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9. maintenance and troubleshooting

1. 2 1 ZA INSPECTION TTE 2 1 22 sien vote rin e 2 1 2 3 PACKAGE GONTENITS IN RRRARERARRRAR ASEE 2 2 2 4 WORKING CONDITIONS 2 3 2 41 ME t ES 2 3 2 4 2 EO CAC OM mme 2 3 ea 2 3 2 4 4 Humidity and temperature conditions esee enne nennen nennen nnns 2 3 2 5 VISUAL CHECKS E 2 3 2 5 1 Mechanical check AAA 2 3 2 9 2 Connection Check iore b ea eaa EE aR eE 24 2 6 REAGENT PACK CONNECTIONS 2 5 2 7 REAGENT AND WASTE HANDLING PRECAUTIONS 2 6 2 8 ELECTRICAL CONNECTIONS 26 2 9 GENERAL POINTS unitaria leia 2 6 2 10 PRINTER nn nn nna nnns nena nnn nnns 2 6 2 10 1 Connection senna axe und ca enini nexu o ded eua E P I Decree 2 7 2 11 REAGENT PRIMING oc
2. AARE EERE AAA 2 7 CHAPTER 3 SPECIFICATIONS 3 1 3 1 PERFORMANCE SPECIFICATIONS 2 2 2 ue nennen aine a 3 1 3 1 1 Expected Values irre tein nete titre hx ER ERROR RR Rupe RREDRRRR REIR RRA A RR RR n RARAS 3 4 3 2 REAGENT SPECIFICATIONS 521i reiten oae A AA Eu YR 3 6 3 2 1 Diluent sysDIL ooo trunco uuu ape tenax Rn n Rn n poii 3 6 3 2 2 Lyse SySLYSE coccion iii E ERE DDAR ARR XRREREOIARARYARR SR SR RR IN XR ERR DAR RN RE ERE Cia 3 6 3 2 3 Detergent sysKLEN inea Ri 3 7 3 2 4 SysCLEAR bleach solution 2 rorniin itane E bak xA ERE Deka 3 7 3 2 5 iii A A ENEIT SR RR R Y ARA 3 7 3 3 3 7 ARA 3 7 3 3 2 Caps of the sampling tubes es 3 8 3 9 3 Blood SPECIMENS A RA 3 8 3 3 4 Known interfering substances 3 8
3. Diag 4 1 The counting principle used for red blood cells RBC white blood cells WBC and platelets PLT is based on the variation in impedance generated by the passage of cells through a calibrated microaperture 1 The sample is diluted in an electrolytic diluent current conductor The conductivity of the diluent differs considerably from the non conductivity of the blood cells 2 The dilution is pulled through the calibrated microaperture Two electrodes are placed on each side of the aperture Electric current passes through the electrodes continuously 3 When the cell passes through the aperture electric resistance or impedance between the two electrodes increases proportionately with the cell volume Volts Pulse Time Electrodes Analyzing Electronic Circuit Constant Vacuum Constant Solution to be Analyzed 075D0002 01 Page 4 1 4 TECHNOLOGY We can derive from Ohm s law V RI V Voltage Current R Resistance Since is constant R increases with each cell passage through the aperture thus V increases proportionately to the cell volume 4 The generated impulses have a very low voltage which the amplification circuit increases so that the electronic system can analyze them and eliminate the background noise 5 Two measuring chambers and detection circuits separately carry out the analysis of white blood cells and that of platelets and red bl
4. may occasionally require troubleshooting if System operations are faulty The background count is unacceptably high Your control values are out of ranges or patient results are suspicious e g consistently high RBC counts or inability to verify results by manual methods Precision is poor Calibration is drifting To locate parts of the analyzer mentioned in the following discussions see the diagrams in section 5 9 2 2 Identification procedure The first step in any troubleshooting session is to identify the source of the system malfunction system operations reagents precision or calibration These steps should be carried out in sequence as described below 9 2 2 1 System operations Press the START key and observe the instrument operation as described in section 4 If the ADVIA 60 CT appears to be operating properly continue with the identification procedure If operations are faulty identify the source of the malfunction and initiate appropriate troubleshooting procedures 9 2 2 2 Reagents If your background count is unacceptable your control values are out of range or your patient results are suspicious reagent deterioration or contamination can be suspected Replace your reagents and perform the concentrated cleaning procedure Obtain a background count and if appropriate reassay controls or patient samples If the background count is acceptable but control values are still out of range
5. If the user presses the ESC key the analyzer requests a new smart card reads the new smart card information and displays the information When the smart card is validated the program initializes the first day values to zero as a protec tion against wrong results This operation is automatic and a waiting message is displayed during this time about 2 seconds for 8 parameters and 4 seconds for 16 parameters NOTE If the smart card is removed during the QC operation the instrument goes back to the FER main menu 7 5 2 2 Select operator Move the cursor to one of the 4 required operator identification and press ENTER A star is displayed next to the chosen identification and the menu turns to the commercial control identification 21029 HH MM ZEE If the operator name is changed during the use of the QC card itis memorized on the card The QC card allows up to 5 operator name changes 7 5 2 3 Select commercial control level SELECT LEVEL gt 1 LOW BLOOD HH MM 2 HIGH BLOOD Using the upper or lower arrows select the commercial control level that will be analyzed Press ENTER A message LOADING LEVEL PLEASE WAIT appears during a half of a second the information on the smart card is read during this time After reading the smart card the following message appears TESTPOINT LOW START QC ESC TO EXIT PRESS START TOASPIRATE The current lot number is displayed Verify the lot number of the co
6. Reproducibility based on 20 consecutive samplings from one fresh normal whole blood sample Linearity Linearity was tested using commercially available low range and full range linearity test kits The kits were analyzed and data was computed according to the manufacturer s instructions Each kit included six levels and one level was used as the reference value Each level was run four times The results of this study are as follows LINEARITY PARAMETERS RANGE LIMITS WBC 10 cells mm 100 0 50r 5 whichever is greater RBC x 108 cells mm 0 to 8 0 0 3 or 3 whichever is greater HGB g dL 0 to 26 0 3 or 3 whichever is greater HCT 0 to 80 2 or 3 whichever is greater PLT x 10 cells mm for HGB gt 2 g dL to 2200 10 or 10 whichever is greater PLT x 10 cells mm A Table 34 for HGB lt 2 g dL O to 4000 10 or 10 whichever is greater Platelet linearity depends on hemoglobin concentration 075D0002 01 Page 3 3 3 SPECIFICATIONS Carryover Carry over was tested by analyzing samples with high concentrations of WBC s RBC s HGB and PLT s Each sample was run in triplicate followed by three background cycles The carryover is calculated using the following formula Background 1 Background 3 Carryover X 100 BC PLT 3 3 1 1 Expected
7. CHAPTER 4 TECHNOLOGY inicien 4 1 4 1 MEASUREMENT PRINCIPLES ics ccccicccscccecccsansdssncccteessenseeseccsscevceccrecvezseesnacsvsassdsvansdscessescnnseceeessevares 4 1 4 1 1 RBC WBC PLT detection 4 1 4 1 2 Hemoglobin measurement 4 3 4 1 3 Hematocrit measurement 4 3 4 2 CELL DISTRIBUTION STUDY lt lt lt nica as ER 43 4 2 1 White blood cell distribution 4 3 Ann 4 3 4 2 1 2 Diluent and lysing action 4 4 4 2 1 3 Volumetric study sio enean raa AARENSEN ETNAS ANSER n ANNERES 4 4 ALZA ROSUNS ici A A Adi 4 4 4 2 2 Distribution of Red Blood Cells cerei ttn indu narra n anni rra ERE Run anu 4 5 4 2 3 Platelet distribution ici rere eet ru AAA AAA 4 5 4 3 STUDY OF GENERAL FLAGS COD EI IR RECO Don E D ER d EENET ARE IN UR RC RR 4 6 4 31 P
8. If the value has to be changed press ENTER the following menu is displayed TARGET WBC EXIT ESC CURRENT SAVE ENTER Enter the new WBC target value if required and press ENTER or press ESC directly The menu turns to RBC target value Repeat the same procedure for RBC HGB HCT PLT and MPV When this last value has been modified or ESC pressed the number of calibrator samples to be analyzed is displayed Page 7 4 075D0002 01 7 CALIBRATION AND QUALITY CONTROL 7 3 5 Change number of calibrator samples CHANGE SAMPLE NO ESC CURRENT MESHENTER ADVIA 60 cT calibration may be performed using to 11 sample aspirations The autocalculation module performs statistics on these results in order to obtain the best calibration coefficients In order to obtain the best calibration possible it is recommended to run the calibration blood a minimum of 5 times The first result is not taken into account in the statistical calculations used for the calibration The first sample is used as a primer Press ENTER to change the required number of calibrator samples or press ESC The following menu is displayed SAMPLE EXIT ESC CURRENT SAVE ENTER Enter the new number of calibrator samples and press ENTER if required or press ESC The run calibration menu is displayed 075D0002 01 Page 7 5 7 CALIBRATION AND QUALITY CONTROL 7 3 6 Run calibration Prepare the calibrator according to the sp
9. Immature nucleated red blood cells will be counted in the WBC White Blood Cell parameter If the number of nucleated red blood cells is sufficient to activate an L1 alarm such interference will be detected However the manual differential white blood cell count performed on the stained blood film will reveal the presence of NRBC s Page 3 8 075D0002 01 3 SPECIFICATIONS Following the manual differential white blood cell count the WBC assay value must be corrected for the presence of nucleated red blood cells The formula utilized for correcting the WBC parameter when nucleated red blood cells are present is counted WBC X 100 CORRECT WBC 100 Hof NRBC 100 WBC Unlysed Red Cells In particularly rare instances the erythrocytes in the blood sample may not completely lyse These non lysed red blood cells may be detected on the WBC histogram with an L1 alarm or as an elevated baseline on the side leading edge of the lymphocytes population Non lysed erythrocytes will cause a falsely elevated WBC count Multiple myeloma The precipitation of proteins in multiple myeloma patients may give elevated WBC counts Hemolysis Hemolyzed specimens contain red cell stroma which may elevate white cell counts Leukemia Aspurious low WBC count may result in this disease state because of the possible increased fragility of the leukocytes leading to some destruction of these cells during counting These white cell fragment
10. MAINTENANCE AND TROUBLESHOOTING K ERROR BAD DATE TRY AGAIN This message is displayed in the date change function when the new date entered is incompatible with the date format previously entered Re enter a correct date or change the date format L ERROR BAD TIME TRY AGAIN This message is displayed in the change time function when the new time has not the required format HH MM Re enter the correct time CYCLE ABORTED BY USER This message is displayed whenever the ESC key is pressed during an hydraulic cycle A confirmation message CYCLE ABORTED is displayed If the abortion is confirmed by pressing the ENTER key an initialization cycle is carried out to reinitialize the motors in their home position After aborting a hydraulic cycle it is necessary to run a STARTUP cycle to rinse the instrument before any further sample analysis N BAD VALUE MINI XXX MAXI XXX this message is displayed in the following occasions When the sample run number is above 9999 When the target values entered in the AUTOCALIBRATION are out of the limits When the number of sample selected in the AUTOCALIBRATION is out of the limits 3 to 11 When the calibration factors entered in the CALIBRATION function are out of the factor limits When the laboratory limit values entered in the CHANGE LAB LIMITS are out of the limits When the flag values entered in the FLAG ADJUST function are out of the limits W
11. Piercing motor When the STARTUP checks have been passed it is now possible to access the SERVICE menu in order to check the operation of the hydraulics and the mechanical parts Page 9 14 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING 9 3 ERROR MESSAGES Some error messages can be displayed and require the operator intervention Follow the instruc tions given for each message and refer to the specified section If the problem cannot be solved call your local technical support provider or distributor A ERROR PRESSURE SYRINGE MOTOR This message can be displayed at the instru ment startup It shows a malfunction on the pressure syringe motor Check that the motor is properly connected on the electronic board If it is call your local technical support provider or distributor B ERROR LIQUID SYRINGE MOTOR This message can be displayed at the instrument startup It shows a malfunction on the liquid syringe motor Check that the motor is properly connected on the electronic board If it is call your local technical support provider or distributor C ERROR TRANSFER MOTOR This message can be displayed at the instrument startup It shows a malfunction on the transfer motor Check that the motor is properly connected on the electronic board If it is call your local technical support provider or distributor D ERROR NEEDLE MOTOR This message can be displayed at the instrument startup It shows a malf
12. Select commercial control 7 13 7 5 2 4 Run commercial control c cceeeeeeneee cece eee eee ee eee teen eee nena sea nnn 7 14 7 5 2 5 Accepting rejecting results 7 14 7 5 2 6 QC AUTOMA C oriretur 7 15 5 3 NN 7 16 gor OG print LANG Ot ices cee O O EEEE 7 16 5 5 STAISU cL 7 17 EAS ooo xe 7 17 AAA OT 7 17 E E 7 18 TOO GAP INS E 7 18 02 Select leve iia totali 7 18 CHAPTER 8 INSTRUMENT CONFIGURATION 8 1 8 1 RESULTS OPTIONS ai ccscicccccancnetenvetnssnunenuasntangnaneetecannaecsdnneiadenuaisentxsannenanestanandaGanenedancanandatexewenessaeths 8 1 O O O TO 8 2 A O 8 2 E I I DE 8 2 8 1 4 Printer A anaana nEn A EANA KE Ea 8 3 8 1 5 Temperature printo Utims iore snaneseansesadannmentssunchanadssehasunedacnancbucsaneuadeskenessaraeass 8 3 AA tne cuand EEEE EAA SAES EEES 8 4 8 1 1 Printdifferential results inicia aerae A Ranas 8 4 8 2 CHANGE LA
13. or patient results are still suspicious continue with identification procedure If replacing reagents and performing concentrated cleaning does not correct the background count call your local technical support provider or distributor 9 2 2 3 Precision Analyze a fresh patient sample 5 to 10 times and calculate the coefficient of variation V6 CV The CV is calculated by dividing the standard deviation of the measurements by the mean and multiplying this result by 100 075D0002 01 Page 9 7 9 MAINTENANCE AND TROUBLESHOOTING where X mean SD standard deviation Xi individual value n of observations The following CVs should be obtained Parameters CV WBC lt 2 5 RBC lt 2 0 HGB lt 1 7 HCT lt 2 0 PLT lt 5 0 Proceed with the identification procedure if precision is acceptable If the precision of any parameter is not within these specifications identify the out of range parameter s and initiate appropriate troubleshooting procedures 9 2 2 4 Calibration If the system appears to be operating properly fresh uncontaminated reagents are being used and the precision is within the specifications the ADVIA 60 cT may need calibration Calibrate your instrument as described in section 7 9 2 3 Troubleshooting parameters The procedures described below should be performed whenever the precision of a parameter is not within the specifications noted above or a parameter result is incorrect or susp
14. requires the operator identification Four different identifications can be entered and modified at any time by the user From the SPECIAL menu move the cursor to the function and press ENTER The CHANGE OP menu is displayed CHANGE OP MO HH MM ZEE v Move the cursor in front ofthe required operator identification to be changed and press ENTER The following menu is displayed example for operator 1 1271 0 EXIT ESC CURRENT SAVE ENTER Enter the new operator identification 4 characters maximum Alphabetic identification can be entered using the UP and DOWN keys Press the ENTER key to memorize the identification or ESC to keep the current figure Repeat the same procedure for the 3 other identifications if necessary 075D0002 01 Page 8 7 8 INSTRUMENT CONFIGURATION 8 3 2 Change password The use of a password is mandatory to access some important functions such as Changing the calibration factors Accessing the technician functions Changing the password The original password is lt 123 gt If the change is requested move the cursor from the SPECIAL menu to function 2 press ENTER The PASSWORD menu is displayed y CHG PASS EXIT ESC CURRENT SAVE ENTER The current password is displayed Enter the new password if necessary 3 numerical characters maximum using the numeric keyboard or ESC to keep the current one 8 3 3 Startup cycle The STARTUP cycle is used every day at the
15. 0 76mm 0 081 2 06 m 0 035 0 89mm 0 090 2 28mm o LOL LUE CAM E dau Designation HYDROPNEUMATIC DIAGRAM y O ADVIA6G C T BOUTEILLE ind Modif A es EU e Cristal REF 502502 O P tube Polyur thane 17 09 98 SUPPRIMER RACCORDS SEAINGUE AIGUILLE DE PRELEVEMENT FAYORISER MISE A L AIR DU TUBE DE SANG Nbn 1 tube Tygon A 3 2 3T 2 2 NC yg B heal a ds uh WANCHON SALOBRA SUN LES VANNES 4A 132 000 0 0 A EE A E NANE T S tube Silicone A 23 01 08 CREATION tube Viton Modification Plan dessin 1e 26 02 97 Par A DA COSTA Ce plan est le propri t de ia soci t ABX et ne peut tre reproduit ou communiqu sans autorisation INVSHOVIG DILVINNANd 976 ONILOOHS318f038 39NVN3 LLNIVIN 6 L0 c000d0SZ0 126 WASTE CHAMBER 178 GALOSBA 1 92 40 1 52 229 EACO17A X DOUBLE BISEAUTAGE L EXTREMITE Vi GALOSBA 5 3 5 50 M l 1 i i A i i 3 i 8 amp db ovs NUM pag Pl i f i gt A lol i E 1 i 1 i a f 1 XBA1904 6 fi 2
16. 05 e 183 i 1 if 1 2 4 SO jj i i A T rc t 1 1 i M QUE A EE 2 i 1 52450 p i A i i 1 i i i 3 i 1 1 zi i E i t j I i 1 1 i l quee i 1 2 28 420 1 ET 4 i 1 82 450 at 19 2 05 590 Translation inch to mm B int 28 980 E ES EEE 0 010 0 25mm 045 1 14mm SS feo oisomn ost E PO 0 026 0 64mm 060 1 52 mn 0 030 0 76 081 2 05 o 0 035 0 89mm 090 2 28mn O Bc IUE LU D signetion HYDROPNEUMATIC DIAGRAM o ee conde Cun ADVIA 60 C T PACK ind IN Et AA oP D 17709798 SUPPRINER RACCOROS SERINGUE ALGUILLE DE PAELEVENENT AVORISER WISE A L AIR DU TUBE DE GANG RE du document NM802702 TA tube Polyur thane C s645 24 02 98 AJOUTER UN WANGHON GALOOGA SUR LES VANNES 4 2 114 12 2 132 NOP 3 2 3T 2 2 tube Tygon 3622 23 01 oafcOaRECTION DE LA REFERENCE DOCUNENT S tube Silicone A 24 08 97 CREATION SUIVANT PROTOTYPE MS amp GCTPK V tube Viton Modification Plan dessin le 26 02 97 Par A DA COSTA Ce plan est la propri t de la soci t ABX et ne peut Btne reproduit ou communiqu sans autonisation SONILOOHS318f03 39NVN3 LNIVIN 6 9 MAINTENANCE AND TROUBLESHOOTING Page 9 22 075D0002 01 CHAPTER 10 SERVICE AND SUPPLIES 10 1 Supplies The fo
17. 1 Autocalibration Calibration card BBC Without pack HGB 2 Coefficients 1 Calibration Password pod 1 All reagents MPV 2 Diluent 2 Print coefficients RDW rA PDW 4 Cleaner 4 SERVICE 1 Sensors 1 Backflush with pack 2 Needle U D 2 Drain 1 Chg pack 3 Carriage L R 3 Prime 2 Capacity gt gt gt 4 Liquid syringe 4 Conc clean 5 Pres syringe 5 Mechanic 6 Valves 6 Cycles Startup 7 Chg Contrast 7 Technician Stand by I I 8 Park 8 Auto clean CBC 9 Piercing 1 With histo 1 Reprint result z 2 Without histo 2 Printout gt 1 1 Reserved 1 2 5 7 3 Units 3 Histo wlo RBC lA LA gt 3 Inter 1 4 Printer 2 Reserved 2 nter EL L L Pri 3 Reserved 3 4 Inter2 1 RESULTS 5 Print purum 6 Print Limits Y N 4 Standard 1 A 7 LMG Y N 5 None 1 Low limits 1 Chg OP 2 Chg pass Password i 2 High limits 3 Print limits 3 Startup cycle 4 Auto clean 5 Print config 6 Buzzer on off 4 Flag limits 3 SPECIAL 1 Chg Time 1 Auto 2 Date format 2 Manual 3 Chg date 8 Start
18. 2 Select level SELECT LEVEL gt 1ALL HH MM 2 LOW BLOOD v SELECT LEVEL 3 NORMAL BLOOD A HH MM 4 HIGH BLOOD Page 7 18 075D0002 01 7 CALIBRATION AND QUALITY CONTROL Using the UP or DOWN arrows select the commercial control level to print one set of graphs or all graphs automatically Press ENTER and the following message appears PRINTING QC RESULTS PLEASE WAIT All graphs will be printed as shown in the example below NOTE QC graphs will be printed out even when values are equal to zero HIGH LOT MINOTROLL6 TIMES 11 25 EXP DATE 8 05 95 DATES 07 02 95 WBC LOW 17 4 HIGH 20 6 25D 2 00 CU 11 85 104 5 39 HIGH 5 79 20 8 4 CU 3 75 REFERENCE MEAN 18 4 LOU 17 8 HIGH 19 8 ACTUAL MEAN 18 3 25 0 89 CU 4 8 5 0 15 20 25 30 REFERENCE MEAN 49 2 LOW 462 HIGH 52 2 Diag 7 10 1 High target value 2 Mean 3 Low target value 075D0002 01 Page 7 19 7 CALIBRATION AND QUALITY CONTROL Page 7 20 075D0002 01 CHAPTER 8 INSTRUMENT CONFIGURATION The ADVIA 60 cr has several operator options Specific laboratory limits Date and time formats Result format RS 232 options Special functions These options can be configurated according to the operator needs through the SETUP function of the MAIN MENU From the MAIN MENU move the cursor to the function and press ENTER The SETUP menu is displayed SETUP gt 1 RESULTS HH MM 2 CHG LAB LIMITS wy
19. 2 1 Diluent sysDIL 1x3 2L For in vitro diagnostic use as an isotonic solution for the determination and differentiation of blood cells Composition Stabilized buffer solution Sodium hydroxide 0 04 Sodium azide 0 09 CAUTION Sodium azide can react with copper and lead plumbing to form explosive metal azides On disposal if disposal into a drain is in compliance with federal state and local requirements flush reagents with a large volume of water to prevent the buildup of azides Physio chemical properties Boiling point About 100 C pH neutral 3 2 2 Lyse sysLYSE 1 x 200 mL For in vitro diagnostic use as an eythrocyte lysing agent for leukocyte counting differentiation and hemoglobin determination on the ADVIA 60 Hematology system Composition Potassium cyanide 0 03 Physio chemical properties Boiling point approximately 100 C pH basic Page 3 6 075D0002 01 3 SPECIFICATIONS 3 2 3 Detergent sysKLEN Function For in vitro diagnostic use in hte cleaning of the Advia 60 Hematology system Composition Organic buffer lt 0 2 Physio chemical properties Boiling point around 100 C pH 9 7 0 2 at 20 C 3 2 4 bleach solution sysCLEAR is used in the concentrated cleaning procedure Diluted bleach solution can also be used Follow the recommended precautions for safe use See the Material Safety Data Sheet for first aid REF 02
20. 20 fmm afd 203 mnm MON 0 10 5 5 43 0 76 GRA ib LO fini c 900000000000 H eu Diag 6 4 On the result printout can be found 1 The sample identification that was entered by the operator 2 The sequence number 3 The STARTUP status 4 The PLT flags 5 The CBC results 6 The WBC flags 7 The Diff results 8 The histogram representations 9 The date sample was run 10 The time sample was run The sequence number is updated to 1 everyday and increases by 1 on each cycle The sequence number cannot be modified by the operator 075D0002 01 Page 6 9 6 STARTUP AND SAMPLE RUN 2 Standard mode RESULTS am 104 ram e di 103 mpr HL YM MON TRA 102 mm 103 fmm 10 mm TIME 2 09 45 O O O O O O O O O O O Diag 6 5 On the result printout can be found 1 The sample run that was entered by the operator 2 The sequence number 3 The PLT flags 4 The CBC results 5 The WBC flags 6 The Diff results 7 The histogram representations 8 The date sample was run 9 The time sample was run The sequence number is updated to 1 everyday and increases by 1 on each cycle The sequence number cannot be modified by the operator The STARTUP status is printed out only when it has failed message STARTUP FAILED Page 6 10 075D0002 01 CHAPTER 7 CALIBRAT
21. 8 1 RESULTS OPTIONS The RESULTS menu allows the operator to access the following options To reprint the results of the last sample in memory To select or not the histogram printouts To select the unit type To select the printer type To select the temperature printout To select or not the limit printouts To select or not the Differential result printout From the setup menu move the cursor to the function RESULTS and press ENTER the RESULTS menu is displayed RESULTS gt 1 REPRINT LAST RESULT HH MM 2PRINTOUT WITH w 075D0002 01 Page 8 1 8 INSTRUMENT CONFIGURATION 8 1 1 Reprint results To reprint the results of the last sample in memory move the cursor to function of the RESULTS menu and press ENTER The results of the last sample is automatically reprinted with the date and time the associated identification sample run and sequence numbers the possible flags and the histograms if their printout is selected 8 1 2 Printout 8 1 3 Units Table 8 1 The distribution curves histograms for WBC RBC and PLT can be printed out when this option is selected From the RESULTS menu move the cursor to function and press ENTER The HISTOGRAM menu is displayed PRINTOUT gt 1 WITH HISTOGRAMS HH MM 2 WITHOUT HISTOGRAMS wy Move the cursor to the required function and press ENTER results will be printed and reprinted with or without the histograms according to the selecti
22. Eai Aasiaa ERRA 8 12 8 4 3 dato omic 8 12 5 MOST OR TIONS EI 8 13 8 5 1 Host COMMUNICATION RS Rda 8 13 A ALC NO 8 13 8 9 3 581 OT 8 13 8 6 BARCODE NERA 8 14 8 7 Patient Memory sieo eir aus es 8 14 8 71 Introductio A EE 8 14 8 7 2 operation MOJO eaea a aae Ea eaaa EEan 8 15 8 7 2 1 A IO 8 15 8 7 2 2 Transmission MONO Ea Own 8 15 6 7 3 RUNMINGMNG samples e 8 16 RETO M Tu o le 8 17 87 9 A FESTE REESE a NR AERE 8 17 8 7 0 MAINS AN ett 8 18 AA A E E 8 18 7 8 Clear smart ici 8 18 CHAPTER 9 MAINTENANCE AND TROUBLESHOOTING 9 1 9 1 MAINTENANCE AND SERVIGE 55 5 tane ferte cna rn nhu haa au EX RR RR RE RR raas rw ERR RR ERR RR 9 1 A sabina errin aada kP PENADA Dar nun Afbann
23. Ltd Diagnostics Division 11 F 237 Sung Chiang Road Taipei 104 Taiwan 886 2 2 5039123 Bayer plc Diagnostics Division Bayer House Strawberry Hill Newbury RG14 1JA United Kingdom 44 0 1635 563000 Page 10 4 075D0002 01 APPENDIX A SYSTEM AND REAGENT ROLLS A 1 System and Reagent Symbols The following symbols appear on the Advia 60 Hematology System and the Advia 60 TIMEPAC reagent package Warning Biohazard Warning Biological Risk WARNING Indicates the risk of personal injury or loss of life if operating procedures and practices are not strictly observed CAUTION Indicates the possibility of damage to or distruction of equipment if operating procedures and practices are not strictly observed Also indicates the possibility of causing erroneous results and actions that could affect system performance Standby State Start up cleaning cycle Keypad Input Enter Function Escape Function Delete Function 075D0002 01 Page A 1 APPENDIX A SYSTEM AND REAGENT SYMBOLS Up Navigation ES EM Down Navigation cf BE C AM p a The input electricity is alternating current Caution Risk of static discharge Consult the instructions for use The analyzer meets the safety requirements of Underwriters Laboratories The analyzer meets the safety requirements of the Canadians Standards Association Revision Number Page A 2 075D0002 01 APPENDIX A SYSTEM AND
24. REAGENT SYMBOLS Serial Number Catalog Number In Vitro Diagnostic Device Manufactured Location Authorized Representative Date of Manufacture CE Mark Product meets the requirements of applicable European Directives Temperature limitation store between x C y C Use by Exp Verw bis fs FH RBER tt Store upright UP 2003 06 Date Format year month 075D0002 01 Page A 3 APPENDIX A SYSTEM AND REAGENT SYMBOLS Page A 4 075D0002 01 APPENDIX B BIOHAZARD PROTECTION B 1 Protecting Yourself from Biohazards BIOHAZARD All products or objects that come in contact with human or animal body fluids should be handled before and after cleaning as if capable of transmitting infectious diseases Wear facial protection gloves and protective clothing The operator should follow the recommendations to prevent the transmission of infectious agents in healthcare settings as recommended for potentially infectious specimens in Protection of Laboratory Workers from Infectious Disease Transmitted by Blood Body Fluids and Tissue 2d edition Approved Guideline 1997 Document M29 A National Committee for Clinical Laboratory Standards NCCLS This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety The following information summarizes the established guidelines for handling laboratory biohazards This summary is based on
25. Shah Alam Selangor Darul Ehsan Malaysia 603 0 5551 02818 Bayer de M xico S A de C V Divisi n Diagn sticos Via Morelos 330 E Santa Clara 55540 Ecatepec Estado de M xico M xico Centro de Atenci n Telef nica CAT 55 57 28 33 12 55 57 28 33 06 Bayer B V Health Care Division Diagnostics Energieweg 1 3641 RT Mijdrecht The Netherlands 31 0 297 280666 Bayer New Zealand Ltd Diagnostics Business Group 3 Argus Place Glenfield Auckland New Zealand 64 800 724 269 Bayer As Brennaveien 18 N 1483 Skytta Norway 47 67 06 86 00 Bayer Sp Z 0 0 Al Jerozolimskie 158 02 326 Warszawa Polska 48 0 22 572 3500 Bayer Diagnostics Europe Ltd sucursal em Portugal Rua da Quinta do Pinheiro 5 2795 653 Carnaxide Portugal 351 21 416 4227 Bayer Puerto Rico Inc Diagnostics Division Victoria Industrial Park Building 1 Carolina Puerto Rico 787 752 8989 075D0002 01 Page 10 3 10 SERVICE AND SUPPLIES Bayer South East Asia Pte Ltd No 9 Benoi Sector Singapore 629844 65 261 3389 Bayer Pty Ltd Healthcare Division 27 Wrench Road Isando 1600 South Africa 27 0 11 921 5048 Quimica Farmac utica Bayer S A Divisi n Diagn sticos Calabria 268 08029 Barcelona Espa a 34 93 4956500 Bayer Schweiz AG GB DS Grubenstrasse 6 CH 8045 Z rich 41 0 1 465 81 11 Bayer AB Drakegatan 1 S 402 24 G teborg Sweden 46 31 83 98 00 Bayer Taiwan Co
26. Values Normal ranges were established at a study performed in Tarrytown NY USA The results were derived from the central 95 of the values in the distribution of 50 apparently healthy individuals MALE N 25 FEMALE N 25 PCT and PDW have not been established as indications in the United States for this product Their use should be restricted to research or investigational use only Expected values vary with sample population and or geographic location It is recommended that each laboratory establish its own normal ranges based on the local population Page 3 4 075D0002 01 3 SPECIFICATIONS Accuracy Approximately 200 patient specimens were analyzed on the ADVIA 60 cT and the ADVIA 120 Hematology Systems at three different locations The following table summarizes the data WBC x 10 mm 205 208 HCT 205 0 972 208 MCV um 208 MCH pg MCHC g dL RDW 205 PLT x 10 mm 205 208 MPV 205 N A 208 LYM 204 200 075D0002 01 Page 3 5 3 SPECIFICATIONS 3 2 REAGENT SPECIFICATIONS In order for the instrument to operate correctly high quality reagents must be used Bayer HealthCare provides all the necessary reagents To order additional reagents contact your local technical support provider or distributor Do not use beyond the expiration date and store the reagents at a temperature between 18 to 25 C The reagents are ready to use and require no preparation 3
27. blood collection tube 1 4 NOTES Bayer HealthCare retains the right to make changes to the instrument and this document Your local technical support provider or distributor will provide the latest revision of this document No part of this document may be copied or reproduced in any form or by any means without prior written consent of Bayer HealthCare Page 1 2 075D0002 01 CHAPTER 2 INSTALLATION 2 1 INSPECTION A thorough inspection is performed prior to the release of an ADVIA 60 cT Hematology System Itis important to verify receipt of all parts Notify any descrepancies with the carrier As instructed the installation procedures must be followed in the order listed below 2 2 UNPACKING The instrument is enveloped in a special protective foam before being placed in a cardboard box Cut the four angles of the box to unpack the system Remove the cardboard box containing the ADVIA 60 cT installation kit from its location Diag 2 1 The ADVIA 60 pack installation kit XEA 335A 075D0002 01 Page 2 1 2 INSTALLATION 2 3 PACKAGE CONTENTS The ADVIA 60 cT boxes contain the following parts ADVIA 60 cT Printer optional User s daily startup and shutdown procedure User s manual ADVIA 60 cT power cable European DAC 011A or ADVIA 60 cT power cable US DAC 012A The ADVIA 60 cT pack installation kit XEA 335 A includes DESIGNATION PART
28. can be switched off if the working day is completed or left in this standby mode overnight or until the next analysis When the instrument is left in standby mode it is necessary to carry out a STARTUP cycle before any sample analysis 075D0002 01 Page 6 7 6 STARTUP AND SAMPLE RUN 6 5 RESULTS When the analysis cycle is completed results are displayed and printed out according to the setup of the instrument 6 5 1 Displayed results The first group of parameters is displayed WBC RBC HGB HCT MCV MCHC PLT A ES 522 1549 099 299 BBS 233 W The second group of parameters can be accessed when moving cursor to the top MPV RDW LYM MO GRA LYM MO A 8 8 13 0 534 2 21 0 41 300 y Identification 1 US mode The patient identification can be reviewed when moving the cursor to the bottom MM DD YY PAT ID A HH MM v 2 Standard mode The patient run number can be reviewed when moving the cursor to the bottom MM DD YY RUN A HH MM v Flags The PLT and LMG flags can be reviewed moving the cursor to the bottom PLT FLAGS A LMG FLAGS v The last sample run can be displayed again at any time when moving the cursor from the main menu to the function RESULTS and pressing ENTER Page 6 8 075D0002 01 6 STARTUP AND SAMPLE RUN 6 5 2 Result printout 1 US mode 9 10 RESULTS pati 0571311987 ARTO PASSED WBC 6 9
29. cause a falsely elevated Hgb result but may be detected by observing the abnormal MCHC values and the increased baseline on the leading edge of the WBC histogram Erroneous hemoglobin results will cause the results of the MCH and MCHC to be erroneous as well Fetal bloods The mixing of fetal and maternal bloods may produce a falsely elevated HGB value HCT Hematocrit Red blood cells agglutination May produce erroneous HCT and MCV values Red blood cells agglutination may be detected by observing the abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be required to obtain an accurate HCT value MCV Mean Corpuscular Volume Red blood cell agglutination May produce an erroneous MCV value Red blood cell agglutina tion may be detected by observing the abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be required to obtain an accurate MCV value Excessive numbers of large platelets and or the presence of an excessively high WBC count May interfere with the accurate determination of the MCV value In such cases careful examination of the stained blood film may reveal the error MCH Mean Corpuscular Hemoglobin The MCH is a function of th HGB value and the RBC count The limitations listed for the HGB and RBC will have an effect on the MCH and may cause erroneous values MCHC Mean Corp
30. guaranteed with certainty and the result transmitted on the RS shows an error code Page 4 6 075D0002 01 4 TECHNOLOGY 4 3 1 Platelet flags MIC following the Platelet result indicates the excessive presence of microcytes in the Platelet measurement zone Verify the result using a Platelet Rich Plasma PRP or a manual count This flag can be adjusted by the user SCH following the Platelet result indicates the presence of schistocytes or Platelet aggregates in the Platelet measurement zone Review scan slide before reporting result This flag can be adjusted by the user SCL following the Platelet result indicates the presence of small cells in the 2 and 3 fL zone A second sample cycle should be carried out and the results verified If this flag should persist perform an automatic cleaning cycle and resample If the flag persists verify using a Platelet Rich Plasma PRP of the sample and make a manual slide count for the Platelets This flag can be adjusted by the user 4 3 2 flag located next to the HGB result shows that the HGB blank carried out during the analysis and the previous analysis blank differed and were outside the system s precision limits Nevertheless the instrument provides a result according to the previous HGB blank This result can be reported Ifthis suspicious flag occurs more than three consecutive times run the checkup procedure 4 3 3 WBC Flags The ADVIA 60 cT has a system
31. ici EE EESE E EAE 9 7 spas Meu 9 8 9 2 3 Troubleshooting 9 8 9 2 3 1 WBC and HGB dein ihe eter e iret iieri sia rectis eet 9 8 923 2 et as 9 10 sp 9 10 9 2 3 4 RBC HCT and PO a 9 11 92 35 P 9 12 0 23 6 9 13 2 3 7 9 13 9 2 4 Troubleshooting system operations 9 13 9 241 POWOE S needed EEEE Delect E 9 13 2 4 2 DIS PLAY c H 9 13 924 3 DII nmm 9 14 9 3 ERROR MESSAGES ERE ia 9 15 9 4 PURPOSE OF THE VALVES ula 9 18 9 5 MENU OVERVIEW ene mtm sot e teen iie iia 9 19 9 6 PNEUMATIC DIAGRAM ea 9 20 CHAPTER 10 SERVICE AND SUPPLIES ccciiciinimiicaniancac n conan sa tarancon dass 10 1 TOM SU PP SS ECHTE 10 1 10 2 FOR SOIVICO O idad 10 2 10 2 1 Bayer Authorized Representative 10 2 10 2 2 Bayer Offices World Wide cocoa 10 2 APPENDIX A SYSTEM AND REAGENT A 1 A 1 System and Reagent Symbols A 1 APPENDIX B BIOHAZARD PROTECTION B 1 B 1
32. instrument before any analysis C Screen details SERVICE gt 2 DRAIN CHAMBER A HH MM 3 PRIME REAGENTS v The position of the cursor is given by the gt as shown above The A and y on the right side of the screen indicate that more menus are available up and down 075D0002 01 Page 5 3 5 DESCRIPTION 5 1 2 Rear panel Main fuses Rear panel RS 232 computer connection Printer output ON OFF switch F1 F2 Main fuses Main power socket 5 3 F2 2501 Diag 5 4 5 1 3 Left side internal view Vacuum pressure syringe Liquid electrovalve block 1 Dilution block Liquid electrovalve block 2 Diag 5 5 Page 5 4 075D0002 01 5 1 4 Front internal view AR Diag 5 6 5 DESCRIPTION LCD display Keyboard Cycle light indicators Sampling needle carriage Start cycle key RBC chamber WBC chamber Spectrophotometer Piercing mechanism Tube holder switches Piercing carriage door switch 075D0002 01 Page 5 5 5 DESCRIPTION Page 5 6 075D0002 01 CHAPTER 6 STARTUP AND SAMPLE RUN 6 1 STARTUP CHECKS 6 1 1 INSTRUMENT STARTUP Turn ON instrument by pressing the ON OFF switch located on the rear panel The display shows the following PLEASE WAIT FOR 3 MIN ESCAPE ESC Th
33. instrument startup to rinse out any detergent in the system The STARTUP cycle includes a background count which must be determined before any samples are analyzed This is necessary to ensure that there are no extraneous interferences that may be detected as background noise and affect the cell count If the results of the bac kground count are not within those specified the analyzer performs a second STARTUP cycle automatically This STARTUP cycle can be run automatically at each instrument startup or manually accessed using the STARTUP key To configure the instrument according to the operator s needs from the SPECIAL menu move the cursor to the function STARTUP and press ENTER The STARTUP menu is displayed STARTUP 1 AUTO HH MM 2 MANUAL Move the cursor to the required setup and press ENTER When the MANUAL setup is selected the following message will be displayed at the instrument startup STARTUP NOT INITIATED PRESS A KEY TO CONTINUE Press a key to access the MAIN menu then the STARTUP key if an analysis is required A message STARTUP NOT INITIATED will be printed out with the analysis results when the STARTUP cycle is not carried out after the startup of the instrument Page 8 8 075D0002 01 8 INSTRUMENT CONFIGURATION 8 3 4 Autocleaning frequency An automatic cleaning involving a cleaner solution is normally carried out every 50 samples The user has the possibilty to setup the automatic clean
34. is heard The tube holder is associated with 3 switches which are able to detect the sampling position the presence of the tube holder and a wrong position of the tube holder The 4 positions can be used for the following sample tubes list is not exhaustive Position 1 Vacutainers Position 2 Mini Vacutainers Position 3 Control and calibration vial position Position 4 Micro sample collection devices Diag 6 2 075D0002 01 Page 6 5 6 STARTUP AND SAMPLE RUN 6 3 5 Analysis Install the sample tube in the tube holder and close the sample door to start the analysis if this mode has been selected or close the sample door and press the START key Diag 6 3 If the instrument has not been used for 1 hour when the first analysis is requested the instrument will start an HGB reference cycle the message PLEASE WAIT is displayed At the end of this cycle the first analysis will be automatically performed when the sample door mode is selected or press the START key again to start the analysis BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix B for recommended precautions when working with biohazardous materials The current Identification stays in memory until the analysis cycle has begun and can be displayed on the screen by pressing the ID SEQ key The analysis cycle lasts 65 seconds At the end of the result printout the LED turns to green and the in
35. mode 1 Memo 2 Transmission NAAA 3 Trans list 4 Trans one i 5 Trans all 4 DATE TIME ae 5 HOST OPTIONS 1 Host Comm 2 Baud rate 3 Transmission 6 Trans from to H Checksum Y N 7 MEMO CARD I patient card 7 Clear card 6 BARCODE Send results RAM 035 A 075D0002 01 Page 9 19 0 6 e6ed L0 20000S20 pe 176 mm a Log Meca a GALOABA GALOOBA 50 51 3 5 50 573 5 51 E 4 1 52 420 WASTE CHAMBER LYSE RBC 1 52 240 4 m AC 5 1210 6 4 52 20 y 199 1 1 i 1 i 1 1 1 t f 3 1 1 1 1 1 I 1 1 1 7 1 62 450 ISOLATOR ISOLATOR i i i 1 i 1 1 1 1 1 I 1 i 1 i i uir 2 28 1100 BLUE pcc A ERE Translation inch to mm 8 int t 0 010 0 25mm 9 045 1 14 0 020 0 50mm 0 064 1 30 et N 0 025 0 64mm 0 060 4 52 mm Q 9 030
36. must be corrected for the sodium citrate dilution effect MPV Mean Platelet Volume Giant platelets that exceed the upper threshold of the Platelet parameter May not be counted as platelets Consequently these larger platelets will not be included in the instrument s calculation of Mean Platelet Volume Very small erythrocytes microcytes erythrocytic fragments Schizocytes and white blood cell fragments May interfere with the proper counting and sizing of Platelets 075D0002 01 Page 3 11 3 SPECIFICATIONS Agglutinated erythrocytes May trap Platelets causing an erroneous MPV result The presence of agglutinated erythrocytes may be detected by observation of the abnormal MCH and MCHC values and by careful examination of the stained blood film Chemotherapy May also affect the sizing of PLTs CAUTION Blood samples collected in EDTA will not maintain a stable Mean Platelet Volume Platelets collected in EDTA swell with time and temperature LYM Lymphocyte count absolute value The lymphocyte count is derived from the WBC count The presence of nucleated red blood cells NRBC certain parasites and erythrocytes that are resistant to lysis may interfere with an accurate LYM count Limitations listed for the WBC count pertain to the LYM count as well LYM Lymphocyte percentage The lymphocyte percent is a function of the WBC count and the number of lymphocytes The presence of nucleated RBC NRB
37. of WBC differential flags alerting the operator to the possible presence of pathological cells abnormal volume distribution histograms or abnormal elevated populations such as in the case of the eosinophils and basophils 1 Flag L1 This flag shows an abnormal number of cells in comparison with lymphocytes in the 30 60 fL zone The pathologic elements which may be found in this area include platelet agregates nucleated red blood cells or atypical lymphocytes The flag corresponds to the number of cells counted in the first five channels out of the total number of lymphocytes The lab operator can adjust the limit which triggers this flag 075D0002 01 Page 4 7 4 TECHNOLOGY 2 Flag M2 Located in the 130 to 160 fL zone this flag informs the lab operator of the presence of lymphoblasts myelocytes abnormal lymphocytes or basophilia too many basophils This flag can be adjusted by the operator It corresponds to the number of cells counted by the detection zone out of the total number of granulocytes The limit which triggers this flag is adjusted by the lab operator 3 Flag G1 Situated in the 160 to 220 fL zone this detects the presence of eosinophils myelocytes and sometimes neutrophilia This flag can be adjusted by the operator It corres ponds to the number of cells counted in the detection area over the total number of granulocytes The limit which triggers this flag is adjusted by the lab operator 4 Fl
38. performed before a sample is run Press the ENTER key in order to run the STARTUP Run a STANDBY cycle if the instrument has to be stopped S ERROR TUBE HOLDER POSITION This message is displayed when the tube holder is not in its proper position Turn it slightly to the right or to the left until a click is heard T ERROR NO SAMPLE TUBE HOLDER This message is displayed when an analysis cycle is requested but no sample tube holder is installed PLEASE CLOSE SAMPLE TUBE HOLDER DOOR This message is displayed when the instrument is set up with the manual start mode and the START key is pressed with the tube holder door open V TUBE HOLDER DOOR ERROR PLEASE OPEN THE DOOR MANUALLY This message is displayed together with an audible alarm when the tube holder door is blocked Open the instrument cover and by means of a flat screwdriver or a finger nail push slightly on the solenoid washer to open the door W SENSOR ERROR OR DILUENT EMPTY This message is displayed when the instrument detects a problem on the drainage operation The waste detection cell may be faulty orthe diluent may have run out X MAX OP SAVED The operator attempted to change a sixth operator s name on the current QC card It is possible to change up to 5 operator names the sixth one will not be recorded 075D0002 01 Page 9 17 9 MAINTENANCE AND TROUBLESHOOTING 9 4 PURPOSE OF THE VALVES Valve 1 Valve 2 Va
39. the cursor in front of the function and pressing the ENTER key When menus and functions are known it is possible to enter directly the menu or function number to access it and press ENTER when a function is requested 075D0002 01 Page 5 1 5 DESCRIPTION Diag 5 2 1 STARTUP key 6 DELETE key 2 STAND BY key 7 ENTER key 3 Identification Key ID SEQ 8 ESCAPE key 4 Start analysis cycle key START 9 Display scroll keys 5 Numerical keyboard 10 Cycle light indicators Command keys 1 STARTUP key When this key is pressed a startup cycle including a cleaning and rinsing procedure is carried out Detergent left in the chambers is rinsed with diluent and the system is ready for the analysis cycles This cycle has a duration of approximately 130 seconds this cycle can be run 2 or 3 times if blank values are not within the acceptable limits 2 STAND BY key this key is used for shutdown at the end of the working day When this key is pressed it is mandatory to carry out a startup cycle before any analysis cycle This cycle has a duration of approximately 65 seconds 3 Identification Key ID SEQ This key is used to enter the patient identification 13 characters maximum letters or numbers and the run number The patient identification can be entered also using the barcode reader when the instrument is set up in the US identification mode 4 Start Analysis Cycle key START This key starts the
40. the cursor to function CALIB COEFF and press ENTER The following menu is displayed PASSWORD HH MM A specific password is requested to enter the function Enter the password 123 or the user defined password and press ENTER The following menu is displayed CALIB COEFF 1 WBC lt 0 97 gt HH MM 2RBC lt 0 98 gt v Enter the new coefficients for WBC and RBC then move the cursor down to the HGB HCT PLT MPV RDW and PDW positions and enter the required new coefficients CALIB COEFF 655 HH MM 4HCT lt 1 03 gt v CALIB COEFF SPL wsez HH MM 6 MPV 0 92 v CALIB COEFF 7 RDW 1 00 gt A HH MM 8 PDW lt 1 00 gt When the required coefficients have been changed press ENTER to record the setup RDW and PDW can be calibrated by means of calibration coefficients These coefficients are incremented to 1 00 by default The RDW and PDW are calculated according to the below formulas RDW result RDW coeff x RDW measured PDW result PDW coeff x PDW measured Press ENTER to modify one of both coefficients Type in a new value and press ENTER to validate NOTE PDW is not available in the United States 075D0002 01 Page 7 9 7 CALIBRATION AND QUALITY CONTROL 7 4 2 Print coefficients From the COEFFICIENTS menu it is possible to print the coefficient values Move the cursor to function PRINT COEFF and press ENTER The printout of the coefficient values starts automatically COE
41. the following if RBC HCT and PLT results all appear to be erroneous Concentrated cleaning procedure Was the concentrated cleaning performed earlier as part of the identification procedure If not perform the concentrated cleaning procedure Then press the START key and closely observe the specific operations of the analyzer listed below in the order specified Identify the malfunction s and initiate appropriate troubleshooting procedure s If upon close inspection all operations still appear to be acceptable call your local technical support provider or distributor Sampling syringe Is the sample syringe moving up and down If the 10 uL syringe is operating properly during sample analysis continue If the sampling syringe is not operating properly during sample analysis call your local technical support provider or distributor Diluent dispenser Do you see any bubbles in the diluent dispenser Is the plunger of the diluent dispenser moving up and down smoothly during sample analysis If no air bubbles are seen and the diluent dispenser plunger is operating properly continue If bubbles are seen or the plunger of the diluent dispenser is not operating properly see Mechanical Checks for actions First dilution Is there a stream of air bubbles in the WBC chamber during the initial dilution cycle Is the sample probe between the edge of the chamber and the center of the chamber close to the bottom Ifthere is a stream of bubbles
42. the instrument performed 3 counts 2 of the 3 counts are within 7 for WBC 5 for RBC 15 for PLT If the maximum of the first two raw counts is lower than 3000 for WBC the limit becomes 9 16000 for RBC the limit becomes 8 400 for PLT the limit becomes 20 Result for the concerned parameter can be accepted D lf results exceed the linearity limits shown below a lt D gt will be printed after the result If the results greatly exceed the limits a result will not be shown on the LCD or the printout The flag DIL will be shown on the LCD and D or 0 will be printed and transmitted to the LIS Repeat the sample using a 1 2 dilution and repeat each time the flag reappears Limits to the linearity ranges WBC gt 100 x 10 RBC gt 8 0 x 105 mm PLT gt 2200 x 10 mm HGB gt 2 g dL PLT gt 4000 x 10 mm HGB lt 2 g dL HGB gt 26 g dL HCT gt 80 NOTE Dilute the sample using autologous plasma or Saline H located next to a result of a parameter shows that the value is above the upper limit set up by the operator L located next to a result of a parameter shows that the value is below the lower limit set up by the operator Temperature Operating reagent temperature should be within the recommended limits 18 C to 32 C 65 F to 90 F The operating temperature can be printed out on the result form When these limits are exceeded the values obtained cannot be
43. triggering sensitivity The factory adjustment values are SCL 8 00 SCH 8 00 MIC 8 00 B WBC morphological flags These flags have to be adjusted by the user according to the representative population of the samples to be analyzed Specialized hospital laboratories may not have the same detection requirements as outpatient laboratories Move the cursor in front of the required flag and press ENTER Enter the new flag value and press ENTER Press the ESC key when all required values have been adjusted to return to the previous menu The factory adjustment values are L1 8 00 M2 8 00 G1 15 00 G3 8 00 Page 8 6 075D0002 01 8 INSTRUMENT CONFIGURATION 8 3 SPECIAL FUNCTIONS These special functions accessible through a password allow the user to 1 Identify 4 users 2 Change the password 3 Choose the startup mode 4 Adjust the cleaning frequency 5 Print the internal setup of the instrument 6 Set ON OFF the cycle end audible signal 7 Choose the identification mode 8 Choose the start analysis mode From the SETUP menu move the cursor to function SPECIAL and press ENTER The message PASSWORD gt is displayed Enter the password lt 123 gt or the user defined password and press ENTER If the password is correct the SPECIAL menu is displayed SPECIAL gt 1 CHANGE OP HH MM 2 CHG PASS lt 123 gt y 8 3 1 Change operator Some of the instrument functions calibration QC
44. 075D0002 01 Page 2 5 2 INSTALLATION 2 7 REAGENT AND WASTE HANDLING PRECAUTIONS Reagents have to be stored at room temperature 18 C to 25 C Lyse reagent contains cyanides and has to be handled according to the local or national regulations Always follow the recommended precautions Collect all the waste generated during testing to facilitate compliance with the local environmental regulations BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix B for recommended precautions when working with biohazardous materials 2 8 ELECTRICAL CONNECTIONS The ADVIA 60 cTis connected to the laboratory electrical supply using the power cable included in the installation kit Connect the power cable to the plug located on the rear left hand side of the device Two 1A fuses are located under the power plug The instrument can be operated at any other voltage from 100 to 240V or frequency from 50 to 60Hz without modification 4 5 990 1 ON OFF SWITCH 2 FUSE HOLDER 3 MAIN SUPPLY PLUG 4 RS 232 OUTPUT 5 PRINTER OUTPUT Diag 2 11 If the instrument has to be connected to a laboratory computer use the plug 4 RS 232 2 9 GENERAL POINTS The ADVIA 60 cT responds to the UL 3101 norm Refer to the Declaration of Conformity Statement for details System performance is guaranteed by Bayer HealthCare under the following condi tions only Services and re
45. 488831 Part number B01 4198 01 4 x 500 mL For in vitro diagnostic use as a cleaning and bleaching solution for the ADVIA 60 Hematology system Composition Sodium Hypochlorite 4 Sodium Hydroxide 0 26 Physio chemical properties Boiling point 100 C pH 12 9 0 5 at 20 C 3 2 5 TIMEPAC See the reagent specifications above REF 07622536 Part number B01 4199 54 TIMEPAC 4 x 145 aspirations The TIMEPAC reagent pack contains the following reagents sysDIL sysLYSE sySKLEN 3 3 LIMITS As with any hematological analysis users must be alert to the possible effect on results of unknown interferences from medications or endogenous substances All patient results must be evaluated by the laboratory and the physician in light of the total clinical status of the patient 3 3 1 Cleaning In section 9 specific start up shutdown and maintenance procedures are listed The maintenance procedures identified are mandatory for the proper use and operation of the 60 FAILURE TO EXECUTE ANY OF THESE RECOMMENDED PROCEDURES MAY RESULT IN DECREASED RELIABILITY OF THE SYSTEM 075D0002 01 Page 3 7 3 SPECIFICATIONS 3 3 2 Caps of the sampling tubes Diag 3 3 Some caps of the sampling tubes are more adapted to cap piercing sampling systems Plastic caps cannot be used Rubber caps can be of different quality materials Use the best quality materials in order to avoid any rubber particl
46. 81 NEEDLE 921 1 1 a t P z PS s OF 4 06 4 Diag 8 2 075D0002 01 Page 8 9 8 INSTRUMENT CONFIGURATION 8 3 6 Cycle end audible signal A cycle end audible signal BEEP can be set up with the SPECIAL menu Move the cursor to the function 8 BUZZER and press ENTER The audible signal menu is displayed BUZZER 2 10N HH MM 2 Orr Move the cursor on the required option and press ENTER The new setup is recorded 8 3 7 Identification mode Two identification modes are available US mode the operator must type in the identification of each patient using letters or numbers The identification will be printed out with the results The STARTUP results are printed out too or Standard mode the operator can enter a run number before running an analysis series This run number will be incremented on each cycle and printed out with the results Move the cursor to the function ID MODE and press ENTER The following menu is displayed ID MODE gt 1 STANDARD HH MM UIS Move the cursor to the required option and press ENTER The new ID MODE is recorded The US Identification mode allows the use of the barcode reader for an alphanumerical identification Page 8 10 075D0002 01 8 INSTRUMENT CONFIGURATION 8 3 8 Start mode The START MODE function allows the operator to choose between 2 different analysis starting modes In the automatic mode the analysis can start directl
47. 9 3 Call your local technical support provider or distributor if this does not correct the WBC and HGB results 075D0002 01 Page 9 9 9 MAINTENANCE AND TROUBLESHOOTING 9 2 3 2 WBC Check the following if only the WBC count is incorrect or suspicious Concentrated cleaning procedure Was the concentrated cleaning procedure performed earlier as part of the identification procedure If not perform the concentrated cleaning procedure Calibration Was the system calibrated earlier as part of the identification procedure If it was not and the WBC countis still erroneous after the concentrated cleaning procedure was performed calibrate the instrument as described in section 7 Continue troubleshooting if This does not correct the WBC results The instrument has already been calibrated as part of the identification procedure Earlier attempts to calibrate the WBC during the identification procedure failed Analyze a sample and observe the operation of the liquid valve lt 6 gt Valve lt 6 gt Is liquid valve 6 opening and closing during analysis cycle If the liquid valve 6 is not opening and closing replace the valve If this does not correct the WBC count call your local technical support provider or distributor If the valve is operating properly call your local technical support provider or distributor 9 2 3 3 HGB Check the following if only the HGB results are incorrect or suspicious Conce
48. A 60 can function between 18 to 32 C 65 to 90 F Maximum relative humidity is 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C If itis kept at a temperature less than 10 C 50 F the instrument should be allowed to sit for an hour at the correct room temperature before use 2 5 VISUAL CHECKS 2 5 1 Mechanical check Using the key from the installation kit unloosen the locker Open the pneumatic protection door WARNING Do not open or close the instrument front door when the door of the piercing mechanism is open Diag 2 2 Unscrew the 5 cover fixation screws and remove the cover pull it backward and lift it up to the rear of the instrument Diag 2 3 075D0002 01 Page 2 3 2 INSTALLATION Push the black plastic carriage locking clip as far as possible to the left and place the sample needle carriage as far forward as possible to the right hand side Check that the aspiration needle is not bent and make sure it is in its upper position 1 Carriage locking clip 2 Sample needle carriage 3 Needle Check the position ofthe chambers Each chamber should be in its proper position with its clips and the electrode block is attached firmly to the RBC chamber 1 Clip 2 RBC chamber Unscrew the 2 screws of the WBC HGB chamber protection cover slightly Remove the cover and check that the chamber is fixed properly in its clips and the elect
49. ADVIA HEMATOLOGY SYSTEM ADVIA 60 Hematology System Operator s Guide Closed Tube Model 075D0002 01 Rev A 2003 09 Bayer HealthCare 2003 Bayer HealthCare LLC No part of this manual or the products it describes may be reproduced by any means or in any form without prior consent in writing from Bayer HealthCare LLC ADVIA is a trademark of Bayer HealthCare LLC Vacutainer is a trademark of Bectin Dickson and Company Manufactured in France for Bayer HealthCare LLC Bayer HealthCare LLC Subsidiary of Bayer Corporation Tarrytown NY 10591 5097 USA Bayer Diagnostics Europe Limited Ec REP Chapel Lane Swords Co Dublin Ireland The information in this manual was correct at the time of printing However Bayer HealthCare LLC continues to improve products and reserves the right to change specifications equipment and maintenance procedures at any time without notice If the system is used in a manner differently than specified by Bayer HealthCare LLC the protection provided by the equipment may be impaired See warning and hazard statements ADVIA 60 HEMATOLOGY SYSTEM User Manual Closed Tube Model Daily Startup and Shutdown Procedures Start up procedure 1 Press the ON OFF switch located on the ADVIA 60 Hematology System rear panel Wait for approximately three 3 minutes 2 Verify that the printer is connected and turned to ON 3 Wait for the end of the STARTUP CYCLE or press the STAR
50. BORATORY LIMITS 2 eeeceeceee eee eeee eee ee eee 8 4 8 2 SO 8 4 8 22 Result high AAA A 8 5 8 2 3 Print limits and flag values 8 5 8 2 4 FAG MICS a 8 6 8 3 SPECIAL FUNCTIONS PIS DARREN RE AR 8 7 8 3 1 C a ASAR 8 7 9 3 2 Change PA O vances OE uae nep Xx RAN n eU 8 8 6 3 3 9 iaa 8 8 8 3 4 Autocleaning 8 9 8 3 5 Internal setup eee eeeeceeeeeeeeee eee nennen nnn nennen nnn t nnn tnnt nnn nen ns nena nennen 8 9 8 3 6 Cycle end audible signal eeeeeseeeeeeeeeeeeenneen nnne nennen nennt neni nn nnns 8 10 8 3 7 Identification mode ccccccccncnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn enn ren nennen hint tnter nne 8 10 ERE MAII n 8 11 8 4 DATE AND FNE RE NN UR ERU EARRARRRERRARRSRAE 8 11 641 Change xum 8 12 8 4 2 Date E E e MARRE aa e aa a AEA AA EE ea ea aa a
51. C certain parasites and erythrocytes that are resistant to lysis may interfere with an accurate LYM count Limitations listed for the WBC count pertain to the LYM as well MON Mononcyte cell count absolute The monocyte cell count absolute is derived from the WBC count The presence of large lympho cytes atypical lymphocytes blasts and excessive number of basophils may interfere with an accurate number of monocytes MON Monocyte percentage The monocyte percentage is a function of the WBC count and the number of monocytes The presence of large lymphocytes atypical lymphocytes blasts and excessive number of basophils may interfere with an accurate MON count The MON count both and is a composite count that includes monocytes eosinophils and basophils GRA Granulocyte cell count absolute The granulocyte cell count is derived from the WBC cell count The excessive presence of eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may interfere with an accurate granulocyte count GRA Granulocyte percentage The granulocyte percentage is a function of the WBC count and the number of the granulocytes The excessive presence of eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may interfere with an accurate GRA count Page 3 12 075D0002 01 CHAPTER 4 TECHNOLOGY 4 1 MEASUREMENT PRINCIPLES 4 1 1 RBC WBC PLT detection principles
52. Change date From the DATE TIME menu move the cursor to the function CHANGE DATE and press ENTER The CHG DATE menu is displayed NEW DATE MM DD YY EXIT ESC CURRENT SAVE ENTER Enterthe new date according to the format recalled in the menu and press ENTER The new date is recorded Page 8 12 075D0002 01 8 INSTRUMENT CONFIGURATION 8 5 HOST OPTIONS The ADVIA 60 cTis capable of transmitting data to an external laboratory computer via the RS 232 interface If you have an external computer to be connected to the analyzer plug one end of the computer cable provided by your computer vendor into the external computer Plug the other end of the computer cable into the cable receptacle at the rear of the instrument The ADVIA 60 CT has to be setup according to the external computer specifications The following functions have to be used by your laboratory computer specialist only The default setup of the serial port are as follow 1 Byte number 8 2 Parity none 3 Stop byte 1 4 Xoff none From the SETUP menu move the cursor to the function HOST OPTIONS and press ENTER The HOST OPTIONS menu is displayed HOST OPTIONS gt 1 HOST COMM HH MM 2 BAUD RATE Move the cursor in front of the required option and press ENTER to access the different settings Move the cursor in front of the required setting and press ENTER to record the new setup The different options and their settings a
53. FFICIENTS DATE 01 11 1997 TIME HH MM WBC RBC HGB HCT PLT MPV CURRENT 0 97 0 88 1 13 1 03 0 95 0 92 RDW COEFF PDW COEFF Diag 7 5 NOTE PDW is not available in the United States 7 4 3 Coefficient limits Check that the calibration coefficients corresponds to the following ranges LIMITS Minimum Mean Maximum Diag 7 6 If not call your local technical support provider or distributor Page 7 10 075D0002 01 7 CALIBRATION AND QUALITY CONTROL 7 5 QUALITY CONTROL PROGRAM 7 5 1 Introduction The ADVIA 60 cT quality control program contains five different functions 1 AUTOMATIC The function of this submenu is to allow the operator to analyze the commercial control bloods and store the results on the memory smart card 2 ANALYSIS The function of this submenu is to allow the operator to analyze a commercial control with fixed WBC thresholds whatever is the ambient temperature 3 PRINT TARGETS The function of this submenu is to allow the operator to print the targets values of the commercial control bloods 4 STATISTICS The function of this submenu is to allow the operator to print the cumulative statistics of the commercial control files 5 GRAPHS The function of this submenu is to allow the operator to print the Levey Jennings graphs of the commercial control files From the MAIN MENU move the cursor to the function QC and press ENTER The QC menu is displa
54. ION AND QUALITY CONTROL 7 1 INTRODUCTION Calibration should be performed upon installation of the ADVIA 60 cT Hematology system Subsequent recalibration is required if there is a significant shift in control values after replace ment of instrument parts a change in reagent lot number or whenever indicated by quality control data Calibration can be achieved in two different ways 1 Bayer SETpoint Calibrator 03 4203 51 is used to calibrate the ADVIA 60 cT Hematology System Refer to the package insert supplied with the calibrator for instructions for use and assay values specific to the ADVIA 60 Hematology system used 2 Calibration coefficients are known and can be entered directly Calibration must be performed on a clean and reproducible instrument blank values must be within the acceptable limits BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix B for recommended precautions when working with biohazardous materials From the MAIN MENU move the cursor to the function CALIBRATION and press ENTER The CALIBRATION menu is displayed CALIBRATION 1 AUTO CALIBRATION HH MM 2 COEFFICIENTS 075D0002 01 Page 7 1 7 CALIBRATION AND QUALITY CONTROL 7 2 SMART CARD OPTION When the instrument is equipped with a smart card reader proceed as follows Install the card in the smart card reader Make sure that the cursor is positioned on function 1 AUTOCALIBRATION a
55. MEMO and press ENTER The following menu is displayed TRANSMISSION gt 1 PRINTER HH MM 2 HOST Move the cursor to the required mode and validate The indicates the current state ofthe memory function 075D0002 01 Page 8 15 8 INSTRUMENT CONFIGURATION 8 7 3 Running the samples Place the sample tube in the sample holder and close the door to start the analysis cycle The following menu is displayed PAT ID NO SAVE ESC CURRENT SAVE ENTER Enter the patient identification and press ENTER Then the analyzer checks if a Patient Memory Card is present If the Patient Memory Card has not been inserted the following message appears ERROR NO SMART CARD NO ESC INSERTA NEW CARD MESBENTER Insert the Patient Memory Card and press ENTER If the smart card is not a Patient Memory Card the following message warns the operator ERROR BAD SMART CARD NO ESC INSERTA NEW CARD MESHENTER Replace the smart card with a Patient Memory Card and press ENTER If the smart card has been introduced in a wrong way ERROR BAD CARD INSERTION NO ESC INSERTA NEW CARD MESHENTER Remove the smart card and insert it with the arrow facing toward the system and on the upper side and press ENTER When the smart card is full ERROR MEMORY CARD FULL NO ESC INSERTA NEW CARD YES ENTER Insert a new one and press ENTER When the analysis is completed the results are stored on the smart card as wel
56. NUMBER QTY Sampling needle ADVIA 60 CT GBC 052 AS O ring 6 mm x 1 5 mm FAA 036 A O ring 0 74 mm x 1 02 mm FAA 054 A Table 2 1 ADVIA 60 common installation kit XEA 312 A The ADVIA 60 cT common installation kit XEA 312 A includes Fuse 1A 220 V 5 x20 mm Bent wrench 2 5 mm Table 2 2 Grease KM 1011 Page 2 2 075D0002 01 2 INSTALLATION 2 4 WORKING CONDITIONS 2 4 1 Environment ADVIA 60 cT should be operated in an indoor location only Operation at an altitude over 2000 meters 6562 feet is not recommended The instrument is designed to be safe for transient voltages according to INSTALLATION CATEGORY ll and POLLUTION DEGREE 2 Please ask your local technical support provider or distributor for any information about operating location when it does not comply with the specifications 2 4 2 Location ADVIA 60 cT should be placed on a clean and level table or work station Please note that 60 printer and reagents weigh approximately 30 kilograms 66 105 Avoid exposure to sunlight Proper ventilation requires that a space of at least 20 cm 8 inches must be left behind the apparatus 2 4 3 Grounding Proper grounding is required Check that the wall ground earth plug is correctly connected to the laboratory grounding electricity installation If there is no ground then use a ground stake Current electricity norms must be applied 2 4 4 Humidity and temperature conditions ADVI
57. Protecting Yourself from B 1 2 5 iii ti B 2 APPENDIX C BIBLIOGRAPHY 22 i C 1 C 1 Bibliography te nir EUH Me IRR HERI MEER C4 jM A Et Index 1 CHAPTER 1 INTRODUCTION 1 1 INTENDED USE The ADVIA 60 cT Closed Tube system is a fully automated Microprocessor controlled hematology analyzer used for the in vitro diagnostic testing of whole blood specimens ADVIA 60 CT16 WBC LYM LYM MON MONA GRA GRAF RBC HGB HCT MCV MCH MCHC RDW PLT MPV and 3 distribution curves WBC RBC PLT ADVIA 60 cT18 WBC LYM LYM MON MON GRA GRA RBC HGB HCT MCV MCH MCHC RDW PLT MPV PDW PCT and 3 distribution curves WBC RBC PLT from 10 uL of whole blood taken from EDTA WBC White blood cell count RBC Red blood cell count HGB Hemoglobin HCT Hematocrit MCV Mean cell volume MCH Mean corpuscular hemoglobin MCHC Mean corpuscular hemoglobin concentration RDW Red cell distribution width PLT Platelet count MPV Mean platelet volume LYM Lymphocyte percent LYM Lymphocyte number MON Monocyte percent MON Monocyte number GRA Granulocyte percent GRAF Granulocyte number PDW Platelet distribution width PCT Plateletcrit The MON count both and is a composite count that includes monocytes eosinophils
58. SERVICE menu is displayed SERVICE gt 1 BACKFLUSH HH MM 2DRAINCHAMBERS y 9 1 3 1 Backflush This cycle allows the user to clean the instrument aperture in case of blockages Move the cursor tothe function BACKFLUSH and press ENTER The backflush cycle is carried out and lasts approximately 22 seconds Check that the liquids are aspirated from the WBC and RBC chambers through the apertures Check that the liquids are also pushed back into the chambers If it is not the case the aperture may be blocked Perform a concentrated cleaning procedure 9 1 3 2 Drain chambers This cycle allows the user to check that the chambers are drained properly and to maintain some parts of the hydraulic manifold as it flushes the liquid out of the instrument This cycle lasts approximately 25 seconds Move the cursor to the function DRAIN CHAMBERS and press ENTER 9 1 3 3 Prime reagents This cycle allows the user to prime the reagents when replacing one or all reagent containers or the pack Move the cursor to the function PRIME REAGENTS and press ENTER Run the required priming cycle Select the function CHANGE PACK and follow the instructions given by the LCD in order to install the pack Once the new PACK installed a priming cycle will be automatically carried out Visually inspect reagent lines and pump Check that they are clear of air bubbles Page 9 2 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING 9 1 3 4 Concentrated cleanin
59. TUP key and validate The background values must be less than WBC 0 3 x 10 WBC mm RBC 0 02 x 10 RBC mm HGB 0 0 g dL PLT 10 x 10 PLT mm If the background values are not within these limits the ADVIA 60 Hematology System will automatically perform another startup cycle If the STARTUP fails refer to Section 9 for troubleshooting procedures 5 Run a blood sample to prime the system a Enter the patient identification or run according to the identification mode chosen using the ID SEQ key b Place the sample tube into the tube holder c Close the door of the tube holder in its sampling position to start the analysis if this starting mode has been setup or press the START key after closing the door The tube holder carriage moves up in the piercing position and the sample aspiration begins The green red LED will blink during sampling d The LED stops blinking and the tube holder carriage moves down when the sampling is completed 6 Perform a QC procedure using ADVIA 60 TESTpoint Hematology Controls Prod No B03 4200 54 B03 4201 54 and B03 4202 54 7 Perform a calibration procedure only if necessary 8 Run patient samples a Enter patient identification e Press the ID SEQ key e Enter the identification up to 13 characters or Run ranging from 1 to 10000 e Press the ENTER key b Place the sample tube into the tube holder c Close the door of the tube holder in its sampling
60. W 1G6 416 248 0771 Bayer S R O Litvinovska 609 3 CZ 190 21 Prague 9 Prosek 420 0 2 66101463 Bayer S A Divisi n Diagn stica A A 80387 Av De las Am ricas No 57 52 Santaf de Bogot D C Colombia 571 09 423 4199 Bayer A S Norgaardsvej32 DK 2800 Lyngby Denmark 45 45 23 50 00 Bayer OY Suomalaistentie 7 FIN 02270 Espoo Finland 358 9 887 887 Page 10 2 075D0002 01 Bayer Diagnostics Tour Horizon 52 quai de Dion Bouton 92807 Puteaux Cedex France 33 0 1 49 06 56 00 Bayer Vital GmbH Gesch ftsbereich Diagnostics Siemensstrabe 3 D 35463 Fernwald Germany 49 0 641 40 03 170 Bayer Hellas S A Akakion 54A Marousi Athens 151 25 Greece 30 0 1 6883648 Bayer HealthCare Co Ltd 20 F Gee Chang Hong Centre 65 Wong Chuk Hang Road Hong Kong 852 28147337 Bayer Hungaria Kft H 1012 Budapest Hungary Palya u 4 6 36 06 1 212 1540 Bayer Diagnostics India Limited 589 Sayajipura Ajwa Road Baroda 390 019 Gujarat India 91 0 26 5562720 Bayer S p A Divisione Diagnostici Via Grosio 10 4 20151 Milano Italia 39 2 3978 1 Bayer Medical Ltd 1 19 15 Ebisu Shibuya Ku Tokyo 150 0013 Japan 81 0 3 440 2411 Bayer Diagnostics Korea Limited Kye Myung Bldg 4F Myungil Don 48 7 Kangdong Ku Seoul 134070 Korea 82 0 2 428 5987 10 SERVICE AND SUPPLIES Bayer Malaysia Sdn Bhd 19th amp 20th Floor Wisma MPSA P O Box 7252 40708
61. a visiten NEEE Aidas 9 1 ER DPEDEICIntucc 9 1 9 1 2 1 Startup and standby cycles eiiis errar ani 9 1 9 1 2 2 Automatic cleaning eerie ternera iin 9 1 9 1 2 3 Instrument general cleaning tnnt nuni nuni 9 1 9 1 3 Service functions saa RR RAN RR RR 9 2 9 1 3 1 se re dri re ra A A ice REN RR RET sans 9 2 9 1 32 Drain chambers ci 9 2 9 1 3 3 Prime reagents da 9 2 9 1 3 4 Concentrated cleanitnig ar 9 3 9 1 3 5 Mechanical checks 00 9 4 9 1 3 6 Cycle functions a 9 6 9 1 3 7 technician functions ia 9 6 9 1 3 8 Automatic cleaning tn nant ARS 9 6 9 1 4 Disposal of System Waste and 9 6 9 2 TROUBLESHOOTING coa 9 7 pM Merl 9 7 9 2 2 Identification procedure ccccccccccnncnnnnnnnnnnnnnanononennnnnnnnnnnnnnnnnrnn rra nena nn nan nennt hint nnn nnn nnns nnn nns 9 7 9 2 2 1 Sn O E 9 7 92 2 2 EM 9 7 9 2 2 3 PIGCISIOD
62. ach impulse coming from the aperture and ranked in the 256 counting channels Acurve is obtained with number of cells on the y axis and cell volume on the x axis The cells will be broken down accordingly the lymphocytes between 30 100 fL the monocytes between 100 150 fL granulocytes between 150 fL and a maximum unlimited volumetrically Pathologic cells will of course place themselves in different zones in the distribution curve Mobile and fixed flags will alert the lab operator of the presence of such pathologic elements The WBC distribution curve disappears when the WBC result is rejected 400 Leukocyte Flags LYM gt 2 Number of Cells 4 2 1 4 Results The lymphocytes monocytes and granulocytes are expressed in percents and absolute numbers LYM LYM MON MON GRA GRA Page 4 4 075D0002 01 4 TECHNOLOGY 4 2 2 Distribution of Red Blood Cells The study of the distribution of RBC detects erythrocyte anomalies linked to anisocytosis A Red Cell Distribution Width RDW will enable you to follow the evolution of the width of the curve in relation to the cell number and average volume K SD With K System constant RDW SD Determined standard deviation according MCV to statistical studies on cell distribution MCV Mean Corpuscular Volume of erythrocytes 4 2 3 Platelet distribution The platelet distribution study counts platel
63. ag G2 This flag makes it possible to follow an abnormal granulocyte peak displacement shows anomalies in the membrane of the granulocytes and also possible lyse or hydraulic anomalies This flag is also triggered if the blood is too old after 6 8 hours The flag is also triggered if the granulocyte volume is less than 250 fL 5 Flag G3 This flag is situated in the zone which is greater than 400 fL It detects the presence of metamyelocytes The flag is set off when the percentage in number compared to the number of granulocytes is higher than the level set The lab operator can adjust the limit which triggers this flag 4 3 4 Comments on the flagging capabilities All anomalies and or abnormal distributions signaled by the ADVIA 60 cT should be verified manually for the presence of pathological elements As a result of the differential resistance of cytoplasmic membranes in the different cell types pathological elements can be found in a number of different zones This also applies to the presence of normal or non pathological cells that have been subject to chemotherapy or some other form of treatment in alarm zones This will result in a false alarm Page 4 8 075D0002 01 CHAPTER 5 DESCRIPTION 5 1 INSTRUMENT Cover Door to pneumatic part Piercing carriage door Front panel hon Diag 5 1 1 ADVIA 60 cT Cover The instrument cover is fixed by the means of 5 screws Before any attempt to
64. analysis when the manual mode for starting the analysis has been set up Page 5 2 075D0002 01 5 DESCRIPTION 5 Numerical keyboard keys from 0 to 9 allow the operator to enter the following figures Date Calibration values Laboratory limits Patient number for analysis Leukocytes differential flag values 0066 BOOE These 2 keys pressed simultaneously will allow an automatic adjustment 0006 of the LCD DEL 6 DELETE Key When it is pressed this key deletes the information entered on the LCD display c 7 ENTER Key This key is pressed to validate the informations entered on the LCD display F 8 ESCAPE Key ESC When it is pressed this key allows the operator SC to exit a function and to come back to the previous menu This key can be used to stop an hydraulic cyle see NOTE below It also opens the tube holder compartment door 9 UP DOWN Keys These keys allow the user to scroll up or down in the instrument menus to access the different functions and to choose alphabetic letters in the patient identification lt gt 10 When the START key is activated the indicator light flashes during the sampling time When the indicator stops flashing the operator is allowed to remove the tube from the sampling position This cycle has a duration of 65 seconds approximately When the ESC key is pressed during a hydraulic cycle it is necessary to run a STARTUP cycle to rinse the
65. and basophils PCT and PDW are not available in the UNITED STATES The rate of determinations is 55 samples per hour in the optimum configuration The system is totally automated including the cap piercing of the sample tube with an internal dilution system and agraphic printer optional for recording all test results including flags and graphic printouts 075D0002 01 Page 1 1 1 INTRODUCTION 1 2 PRESENTATION The instrument which is small in size has 9 main parts 1 The electrical supply 2 The electronic board 3 The dilution pneumatics 4 A control panel including a keyboard and a LCD screen 5 Acap piercing mechanism 6 A reagent compartment 7 Aprinter optional that prints out the results and the plotting of the distribution curves 8 A smart card reader optional for quality control result records and calibration direct entries 9 Abarcode reader optional for a direct entry ofthe alphanumerical identifications All the controls are grouped together on one panel at the front of the system Diag 1 1 1 3 OPEN TUBE AND CLOSED TUBE MODELS The ADVIA 60 is also available in two mechanical models The ADVIA 60 or is an Open Tube model whereby the operator needs to remove the stopper from the blood tube before introducing the sample via the sampling probe The ADVIA 60 cr is a Closed Tube model permitting sampling of the blood specimen without removing the stopper from the
66. and the sample probe is in its proper position in the WBC chamber between the edge of the chamber and the center of the chamber close to the bottom continue by observing the RBC chamber see RBC chamber below If there is no stream of bubbles in the WBC chamber during the initial dilution cycle check the operation of the liquid valve lt 12 gt If the liquid valve 12 is not opening and closing replace the valve If this does not correct the problem call your local technical support provider or distributor If the valve is operating properly call your local technical support provider or distributor If the sample probe is not in its proper position in the WBC chamber between the edge of the chamber and the center of the chamber close to the bottom call your local technical support provider or distributor 075D0002 01 Page 9 11 9 MAINTENANCE AND TROUBLESHOOTING Diag 9 5 RBC chamber Is the sample probe between the edge of the chamber and the center of the chamber close to the bottom If the sample probe is in its proper position in the RBC chamber between the edge of the chamber and the center of the chamber close to the bottom and therefore system operations appear to be acceptable call your local technical support provider or distributor If the sample probe is not in its proper position in the RBC chamber between the edge of the chamber and the center of the chamber close to the bottom call yo
67. cases nh cana das cece tes Sea reos ieu ex esee oxi 7 2 7 3 AUTOCALIBRATI N ias 7 2 AR TO 7 2 1 3 2 Change lot number it a aos 7 8 1 3 3 Change expiration date A AANERN KEERA 7 4 3 4 Change target Values AKEE Tenn 7 4 7 3 5 Change number of calibrator 5 7 5 1 3 0RUN I m 74 7 4 CALIBRATION COEFFICIENTS cccccesseeeeeeeeeceeseeeeeeeeeeeneceeseeeessseceeseeeesesneaeeseeeneseeeesenenseeeaeesenes 7 9 7 4 1 Changing calibration coefficients 7 9 4 2 Print Coefficients nianma RRRRKERAMARARRKRRKRRRRERRR RR 7 10 7 4 m en ie dguppcsee Et 7 10 7 5 QUALITY CONTROL PROGRAM eeeeeeeeeeeee eene nnn mener nnn ntn nene nens a nannte nena n nnnm 7 11 A UCU OM e 7 11 7 5 2 A O 7 12 5 2 1 Insert smart tc 7 12 7 5 2 2 Select 7 13 7 5 2 3
68. display at the end of each analysis 8 1 5 Temperature printout The temperature of the diluent during the analysis has to remain in between the specified limits 18 32 C 65 90 F Results obtained for temperature outside these limits cannot be certified When the temperature printout is requested move the cursor to the function PRINT TEMP and press ENTER The TEMPERATURE menu is displayed PRT TEMP INES HH MM 2 Move the cursor to the required option and validate The temperature measured on the diluent circuit will be printed out on each result sample and QC results 075D0002 01 Page 8 3 8 INSTRUMENT CONFIGURATION 8 1 6 Print limits The laboratory limits can be printed out underneath each result when this option is selected From the RESULTS menu move the cursor to function 8 and press ENTER The PRINTLIMITS menu is displayed PRT LIMITS 4 VES HH MM 2 NO The indicates the current state Move the cursor to YES to print the results with the limits and press ENTER Move the cursor to NO to print the results without the limits and press ENTER 8 1 7 Print differential results The operator has the choice to print out or not the differential results From the RESULTS menu move the cursor to function and press ENTER The PRT LMG menu is displayed PRTLMG gt 1 YES HH MM 2 NO The current state of the printout is indicated by the Move the cursor to YES to print out the d
69. e corrected especially if the RBC count is extremely low Agglutinated red blood cells May cause a falsely decreased RBC count Blood samples containing the agglutinated red blood cells may be identified by observing abnormal MCH and MCHC values as well as by examination of the stained blood film Cold agglutinins IgM immunoglobulins which are elevated in cold agglutinin disease may lower RBC and PLT counts and increase MCV 075D0002 01 Page 3 9 3 SPECIFICATIONS HGB Hemoglobin Turbidity of the blood sample Due to any number of physiologic and or therapeutic factors may produce falsely elevated HGB results To obtain accurate hemoglobin results when increased turbidity of the blood sample occurs determine the cause of the turbidity and follow the appropriate method below 1 Elevated WBC An extremely elevated WBC will cause excessive light scatter In these cases use reference manual methods The diluted sample should be centrifuged and the supernatant fluid measured on a spectrophotometer 2 Elevated lipids Elevated lipids in the blood sample will give the plasma a milky appearance This condition can occur with hyperlipidemia hyperproteinemia as in gammapathies and hyperbilirubinemia Accurate hemoglobin determinations can be achieved by using reference manual methods and a plasma blank Increased turbidity may also be seen in case where the red blood cells are resistant to lysing This condition will
70. e going from a contaminated area to a non contaminated area or when you remove or change gloves Perform procedures carefully to minimize aerosol formation e Wear facial protection when splatter or aerosol formation are possible Wear personal protective equipment such as safety glasses gloves lab coats or other protective clothing when working with possible biohazard contaminants 075D0002 01 Page B 1 APPENDIX B BIOHAZARD PROTECTION Keep your hands away from your face Cover superficial cuts and wounds Dispose of contaminated materials according to your laboratory s biohazard control procedures Disinfect your work area with a 15 bleach solution Do not eat drink smoke or apply cosmetics or contact lenses while in the laboratory Do not pipette any liquid including water with your mouth Do not place any tools or any other items in your mouth Do not use the biohazard sink for any personal cleaning such as rinsing cups or washing hands To prevent needlestick injuries needles should not be recapped purposely bent cut broken removed from disposable syringes or otherwise manipulated by hand B 2 References 1 Centers for Disease Control 1988 Update Universal precautions for prevention of transmis sion of human immunodeficiency virus hepatitis B virus and other bloodborne pathogens in healthcare settings MMWR 37 377 382 387 388 National Committee for Clinical Laboratory Standards Protec
71. ean value is greater than 20 The calibration failed and the results are printed out The calculated coefficients are rejected the instrument keeps in memory the previous calibration coefficients and returns to the calibration menu NOTE If the calibration has failed on one or more parameters no parameter is calibrated If the calibration fails the user can restart the calibration or enter directly the calibration NOTE coefficients through the coefficient function of the calibration menu using the password CALIBRATION DATE 04 02 98 TIME 09 21 CALIBRATION FAILED OPERATOR JMG LOT Nr SETpoint 5 32 5 34 0 89 0 37 REJ COEFF 1 16 0 90 CURRENT 0 97 0 88 STATUS FAILED OK If the printer is not used when the calibration fails the following menu is displayed SAVED COEFF WBC 097 RBC 0 88 HGB 0 95 A REJECT COEFF 1 16 0 90 0 90 y Rejected and saved coefficients are displayed using the DOWN and UP keys in order to check and to record the faulty parameter s Press the ESC key to return to the main calibration menu Page 7 8 075D0002 01 7 CALIBRATION AND QUALITY CONTROL 7 4 CALIBRATION COEFFICIENTS Calibration can be achieved directly by changing the calibration coefficients when they are known Move the cursor to function COEFFICIENTS and press ENTER The following menu is displayed COEFFICIENTS 1 CALIB COEFF HH MM 2 PRINT COEFF 7 4 1 Changing calibration coefficients Move
72. ecific instructions temperature mixing etc RUN CAL NO ESC YES ENTER Press the ENTER key The start calibration menu is displayed START CALIBRATION 1 X ESC TO EXIT CALIBRATION ENTER TOASPIRATE Instrument is requesting the first run of the calibrator Install the calibrator tube in the correct holder position Close the sample door to start the analysis if this mode has been selected or close the sample door and press the cycle button located on the front panel When the analysis cycle ends the first result menu is displayed WBC RBC HGB HCT PLT MPV PRESSENTER TO CONTINUE Check that the results are within the limits given in the calibrator instructions and press ENTER The first validation menu is displayed VALID CALIBRATION 1 X ESC TO DISCARD ENTERTO VALID If the results are not within the acceptable limits use the ESC key to reject the results and to restart the first run NOTE Results having flags or for HGB are automatically rejected If the results are correct press the ENTER key The menu of the second calibration run is displayed START CALIBRATION 2 X ESC TO EXIT CALIBRATION ENTER TOASPIRATE Run the second calibrator sample and follow the same procedure until the number of samples set up is obtained When the last result has been validated the instrument calculates the statistical calibration factors for each parameter Mean target coefficient o
73. em 9 1 2 1 Startup and standby cycles At the beginning of each day a startup cycle must be performed This can be performed automatically without the operator s involvement or manually by pressing the STARTUP key At the end of each day press the STAND BY key The instrument goes into STANDBY at the end of the cycle This cycle takes 1 minute Leave the instrument in this mode overnight instru ment has to be switched off in this mode with sysKLEN in the chambers 9 1 2 2 Automatic cleaning A cleaning cycle is activated automatically after the number of samples programmed by the operator The cycle frequency can be adjusted to the laboratory workload This one can be run directly from the service menu 9 1 2 3 Instrument general cleaning In general intrument has to be cleaned with a wet piece of cloth Use water and a drop of liquid soap if necessary to clean the outside of the instrument Never use solvant or abrasive materials Wipe off any trace of blood as soon as possible Disconnect instrument from the main electrical supply before any cleaning intervention and make sure the instrument is clean and dry before reconnection 075D0002 01 Page 9 1 9 MAINTENANCE AND TROUBLESHOOTING 9 1 3 Service functions Several service functions are available for the user to clean and check his instrument These functions are accessible from the Main menu Move the cursor to the Function SERVICE and and press ENTER The
74. en the front panel LED turns from red to green to indicate that the initialization phase is completed Wait for the end of the automatic startup cycle or press the STARTUP key the instrument will perform a startup cycle and perform a blank cycle for a background count an analysis cycle on reagent without any blood sample If the background count does not exceed the following WBC 0 3x 10 mm 0 3 on the display RBC 0 02 x 108 0 02 on the display PLT 10x 10 mm 10 on the display the Startup is completed and the message STARTUP PASSED is printed out with results US mode Ifthe results are above these limits the instrument will automatically perform another background cycle If the problem persists after 3 cycles a message STARTUP FAILED CHECK REAGENTS is displayed run the checkup procedure During the startup cycle an HGB blank test is carried out If the HGB blank is not within accepta ble values after 3 cycles a flag STARTUP FAILED CHECK REAGENTS and HGB REFE RENCE FAILED is printed out with startup results Run the checkup procedure If the startup fails the message STARTUP FAILED is printed out with all the results until a new startup is carried out During the startup if the HGB blank test is unacceptable the background count is not carried out and a new attempt is automatically performed 3 maximum When the instrument has not been used for 4 hours a startup cycle must be run before run
75. er HealthCare has a list of recommended sample collection tubes at your disposal 6 2 2 Mixing It is critical to assure that all the blood samples are thoroughly and gently mixed with a gentle up and down and rolling motion prior to each sample aspiration Page 6 2 075D0002 01 6 STARTUP AND SAMPLE RUN 6 3 DAILY QUALITY CONTROL CALIBRATION VERIFICATION Refer to your laboratory quality assurance program to ensure quality throughout the entire testing process It is recommended that the system be controlled using Bayer TESTpoint Hematology Controls Low Normal and High Prod Nos 03 4200 54 03 4201 54 and 03 4202 54 respectively Refer to the package insert supplied with the control for instructions for use Controls are intended to be integrated into a clinical laboratory s own quality control program and procedures The following is a suggested protocol The actual frequency of control in a laboratory will be based upon many factors such as workflow system experience government regulation etc These controls should be assayed 1 beginning of each shift 2 Whenever a new reagent container same or different lot is used 3 Following the performance of any system maintenance or cleaning A satisfactory level of performance is achieved when the control values obtained for each level are within the acceptable range for the system as published in the package insert provided with the Bayer TEST
76. er is displayed Verify the lot number of the commercial control The message NEW QC is to explain that this smart card is used for the first time With every BLOOD CONTROL LOT a smart card is available and to avoid confusion the number of runs stored on the QC smart card or the message NEW QC is displayed If the analyzer index and the smart card index index the number of QC stored on the smart card are different a warning message is also displayed Page 7 12 075D0002 01 7 CALIBRATION AND QUALITY CONTROL List of the different messages NEW QC The smart card has not been used it is the beginning of a new QC XX QC RUN xx QC are stored on this smart card and the index in the smart card and in the analyzer are identical QC DIFF The QC index in the analyzer and the index on the QC smart card are different certainly it comes from the confusion between 2 QC smart cards If the user presses the ENTER key the change is validated and index analyzer equal index QC smart card If the user presses the ESC key the analyzer requests a new smart card it reads the new smart card information and displays the information SMART CARD FULL From 31 to 80 QC sample runs varies according to type of smart card have been stored it is impossible to continue running the QC with this smart card you must change your smart card Press the ENTER key to validate the smart card or if it is not the proper smart card press the ESC key
77. es 19 12 1997 TIME 09 12 LOW HIGH 10 0 10 ma REC 5 90 10 mm 16 3 g dl RET z 56 MCU 2 an Move the cursor to function HCH t 0 a 3 pRint LIMITS and press ENTER The high and low XLYM c limits as well as the flag values are printed out WEC sunn e oo ou o HMDN a c FLT Flags BCLX 8 8 NICK 8 WBC Flags Liks n2 8 5 8 103 mm 105 ma gt 107 ina a a s n 3 TJ lt lt gt 61 1 63A 0 0 0 o Diag 8 1 NOTE PCT and PDW are not available in the United States 075D0002 01 Page 8 5 8 INSTRUMENT CONFIGURATION 8 2 4 Flag limits A Platelet flag adjustment From the menu CHG LAB LIMITS move the cursor to the function FLAGS and press ENTER The flag menu is displayed FLAGS LIMITS gt 1 618 lt 8 0 gt HH MM 2 SCH 8 07 v Move the cursor in front of the flag to be adjusted and press ENTER The following menu SCL for exemple is displayed SCL EXIT ESC ACTUEL 8 00 SAVE ENTER Enterthe flag required value and press ENTER or press ESC to keep the current value Move the cursor in front of the next flag and repeat the same procedure Press the ESC key when all required values have been adjusted to return to the previous menu The lower the flag value the higher the
78. es entering the sample tube when the cap is pierced It is also recommended to use caps specially designed to avoid any blood retention the upper part of the cap 1 Type 1 Wrong 2 Type 2 Good Avoid using Type 1 caps as they may block the atmosphere connection because of the blood trapped inside the cap This type of cap also can drop some blood when opening the tube and introduce pressure when closing the tube Type 2 caps are recommended as they are specially designed to prevent these problems NOTE It is recommended not to pierce more than three times through the caps 3 3 3 Blood specimens Verification of any abnormal test result including flagged results or results outside ofthe normal range should be performed using reference methods or other standard laboratory procedures for the conclusive verification of results The sections below list known limitations of automated blood cell counters which use the principle of impedance BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix B for recommended precautions when working with biohazardous materials 3 3 4 Known interfering substances WBC White Blood Cells Leukocytes WBC results that exceed the linearity limits of the system will require dilution of the blood sample Re assaying the diluted sample will help to obtain the correct assay value NOTE Dilute the sample using autologous plasma or Saline NRBC
79. ets detects platelet anomalies and alerts the lab operator in the event of a non platelet cell population schistocytes microcytes etc 1 Platelets are counted between a low threshold placed at 2 fL and a variable high threshold The varia ble high threshold varies according to the microcyte population which is present in the platelet analysis zone 1 Small Cells SCL 2 Schistocytes SCH 3 Microcytes MIC Diag 4 4 2 Measuring the MPV The MPV Mean Platelet Volume is directly derived from the analysis of the platelet distribution curve The MPV is expressed in or fL 3 Calculating PCT PLT 108 x MPV um PCT 10000 4 Measuring the PDW Platelet Distribution Width This count is derived from the platelet curve PDW Width of the curve between 15 of the number of platelets starting from 2 fL S1 and 15 of the number of platelets beginning with the variable top threshold 52 Diag 4 5 1 PDW 075D0002 01 Page 4 5 4 TECHNOLOGY 4 3 STUDY OF GENERAL FLAGS With the print out of results the following general flags may occur following either WBC RBC HCT or PLT indicates that the system analyzed the sample three times but that all three counts differed and were outside the systems precision limits The result should be verified by repeating the sample or checked according to one of the laboratory reference methods following a parameter indicates that
80. f variation percentage difference between the target value and the mean CHG new calibration coefficient as well as a recall of the previous calibration coefficient and a pass fail status appear on the result printout Page 7 6 075D0002 01 7 CALIBRATION AND QUALITY CONTROL A Calibration passed If the statistical figures are within the acceptable limits Coefficient of variation is within the limits given in Table 7 1 and The percentage difference between the target and the mean value is less than 20 The calibration passed and the results are printed out The calculated coefficients become the new calibration coefficients and the calibration is completed PARAMETERS The first run of the calibrator is not taken into account in the statistical calculations a is printed out next to the run number CALIBRATION DATE 04 02 98 TIME 09 21 OPERATOR JMG LOT Nr SETpoint CURRENT STATUS The following message is displayed CALIBRATION ENDED WITH NEW COEFF PRESS AKEY TO CONTINUE Press any key to return to the MAIN MENU 075D0002 01 Page 7 7 7 CALIBRATION AND QUALITY CONTROL B Calibration failed If the statistical figures are not within the acceptable limits the following menu is displayed CALIBRATION FAILED PRESS AKEY TO CONTINUE Coefficient of variation is not within the limits given in Table 7 1 or The percentage difference between the target and the m
81. fere with the proper counting of platelets and cause elevated PLT counts Agglutinated erythrocytes May trap platelets causing an erroneously low platelet count The presence of agglutinated erythrocytes may be detected by observation of abnormal MCH and MCHC values and by careful examination of the stained blood film Giant platelets in excessive numbers May cause an erroneously low platelet count since these large platelets may exceed the upper threshold for the platelet parameter and are not counted Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells which may cause low PLT counts Reference manual methods may be necessary to obtain an accurate platelet count Hemolysis Hemolyzed specimens contain red cell stroma which may elevate platelet counts A C D blood Blood anticoagulated with Acid Citrate Dextrose may contain platelet aggregates which could depress the platelet count RBC inclusions Erythrocyte inclusions such as Howell Jolly bodies Heinz bodies siderotic and basophilic granules etc may produce a spuriously increased platelet count Platelet agglutination Clumped platelets due to poor collection techniques or platelet satellitosis caused by EDTA activation of immunoglobulins may cause a decreased platelet count and or an elevated WBC count The specimen should be recollected in sodium citrate anticoagulant and reanalyzed for only the platelet count The final PLT result
82. g This procedure provides a strong cleaning of the RBC and WBC apertures This cycle lasts approximately 3 minutes and involves the operator intervention to fill the chambers with sysCLEAR or diluted bleach solution The diluted bleach solution is obtained by a 1 5 dilution of a commercial bleach solu tion containing from 10 to 15 of sodium hypochlorite WARNING Commercial strength bleach is 10 to 15 sodium hypochlorite When handling bleach which can be used as a cleaning and antiviral agent wear protective clothing gloves and safety glasses It is harmful if swallowed and may cause eye or skin irritation Use bleach that is free of heavy metals To prepare a 1 5 dilution of a commercial bleach solution dilute one part of bleach with five parts of clean distilled water or clean deionized water The prepared solution is stable for one week when stored at room temperature Move the cursor to the function 4 CONCENTRATED CLEANING and press ENTER The followin 9 menu is displayed PLEASE OPEN COVER DOOR PRESS AKEY TO CONTINUE Open the instrument cover door and press any key The following menu is displayed POUR 3ML OF SYSCLEAR IN WBC CHAMBER PRESS AKEY TO CONTINUE Using a5 mL syringe pour 3 mL of sysCLEAR into the WBC chamber and press any key The next menu is displayed POUR 3ML OF SYSCLEAR IN RBC CHAMBER PRESS AKEY TO CONTINUE Pour 3 mL of sysCLEAR inside the RBC chamber and press any key The nex
83. h stored quality control run the reference means and upper and lower limits the actual mean results of the quality controls runs the 2 standard deviation value and the percent coefficient of variation 7 5 5 1 Select statistics From the QC MENU move the cursor to the function STATISTICS and press ENTER QC 4 STATISTICS A HH MM 5 GRAPHS The QC card is read 7 5 5 2 Select level SELECT LEVEL gt 1 ALL HH MM 2 LOW BLOOD v SELECT LEVEL 3NORMAL BLOOD A HH MM 4HIGH BLOOD Using the UP or DOWN arrows select the commercial control level to print or select ALL to print all three levels automatically Press ENTER and the following message appears PRINTING QC RESULTS PLEASE WAIT All statistics will be printed 075D0002 01 Page 7 17 7 CALIBRATION AND QUALITY CONTROL LOW LOTA XXX TIME 12 10PM EXP DATE 12 31 97 DATE 12 14 97 No DATE TIME MCHC PLT 12 01 97 10 12 REFERENCE MEAN Low HIGH Diag 7 9 7 5 6 Graphs The ADVIA 60 cT plots Levey Jennings charts for each parameter of the quality control files stored The Levey Jennings chart will plot one point for every control data point stored Beneath each chart the Reference Mean two SD value and the actual mean two SD value and CV are provided 7 5 6 1 Select graphs From the QC MENU move the cursor to function GRAPHS and press the ENTER key QC 4 STATISTICS A HH MM gt 5 GRAPHS The QC smart card is read 7 5 6
84. hen the automatic cleaning frequency value entered in the AUTO CLEANING function is out of the limits Maximum and minimum values available are displayed with the corresponding error message Correct the values according to the specified indications O STARTUP NOT INITIATED This message is displayed when the instrument is turned on and the startup cycle is not automatically carried out This STARTUP cycle is mandatory after each STANDBY cycle in order to flush the instrument from the cleaning reagent A blank cycle on reagents is performed to check the cleanliness of the instrument When this message is displayed and a sample analysis is requested press the STARTUP cycle key P STARTUP FAILED CHECK REAGENTS This message is displayed when the instrument gives out of range blank values after 3 consecutive startup cycles Check the expiration dates replace the reagents if necessary or perform a concentrated cleaning Page 9 16 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING Q HGB REFERENCE FAILED this message is displayed when the instrument gives out of range HGB blank values after 3 consecutive HGB reference blank cycles Check the expiration dates replace the reagents if necessary or perform a concentrated cleaning R 4HOURS ELAPSED BETWEEN LAST OPERATION this message is displayed when the instrument has not been used for at least 4 hours In order to prevent any drift in the results a STARTUP has to be
85. icious 9 2 3 1 WBC and HGB Perform the following if both your WBC and HGB results are incorrect or suspicious Press the START key and closely observe the specific operations of the analyzer listed below in the order specified Identify the malfunction s and initiate appropriate troubleshooting procedure s Sample probe During the initial dilution cycle is the sample probe between the edge of the WBC chamber and the center of the chamber close to the bottom Page 9 8 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING If it is continue If sample probe is not in its correct position in the mixing chamber call your local technical support provider or distributor Diag 9 1 Diluent dispenser Do you see bubbles in the diluent dispenser Is the plunger of the diluent dispenser moving up and down smoothly during sample analysis If you do not see bubbles and the diluent dispenser is operating properly continue If you see bubbles or if the diluent dispenser is not operating properly refer to Mechanical Checks for appropriate actions Diag 9 2 Transfer of lyse to WBC chamber Is the lyse pump plunger moving up and down smoothly Can you see air bubbles If the lyse pump is operating properly and no bubbles are seen thus system operations all appear to be acceptable call your local technical support provider or distributor If bubbles are seen change the reagent pack and prime the reagent lines Diag
86. ifferential and press ENTER Move the cursor to NO to print out the results without the differential and press ENTER 8 2 CHANGE LABORATORY LIMITS Laboratory limits can be set by the operator according to its own specifications Results that exceed the laboratory limits are identified with a flag H for results above the upper limit L for results below the lower limit From the SETUP menu move the cursor to the function CHG LAB LIMITS and press ENTER The LAB LIMITS menu is displayed CHG LAB LIMITS gt 1LOW LIMITS HH MM 2 HIGH LIMITS 8 2 1 Result low limits Move the cursor to function LOW LIMITS and press ENTER The LOW LIMITS menu is displayed LOW LIMITS gt 1WBC LOW XX HH MM 2RBCLOW XX Page 8 4 075D0002 01 8 INSTRUMENT CONFIGURATION Move the cursor next to the required parameter and press ENTER the following menu RBC for example is displayed RBC LOW EXIT ESC CURRENT SAVE ENTER Enter the required low value and press ENTER or press the ESC key to keep the current value Move the cursor to the next required parameter and follow the same procedure Press the ESC key when all modifications have been carried out 8 2 2 Result high limits From the CHG LAB LIMITS menu move the cursor to function HIGH LIMITS and press ENTER HIGH LIMITS gt 1 WBC HIGH XX HH MM 2RBC HIGH lt gt v Follow the same procedure for the result low limits 8 2 3 Print limits and flag valu
87. ing frequency according to the number of samples usually run in his laboratory From the SPECIAL menu move the cursor to the function CLEAN FREQ and press ENTER The CLEAN FREQ menu is displayed CLEAN FREQ EXIT ESC CURRENT SAVE ENTER Enter the required frequency and press ENTER The new automatic cleaning frequency is recorded 8 3 5 Internal setup printout The setup of all user options can be printed out using this function Move the cursor to function PRINT CONFIG and press ENTER The instrument internal setup limits and configuration is printed out DATE 18 11 1999 TIME s i354 OPERATOR 1 LOT COEFF REC HGE HCT PLT MPV RENT 1 14 0 89 1 12 1 05 1 18 0 94 TARGET 7 4 4 57 13 2 35 6 235 14 2 RDW COEFF r 1 00 FDW COEFF 1 00 VERSI N 1 4 TYFE ADVIA6G TUBE CLOSE REAGENT PACK STARTUF MANUAL FARAM 18 PARAMS BUZZER OFF UNITS STANDARD PRINTER RESERVED 1 PRINTOUT WITH HISTOGRAMS LMG YES PRT LIMITS HOST COMM STANDARD BARCODE NO CHECKSUM 1 NO DATE FMT DD MM YY ID MODE STANDARD CARD READER YES CARD RUN MODE E USER START MODE AUTO TEMPERATURE 27 6 Deg SERIAL 21845 STARTUP i 17 STAND EY 4 CEC ox CLEAN FRED i 50 FASSWORD 123 SAMPLES amp BUBBLING 1 175 BUBBLING 2 120 NEEDLE 617 CARRIAGE 916 PIERCING 5 LATEX DEPTH t o 762 647 NEEDLE S860 NEEDLE 925 NEEDLE 5 9
88. justment menu can be accessed from any other menu by pressing simultaneously the DEL and keys H Park Raises the vacuum waste syringe piston in the upper position and the dilution block syringes in the lower position Piercing Allows the operator to check the needle height adjustment acccording to the sample tube holder position Close the sample compartment door Move the cursor to the function PIERCING and press ENTER A piercing test is carried out and the needle low position measured The following menu is displayed NEEDLE X CURRENT XXX STANDARD XXX If the needle height has to be readjusted call your local technical support provider or distributor 075D0002 01 Page 9 5 9 MAINTENANCE AND TROUBLESHOOTING 9 1 3 6 Cycle functions These functions allow the user to check the cycle numbers run on the instrument From the SERVICE menu move the cursor to the function 8 CYCLE and press ENTER The CYCLE menu is displayed CYCLES gt 1STARTUP 4097 HH MM 2STANDBY 6234 The following cycles can be reviewed STARTUP STANDBY and CBCs 9 1 3 7 Technician functions This functions allows the field service engineer to check the instrument on a technical basis These functions can be accessed only with the use of a specific password 9 1 3 8 Automatic cleaning Move the cursor to function and press ENTER AUTO CLEANING PLEASE WAIT 3MNS 00S kkkkkkkkkkkkkkkkkkkkkkkkkkk The cycle freq
89. l as the patient identification NOTE The graphic results are not recorded on the smart card Sixty results can be stored on the smart card When this one is full the operator must either replace the smart card with a new one or clear the results from the old smart card The results are stored under a backup number which corresponds to the index of the results recorded on the smart card NOTE Results cannot be recorded if the MEMO is OFF Page 8 16 075D0002 01 8 INSTRUMENT CONFIGURATION 8 7 4 Print list The PRINT LIST option allows the operator to print out all the patient identifications recorded on the Patient Memory Card the time and the date of the analysis as well as the backup number column MEMO From the MEMOCARD Patient Card menu move the cursor to PRINT LIST and press ENTER MEMO CARD gt 3 PRINT LIST HH MM 4 TRANS ONE Example DATE 10 23 1998 10 23 1998 10 23 1998 10 26 1998 10 26 1998 Diag 8 3 8 7 5 Trans one Reprinting or sending to the host one result involves the backup number This backup number is displayed with results underneath the patient identification MM DD YY PAT ID HH MM From the MEMOCARD Patient Card menu move the cursor to TRANS ONE and press ENTER the following menu is displayed MEMO NO SAVE ESC CURRENT SAVE ENTER Enter the backup number of the results to be printed out and press ENTER The results are printed out with
90. latelet Alas EIE 4 7 4 3 2 flaG ia 4 7 43 3 WBC FAQS ai 4 7 4 3 4 Comments on the flagging capabilities nnne nnn nn 4 8 CHAPTERS DESSRIPTI N 2 ne UR 5 1 SA INSTRUMEN pee Q 5 1 5 1 1 Front panel and command 5 1 USING the keyboard lt a 5 1 B COMMANA KOS eet 5 2 5 1 2 Rear panel Main 1 5 4 5 1 3 LEM SIG Internal ana 5 4 5 1 4 Front internal view ENAA EENAA nN nnn nnn n nn nen nnn 5 5 CHAPTER 6 STARTUP AND SAMPLE 6 1 6 1 STARTUP CHECKS costilla liado 6 1 6 1 1 INSTRUMENT STAR TUP iaa ii 6 1 6 1 2 Reagent pack q A 6 2 6 2 SAMPLE COLLECTION AND MIXING ccccceeessseeeceeeeeessneeeeeeeeesaeeeeeeesnsaaeeeeeeeeeesseeeeeseeenseseeeeees 6 2 6 2 1 Sample collection ico rrt e AERE aan 6 2 6 2 2
91. llowing supplies are available from your local distributor Bayer TESTpoint Hematology Controls 075D0002 01 Page 10 1 10 SERVICE AND SUPPLIES 10 2 For Service To contact the legal representative for Bayer within the European community contact the Bayer Authorized Representative For service contact your local technical support provider or distributor 10 2 1 Bayer Authorized Representative Bayer Diagnostics Europe Limited Chapel Lane Swords Co Dublin Ireland 10 2 2 Bayer Offices Worldwide Manufactured by Bayer HealthCare LLC Subsidiary of Bayer Corporation Diagnostics Division 511 Benedict Avenue Tarrytown NY 10591 5097 USA 914 631 8000 Bayer S A Divisi n Diagn sticos Ricardo Guti rrez 3652 B1605EHD Munro Buenos Aires Argentina 54 0 11 4762 7000 Bayer Australia Limited ABN 22 000 138 714 Diagnostics Business Group 2 Keith Campbell Court Scoresby Victoria 3179 Australia 61 0 3 9212 8444 Bayer Austria GesmbH Gesch ftsbereich Diagnostika Lerchenfelder Gurtel 9 11 A 1164 Wien Austria 43 0 1 711 46 2424 Bayer s a n v Division Diagnostics Avenue Louise 143 Louizalaan 1050 Bruxelles Brussel Belgium 32 0 2 535 66 81 Bayer S A Produtos Diagn sticos Rua Domingos Jorge 1100 04779 900 S o Paulo SP Brazil 55 11 5694 5166 Bayer Inc Bayer Diagnostics Healthcare Division 77 Belfield Road Toronto Ontario Canada M9
92. lume distribution analysis Brit J Hem 128 148 International Committee for Standardization in Hematology 1978 Recommendations for reference method for hemoglobinometry in human blood ICSH Standard EP6 2 1977 and specifications for international hemoglobincyanide reference preparation ICSH Standard EP6 3 1977 J Clin Path 31 139 143 075D0002 01 Page C 1 APPENDIX C BIBLIOGRAPHY Page C 2 075D0002 01 Index A Autocleaning Frequency 8 9 C Calibration 6 3 7 2 7 6 Change Date and Time 8 11 Change Laboratory Limits 8 4 Change Operator 8 7 Checks Visual 2 3 Concentrated Cleaning 9 3 D Date Change 8 11 F Flags 4 6 Print 8 5 Review 6 8 Set Limits 8 6 Troubleshooting 9 8 Identification Mode 9 7 Interfering Substances 3 8 L Laboratory Limits Change 4 6 8 4 8 6 Levy Jennings Charts 7 18 Operating Conditions 2 3 Operator Change 8 7 INDEX Printer Select 8 3 Q Quality Control 6 3 Messages 7 13 R Reagent Pack Connnections 2 5 Installation 2 5 Priming 2 7 Specifications 3 6 S Select Printer 8 3 Smart Card Calibration 7 2 7 12 Patient Results 8 14 Quality Control 7 12 Specifications Expected Values 3 4 Reagents 3 6 Start Up 6 1 8 8 Startup Cycle 8 8 T Time Change 8 11 Troubleshooting 9 8 075D0002 01 Index 1 INDEX Index 2 075D0002 01
93. lve 4 Valve 5 Valve 6 Valve 7 Valve 8 Valve 9 Valve 10 Valve 11 Valve 12 Valve 13 Diag 9 Controls the lyse distribution Cancels the pressure vacuum in the pressure vacuum syringe Controls the cleaner input in the WBC counting head during the rinsing Controls the drain of the pressure vacuum syringe Activates the vacuum needed in the WBC amp RBC counting heads Controls the diluent input in the RBC counting head during the rinsing Controls the aspiration of the diluent air output inside the needle rinse block Routes the diluent distribution to the inside or outside of the piercing needle Controls the diluent inside the aspiration needle Controls the diluent distribution Controls the drain of the WBC chamber Controls the drain of the RBC chamber 1 Two Ways 2 3 Ways Page 9 18 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING 9 5 MENU OVERVIEW ADVIA 60 CT Parameters 1 Pat ID Run SELECT LEVEL 1 Low Select OP 2 Normal 3 High 1 Automatic 1 RESULTS 2 Analysis i Smart card SELECT LEVEL 2 Low 2 QC he Statistics 3 Normal 4 High 5 Graphs Run calibration Valid calibration Start calibration Chg target Chg sample Nb 3 CALIBRATION Chg lot Select OP Chg exp date
94. mmercial control blood 075D0002 01 Page 7 13 7 CALIBRATION AND QUALITY CONTROL 7 5 2 4 Run commercial control Prepare the commercial control according to the specific instructions temperature mixing etc Install the calibrator tube in the correct holder position Close the sample door to start the analysis if this mode has been selected or close the sample door and press the cycle button located on the front panel When the analysis cycle ends the first QC results menu is displayed WBC RBC HGB HCT XXXH XXX XXXL XXX v The complete listing of results can be rewieved when moving the cursor up or down Press the ESC key to exit this menu e c DATE 10 11 1997 TIME 15 11 LOT 4225 NORMAL EXP DATE 05 01 98 OPERATOR TSTL Q C 1 SEQ 2 STARTUP PASSED 7 5 107 mm t 80 RBC 4 39 105 mm 29 7 HGB 13 1 g dl 37 0 g dl HCT 35 3 X 146 24 PLT 255 107 mm t 8 1 pun DIFF XLYM 2 2 10 mmn MON p 0 5 L 10 mm 7 4 8 107 mm O O O O O O O O O Diag 7 7 7 5 2 5 Accepting rejecting results The results are compared to the control assay ranges stored on the memory card If any result is out of range an H High or L Low will be shown on the display and the printout If a third count must be processed a dollar or a star will be shown on the display and the ru
95. n is rejected If the HGB blank is not within acceptable limits a is displayed and the run is rejected You must rerun the control The following message appears when the ENTER key is pressed RUN REJECTED PRESS AKEY TO CONTINUE If the results are correct no star dollar or will appear the following menu appears VALID LOW NO ESC WES 7 14 075D0002 01 7 CALIBRATION AND QUALITY CONTROL 1 ACCEPT Ifthe results are accepted they will be stored on the QC smart card and the display will return to the SELECT LEVEL SELECT LEVEL gt 1 LOW BLOOD HH MM 2 HIGH BLOOD It is possible to exit the QC or run another control level The control level stored on the smart card disappears in the listing of the control levels remaining it is impossible to store 2 identical control levels to avoid confusion After the second run in order to save time the analyzer loads automatically the last control blood level without going to the SELECT LEVEL no choice is requested 2 REJECT AND RERUN If any results are not within the acceptable limits it is possible to reject the results and to repeat the control analysis 7 5 2 6 Exiting QC automatic EXIT BEFORE END OF QC If at any time the operator wants to exit this QC AUTOMATIC MENU the ESC key can be pressed and the following warning message appears EXIT NO ESC YES ENTER After 1 2 or 3 correct results are stored it is possible to e
96. n 18 to 32 C 65 to 90 F Maximum relative humidity 80 for temperatures up to 31 C decreasing linearly to 50 relative humidity at 40 C Smart Card option Reader GCI 400 ADVIA 60 SETpoint Calibrator memory card GFM 2K Patient memory card MCOS 24K capacity 60 CBCs ADVIA 60 TESTpoint Control memory card MCOS 24K 16 parameters MCOS 16K 8 parameters 075D0002 01 Page 3 1 3 SPECIFICATIONS Storage capacity Number of QC available of QC Aspirations day QC8P card QC16P card 80 80 44 60 Table 3 1 31 41 Hemoglobin HGB WBC chamber LED 550 nm Size of apertures WBC 80 um RBC PLT 50 um Final dilutions WBC approximately 1 250 RBC PLT approximately 1 15000 Throughput 55 samples hour approximately Capacity of internal memory Last sample only 60 samples with the memory Smart Card Anticoagulent EDTA is recommended Volume of whole blood sample 10 uL Reagent consumption Software version V 1 6 Prime all reagents Concentrated cleaning 6 0 mL Page 3 2 075D0002 01 3 SPECIFICATIONS Reagent pack Total capacity 4 2 liters Measuring principles WBC RBC PLT Impedance change Hematocrit Numeric integration Cyanmethemoglobin method 550 nm Barcode reader option EAN 8 EAN 13 C 39 C 128 ITF 2 5 CODABAR STF C 93 with or without checksum
97. nd press ENTER Diag 7 1 As the lot number the expiration date and the target values are recorded into the memory card only 2 operations remain The operator selection The selection of the number of the calibrator samples Once these two steps are done run calibration NOTE The card can be removed as soon as the lot number has been validated 7 3 AUTOCALIBRATION From the calibration menu move the cursor to function 1 JAUTOCALIBRATION and press ENTER The CALIBRATION menu will unfold step by step through the operator selection the calibrator lot identification the target values and the number of samples to be analyzed before starting the calibration 7 3 1 Select operator Move the cursor to one of the 4 required operator identification and press ENTER A star is displayed next to the chosen identification and the menu turns to the calibrator identification SELECT OP 1 OI 1 HH MM gt 20P 2 v Page 7 2 075D0002 01 7 CALIBRATION AND QUALITY CONTROL 7 3 2 Change lot number CHANGE LOT ESC CURRENT SETPOINT YES ENTER The current lot number is displayed If the lot number of the calibration blood has to be changed press ENTER The following menu is displayed LOTA EXIT ESC CURRENT SETPOINT SAVE ENTER Without barcode reader enter the new lot number 10 characters maximum Numbers can be entered directly using the numerical keyboard letters can be ente
98. ng measuring range WBC approximately 30 to 460 fL RBC approximately 25 to 300 fL Plt approximately 2 to 33 fL 4 2 1 White blood cell distribution The WBC volumetric distribution study reveals the following three leukocyte subpopulations Lymphocytes Monocytes Granulocytes 4 2 1 1 Analysis principle The principle is based on the volumetric study of leukocytes after use of a patented diluent and a lysing reagent The lysing action varies according to the temperature of the dilution ambient temperature In order to correct these fluctuations within the operating temperature range 18 C to 32 C 65 F to 90 F a temperature sensor is placed on the diluent circuit and the position of the separation thresholds varies according to the temperature 075D0002 01 Page 4 3 4 TECHNOLOGY 4 2 1 2 Diluent and lysing action The diluent preserves and prepares the cell membrane for the differential reaction The lyse has a differential mode of action on cytoplasmic membranes The lymphocyte cytoplasmic membranes allow the release of water soluble cytoplasm and shrink the membrane around the nucleous the monocytes undergo an intermediate reaction while the granulocytes have a limited reaction due to a molecule and their cytoplasmic structure which protects them from the shrinking action of the lyse 4 2 1 3 Volumetric study After the differential lysing action ADVIA 60 cT analyzes the heights of e
99. ning sample analyses NOTE If analyses are performed when the startup cycle has not been carried out the message STARTUP NOT INITIATED Is displayed and printed out 075D0002 01 Page 6 1 6 STARTUP AND SAMPLE RUN 6 1 2 Reagent pack A low reagent level is indicated by the number of CBCs left from 5 to 0 when the operator tries to run an analysis cycle WARNING PACK LOW LEVEL 5 ESC TO EXIT START TO CONFIRM If this occurs operator has the choice either to run the cycle pressing the START key or to replace the Reagent pack with a new one 6 2 SAMPLE COLLECTION AND MIXING 6 2 1 Sample collection Sample collection should be done on venous blood by the means of vacuum or atmospheric sample collection tubes It is possible to collect capillary blood into a microtainer with a minimum volume of 100 uL for example in a pediatric lab and analyze this on the ADVIA 60 EDTAis the recommended anticoagulent for analysis on the ADVIA 60 Samples should be processed as soon as possible and within 6 8 hours of collection BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix B for recommended precautions when working with biohazardous materials CAUTION The sample collection tube should be filled with the exact quantity of blood indicated on the tube itself Any incorrectly measured blood sample collection will show a possible variation in the results Bay
100. ntrated cleaning Was the concentrated cleaning performed If it was not perform the concentrated cleaning Continue troubleshooting if this does not correct the HGB result Calibration Was the system calibrated earlier as part of the identification procedure If HGB was not calibrated as part of the identification procedure calibrate it as described in section 7 If all attempts to calibrate this parameter have failed press the START key and closely observe the specific operations of the analyzer listed below in the order specified Identify the malfunction s and initiate appropriate troubleshooting procedure s If upon close inspection all operations still appear to be acceptable call your local technical support provider or distributor Lyse pump Is the lyse pump plunger moving up and down smoothly Can you see air bubbles If the lyse pump is operating properly and bubbles are not observed continue If lyse pump is not operating properly or bubbles are observed see Mechanical Checks for troubleshooting procedure Page 9 10 075D0002 01 Diag 9 4 9 MAINTENANCE AND TROUBLESHOOTING HGB LED Is the HGB LED illuminated when the system power is on If itis and therefore all system operations are acceptable call your local technical support provider or distributor If the HGB LED is not illuminated when the system power is on call your local technical support provider or distributor 9 2 3 4 RBC HCT and PLT Check
101. on if an audible alarm occurs and the display remains dark check the following Are both connectors properly fitted Check the flat cable connection on the display Check the flat cable connection on the electronic board If they are and you have therefore been unable to identify the source of the display failure and no audible alarm occured press simultaneously on the and DEL keys to access the display adjustment menu Follow the procedure described in Mechanical Checks If the display remains dark call your local technical support provider or distributor 075D0002 01 Page 9 13 9 MAINTENANCE AND TROUBLESHOOTING Diag 9 6 9 2 4 3 Motors After having switched on the instrument or whenever a problem occurs the display may show some error messages concerning a failure in one of the motor initialization These messages appear for a few seconds on the display and are as follow ERROR NEEDLE MOTOR TRANSFER MOTOR ERROR ERROR LIQUID SYRINGE MOTOR ERROR PRESSURE SYRINGE MOTOR ERROR PIERCING MOTOR ERROR CARRIAGE MOTOR Are the motor connectors properly fitted on the electronic board If they are and you have therefore been unable to identify the source of the motor failure call your local technical support provider or distributor LL a 3 PE i be 1 Pressure syringe motor 4 Needle motor 2 Liquid syringe motor 5 Fan motor 3 Transfer motor 6
102. on The third function HISTO WITHOUT RBC allows to print out the results with the PLT and WBC histograms This function avoids the lapse of time taken to print out all the histograms at the end of an analysis cycle recommended with the CITIZEN printer The operator has the choice between 4 different unit systems accessible when moving the cursor from the RESULTS menu to the function UNITS and pressing ENTER The UNITS menu is displayed UNITS gt 1 STANDARD HH MM 2 SI v The 4 different systems are STANDARD INTER 1 INTER2 10 mm 109 L 10 mm 106 mm 102 10 mm 10 mm 109 L 10 mm L L g dL mmol L g dL um fL fL pg fmol pg g dL mmol L g dL um fL fL Move the cursor in front of the required unit system and press ENTER Page 8 2 075D0002 01 8 1 4 Printe 8 INSTRUMENT CONFIGURATION r selection Four different printers and a no printout option can be selected from the RESULTS menu Move the cursor to the function PRINTER and press ENTER The PRINTER menu is displayed PRINTER gt 1 RESERVED 1 2 RESERVED 2 v Move the cursor to the required printer 1 RESERVED 1 EPSON 80 columns printer 2 RESERVED 2 STAR printer 3 RESERVED 3 SEIKO thermal printer 4STANDARD CITIZEN dot matrix printer 5 NONE or if no printout is required move the cursor to the function NONE and press ENTER In this last case results will have to be recorded by the operator from the
103. ontrol tube is equipped with a barcode label press the ID SEQ key ofthe front panel to enter the control ID The identification menu is displayed PAT ID EXIT ESC CURRENT SAVE ENTER Read the control identification barcode label using the barcode reader When the reading is completed a beep occurs and the control lot identification is displayed on the screen Press the ENTER key when the identification is entered or ESC key to save the displayed one a message PLEASE CLOSE HOLDER DOOR is displayed Install the sample tube in the tube holder and close the sample door to start the analysis if this mode has been selected or close the sample door and press the START key Diag 6 1 Page 6 4 075D0002 01 6 STARTUP AND SAMPLE RUN 6 3 3 Standard identification mode Press the ID SEQ key to enter the control Run The following menu is displayed RUN EXIT ESC NEXT SAVE ENTER Enter the run number from 1 to 9999 using the numeric keys of the front panel Press the ENTER key to record the number or the ESC key to save the displayed one A message PLEASE CLOSE HOLDER DOOR is displayed 6 3 4 Sample tube holder selection The sample tube holder has 4 positions according to the sample tube characteristics The required posi tion is selected when it is facing the inside of the sampling compartment Turn the sample tube holder in either side to place the required position until the click
104. ood cells Volts Threshold Time Diag 4 2 6 The dilutions used for these different measurements are the following WBC 10 uL of whole blood mixed with 2 50 mL of diluent the final dilution is at 1 250 then 0 60 mL oflyse are added before the count resulting in a final dilution of 1 300 RBC PLT 30 pL of the dilution at 1 250 are mixed with 2 50 mL of the diluent resulting in a dilution of 1 21 000 7 Each type of cell WBC RBC PLT is analyzed by the microprocessor which also handles the cell distribution histograms 8 To count the platelets the ADVIA 60 cT uses high performing electronics which avoids the use of complex hydraulic systems for the elimination of faulty impulses generated at the rear side ofthe aperture When red blood cells reenter the analysis zone this creates impulses with a height comparable to platelet impulses but with a different shape The instrument uses a very sophisticated impulse sorting system This system rejects any impulse which does not have the typical platelet shape This sorting system maintains a very reliable aperture and a traditional hydraulic system 9 ADVIA 60 provides distribution curves by analysis on 256 counting channels for the WBC RBC and Platelets Page 4 2 075D0002 01 4 TECHNOLOGY 4 1 2 Hemoglobin measurement principle 1 During the STARTUP cycle an HGB blank test sequence including two blank measures is run If the diffe
105. pairs are provided by your local technical support provider or distributor the electrical supply of the laboratory follows the national or international regulations the system is operated under the following instructions 2 10 PRINTER optional Itis mandatory to connect a printer which fulfills the following conditions the printer is recommended by your local technical support provider or distributor the printer is approved by the CE norms EEC only the printer is certified CSA Page 2 6 075D0002 01 2 INSTALLATION 2 10 1 Connection The printer is connected to ADVIA 60 cT with the cable delivered with the instrument Lock the connector in place by tightening the 2 screws on each end of the connector to the ADVIA 60 cT Attach the other end of the cable to the printer and lock the printer connector in place by the means of the 2 clips located on the connector itself Diag 2 12 On the ADVIA 60 it is necessary to select the printer format RESERVED 1 of the PRINTER menu function 4 accessible through the OPTIONS menu function 5 of the main menu then RESULTS function 1 2 11 REAGENT PRIMING When the ADVIA 60 cT is first installed it contains no reagents All the reagents have to be primed now Turn ON instrument by pressing the ON OFF switch located on the rear panel When the instrument turns on the display shows PLEASE WAIT FOR 3 MIN ESCAPE ESC This time is requi
106. point Hematology Controls Refer to Section 7 Calibration and Quality Control for instructions for use Before analyzing samples it is recommended that the operator analyze three levels of control material low normal and high to verify that the system is within acceptable limits Two Identification modes are available 1 US mode that requires the patient or control identification on each analysis This mode allows the use of the barcode reader 2 Standard mode increments a run number on each analysis BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix B for recommended precautions when working with biohazardous materials 075D0002 01 Page 6 3 6 STARTUP AND SAMPLE RUN 6 3 1 US mode identification without barcode reader Press the ID SEQ key of the front panel to enter the control ID The identification menu is displayed PAT ID EXIT ESC CURRENT SAVE ENTER The identification can be entered using 13 characters letters or numbers Letters can be entered using the UP and DOWN keys of the front panel Press ENTER for each letter to step to the next one Press the ENTER key when the identification is entered or ESC key to save the displayed a message PLEASE CLOSE HOLDER DOOR is displayed The identification displayed in actual stays in memory until a cycle is run 6 3 2 US mode identification with barcode reader When the blood c
107. port provider or distributor if this does not correct the PLT result Sample probe During the initial dilution cycle is the sample probe between the edge of the mixing chamber and the center of the chamber close to the bottom If it is continue If sample probe is not in its correct position in the mixing chamber call your local technical support provider or distributor 9 2 4 Troubleshooting system operations The procedures described on the next pages should be performed whenever system operations are faulty Identify the source of the malfunction and initiate the appropriate troubleshooting procedure A SERVICE menu is available in the ADVIA 60 program to help the user in the troubleshooting of the hydraulic transfers and mechanical operations This SERVICE menu can be accessed when the following checks have been passed 9 2 4 1 Power Check the following if you are unable to analyze a sample because of a lack of power to the ADVIA 60 cT Is the power switch on If it is continue 15 the power cord plugged into the wall outlet If it is continue Is there current in the wall outlet If there is continue If there is no current call your maintenance department Are the fuses still functioning If they are and you are to identify the source of the power failure call your local technical support provider or distributor If the fuses are defective or blown replace them 9 2 4 2 Display When the instrument is switched
108. position to start the analysis if this starting mode has been Setup or press the START key after closing the door The tube holder carriage moves up in the piercing position and the sample aspiration begins The green red LED will blink during sampling d The LED stops blinking and the tube holder carriage moves down when the sampling is completed Shutdown procedure 1 Perform a general cleaning rinse cycle of the ADVIA 60 Hematology System using the STAND BY key on the front panel This cycle lasts for approximately one 1 minute The instrument will cycle into the STAND BY mode 2 Press the ON OFF switch to OFF NOTE When the instrument is left in STAND BY mode a STARTUP CYCLE must be performed prior to any analysis cycle B Bayer HealthCare 2003 Bayer HealthCare LLC All rights reserved R Table of Contents CHAPTER 1 INTRODUCTION 1 1 1 1 INTENDED USE iii 1 1 1 2 PRESENTATION 2 3 rni rone tee ce ocu e era bn nue uua cas taccesessesedssnaasenssedanaenddnenaazecne Y RRRRRPARRRRRRRRRRRRAR 1 2 1 3 OPEN TUBE AND CLOSED TUBE MODELS siecciccscccccceccissacecessseaneesecenscntecnercoecceecoreaecessseetacensenassiea ese 1 2 1 4 1 2 CHAPTER 2 INSTALLATION
109. re as follow 8 5 1 Host communication 1 FORMAT 1 2 FORMAT 2 3 STANDARD 4 TR OFF transmission OFF 8 5 2 Baud rate 1 300 2 1200 3 2400 4 4800 5 9600 8 5 3 Transmission From the HOST OPTIONS menu move the cursor to the function TRANSMISSION and press ENTER The last results are transmitted to the external laboratory computer via the RS 232 075D0002 01 Page 8 13 8 INSTRUMENT CONFIGURATION 8 6 BARCODE SETUP The barcode reader can be set up according to the barcode label specifications checksum From the SETUP menu move the cursor to the function 6 BARCODE and press ENTER The BARCODE menu is displayed CHECKSUM 21 VES HH MM 2 Move the cursor to the required option and validate Make sure that the US identification mode has been set up for use of the barcode reader 8 7 Patient Memory Card 8 7 1 Introduction This menu is available only if the ADVIA 60 cr is equipped with a smart card reader The MEMORY program contains the seven following functions 1 MEMO allows the operator to enable disable the memory function 2 TRANSMISSION allows the operator to select the transmission mode printer or host 3 PRINT LIST the purpose of this submenu is to print or to send to the host the list of the patient identification stored on the memory smart card 4 TRANS ONE this submenu allows the operator to print or to send to the ho
110. red at the startup for the instrument initialization and stabilization specifically for the HGB diode to reach its operationnal temperature After three minutes the LED of the front panel turns from red to green and the display shows the following STARTUP NOT INITIATED PRESS A KEY TO CONTINUE This message appears when the instrument is setup with the manual startup cycle to prevent any analysis cycle before running a startup cycle Press any key the main menu is displayed MAIN MENU 1 RESULTS HH MM 2QC v 075D0002 01 Page 2 7 2 INSTALLATION From the MAIN MENU move the cursor to the function SERVICE and press ENTER The service menu is displayed SERVICE gt 2 DRAIN CHAMBER A HH MM 3 PRIME REAGENTS v Move the cursor to PRIME REAGENTS and press the ENTER key Select the function CHANGE PACK and follow the instructions given by the LCD in order to install the pack REAGENT PACK gt 1 CHANGE PACK HH MM 2 lt 502 v Once the new PACK is installed a priming cycle will be automatically carried out and the following menu displayed PRIME WAIT FOR 2 MIN 3 S EEES Before analyzing samples visually inspect reagent lines and pumps for air bubbles Repeat priming if air bubbles are still present Call the local technical support provider or distributor if priming does not eliminate air bubbles From the REAGENT PACK menu the function CBC LEFT displays the number of analysis cycles left to
111. red using the DOWN and UP keys For each letter press the ENTER key to validate it and enter the next one validate a second time to record the lot number The menu turns to the expiration date If the lot number has not changed press the ESC key the menu turns directly to the expiration date With barcode reader When the calibration blood tube is equipped with a barcode label read the calibration blood identification barcode label using the barcode reader When the reading is completed a beep occurs and the control lot identification is displayed on the screen Press ENTER to validate The menu turns to the expiration date Diag 7 2 075D0002 01 Page 7 3 7 CALIBRATION AND QUALITY CONTROL 7 3 3 Change expiration date The current expiration date is displayed CHANGE EXP DATE DD MM YY NO ESC CURRENT YES ENTER If it is correct press the escape key the menu turns to the target values If the expiration date needs to be changed press ENTER the following menu is displayed EXP DATE DD MM YY EXIT ESC CURRENT SAVE ENTER Change the expiration date according to the format requested on the display and press ENTER The menu turns to the target value modifications 7 3 4 Change target values The following menu with the current WBC target value is displayed CHANGE TARGET WBC NO ESC CURRENT YESH ENTER If the WBC target value is correct press ESC the menu turns to RBC target value
112. remove the cover open the pneumatic access door on the front of the system WARNING Do not open or close the instrument front door when the piercing carriage door is open Do not open the piercing carriage door when the aspiration needle is in its lower position 2 Pneumatic access door This door gives an access to the pneumatic parts It also allows the operator to check the hydraulic cycle operation It is recommended to keep the door locked during the measuring cycles as it is equipped with an electrical interference shield 3 Piercing carriage door This door gives access to the sample tube holder which moves up during the sampling cycle in order to pierce the tube cap Then the aspiration needle moves down into the sample tube inside the piercing needle and aspirates the 10 uL whole blood sample Its internal and external rinsing is patented and is fully automatic 4 Control panel This panel allows the operator to communicate with the instrument To access the different cycles To identify the patients To setup the instrument etc 5 1 1 Front panel and command keys A Using the keyboard All functionalities of the instrument have been dispatched in menus Each menu has a certain number of functions These menus are all accessible through the MAIN MENU displayed at the instrument startup Navigation in the menus is done using the gt cursor command keys UP and DOWN Entry in a function is done by moving
113. rence between these two measures is too large a third measurement is performed HGB reference blank measurement will occur if the operator has required a CALIBRATION operation has required a QC operation has left the instrument more than 10 minutes after the STARTUP has left the instrument more than 60 minutes after ANALYSIS has not carried out the STARTUP cycle after switching on the instrument 2 On every cycle an Hgb blank is carried out on diluent and compared to the previous HGB blank analysis 3 0 60 mL of lyse agent is added to the 2 5 mL of 1 250 dilution 4 The hemoglobin freed by the lyse of the red blood cells combines with potassium cyanide to form chromogenous cyanmethemoglobin compound 5 The compound is then measured by spectrophotometry through the WBC cuvette at 550 nm 6 The result is given with the units set up in Section 8 Instrument Configuration 4 1 3 Hematocrit measurement principle 1 The height of the impulse generated by the passage of a cell through the microaperture is directly proportional to the volume of the analyzed cell 2 The hematocrit is measured as a function of the numeric integration of the MCV 3 The result is given with the units set up in Section 8 Instrument Configuration 4 2 CELL DISTRIBUTION STUDY ADVIA 60 cT carries out volumetric distributions histograms for WBC and RBC on 256 analysis channels and 128 channels for PLT with the followi
114. ress ENTER The results are printed out in the usual format without the graphs 8 7 8 Clear smart card A single result cannot be erased by itself This function allows the operator to erase all the results recorded on the smart card From the MEMOCARD Patient Card menu move the cursor to CLEAR CARD and press ENTER A message is displayed to alert the operator before erasing any data Press the ENTER key to erase any data or press the ESC key to cancell this function The results are erased and the backup number is updated to 0 The smart card can be reused Page 8 18 075D0002 01 CHAPTER 9 MAINTENANCE AND TROUBLESHOOTING 9 1 MAINTENANCE AND SERVICE 9 1 1 Overview One of the principle factors contributing to accurate and reliable results is a well maintained instrument Routine maintenance is required to keep your instrument functioning properly The ADVIA 60 cT is designed to keep this maintenance automated and to a minimum This section describes the daily and periodic maintenance procedures BIOHAZARD Wear personal protective equipment Use universal precautions Refer to Appendix B for recommended precautions when working with biohazardous materials 9 1 2 Daily maintenance These cleaning procedures are required daily to maintain optimum performance of your ADVIA 60 CAUTION Failure to perform any of these recommended cleaning procedures may result in decreased reliability of your syst
115. rode block is attached firmly to the chamber Re install the HGB WBC chamber cover 1 Chamber protection cover Diag 2 6 2 5 2 Connection check Check that the connectors on the printed circuit board are securely in place Re install the instrument cover Diag 2 7 Page 2 4 075D0002 01 2 INSTALLATION Remove the fuse holder from its location on the rear panel pressing on the holder lock and check the fuse characteristics they should be 1 Amperes 220 Volts Slow Blow 2 6 REAGENT PACK CONNECTIONS The ADVIA 60 Hematology System TIMEPAC Reagents includes the entire set of reagents a Pack andis able to receive the waste liquids Three soft pockets contain the reagents sysDIL SysKLEN and sysLYSE and are closed by means of the valve connectors located at the bottom of the pack The fourth pocket is empty and is intended for receiving waste liquids To order additional reagents contact your local technical support provider or distributor Remove the reagent output protections as well as the waste input protection Diag 2 9 Install the pack directly into the compartment of the instrument Push the pack down in order to plug correctly the pack on the male connectors The free male connector must be plugged on the pack upper valve in order to receive the waste liquids CAUTION To prevent leaks in the reagent pack avoid unplugging reagent pack more than once
116. run with the same pack It is also possible to run a priming cycle at any time using the selection PRIME of the REAGENT PACK menu CAUTION To prevent leaks in the reagent pack avoid unplugging reagent pack more than once Page 2 8 075D0002 01 CHAPTER 3 SPECIFICATIONS 3 1 PERFORMANCE SPECIFICATIONS Diag 3 1 ADVIA 60 performs automated blood counts and requires no manual operations for aspirating blood dilution measuring calculations print out and computer transfer The parameters given according to the internal setup ADVIA 60 WBC LYM LYM MON MON GRA GRA RBC HGB HCT MCV MCH MCHC RDW PLT MPV and 3 distribution curves WBC RBC PLT ADVIA 60 WBC LYM LYM MON MON GRA GRA RBC HGB HCT MCV MCH MCHC RDW PLT MPV PDW and 3 distribution curves WBC RBC PLT PCT and PDW are not available in the United States Dimensions Height approximately 440 mm 16 5 inches Width approximately 360 mm 14 2 inches Depth approximately 330 mm 12 6 inches Weight approximately 14 Kgs 31 Ibs Power supply 100 Vac to 240 Vac 10 50 Hz to 60 Hz LCD screen 2 lines of 40 characters backlighted Power Consumption Maximum 150 VA 30 10 In use 110 VA 30 10 Stand by mode 35 VA 30 10 Conditions for use ADVIA 60 cT can function betwee
117. s will also interfere with the white cell partial differential parameters LYM MON GRAN A spurious low WBC count may also be seen in patients with lymphocytic leukemias due to the presence of abnormally small lymphocytes which may not be counted by the instrument Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of the leukocytes which may cause low WBC counts Cryoglobulins Increased levels of cryoglobulin that may be associated with myeloma carcinoma leukemia macroglobulinemia lymphoproliferative disorders metastic tumors autoimmune disorders infections idiopathic disease aneurism pregnancy thromboembolic phenomena diabetes etc can elevate the WBC RBC or PLT counts and the HGB value The specimen can be warmed up to 37 C and reanalyzed immediately or a manual WBC RBC or PLT count can be performed RBC Red Blood Cells Erythrocytes The red blood cell dilution contains all the formed elements in the blood erythrocytes leukocytes and platelets During the counting of the erythrocytes red blood cells platelets are not counted since their size falls below the minimum threshold Leukocytes White blood cells on the other hand are included in the RBC count However since the normal ratio between red blood cells and white blood cells is so extreme the influence of the WBC on the RBC is negligible High WBCs Inrare cases where the WBC is extremely high the RBC count may b
118. sample door to start the analysis if this mode has been selected or close the sample door and press the cycle button located on the front panel The analysis is carried out Results are displayed and printed out DATE 10 11 1997 TIME 09 54 LOT HIMXZZON ANALYSIS SEQ 1 STARTUP PASSED WBR HGE HCT PET PCT E l0T mm t 1 pun i mnm t 30 2 py g dl 37 4 H g dl 10 mp pm un 4x boon tas tn Or fi Nid DIFF LYM 21 Y t a 10 mp MON s MON 0 8 LOF ap HORA O O O O O O O O O O O O O O Diag 7 8 7 5 4 QC print targets The commercial control blood target values can be printed at any time Normally these values are printed on the assay sheets of your control From the QC MENU move the cursor to the function PRINT TARGETS and press ENTER The QC targets are printed out QC 2 ANALYSIS HH MM 3PRINTTARGETS 4 Page 7 16 075D0002 01 7 CALIBRATION AND QUALITY CONTROL 7 5 5 QC statistics The commercial control files can be printed for permanent records at any time It is recommended to print the files at the end of each month Each file printout includes the following information File Name blood level Lot number of control expiration date of control date and time of print request date and time of the run operator and the data points for eac
119. sedis sec E E 6 2 6 3 DAILY QUALITY CONTROL CALIBRATION VERIFICATION nnnm 6 3 6 3 2 US mode identification with barcode 6 4 6 3 1 US mode identification without barcode 6 4 6 3 3 Standard identification 6 5 6 3 4 Sample tube holder selection 6 5 6 3 5 ANALYSIS 6 6 6 4 RUNNING SAMPLES cocinan cidad idad 6 7 6 4 1 Sample identification erronee rra nu annuo to nuca nn aeree rre REPE EPA RR Y RR Y ENOKA apo sedans 6 7 6 4 2 Automatic cleaning iiir iiit enenatis tanc cris 6 7 6 4 3 End of the day rinsing rene tene trinus eL rr uua asaan En nnne 6 7 6 3 RESULTS ILICE LIII HE 6 8 6 5 1 Displayed results einn otii ento etii KR nane n 6 8 AAA A 6 9 CHAPTER 7 CALIBRATION AND QUALITY CONTROL ceres 7 1 11 INTRODUCTION 0 A aaa 7 1 7 2 SMART CARD OPTION
120. st one result only 5 TRANS ALL this submenu allows the operator to print out or to send to the host all the results recorded on the memory smart card 6 TRANS FROM TO print out or send to the host results from XXX to YYY 7 CLEAR CARD erase all the results recorded on the memory smart card From the SETUP menu move the cursor to the function MEMO CARD and press ENTER The memory menu is displayed MEMO CARD gt 1 MEMO lt ON gt HH MM 2 TRANSMISSION wv Page 8 14 075D0002 01 8 INSTRUMENT CONFIGURATION 8 7 2 Memo operation mode 8 7 2 1 Memo on off Insert the Patient Memory Card into the slot in the upper left corner of the analyzer From the MEMOCARD menu move the cursor to function MEMO and press ENTER The following menu is displayed MEMO gt HH MM ZEE This function allows the user to enable or disable the result backup on the Patient Memory Card The indicates the current state of the memory function To activate the MEMO function move the cursor to 1 ON and press ENTER To disable move the cursor to 2 OFF and press ENTER As soon as the MEMO is ON the identification mode turns to US mode It is mandatory to enter the identification before running the analysis 8 7 2 2 Transmission mode The operator can chose the transmission mode of the results recorded on the Patient Memory Card printer or host computer From the MEMOCARD menu move the cursor to function
121. strument is ready for the next analysis If any of the control results are outside the accepta ble ranges perform the following a Rerun the control b Clean the system and rerun the control c Open a new vial d Recalibrate the system Page 6 6 075D0002 01 6 STARTUP AND SAMPLE RUN 6 4 RUNNING SAMPLES 6 4 1 Sample identification After completing the start up procedure run a non pathological blood from the previous day followed by the quality control analyses and then the sample analyses 1 Enter either the patient identification US mode or the patient run Standard mode 2 Install the sample tube in the tube holder and close the sample door to start the analysis if this mode has been selected or close the sample door and press the START key 6 4 2 Automatic cleaning When the instrument has run 50 samples from the date changing an automatic cleaning procedure is carried out This cycle lasts 10 minutes approximately while the autocleaning menu is displayed AUTO CLEANING PLEASE WAIT 2MNS 13S kkkkkkkkkkkkkkkkkkkkkkkkkkk NOTE The automatic cleaning frequency can be adjusted by the user from 1 to 50 as described e x in the instrument setup 6 4 3 End of the day rinsing It is necessary to run a standby shutdown cycle at the end of the day Press the STAND BY key the instrument performs a complete cleaning with detergent and puts the system into the stand by mode The instrument
122. t menu is displayed PLEASE CLOSE COVER DOOR PRESS AKEY TO CONTINUE Close the instrument cover door and press any key The following menu is displayed CONCENTRATED CLEANING WAIT 2MNS 27S kkkkkkkkkkkk Stars are displayed at the beginning of the cycle Every 10 seconds a star is cleared off The procedure involves different cycles backflush aspiration rinsing which allow a perfect cleaning of the apertures After this procedure is completed run a startup cycle then sample analysis can begin 075D0002 01 Page 9 3 9 MAINTENANCE AND TROUBLESHOOTING 9 1 3 5 Mechanical checks Move the cursor to the function MECHANIC and press ENTER The MECHANIC menu is displayed MECHANIC gt 1 CHECK SENSORS HH MM 2 NEEDLE U P v A Sensor operations This function allow the user to check the correct detection of the motor home positions Move the cursor to the function CHECK SENSORS and press ENTER The CHECK SENSORS menu is displayed NEEDLE SENSOR 0 CARRIAGE SENSOR 0 NEEDLE SENSOR open the instrument front door and push upward the sampling needle support to the top Check the correct detection on the display 0 turns to 1 followed by 10 stars CARRIAGE SENSOR with the sampling needle in its upper position move the sampling carriage on the right hand side position Check the correct detection on the display 0 turns to 1 followed by 10 stars NEEDLE SENSOR q ree CARRIAGE SENSOR 1 ree Press an
123. the backup number on the right below the time NOTE The total number of results stored on the card is displayed in CURRENT 075D0002 01 Page 8 17 8 INSTRUMENT CONFIGURATION 8 7 6 Trans all This function allows the operator to reprint or to send to the host all the results stored on the smart card Check the quantity of paper before running a REPRINT ALL From the MEMOCARD Patient Card menu move the cursor to TRANS ALL and press ENTER The results are printed out or sent to the host in the usual format without graphs If the printout has to be interrupted press ESC until it has been detected by the program the program checks the keys only at the end of a result printout 8 7 7 Trans from to This function allows the operator to printout or to send to the host only one part of the results recorded on the smart card From the MEMOCARD Patient Card menu move the cursor to e TRANS FROM TO and press ENTER TRANS FROMTO gt 1 BEGIN lt gt 2 END lt gt Move the cursor to BEGIN and press ENTER the BEGIN submenu is displayed BEGIN NO SAVE ESC CURRENT 1 SAVE ENTER Type in the backup number of the first result to be transmitted and press ENTER Move the cursor to END and press ENTER the END submenu is displayed END NO SAVE ESC CURRENT 3 SAVE ENTER Type in the backup number ofthe last result to be transmitted and press ENTER Move the cursor to SEND RESULTS and p
124. the guidelines developed by the National Institutes of Health NIH the Centers for Disease Control CDC the NCCLS Document M29 A Protection of Laboratory Workers from Instrument Biohazards and Infectious Disease Transmitted by Blood Body Fluids and Tissue and the Occupational Safety and Health Administration s Bloodborne Pathogens Stan Use this summary for general information only It is not intended to replace or supplement your laboratory or hospital biohazard control procedures By definition a biohazardous condition is a situation involving infectious agents biological in nature such as the hepatitis B virus the human immunodeficiency virus HIV and the tuberculosis bacterium These infectious agents may be present in human blood and blood products and in other body fluids The following are the major sources of contamination when handling potentially infectious agents needlesticks sharp objects such as probe tips hand to mouth contact hand to eye contact direct contact with superficial cuts open wounds and other skin conditions that may permit absorption into subcutaneous skin layers splashes or aerosol contact with skin and eyes To prevent accidental contamination in a clinical laboratory strictly adhere to the following procedures Wear gloves while handling parts of the instrument that have contact with body fluids such as serum plasma urine or whole blood Wash your hands befor
125. tion of laboratory workers from instrument biohazards and infectious disease transmitted by blood body fluids and tissue approved guideline NCCLS Document M29 A Villanova PA NCCLS 1997 Dec 90p Federal Occupational Safety and Health Administration Bloodborne Pathogens Standard 29 CFR 1910 1030 Page B 2 075D0002 01 APPENDIX C BIBLIOGRAPHY C 1 Bibliography The following information was used to create the reagent information in this manual Bessman JD 1986 Automated Blood Counts and Differentials Johns Hopkins University Press Groner W Simson E 1995 Practical Guide to Modern Hematology Analyzers Wiley 1 241 Corash L 1983 Platelet Sizing Techniques Biological Significance and Clinical Application Current Topics in Hematology Alan R Liss Inc pp 99 122 Hadley GG and Weiss SP 1955 Further notes on the use of EDTA as an anticoagulant Am J Clin Path 25 1090 1093 Koepke JA 1976 The calibration of automated instruments for accuracy in hemoglobinometry Lab World July 180 184 NCCLS 1984 H3 A2 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture NCCLS 1984 H4 A2 Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture Grover NB Naaman J Ben asson S and Dojanski F 1972 Electrical sizing of particles in suspension Ill Rigid spheroids and red blood cells Biophys J 12 1099 1116 Hughes Jones 1974 Differential Leucocyte counts by vo
126. uency can be adjusted to the laboratory workload 9 1 4 Disposal of System Waste and Supplies Laws and regulations enacted to protect the environment and to encourage resource conservation require the disposal of hazardous and biohazardous wastes in a specified manner Some of the wastes from the ADVIA 60 cT Hematology System can be classified as hazardous or biohazardous wastes It is essential that the laboratory take appropriate steps to determine the laws and regulations applicable to their disposal and to effect compliance If it is necessary to sample instrument wastes and effluent in order to evaluate compliance with applicable regulations the laboratory should contact a local licensed biohazardous waste disposal firm for assistance The principal wastes associated with the use of the ADVIA 60 cT Hematology System are the TIMEPAC reagent containers and the sysCLEAR reagent Test tubes with human specimens and control materials should also be handled and disposed of in accordance with the prevailing regulations and guidelines of agencies with jurisdiction over the laboratory Refer to the product label and to Material Safety Data Sheets for details concerning any special precautions related to the handling of ADVIA 60 TIMEPAC containers Material Safety Data Sheets are available from Bayer HealthCare Page 9 6 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING 9 2 TROUBLESHOOTING 9 2 1 Overview Your ADVIA 60
127. unction on the needle motor Check that the motor is properly connected on the electronic board If it is call your local technical support provider or distributor E ERROR PIERCING MOTOR This message can be displayed at the instrument startup It shows a malfunction on the piercing motor Check that the motor is properly connected on the electronic board If it is call your local technical support provider or distributor F PRINT IN PROGRESS This message appears when the operator attempts to print some data during a result printout G ERROR OUT OF PAPER This message is displayed when the printer runs out of paper Press ESC to clear off the message and to complete the cycle the last result can be reprinted after installing a new roll of paper or install a new roll of paper and press ENTER the result will be automatically printed out H ERROR PRINTER OFF LINE This message is displayed when the printer is off line Check the status of the online lamp or select lamp according to the type of the printer in use Press ENTER when the line is on to print automatically the result l ERROR NO PRINTER This message is displayed when the printer is off or not connected Reconnect the printer or set up the instrument without printer J ERROR PRINTER NOT SELECTED This message is displayed when a printout is requested and no printer has been selected Select a printer 075D0002 01 Page 9 15 9
128. ur local technical support provider or distributor 9 2 3 5 RBC Perform the following actions if only the RBC parameter is erroneous or suspicious Analyze a normal control and observe the specific operation of the analyzer listed below in the order specified Identify the malfunction s and initiate appropriate troubleshooting procedure s If upon close inspection all operations still appear to be acceptable call your local technical support provider or distributor Valve lt 6 gt Is liquid valve 6 opening and closing during analysis cycle If the liquid valve 6 is not operating properly replace the valve If the valve is still not operating properly call your local technical support provider or distributor If the valve is operating properly continue the procedure Sampling syringe Is the sample syringe moving up and down If the 10 uL syringe is not operating properly during sample analysis see Mechanical Checks for troubleshooting actions If the sampling syringe is operating properly during sample analysis continue the procedure Diluent dispenser Do you see any bubbles in the diluent dispenser Is the plunger of the diluent dispenser moving up and down smoothly during sample analysis If no air bubbles are seen and the diluent dispenser plunger is operating properly continue If bubbles are seen orthe plunger of the diluent dispenser is not operating properly see Mechanical Checks for troubleshooting actions Val
129. uscular Hemoglobin Concentration The MCHC is a function of the HGB and HCT values The limitations listed for the HGB and HCT will have an effect on the MCHC and may cause erroneous values Page 3 10 075D0002 01 3 SPECIFICATIONS RDW Red Blood Cell Distribution Width The red blood cell distribution width is a function of the RBC count The red blood cell dilution contains all of the formed elements in the blood erythrocytes leukocytes and platelets During the counting of the erythrocytes Red Blood Cells platelets are not included in RBC count since their size falls below the minimum threshold However leukocytes White Blood Cells are counted and included in the RBC count Since the normal ratio between RBC and WBC is so extreme the influence of the WBC is extremely low and the RBC count may need to be corrected especially if the RBC count is extremely low Agglutinated RBC May cause a falsely decreased RBC count and erroneous RDWs Blood samples containing the agglutinated RBC may be detected by observing abnormal MCH and MCHC values as well as by examination of the stained blood film Nutritional deficiency or blood transfusion May cause elevated RDW results due to iron vitamin B12 or folate conditions High RDWs may also be present from bi modal RBC distribution in blood transfusion PLT Platelets Very small erythrocytes microcytes erythrocytes fragments schizocytes and WBC fragments May inter
130. ves 8 and lt 11 gt Are liquid valves 8 and 11 opening and closing during analysis cycle If the liquid valves 8 and 11 are not opening and closing replace the valves If this does not correct the RBC count call your local technical support provider or distributor If valves are operating properly call your local technical support provider or distributor Page 9 12 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING 9 2 3 6 HCT Check the following if only the HCT result is incorrect or suspicious Calibration Was the system calibrated earlier as part of the identification procedure If HCT was not calibrated as part of the identification procedure calibrate it as described in section 7 Call your local technical support provider or distributor if this does not correct the HCT result 9 2 3 7 PLT Perform the following actions if only the PLT parameter is erroneous or suspicious Review patient results Sample flags Were there frequent flags next to the PLT results If there were replace your reagents and perform the concentrated cleaning procedure if it was not already done as part of the identification procedure If you do not observe flags on patient samples continue Calibration Was the system calibrated earlier as part of the identification procedure If PLT was not calibrated as part of the identification procedure calibrate it as described in section 7 Call your local technical sup
131. xit QC and save it The analyzer checks the number of correct results before exiting the QC PROGRAM Then the following message appears VALID QC NO ESC YES ENTER Then the following message appears QC STORED PRESS A KEY TO CONTINUE 1 VALID QC If the QC is validated the index of the QC smart card is increased as well as the internal index of the analyzer 2 INVALID QC If the QC is not validated the following message appears QC NOT VALID PRESS AKEY TO CONTINUE All the previous data stored this day are erased to avoid confusion in the processing of the printing results This operation is automatic and a waiting message is displayed during this time about 2 seconds for 8 parameters and 4 seconds for 16 parameters 075D0002 01 Page 7 15 7 CALIBRATION AND QUALITY CONTROL 7 5 3 Analysis This function 2 anatysis allows the operator to run a control as a normal analysis cycle but with specific LMG thresholds for QC blood independant from the temperature From the QC main menu move the cursor to the function and press ENTER LOT EXIT ESC CURRENT MX223N SAVE ENTER Enter a lot identification when required and press ENTER An HGB blank reference measurement is done prior to the analysis When this cycle is completed the following message is displayed ANALYSIS PRESS THE SAMPLING BAR Install one of the levels of control blood tubes in the correct holder position Close the
132. y key to exit the function B Needle up and down operation Move the cursor to the function NEEDLE U D and press ENTER Closely observe the needle translation the movement has to be smooth and regular C Carriage left right operation Move the cursor to the function CARRIAGE L R and press ENTER Closely observe the needle translation the movement has to be smooth and regular D Liquid syringe Move the cursor to the function LIQUID SYRINGE and press ENTER Closely observe the syringe translation the movement has to be smooth and regular E Pressure vacuum syringe Move the cursor to the function PRESSURE SYRINGE and press ENTER Closely observe the syringe translation the movement has to be smooth and regular F Valves Vove the cursor to the function 6 varves and press ENTER Closely observe the valve operations the movement has to be straight and regular NOTE On the ADVIA 60 the valve 3 is not installed Page 9 4 075D0002 01 9 MAINTENANCE AND TROUBLESHOOTING G Change contrast The display contrast can be adjusted for a better readability Move the cursor to the function CHG CONTRAST and press ENTER The CHG CONTRAST menu is displayed CONTRAST APRESS ENTERTO VALID HH MM v Press the UP key of the numeric keyboard to increase the contrast or press the DOWN key to reduce the contrast When the best contrast is obtained press ENTER to validate the setup The contrast ad
133. y when the operator closes the sample door In the manual mode the analysis can start after closing the sample door when the operator presses the START cycle key To setup the instrument according to the operator s needs from the SPECIAL menu move the cursor to the function START MODE and press ENTER The START MODE menu is displayed START MODE gt 1 AUTO 2 MANUAL NOTE Pressing the ESC key will open the door of the tube holder compartment 8 4 DATE AND TIME Date and time can be changed according to the country specifications From the SETUP menu move the cursor to the function DATE TIME and press ENTER The DATE TIME menu is displayed DATE TIME gt 1 CHG TIME HH MM 2DATE FORMAT y 075D0002 01 Page 8 11 8 INSTRUMENT CONFIGURATION 8 4 1 Change time Move the cursor to the function and press ENTER The CHANGE TIME menu is displayed NEW TIME HH MM EXIT ESC CURRENT SAVE ENTER Enter the required time in the format HH MM and press ENTER The new time is recorded 8 4 2 Date format From the DATE TIME menu move the cursor to the function DATE FORMAT the current setting is displayed and press ENTER The DATE FORMAT menu is displayed DATE FMAT gt 1 MM DD YY HH MM 2 DD MM YY 4 different date formats can be used MM DD YY DD MM YY YY MM DD YY DD MM Move the cursor in front of the required selection and press ENTER The new date format is recorded 8 4 3
134. yed QC 1 AUTOMATIC HH MM 2 ANALYSIS v 075D0002 01 Page 7 11 7 CALIBRATION AND QUALITY CONTROL 7 5 2 QC Automatic From the QC menu move the cursor to function AUTOMATIC and press ENTER The AUTOMATIC menu will unfold step by step through the smart card insertion the operator selection the commercial control identification and lot etc 7 5 2 1 Insert QC smart card First the analyzer checks if a CARD READER is present if a card reader is not present the QC PROGRAM will be aborted and the following message will appear ERROR NO SMART CARD READER PRESS AKEY TO CONTINUE After a key is pressed the analyzer comes back to the QC menu because it is impossible to run automatic QC without a smart card reader Then the analyzer checks if a QC smart card is present If the smart card has not been inserted the following message appears ERROR NO SMART CARD NO ESC INSERT NEW CARD VESBENTER Insert the QC smart card into the slot in the upper left corner of the analyzer and press ENTER to VALIDATE If you have no QC smart card press ESC to come back to the QC menu because it is impossible to run automatic QC without a QC smart card If the smart card is present the previous message does not appear and automatically the lot and the expiration date will be read and are processed and the following message appears LOT TESTPOINT NEW QC NO ESC EXP DATE 06 03 98 YES ENTER The current lot numb

9. maintenance and troubleshooting

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