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7. CALIBRATION AND QUALITY CONTROL

Page 7/17

075D0002-01

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 each 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 

4

 STATISTICS and press 

ENTER

.

The QC card is read.

7.5.5.2. Select level

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:

All statistics will be printed.

SELECT LEVEL

3 NORMAL BLOOD

HH:MM

4 HIGH BLOOD

QC

4 STATISTICS

HH:MM

5 GRAPHS

SELECT LEVEL

> * 1 ALL

HH:MM

     2 LOW BLOOD

PRINTING QC RESULTS
PLEASE WAIT...

Содержание ADVIA 60

Страница 1: ...075D0002 01 Rev A 2003 09 ADVIA 60 Hematology System Operator s Guide Closed Tube Model...

Страница 2: ...and Company Manufactured in France for Bayer HealthCare LLC The information in this manual was correct at the time of printing However Bayer HealthCare LLC continues to improve products and reserves t...

Страница 3: ...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 usin...

Страница 4: ......

Страница 5: ...NG 2 7 CHAPTER 3 SPECIFICATIONS 3 1 3 1 PERFORMANCE SPECIFICATIONS 3 1 3 1 1 Expected Values 3 4 3 2 REAGENT SPECIFICATIONS 3 6 3 2 1 Diluent sysDIL 3 6 3 2 2 Lyse sysLYSE 3 6 3 2 3 Detergent sysKLEN...

Страница 6: ...der selection 6 5 6 3 5 Analysis 6 6 6 4 RUNNING SAMPLES 6 7 6 4 1 Sample identification 6 7 6 4 2 Automatic cleaning 6 7 6 4 3 End of the day rinsing 6 7 6 5 RESULTS 6 8 6 5 1 Displayed results 6 8 6...

Страница 7: ...g frequency 8 9 8 3 5 Internal setup printout 8 9 8 3 6 Cycle end audible signal 8 10 8 3 7 Identification mode 8 10 8 3 8 Start mode 8 11 8 4 DATE AND TIME 8 11 8 4 1 Change time 8 12 8 4 2 Date form...

Страница 8: ...9 2 3 2 WBC 9 10 9 2 3 3 HGB 9 10 9 2 3 4 RBC HCT and PLT 9 11 9 2 3 5 RBC 9 12 9 2 3 6 HCT 9 13 9 2 3 7 PLT 9 13 9 2 4 Troubleshooting system operations 9 13 9 2 4 1 Power 9 13 9 2 4 2 Display 9 13 9...

Страница 9: ...CH 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 M...

Страница 10: ...are grouped together on one panel at the front of the system 1 4 NOTES Bayer HealthCare retains the right to make changes to the instrument and this document Your local technical support provider or...

Страница 11: ...er As instructed the installation procedures must be followed in the order listed below 2 2 UNPACKING Diag 2 1 The ADVIA 60 CT pack installation kit XEA335A The instrument is enveloped in a special pr...

Страница 12: ...2 Fitting 1 6mm EAB 032 A 1 ADVIA 60 cover FBH 015 A 1 ADVIA 60 cover key FAJ 004 A 1 Allen key 1 5 mm MAB 003 A 1 Allen key 2 0 mm MAB 001 A 1 Allen key 2 5 mm MAB 069 A 1 Bent wrench 2 5 mm MAB 002...

Страница 13: ...IA60 CT shouldbeplacedonacleanandleveltableorworkstation PleasenotethatADVIA60 CT printer and reagents weigh approximately 30 kilograms 66 lbs Avoid exposure to sunlight Proper ventilation requires th...

Страница 14: ...he 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 of the chambers Each chamber should be in its pr...

Страница 15: ...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 ord...

Страница 16: ...FUSE HOLDER 3 MAIN SUPPLY PLUG 4 RS 232 OUTPUT 5 PRINTER OUTPUT If the instrument has to be connected to a laboratory computer use the plug 4 RS 232 2 9 GENERAL POINTS The ADVIA60 CT responds to the U...

Страница 17: ...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...

Страница 18: ...GENTS and press the ENTER key Select the function 1 CHANGE PACK and follow the instructions given by the LCD in order to install the pack REAGENT PACK 1 CHANGE PACK HH MM 2 CBC LEFT 150 Once the new P...

Страница 19: ...MANCE SPECIFICATIONS ADVIA 60 CT performs automated blood counts and requires no manual operations for aspirating blood dilution measuring calculations print out and computer transfer The parameters g...

Страница 20: ...t consumption Software version V 1 6 Table 3 2 Table 3 1 CYCLE sysDIL sysLYSE sysKLEN sysCLEAR Analysis cycle 17 5 mL 0 60 mL 0 85 mL x Prime all reagents 40 0 mL 11 6 mL 5 2 mL x Prime diluent 27 0 m...

Страница 21: ...anmethemoglobin 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 Table 3 3 Table 3 4 PARAMETERS LINEARITY RANGE LIMITS WBC x 103 cells mm3...

Страница 22: ...DW 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...

Страница 23: ...0 902 MCH pg 205 0 974 180 0 945 208 0 916 MCHC g dL 205 0 360 180 0 314 208 0 330 RDW 205 0 656 180 0 400 208 0 607 PLT x 103 mm3 205 0 990 180 0 972 208 0 985 MPV m3 205 0 877 N A N A 208 0 801 LYM...

Страница 24: ...nation and differentiation of blood cells Composition Stabilized buffer solution Sodium hydroxide 0 04 Sodium azide 0 09 Physio chemical properties Boiling point About 100 C pH neutral 3 2 2 Lyse sysL...

Страница 25: ...tro diagnostic use in hte cleaning of the Advia 60 Hematology system Composition Organic buffer 0 2 Physio chemical properties Boiling point around 100 C pH 9 7 0 2 at 20 C 3 2 4 sysCLEAR bleach solut...

Страница 26: ...ommended to use caps specially designed to avoid any blood retention in the upper part of the cap 1 Type 1 Wrong 2 Type 2 Good 3 3 3 Blood specimens Verification of any abnormal test result including...

Страница 27: ...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 car...

Страница 28: ...e 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 pro...

Страница 29: ...rmal 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 th...

Страница 30: ...ber 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 th...

Страница 31: ...vity 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 apertu...

Страница 32: ...a final dilution of 1 300 RBC PLT 30 L 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 microproces...

Страница 33: ...ument 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 following measuri...

Страница 34: ...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...

Страница 35: ...vent 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 acco...

Страница 36: ...omes 9 16000 for RBC the limit becomes 8 400 for PLT the limit becomes 20 Result for the concerned parameter can be accepted D If results exceed the linearity limits shown below a D will be printed af...

Страница 37: ...user 4 3 2 HGB 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 Neve...

Страница 38: ...omalies 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 granuloc...

Страница 39: ...el 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...

Страница 40: ...can be run 2 or 3 times if blank values are not within the acceptable limits B Command keys 4 Start Analysis Cycle key START This key starts the analysis when the manual mode for starting the analysi...

Страница 41: ...he 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 appr...

Страница 42: ...5 3 1 Rear panel 2 RS 232 computer connection 3 Printer output 4 ON OFF switch 5 F1 F2 Main fuses 6 Main power socket Diag 5 4 5 1 3 Left side internal view Diag 5 5 1 Vacuum pressure syringe 2 Liquid...

Страница 43: ...lay 2 Keyboard 3 Cycle light indicators 4 Sampling needle carriage 5 Start cycle key 6 RBC chamber 7 WBC chamber 8 Spectrophotometer 9 Piercing mechanism 10 Tube holder switches 11 Piercing carriage d...

Страница 44: ...5 DESCRIPTION Page 5 6 075D0002 01...

Страница 45: ...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 n...

Страница 46: ...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 STARTTO CONFIRM If this occurs operator ha...

Страница 47: ...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 contr...

Страница 48: ...LOSE HOLDER DOOR is displayed 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 C...

Страница 49: ...hich 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...

Страница 50: ...and rerun the control c Open a new vial d Recalibrate the system NOTE The current Identification stays in memory until the analysis cycle has begun and can be displayed on the screen by pressing the I...

Страница 51: ...yses 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...

Страница 52: ...the cursor to the bottom Flags The PLT and LMG flags can be reviewed moving the cursor to the bottom The first group of parameters is displayed The second group of parameters can be accessed when movi...

Страница 53: ...as 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...

Страница 54: ...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 e...

Страница 55: ...ckage 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 Fro...

Страница 56: ...displayed next to the chosen identification and the menu turns to the calibrator identification 7 2 SMART CARD OPTION Diag 7 1 Make sure that the cursor is positioned on function 1 AUTOCALIBRATION an...

Страница 57: ...date 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...

Страница 58: ...S ENTER EXP DATE DD MM YY EXIT ESC CURRENT SAVE ENTER 7 3 4 Change target values The following menu with the current WBC target value is displayed If the WBC target value is correct press ESC the menu...

Страница 59: ...ADVIA60 CT calibration may be performed using 3 to 11 sample aspirations The autocalculation module performs statistics on these results in order to obtain the best calibration coefficients CHANGE SAM...

Страница 60: ...atistical calibration factors for each parameter Mean target coefficient of variation percentage difference between the target value and the mean CHG new calibration coefficient as well as a recall of...

Страница 61: ...ng message is displayed Press any key to return to the MAIN MENU A Calibration passed If the statistical figures are within the acceptable limits Coefficient of variation is within the limits given in...

Страница 62: ...8 240 5 8 2 5 28 16 1 47 5 228 6 6 5 5 30 16 0 47 1 235 MEAN 6 78 5 32 16 1 47 1 231 4 TARGET 6 5 5 34 16 1 47 221 CV 11 7 0 89 0 43 0 54 2 69 CHG 4 30 0 37 0 0 21 4 70 REJ COEFF 1 16 0 90 1 13 0 98 0...

Страница 63: ...the cursor down to the HGB HCT PLT MPV RDW and PDW positions and enter the required new coefficients When the required coefficients have been changed press ENTER to record the setup RDW and PDW can be...

Страница 64: ...unction PRINT COEFF and press ENTER The printout of the coefficient values starts automatically Diag 7 5 7 4 3 Coefficient limits Check that the calibration coefficients corresponds to the following r...

Страница 65: ...loods 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...

Страница 66: ...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...

Страница 67: ...rmation 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 duri...

Страница 68: ...rol 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...

Страница 69: ...e to exit QC and save it The analyzer checks the number of correct results before exiting the QC PROGRAM Then the following message appears Then the following message appears 7 5 2 6 Exiting QC automa...

Страница 70: ...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 Install one of the 3 leve...

Страница 71: ...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...

Страница 72: ...CV are provided 7 5 6 1 Select graphs From the QC MENU move the cursor to function 5 GRAPHS and press the ENTER key The QC smart card is read QC LOW LOT XXX TIME 12 10PM EXP DATE 12 31 97 DATE 12 14...

Страница 73: ...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 1 High target value 2 Mean 3 Low target...

Страница 74: ...7 CALIBRATION AND QUALITY CONTROL Page 7 20 075D0002 01...

Страница 75: ...S 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 s...

Страница 76: ...e 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 The...

Страница 77: ...nd press ENTER In this last case results will have to be recorded by the operator from the display at the end of each analysis 8 1 5 Temperature printout The temperature of the diluent during the anal...

Страница 78: ...played The current state of the printout is indicated by the Move the cursor to YES to print out the differential and press ENTER Move the cursor to NO to print out the results without the differentia...

Страница 79: ...ss 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 2 HIGH LIMITS and press ENTER Follow the same procedure fo...

Страница 80: ...return to the previous menu 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 populatio...

Страница 81: ...8 3 1 Change operator Some of the instrument functions calibration QC requires the operator identification Four different identifications can be entered and modified at any time by the user From the S...

Страница 82: ...nfigure the instrument according to the operator s needs from the SPECIALmenu move the cursor to the function 3 STARTUP and press ENTER The STARTUP menu is displayed Move the cursor to the required se...

Страница 83: ...boratory From the SPECIAL menu move the cursor to the function 4 CLEAN FREQ and press ENTER The CLEAN FREQ menu is displayed Enter the required frequency and press ENTER The new automatic cleaning fre...

Страница 84: ...and printed out with the results Move the cursor to the function 7 ID MODE and press ENTER The following menu is displayed Move the cursor to the required option and press ENTER The new ID MODE is re...

Страница 85: ...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 8 START MODE and press ENTER The START MODE menu is displaye...

Страница 86: ...The DATE FORMAT menu is displayed 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 rec...

Страница 87: ...s 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 are as follow 8 5 1 Host communication 1 FORM...

Страница 88: ...t 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...

Страница 89: ...unction move the cursor to 1 ON and press ENTER To disable move the cursor to 2 OFF and press ENTER MEMO 1 ON HH MM 2 OFF 8 7 2 2 Transmission mode The operator can chose the transmission mode of the...

Страница 90: ...y Card is present If the Patient Memory Card has not been inserted the following message appears Insert the Patient Memory Card and press ENTER If the smart card is not a Patient Memory Card the follo...

Страница 91: ...or to 3 PRINT LIST and press ENTER 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...

Страница 92: ...cursor to 1 BEGIN and press ENTER the BEGIN submenu is displayed Type in the backup number of the first result to be transmitted and press ENTER Move the cursor to 2 END and press ENTER the END submen...

Страница 93: ...ing 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...

Страница 94: ...the instrument This cycle lasts approximately 25 seconds Move the cursor to the function 2 DRAIN CHAMBERS and press ENTER 9 1 3 3 Prime reagents This cycle allows the user to prime the reagents when r...

Страница 95: ...BER PRESS A KEY TO CONTINUE 9 1 3 4 Concentrated cleaning This procedure provides a strong cleaning of the RBC and WBC apertures This cycle lasts approximately 3 minutes and involves the operator inte...

Страница 96: ...U P NEEDLE SENSOR 0 CARRIAGE SENSOR 0 NEEDLE SENSOR 1 CARRIAGE SENSOR 1 Press any key to exit the function B Needle up and down operation Move the cursor to the function 2 NEEDLE U D and press ENTER C...

Страница 97: ...rast adjustment 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...

Страница 98: ...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 thei...

Страница 99: ...y 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 pati...

Страница 100: ...cations 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 precis...

Страница 101: ...e actions 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 3 Transfer of lyse to WBC chamber Is t...

Страница 102: ...l 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 inc...

Страница 103: ...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...

Страница 104: ...yringe 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...

Страница 105: ...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 appro...

Страница 106: ...INGE 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 ide...

Страница 107: ...ument startup It shows a malfunction 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 P...

Страница 108: ...ect time M 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 p...

Страница 109: ...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 U PLEASE CLOSE SAMPLE TUBE HOLDER DOOR This message...

Страница 110: ...ivates the vacuum needed in the WBC RBC counting heads Valve 7 Controls the diluent input in the RBC counting head during the rinsing Valve 8 Controls the aspiration of the diluent air output inside t...

Страница 111: ...3 Lyse 4 Cleaner 1 Chg pack 2 Capacity 3 Prime Without pack with pack 1 Reprint result 2 Printout 3 Units 4 Printer 6 Print Limits Y N 7 Flag LMG Y N 1 Low limits 2 High limits 3 Print limits 1 RESUL...

Страница 112: ...9 MAINTENANCE AND TROUBLESHOOTING Page 9 20 075D0002 01 9 6 PNEUMATIC DIAGRAM...

Страница 113: ...9 MAINTENANCE AND TROUBLESHOOTING Page 9 21 075D0002 01...

Страница 114: ...9 MAINTENANCE AND TROUBLESHOOTING Page 9 22 075D0002 01...

Страница 115: ...ysKLEN Detergent B01 4197 01 03340897 sysCLEAR Bleach Solution B01 4198 01 02488831 Bayer TESTpoint Hematology Controls Low B03 4200 54 04575197 Normal B03 4201 54 00133238 High B03 4202 54 00056756 A...

Страница 116: ...ssel Belgium 32 0 2 535 66 81 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 te...

Страница 117: ...Limited Kye Myung Bldg 4F Myungil Don 48 7 Kangdong Ku Seoul 134070 Korea 82 0 2 428 5987 Bayer Malaysia Sdn Bhd 19th 20th Floor Wisma MPSA P O Box 7252 40708 ShahAlam Selangor Darul Ehsan Malaysia 6...

Страница 118: ...tica 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 Sw...

Страница 119: ...ocedures and practices are not strictly observed Also indicates the possibility of causing erroneous results and actions that could affect system performance Standby State Keypad Input Enter Function...

Страница 120: ...round Fuse The input electricity is alternating current ON OFF Revision Number The analyzer meets the safety requirements of the Canadians StandardsAssociation Consult the instructions for use The ana...

Страница 121: ...r Date of Manufacture CE Mark Product meets the requirements of applicable European Directives Manufactured Location Authorized Representative In Vitro Diagnostic Device Temperature limitation store b...

Страница 122: ...APPENDIX A SYSTEM AND REAGENT SYMBOLS Page A 4 075D0002 01...

Страница 123: ...ard 1 3 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 s...

Страница 124: ...ands 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 Con...

Страница 125: ...ccuracy 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 Diagno...

Страница 126: ...APPENDIX C BIBLIOGRAPHY Page C 2 075D0002 01...

Страница 127: ...ion Mode 9 7 Interfering Substances 3 8 L Laboratory Limits Change 4 6 8 4 8 6 Levy Jennings Charts 7 18 O Operating Conditions 2 3 Operator Change 8 7 P Printer Select 8 3 Q Quality Control 6 3 Messa...

Страница 128: ...INDEX Index 2 075D0002 01...

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