove the diluet filter usig pliers, if ecessary. 3. Istall a ew filter. Make sure that the water flow arrows o the filter are directig water ito the aalyzer. 4. Perform a system prime. As Needed Maiteace 1 Clea washtower. a. Classic, L, ad S 1. Switch off system power. 2. Move a trasfer arm away from the washtower. 3. Use a Phillips head screw driver to remove the three screws from the top of the tower. 4. Pull straight up o the top plate to remove it ad soak i 10% Clorox for 10 miutes. 5. Use a cotto swab to clea the ier opeig of the top plate. 6. Thoroughly rise the plate with Reaget Grade, Type 1 water. 7. Place the top plate back o the washtower ad screw it dow. COBAS MIRA System User s Guide 27

COBAS MIRA Maiteace As Needed Maiteace (cot d) b. Plus 1. Remove the foam isert from the washtower. 2. Press <INFO> <6> <1> <PRIME> <F1> <START>. While the probes are primig, add 25% bleach to the washtower with a full trasfer pipet twice. 3. Replace the foam isert with the otch to the back. 2 Perform trasfer adjust/r-s Needles Adjust (Plus oly). Procedure for trasfer adjust: 1. Before begiig the TRANSFER ADJUST procedure, check to make sure that: all metal cotact surfaces are dry ad clea reaget probe ad sample eedle are parallel all reaget ad sample racks are removed from the rack platform. 2. Press <INFO>, <6> SYSTEM CHECKS, <7> TRANSFER, <1> TRANSFER ADJUST. 3. Place Reaget 5S umber 1 rack o rack positio 1. 4. Place Sample 16A rack o rack positio umber 3. Make sure that the trasfer adjust tool is i place i positios 4 ad 5 o the rack. 5. Press <F1> START. 6. This procedure takes approximately 5 miutes ad stops automatically. If the trasfer adjust was ot successful, the message FIRST ADJUST R-S NEEDLES is displayed. I this case, perform the R-S NEEDLES ADJUST procedure, followed by aother TRANSFER ADJUST. Procedure for R-S Needles Adjust: 1. Press <INFO>, <6> SYSTEM CHECKS, <7> TRANSFER, <2> R-S NEEDLES ADJUST. 2. Place Reaget 5S umber 1 rack o rack positio 1. 3. Pleace Sample 16A rack o rack positio umber 3. Make sure that the trasfer adjust tool is i place i positios 4 ad 5 o the rack. 4. Verify that positio 4 of the rack platform is empty. 5. Press <F1> START. 6. Whe the message CURSOR-KEYS ACTIVE appears, use the arrow keys to ceter the reaget probe over the cross o the trasfer tool. 7. Press <F2> SAMP ad check the positio of the sample eedle. Do ot use the cursor keys to adjust the sample eedle. 8. Press <F3> ADJUST to move the sample eedle ito positio 4 of the rack platform. Correct the positio 4 of the rack platform. Correct the positio of the eedle by carfully bedig the eedle directly below the tube holder (stepper foot). 9. Press <F3> CHECK to check the positio of the sample eedle agai. 10. Repeat <F3> ADJUST/CHECK if ecessary. 11. Press <F1> STOP whe completed. 12. Repeat the TRANSFER ADJUST <INFO> <6> <7> <1>. 28 COBAS MIRA System User s Guide

ISE Maiteace ISE Maiteace Daily Maiteace 1 Swirl the Stadards 1 ad 2 ad Referece solutio bottles to remove ay codesatio. Replace bottles if almost empty. 2 Switch o the aalyzer, if ecessary. 3 Prime the Stadards/Referece. 1. Press <INFO> <6> System Checks, <6> Module, <1> Prime. 2. Select the desired solutio to prime by pressig <1> Stadard 1, <2> Stadard 2, <3> Referece, or <4> Mixtower. Begi with Stadard 1. 3. Press <F1> Start to iitiate primig. Check the flow of Stadard Solutio 1 by removig metal straw util a air bubble is itroduced ito the tubig. Watch the bubble move through the tubig util it passes through the electrodes. Repeat this process for Stadard 2. 4. Press <F1> Stop to halt primig. 5. Repeat steps 2-4 for Stadard 2. For referece solutio, do ot remove the metal straw. Istead, look i the Referece electrode to verify the strig of pearls effect. 4 Prime the mixtower. Procedure: 1. Remove the CAL-CS 8 rack ad the black mixtower shield. 2. Press <INFO><6> SYSTEM CHECKS, <6> ISE MODULE, <1> PRIME SYSTEM <F4> NEXT SET. 3. Press <4> MIXTOWER. 4. Press <F1> START. 5. Observe: The water level should ot rise above the air ozzles. The mixtower should rise ad drai three times ad have a white etched appearace after dryig. There should ot be ay dried serum or dirt i the mixtower. Isufficiet water results i carryover betwee samples. Too much water results i samples becomig diluted. 6. Press <F1> STOP to halt pritig. 7. If ecessary, remove ad clea the mixtower with a cotto swab wetted with 25% Clorox solutio. Rise with copious amouts of deioized water, dry, ad replace. 8. Replace the black mixtower shield ad CAL-CS 8 rack. 5 Perform a Fluid Adjust 1. Press INFO <6> <6> <4> FLUID ADJUST. Fill a sample cup with a strogly colored serum, ad place it o CAL-CS 8 rack i idicated Cups-Pos. 2. Remove the plastic ISE cover ad safely place the stadard bottles o the module platform. Flip up the Faraday cage cover to reveal the electrodes. COBAS MIRA System User s Guide 29

ISE Maiteace Daily Maiteace (cot d) 3. Press <F1> Start to iitiate sequece. Watch the head of the serum as it moves from the mixtower. 4. Whe the cycle is fiished, check whether the head of serum segmet ca be see i the middle of the chloride electrode. 5. If the sample is ot correctly positioed, chage the trasfer factor. Press <ENTER> to store the ew factor. Press <F1> Start to repeat the Fluid Adjust. A lower factor moves the segmet to the left; a higher factor moves the segmet to the right. 6. Whe satisfied with the positio of fluid segmet, press <ESCAPE> to exit the procedure. Record the fial trasfer factor o the ISE log. The ISE Module is automatically rised. 6 END OF DAY - Clea, Etch (if required), Activate 1. Clea Procedure a. For Plus or Plus CC, keep the 25% Clorox i the tip cleaer positio from the Needle tube clea procedure (Daily Startup sectio, Daily Shutdow procedure). b. For Classic, L, or S, fill a sample cup with 25% Clorox ad place i the ETCH positio o the ISE bridge. Press <INFO>, <6> System Checks <6> ISE <5> Electrode Treatmet <2> Cleaer. Press <F1> Start. The procedure automatically termiates. Discard the 25% Clorox whe complete. 2. Place a sample cup with Etcher Solutio i the etch positio o the aalyzer. 3. Press <INFO>, <6> SYSTEM CHECKS, <6> ISE, <5> ELECTRODE TREATMENT, <1> ETCHER. Press <F1> START (approximately five miutes). 4. Perform a activatio. Make sure that there is a cup of serum i the Fluid Adjust positio. Press <INFO>, <6> SYSTEM CHECKS, <6> ISE, <5> ELECTRODE TREATMENT. <F1> START. Perform There these etch ad activatio procedures daily at the close of the day if 20 or more specimes are ru per day. Perform these procedures weekly if 20 or fewer specimes are ru over the course of the day. is o idicatio o the scree to display the completio of the ISE cleaig procedures. Press <STATUS> ad view the ISE status i the lower right corer of the moitor. If it says ISE: SYSTEM CHECK, the procedure is still i process; it chages to ISE: STAND-BY whe the procedure is complete. Mothly Maiteace 1 Replace the Stadard 1 ad 2 ad Referece bottles. 30 COBAS MIRA System User s Guide

ISE Maiteace Six Moth Maiteace Chage ISE Tubig The tubig attached to the referece electrode is ot replaced. 1 Remove Stadard 1, Stadard 2, ad Referece solutio bottles. 2 Drai the ISE module. Press <INFO> <6> <6> <2>; drai Stadard 1, 2, ad referece solutio. 3 Place a beaker of distilled water o the plexiglass cover ad isert the three metal tubes. 4 Press <INFO> <6> <6> <1> to access PRIME SYSTEM. 5 Perform a primig to rise the fluid system with water. Select Stadard 1, Stadard 2, ad referece. 6 Remove the beaker of water. 7 Perform a drai procedure to empty the fluid system <INFO> <6> <6> <2>. 8 Remove the plexiglass cover from the ISE module. 9 Press <INFO> <6> <6> <3> to access VALVE DISENGAGEMENT. The valves should ot be lifted for more tha a few miutes because they ca overheat. 10 Press <F1> START to ope the valves. 11 Move the tubig over the valves. 12 Press <F1> STOP to close the valves. The valves are also closed by pressig the ESCAPE, RETURN, or ay other program key. 13 Release the peristaltic pump clamp by pullig up the silver kob located o the left of the pump. 14 Remove tubig clamps from the posts o both sides of the peristaltic pump. Systematically remove ad replace all tubig. Refer to the chart icluded with the tubig set. Use the expader tool supplied with the ISE module to spread the eds of tubig D before placig o coectors. Be careful ot to pucture ay tubig. Clea up ay spills. 15 Replace tubig clamps. Close peristaltic pump. Replace cover ad the solutios i the appropriate positios. Replace the straws i the stadards. 16 Prime the system <INFO> <6> <6> <1>. Prime Stadard 1, 2, ad Referece Solutio. 17 Check the fluid adjust <INFO> <6> <4>. 18 Perform a serum activatio to wet the sample tubigs <INFO> <6> <6> <5> <3>. COBAS MIRA System User s Guide 31

ISE Maiteace As Needed Maiteace Electrode Maiteace Perform Electrode Maiteace Procedure weekly (at the ed of the day) if 20 or fewer ISE samples (o average) are assayed each workig day; or perform the procedure daily (at the ed of the day) if more tha 20 ISE samples (o average) are assayed each workig day. See page 30, Daily Maiteace, step 6, Ed of Day Maiteace for details. 1 Clea the electrodes (25% dilutio of regular Clorox bleach). 2 Etch the electrodes with the Roche ISE Etcher Solutio (Order #42374). 3 Serum-activate the electrodes. A Do The serum activatio must be performed by pressig INFO <6> <6> <5>, or the ISE activatio does ot automatically occur util the first ISE sample is assayed. It is importat to perform the serum activatio shortly after the ETCH procedure is performed. Use of patiet specime, ot cotrol material, is recommeded. ot use bleach that has bee stored for more tha 1 year. Accordig to the Clorox Compay, up to 20% of its potecy is lost after oe year. Make fresh weekly, a 25% bleach solutio for cleaig procedures o a ISE module ad store i the refrigerator protected from light. shuts, tubig, ad Mixtower ca clog with fibri. Routiely primig the Mixtower for 5 miutes at the ed of the day ca reduce the icidece of overflows. Electrode Replacemet 1 Remove the Stadard 1, Stadard 2, ad Referece solutio bottles ad the plexiglass cover. 2 Perform a drai procedure to empty the fluid system <INFO> <6> <6> <2>. Drai Stadards 1, 2, ad referece solutios. 3 Ulock the electrodes by pressig the upper black part o the left side of the Faraday cage. 4 Remove electrode, wipe chamber with dry tissue, ad isert ew electrode. Whe replacig the electrodes, the O-rigs must be o the left side of the electrode ad seated properly. 5 Lock the electrodes by pressig dow o the lower ed of the black part. 6 Close the electrode housig. 7 Replace cover ad the solutios i the appropriate positios. 8 Prime the system <INFO> <6> <6> <1>. Prime Stadards 1, 2, ad Referece Solutio. 9 Check the fluid adjust <INFO> <6> <6> <4>. 10 Perform a electrode treatmet etchig <INFO> <6> <6> <5>. Record the four-digit QC umber ad electrode istallatio date o the ISE Maiteace Log sheet. 32 COBAS MIRA System User s Guide

ISE Maiteace Electrode Replacemet Sodium Electrode 1 Etch with ew Etcher (well withi the expiratio date). 2 Activate with patiet serum 3X. 3 Calibrate ad ru QC. 4 Record slope. 5 If QC ad slope are okay, ru patiets. 6 If slope ad QC are low, wide the slope rage ad QC rages. 7 Ru 30 patiet serum samples. 8 If still low, clea with reaget tip cleaer 3X. 9 Recalibrate ad record slope. 10 If still usuccessful, clea with 25% bleach 2X. 11 If still usuccessful, replace electrode ad call Customer Techical Support at 1-800-428-2336. COBAS MIRA System User s Guide 33

ISE Maiteace Notes 34 COBAS MIRA System User s Guide

COBAS MIRA Troubleshootig COBAS MIRA Troubleshootig Chemistry Problems Causes Trasfer out of aligmet No sample pick up Cotamiated/expired stadard Cotamiated/expired reaget Reaget ot stable for expected time New lot of reaget Icorrect program parameters Icorrect temperature Temperature erratic Poor pipettig precisio Cotamiated water i aalyzer Actio Ru RS Needles adjust <INFO> <6> <7> <2> ad trasfer adjust <INFO> <6> <7> <1> to realig (Plus oly). Observe that sample ad reaget are picked up ad pipetted ito the cuvette. If this does ot occur, call Customer Techical Support at 1-800-428-2336. Press <INFO> <6> <1>. Prime sample eedle i Up positio ad look for steady stream. Check for bet, clogged, or missig sample eedles. Clear or replace the eedle. Check the sample cup level. Check for air bubbles i the sample syrige. Use fresh calibrator/stadard. Use fresh reaget. Store reaget i closed bottle at the temperature idicated o the label whe ot i use. Recalibrate with a ew lot of reaget. Record calibratio date ad compare previous factor to the ew factor. Note o cotrol sheet whe a ew lot is used. Verify test parameters uder <ROGRAM> <2> with the package isert. Press <F1>. Modify to make correctios. (Worklist ad QC file for this test must be empty.) Check temperature o status scree. Istrumet temperature is programmed uder <PROGRAM> <6> <1> ad should be set to 37.0 C. Check room temperature. If temperature is extreme, it may cause ezyme results to be higher or lower. If the problem caot be resolved, call Customer Techical Support at 1-800-428-2336. Check status scree for rotor temperature. The rotor temperature should read betwee 36.9-37.1 C. If the temperature fluctuates more tha +0.1 C, call Customer Techical Support. Check aalyzer ad rotor temperatures <INFO> <6> <3>. Perform P150-250 precisio tests. Check sample cups ad syriges for bubbles. Replace syrige tips if ot doe i the last four weeks. Check the itegrity of the water source. Use reaget grade type 1 water oly. Whe fillig the water reservoir at the begiig of the day, pour out old water before refillig. COBAS MIRA System User s Guide 35

COBAS MIRA Troubleshootig Chemistry Problems (cot d) Causes Improper mixig Cuvettes Rejected/Not Available Causes No empty cuvettes i aalyzer Actio Observe syriges ad eedle movemet durig mixig at the rotor. If mixig is ot carried out properly, call Customer Techical Support at 1-800-428-2336. Actio Load cuvettes. Faulty photometer Poor Precisio (Classic oly) Liste for a flash soud at begiig of ru. If the problem caot be resolved, call Customer Techical Support at 1-800-428-2336. Poor precisio, upo performig the P150/P250 precisio tests or poor precisio o more tha oe chemistry, may be caused by oe or more of the followig: Causes Actio Bubbles i the pipettig system Bubbles cligig to syrige pluger Wor syrige pluger tips Obstructed sample eedle Bubbles at bottom of sample cups Prime lies. Remove syrige ad prime util air bubbles are removed. Clea syrige with deproteiizer solutio, or oe part 5% Clorox ad three parts reaget grade water. Rise thoroughly with reaget grade type 1 water. Check tubig coectios for tightess. Replace pluger tips mothly. Perform eedle/tube cleaig (see Maiteace sectio). If the problem caot be solved, replace the sample eedle. Refill sample cups, or tap closed cups getly agaist smooth surface. Use of Roche sample cups oly is strogly recommeded. Poor desig of geeric cups has caused precisio problems. Cotamiated water ad tubig Cotact the Customer Techical Support at 1-800-428-2336. 36 COBAS MIRA System User s Guide

COBAS MIRA Troubleshootig No Suitable Racks Foud 1. Ru a RACK reader check, <INFO> <6> < 2>. 2. Check the racks that are o the istrumet agaist the racks listed o the display. If they match, go to step 3. If they do ot match, clea the rack reader ad the holes at the ed of the racks with a lit-free tissue ad retry. Call Roche Respose Ceter Customer Techical Support at 1-800-428-2336 if they still do ot match. 3. Check <INFO> <3> ad <INFO> <4>, all test levels, to see if a test is blikig. If a test is blikig, a PCA or PCS has bee requested, perhaps accidetly. Chage the request to CA or CS uder Routie to take it off the worklist if o patiets are ordered for the test. 4. Check the sample rack umber. Does it match with the sample cups that are ordered? 5. Have there bee recet chages to test parameters? Chages uder Program 2 result i a automatic calibratio; reaget ad calibrator must be provided. 6. Have cotrol/calibrator values bee revised? Check cup positios for errors. The istrumet may be lookig for a Cal/CS 30 rack for a double-digit cup positio. 7. Check reaget rack programmig uder Program 5. 8. Delete worklists ad order the tests idividually util the test causig the error is foud. Test/Rack Programmig Error There is a error i the test parameters or rack programmig. After receivig the error for detail of the issue, press <ESCAPE> immediately. The specific test/rack programmig message displays. COBAS MIRA System User s Guide 37

COBAS MIRA Troubleshootig Notes 38 COBAS MIRA System User s Guide

Troubleshootig ISE Module Troubleshootig the ISE Module Mixtower Overflowig Step 1 Step 2 Check the fuctio of the ISE waste pump. Perform Drai Stadard 1 <INFO><6><6><2>. Lift the straw out of the Stadard 1 bottle. Press <F1>, Start. Liste for the waste pump. If pump is ot cyclig, check/replace ISE fuse 5 (5 amp slo blo) o back of ISE Module. Power dow before removig the fuse (toggle switch above the power cord). If pump is still ot cyclig, or the Mixtower is still overflowig, there is a possible waste pump failure. Call the Roche Respose Ceter Customer Techical Support at 1-800-428-2336. Clea Mixtower; check replace tubig. Remove the black cover of the Mixtower ad remove ay remaiig water. Usig a cotto tipped applicator, swab out the Mixtower with 25% dilute Clorox bleach. Prime Mixtower <INFO> <6> <6> <1> <F4> <4> <F1> Start. If Mixtower is still overflowig, remove ad clea the Mixtower usig a trasfer pipette ad 25% bleach. Note the tubig coectio assembly before discoectig (see diagram o followig page). Push the bleach solutio through the small opeig at the bottom of the Mixtower. Rise well with reaget grade water ad shake dry. Drai Stadard 1 ad 2 solutio tubigs dry <INFO><6><6><2>. Lift the straw at the STD bottle ad press <F1> Start. Perform Valve Disegagemet <INFO><6><6><3><F1>. Remove ad check tubigs F, J, K, L, ad M for clogs or cuts. Clea or replace tubigs as ecessary. Valves ca overheat; therefore, do ot leave valves ope for more tha a few miutes. Remove both ISE Shuts. Clea out the shuts usig a trasfer pipette ad 25% dilute Clorox bleach. Rise well with reaget grade water. Reistall the Mixtower ad shuts. Prime Mixtower <INFO><6><6><1><F4><4>. If still overflowig, proceed to Step 3. Tubig J W1 Fittig Mixtower Tubig L Large Shut Tubig F Small Shut Tubig K COBAS MIRA System User s Guide 39

Troubleshootig ISE Module Mixtower Overflowig (cot d) Step 3 Step 4 Clea Waste Fittig W1 Discoect tubig L from waste fittig W1. Perform Drai Stadard 1 <INFO><6><6><2><1>. Use moderate pressure o the syrige pluger to clear iteral blockages. Recoect tubig L. Isert the Stadard 1 straw ito a beaker cotaiig 100 ml of 25% dilute Clorox bleach. Press <INFO> <6> <6> <2> <1> <F1> START to drai 100 ml reaget Clorox bleach to clear iteral blockages. Follow with 200 ml reaget grade water. Prime Mixtower; if still overflowig, proceed to Step 4. Fill a 10 ml syrige with 25% bleach. Use a butterfly that has the eedle ed cut off to coect the syrige to waste fittig W1. Clea the Rear Waste Lie Remove the Quick Discoect waste fittig at the back of the ISE Module by holdig the silver body statioary while graspig the checkered collar ad turig it clockwise. Ispect the fittig ad waste tubig for blockage. The fittig ad tubig ca be cleaed with 25% dilute bleach. Recoect the fittig. Prime Mixtower; if still overflowig, call Customer Techical Support at 1-800-428-2336. Fuse FS 5 5Amp Quick Discoect to Waste Sodium Cotrols Low or Sodium Slope Low Step 1 ETCH with ISE Etcher (order #42374) <INFO><6><6><5><1><F1>. Check ISE Etcher SOLUTION expiratio date. Use tip cleaer solutio if etcher is expired. Serum Activate. <INFO><6><6><5><3><F1>. If sodium results are still low, proceed to Step 2. Step 2 CLEAN with Reaget Tip Cleaer (order # 42282) <INFO><6><6><5><2><F1>. Perform up to three times. Serum Activate. If sodium results are still low, proceed to Step 3. 40 COBAS MIRA System User s Guide

Troubleshootig ISE Module Sodium Cotrols Low or Sodium Slope Low (cot d) Step 3 Drai Stadard 1 ad 2 tubigs dry <INFO><6><6><2>. Remove the Sodium Electrode from the Faraday cage. Ope the cage ad ulock the electrodes by pressig the upper black part o left the left side of the cage. Lift out the electrodes. Dampe the spogy sectio of Oral B brad - Super Floss with ISE Etcher ad pass the stiffeed ed through the electrode capillary several times from both directios. Reistall the electrode, Etch with Etcher, serum activate, ad recalibrate. For stubbor problems repeat this procedure usig the Reaget Tip Cleaer. If sodium results are still low, proceed to Step 4. Step 4 Replace the Sodium Electrode (order #1029371). Ustables ad/or Overrage These errors are usually caused by air leaks or clogs i the ISE sample pathway. Step 1 Check Fluid Adjust <INFO> <6> <6> <4>. Repeat the Fluid Adjust two times. Verify that the sample positio is stable. The head of the sample segmet must stop iside the chloride electrode positio. It is permissible for a few leadig bubbles to be i the begiig of the sample slug. The remaider of the sample slug should ot be broke up with air bubbles. Reset the Fluid Adjust if the sample positio is stable but ot i the electrode. Decrease the factor to move the sample to the left, icrease the factor to move the sample to the right. Remember to press <ENTER> to chage the value. If Fluid Adjust is erratic, see ISE TROUBLESHOOTING sheet Fluid Adjust Problem............ Step 2 Check the primig of the ISE Stadards ad Referece Solutio <INFO> <6> <6> <1>. Prime Stadards 1 ad 2. Pull the straws from the Stadard 1 ad Stadard 2 bottles while primig to itroduce a air bubble. Prime Referece. Observe the lower tubig to the right of the electrode cage. A costat flow of droplets exitig the lower tubig must be see. This flow of droplets resembles a strig of pearls effect. Step 3 Perform Routie Electrode Treatmets <INFO> <6> <6> <5>. Perform the treatmets i the followig sequece: Clea the electrodes with 25% bleach (deproteiizes the sample pathway). Etch with ISE Etcher (icreases the sesitivity of the Sodium electrode). Serum Activate (coditios the tubig ad electrodes). COBAS MIRA System User s Guide 41

Troubleshootig ISE Module Ustables Occurig o Quality Cotrol or Patiet Samples but ot ISE Calibratio Step 1 Step 2 Step 3 Clea ad check the Mixtower. Usig a cotto tipped applicator, swab out the Mixtower with 25% dilute Clorox bleach. Prime the Mixtower. Usig a trasfer pipette, dispese about 2 ml of 25% bleach ito the Mixtower durig its dryig cycle. Repeat for about six cycles. Prime the Mixtower for about 1 miute. The water level should ot rise above the air ozzles iside. Be sure a white, etched appearace is visible ad o moisture is see at the bottom of Mixtower betwee primes. Liste for three swishig souds betwee prime cycles. If the Mixtower is ot primig, check the B tubigs uder the bridge which is screwed oto the aalyzer. They may be crimped. Remove the Mixtower ad check for hairlie cracks. Reistall the Mixtower. Be careful ot to crimp the tubigs. Remove ad clea the ISE Shuts ad Electrode Spacer. Drai Stadard 1 ad Stadard tubigs dry <INFO> <6> <6> <2>. Pick the straw up from the stadard bottle ad slide the tubigs out from uder the valves. Press <F1> <STOP>. Perform Valve Disegagemet <INFO> <6> <6> <3> <F1> Start. Remove both ISE Shuts. Do ot allow the valves to remai i the up positio; they will overheat. Ope the Faraday Cage by pressig the upper black part o the left side of the cage. Remove the electrodes ad Electrode Spacer located at the left of the Chloride electrode (remove from the tubig). Usig a isopropyl alcohol wipe, clea out the Faraday cage. Dry the cage with a lit-free tissue (Kimwipe). Clea out the shuts ad Electrodes Spacer usig a trasfer pipette ad 25% dilute Clorox bleach. Rise well with reaget grade water ad shake dry. The shuts ca be scrubbed by passig Oral B brad - Super Floss through each fittig. Replace ISE Tubig. Remove the Stadard 1, Stadard 2, ad Referece solutios. Drai Stadard 1 Stadard 2 tubigs dry <INFO><6><6><2>. Perform Valve Disegagemet, <INFO> <6> <6> <3> <F1> Start. Release the tubigs from uder the pich valves. Press <F1><STOP>. Do ot allow the valves to remai i the up positio; they will overheat. Replace tubigs K, J, F, ad H (refer to ISE Tubig Set diagram). Replace Full ISE Tubig Set if ecessary. Ustables Occurig o ISE Calibratios Step 1 Clip the tubig at the Stadard Level 1 ad 2 straws. Prime Stadard 1 <INFO> <6> <6> <1> <F1> Start. Pick the straw up from the Stadard 1 bottle ad watch for air to come through the tubig. Press <F1> Stop. Replace the straw i the Stadard 1 bottle. Remove the tubig from the straw. Clip about 1/8 ich from the ed of the tubig ad replace it o the straw. Reprime the Stadard. Repeat the procedure with Stadard 2. Request a calibratio uder Routie. 42 COBAS MIRA System User s Guide

Troubleshootig ISE Module Ustables Occurig o ISE Calibratios (cot d) Step 2 Step 3 Clea the large ISE Shut, Electrode Cage, ad tubigs. Remove the Stadard 1, Stadard 2, ad Referece solutios. Drai Stadard 1 ad Stadard 2 tubigs dry <INFO> <6> <6> <2>. Perform Valve Disegagemet <INFO> <6> <6> <3>. Move the tubig out from uder each pich valve. Remove the large Liquid Shut. Do ot allow the valves to remai i the Up positio for more tha a few miutes; they will overheat. Clea out the shut usig a trasfer pipette ad 25% dilute Clorox bleach. Rise well with reaget grade water. The shut ca be scrubbed by passig Oral B brad - Super Floss through each fittig. Reistall the shut. Remove the electrodes. Do ot discoect the Referece Electrode tubigs from the electrode or the pump posts. The Referece electrode ca be folded over to the right of the Faraday Cage. Remove ad clea the Electrode Spacer located to the left of the Chloride electrode. Use a isopropyl alcohol wipe ad lit-free tissues to clea ad dry iside ad aroud the Faraday Cage. Reistall the spacer ad electrodes. Prime tubigs ad replace ISE Stadards ad ISE Tubig Set. Isert each of the two metal straws of Stadard 1 ad 2 i separate cotaiers filled with warm reaget grade water. Prime Stadard 1 ad Stadard 2 tubigs with reaget grade water for two miutes each. Be sure to check that all tubigs are primig. Follow by primig air for at least oe miute. Wipe the straws dry with a lit-free tissue. Replace the ISE Stadards with ewly opeed solutios. Replace the ISE Tubig Set if ecessary. Low Results or Poor Precisio Cleaig the Mixtower may resolve this problem. If sodium results (oly) are low, see ISE Troubleshootig Sodium Quality Results Low or Sodium Slope Low. Step 1 Step 2 Review History of Complait. Compare curret quality cotrol results to established quality cotrol meas. Has there bee a lot umber chage i QC material? Review recet ISE maiteace. Has the ISE Tubig Set bee chaged i the last 6 moths? Did problems occur after a tubig chage? Are the electrode treatmets performed at the recommeded itervals? (Refer to Electrode Maiteace Schedule.) Check ISE parameters. PROG <2> TESTS Coversio Factor set to 1.0000 ad Offset 0.0000 for each ISE test. INFO <3> CALIBRATION CONTROL displays curret Calibratio Slopes ad programmed Stadard cocetratios. Check that the programmed stadard values match the cocetratios o the ISE stadard bottles. COBAS MIRA System User s Guide 43

Troubleshootig ISE Module Low Results or Poor Precisio (cot d) Step 3 Perform Fluid Adjust <INFO> <6> <6> <4>. Repeat the Fluid Adjust to verify that the sample positio is stable. The head of the sample segmet must stop iside the chloride electrode positio. It is permissible for a few leadig bubbles to be i the begiig of the sample slug. The remaider of the sample slug should ot be broke up with air bubbles. If Fluid Adjust is erratic, see ISE TROUBLESHOOTING Fluid Adjust Problem. Step 4 Perform Routie Electrode Treatmets <INFO> <6> <6> <5>. Step 5 Step 6 Perform the treatmets i the followig sequece: Clea the electrodes with 25% bleach (deproteiizes the sample pathway). Etch with ISE Etcher (icreases the sesitivity of the Sodium electrode). Serum Activate (coditios the tubig ad electrodes). Clea ad check the Mixtower. Usig a cotto-tipped applicator, swab out the Mixtower, with 25% dilute Clorox bleach. Prime the Mixtower. Usig a trasfer pipette, dispese 25% bleach ito the Mixtower durig its dryig cycle. Repeat with bleach for about six cycles. Prime the Mixtower for about 1 miute. The water level should ot rise above the air ozzles iside. Be sure that a white, etched appearace is visible ad o moisture is see at the bottom of Mixtower betwee primes. Liste for three swishig souds betwee prime cycles. If the Mixtower is ot primig, check the B tubigs uder the Sample Etry Bridge. They may be crimped. (Refer to ISE Tubig Set diagram). Remove the Mixtower ad check for hairlie cracks. If the Mixtower is cracked, it must be replaced. Reistall the Mixtower. Make sure tubig coectios are correct. Remove ad clea the ISE Shuts ad Electrode Spacer. Remove the Stadard 1, Stadard 2, ad Referece solutio bottles. Drai Stadard 1 ad Stadard 2 tubigs dry <INFO> <6> <6> <2>. Perform Valve Disegagemet <INFO> <6> <6> <3>. Remove both ISE Shuts. Do ot allow the valves to remai i the Up positio; they will overheat. Clea out the shuts usig a trasfer pipette ad 25% dilute Clorox bleach. Rise well with reaget grade water ad shake dry. Ope the Faraday Cage. Remove the Electrode Spacer located to the left of the Chloride electrode. Clea with 25% Clorox bleach. Rise well with reaget grade water ad shake dry. Reistall. Step 7 Clea Waste Fittig W1. Discoect tubig L from waste fittig W1 (see ISE Tubig Set Diagram). Fill a 10 ml syrige with 25% bleach. Use a Butterfly tubig that has the eedle ed cut off to coect the syrige to waste fittig W1. Perform Drai Stadard 1 <INFO> <6> <6> <2> <1> <F1> <START>. Use moderate pressure o the syrige pluger to clear iteral blockages. Recoect tubig L. Isert the Stadard 1 straw ito a beaker cotaiig 100 ml of 25% dilute Clorox bleach to clear iteral blockages. Press F1 Start. Follow with 200 ml reaget grade water. 44 COBAS MIRA System User s Guide

Troubleshootig ISE Module Low Results or Poor Precisio (cot d) PLUS - Proceed to Step 9. Step 8 Tur off Level Detectio <PROG> <6> <5>. If results are OK, replace reaget probe. If results are ot OK, proceed to Step 9. Step 9 Perform <INFO> <6> <6> <6> CALIBRATION ad MEASUREMENT. DO <INFO> <6> <6> <6> Calibratio first to establish a slope for the diagostic measuremet. DO <INFO> <6> <6> <6> Measuremet of both ISE Stadards as samples four times each for Na, K, ad Cl. This is a quick check of precisio. Place a sample cup cotaiig a stadard i the cup positio idicated o the display. Typical recovery is: Na K Cl Stadard 1 148-151 2.9-3.1 135-140 Stadard 2 97-103 6.8-7.1 89-95 If recovery o ay oe measuremet is outside of rages perform the followig: Replace Stadards Set. Replace ISE Tubig Set. Replace sample eedle. Replace tygo tubig loop (Classic). Replace electrode(s). Fluid Adjust Problem Step 1 Step 2 Check/replace ISE tubig. Remove the Stadard 1 ad Stadard 2 solutios. Drai Stadard 1 ad 2 tubigs dry <INFO> <6> <6> <2>. Pick the straw out of the bottle to drai the stadard. Check air segmetig tubig K for cuts or poor fit. Check air iput tubigs (2), M for cuts or poor fit. Check all tubig coectios at ISE shuts ad uder pich valves. Check the peristaltic pump tubigs. Tubig G may be flatteed. Clea the sample pathway. Usig a cotto applicator, swab out the Mixtower with 25% dilute Clorox bleach. Prime the Mixtower. Usig a trasfer pipette, dispese 25% bleach ito the Mixtower durig its dryig cycle. Repeat with bleach for about six cycles. Prime the Mixtower for about 1 miute. The water level should ot rise above the air ozzles iside. Be sure a white, etched appearace is visible ad o moisture is see at the bottom of the Mixtower betwee primes. Liste for a swishig soud betwee primes. COBAS MIRA System User s Guide 45

Troubleshootig ISE Module Fluid Adjust Problem (cot d) Step 3 Step 4 Step 5 Step 6 Check the Electrode O-Rigs ad Electrode Spacer. Remove the Stadard 1 ad Stadard 2 solutios. Drai Stadard 1 ad 2 tubigs dry <INFO><6><6><2>. Ope the Faraday Cage ad be sure all electrodes are istalled correctly. A O-rig must be o the left side of each electrode. Replace the O-rigs if ay leakage is visible betwee the electrodes. Remove the plastic Electrode Spacer to the left of Chloride electrode from the tubig. Use a trasfer pipette to push 25% bleach through the spacer. Repeat with reaget grade water. Replace the ISE Tubig Set. Check waste fittig W2 for blockage. Fill a 5 ml syrige with 25% bleach. Use a Butterfly that has the eedle ed cut off to coect the syrige to Waste fittig W2. Use moderate pressure to clear blockages. Check the peristaltic pump. Remove the peristaltic pump tubigs. Use a stylet to clea out ay deposits iside the tubig fittigs at the pump wheel. ISE Module No Respose Message The ISE iterface is cotrolled by the COBAS MIRA aalyzer. The RS-232 cable iterfaces the two uits together. Lie power fluctuatios or iterruptios ca break off commuicatio betwee the two istrumets. This aalyzer will exhibit the followig error, ISE No Respose. The ISE is o loger accessible through the aalyzer software. This error ca be resolved by takig the followig steps. Step 1 Step 2 Step 3 Step 4 If there are ay test results that are prited, go to <INFO><2>, <F2> Iterim Report ad press <PRINT>. (Results that are ot prited are lost whe the istrumet is powered off.) Power off the aalyzer ad ISE. The ISE power switch is located aroud the back left side of the module above the power cord. Perform ISE Power Up Sequece. Wait 1 miute; switch o the ISE; wait aother miute; the power o the aalyzer. The ISE iitializes i about 10 secods. If Step 2 is usuccessful, power off the aalyzer ad ISE. Check, reseat the aalyzer to ISE Module iterface (grey) cable. Perform ISE power up sequece. If Steps 1-3 are usuccessful, power off the aalyzer ad ISE ad uplug the istrumet. Check the mai power fuses FS1 ad FS2, which are located just above the power switch i the back of the module. Pry the small, black flap ad ope with a flat blade screwdriver. If the orage Idicator Light o the frot of the ISE Module is ot illumiated whe the ISE power is o ad the bulb ot bured out, replace the fuses. Remove ad check FS3 ad FS4; replace if ecessary. Perform ISE Power Up Sequece. If the ISE does ot iitialize, cotact the Customer Techical Support at 1-800-428-2336. 46 COBAS MIRA System User s Guide

Troubleshootig ISE Module Slope Rage The 2-poit calibrated slope is lower/higher tha the programmed limit. 1 Check programmed slope limits (<PROG> <6> <1>). Modify if ecessary. Low High Na 45 68 K 50 65 Cl -60-30 2 Prime (<INFO> <6><6> <1>) Stadards 1 ad 2 ad Referece Solutio. Lift straw out of Stadard bottle to itroduce a air bubble ad watch it prime through the lie. Chage stadards/tubig if ecessary. Repeat 2-poit calibratio by pressig <START>. 3 Stadards are empty or cotamiated. Replace solutios ad prime. Repeat calibratio. 4 Slow respose o electrodes: < Slope Rage o Sodium: Perform Etch. (Check expiratio date of Etcher Solutio; use tip cleaer if ecessary.) Follow with a Activatio ad 2-poit calibratio. < Slope Rage o Potassium or Chloride: Perform Clea with 1:4 dilutio of Clorox bleach. Follow with a Activatio ad 2-poit calibratio. > Slope Rage o all electrodes: Perform a Etch usig huma serum as the solutio. CALC Error The 2-poit calibrated slope of the electrode is zero. 1 Prime (<INFO><6><6><1>) Stadards 1 ad 2. Pick the straw up out of the stadard bottle to pull up a air bubble ad watch it move through the tubig. While primig, check the stadard tubig uder the pich valves for salt crystals. Roll the tubig betwee your figers to break up the crystals. Chage stadards/tubig if ecessary. Repeat 2-poit calibratio by pressig <START>. 2 Replace electrode(s); repeat calibratio. 3 If problems persist, call Customer Techical Support at 1-800-428-2336. Leakage i Electrode Cage Drai the Stadard 1 ad 2 lies dry, Ifo, 6, 6, 2. Ope the Faraday Cage by pressig the upper black part o the left side of the cage. Remove the electrodes ad check each oe for a itact O-rig that is seated properly. Clea out the cage with a lit free tissue ad a little reaget grade water, dry, ad wipe out the cage with a alchohol prep ad allow it to air dry. Reistall all electrodes ad lock the cage. Prime Stadards. COBAS MIRA System User s Guide 47

Troubleshootig ISE Module Slope o Chloride Electrode Icorrect Causes Electrode must be reactivated Actio Clea of the electrodes with 25% bleach solutio. Too Low or No-Reproducible ISE Results Causes Electrode over coditioed Icorrect adjustmet of the sample Mixtower ot dryig thoroughly Cotamiated stadard or referece Cotamiated sample eedle/tubig Cotamiated tubig o the ISE Ivalid flow of referece electrolyte Too High ISE Results Causes No water flow durig mixtower prime Actio Reduce frequecy of etchig procedures from daily to weekly if less tha 20 samples are ru per day. Perform Serum Etch to brig the Na slope dow. (Use serum rather tha ETCHER solutio.) Check fluid adjust. (See segmet i the electrode chael Maiteace sectio.) Follow Mixtower Overflow procedures. Place ew stadard 1, stadard 2, ad referece bottles o the ISE module. Prime. Regularly perform daily maiteace icludig the eedle/tube cleaig. Replace the sample eedle ad tubig o the trasfer arm. (Classic) Regularly perform daily maiteace icludig cleaig of the electrodes. Replace the ISE tubig o the ISE module, if ecessary. This is a 6-moth maiteace procedure. Check flow by primig <INFO><6><6><1>PRIME SYSTEM. Choose 3 for the referece solutio ad observe the pearl chai effect at the electrode. Refer to page 6.40 i the COBAS MIRA Plus Operator s Maual for help. Actio Check tubig uder the bridge from the aalyzer to the ISE; it may be crimped shut. Uscrew the black kurled screw ad lift the bridge to check the tubig. 48 COBAS MIRA System User s Guide

Troubleshootig Probes ad Pipettors Troubleshootig for Probes ad Pipettors Classic, Plus, L, ad S Pipette Drive Assembly Dirt buildig up o the pipette drive assembly or a lack of lubricatio ca cause P (Reag. Samp) Step Errors ad P (Reag. Samp) 0 Pos Errors. These errors ca be resolved by cleaig ad lubricatig the followig assembly. 1 Remove the cover to the syrige assembly. Locate ad clea the metal pipette guide rods with a alcohol prep. 2 Dry the rod assemblies with a tissue or lit-free tissue. 3 Lightly lubricate the guide rods with WD-40 or aother light lubricat. 4 Check operatio of istrumet uder prime, <INFO> <6> <1>, Z POSITION: UP, PIPETS: ON. 5 Chage syrige tips if errors occur. COBAS MIRA System User s Guide 49

Troubleshootig Probes ad Pipettors Notes 50 COBAS MIRA System User s Guide

Flags ad Messages Flags ad Messages Commo Flags ad Error Messages with Possible Solutios SIGN No reactio or reactio was detected i the opposite directio as programmed. 1 Air bubble or fibri i sample cup remove or repour. Check prime of sample eedle. Press <INFO><6><1>. 2 Out of start (secod) reaget or sample replace. 3 No aalyte detected, egative (Bilirubis, Alcohol, etc.) report as such. 4 Wrog reaget i reaget rack replace. 5 Substrate exhaustio (ezymes) dilute ad reassay. > SAMPLE LIMIT Differece i absorbace betwee sample cuvette ad reaget blak cuvette at the defied readig exceeds the programmed limit. 1 Caused by hemolyzed, icteric, ad lipemic specimes check itegrity of specime ad ote. The istrumet cosiders the result valid. Follow your lab protocol for evaluatig ad reportig the result. 2 If flag occurs frequetly o oe assay, check reaget stability. If flag cotiues to be prevalet, recalibrate the assay with fresh reaget to store a ew reaget blak. Dow Arrow Automatic post-dilutio. The iitial value was greater tha the test rage of the assay. The istrumet performed a post-dilutio. The ew value was multiplied by the dilutio factor ad is the reported result. > Reactio Limit Chage i absorbace betwee a first readig ad defied poit are ot withi the programmed limit. Very high ezyme cocetratio i sample Repeat with diluted sample (automatically doe if postdilutio is programmed.) > or < TEST RANGE Result is outside the liear rage. 1 High samples Repeat with diluted sample (automatically doe if post-dilutio is programmed). 2 Low samples Report as lower tha test rage; or if post-cocetratio is programmed, a larger sample volume is reassayed automatically. CALC ERROR Calculatio program caot calculate a result. 1 Check parameters ad math model i test parameters. 2 Esure calibrator was prepared per package isert. Prepare fresh calibrator as directed. 3 Reassay usig fresh reagets. COBAS MIRA System User s Guide 51

Flags ad Messages CALC RANGE Commoly see o the highest or lowest stadard of a o-liear calibratio curve. The calibratio is acceptable uless the message is prited for aother level of calibrator other tha the highest or lowest. (Refer to the Data Aalysis sectio of the appropriate aalyzer operator s maual.) > or < REAGENT RANGE O calibratio, reaget blak does ot fall withi programmed absorbace limits. 1 Old reagets prepare fresh. 2 Reagets are ot allowed to sit log eough after recostitutio prepare fresh as directed. 3 Recostituted icorrectly prepare fresh as directed. 4 Check the water used to recostitute for bacterial cotamiatio. Prepare reaget with reaget grade type 1 water from a differet source. 5 Verify that all maiteace has bee performed recetly. Check for bacterial cotamiatio i water reservoir or washtower. Verify that ew cuvettes are beig used. Do ot use washed cuvettes. > or < BLANK RANGE O calibratio, there is a absorbace chage (reactio) outside the programmed rage. 1 Cotamiated reagets prepare fresh. 2 Cotamiatio o system check reaget probe, washtower, water reservoir, cuvettes, ad maiteace performed. 3 Reagets are ot allowed to sit log eough after recostitutio prepare fresh ad allow to sit as directed. 52 COBAS MIRA System User s Guide

Flags ad Messages C (Cofidece) Error Report Calibratio Error Follows results o tests with uacceptable calibratios or cotrols. 1 Check test parameters. Correct if ecessary. Verify that the calibrator value is correct for the lot umber used. For edpoit assays, check the factor agaist the factor rage. 2 Recostitute fresh reaget ad calibrator. Reassay. 3 Check P150 ad P250 if error reoccurs. 4 Obtai raw data: <INFO> <1> Test Results, <F1> Data,<F3> Raw Data, <ENTER> for all samples, select the test, <PRINT>. Data must be requested immediately after a ru is completed. 5 If the error remais, call Customer Techical Support at 1-800-428-2336. Cotrol Error <or> Cofidece Rage 1 Check programmed rages for the lot umbers of cotrols used. Correct if ecessary uder <PROG> <5> Racks, select the Cal/CS rack, <F2> Cotrols, <F1> Chage Rage. 2 Check the calibratio factor agaist the factor rage for a edpoit assay. Recalibrate with fresh reaget ad calibrator if ecessary. If the factor is correct, recostitute fresh reaget ad cotrol. Reassay. 3 Check P150 ad P250 if error reoccurs. Perform maiteace if ecessary. 4 Obtai raw data: <INFO> <1> Test Results, <F1> Data, <F3> Raw Data, <ENTER> for all samples, select the test, <PRINT>. 5 If the error remais, call Customer Techical Support at 1-800-428-2336. To Accept Flagged Results 1 Press <INFO>. 2 Press <1> Test Results. 3 Press <F2> Accept Patiet. 4 Select sample cup umber, or press <SPACE> for all samples. 5 Select test to be accepted. Results will be marked with a A. For software versios <8735, press <INFO><1><F1> Cov, select samples ad tests ad correct flagged parameters. The press <F2> Calc, review recalculated results ad press <F3> Accept Patiet if acceptable. To Reactivate Results You ca reactivate either flagged results (sigle or multiple) or uflagged results depedig o the fuctio key selected. <F3> React Select specific or all samples ad tests. Results ad/or flags are removed, ad the request is reactivated o the worklist. For Software versio > 9215, <F3> React oly affects flagged results. <F4> React All (Software versio >9215) Selectio applies to all results, flagged or valid. Results ad/or flags are removed, ad the request is reactivated o the worklist. COBAS MIRA System User s Guide 53

Flags ad Messages Reservoir Bottle Empty or No Water Available Fill reservoir ad empty waste cotaier. Press <TEXT> key to clear the message ad activate pumps. If message cotiues, remove i-lie filter o exteral reservoir bottle. Black filters have a fie mesh scree that ca be removed ad cleaed. Uscrew the base of the filter to get to the mesh scree. Clea with 25% bleach. Rise well with reaget grade water ad reistall with the base (wider ed) closer to the reservoir. Trasparet filters are disposable ad must be replaced. Level Detectio (LD Errors) Check reaget probe placemet remove probe ad clea cotact, or try ew probe. Check cocectios i the trasfer arm. Plus oly LD (Reag, Sample), KHZ value: a) low KHZ (4.8, 5.2 etc), moisture issue. Dry probe/eedle housig with lit-free tissue, caed air. b) KHZ value ear 70, reaget probe or sample eedle istalled icorrectly. Trasfer Area Blocked or XYZ Remove ay obstructio (reaget caps, elbows, misplaced racks, etc.) Oce corrected, press <START>. Worklist Not Empty Routie or STAT worklist is ot empty. The worklist must be deleted before a modificatio is possible. Check Ifo 3 ad Ifo 4 for ay tests that are blikig. This idicates that a precalibratio or precotrol has bee ordered. Go to Routie to chage the request to CA or CS to take the requests off the worklist (without ay patiets ordered). 54 COBAS MIRA System User s Guide

Error Codes Error Codes Obtai hardcopy of data that has ot yet prited uder INFO <2><F2> ad press prit. $ Before removig ANY covers off of the aalyzer, power off the istrumet ad uplug the power cord. Error Code Numbers Actio 1-14 Power off/o, reseat Photometer PCB I additio for these errors: Switch off overhead lights 1, 11, 12, 13 Cover rotor lid with dark paper, provide hole for pipettig ito cuvette 9 Reseat Motor Cotrol 1 PCB 15-17 Power off/o Reseat flat gray cable o Motor Cotrol II PCB 18, 21, 31 Power off, rotate rotor maually, remove cuvettes ad check for obstructios Blow air o sesor at 9:00 positio o rig Reseat Motor Cotrol 1 PCB 20 Check for obstructios i left to right directio Clea off X guide rails Blow air o sesor o left side of istrumet Power o/off Reseat Motor Cotrol 1 PCB 23, 24, 25, 27, 28, 33, 34, 35 Check for obstructios i the correspodig directio Lubricate appropriate drive shaft Power off/o I additio for: 25 ad 28 Push dow o Z drive mechaism ad retry (Classic, S/L oly) 35, 38, 39 (Plus/Plus CC Clea ad lubricate THK rails uder orage belt. ONLY) I additio for: 39 Check for wires, tagles with barcode reader 40 Power off/o Reseat Motor Cotrol 1 PCB 41, 42 Power off/o Reseat Motor Cotrol II PCB 43 (Classic oly) Power off/o Reseat CRT Cotrol PCB 44 (Classic oly) Power off, clea ad lubricate priter drive assembly ad power o. Power off, reseat keyboard cable, power o 46 Power off/o Call Customer Techical Support 47 Power off/o Check flashbox fuse Check fuses i back of Classic oly COBAS MIRA System User s Guide 55

Error Codes Error Code Numbers Actio 48 Dry reaget probe ad temp head LD errors/r = XkHz Blow air o itercoect board Touch Error Check for water leakage o itercoect board S/R Empty Check for bleach i water system 49 Clear paper from priter ad re-feed paper Press the TEXT key Power off/o 50, 51 Power off/o 52 Power off/o Plus/Plus CC oly: Blow air o itercoect board Reseat cables o temp head 56 Power off aalyzer ad exteral computer Reseat ad check cable coectios Power up computer the aalyzer 57 Check PROG <6> <3> ad verify they match the computer Power off ad the computer o ad the aalyzer 59 (S/L Plus/Plus CC oly) Power off/o Reseat Commuicatios Cotrol PCB 65 Memory is corrupted, page service 74 Power off/o Clea ad lubricate associated guide rails 75, 76, 77, 78 Clea ad dry sample ad reaget probes Ru RS eedle adjust (INFO <6><7><2>) Verify aalyzer cover/switch is closed 99 Clea rack reader Power off/o 110 Page service 132, 133, 134, 135, 136, 137 Check aalyzer for obstructed cuvettes Maually remove all cuvettes from aalyzer Ru INFO <6><8>, Load/Uload commads 138, 139 Power off/o Reseat the Chager/Cooler Cotrol PCB 144, 145 Power off/o 148 Check for trasfer arm obstructios Clea rack reader Verify placemet of R5s#1 ad 16A racks i positios 1 ad 3 of rack plate Ru RS eedle adjust Power off/o 56 COBAS MIRA System User s Guide

No-Routie Procedures No-Routie Procedures To Accept a Out-of-Rage Cotrol Accept out-of-rage cotrols oly with appropriate justificatio. 1 Press <INFO>. 2 Press <1> Test Results. 3 Press <F1> Data. (Skip this step if software versio <8735.) 4 Press <F1> Covert. 5 Press <ENTER>. 6 Select appropriate test. 7 Press <F3> Calc Check=Off. 8 Press <F4> Eter Test. To Obtai Raw Data 1 Press <INFO> <1> Test Results. 2 Press <F1> Data. (Skip this step if software versio <8735.) 3 Press <F3> Raw Data. 4 Press <ENTER>. 5 Select appropriate test or press <SPACE> to select all tests. 6 Press <PRINT> for a pritout of raw data. 7 Press <F1> Plot to plot absorbace readigs versus time. Press <PRINT> for a hard copy. Deletio of Tests From Profile ad Test Meu To delete a test file ame ad parameters, proceed as follows: (QC must be closed first) 1 Press <PROG><2> to access the TESTS program. The scree displays the assigmet table for test level 1. 2 To chage the display to aother test level, press <F4> TEST LEVEL ad select the correspodig umber (1 to 4). 3 Select the test key (A to Z) to be deleted. The first page GENERAL of the test parameters appears. 4 Press <F1> MODIFY. The cursor appears at the first parameter. 5 Press <F2> DELETE TEST. The message CONFIRM BY ENTER appears. Press <ENTER>. The etire test file is the deleted, ad the scree displays the test assigmet table. The test is also deleted from ay profile to which it was assiged. Select aother test or press <ESCAPE> to exit the TEST sectio. COBAS MIRA System User s Guide 57

No-Routie Procedures Total ad Direct Bilirubi Calibratio Procedure Obtai a ew calculatio factor mothly, whe a ew lot umber of reaget is used, or cotrols idicate a eed to calibrate. 1 Provide fresh calibrator ad reagets for Total ad Direct Bilirubi i the proper rack positios. 2 Order precalibratio (PCA or PC) for TBIL 3 Press <START> to begi the calibratio. 4 The ew calculatio factor prits ext to *F. Verify that the factor is i rage for the assay. 5 Modify the Direct Bilirubi Factor Parameter uder Program 2 with the ew Total Bilirubi Factor. To modify a parameter, quality cotrol results must be closed for the test, ad the worklist must be empty. Check paper supply. Press <INFO><4>. Choose test; press Close Quality. Press Eter. 58 COBAS MIRA System User s Guide

COBAS MIRA Spare Parts COBAS MIRA Spare Parts Spare Part Aalyzer Part Number Sample Needle Classic (5/pkg) 29274 Tubig 8089426 Brass Collar 7300264 S, L (1 Cassette) 28078289001 Plus (3/pkg) 8078343 Reaget Probe All aalyzers 8077347 Foam Isert-Washtower Plus 8078653 Syriges All aalyzers Reaget (1000uL) 8078955 Sample (100uL) 28076812001 Syrige Pluger Tips All aalyzers Tip for Reaget Syrige 8061173 Tip for Sample Syrige 8061165 Cuvette Segmets All aalyzers Case of 500 29894 For chager; case of 300 44077 Reaget Cotaiers All aalyzers R5S Reaget Cotaier (15mL) 37307 R5S Reaget Cotaier (35mL) 37293 Reaget Cotaier (4 ml) 34634 Reaget Cotaier (10mL) 34626 Glass Vials/Caps (12 ml, 25/pkg) 44042 Sample Cups All aalyzers Blue 06789 Red 19449 White 27115 Yellow 22016 Reaget Racks All aalyzers Reaget 10 Rack 39630 Reaget 5s Rack 38036 Sample Racks All aalyzers Sample 30 Rack 39631 Sample 16a Rack 42125 Sample 16b Rack 42126 Cal/Cs Racks All aalyzers Cal/Cs 8 Rack 8078963 Cal/Cs 30 Rack 39631 Diluet Filter All aalyzers I-lie filter o water reservoir tubig 8089086 Solutios All aalyzers Precisio Testig Set 44337 Tip Cleaer 42282 Reaget Water 47442 Etcher Solutio 42374 COBAS MIRA System User s Guide 59

COBAS MIRA Spare Parts Spare Part Aalyzer Part Number Tubig ISE All aalyzers Tubig Set 8077975 Electrodes All aalyzers Na 1029371 K 1029355 Cl 1039415 Referece 1029398 Stadards All aalyzers Stadard 1 46997 Stadard 2 46998 Referece Solutio 46999 Priter Paper Classic Thermal Paper (80 mm) 27180 S, L, Plus Thermal Paper (110 mm) 44019 60 COBAS MIRA System User s Guide

Iterfacig Iterfacig to COBAS MIRA Systems Classic (Serial Numbers below 26-5437) This istrumet model ca be idetified by the tygo tubig loop over the sample eedle. Requires Uiversal Iterface prited circuit board(s) (Part No. 9490630). If a Classic is iterfaced to two compoets, (for example, the ISE module ad a host computer) two boards are ecessary. The switches are hard-wired o this board ad must be set correctly before commucatios ca take place. Classic Iterface Board ISE Switch Settigs Set to ON positio: Set to OFF positio: Switch umbers Switch umbers 2, 8, 12, 13, 18, 19 1, 3, 5, 6, 7, 9, 10, 11, 14-17, 20-23 Switch #24 set to positio 2. S4 positio #3 for 2400 Baud rate Host Computer Switch Settigs Set to ON positio: Set to OFF positio: Switch umbers Switch umbers 7, 11 5, 6, 8, 9, 10, 12 Switch #24 set to positio 2. Switch settigs S4 (Baud Rate) ad S13-S24 are set to the host computer specificatios. The switches o the board are labelled with S ad a umber. Refer to the followig tables. Board Cofiguratio Classic Fuctio Switch ON OFF Number Address selectio S1 madatory Address selectio S2 madatory Address selectio S3 madatory Baud rate S4 9600/4800/2400/1200/600/300/150/110 Baud Address selectio S5 refer to Address Defiitios, page C-4 of S6 COBAS MIRA Classic Operator s Maual, S7 Appedix S8 S9 S10 S11 S12 COBAS MIRA System User s Guide 61

Iterfacig Board Cofiguratio Classic (cot d) Fuctio Switch ON OFF Number OPERATING MODE 1: CTS* S13 CTS = 1 (o hadshake) Hadshake Operatig Mode S14 Hardware Echo* S15 eabled disabled Parity bit* S16 disabled eabled Parity check* S17 ODD EVEN Data format* S18 7 bits 8 bits Stop bit* S19 1 bit 2 bits Lie Termiatio S20 CR, LF (COBAS Output oly) S21 CR, LF, XOFF S22 CR, LF, XOFF, DEL LF S23 CR, LF, XOFF, DEL, DEL Trasfer mode S24 U:RS-232-C (switch pos 2) I: 20mA curret loop * refer to page C-3 of the COBAS MIRA Classic Operator s Maual, Appedix Fuctio Switch ON OFF Number OPERATING MODE 2: Not used S13 Operatig Mode S14 XON/XOFF Not used S15 Parity bit* S16 disabled eabled Parity check* S17 ODD EVEN Data format* S18 7 bits 8 bits Stop bit* S19 1 bit 2 bits Lie Termiatio* (Output) S20 CR, LF LF CR-Killer* (Iput oly) S21 eabled disabled Not used S22 Not used S23 Trasfer mode S24 U:RS-232-C (switch pos 2) I: 20 ma curret loop * refer to page C-3 of the COBAS MIRA Classic Operator s Maual, Appedix 62 COBAS MIRA System User s Guide

Iterfacig S, L, Plus ISE Commuicatio This requires the Multi-Iterface prited circuit board, part umber 9001340 (oemc) or 8069263 (EMC). Refer to the diagram below for the proper locatio of the ISE iterface cable. Cable Coectio for Host Cable Host Commuicatio Plug a RS-232 cable ito the RS-232/HOST port of the CPU as idicated above. <PROGRAM> <6> <3> (Output Mode) parameters are set to correspod with the host computer. Uder the Iterface headig o the first scree, the status parameter is set to o. This turs o the RS-232 iterface. Refer to the Programmig sectio of the operator s maual for the list of parameters ad optios for the S, L, ad Plus. COBAS MIRA System User s Guide 63

Iterfacig RS-232 Cable 25-25 Pi Cofiguratio (PC) Host TxD 2 3 RxD COBAS MIRA aalyzer RxD 3 2 TxD Com 1 or Com 2 RTS 4 8 DCD Iterface Coector CTS 5 6, 20 DTR Sub D 25 Female DTR 6, 20 5 CTS Sub D 25 Female DCD 8 4 RTS GND 7 7 GND 9-25 Pi Cofiguratio (PC) Host CD1 1 COBAS MIRA aalyzer RxD 2 2 TxD Com 1 or Com 2 TxD 3 3 RxD Iterface Coector DTR 4 4 RTS Sub D 9 Female DSR 6 5 CTS Sub D 25 Female GND 5 7 GND RTS 7 8 CD 6 CTS 8 20 DTR 64 COBAS MIRA System User s Guide