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HORIBA ABX Micros 60 CS-CT Chemistry Analyzer

1. 50 100 250 300 On the Printout the information printed is as followed 1 The Date the sample was analyzed 2 The Time the sample was analyzed 3 The Sample Identification that the Operator had entered either Manually or Barcode 4 The Sequence number of the sample run 5 The Instrument STARTUP status 6 The PLT flags if any were reported 7 The 16 Parameter CBC results with Limit flags and units 8 The WBC flags if any were reported 9 The 8 part Differential LMG results 10 The WBC RBC and PLT Histograms RABO43EEN section 3 Startup and Sample Run 11 Micros 60 MICROS 60 CS CT Note The Last sample result run can be displayed again at any time before running the next analysis From the Main Menu select 1 RESULTS Use the Up and Down arrow keys to view any part of the Last sample results RESULTS DATE 01 20 2002 RUN 12345 SEQ 4 27 PLT Flags 7 5 10 77 mm 4 90 10 mm 15 0 g dl 43 9 287 10 mm WBC Flags LYM 39 3 MON 73 GRA 53 4 WBC 50 100 250 300 450 0 0 On the Printout the information printed is as followed 1 The Date the sample was analyzed 2 The Time the sample was analyzed 3 The Sample RUN that was entered by the Operator 4 The Sequence number of the sample run 5 The PLT flags if any were reported 6
2. Calibration Procedures 1 From the Calibration Menu select 7 AUTOCALIBRATION 2 Select one of the 4 Operators O P which may be entered in the System Set up menu See Section 5 Instrument Configuration 3 Special Functions 3 7 Changing Operator Identification After selecting one of 4 operators press the ENTER key The LCD will display a message as indicated Press the Escape ESC key This will allow you to enter into the Calibration menu and edit all the calibration information Manually Change Lot number 1 Press the ENTER key to enter the new lot number of the calibrator material 2 Enter the new Lot Number of the current calibrator from the Assay sheet that comes with the calibration material Use the Up and Down arrow keys to enter the Alpha characters Use the Numeric keys to enter the Numbers Press the ENTER key to save the new lot number and move to the next entry As indicated RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control O Change Expiration date 3 The next screen will indicate changing the Expiration date of the new calibrator 4 Press the ENTER key enter the new expiration date from the Calibration Assay sheet Use the Period key after entering the Month Use the Period key after the Day Press the ENTER key to save the new expiration date and move
3. Type of Unit Measurements Type of printer selected result printout options with or without histograms Print out the LMG s Yes or No Print the Laboratory limits with the results Yes or No Type of Host Computer communications Barcode reader Yes or No Checksum with barcode reader Yes or No The date format MM DD YY or DD MM YY Sample Identification mode Smart Card reader Yes or No The Memo card option On or Off The Instrument Run mode set for USER and USER Only The Cycle Start mode Auto or Manual The temperature of the Diluent The last 5 digits of the Instrument serial number Complete number is on the back panel of the unit The Number of Startup cycles ran The Number of Standby cycles ran The number of CBC cycles ran The number of cycles to be run before the cleaning cycle starts The User Password The Number of samples to be run during calibration Stepper motor steps 4 operator ID s 13 Micros 60 3 6 Buzzer audiable signal Cycle End This sub menu allows the operator to set an audible tone Beep when the analysis cycle is complete To enter into the Buzzer Menu from the 3 SPECIAL Menu use the Down arrow key to 6 BUZZER Y N as indicated on the display 1 Press the ENTER key to access this sub menu 2 Use the Up or Down arrow keys to make your selection and then press the
4. flag depending on the severity of the results MICROS 60 CS CT Important If the Exclamation flag occurs more than 8 consectutive sample runs troubleshoot the HGB parameter in the following section of this manual See Section 6 Maintenance and Troubleshooting Troubleshooting Parameters HGB 14 5 3 Morphology Flags O The PLT Histogram has 128 channels between 2fl and 30fl A mobile Threshold Positioned to 25fl by default moves according to the Microcyte population present in the Platelet analysis area The PLT flags are as followed 1 An excessive presences of cells to the right of the Threshold area 25fl will trigger the MIC Microcytes flag The Mobile threshold looks for a valley between the 25fl standard value and 18fl 2 When there is No valley between PLT and RBC populations a reject PLT flag is triggered PLT results are not reliable and must be verified by a Manual Platelet Count 3 If the number of particles between 18fl and 25fl are too high the SCH Schizocytes flag will be triggered Suspected abnormalities include Presence of Schizocytes Presence of Platelet aggregates Verify the Platelet results on a stained blood smear 4 The SCL Small cells flag indicates the presence of small cells in the 2fl to 3fl zone The PLT results may be reported as and there may also be No PLT Histogram MICROS 60 CS CT Important All Pla
5. ENTER key to accept the choice 3 7 Sample Identification Mode This sub menu will allow the operator to select as to how they want to identify their blood samples 2 options are available in this sub menu 1 US Mode allows the operator to type in up to 13 Alphanumeric characters for a blood sample identification See Section 4 Startup and Sample Run 2 Sample Selection and Identification 2 7 Sample Identification Modes for details 2 STANDARD Mode allows the operator to enter numbers Only from 1 to 99999 See Section 4 Startup and Sample Run 2 Sample Selection and Identification 2 7 Sample Identification Modes for details MICROS 60 CS CT Important Startup Results will be printed out in the US MODE Only If STANDARD Mode is select for sample identification the Startup results Will Not be printed out nor will it print out the Startup status unless Startup has Failed 14 To enter into the ID Mode menu from the 3 SPECIAL Menu use the Down arrow key to 7 ID MODE as indicated 1 Press the ENTER key to access the sub menu 2 Select a mode of sample identification and press the ENTER key to accept the mode Remember Startup results Will Not be printer out if STANDARD Mode is selected 3 8 Start Mode Analysis cycle This sub menu will allow the operator to select between closing the tube holder door or pushing th
6. Micros Micros CRP Hematology Devices for in vitro dagnostic use 15 01 05 A95A00006B 0802010 10L 10L CE easi HORIBA ABX BP 7290 34184 Montpellier cedex 4 France 1 Functions Buffered isotonic solution for the determination of blood cell counting and the measurement of hematocrit on HORIBA ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance character istics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproduc ibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual D Conservation amp expiration Storage conditions Stored at 18 C 65 F to 25 C 77 F and away from the light Expiration date refer to expiration date reagent packaging label Measurements principles amp results Directions for use see Reagent Location and connection in the instrument User Manual Measuring Principles see Measuring Principles in the instru ment User Manual Results Refer to the instrument User Manual a Modification from index A to B Company name change FORM 0866 rev 1 S A au capital de 44 000 000 Eu
7. Specifications ABX MICROS 60 CS CT 16 16 Parameters LYM Lymphocyte Percentage MON Monocyte Percentage GRA Granulocyte Percentage RBC Red blood cells HCT Hematocrit MCH Mean Corpuscular Hemoglobin RDW Red cell Distribution Width MPV Mean Platelet Volume ABX MICROS 60 CS CT 18 18 Parameters LYM Lymphocyte Percentage MON Monocyte Percentage GRA Granulocyte Percentage RBC Red blood cells HCT Hematocrit MCH Mean Corpuscular Hemoglobin RDW Red cell Distribution Width MPV Mean Platelet Volume PCT Plateletcrit MICROS 60 CS CT Note PCT and PDW have Not been established as indications for this product in the United States The use of PCT and PDW should be restricted to Research Use Only RABO43EEN section 1 Specifications Micros 60 1 2 Throughput Analysis e Apporximately 55 Samples hour 1 3 Memory Capacity Smart Cards e Last sample ONLY Internal Memory capacity e 60 Samples Memory Smart Card option e 99 Samples Quality Control Smart Card option 1 4 Statistics and Quality Control e Extended Quality Control package Optional e Quality Control Smart Card option 1 5 Reagents 3 Reagents 1 Pack of Reagents ABX MINIDIL LMG 10L ABX MINICLEAN 1L ABX MINILYSE or MINILYSELMG 1L ABX LYSEBIO 0 4L or 1L ABX MINIPAK LMG 4 2L ABX Minipak contains all 3 Reagents for a Total Volume of 4 2L 1 6 C
8. Diluent Temperature Sensor 8 Liquid Syringe 9 Valve Block 9 10 Vacuum Waste Chamber 11 Liquid Sensor 10 11 RABO43EEN section 2 Description 4 Technology Description amp Technology 2 Technology 2 1 Sampling 1 Blood Collection tube is placed into the Tube Holder 2 The Tube Holder Door is then closed by the operator 3 The Cap piercing Mechanism moves the Tube holder Up and pierces the sample tube 4 Aspiration of 10ul of Blood 5 Needle Carriage assembly moves to the Left over the WBC HGB Chamber 6 Internal and External Cap piercing needle rinses External Sample probe rinses 7 Blood sample is delivered into the WBC Chamber for the First dilution 8 Aspiration of 28 3ul of diluted blood from the WBC Chamber 9 Needle Carriage assembly moves to the Right over the RBC PLT Chamber 10 Internal and External Cap piercing needle rinses External Sample probe rinses 11 Diluted Blood sample is delivered into the RBC Chamber for the RBC PLT measurement 2 2 Dilutions WBC HGB Dilution Initial blood volume 10 0ul Volume of ABX Minidil LMG 2 1 ml Volume of ABX Alphalyse 0 52 ml Final dilution ratio 1 260 WBC Measurement Method Impedance Aperture diameter 80 um Count Vacuum 200mb Count period 2 x 5 seconds Temperature reaction ambient Method Photometry Wavelength 55950nm Count period 2 x 5 seconds Temperature reaction ambient 10ul of blood sample contained in the sample
9. The 16 Parameter CBC results with Limit flags and units 7 The WBC flags if any were reported 8 The 3 part Differential LMG results 9 The WBC RBC and PLT Histograms 12 TIME 09 25 10 mm 1 2 3 2 10 mm 0 3 0 8 10 mm 1 2 6 8 PLT RAB043EEN section 3 Startup and Sample Run 4 3 Micros 60 CS CT18 MICROS 60 CS CT Note The ABX MICROS 60 CS CT18 has all the same characteristics as the MICROS 60 CS CT16 with the exception 2 parameters PCT and PDW which are reported on the MICROS 60 CS CT78 results 5 Flags These Instrument flags and alarms can be classified in 5 different groups 1 Flags and alarms linked to a result when it exceeds normal limits 2 Flags and alarms linked to a result or to the operation of the Instrument leading to a Default analysis 3 Flags and alarms linked to the Morphology of a blood cell population 4 Flags and alarms linked to the statistical functions of the instrument 5 Flags and alarms linked to Instrument operation 5 1 Normal Limits The H flag located next to a parameter result indicates that the value is Above the Upper limit set by the operator See Section 5 Instrument Configuration 2 Change Laboratory Limits 2 2 Result High limits The L flag located next to a parameter result indicates that the value is Below the Lower limit set by the op
10. X YXi SD aA Y X Xi n n 1 DEFINITIONS X the calculated Mean gt the Sum of n the total number of samples Xi the individual parameter value SD Standard Deviation CV SD x 100 X Once the CV s have been calculated compare them to the specified limits O If the system seems to be operating properly fresh uncontaminated reagents are being used and the precision is within the specifications the ABX MICROS 60 may need calibration Refer to Section 3 Calibration amp Quality Control 1 Calibration Program for calibration instructions 2 3 Troubleshooting Parameters The procedures described below should be performed whenever the percision of a parameter is not within its CV specifications or the parameter is incorrect or Suspicious When all parameters are affect it is necessary to look for a common cause e g Vacuum pressure sample aspiration chamber filling and draining correctly common reagent pollution etc When only one parameter is affected it is necessary to look for a cause in this specific area of analysis The different tables listed give the noted problems for the parameter in question possible cause of the problem and the necessary user action to correct the problem RABO43EEN section 6 Maintenance and Troubleshooting Micros e Startup Failed check reagents High Background counts e Startup Failed check reagents High Background counts e No results in
11. 33 467 14 1517 19 2 Micros 60 6 Waste Handling Procedure MICROS 60 CS CT When disposing of waste protective clothing must be worn lab coat gloves eye protection etc Follow your local and or national guidelines for biohazard waste disposal If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste Dispose of the waste container according to the local or national regulatory requirements 7 Reagent Consumption Reagent consumption is given in milliliters ml It has been calculated from an average on 100 cycles for a specific program version Program version V1 6 Consumption mi per zea cle se Miniclean Minoclair Prime All Reagents 40 0 11 6 5 2 Prime Diluent 27 00 Mo M M Prime Lyse 11 6 Prime Cleaner MoO M BBM Auto Clean 16 4 0 6 15 2 ue Concentrated Cleaning 164 O06 8915 60 Cal Photometer 6 0 18 O RABO43EEN section 1 Specifications Hematology Devices for in vitro dagnostic use ABX Minipack UMG 15 01 05 A95A00032B 0602050 Exclusive use oa 3al CE per HORIBA ABX BP 7290 34184 Montpellier cedex 4 France 1 Functions Measuring Principles see Section Technology in the instru ment User Manual R1 Enzymatic solution with proteolytic action for the cleaning of Results Refer to the instrument User Manual HORIBA ABX blood cell counter
12. 8 Once you have edited the necessary parameters press the Escape ESC key to exit back to the Chg Lab Limits Menu as indicated on the Display 2 2 Results High Limits 1 Use the Up or Down arrow keys to select the 2 HIGH LIMITS sub menu as indicated on the display 2 Press the ENTER key to enter into the parameter High Limits sub menu as indicated on the display 3 Select 1 WBC HIGH and Press the ENTER key to edit the WBC High value as indicated on the display 4 Enter the New value with the Number keys and use the Decimal key for placing the decimal point in the correct order 5 Once you have entered the correct value press the ENTER key to accept the change The display will return to the HIGH LIMITS Menu as indicated 6 Use the Up or Down arrow keys to select the next High Parameter to be edited 7 Repeat Steps 4 through 6 to edit the remaining High parameters 8 Once you have edited the necessary parameters press the Escape ESC key to exit back to the Chg Lab Limits Menu as indicated on the Display 2 3 Print Limits This CHG LAB LIMITS sub menu allows the operator to printout the current Laboratory Limits and Morphology Flag values 1 From the Chg Lab Limits Menu use the Down arrow key to select 3 PRINT LIMITS as indicated on the display 2 Press the ENTER key The current
13. CE easi HORIBA ABX BP 7290 34184 Montpellier cedex 4 France 1 Functions Buffered isotonic solution for the determination of blood cell counting and the measurement of hematocrit on HORIBA ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance character istics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproduc ibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual Conservation amp expiration Storage conditions Stored at 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label Measurements principles amp results Directions for use see Section Installation Reagent Location and connection in the instrument User Manual This reagent is for professional in vitro diagnostic use only Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Description amp technology in the instru ment User Manual a Modification from index A to B Company name change FORM 0866 rev 1 S A au Capital de 44 000 000 Eu
14. Laboratory Limits will automatically print out as indicated on page 7 in this section RABO43EEN section 5 Instrument Configuration Micros 60 Laboratory Limits are printed as followed LIMITS DATE 01 20 2002 TIME 10 54 HIGH WBC 10 0 10 mm RBC 5 80 10 mm HGB 16 5 g dl HCT E i 50 0 MCV E 97 um MCH l 33 5 pg MCHC 3 35 0 g dl PLT 390 10 mm MPV E l 11 0 um RDW i 15 0 LYM E 480 MON 10 0 GRA 76 0 LYM 3 2 10 mm MON 0 8 10 mm GRA z 6 8 10 mm PLT Flags E SCL 8 0 SCH 8 0 MIC 8 0 WBC Flags L1 8 0 M2 8 0 G1 15 0 G3 8 0 3 Once the Limits have printed out Verify your entries Check each parameter to make sure that you have entered the correct number and placement of the decimal point MICROS 60 CS CT Note PCT and PDW are not available in the United Stares These parameters are strictly use for Research and Investigational purposes Only RABO43EEN section 5 Instrument Configuration Instrument Configuration 2 4 Morphology Flag Limits MICROS 60 CS CT Important The Factory Default flag values programmed on the ABX MICROS 60 were set based on a study of Normal cell populations These Default values can be adjusted to accommodate specific Populations and or Geographical locations based on those specific studies It is highly recommended to maintain the Default values un
15. Normal 3 High CALIBRATION 1 Autocalibration j 2 Coefficients 3 CALIBRATION COEFFICIENTS 1 Calibration Coefficients PASSWORD 2 Print Coefficients WBC RBC HGB HCT PLT MPV RDW COEFF PDW COEFF WITH PACK 1 Chg Pack 2 Capacity 3 Prime Pack WITHOUT PACK 1 All Reagents 2 Diluent 3 Lyse SERVICE 4 SERVICE 1 Backflush 8 Auto Clean 4 Cleaner MECHANIC 1 Check Sensors 2 Needle U D 3 Carriage L R 4 Liquid Syringe CYCLE 1 Startup 2 Standby 3 CBC 5 Pressure Syringe 6 Valves 7 Chg Contrast 8 Park 9 Piercing 16 RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting O f SETUP aaa A i ERS gt 1 Results 3 Special 2 Chg Lab Limits 4 Date Time 5 Host Options 6 Barcode 7 Memo Card nN M N RAB043EEN section 6 Maintenance and Troubleshooting h 7 Print LMG s HOST OPTIONS gt 1 Reprint Results 5 SETUP y 3 Transmission RESULTS 2 Printout lt gt my PRINTERS 1 Reserved 1 EPSON 2 Reserved 2 STAR 3 Reserved 3 5 Print Temperature 6 Print Lab Limits dd SEIKO 4 Standard CITIZEN 5 None CHG LAB LIMITS 1 Low Limits 2 High Limits 3 Print Limits
16. O Concentrated Cleaning This service function allows the operator to perform a very strong cleaning of the WBC and RBC counting chambers and apertures This cycle time may vary due to the Revision of Software This service function is utilized when frequent parameter and or morphology flags a present on normal patient analysis e From the Service Menu use the Down arrow and select 4 CONCENTRATED CLEANING 2 solutions are recommended for this procedure 1 ABX MINOCLAIR a solution which contains about 25 bleach 2 75 Regular CLOROX bleach solution 3 parts Bleach 1 part Deionized Water e Both solutions described above will work depending the severity of the blockage in the chamber or aperture e Press the ENTER key to access this function and follow the steps that appear on the displayas indicated 1 Open the main cover door of the ABX MICROS 60 as indicated RABO43EEN section 6 Maintenance and Troubleshooting 2 If the ABX MICROS 60 has a cover over the WBC HGB chamber dispense which ever solution you choose into the RBC chamber and into the hole on the top of the WBC chamber cover so that it goes into the chamber e f the ABX MICROS 60 has a cover on both WBC and RBC chambers dispense which ever solution you choose into the holes on top of both chamber covers so that is goes into the chambers 3 After the solution has been added to both chambers press any key to contin
17. Startup was select in the instrument configuration 3 If the ABX MICROS 60 does not automatically run a Startup after the unit has been powered On for more that 3 minutes press the lt STARTUP gt key located on the front panel 4 After Startup verify that the Background counts are within their limits as indicated O Check and verify that the Background counts do not exceed the following parameter Limits WBC 0 3 108 mm RBC 0 02 10 mm HGB 0 3 g dl HCT O PLT 10 10 mm 5 If Backgrounds are unacceptable the ABX MICROS 60 automatically performs a Second and Third count 6 If counts are still unacceptable perform a Concentrated Cleaning From the Main Menu Select lt 4 gt SERVICE then lt 4 gt CONCENTRATED CLEANING 7 Follow the instructions on the LCD screen 8 Run another lt STARTUP gt 9 If the second Startup fails call your local HORIBA ABX Technical Support Representative 4 3 Standby At the end of the working day press the lt STANDBY gt key This will place cleaner into the chambers for an overnight cleaning 18 RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting 4 4 Sample Analysis 1 Press the lt ID gt key and enter either the Sample Identification using the lt Number gt keys or the lt UP gt and lt DOWN gt arrow keys for alphabetical characters or Run Number using the number keys only 2 Press t
18. This warning message is given according to the numbers of CBC cycles left in the pack The warning message is as followed To replace the Minipak follow these steps through the menus From the Main Menu select 4 SERVICE 3 PRIME then 3 PRIME PACK The ABX MICROS 60 will show the remaining steps to follow on the LCD display Once this Pack replacement is complete the instrument automatically resets the CBC cycle counter to 160 cycles 1 3 Printer Power and On line Checks Prior to Instrument Startup always check the Printer to verify that the Power is turned ON and that the LED s are in the Ready state Check that the Printer has sufficient paper for the daily operations Check the alignment of the paper if your printer is a Tractor Feed printer 1 4 Instrument Startup Power ON the Instrument by pressing the ON OFF switch located on the back lower center of the rear panel The LCD display will show the following This indicates an instrument warm up period for the internal electronics RABO43EEN section 3 Startup and Sample Run Startup and Sample Run O Once the Instrument warm up phase is complete the Front panel L E D will turn from Red to Green indicating that the initialization phase is complete The ABX MICROS 60 will now automatically run a STARTUP CYCLE if and only if the instrument has been programmed for an AUTO Startup cycle If the ABX MICROS 60 does not
19. designed for use with the ABX MICROS 60 analyzers Call your local HORIBA ABX Customer Service Representative for information and ordering of this specialized product A The ABX MICROS 60 CS CT Quality Control program contains 5 different functions in its Menu 1 AUTOMATIC The function of this Q C sub menu is to allow the operator to analyze Commercial Control blood products MINOTROL and store the results on the Quality Control Smart Card 2 ANALYSIS The function of ths Q C sub menu is to allow the operator to analyze Commercial Control blood products MINOTROL with fixed WBC Thresholds specifically for use Without a Smart Card 3 PRINT TARGETS The function of this Q C sub menu is to allow the operator to print the Target values of the Commercial Control blood products from the Quality Control Smart Card Only 4 STATISTICS The function of this Q C sub menu is to allow the operator to print the cumulative statistics for the Commercial Control blood products from the Quality Control Smart Card Only 5 GRAPHS The function of this Q C sub menu is to allow the operator to print the Levey Jennings graphs of the Commercial Control blood products from the Quality Control Smart Card Only MICROS 60 CS CT Caution When running Quality Control Without the use of a Smart Card pay close attention to the Result parameter Limits if the system was programmed to print ou
20. determination of the MCV value Careful examination of a stained blood smear may reveal the error O The MCH is determined according to the HGB value and the RBC count The Limitations listed for HGB and RBC will have an effect on the MCH and may cause erroneous values O The MCHC is determined according to the HGB and HCT values The Limitations listed for HGB and HCT will have an effect on the MCHC and may cause erroneous values RABO43EEN section 1 Specifications O The Red blood cell distribution width is determined according to the RBC count The red blood cells pass through a Micro aperture that will generate electronic pulses as the cells pass through it These pulses are then Grouped according to size Thresholded and calculated to form a Histogram Distribution curve This distribution curve is then used to calculate the distribution of the Red blood cells as a percentage of the curve This curve is then used in determining the RBC size abnormalities as in Anisocytosis Agglutinated Red Blood cells May cause a falsely low RBC count and erroneous RDW s Blood samples containing the agglutinated RBC s may be detected by observing abnormal MCH and MCHC values as well as examination of a stained blood smear Nutritional Deficiency or Blood Transfusion May cause elevated RDW results due to Iron Vitamin B12 or Folate conditions High RDW s may also be present from Bi modal RBC distribution from Tr
21. e Incorrect sample mixing e Perform a Concentrated cleaning re run Startup e Remove and flush out sample probe e Check 3 syringe block and call HORIBA ABX Technical support e Check and or replace Reagent s if necessary re run Startup e Perform a Concentrated cleaning re run Sample e Check for diluent in chamber during cycle call HORIBA ABX Technical support e Perform a Concentrated cleaning re run Sample e Perform a Concentrated cleaning re run Sample e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Perform a Concentrated cleaning re run Sample e Re calibrate and re run QC e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Perform a Concentrated cleaning re run Sample e Perform a Concentrated cleaning re run Sample e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Mix sample just before placing it into the tube holder for each sample RABO43EEN section 6 Maintenance and Troubleshooting y y Micros e Startup Failed check reagents High Background counts e Startup Failed check reagents HGB Reference Failure e No results in analysis e Very high results on WBC Hgb e on HGB results only e Suspiciuos patient results e QC results are outside of the acceptable limits e Poor Repeatability e Possible dirty Aperture e Possible Partial blockage in sample probe e Possible Leakage from syringe b
22. e Possible defective motor call HORIBA ABX Technical support RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting Specific ERROR Messages continued Corrective Action ERROR Message e Printer is Off Line reset printer From Main menu select 5 SETUP 1 RESULTS 1 REPRINT RESULTS e Power On and or reconnect printer to unit From Main menu select 5 SETUP 1 RESULTS 1 REPRINT RESULTS e Bad Date Try again error e Use the Period key between each group of numbers when entering the date ePossible wrong date format check for the correct date format re enter the date Use the Period key between each group of numbers when entering the date e Press the STARTUP key to run a Startup MICROS 60 CS CT Note Minimum and Maximum values are displayed with the corresponding error message Correct your value to be within the specified ranges given If unable to be within the range specified call your local HORIBA ABX Technical Support Representative RABO43EEN section 6 Maintenance and Troubleshooting 15 Micros 60 RESULTS Parameters 1 Pat ID Run Flags Parameters 2 CALIBRATOR SMART CARD Select OP Chg Lot Chg Exp Date O 1 RESULTS Chg Target Chg Sample Nb Run Calibration Start Calibration QC SMART CARD Valid Calibration Select OP Lot SELECT LEVEL 1 Low 2
23. mix the control material as indicated on the instruction sheet that comes with the control kit 2 Run the Normal Level control 6 times as a regular patient analysis When the cycles are complete note only the RDW results Write down these result for future reference use 3 Calculate the Mean value for all 6 results and write it down for future reference use RABO43EEN section 4 Calibration and Quality Control Micros 60 rr atA I K a o ST EF R pW 3 Te YATION tarm a bal INEZ VY Wali VWIiAaAtiUll LUTTE d VIUALILY f mvyrtunt Clan Mia AS EA OA Al CONTO standara CONUNUCAa 4 Take the Minotrol Assay sheet that comes with the control kit and note Only the Normal Control Mean Assay value for RDW 5 Calculate the New RDW coefficient as followed e Take the Normal Control Mean Assay value for RDW e Divide it by the Mean value of the Normal control ran 6 times as a sample e Times the current RDW calibration coefficient This will equal the New RDW Calibration coefficient 6 To Enter into the calibration coefficient menu from the Main Menu select 3 CALIBRATION 2 COEFFICIENTS 1 CALIB COEFF enter the password and use the Down arrow key to 7 RDW 7 Press the ENTER key to enter the New coefficient for RDW Press the ENTER key again to accept the New coefficient after it has been entered 8 Press the Escape ESC key until you return to the Main
24. the system and run a Startup If the problem persists during or after startup identify the source of the malfunction and initiate the appropriate troubleshooting procedures RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting If your Background count is unacceptable Quality Control values are out of range or your pateint results are suspicious Reagent deterioration or contamination may be suspected Replace your reagents and perform a Concentrated Cleaning procedure If the background count is acceptable but the Quality Control values are still out of range or patient results are still suspicious continue with the indentification procedure If replacing the reagents performing a concentrated cleaning procedure does not correct the background count problem call your local HORIBA ABX Technical Support Representative for further instructions O In order to verify the percision of the instrument it is recommended to run a Fresh Normal Whole blood sample 10 times mixing between each analysis cycle after all 10 run are complete calculate the Coefficient of Variation percentage CV Compare the CV results with those listed in Section 1 Specifications 3 Summary of Performance Data 3 7 Repeatability lf the percision of any parameter is not within these specifications identify the out of range parameter s and initiate appropriate troubleshooting procedures O
25. 14 Place the cap back onto the vial gently and thoroughly mix the material for the next calibration sample run When the first sample is complete the results will be displayed on the LCD screen as indicated Verify that the results are within 20 of each parameter target value indicated on the Calibrator Assay sheet Press the ENTER key to continue 15 The next LCD display will ask you if you want to Accept or Reject the results if and only if the results were not rejected previously A MICROS 60 CS CT Important Calibration results having Error flags such as or for HGB will automatically be rejected The system will automatically re set itself to rerun that sample If you acquire 3 rejects continuously on the same number sample abort Calibration and contact your local HORIBA ABX Technical Support representative The LCD display will indicate If the results are Not within acceptable limits it is possible to reject the results and restart that sample run Press the Escape ESC key on the front panel to Reject the results The instrument will re start the sample at the same number 16 If the results are good press the ENTER key to accept the first sample into the calibration data The LCD screen will display the next sample to be run as indicated RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control 17 Run the rem
26. 1999 RAB043EEN section 1 Specifications Specifications 3 2 Precision Claims JU BC lt 2 0 5 x 10 uL aE CT lt 2 0 45 Source 510K submission 4 KO30799 3 3 Precision Repeatability Based on 20 consecutive samplings from 1 Fresh Normal Whole Blood without any alarms JU BC lt 2 0 5 x 10 uL L CT lt 2 0 45 RAB043EEN section 1 Specifications Micros 60 3 4 Linearity eLinearity range The Manufacturer s tested linearity zone of the instrument using linearity kits and or human blood eLinearity limits Maximum and minimum values within the instrument returns no dilution alarm eVisible Range Range values given by the instrument These values above linearity limits are given as an indication They are given associated with a D flag This Visible range is outside Manufacturer s range eLinearity Kits Linearity was tested using available Low Range and Full Range Linearity Test kits The Test kits were analyzed and data was computed according to the Manufacturer s instructions eHuman Blood Linearity was also obtained on human blood using a minimum of 5 dilution point The results of this study are as followed RBC 10 mn VAN 0 8 8 18 0 07 43 LT 10 mm B 5 4990 O 4000 4000 6000 10 10 P HCT MIDE O 80 80 90 Lo A A for HGB gt 2 g dL and RBC gt 0 5x10 pL B for HGB lt 2 g dL
27. 2 numbers then press the decimal key again Now enter the last 2 numbers and press the ENTER key to save the new date as indicated MICROS 60 CS CT Important An Error message BAD DATE TRY AGAIN will occur if you don t enter the date correctly Make sure to use the decimal key after the first 2 numbers and after the second 2 numbers when entering the date correctly 3 Press the Escape ESC key to exit the DATE TIME Menu 5 Host Computer Options The ABX MICROS 60 is capable of transmitting data to an External Computer by way of the RS 232 interface connection on the back panel of the analyzer MICROS 60 CS CT Important The external computer Communication format must be set up according to the computer Vendor s specifications The output must match those formats specifications If there are any questions regarding output format setup contact your local HORIBA ABX Technical Support Representative tor information on the specific output format types 16 To enter into the Host Options Menu from the SETUP Menu use the Down arrow key to select 5 HOST OPTIONS as indicated on the display Press the ENTER key to access the sub menu 5 1 Host Communications This sub menu will allow the operator to select from 4 different Output format options for an external computer 1 FORMAT ARGOS No character identifiers 2 FORMAT R 4 D No character iden
28. 5 Use the Up or Down arrow keys to select the next operator ID to be edited 6 Repeat Steps 3 through 5 to edit the remaining operator ID s 3 2 Change the User Password This Instrument password is an important step in accessing some of the Menus in the Instrument program setup The use of this password allows the operator to Change the Calibration Coefficients Enter the Special Functions Menu Change the Password itself 1 From the Special Menu select 2 CHG PASSWORD then press the ENTER key to access that sub menu as indicated 2 Use the Number keys to enter any combination of 3 numbers as indicated MICROS 60 CS CT Important If the user edits the Default password from 123 to any other combination of numbers it is mandatory to record this new number and have it accessable to all users who need access to the menu functions which require this password This will secure specific operator intervention in these menus 3 Press the ENTER key to accept the password change Press the Escape ESC to save the previous password RABO43EEN section 5 Instrument Configuration y y Micros 60 3 3 Start up Cycle The STARTUP cycle is used daily prior to any normal operation to ensure that Detergent from the STANDBY cycle is completely rinsed out of the system This daily STARTUP cycle is very important to operation of the system It includes a
29. CS CT Important Error flags such as H L and for HGB on control results are NON valid results The parameters with these specific flags should be reviewed and questioned before continuing with the next level of control blood If the operator Rejects the results by pressing the Escape ESC key you have the option of re running that same control level again or selecting another level No results will be stored on the QC smart card RABO43EEN section 4 Calibration and Quality Control Micros 60 Rejecting Results continued MICROS 60 CS CT Important If a control level blood displays any Error flags H L for HGB after being analyzed Twice in sequence for the same level ABORT Q C and contact your local HORIBA ABX Technical Support Representative before continuing with Quality Control analysis Exiting Q C Automatic If the operator needs to Exit Q C at any time before all levels of control bloods are analyzed it is possible to do so by following these simple steps 1 Wait until the cycle of the control level blood being analyzed is complete 2 Press the Escape ESC key and the ABX MICROS 60 will ask you if you want to accept or reject the results as indicated on the display 3 Press the escape ESC key and the display will return to START QC display as indicated 4 Press the Escape ESC key and the ABX MICROS 60 will a
30. D Dor 0 MICROS 60 CS CT Important Whole Blood parameter results within visible range will still give a result value A with a D indication These results require a dilution or PRP analysis for PLT of the sample RABO43EEN section 3 Startup and Sample Run 13 Micros 60 O A Reject flag shown by an asterisk following the Parameters WBC RBC HCT or PLT indicates that the ABX MICROS 60 has analyzed that parameter for a maximum of 3 counts All 3 counts were outside the system percision limits for that specific parameter The results should be verified by re running the sample O A reportable result shown by a Dollar sign following the parameters WBC RBC HCT or PLT indicates that the ABX MICROS 60 has analyzed that parameter for a maximum of 3 counts Two out of three counts were within the system percision limits for that specific parameter The results can be reported but the parameter should be monitored for the next sample analyzed A suspicious flag shown by an Exclamation located next to the Hemoglobin result shows that the HGB Blank carried out during the analysis differs from the previous cycle s HGB Blank This means that both HGB blanks were outside the Instrument percision limits This result can be reported but the parameter should be monitored for the next sample analyzed The MCH and MCHC may also be affected by this
31. Eosinophils Myelocytes Neutorphile polynucleose This flag corresponds to the number of cells counted in the detection zone in comparison to the total number of Granulocytes 4 The G2 flag indicates an excessive number of cells in the 220fl to 250fl zone This flag makes it possible to follow an abnormal Granulocyte peak displacement Some of the cell variances will include Anomalies in the cell membrane of the Granulocytes possible Lyse flow error Fluidic errors Old blood after 6 to 8 hours un refrigerated Granulocyte cell size less than 250fl 5 The G3 flag indicates an excessive number of cells larger than 400fl The pathological elements which may be found in this area will include Metamyelocytes Many types of Large Immature Cells This flag corresponds to the number of cells counted in the detection zone in comparison to the total number of Granulocytes This cell count will be Higher than the set level MICROS 60 CS CT Important All Anomalies and or Abnormal distribution flags given by the ABX MICROS 60 should be Manually verified by the examination of a stained peripheral blood smear 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 anumber of different zones This also applies to presence of Normal or non pathological cells that have been subje
32. ID s to Printer or Computer Print one result to Printer or Computer Print all results to Printer or Computer Print specific numbers of sample results to Printer or Computer To enter into the Transmissi sub menu from the MEMO CARD Menu use the Down arrow key to select 2 TRANSMISSI as indicated 1 Press the ENTER key to access this mode of transmission sub menu 2 Choose one of 2 options to have your results from the memory card sent to 1 PRINTER the printer that is attached to the ABX MICROS 60 2 HOST COMP a Host Computer that is attached to the RS 232 port of the ABX MICROS 60 3 Press the ENTER key after making your selection 7 4 Print List This Memory card sub menu allows the operator to print out a complete list of all the sample Identification numbers on the card This Sample Identifictaion list will include the following information MEMO Number in sequence The date of the analysis The Time of the analysis The Sample Identification number entered by the operator To enter into the Print List sub menu from the MEMO CARD Menu use the Down arrow key to select 3 PRT LIST as indicated 1 Press the ENTER key to Print the complete sample identification list from the memory card PRT LIST MEMO DATE 07 21 1999 07 21 1999 07 21 1999 TIME 11 45 11 47 11 48 11 53 11 55 13 34 07 21 1999 07 21 1999 07 21 1999
33. Measuring Principles see Section Technology in the instru ment User Manual Results Refer to the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance representative changes call your HORIBA ABX a Modifications from Index B to C Company name change FORM 0866 rev 1 S A au Capital de 44 000 000 Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp Handling precautions Composition Organic Buffer lt 20 Proteolytic enzyme 9 6 0 4 T 20 C 72 2 Q T 20 C pH Resistivity Description Colorless liquid Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Specimen collec tion and Mixing in the instrument User Manual Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal Follow your laboratory s protocol when neu tralizing and disposing of waste Please refer to the MSDS associated with the reagent Latest version documents on www horiba abx com HORIBA GROUP ABX Minidil LUM G O Exclusive use
34. Menu 9 Now take all 8 Levels of controls LOW NORMAL HIGH and run them 1 time each as a regular patient analysis When the cycles are complete note only the RDW results and compare them to the Minotrol control Assay values for RDW on the Assay sheet Verify that the RDW results are somewhat close to the Mean Assay values and within the Ranges as specified for all 3 Levels 10 The RDW calibration is now complete Be sure to monitor your RDW results and verify that they fall within your patient population Verify that Normal RDW results will be within the established ranges set in the set up menu See Section 5 Instrument Configuration 2 Change Laboratory Limits 2 7 2 2 Result Low Limits Result High Limits 10 MICROS 60 CS CT Note Certain Pathological conditions will affect the RDW results See Section 1 Specifications 4 Limitations 4 3 Known Interfering substances 1 5 Calibration Coefficients Calibration may also be achieved by changing the Calibration Coefficients directly From the Mani Menu select 3 CALIBRATION 2 COEFFICIENTS The following menu will be displayed on the LCD screen as indicated In this Menu the operator has the option of either Editing the current calibration coefficients or Printing the current calibration coefficients MICROS 60 CS CT Important The ABX MICROS 60 is an accurate and reliable instrument when proper
35. R3 Sodium fluoride lt 3 Expiration date refer to expiration date reagent packaging label Sodium Azide o ocoomo o lt 0 1 Sodium Hydroxyde lt 1 da ce Dimethylourea 0 1 3 Measurements principles amp results i 7 4 0 1 T 20 C Directions for use see Section Reagent Location and connec Resistivity 60 6 Q T 20 C E tion in the instrument User Manual Description Limpid and odourless aqueous aB A solution O tO S a Modification from index A to B Company name change z O LL S A au capital de 44 000 000 Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Latest version documents on www horiba abx com Explore the future HORIBA GROUP AAA Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent TON Once the waste seal has been broken the Minipack must be considered as potentially infectious Use established good laboratory working practices when handling the Pack Specimen Collection and Mixing see Section Specimen collec tion and Mixing in the instrument User Manual 5 Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal Follow your
36. RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control 5 Once you have entered the Lot number press the ENTER key to accept it A brief HGB Blank reference measurement is performed before the analysis cycle a Message is displayed as indicated 6 When the HGB Blank reference measurement is complete a message is displayed as indicated 7 Once the Control blood has equilibrated to room temperature Gently and thoroughly mix the level of control blood to be analyzed Follow the product instructions that come with the Minotrol control kit for proper mixing 8 Select the tube holder position for control material and rotate it to the 12 00 o clock position inside the tube holder compartment MICROS 60 CS CT Warning Remove the Cap from the Quality Control vial before placing it into the Sample tube holder Severe Sampling needle damage will occur if the cap remains on the vial 9 Once the cap has been removed Place the vial into the tube holder and close the tube holder door The control analysis cycle will begin 10 When the analysis cycle is complete the results are displayed and printed out as on Page 18 of this Section 11 See Quality Control Reminder in the next column MICROS 60 CS CT Caution When running Quality Control Without the use of a Smart Card pay close attention to the Result parameter Limits if the system was pro
37. The information in this manual is distributed on an as is basis without warranty While every precaution has been taken in the preparation of this manual HORIBA ABX will not assume any liability to any persons or entities with respect to loss or damage caused or alleged to be caused directly or indirectly by not following the instructions contained in this manual or by using the computer software and hardware products described herein in a manner inconsistent with our product labeling O Other Product names mentioned within this publication may be trademarks or registered trademarks of other companies O O HORIBA All rights reserved No part of this manual may be reproduced or transmitted in any way shape or form or by means of any electronic mechanical photocopying recording or otherwise without the written consent of HORIBA ABX O To alert the operator of potentially hazardous conditions one of the bold captioned headings which are described below is provided wherever necessary throughtout this text WARNING Flags a procedure that if not followed properly can prove to be extremely hazardous to either the operator or the environment or both CAUTION Emphasizes operating procedures that must be followed to avoid possible damage to or destruction the instrument IMPORTANT Emphasizes operating procedures that must be followed to avoid erroneous results NOTE Emphasizes the important information especially helpful t
38. This calculation is almost the same as the MCV Thrombocrit Plateletcrit is calculated according to the formula PLT 10 mm x MPV um PCT 10 000 The PDW Platelet Distribution Width is calculated form the Platelet Histogram Distribution curve The PDW is represented by the width of the curve between 15 of the number of platelets starting from the Low Threshold 2fl S1 and 15 of the number of platelets begining with the Variable High Threshold S2 O The PDW determination area is shown by the distribution curve below MICROS 60 CS CT Note PCT and PDW are not available in the United States These parameters are strictly used for Research and purposes Only Investigational O The WBC Mesaurement principles are based upon the same as the RBC PLT measuring principles The WBC count is performed in the WBC HGB Chamber The electronic signal processing device places and electronic Threshold between the WBC s and the PLI s The electronic pulses are then placed into 256 Channels according to pulse size The pulses are then Thresholded grouped then mathematically calculated to create a Numerical value for the determination of WBC s The WBC Histogram is a distribution study that reveals the following 3 types of White blood cell sub populations Lymphocytes Monocytes and Granulocytes The Diluent and Lyse of the ABX MICROS 60 play a very
39. aborted and the following message will appear on the LCD display as indicated Once a key has been pressed the analyzer automatically returns to the Q C menu because it is impossible to run Q C Automatic without a Smart Card Reader The second step that takes place is that the ABX MICROS 60 checks for the presence of a Quality Control Smart Card If the card has not been inserted or if the card has been inserted incorrectly or if there is a technical failure with the present reader the following message will appear on the LCD display as indicated MICROS 60 CS CT Caution The ABX MICROS 60 will only accept the Quality Control Smart Card while in the Q C program It will not accept 1 A Q C card that has expired 2 A Memory Card lf you have the correct card and are still having the Error messages indicated above contact your local HORIBA ABX Technical Support Representative for further instructions regarding this issue 14 If the Escape ESC key is pressed the analyzer automatically returns to the Q C menu because it is impossible to run Q C Automatic without a Q C Smart Card If the Q C smart card is in the reader and the previous Error messages do not appear the ABX MICROS 60 will automatically read the card and display the Lot and Expiration date of the current card as indicated MICROS 60 CS CT Caution It is mandatory to verify that the Quality Control Smart card be
40. analysis e Suspicious patient results e Alarm flags on most parameters e QC outside acceptable limits e Poor Repeatability e Poor Chamber drainage e Out of Reagent s e Contaminated Reagent s e Possible dirty Apertures e Blocked sample probe e Sample probe depth not adjusted correctly e Possible dirty Apertures e Possible partial blocked sample probe e Possible leakage from syringe block e Possible Tube cap debris in T fitting below WBC chamber e Possible dirty Apertures e Possible Tube cap debris in T fitting below WBC chamber e Possible dirty Apertures e Possible leakage from syringe block e Possible Tube cap debris in T fitting below WBC chamber e Poor calibration e Possible dirty Apertures e Possible leakage from syringe block e Possible Tube cap debris in T fitting below WBC chamber e Poor calibration e Possible Tube cap debris in T fitting below WBC chamber e Possible Vacuum Waste syringe malfunction e Check and or replace Reagent s if necessary e Check and or replace Reagent s if necessary e Perform a Concentrated cleaning re run Startup e Remove and flush out sample probe e Call HORIBA ABX Technical support for assistance e Perform a Concentrated cleaning re run Sample e Remove and flush out sample probe e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Call HORIBA ABX Technical support for assistance e Pe
41. and RBC gt 0 5x10 uL Source 510K submission K030799 RABO43EEN section 1 Specifications Specifications 3 5 Carry over Carry over was tested by analyzing samples with High Concentrations of WBC s RBC s HGB and PLT s Each sample was analyzed in triplicate followed by 3 Background cycles The Carry over is calculated by using the following formula Background1 Background3 Carry over X 100 Sample3 Background3 HGB g dl 10 mmY RBC 10 mmY Y Parameters WBC Units 10 mm Carry over Actual 0 3 0 00 0 0 0 0 RABO43EEN section 1 Specifications Micros 60 3 6 Normal Ranges These Normal ranges were established from a study performed in Somerville NJ U S A This study encompasses the central 95 of the values in the distribution of 43 Normal Healthy and Drug Free individuals These Ranges are as followed Parameters Male N 21 Female N 22 Lymphocytes 23 47 19 41 Granulocytes 49 74 53 79 HGB g dl 13 5 16 5 12 0 15 0 MCV um 83 101 84 96 MCHC g dl 32 35 32 35 PLT 10 mm3 145 355 150 330 PCT and PDW have not been established as indications for this product in the United States The use of PCT and PDW should be restricted to Research Use Only MICROS 60 CS CT Important Expected values will vary with sample population and or geographical location It is highly recommend
42. any key to return to the MAIN MENU of the ABX MICROS 60 1 3 Calibration Failed In order for ABX MICROS 60 to Fail Calibration the data must meet the statistical criteria which contain 2 conditions 1 The Coefficient of Variations are out of thier specified limits as shown on Page 6 in this Section 2 The difference between the Target value and the Mean for each parameter that failed calibration is greater than 20 When ABX MICROS 60 Fails calibration the results will be printed out the Calibration coefficients are Rejected and the previous coefficients will remain unchanged in memory Once the calibration information has printed out the screen will indicate MICROS 60 CS CT Note When the Calibration STATUS indicates FAILED on one or more parameters even though stating OK on the other parameters Calibration will not take place MICROS 60 CS CT restart the calibration again or call your local HORIBA ABX Technical Support representative for further instructions Note When the Calibration Fails the operator may RABO43EEN section 4 Calibration and Quality Control 7 Micros 60 If the calibration fails and the Printer is not used the following menu will be displayed on the LCD as indicated Rejected and saved coefficients can be displayed by using the Up and Down arrow keys on the front panel Press the Escape ESC key to return to
43. are compared to the ranges on the Smart Card If the results are acceptable NO Flags press the lt ENTER gt key twice to accept the level result If the results are unacceptable with Flags H L repeat the analysis of that level 8 Continue with the next level of MINOTROL until all 3 levels have been run 9 When all 3 levels of Controls have been ran the display will indicate Valid QC Press the lt ENTER gt key to store the accepted QC data onto the card 10 If any level of control fails twice when repeated perform a Concentrated Cleaning and re run the control 11 If controls fail again after the concentrated cleaning call your local HORIBA ABX Technical Support Representative 20 RABO43EEN section 6 Maintenance and Troubleshooting Manual Probe Cleaning e Unblocking Sample probe e Replacing Sample probe O e Low results on all parameters in any analysis mode e No results on all parameters in any analysis mode e Possible high backgrounds on startup O e 5ml or 10ml syringe e Absorbant paper e 5 inch small diameter tubing e Small paper cup O e ABX MINOCLAIR 0 5L Part number 0401005 e Or 75 Regular Clorox Bleach solution Mix 3 parts Bleach to 1 part Deionized Water O e Approximately 15 minutes O e As needed In case of partially blocked probe e Bent probe O e Sample Probe P N GBC 052 AS Micros 60 1 Unblocking the Sample Probe O 1 From the
44. be printed out on the results To select the Patient Parameter limits to be printed out or not to be printed out on the results To select the LMG s Lymphs Monos and Grans to be printed out or not to be printed out on the results Available only for ABX MICROS 60 CS CT16 or CS CT18 parameter analyzers From the Set up Menu select 1 RESULTS then press the ENTER key to enter into the Results sub menu As shown on the display 1 1 Reprint Results This sub menu allows the operator to reprint the results of the last sample ran MICROS 60 CS CT Important The ABX MICROS 60 will only hold 1 result in the system Memory This result is usually the very last sample sample analyzed either a Patient sample or a Quality Control level blood only A Calibrator blood result is stored in an entirely different system format 1 From the Results Menu select 1 REPRINT RESULTS as indicated on the display 2 The last results in memory will automatically printout with the following information Date and Time the associated Identification Sample run and Sequence Number Possible Flags if any the Histograms if selected in the setup 1 2 Printout This sub menu allows the operator select or not to select the WBC RBC and PLT Histograms for the results printout 1 From the Results Menu select 2 PRINTOUT using the Down arrow key as indicated on the display The
45. blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance character istics see Section Specifications in the instrument User Manual Conservation amp Expiration Storage conditions Stored at 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label Measurements principles amp results Directions for use see Section Reagent Location and connec tion in the instrument User Manual Measuring Principles see Section Technology in the instru ment User Manual Results Refer to the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance representative changes call your HORIBA ABX a Modifications from Index B to C Company name change FORM 0866 rev 1 S A au capital de 44 000 000 Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp Handling precautions Composition Sodium hypochlorite 9 v v at 13 of active chloride Sodium hydroxide 0 26 pH 12 4 0 5 T 20 C Resistivity Not available Description Yellowish liquid Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottl
46. can shock and injure the user Do not tamper with the instrument and do not remove any components covers doors panels and so on unless otherwise instructed within this document Moving parts It is strictly forbidden to disable sensors as it may cause operator injuries Protections covers must not be opened during instrument operations 2 3 Biological risks MICROS 60 CS CT Consider all Specimens Reagents Calibrators Controls etc that contain human blood or serum as potentially infectious Use established good laboratory working practices when handling specimens Wear protective gear Gloves Lab coats Safety glasses and or Face shields and follow other bio safety practices as specified in OSHA Blood borne Pathogens Rule 29 CFR part 1910 1030 or equivalent bio safety procedures HORIBA ABX uses disinfectant product for instrument decontamination and highly recommends it to decontaminate your instrument refer to Instrument general cleaning to perform the instrument decontamination procedure Micros 60 2 4 Instrument general cleaning The external surfaces of the instrument must be decontaminated considering the biological environment MICROS 60 CS CT 1 Never spill liquids on the instrument 2 Never use Disinfectant product that contains alcohol e All contaminated surfaces covers counting assembly area Slightly wet a sponge with disinfectant product See 1 and wipe the dirty surfaces e
47. emphasis on maintaining the system is strongly suggested MICROS 60 CS CT must be filled to the exact quantity of blood indicated on the tube itself Any incorrectly measured blood sample collections will show a variation in results 4 2 Blood Specimens P 1 Important The sample collection tube Sample Collection and mixing All Blood samples should be collected using proper technique 12 RAB043EEN section 1 Specifications Fresh Whole Blood specimens are recommended The ICSH nternational Committee for Standardization in Hematology defines a Fresh blood specimen as One processed within 4 hours after collection Well mixed Whole Blood specimens collected in EDTA anti coagulant and run within eight hours after collection provide the most accurate results for all parameters The White cell size distribution may shift when specimens are assayed between 5 and 20 Minutes after collection and more than 8 hours after collection MICROS 60 CS CT Caution Anti Coagulants used in blood collection may vary in the effects of changing the characteristics of the blood components Caution is advised when selecting an anti coagulant for analysis on the ABX MICROS 60 A This ts a list of Commonly used anti coagulants used for whole blood collections Heparin Causes an increase in cell clumping WBC s and PLIT s and modifies cytoplasmic color with Romanowsky staining Blue background An in
48. entering the sample tube when piercing the tube It is also recommended to use Caps specifically designed to avoid any blood retention in the upper portion of the cap RABO43EEN section 1 Specifications 13 Micros 60 4 3 Known Interfering Substances MICROS 60 CS CT Note Verification of any Abnormal test result including Flagged results or results Outside their normal range should be performed using Reference methods or other Standard Laboratory procedures for the conclusive verification of these abnormal results The section below starts the list of the Known limitations of automated blood cell counters which use the principle of Impedence WBC results that exceed the linearity limits of the system will require a Dilution of the blood sample Re assaying the diluted blood sample will help to obtain the correct assay value As in some Leukemia patients NRBC 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 enough to activate an L1 Alarm such interference will be detected However a Manual differential white blood cell count performed on a stained blood smear will confirm the presence of NRBC s Following the Manual differential white blood cell count the WBC assay value Must be corrected to subtract the NRBC s from the total white blood cell count This will give a true and correct c
49. into the white needle guide 12 Place the New Sample probe in the white needle guide 13 Place the retaining collar of the probe into its slot 14 Place the Retaining clip back onto the mounting bracket Leave a 3mm gap between the probe and clip This will ensure that the sample probe will move freely when moving up and down through the needle guide 15 Re connect the Sample tubing to the top of the probe so that it is air tight 16 Hold the Sample probe mounting bracket on the upper right edge and move the sample probe Upwards until the tip of the sample probe is inside the piercing needle 17 Press the STARTUP key to run a Startup and verify that the background results are within their limits 18 Re run the Quality Controls to verify correct results Micros 60 Extended Concentrated Cleaning e Concerns e RBC PLT Chamber and Aperture cleaning e WBC HGB Chamber and Aperture cleaning MICROS 60 CS CT Important Abnormalities or mishape may occur on blood counts due to a pollution e g clotted samples pathological anomalies fibrin layer etc which may not be removed by normal cleaning cycles Standby Auto clean If the Cleaning cycles are non affective in resolving the error perform the following concentrated cleaning procedure e Required Tools e 5ml or 10ml syringe e Required Products e ABX MINOCLAIR 0 5L Part number 0401005 e Or 75 Regul
50. probe is pushed with 1 2ml of ABX Minidil LMG along with 0 5ml of ABX Minidil LMG from the outer probe into the WBC HGB Chamber 0 4ml of ABX Minidil LMG is added the WBC HGB Chamber making the diluent volume 2 1m 0 52ml of ABX Alphalyse is added to the mixture This makes the total dilution for WBC HGB RBC PLT Dilution Initial Diluted blood volume 28 3 Volume of ABX Diluent 2 5m Final dilution ratio 1 15 000 Method Impedence Aperture diameter 50ul Count Vacuum 200mb Count period 2 x 5 seconds Temperature reaction ambient 28 3ul of diluted blood is aspirated from the WBC chamber The Needle carriage assembly moves to the Right over the RBC PLT chamber 2 0ml of ABX Minidil LMG and the 28 3ul of diluted blood is injected into the RBC PLT chamber from the inner Sample probe 0 5ml of ABX Minidil LMG is added to the dilution in the chamber from the outer sample probe This makes the total dilution for the RBC PLT i Ti i a 5 1 1 1 Diluent Lyse WBC Sample LHgb E RAB043EEN section 2 Description amp Technology Micros 60 2 3 CBC Measurement Principles The RBC s and PLI s are measured by an Electronic Impedance Variation principle This means that an electronic field is generated around the micro aperature in which the Blood cells pass through The cells create a resistance in the electronic field as they pass through the Calibrated micro aperture This inturn causes an elec
51. test sequence which includes 2 Hemoglobin blank measurements Each analysis cycle run after Start up also has a Hgb Blank measurement which is compared to the initial Start up Hgb Blank Each analysis cycle run thereafter compares the Hgb Blank reading to the previous cycle Hgb Blank reading During the WBC analysis cycle 0 52ml of Lyse Reagent is added to 2 05ml of diluted blood in the WBC Chamber The Lyse Reagent contains potassium ferricyanide Fe Cn K and potassium cyanide KCN This Lysing reagent breaks down the RBC Cell membrane and releases the Hemoglobin within the RBC The Hemoglobin then combines with the potassium cyanide to form a chromogenous cyanmethemoglobin compound This chemical compound is measured by Spectrophotometry through the optical pathway in the WBC chamber The light wavelength of measurement is at 550nm HGB using ABX Lysebio Reagent for erythrocyte lysis and cyanide free determination of hemoglobin All the heme iron is oxidized and stabilized producing chromogenic species for quantitation by spectrophotometry at a wavelength of 550nm Results The Hgb results are given as such HGB Log blank value Sample value x the Calibration Coefficient O The Hematocrit is a combination measurement of electronic pulses and mathematical calculations All the RBC pulses are grouped into various sizes Each group pulse height is then averaged All the pulse height averages are then averaged one fin
52. the Main Menu Failed Calibration printout is as indicated CALIBRATION DATE FTES TIME 09 48 OPERATOR ABC LOT MCAL212 WBC 10 2 9 9 S L 10 0 9 9 9 8 9 9 14 1 36 5 9 9 13 5 2 2 260 1 0 0 7 2 3 0 0 5 09 5 74 L 5 26 1 09 0 89 1 11 1 08 1 20 CURRENT 1 09 1 05 1 07 1 02 1 26 STATUS OK FAILED OK FAILED OK RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control 1 4 RDW Calibration The RDW calibration is a separate calibration outside the Auto calibraion menu MICROS 60 CS CT Note The RDW calibration is normally performed by taking blood samples from 100 Healthy Normal and Drug free individuals These blood samples are then analyzed on a instrument that has been calibrated for RDW determination The Mean and Standard Deviation are then calculated from that population analyzed The same 100 samples are then analyzed on the ABX MICROS 60 A Population Mean is calculated and then compared to the known calculated Mean from the comparison instrument The RDW calibration coefficient for the ABX MICROS 60 is then calculated from the difference ofthe two Mean values MICROS 60 CS CT Note Expected RDW values may vary with sample population and or geographical location It is highly recommended that each Laboratory establish its own normal ranges based on the local population The RDW calibration coefficient default value is normall
53. to be followed in using the device Principle of the method specific analytical performance character istics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproduc ibility limits of detection limitations of the method and information about the use of available reference measurement pro cedures and materials by the user see Section Specifications in the instrument User Manual Conservation amp expiration Storage conditions stored at 18 C 65 F to 25 C 77 F Product will degrade if exposed to air keep cap probe assembly securely tigthtened Expiration date refer to expiration date reagent packaging label Measurements principles amp results Directions for use see Section Reagent Location and connec tion in the instrument User Manual This reagent is for professional in vitro diagnostic use only Measuring Principles see Section Technology in the instru ment User Manual Results see Section Results in the instrument User Manual FORM 0866 rev 1 a Modification from index A to B Company name change S A au capital de 44 000 000 Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future Performance data see Section Specifications in the instrument User Manual Note if performance representative changes call your HORIBA ABX Composition amp h
54. 3EEN section 5 Instrument Configuration Instrument Configuration MICROS 60 CS CT Note The system Default password is normally set as 123 If you enter this password correctly and display still indicates 3 SPECIAL call your local HORIBA ABX Technical Support Representative for further instructions A 3 1 Change Operator Once you have entered the Special Functions menu the first sub menu option will give the operator the ability to change the Operator Identifications for 4 different operators Some of the Instrument functions such as Quality Control and Calibration ask for an operator identification when utilizing these functions The 4 different operator identifications can be modified at any time by the user 1 From the Special Menu select 7 CHG OP then press the ENTER key to access that sub menu as indicated 2 Select one of any 4 operator ID s to be edited as indicated When entering an operator identification the user has the ability to enter up to 4 Alphanumeric characters Use the Number keys to enter up to 4 numbers or use the Up or Down arrow keys to enter Alphabetical characters Press the ENTER key after entering Each Alpha character 3 Press the ENTER key to edit the operator selected as indicated 4 Once you have edited the operator ID press the ENTER key to return to the Change Opeartor CHG O P Menu
55. 4 Flag Limits i PASSWORD A 1 Chg Operator ID DATE TIME 1 Chg Time 2 Chg Password 3 Startup Cycle 2 Date Format 3 Chg Date 4 Clean Frequency 5 Print Configuration 6 Buzzer Yes No 7 1D Mode A 8 Start Mode gt gt 1 Host Comm 2 Baud Rate MEMO CARD 1 Memo 2 Transmission 3 Print list 4 Reprint One 5 Reprint All 6 Reprint From To 7 Clear Card SS gt Checksum Y N PRINTOUT lt gt 1 With Histograms 2 Without Histograms 3 Without RBC Histogram UNITS 1 Standard 2 S I 3 Inter 1 4 Inter 2 FLAG LIMITS 1 SCL 2 SCH 3 MIC 4 L1 5 M2 6 G1 1 63 STARTUP CYCLE 1 Auto 2 Manual ID MODE 1 Standard 2 US START MODE 1 Auto 2 Manual HOST COMM 1 Format ARGOS 2 Format R amp D 3 Format ABX 17 Micros 60 4 Quick Operations Reference 4 1 Power ON Instrument 1 Verify that the unit is connect to a power source Turn the power switch located on the back panel at the bottom center to the ON position The ABX MICROS 60 will indicate PLEASE WAIT FOR 3min Verify that the Printer is filled with paper and power ON the printer 4 2 Startup 2 The ABX MICROS 60 will automatically run a Startup after the unit has been powered On for 3 minutes if and only if Auto
56. 4 1 Micros 60 CS CT8 O Displayed Results The Parameter results are as displayed on the LCD screen once the analysis cycle is complete O Indentification 1 US Mode sample Identification can be reviewed on the LCD screen in the RESULTS menu by moving the Up or Down Arrow keys as shown 2 Standard Mode The Patient Run can be reviewed on the LCD screen in the RESULTS menu by moving the Up or Down Arrow keys as shown OFlags The PLT flags can be reviewed on the LCD screen in the RESULTS menu by moving the Up or Down Arrow keys as shown MICROS 60 CS CT Note The Last sample result run can be displayed again at any time before running the next analysis From the Main Menu select 1 RESULTS Use the Up and Down arrow keys to view any part of the Last sample results RABO43EEN section 3 Startup and Sample Run 7 Micros 60 RESULTS DATE 01 20 2002 TIME 09 25 ID SMITH_1234567 SEQ 27 STARTUP PASSED Pit Flags WBC 10 0 10 mm um RBC 4 90 10 mm Pg HGB 15 0 g dl l g dl HCT 439 E 10 mm On the Printout the information printed is as followed 1 The Date the sample was analyzed 2 The Time the sample was analyzed 3 The Sample Identification that the Operator had entered either Manually or Barcode 4 The Sequence number of the sample run 5 The Instrument STARTU
57. 42 SIRET 328 031 042 000 42 APE 332 B Explore the future Note if performance call HORIBA ABX representative changes your Composition amp handling precautions Composition Quarternary ammonium salt lt 5 Non ionic based surfactant lt 3 pH Resistivity 6 95 0 1 T 20 C 40 1 Q T 20 C Description Colorless odourless Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Workflow in the instrument User Manual Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Specifications in the instru ment User Manual Please refer to the MSDS associated with the reagent Latest version documents on www horiba abx com HORIBA GROUP ABX Minilyse UMG O Exclusive use Micros Hematology Devices for in vitro dagnostic use 15 01 05 A95A00010B 0702010 1L a CE easi HORIBA ABX BP 7290 34184 Montpellier cedex 4 France 1 Functions Erythrocyte lysing reagent for white blood cell counting and differ entiation and hemoglobin determination on HORIBA ABX blood cell counters Measurement procedure
58. ATE 01 20 2002 LOT M211 EXP DATE 02 20 2002 OPERATOR OP 1 SEQ 1 STARTUP PASSED 2 3 10 mm 2 36 10 mm 5 6 L g dl 15 9 70 10 mm 59 6 14 2 26 2 WBC 50 100 250 300 450 30 MICROS 60 CS CT Note Printed results may vary on the amount of data displayed on the printout Limits LMG s Histograms and Parameters are all dependant upon the initial instrument setup See Section 5 Instrument Configuration 1 Results Options Printout Print Limits Print LMG s TIME 09 25 um Pg g dl um 10 mm 10 mm 10 mm PLT 16 RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control e2 3 Accepting or Rejecting QC Results The results from the control blood are compared to Assayed ranges stored on the Quality Control Smart card If any of the parameter results are Out of Range an H High or L Low will be shown on the display and on the printout as well If a third counting sequence is initiated during the analysis cycle and a specific parameter is in question a Dollar sign or a Star will be shown on the display next to the parameter and the run will Automatically be Rejected lf the HGB Blank is not within acceptable limits an Exclamation is displayed next to HGB and the run will Automatically be Rejected You MUST rerun the control blood if the display indicat
59. Background count which must be verified prior to any analysis of samples This is necessary to ensure that there are No extraneous interferences that may be detected as background noise which will affect the cell count See Section 5 Startup and Sample Run 1 Startup Checks 7 4 Instrument Startup for more information regarding Startup This Special functions sub menu will allow the operator to choose between an Automatic or a Manual Startup To enter into the Startup menu from the 3 SPECIAL Menu use the Down arrow key and select 3 STARTUP as indicated 1 Press the ENTER key to access this sub menu 2 Choose between 1 AUTO or 2 MANUAL for your instrument Startup choices as indicated The Asterisk indicates the current selection 1 AUTO will automatically run a Startup after the instrument warmup period once the ABX MICROS 60 has been powered ON 2 MANUAL will allow the operator to Manually press the STARTUP key to initiate the Instrument Stratup cycle after instrument warmup 12 3 Press the ENTER key to accept the change once you have made your selection MICROS 60 CS CT Note If the message STARTUP NOT INITIATED appears on the display after selecting the mode for startup press the Escape ESC key until you return to the Main Menu then press the STARTUP key to initiate the Startup cycle This will prevent the STARTU
60. EAN bottle and the white tube to the LYSE bottle Close the compartment cover MICROS 60 CS CT When the ABX MICROS 60 CT is A set up with the 16 or 18 parameters mode it is mandatory to use specific LYSE LMG and MINIDIL LMG reagents MICROS 60 CS CT Diag 9 9 Caution The Diluent container will be located on the bench at the same level than the Instrument 9 6 2 Waste connection Install the male connectors included in the installation kit at the liquid input and output located at the bottom of the instrument rear panel Diag 9 10 y A ally Connect the diluent container see CAUTION above using the diluent straw and a 3x6 cristal tube 1 meter maximum on the diluent input located at the bottom of the instrument rear panel Diag 9 10 Connect the waste N a container using the cristal tube 3 x 6 on the m waste output and place the waste container below the instrument level under the bench Diag 9 10 MICROS 60 CS CT your laboratory s protocole when neutralizing and disposing of waste Dispose of the waste container according to the local or national regulatory requirements Warning If required waste can be neutralized before being discarded Follow 18 Introduction 9 6 3 Reagent pack connection The Reagent Pack includes the entire set of reagents in a Pack and is able to receive the waste liquids Three soft pockets contain the 3 reagents MINIDIL LMG MINICLEAN and L
61. GAIN will occur if you don t enter the time correctly Make sure to use the decimal key between the hours and minutes when entering the time correctly 4 Press the ENTER key to accept the new time 4 2 Change the Date Format This sub menu will allow the operator to change to format of the date according the Country s specifications To enter into the Date format menu from the Date Time menu use the Down arrow key to select 2 DATE FMT as indicated on the display 1 Press the ENTER key to enter into this sub menu This sub menu has 4 different date formats as indicated Month Day Year MM DD YY Day Month Year DD MM YY Year Month Day YY MM DD Year Day Month YY DD MM 2 Use the Down arrow key to select the format which is specific for your applications as indicated 3 Press the ENTER key to accept that specific date format 4 3 Change Date This sub menu allows the operator to change the actual date once the correct format has been selected To enter into the Change Date Menu from the DATE TIME Menu use the Down arrow key and select 3 CHG DATE as indicated 1 Press the ENTER key to access this sub menu as indicated on page 16 RABO43EEN section 5 Instrument Configuration 15 Micros 60 O Change Date continued 2 Enter the first 2 numbers then press the Decimal key Enter the second
62. Introduction Micros 60 CS CT User Manual P N RABO43EEN CE m HORIBAABX oO Diagnostics 34184 MONTPELLIER Cedex 4 FRANCE Explore the future HORIBA GROUP Liste of modifications List of modifications from RABO42DA to RABO42EEN 4 All manual ABX Diagnostics replaced with HORIBA ABX 4 Section Introduction page 3 paragraph Notice of liability InN a manner inconsistent with our product labeling added at the end of paragraph 4 Section Introduction page 15 paragraph 9 3 Package content User manual part number RAB043D changed to RABO43EEN 4 Section 1 page 4 paragraph 1 5 Reagents ABX LYSE 0 4L replaced with ABX MINILYSE or ABX MINILYSE LMG 1L ABX LYSEBIO 0 4L or 1L added 4 Section 2 page 5 paragraph 2 3 CBC measurement principles HGB Principle of ABX LYSEBIO added 4 Section 3 page 14 paragraph 5 3 Morphology flags point 3 The SCH flag will cause a Platelet reject flag removed Micros 60 1 Revisions Index Technical Note Software rev Section Date Ba RAHAA V4 A 10 28 02 Bb RAH911AA V1 4 1 3 6 11 04 02 Cb ECR1354 V1 6 UL correction 1 01 09 03 Da RAH986A V1 6CEIVDNorms Intro 1 25 09 03 EEN RAN147A V1 6 HORIBA ABX All 09 03 05 e This Document applies to the most latest software version e When a Subsequent software changes the information in this document a new section and or sections will be released Introduction O
63. MAIN MENU select 4 SERVICE 2 Close the Tube Holder Door 3 Open the main door of the ABX MICROS 60 4 Now press the Escape ESC key to open the tube holder door 5 Remove the tube holder 6 Hold the Sample probe mounting bracket on the upper right edge and move the sample probe Downwards until you can see the top of the probe and sample tubing 7 Remove the tubing from the top of the sample probe 8 Place the Small paper cup just below the piercing needle where the tube holder was Directly below the sample probe 9 Connect a piece of tubing to the tip of the syringe and aspirate the the solution suggested from the required products on page 1 10 Place the free end of the syringe tubing on the top end of the sample probe and flush the probe Verify that the solution is flowing directly into the paper cup MICROS 60 CS CT Note If the Sample probe is free from blockage the solution stream will appear to be straight and pole like If a blockage is present the solution stream will appear to be flared and or at an angle Flush the probe until the stream is straight 11 Once the sample probe is free from blockage carefully remove the paper cup 12 Re connect the Sample tubing to the top of the probe so that it is air tight 13 Hold the Sample probe mounting bracket on the upper right edge and move the sample probe Upwards until the tip of the sample pro
64. MICROS 60 CT This model is a Closed Tube unit Without a Smart Card reader This unit has a Blood collection tube cap piercing mechanism which allows the operator place the tube directly into the analyzer for analysis without removing the cap e The ABX MICROS 60 CS This model is a Closed Tube unit With a Smart Card reader The Smart Card reader gives the operator the ability to record results and perform automated Quality Control This unit has a Blood collection tube cap piercing mechanism which allows the operator place the tube directly into the analyzer for analysis without removing the cap Note OT OS CT and CS are indicated in the instrument 13 Micros 60 9 Installation 9 1 Inspection A thorough inspection is carried out on the ABX MICROS 60 CT before sending it We nevertheless recommend checking the total system as soon as it is received to report any anomalies to the carrier The installation procedures must imperatively be followed in the order given below 9 2 Unpacking Diag 9 1 14 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 ABX MICROS 60 CT installation kit from its location see Diag 9 1 Two different installation kits are available according to the instrument type AABX MICROS 60 CT bottle installation ki
65. Maintain a copy of these results each month for Quality Control Analysis verification NORMAL LOT M211 TIME 07 31 EXP DATE 02 20 02 DATE 03 01 02 No DATE TIME OP WBC RBC MCH MCHC PLT 01 03 02 09 57 OP 2 7 4 l l i 29 7 37 5 279 01 04 02 08 23 OP 1 7 3 l l l 37 4 247 01 05 02 10 57 OR 3 7 3 i i 38 0 254 WBC RBC MCH MCHC PLT 7 4 4 52 i l 29 6 37 5 249 6 8 4 34 27 6 345 219 8 0 4 70 31 6 40 5 279 WBC RBC MCH MCHC PLT 7 4 4 54 l 29 4 37 5 252 0 13 0 06 0 43 0 53 11 22 1 70 1 37 1 46 1 40 4 45 RABO43EEN section 4 Calibration and Quality Control Micros 60 2 7 Q C Graphs Only with Q C Smart Card The ABX MICROS 60 plots Levey Jennings charts for each parameter of the Quality Control files stored on the Q C Smart card Each Levey Jennings chart will plot 1 data point per parameter per control run for every control data point stored Select Graphs 1 From the Q C Menu select 5 GRAPHS then press the ENTER key to enter into the Graphs sub menus as indicated on the display 2 Use the Down arrow key to select one of 3 levels to be printed out or select ALL to print out a 3 levels Selection will be indicated on the display 3 Once your selection has been made press the ENTER key to print out the Levey Jennings charts The display will state as indicated 4 The parameter charts are determined by the internal software setup of the ABX MICROS 60 See
66. Normal and High analyzed 1 time each When the card is full you must insert a New Card and press the ENTER key to accept the new card information Select Operator Once you have accepted the QC Smart card information the display will prompt you to select an Operator OP Use the Down arrow key to select one of 4 operators which can be previously programmed in the system set up menu See Section 5 Instrument Configuration 3 Special functions 3 7 Change Operator 4 Select one of the 4 operators and then press the ENTER key A star will be placed next to the chosen operator as indicated on the display 5 Once the operator has been select press the ENTER key and the menu will be displayed Select Commercial Control Level The next display to appear will ask you as to which level of commercial control you would like to analyze first the Display is as indicated 6 Use the Down arrow key to select 1 of 3 levels of commercial control to analyze Low Normal or High Once the selection has been made press the ENTER key to accept that level A message LOADING LEVEL PLEASE WAIT will be displayed for about one half of a second The information on the QC Smart card is read at this time After the information is read off of the card ABX MICROS 60 will ask if you want to run the level of commercial control selected as indicated on the display 7 Veri
67. P status 6 The PLT flags if any were reported 7 The 8 Parameter CBC results with Limit flags and units MICROS 60 CS CT 1 each calendar day The Number increases by increments of 1 each analysis cycle sequentially This Sequential number can not be modified by the Operator 1 Note The Sequence Number is updated to the number 8 RAB043EEN section 3 Startup and Sample Run Startup and Sample Run RESULTS DATE 01 20 2002 TIME 09 25 RUN 12345 SEQ 27 Pit Flags WBC 10 0 10 mm MCV 90 ums RBC 4 90 10 mm MCH 30 6 Pg HGB 15 0 g dl MCHC l 34 1 g dl HCT 43 9 PLT 287 10 mm On the Printout the information printed is as followed 1 The Date the sample was analyzed 2 The Time the sample was analyzed 3 The Sample RUN that was entered by the Operator 4 The Sequence number of the sample run 5 The PLT flags if any were reported 6 The 8 Parameter CBC results with Limit flags and units MICROS 60 CS CT Note The Sequence Number is reset to the number 1 each calendar day The Number increases by increments of 1 each analysis cycle sequentially This Sequential number can not be modified by the Operator RABO43EEN section 3 Startup and Sample Run Micros 60 4 2 ABX Micros 60 CS CT16 Displayed Results The first group of Parameter results are as displayed on the LCD screen once the analysis cycle is c
68. P NOT INITIATED message from appearing on the printout of any analysis cycle run prior to instrument Stratup 3 4 Autocleaning frequency This sub menu allows the operator to change the cycle frequency of the automatic cleaning cycle which occurs when the cycle number programmed has been reached The Default Cleaning cycle number is factory set to 50 analysis cycles The user has the option of changing this number from 1 to 99 999 This Automatic Cleaning cycle involves the use of the solution ABX Miniclean which is an enzymatic cleaner This solution breaks down protien buildup in the Counting Chambers and Apertures To enter into this sub menu from the 3 SPECIAL Menu use the Down arrow key and select 4 CLEAN FREQ as indicated 1 Press the ENTER key to enter into Clean Frequency Menu as indicated on the display RABO43EEN section 5 Instrument Configuration Instrument Configuration MICROS 60 CS CT Important It is Highly recommended to set this cycle number based on the number of analysis cycles run during each operating day All facilities are different as to the number of blood samples run each day If the operator Knows the number of samples to set the cleaning cycle by they may do so in the following procedures listed below If the operator has any questions regarding the autoclean frequency contact your local HORIBA ABX Technical Support Representative for suggestions a
69. PARK then press the ENTER key to place the syringe in the park position Piercing Sample Probe Depth This Service function allow the operator to check the Depth of the sample probe as it enters the tubes in the tube holder The tube holder has 4 different positions A sample tube may be placed in one particular position and the depth of the sample probe entering that tube can be checked From the Mechanic Menu select 9 PIERCING then press the ENTER key to access this function 1 Place a sample tube in the position that you would like to verify the depth of the sample probe 2 The display will instruct you to CLOSE THE TUBE HOLDER DOOR 3 Once the tube holder has been closed the sample probe will move down inside the sample tube The following menu is displayed e NEEDLE 5 the current position of the tube holder e CURRENT the current steps of the sample probe movement from the Up position to the Down position inside the sample tube e STANDARD the default number of steps for the position in the tube holder MICROS 60 CS CT Note If the sample probe needs adjusting in any position of the tube holder contact your local HORIBA ABX Technical Support Representative for assistance with this adjustment 1 4 Instrument Cycles This Service function allows the operatr to view the number of cycles the ABX MICROS 60 has run This Cycle Menu will contain 3 cycle
70. Platelet PRP samples and Whole Blood component concentrates MICROS 60 CS CT Important When analyzing Whole Blood component concentrates you mus consider the Linear Range of the component parameter and its associated parameters if any These concentrates may prematurely pollute the counting aperture when analyzing them It is suggested that you perform 3 Backflushes and or a Concentrated Cleaning after analyzing the concentrates The ABX MICROS 60 CT CS is available in 5 8 16 and 18 parameters These parameters are noted according to the system setup System Parameters and their specific meaning RBC Red Blood Cell count HCT i Hematocrit MCH Mean Copuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Cell distribution Width MPV Mean Platelet Volume LYM Lymphocyte number MON Monocyte number GRA E Granulocyte number PCT E Plateletcrit MICROS 60 CS CT Note PCT and PDW have not been established as indications for this product in the United States The use of PCT and PDW should be restricted to Research Use Only A The Rate of determination is approximately 55 samples per hour in the optimum configuration The system is totally automated including the cap piercing of the sample tube an internal dilution system and a Graphic printer for recording all test results including flags and graphics 11 Micros 60 7 Paramete
71. Press the ENTER key to start the calibration process A message will be displayed on the LCD as the ABX MICROS 60 performs a Prime cycle prior to aspirating the first sample RABO43EEN section 4 Calibration and Quality Control 4 Micros 60 O Calibration Procedures continued When the cycle is complete another message will appear stating as indicated 12 Select the tube holder position for the calibrator vial and rotate it to the 12 00 o clock position Now gently and thoroughly mix the Calibrator material as indicated on the Instruction sheet that comes with the calibrator MICROS 60 CS Warning Remove the Cap from the Calibrator vial before placing it into the tube holder Severe Sampling needle damage will occur if the cap remains on the vial 13 Place the calibrator into the tube holder and press the START key on the front panel to initiate the cycle of first sample The LCD display will indicate CLOSE THE TUBE HOLDER DOOR The cycle will begin and the sample will be aspirated During the cycle the tube holder door will open so the calibrator vial can be removed for the next sample MICROS 60 CS CT Important Wipe any excess blood from the Cap and Threads of the calibrator vial with a Lint free tissue to prevent any dried blood from re entering into the calibrator material Dried Blood re entering into the vial may give Error flags and reject the sample runs
72. R456 ABC123 RABO43EEN section 5 Instrument Configuration 19 Micros 60 7 5 Reprint One Result TR ONE This Memory card sub menu allows the operator to select one specific sample results from the card to be printed out That one sample results will be printed out according to the Results printout options from the RESULTS Menu such as PRINTOUT With Histograms Without Histograms Without RBC Histogram Only UNITS Standard Sl Inter 1 Inter 2 PRINT LIMITS Yes or No PRINT LMG s Yes or No 1 Place the Memory card in the reader 2 From the Memo Card Menu select 3 PRT LIST Wait until all the Sample Identification list is completely printed out 3 From the Memo Card Menu select 4 TR ONE and press the ENTER key The display will indicate 4 Selectthe Sample identification number from the list that you want the results printed from Note the MEMO number next to that ID number Enter the MEMO number next to the sample ID number and press the ENTER key That sample results will now print out 7 6 Reprint All Results TR ALL This Memory card sub menu will allow the operator to select all the results on the card to be printed out Verify that you have a sufficient quantity of paper in the printer for this function Each individual results will be printed out on a separate sheet of paper 20 MICROS 60 CS CT Note Line Mode Results All results printed
73. Section 1 Specifications 1 Technical Specifications 7 7 Parameters for the parameters that are printed out on the Levey Jennings charts MICROS 60 CS CT Note Printed results may vary on the amount of data displayed on the printout Limits LMG s Histograms and Parameters are all dependant upon the initial instrument setup See Section 5 Instrument Configuration 1 Results Options Printout Print Limits Print LMG s 22 RAB043EEN section 4 Calibration and Quality Control Calibration amp Quality Control Levey Jennings charts are printed out with the following information included File Name Blood Level Lot of the Control Expiration date of the control Date and Time of the print data request the Parameter Name and the Parameter graph with 40 total data points Below each graph the Reference Assay Mean Upper and Lower limits the Actual Mean results of the total control runs the 2 Standard Deviation value and the Percent Coefficient of Variation TIME 10 07 EXP DATE 02 20 02 DATE 01 20 02 5 10 15 20 25 30 35 40 REFERENCE 7 4 LOW 6 8 HIGH 8 0 7 4 28D 0 13 CV 1 70 5 10 15 20 25 30 35 40 REFERENCE MEAN 4 52 LOW 4 34 HIGH 4 70 ACTUAL MEAN 4 54 25D 0 06 CV 1 37 MICROS 60 CS CT Note Q C Graphs will be printed out even when the parameter results are equal to zero RABO43EEN section 4 Calibration and Quality Control 23 Micros 60 24 RABO43EEN section 4 Ca
74. Stainless steel parts Slightly wet a sponge with disinfectant product See 1 and wipe the dirty surfaces Dry with a soft cloth 1 Products having the following microbiological properties Bactericidal Fungicidal Active on Aspergillus fumigatus Active on Mycobacterium tuberculosis B K Antiviral VIH HBV and rotavirus Product Example validated by HORIBA ABX ANIOS detergent disinfectant WIP ANIOS ref 1316 424 e Concentrated cleaning MICROS 60 CS CT Please also refer to the W H O World Health Organization guidelines Laboratory Biosafety Manual 2nd edition for further information Counting chambers and hydraulics parts are decontaminated by using the Concentrated cleaning function as described in Section 6 Maintenance and troubleshooting page 5 e Sampling probe Sampling probe must be decontaminated as follows 1 Prepare a solution of Sodium Hypochlorite to 100mI I 2 Fill a 5ml tube with this solution 3 Run 5 analysis on bleach Introduction MICROS 60 CS CT y Please also refer to the W H O World Health Organization guidelines Laboratory Biosafety Manual 2nd edition for further information 3 Working Conditions 3 1 Environment The operation of the ABX MICROS 60 should be restricted to indoor location use only Operation of the instrument at altitudes of over 2000 Meters 6000 feet is not recommended The instrument is designed for safety from voltages surg
75. YC 2 MANUAL 4 CLEAN FREQ 6 BUZZER YES NO CE e 2 US 8 START MODE 2 TRANSMISSI 2 MANUAL 1 PRINTER 2 HOST COMP 2 DATE FORMAT L FORMAT ARGOS 4 REPRINT ONE 2 FORMAT R amp D 3 FORMATABX 6 PRINT FROM TO OST COI A TR OFF 2 BAUD RAT 1 BEGIN SSION 2 END L CHECKSUM Y N With Barcode Reader Only s 8600 3 REPRINT RESULTS Memo Card ON RABO43EEN section 5 Instrument Configuration Instrument Configuration The ABX MICROS 60 has several operator options in this section Specific Laboratory limits Date and Time formats Results format RS 232 options Special functions These options can be configured according to the operator s needs through the SETUP Menu functions O Access Setup Menu To access the Set up Menu from the Main Menu use the Down arrow key and select 5 SETUP then press the ENTER key Or select the number 5 key on the number pad MAIN MENU 5 SETUP 1 Results Options The 1 RESULTS Sub menu will allow the operator to access and edit some of the following sub menu functions such as Reprint the result of the last sample in the system Memory To select the Histograms to be printed out or not to be printed out on the results To select the Unit of Measurement type To select the type of printer To select the Temperature to be printed out or not to
76. YSE LMG 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 Remove the reagent output protections as well as the waste input protection Diag 9 11 Diag 9 11 Install the pack directly into the compartment of the instrument as shown on the Diag 9 12 Push the pack down in order to plug correctly the pack on the male connectors Diag 9 12 The free male connector see Diag 9 12 must be plugged on the pack upper valve in order to receive the waste liquids if m J m Diag 9 13 MICROS 60 CS CT A Warning If Seal Diag 9 13 is broken this Minipack should be treated as a biohazardous Waste 19 Micros 60 MICROS 60 CS CT Warning In order to avoid leak problems it is recommended not to unplug several times the same reagent pack MICROS 60 CS CT Note For instruments equipped with the reagent pack all the waste generated is collected during testing to facilitate compliance with the latest environmental regulations 9 7 Electrical connections The ABX MICROS 60 CT is 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 Diag 9 13 Two 1A fuses are located under the power plug The instrument can be operated at any other voltage from 100 to 240V or frequency fro
77. aced accordingly as to the number of cells and size of the cells in each group The distribution of the WBC sub populations are as followed The Lymphocytes are between 30 100fl The Monocytes are between 100 150fl The Granulocytes are between 150 gt 450fl This inturn creates the term LMG s for a 3 part WBC differential on the ABX MICROS 60 MICROS 60 CS CT Note e The Granulocytes sub population of the WBC s contains 3 sub populations within itself which are somewhat the same in nature They all contain Cytoplasmic granuler material which stain various colors when viewed microscopically These 3 sub populations are as followed e Neutrophils e Fosinophils e Basophils The distribution of these cells depends on the pathological and physiological conditions of the individuals analyzed MICROS 60 CS CT Note Pathological cells will of course place themselves in different zones within the WBC distribution curve Mobile and Fixed Alarm flags will alert the lab operator of the presence of these Pathological elements Results The Lymphocytes Monocytes and Granulocytes results are given as a precentage of the entire WBC count along with absolute numbers as well to reflect on the actual WBC count itself They are presented as followed LYM LYM MON MON GRA GRA RABO43EEN section 2 Description amp Technology Micros 60 Cells passing through the apertur
78. adjust for the workload of the Laboratory See Section 5 Instrument Configration 3 Special Functions 3 4 Autocleaning Frequency for editing the cycle number This Automatic cleaning cycle can also be activated manually by entering the SERVICE MENU From the Main Menu select 4 SERVICE use the Down arrow key to select 8 AUTO CLEAN then press the ENTER key to activate the cycle O In General the ABX MICROS 60 should be wiped down on a daily basis for dried blood deposits Use warm water and a drop of liquid soap on a damp cloth if necessary to clean the outside of the instrument MICROS 60 CS CT Warning Never use solvants or abrasive materials to clean the instrument Wipe off any trace of blood spillage as soon as possible Always disconnect the main electrical supply before cleaning the exterior of the analyzer Make sure that the instrument is completely dry before re connecting the electrical power RABO43EEN section 6 Maintenance and Troubleshooting Micros 60 1 2 Service Functions Several service functions are available for the operator to clean and check the instrument These functions are accessable from the Main Menu Use the Down arrow to select 4 SERVICE Press the ENTER key to access these sub menus as indicated on the display SERVICE gt 1 BACKFLUSH 12 20 2 DRAIN CHAMBERS Y O This service function will allow the operator to clean t
79. aining calibrator samples repeating Steps 13 through 16 for each sample Remember to Gently and thoroughly mix the calibrator material between each sample run Also Wipe the cap and threads of the vial between each run When the last sample result has been validated the ABX MICROS 60 calculates the statistical calibration factors for each parameter These statistical calculations include the Mean Target Coefficient of Variation Percent difference between the Target value and the Mean Pervious Calibration coefficients and the New Calibration Coefficients The Status will indicate on the printout if a parameter has Passed or Failed Calibration O 1 Once the calibration is complete and has Passed the Calibration criteria Press the Escape ESC ket until you have returned to the Main Menu 2 Run the remaining Calibrator material 3 times as a regular patient analysis Remember to gently and thoroughly mix the material between each sample run 3 When each cycle is complete record the results in Table 3 Verify Calibration on the Minocal Assay sheet 4 Once all results have been entered calculate the Total and Mean values for each parameter listed 5 Now compare the Mean value for each parameter to the Assay Mean values and ranges listed for the ABX MICROS 60 6 Verify that all the calculated parameters fall within the specific parameter Ranges on the Assay sheet 7 If all parameters are withi
80. al support e Possible electronic interference call HORIBA ABX Technical support e Check and or replace reagent s e Perform a Concentrated cleaning re run startup e Possible HGB Reference voltage is out of range call HORIBA ABX Technical support for assistance e For Pack units remove Waste line from pack push down on and hold in pack waste valve push on side of pack to force air out of waste badder Reconnect waste line e Check for obstruction or restriction of Waste line e Waste container must be vented e Possible defective motor call HORIBA ABX Technical support e Check for 3 syringe block moving smoothly call HORIBA ABX Technical support e Possible disconnected cable from main board remove unit cover check all connectors e Possible defective motor call HORIBA ABX Technical support e Possible restriction of movement from the chambers to home position check for restriction e Possible defective carriage sensor From main menu select 4 SERVICE 5 MECHANIS 1 SENSORS Move carriage to right from home position sensor should turn from O to 1 if good e Possible defective motor call HORIBA ABX Technical support e Possible restriction of movement from the Down position to Up home position check for restriction e Possible defective needle sensor From main menu select 4 SERVICE 5 MECHANIS 1 SENSORS Move needle down then Up to home position sensor should turn from O to 1 if good
81. al time for a Mean average of all the RBC pulse heights This is a function of the numeric integration of the MCV Results are given as a percentage of this integration O e MCV Mean Cell Volume is calculated directly from the entire RBC histogram e MCH Mean Cell Hemoglobin is calculated from the Hemoglobin value and the RBC count e Calculations are as followed HGB MCH pg x 10 RBG Results The MCH Results are given in Picograms pg e MCHC Mean Corpuscular Hemoglobin Concentration is calculated according to the Hemoglobin and Hematocrit values e Calculations are as followed HGB MCHC g dl x 100 HCT Results The MCHC Results are given in Grams per Deciliter g dl RABO43EEN section 2 Description amp Technology Micros 60 e The RDW Red cell Distribution Width is used to determine erythrocyte abnormalities linked to Anisocytosis The RDW will enable you to follow the evolution of the width of the RBC Histogram in relation to the number of cells and their average volume This is also a calculation of the RBC Histogram e Calculations are as followed K SD RDW MCV K Calibration Coefficient for RDW SD Standard Deviation according to statistical studies on cell distribution within the RBC Histogram MCV Mean Cell Volume of the erythrocytes The MPV Mean Platelet Volume is directly calculated from the Platelet Histogram distribution curve
82. alibration e Automatic Calibration procedure e Direct entering of Calibration Coefficients 1 7 Measurements and Computation e Impedance change for WBC RBC PLT e Spectrophotometry for HGB e Impedance change for LYM MON GRA e Computation from stored Data that was directly measured for MCV MCH MCHC RDW MPV LYM MON GRA 1 8 Outputs e Hard Copy printing e External output RS232 1 9 Display LCD Screen 2 Lines of 40 Characters Backlighted 1 10 Barcode Reader Options EAN 8 EAN 13 C 39 C 128 ITF 20f5 CODABAR STF and C 93 with or without Checksum RABO43EEN section 1 Specifications Specifications 2 Physical Specifications 2 1 Power Requirements e Power supply 100V 110V 10 220V 240V 10 50 60Hz e Power Consumption Maximum 150Vac 30 10 In use 110Vac 30 10 Stand by mode 35 Vac 30 10 2 2 Operating Temperature Humidity e 18 to 32 C or 65 to 90 F e Maximum relative Humidity 80 for temperatures up to 31 C or 88 F e Decreasing linearity to 50 relative Humidity at 40 C of 104 F e Avoid exposure to direct Sunlight e Avoid exposure to Air conditioning and or Heating ducts 2 3 Dimensions and Weight e Height Approximately 440mm 16 5 inches e Width Approximately 360mm 14 2 inches e Depth Approximately 330mm 12 6 inches e Weight Approximately 14Kgs 31 Ibs 2 4 Wastes e Automatic disposal e Waste handling a
83. alled a priming cycle will be automatically carried out and the following menu is displayed PRIME WAIT FOR 2 MIN3 S XK kk KK KEK KKK MICROS 60 CS CT Important Before analyzing samples visually inspect reagent lines and A pumps for air bubbles Repeat priming if air bubbles are still present Call the HORIBA ABX representative service department if priming does not eliminate air bubbles Introduction From the REAGENT PACK menu the function CBC LEFT displays the number of analysis cycles left to run with the same pack It is also possible to run a priming cycle at any time using the selection PRIME REAGENTS of the SERVICE menu A MICROS 60 CS CT Caution It is recommended not to remove the pack several times before the reagents are totally used in order to avoid leak problems 23 Micros 60 24 10 Manual Contents section 1 section 2 section 3 section 4 section 5 section 6 Specifications Description amp Technology Startup and Sample Run Calibration and Quality Control Instrument Configuration Maintenance amp Troubleshooting Specifications Contents 1 Technical Specifications V1 6 1 1 Parameters 1 2 Throughput Analysis 1 3 Memory Capacity Smart Cards 1 4 Statistics and Quality Control 1 6 Calibration 1 7 Measurements and Computation 1 8 Outputs 1 9 Display 1 10 Barcode Reader Options 2 Physical Specifications 2 1 Power Requireme
84. andling precautions Composition Potassium Cyanide cocoomooo lt 0 1 Quaternary Ammonium Salt lt 20 pH 10 0 5 T 20 C Resistivity 213 10 Q T 20 C Description aqueous solution limpid Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested The product can be absorbed through an open wound or inhalation Please refer to the MSDS associated with the reagent Special precautions Avoid contact with acid and aqueous acid en vironment extremely toxic cyanide acid vapour can be formed Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Specimen collec tion and Mixing in the instrument User Manual Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal Follow your laboratory s protocol when neu tralizing and disposing of waste Please refer to the MSDS associated with the reagent Latest version documents on www horiba abx com HORIBA GROUP ABX Minoclair O Exclusive use ABC Vet Minos Micros Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Hematology Devices for in vitro dagnostic use 15 01 05 A95A00029C 0401005 0 5L 0 5L CE easi HORIBA ABX BP 7290 34184 Montpellier cedex 4 France 1 Functions Cleaning and bleaching solution for HORIBA ABX
85. ansfused Blood This will be detected by the RBC Histogram showing 2 distinctive peaks on the distribution curve Specifications O Very Small Erythrocytes Microcytes Erythrocyte s fragments Schizocytes and WBC fragments may interfere with the proper counting of Platelets and cause elevated Platelet counts Agglutinated Red Blood cells May trap platelets causing an erroneously Low platelet count The presence of agglutinated RBC s may be detected by observing abnormal MCH and MCHC values and by careful exmination of a stained blood smear Giant Platelets in Excessive Numbers May Cause an erroneously low platelet count since these Large platelets may exceed the Upper Threshold limit for platelets and are not counted as platelets Chemotherapy Cytotoxic and Immunosuppressive drugs may increase the fragility of these cells which may cause Low platelet counts Reference Manual methods may be necessary to obtain an accurate platelet count Hemolysis Hemolyzed specimens contain Red blood cell Stroma which may cause elevated platelet counts A C D Blood Blood anti coagulated with Acid Citrate Dextrose may contain Platelet Aggregates which could give falsely low platelet counts RBC Inclusions Erythrocyte inclusions such as Howell Jolly bodies Heinz bodies Siderotic and Basophilic granules etc may produce considerably elevated platelet counts Platelet Agglutination Clumped Plate
86. ar Clorox Bleach solution Mix 3 parts Bleach to 1 part Deionized Water e Intervention Time e Approximately 30 minutes e Specific Kits or Consumable products e None Micros 60 1 From the Main Menu use the Down arrow key to select 4 SERVICE then press the ENTER key to access the service functions 2 Use the Down arrow key to select 1 BACKFLUSH then press the ENTER key to backflush the WBC and RBC counting apertures 3 Perform a Backflush cycle 2 more times 4 Use the Down arrow key to Select 2 DRAIN CHAMBERS then press the ENTER key to start the draining 4 Open the main door of the ABX MICROS 60 and locate the WBC and RBC chambers Some unit chamber shields are different Either one chamber has a Black shield around it This would be the WBC chamber or both chambers have a Black shield around them 5 Locate the opening on the top of the chamber shield s 6 Fill both chambers with 5ml of the MINOCLAIR or the 75 bleach solution which ever is available 7 Let the solution set for 10 minutes in the chambers 8 After 10 minutes run a Concentrated cleaning From SERVICE Menu select 4 CONCENTRATED CLEANING Press the ENTER key and follow the steps indicated on the LCD screen When the system asks you to fill the chambers with cleaner use the MINOCLAIR or 75 Bleach solution the cleaning cycle time may vary due to the version of softwa
87. ations A MICROS 60 CS CT The HORIBA ABX reagents specified for this instrument may have followed one or both of the approval methods below 1 have been registered by the A F S S A P S Agence Fran aise de S curit Sanitaire des Produits de Sante according to the procedure relative to laboratory reagents used for biological analyses 2 or approved in accordance with the European Directive 98 79 CE Annex III for in vitro medical devices Please refer to the packaging of each reagent concerned to establish the approval method Refer to Reagent Leaflets for all reagent specifications MICROS 60 CS CT Caution HORIBA ABX Maunfactures and Markets Reagents Calibrators and Quality Control bloods specially designed for use with the ABX MICROS 60 OS OT analyzers The use of products not recommended by HORIBA ABX may give erroneous results or instrument opreation problems Contact your local HORIBA ABxX center for all information regarding 5 1 General Recommendations Reagents used on the ABX MICROS 60 for Analysis Rinsing and Cleaning are described on the following pages The recommendations for Use Handling and Storage of these reagents must be followed to their fullest extent Regularly check the Expiration date of your reagents RABO43EEN section 1 Specifications Specifications Check with your Shipping company and verify that your reagent shipment has not encountered impor
88. automatically run a Startup cycle after the initialization phase is complete press the STARTUP key on the instrument front panel to initiate the cycle The ABX MICROS 60 will perform a Startup cycle which primes all the reagents checks the electronics and Mechanical movements Then the instrument will perform a Blank Cycle for a Background Count An analysis cycle based on Reagents without any Blood sample The instrument then prints out the Blank cycle results O Check and verify that the Background counts do not exceed the following parameter Limits WBC 0 3 10 mm RBC 0 02 10 mm HGB 0 0 g dl HCT O PLT 10 108 mm If the Background count is above any of the parameter limits the ABX MICROS 60 will automatically perform another STARTUP cycle f the Problem persists after 3 consecutive cycles a message will be printed out stating Startup Failed Check Reagents Refer to the Maintenance and Troubleshooting section in this Manual for identifying and resolving the problem in question MICROS 60 CS CT Note If the HGB Blank test is unacceptable during the first STARTUP Cycle 2 more Startup cycles will be performed If all 3 Starup cycles fail the HGB Blank test an error message will be printed out Stating Startup Failed HGB Reference Failed MICROS 60 CS CT Note If any analysis cycles are run prior to a Startup cycle a message will be displayed on the LCD and pr
89. be is inside the piercing needle 14 Press the STARTUP key to run a Startup and verify that the background results are within their limits 15 Re run the Quality Controls to verify correct results Manual Probe Cleaning 2 Replacing the Sample Probe O 1 From the MAIN MENU select 4 SERVICE 2 Close the Tube Holder Door 3 Open the main door of the ABX MICROS 60 4 Now press the Escape ESC key to open the tube holder door 5 Remove the tube holder 6 Hold the Sample probe mounting bracket on the upper right edge and move the sample probe Downwards until you can see the top of the probe and sample tubing 7 Remove the tubing from the top of the sample probe 8 Remove the sample probe Retaining Clip Pull the clip out horizontally towards the front of the analyzer 9 Hold the Sample probe mounting bracket on the upper right edge and move the sample Upwards until the top of the probe is just below the front panel 10 Very carefully pull the sample probe slightly out of its retaining slot 11 Now hold the sample probe around the retaining collar very carefully lift Up the probe so that it is free from the White needle guide MICROS 60 CS CT Caution The sample probe is fargile and may bend if not inserted into the needle guide correctly Be carefull when placing the probe Try to maintain a vertical position of the probe when inserting it
90. bles This procedure should be done whenever a new bottle of nG ent is installed From the MAIN MENU move the cursor to the function SERVICE and press ENTER The service menu is displayed SERVICE 1 BACK FLUSH HH MM 2 DRAIN CHAMBERS y Move the cursor to function PRIME REAGENTS and press ENTER The PRIME menu is displayed PRIME 1 ALL REAGENTS HH MM 2 DILUENT y Select either the function prime ALL REAGENTS or move the cursor next to the required reagent and press ENTER 21 Micros 60 22 ALL REAGENTS WAIT FOR2 MN3S kkkkkkkkkkkkkkkkkxk MICROS 60 CS CT 1 Important Before analyzing samples visually inspect reagent lines and pumps for air bubbles Repeat priming if air bubbles are still present Call the HORIBA ABX representative service department if priming does not eliminate air bubbles MICROS 60 CS CT Caution Never initiate two Lyse prime cycles back to back This causes A excessive foaming in the waste chamber Run a blank cycle between each Lyse prime cycle 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 y 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 CBC LEFT lt 150 gt y Once the new PACK is inst
91. bout specific applications 2 Enter the desired number of the analysis cycles to be run before cleaning as indicated 3 Press the ENTER key to accept the new number or press the Escape ESC key to save the previous number 3 5 Print Instrument Configuration Internal Setup in System Memory This sub menu allows the operator to print out the internal Instrument settings from all the menus which allow user intervention To enter into the Internal setting print menu from the 3 SPECIAL Menu use the Down arrow key to 5 PRINT CONFIG as indicated on the display 1 Press the ENTER key to print out the internal instrument stetup The LCD Display will indicate RABO43EEN section 5 Instrument Configuration The following information will be printed out as noted Date and Time of print request Laboratory Limits and Flag values Instrument Configuration heading Date and Time of print request Last operator to use Quality Control Latest Calibration Lot Number The most current Calibration Coefficients and last calibrator Target values The most current RDW calibration coeff Most current instrument software version Type of analyzer Open or Closed tube system Reagent Pack Yes or No Yes for Reagent pack No for separate Reagents Startup mode Number of parameters that the instrument reports Cycle alarm On or Off audible tone
92. bration and Quality Control 11 Micros 60 Print Coefficients From the Calibration Menu select 2 COEFFICIENTS 2 PRINT COEFF The current calibration coefficients will automatically printout as indicated COEFFICIENTS DATE 01 20 2002 TIME 14 26 WBC RBC HGB HCT PLI MPV CURRENT 0 97 0 88 1 13 1 08 0 95 0 92 RDW COEFF PDW COEFF MICROS 60 CS CT Note PCT and PDW are not available in the United States These parameters are Strictly used for research and investigational purposes Only Calibration Coefficient limits After any calibration has been performed on the ABX MICROS 60 Verify that all parameter calibration coefficients are within their specified ranges as indicated Parameters WBC RBC HGB HCT PLT MPV RDW PDW Coefficient limits Minimum 0 89 0 73 0 83 0 87 0 99 0 75 0 75 0 75 Target 1 09 0 89 1 11 1 08 1 20 0 94 1 00 1 00 Maximum 1 29 105 1 39 129 141 113 1 25 1 25 If any of the Calibration coefficients are out of their specified ranges after calibrating the ABX MICROS 60 contact your local HORIBA ABX Technical Support Representative 12 RAB043EEN section 4 Calibration and Quality Control Calibration amp Quality Control 2 Quality Control Program 2 1 Quality Control Options MICROS 60 CS CT Important It is highly recommended that you use the ABX MINOTROL Quality Control blood product when running Q C on the ABX MICROS 60 analyzer This product is specifically
93. 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 as shown in Diag 9 4 Check that the aspiration needle is not bent and make sure it is in its upper position Check the position of the chambers as shown in Diag 9 5 below 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 Diag 9 6 9 4 2 Connection check Diag 9 7 Diag 9 8 Introduction Unscrew slightly the 2 screws of the WBC HGB chamber protection cover Remove the cover and check that the chamber is fixed properly in its clips and the electrode block is attached firmly to the chamber Diag 9 6 Re install the WBC HGB chamber cover Check that the connectors on the printed circuit board are securely in place Diag 9 7 Re install the instrument cover Remove the fuse holder from its location on the rear panel pressing on the holder lock Diag 9 8 and check the fuse characteristics they should be 1 Amperes 250 Volts Slow Blow 17 Micros 60 9 6 REAGENT CONNECTIONS Two reagent packages are available Bottles and containers Reagent pack 9 6 1 Bottle connections Lyse and cleaning reagents are placed inside the reagent compartment as shown in the Diag 9 9 Install the reagent straws and the bottle stoppers Connect the blue tube to the MINICL
94. cated 6 Press the ENTER key to accept the starting MEMO number 7 Use the Down arrow key to 2 END and press the ENTER key to access this sub menu 8 Review the printed list and enter the ending MEMO number that you wish to end with as indicated 9 Press the ENTER key to accept the ending MEMO number 10 Use the Down arrow key to 3 SEND RESULT and press the ENTER key to send the specific group of results to the printer and or the host computer as indicated 11 The specific group of sample results will now print out individually on separate sheets of paper 7 8 Clear Card Erasing All Results from the Card This Memory card sub menu will allow the operator to delete all the Patient sample results from the card MICROS 60 CS CT Caution It is highly recommended to print out all the complete results from the card before performing this function The Clear card funtion deletes ALL results no partial clearing Once results have been cleared from the card they cannot be retrieved at any time To enter into the Clear Mard sub menu from the MEMO CARD Menu use the Down arrow key to select 7 CLEAR CARD as indicated 1 Place the Memory card in the reader 2 Press the ENTER key A message will appear on the display as indicated 3 Press the ENTER key to clear the card or press the Escape ESC key t
95. ccording to Local National regulations 2 5 Minimum Sample Volume e Minimum blood sample requirement 50ul e Analyzer sample volume 10ul 2 6 Dilution Ratios e WBC Approximately 1 250 e RBC PLT Approximately 1 15000 2 7 Counting Aperture Diameter e WBC 80um e RBC 50um 2 8 Hemoglobin Measurement e Performed in the WBC HGB Chamber e Light source LED Light Emiting Diode at Wavelength 550nm RABO43EEN section 1 Specifications Micros 60 3 Summary of Performance Data V1 6 3 1 Precision Reproducibility The Micros 60 was initially calibrated with Minocal Calibrator Lot N MCAL 325 Expiry Date 11 05 2002 Three levels of ABX Minotrol 16 control material Lot N M243 were run in duplicate twice daily for 20 days The results were used to quantify within run precision SD of the run means SD of the daily means and the Total Imprecision with the NCCLS EP 5 Guidelines M243 High 0 05 0 04 0 04 0 06 RBC M243 Normal 0 05 0 04 0 04 0 06 M243 Low 0 04 0 03 0 03 0 04 M243 High 0 52 079 0 96 1 17 HCT M243 Normal 0 56 0 51 0 74 0 91 M243 Low 0 26 0 26 0 32 0 42 M243 High 09 0 62 0 78 ileal RBC M243 Normal 1 02 0 88 0 8 1 24 M243 Low 1 46 1 07 Tas ie M243 High 1 06 1 62 1 96 2 99 HCT M243 Normal al 1 38 2 2 47 M243 Low 1 6 1 6 1 96 2 53 Source 510K submission K030799 Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guidelines NCCLS document EP 5 ISBN 1 56238 145 8
96. ccurate HCT value O The Red blood cell dilution contains all the formed elements in the blood Erythrocytes Leukocytes and Platelets During the counting of the RBC s Platelets are below the RBC size Minimum Threshold therefore they are not counted as RBC s 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 counting the WBC s during the RBC count is negligible High WBC s In rare cases where the WBC s are extremely high the RBC count may be corrected especially if the RBC count is extremely low in comparison to the high WBC count Agglutinated Red Blood cells May cause a falsely low RBC count Blood samples containing the agglutinated Red blood cells may be identified by observing abnormal MCH and MCHC values as well as examination of a stained blood smear Cold Agglutinins IgM Immunoglobulins which are elevated in Cold Agglutinins disease may lower RBC and PLT counts and Increase the MCV RABO43EEN section 1 Specifications 15 Micros 60 O Turbidity of the Blood sample Any number of physiologic and or theraputic factors may produce falsely elevated Hemoglobin results To obtain accurate HGB 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
97. crease in HCT and MCV with high Heparin concentrations gt 7 5UL capillary tube Specifications Trisodium Citrate Because the anti coagulant is liquid it includes a dilution estimated at 10 11 when filling 5ml tubes with whole blood This anti coagulant is used in Coagulation It is sometimes used in Hematology when an EDTA induced Pseudothrombocytopenia is suspected Acid Citrate Dextrose ACD and Citrate Phosphate Dextrose with Adenine CPDA The most commonly used anti coagulants for cell concentrates in particular Platelet concentrates is normally not used for cell counting There is no seriously known interference EDTA Amoung the EDTA salts EDTA K USA and Japan EDTA K USA and Europe and sometimes NA EDTA are used EDTA K and EDTA K are the most frequently used anti coagulants for Hematology testing Worldwide Mainly because they have been recommended by ICSH since 1993 The other EDTA salts are acceptable as well EDTA can include Pseudothrombocytopenia estimated frequency 1 800 through Platelet clumping Fluoride Was used before EDTA replaced it NO side affects as known so far Some sample collection tube Caps are more adaptable to Cap piercing sampling systems Obviously Plastic caps cannot be used Rubber caps can have a variation of materials that they are made from It is highly recommended to use the best quality of material in order to avoid any rubber particles
98. cted to Chemotherapy or some other form of treatment which affects the alarm zones These types of treatments will result in False alarms RABO43EEN section 3 Startup and Sample Run 15 Micros 60 16 A MICROS 60 CS CT Note All Morphology flags can be adjusted by the operator See Section 5 Instrument Configuration 2 Change Laboratory Limits 2 4 Flag Limits The Factory Default flag values programmed on the ABX MICROS 60 were set based on a study of Normal cell populations These Default values can be adjusted to accommodate specific Populations and or Geographical locations based on those specific studies It is highly recommended to calculate the percentage of flags in a specific population before making any adjustments RABO43EEN section 3 Startup and Sample Run Calibration amp Quality Control Contents 1 CALIBRATION PROGRAM 2 1 1 Calibration 2 1 2 Calibration passed 6 1 3 Calibration failed 7 1 4 RDW Calibration 9 1 5 Calibration coefficients 10 2 QUALITY CONTROL 13 2 1 Quality Control options 13 2 2 Q C Automatic 13 2 3 Accepting or Rejecting QC results 17 2 4 Q C Analysis 18 2 5 Q C Print Targets 19 2 6 Q C Statistics 20 2 7 Q C Graphs 22 RABO43EEN section 4 Calibration and Quality Control 2 Micros 60 1 Calibration Program The ABX MICROS 60 Calibration can be achieved in 2 different ways 1 Calibration is performed using a Calibrato
99. d card and press the ENTER key If the operator inserts the memory card in the wrong direction a message will appear on the display as indicated Remove the memory card place the chip in the Up position and forward to the point of insertion Insert the card and press the ENTER key RABO43EEN section 5 Instrument Configuration Instrument Configuration Running Samples continued If the operator inserts the memory card presses the ENTER key and a message appears on the display Remove the Full card insert a New memory card and press the ENTER key Or Print out all the results on the Full card clear the results from the card and re insert the memory card then press the ENTER key MICROS 60 CS CT Note The Memory card can store up to 60 results for the ABX MICROS 60 CS16 or CS18 When the card is Full it is highly suggested to print out All the stored results from the card before using a new card or clearing the full card This recommendation is suggested due to Lost Stolen or Damaged cards If all results have been printed a hard copy can be filed and viewed for future reference 7 3 Transmission of Results This sub menu allows the operator to select as to where they want the results from the memory card to be transmitted to Printer or External computer The Memo functions for both printer and external computer include Print list of sample
100. d cell counting and he moglobin determination on HORIBA ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance character istics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproduc ibility limits of detection limitations of the method and information about the use of available reference measurement pro cedures and materials by the user see Section Specifications in the instrument User Manual Conservation amp expiration Storage conditions stored at 18 C 65 F to 25 C 77 F Product will degrade if exposed to air keep cap probe assembly securely tightened Expiration date refer to expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Reagent Location and connec tion in the instrument User Manual This reagent is for professional in vitro diagnostic use only Measuring Principles see Section Technology in the instru ment User Manual Results see Section Results in the instrument User Manual Performance data see Section Specifications in the instrument User Manual FORM 0866 rev 1 a Modification from index A to B Company name change S A au Capital de 44 000 000 Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explo
101. d the Sample carriage 2 NEEDLE U D This allows the operator to check the Up and Down movement of the sample probe 3 CARRIAGE L R This allows the operator to check the Left to Right movement of the sample carriage 4 LIQUID SYRINGE This allows the operator to check syringe block that moves Sample Diluent and Lyse into the chambers 5 PRESSURE SYRINGE This allows the operator to check the Vacuum Waste syringe for complete movement up and down 6 VALVES This allows the operator to operate all valves on the analyzer in a sequencial order from 1 to 13 7 CHG CONTRAST This allows the operator to change the contrast of the LCD display 8 PARK This allows the operator to place the Vacuum Waste syringe in a position suitable for long term storage of the analyzer 9 PIERCING This allows the operator to view the sample probe depth on any position in the tube holder 1 To access the Check Sensors Menu place the cursor on 1 CHECK SENSORS and press the ENTER key The display will indicate e NEEDLE SENSOR 2 Open the main door of the ABX MICROS 60 and move the sample needle upwards by the top support bracket If the sensor is good it turns from 0 to 1 followed by 10 stars e CARRIAGE SENSOR 3 With the sample needle in the Up position move the sample carriage towards the right If the sensor is good it turns from O to 1 followed by 10 stars a
102. display the previous identification O Standard Mode lf the Standard Mode identification was selected from the set up menu Press the ID key on the front panel to enter the sample RUN The following menu will be displayed on the LCD as indicated The Run Number can be entered by using the Number keys Only Enter a run number from 1 to 99999 then press the ENTER key when finished to save the current Run or press the Escape ESC key to display the previous Run Once the Modes of Identification have been entered a message will appear on the LCD display stating CLOSE THE TUBE HOLDER DOOR if and only if Auto Start has been selected in the system set up menu If Auto Start has not been selected in the set up menu press the START key on the front panel of the ABX MICROS 60 to start the analysis cycle RABO43EEN section 3 Startup and Sample Run Startup and Sample Run 2 2 Sample Tube Holder Selection The Sample Tube Holder has 4 positions according to the sample tube characteristics The required position is selected when it is at the 12 00 o clock position inside the sampling compartment Turn the tube holder either Right or Left A Clicking sound will be heard once it is correctly placed The tube holder is associated with 3 switches located on the inside Right hand side of the Piercing Mechanism These switches detect the posit
103. e START key to start the analysis cycles 2 options are available in this sub menu 1 AUTO allows the operator to close the tube holder door to start an analysis cycle 2 MANUAL the operator has to Manually push the START key to initiate an analysis cycle once the tube holder door has been closed To enter into the Start Menu from the 3 SPECIAL Menu use the Down arrow key to 8 START MODE as indicated on the display 1 Press the ENTER key to access this sub menu 2 Use the Up or Down arrow keys to make your selection and then press the ENTER key to accept the choice 3 When all entries are complete press the Escape ESC key to exit the SPECIAL Menu RABO43EEN section 5 Instrument Configuration Instrument Configuration 4 Date and Time This SETUP sub menu will allow the operator to change Time Date format and Date on the instrument to accommodate different Time zones and Geographical locations when needed To access this sub menu from the SETUP menu use the Down arrow key and select 4 DATE TIME as indicated Press the ENTER key to access the Date and time sub menu as indicated 4 1 Change Time 1 Select 1 CHG TIME and the display will indicate 3 Enter the Hours set for 24 hr then press the Decimal key Now enter the Minutes MICROS 60 CS CT Important An Error message BAD TIME TRY A
104. e e Re calibrate and re run QC e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Perform a Concentrated cleaning re run Sample e Perform a Concentrated cleaning re run Sample e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Mix sample just before placing it into the tube holder for each sample 12 RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting e 2 4 Troubleshooting System Operations Problem Noted Possible Cause Corrective Action e No Display on LCD screen e Possible disconnection of e Call HORIBA ABX Technical cable to display support for instructions on ite a re connection of cable e Possible incorrect adjustment e Press DEL key and Period on LCD contrast key simultaneously re adjust contrast RABO43EEN section 6 Maintenance and Troubleshooting 13 Micros 2 5 troubleshooting Specific ERROR Messages e Startup Failed Check Reagents e Startup Failed Check reagents HGB Reference Fail e Pressure syringe motor error Pack Units e Pressure syringe motor error Separate reagent Units e Liquid syringe motor error e Carriage motor error e Needle motor error 14 e Check and or replace reagent s e Perform a Concentrated cleaning re run startup e Remove and flush out sample probe re run startup e Check 3 syringe block for leakage call HORIBA ABX Technic
105. e LYM count Limitations listed for the WBC count pertain to the LYM count as well 18 O The Lymphocyte percentage is determined according to the WBC count and the Number of Lymphocytes The presence of NRBC s certain Parasites and erythrocytes that are resistant to the Lysing action may interfere with an accurate LYM count Limitations listed for the WBC count pertain to the LYM count as well O The Mononuclear cell count is derived from the WBC count The percentage of Large Lymphocytes Atypical Lymphocytes Lymphoblasts and an excessive number of Basophils may interfer with an accurate Monocyte count O The Monocyte percentage is determined according to the WBC count and the number of Monocytes The presence of Large Lymphocytes Atypical Lymphocytes Lymphoblasts and an excessive number of Basophils may interfere with an accurate Monocyte count The Granulocyte cell count is derived from the WBC count The excessive presence of Eosinophils Metamyelocytes Myelocytes Promyelocytes Myeloblasts and Plasma cells may interfere with an accurate Granulocyte count O The Granulocyte percentage is determined according to the WBC count and the number of Granulocytes The excessive presence of Eosinophils Metamyelocytes Myelocytes Promyelocytes Myeloblasts and Plasma cells may interfere with an accurate Granulocyte count RABO43EEN section 1 Specifications 5 Reagent Specific
106. e closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Specimen collec tion and Mixing in the instrument User Manual Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal Follow your laboratory s protocol when neu tralizing and disposing of waste Please refer to the MSDS associated with the reagent Concentrated cleaning exclusive use Minoclair may also be used as disinfectant and cleaning product on HORIBA ABX Blood cell counters see Section Concentrated clean ing in the user manual on the following instruments ABC vet Micros 60 Micros CRP Pentra 60 Pentra 60C Pentra 80 Pentra XL80 Latest version documents on www horiba abx com HORIBA GROUP Description amp Technology Contents 1 DESCRIPTION 2 2 TECHNOLOGY 3 2 1 Sampling 3 2 2 Dilutions 3 2 3 CBC Measurement Principles 4 2 4 LMG Differential Measuring Principles 7 RAB043EEN section 2 Description amp Technology Micros 60 1 Description LCD Display Screen Key Pad Control Panel Smart Card Reader Optional Reagents Compartment BON O Micros Front view O jou A O N O Micros Left side view 1 Sample Probe and Carriage Assembly 2 Piercing Needle Assembly 3 WBC HGB Chamber 4 RBC Chamber 5 Cap piercing Mechanism and Tube Holder 6 Overflow Protection Tanks 7
107. e creating electronic pulses O Lymphoctyes Pulse Height Monocytes O Granulocytes Time Pulses are grouped according to the Number of cells and the Size of the cells Number of Cells Mco Cell Size Pulses are electronically calculated and smoothed to show the WBC Distribution curve Number of Cells Cell Size RABO43EEN section 2 Description 4 Technology Startup and Sample Run Contents 1 STARTUP CHECKS 2 1 1 Reagent Level checks for Bottle Units 2 1 2 Reagent Level checks for Pack units 2 1 3 Printer Power and on line checks 2 1 4 Instrument Startup 2 1 5 Blood sample collection Reference 3 1 6 Daily Quality Control and Calibration 3 verification notice 2 SAMPLE SELECTION AND IDENTIFICATION 4 2 1 Sample Identification modes 4 2 2 Sample Tube Holder selection 5 2 3 Analysis 5 3 RUNNING SAMPLES 5 3 1 Sample Identification 5 3 2 Automatic Cleaning cycle 6 3 3 End of the Day rinsing 6 4 RESULTS 6 4 1 ABX MICROS 60 CS CT8 6 4 2 ABX MICROS 60 CS CT16 10 4 3 ABX MICROS 60 CS CT18 13 5 FLAGS 13 5 1 Normal limits 13 5 2 Flags causing default analysis 13 5 3 Morphology flags 14 RAB043EEN section 3 Startup and Sample Run Micros 60 1 1 Reagent Level Checks Bottled Units Individual Reagents First thing prior to Startup is Checking the levels of each Reagent before operating the system If a reagent level is Low Replace the reagent and Prime the
108. ed that each Laboratory establish its own Normal ranges based upon the local population 10 RABO43EEN section 1 Specifications Specifications 3 7 Accuracy The Accuracy performance was proven by analyzing approximately 200 patient specimens on the ABX MICROS 60 along with a commercially available Reference Analyzer located in 3 different locations throughout the United States The following table summarizes the data Site 1 Site 2 Site 3 Parameters n R n R n R RBC 10 mm 198 0 995 212 0 995 204 0 990 HCT 198 0 980 212 0 994 204 0 982 MCH pg 188 0 969 212 0 962 204 0 962 RDW 198 0 950 212 0 944 204 0 895 MPV um 191 0 639 204 0 709 203 0 863 Monocytes 98 0 552 104 0 787 119 0 461 Reference Analyzers Baker System 9000 Coulter S Plus IV Coulter JT n Number of specimens analyzed R Correlation coefficient from the regression curve Reference ABX MICROS 60 As mentioned above this clinical study was performed at 3 different sites throughout the United States 3 8 Leucocytes Differential count Not available at the time of publication 3 9 Sample stability study Not available at the time of publication RAB043EEN section 1 Specifications 1 mk Micros 60 4 Limitations MICROS 60 CS CT WARNING Potential Biohazard Consider all Specimens Reagents Calibrators Controls etc that contain Human blood or serum as potentially infectious Use established good labo
109. emember the ABX MICROS 60 will only hold the last sample analyzed in the Internal memory The Memory Card option will allow the operator to perform the following tasks from the memory card It will allow the operator to turn the memory card function On or Off Print a list of all the sample Identifications that have been stored on the card Select one sample result to Print Select all sample results to Print To select from a specific number of samples to be printed The ability to erase all the samples stored and re use the card if necessary RABO43EEN section 5 Instrument Configuration 17 Micros 60 Memory Card continued To transmit your results from the memory card to a printer or to a host computer To enter into the Memo Card Menu from the SETUP Menu use the Down arrow key to 7 MEMO CARD as indicated 1 Press the ENTER key to access this sub menu as indicated 7 1 Memo On Off 2 Select the first option 1 MEMO This will allow you to 1 MEMO ON will allow you to use the Memory card 2 MEMO OFF if you do not want to use a memory card for sample results storage MICROS 60 CS CT Note If you choose 1 MEMO ON and are not using the memory card a message NO SMART CARD will appear on the display when you start a sample analysis cycle You must use a memory card when analyzing samples If you don not want to use a memory card
110. erator See Section 5 Instrument Configuration 2 Change Laboratory Limits 2 7 Result Low limits MICROS 60 CS CT Important Results exceeding the H and L limits should be re analyzed and questioned as to the pathological condition of the patient or the operation of the instrument Startup and Sample Run 5 2 Flags causing Default Analysis These flags are shown in different ways as indicated e Results Defaulted to 0 0 e Results associated with an Asterisk Dollar sign or Exclamation mark for HGB e Results exceeding the Linear range of the analyzer see tables below O Results displayed PARAM LINEARITY VISIBLE gt VISIBLE LIMITS RANGE RANGE WBC x10 mm result result D DIL RBC x10 mm result result D DIL PLT x103 mm HGB gt 29 dL result result D DIL HGB lt 2g dL result result D DIL HGB g dL result result D DIL HCT result result D DIL Result printout and transmitted PARAM LINEARITY VISIBLE gt VISIBLE LIMITS RANGE RANGE WBC x10 mm result result D Dor 0 RBC x10 mm result result D Dor 0 PLT x103 mm HGB gt 29 dL result result D Dor se HGB lt 2g dL result result D Dor 0 HGB g dL result result D Dor 0 HCT result result
111. es If the results are good and the Error flags for HGB do not appear on the display press the Escape ESC key and the following menu will be displayed as indicated The operator now has the option of accepting or rejecting the results Accepting Q C Results Verify that there are No H or L flags on the display or printout before accepting your results If the operator Accepts the results by pressing the ENTER key they will be stored on the QC Smart card and the display will return to SELECT LEVEL as indicated Use the Up or Down arrow keys to select the next control level for analysis 13 Once the next level has been selected Press the ENTER key to load that control level 14 Gently and thoroughly mix the next control level blood Repeat Steps 10 through 12 15 After accepting the second control level results the ABX MICROS 60 automatically loads the last control level without returning to the SELECT LEVEL display 16 Gently and thoroughly mix the next control level blood Repeat Steps 10 through 12 17 Once the last control level has been accepted the display will indicate 18 Press the ENTER key and all levels of control results will be stored on the QC Smart card as indicated on the display 19 Press the Escape ESC key to exit the Q C Menu and retrn to the Main Menu Rejecting Results MICROS 60
112. es according to INSTALLATION CATEGORY ll and POLLUTION DEGREE 2 IEC EN 61010 1 Please contact your local HORIBA ABX representative for information regarding operation locations when it does not comply with the recommended specifications 3 2 Location The ABX MICROS 60 should be placed on a clean and level table or workbench Please note that the ABX MICROS 60 printer and reagent weights are approximately 30 kilograms 66 Ibs Avoid exposure to sunlight Proper ventilation requires adequate space behind the instrument At least 20 cm 8 inches must be maintained behind the instrument Place your instrument where it is not exposed to water or vapor Place your instrument where it is free from vibration or shock Place your instrument where an independent power receptacle can be used Use a receptacle different from the one used by a device that easily generate noise such as a centrifuge etc Provide a space of at least 20 cm 8 inches at the back of the instrument for arranging the power cable and tubings The Power switch and Input voltage supply connection should always be accessible When positioning the system for operational use leave the required amount of space for easy accessibility to these items Micros 60 3 3 Grounding Proper grounding is required when connecting the ABX MICROS 60 to an electrical power outlet Have the facilities electrician check that the earth ground connection is correct and sol
113. extremely elevated WBC will cause excessive light scatter from the L E D In these cases use Reference Manual methods The Diluted sample should be Centrifuged and the Supernatant fluid measured with a Spectrophotometer 2 Elevated Lipids Elevated Lipids in the blood will give the plasma a milky appearance This condition can occur with Hyperlipidemia Hyperproteinemia as in gammapathies and Hyperbilirubinemia Accurate Hemoglobin measurement can be achieved by using reference Manual methods and a plasma blank Increase in Turbidity may also be seen in cases where the Red blood cells are resistant to the Lysing action This condition will cause a falsely elevated HGB result but may be detected by observing the abnormal MCH and MCHC values and the increased baseline on the Left leading edge of the WBC Histogram Erroneous HGB 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 Hemoglobin value 16 O Red Blood cell Agglutination May produce an erroneous MCV value Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values as well as examination of a stained blood smear 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
114. fy that the lot number on the screen matches the lot on the Commercial control blood Run Commercial Control Blood 8 Once the Control blood has equilibrated to room temperature Gently and thoroughly mix the level of control blood indicated on the display Follow the product instructions that come with the Minotrol control kit for proper mixing 9 Select the tube holder position for control material and rotate it to the 12 00 o clock position inside the tube holder compartment 10 Press the START key on the front panel to start the cycle A brief prime cycle will occur if the ABX MICROS 60 has not been used in the last 15 minutes When this brief cycle is complete the display will indicate MICROS 60 CS CT Warning Remove the Cap from the Quality Control vial before placing it into the Sample tube holder Severe Sampling needle damage will occur if the cap remains on the vial 11 Once the cap has been removed Place the vial into the tube holder and close the tube holder door The control analysis cycle will begin RABO43EEN section 4 Calibration and Quality Control Micros 60 Run Commercial Control Blood continued When the control analysis cycle is complete the results are displayed as indicated 12 To view the remaining results on the display use the Up and Down arrow keys to scroll through the results The control results are printed out as indicated D
115. g the decimal point in the correct order Once you have entered the correct number press the ENTER key to accept the New value The display will return to the Flag Limits menu as indicated 10 4 Use the Up or Down arrow keys to select the next Flag Limit to be edited 5 Repeat Steps 2 through 4 to edit the remaining Flag Limits if necessary 6 Once you have edited the necessary Flag Limits press the Escape ESC key to exit back to the Chg Lab Limits Menu as indicated on the Display 3 Special Functions The 3 SPECIAL sub menu will allow the operator to access and edit some of the following sub menu functions such as Changing 4 Operator identifications Changing the User Password if necessary Choosing the STARTUP Modes Changing the cycle number for the cleaning frequency Printing the Internal Instrument Setup Turning the audible cycle signal ON or OFF Choosing the Identification mode Choosing the START analysis mode To enter into the Special Functions Menu from the 5 SETUP Menu use the Down arrow key to select 3 SPECIAL as indicated 1 Press the ENTER key to access the Special Functions Menu The display will ask for a Password to be entered as indicated 2 Enter the system Default password lt 123 gt then press the ENTER key The password will not be visible to the operator as it is being entered RABO4
116. grammed to print out the limits These limits Are not Quality Control limits These limits are the ones that were established in the set up menu See Section 5 Instrument Configuration 2 Change Laboratory Limits 2 1 2 2 Result Low Limits and Result High Limits Verify your control results with the Assay sheet that comes with the control material Verify that each Control level parameter is within its assayed limits 2 5 Q C Print Tagrets Only with Q C Smart Card This Q C sub menu allows you to print out the Assay ranges of all 8 levels of commercial control blood from the Q C Smart Card 1 Insert the Q C Smart Card into the reader with a firm push until it clicks into place 2 From the Q C Menu select 3 PAT TARGETS The display on the ABX MICROS 60 will show the Lot identification and Expiration date of the control blood product as indicated 3 Press the ENTER key and the analyzer will load the information from the Q C Smart Card and print out all 3 level assay ranges A message will appear on the display as indicated 4 The printout will show Low limit and High limit for each parameter for each assayed level of control HIGH NORMAL and LOW RABO43EEN section 4 Calibration and Quality Control Micros 60 2 6 Q C Statistics Only with Q C Smart Card This Q C sub menu allows the operator to print out all the stored cumulative data for all 3 levels
117. hart as indicated Parameters Units Standard SI International 1 International 2 Country U S Eur Eur R Lab Not in U S RBC 10 mm 1012 L 10 mm Oe HCT I L I L MCV um fl fl fl MCHC g dl mmol L g dl g L LYM MON GRA R Lab Research Laboratories RABO43EEN section 5 Instrument Configuration Instrument Configuration 1 4 Printer Selection This sub menu allows the operator to select the type of printer to be used along with the ABX MICROS 60 There are 4 basic different model types of printers that are specifically designed to operate with the ABX MICROS 60 analyzer To enter into the Printer sub menu from the Results Menu use the Down arrow key and select 4 PRINTER press the ENTER key to enter into this sub menu as indicated on the display 1 Use the Down arrow to select the printer type and press the ENTER key to accept that selection The Printer types are as listed 1 RESERVED 1 for Epson LX series printers 2 RESERVED 2 for Star printers 3 RESERVED 3 for Seiko Thermal printers 4 STANDARD for Citizen Dot Matrix printers 5 NONE for Use with External Computers MICROS 60 CS CT Note The 5 NONE printer selection is used for an External Computer that is specifically use as an Extended Package or and L I S Q C connection This selection is also used if a printer is not go
118. he lt ENTER gt key to accept the entry 3 Mix the sample gently and thoroughly before placing it into the tube holder 4 Place the sample into the tube holder close ther tube holder door The analysis cycle will start automatically if and only if Auto Start was selected in the instrument configuration If not press the lt START gt key to start the analysis cycle 5 The LED on the front panel will turn Green when the cycle is complete 6 Results will automatically print out 7 If any sample has Flags D Refer to Section 3 Startup and Sample Run 5 Flags 8 If the sample has flags repeat the sample 9 If the repeated sample still has flags perform a Concentrated Cleaning and re run the sample 10 If the repeated sample still has flags call your local HORIBA ABX Technical Support Representative 4 5 Calibration 1 For MINOCAL Follow the Calibrator Package insert for mixing and Handling instructions 2 Refer to Section 4 Calibration and Quality Control 1 1 Calibration 3 From the Main Menu select lt 3 gt CALIBRATION then lt 1 gt AUTOCALIBRATION 4 Press the ESC Escape key and follow the information given on the LCD display 5 The display will indicate Run Cal press the lt ENTER gt key 6 The display will indicate Start Calibration run X X press the lt ENTER gt key 7 Mix the Calibrator REMOVE CAP place it into the tube ho
119. he counting chamber apertures in case of blockage From the Service Menu select 7 BACKFLUSH then press the ENTER key to start the process This cycle takes approximately 20 seconds to complete e Open the instrument door and verify that liquid is being pulled through the apertures watch for few micro bubbles in the count tubing coming from the count head e When the backflushing starts verify that liquid is being pushed back through the apertures watch for few micro bubbles coming into the chambers through the count head e f you cannot see any micro bubbles moving through tubing or in the chambers the aperture may still be blocked In this case perform a Concentrated Cleaning This service function will allow the operator to check for proper chamber draining and to maintain some of the parts of the hydralic manifold as it flushes waste out of the instrument e This cycle takes approximately 7 seconds to complete From the Service Menu select 2 DRAIN CHAMBERS then press the ENTER key to darin the chambers e Verify the proper draining of the waste through the waste tubing located on the back of the instrument if it is not flushing waste sufficently check the waste tubing connection and verify that there is no blockage or crimping of the tubing e Verify that both the WBC and RBC chamber are draining properly not slow but fairly rapid If not view the troubleshooting section O Th
120. id A dedicated outlet is the best connection possible for reduction of electronic interference If there is No ground then use a ground Stake Current electrical safety standards must be applied when using the ground stake 3 4 Humidity and Temperature Conditions e The ABX MICROS 60 must operate between temperature of 18 to 32 C 65 to 90 P Maximum relative humidity should be 80 for temperature up to 31 C 88 F decreasing linearity to 50 relative humidity at 40 C 104 F If it is 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 3 5 Electromagnetic Environment Check e The ABX MICROS 60 has been designed to produce less than the required level of electromagnetic interference in order to operate in conformity with its destinstion The electromagnetic interferences caused by the ABX MICROS 60 are limited to a level allowing the correct operation of other instruments in conformity with their destination e In case of instrument problems check that the instrument is not placed in proximity of electromagnetic fields or short wave emissions radars X rays Scanners Cell phones etc 3 6 Environmental Protection Disposal Used accessories and consumables Must be collected by a laboratory specialized in elimination and recycling of this kind of material according to the local legislation Disposal Micros 60 instrument It sho
121. important part when sizing the WBC sub populations in the WBC distribution curve RABO43EEN section 2 Description amp Technology Description amp Technology 2 4 Differential Measuring principles Diluent and Lysing action The Diluent preserves and prepares the WBC cell membrane for the differential reaction The Lysing reagent has a differential mode of action on the WBC cytoplasmic membranes When the Lyse reacts with the Lymphocyte cytoplasmic membrane it allows the release of water soluble cytoplasm and shrinks the membrane around the nucleous When the Lyse reagent reacts with the Monocyte cytoplasmic membrane it has an intermediate reaction which keeps the cell somewhat stable maintaining its large size in comparison to the lymphocytes When the Lyse reagent reacts with the Granulocytes it has a limited reaction due to a molecule in their cytoplasmic structure which protects them from shrinking action of the lyse This inturn makes the Granulocytes the larger of the WBC sub populations in the cell differentiation After the Differential lysing action the ABX MICROS 60 analyses the height of each electronic pulse as the WBC s pass through the Micro aperture The pulses are then Channeled Thresholded grouped according to their size from 30fl gt 450fl and calculated Mathematically to create the WBC distribution curve which inturn is known as the WBC Histogram The 3 sub populations of WBC s are pl
122. ing used matches the Instrument Type Micros 60 the Lot and Expiration date of the Quality Control material being used for this program Y C Cmart Carrel AAaccaann Q C Smart Card Messages NEW QC means that this card is being used for the very first time XX QC RUN When the card already has Q C data on it the display will show the next sample run for Quality control i e 18 QC RUN inplace of New QC This number indicates the next Q C run after the stored runs For example 1 complete QC RUN contains all 3 levels of controls Low Normal and High analyzed 1 time each QC DIFF means that there is a difference between the QC index in the ABX MICROS 60 and the QC index on the QC Smart card This usually occurs when there is confusion between 2 QC Smart cards If the operator presses the ENTER key the analyzer accepts the differences and automatically equals the indexes between the ABX MICROS 60 and QC Smart Card If the operator presses the Escape ESC key the analyzer requests a New Card reads the New card information and displays it RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control SMART CARD FULL means that the QC Smart Card has reached its limit on stored QC data and cannot store anymore on that specific card A Maximum of 83 QC runs can be stored on QC Smart Card 1 complete C RUN contains all 3 levels of controls Low
123. ing to be used in conjunction with the ABX MICROS 60 analyzer 2 Once the Printer type has been selected verify that a result will print from your selection 3 From the Set up Menu select 1 RESULTS 1 REPRINT RESULTS Now verify that the last result ran will transmit to the printer and printout from the printer selection previously made 1 5 Temperature Printout This sub menu allows the operator to have visual confirmation of the Diluent Temperature displayed on the results printout MICROS 60 CS CT Important he operating temperature of the Diluent during analysis must remain between the specified limits 18 C 32 C or 65 F to 85F Results obtained in temperatures outside these limits are questionable and may not be valid To enter into the Print Temp sub menu from the Results Menu use the Down arrow key and select 5 PRINT TEMP Y N then press the ENTER key The display will show as indicated 1 Use the Up or Down arrow keys to select 1 YES Print with Temperature 2 NO Print without Temperature then press the ENTER key to accept the change as indicated on the display The asterisk indicates the current state 1 6 Print Limits This sub menu allows the operator to have the option of printing out the Laboratory Limits with the results printout To enter into the Print Limits sub menu from the Results Menu use the Down arrow key
124. inted out stating STARTUP NOT INITIATED When the ABX MICROS 60 has not been used within 4 hours of the last cycle it is necessary to perform a STARTUP cycle before running an analysis cycle 1 5 Blood Sample Collection Refer to Section 1 Specifications 4 2 Blood Specimens Sample collection and mixing for collection requirements Blood samples must be Gently and Thoroughly mixed with a rocking or tilting motion just before placing the sample into the Tube Holder for the analysis cycle 1 6 Daily Quality Control and Calibration Verification note Before analyzing any patient blood samples it is recommended that the Operator performs Quality Control analysis on 8 levels of Control Blood Material Low Normal and High to verify that the ABX MICROS 60 is performing within the specified ranges of the Quality control material RABO43EEN section 3 Startup and Sample Run Micros 60 2 Sample Selection and Identification 2 1 Sample Identification Modes US Mode MICROS 60 CS CT Note The Sample Identification Modes are selected from the Set up Menu in the system configuration Refer to Section 5 Instrument Configuration 3 Special Functions 3 7 Sample Identification Modes for selecting the Mode for your daily operations This Mode requires a patient Identification on each analysis run This Mode also allows the use of a Barcode Reader if Applicable US Mode Identification Wi
125. ion of the tube holder A different configuration of Notches on the side of the tube holder give the switches the ability to detect the position desired The 4 positions can be used for the following Sample tubes with the standard tube holder Position 2 Micro sample collection device Up to 0 5ml Position 4 Mini Vacutainers at 3ml Position 5 Vacutainers at 5ml Position 6 ABX Control Calibrator and Latex Vials ONLY at 2ml 2 3 Analysis e Select the position of the tube holder e Mix the sample Gently and Thoroughly e Place the sample in that position of the tube holder e Close the Tube Holder door e The analysis cycle will begin if and only if Auto Start was selected in the set up menu e Press the START key if and only if Manual Start was select in the set up menu The Analysis cycle will take approximately 60 seconds At the end of the cycle the result prints out the LED on the front panel turns from Red to Green and the ABX MICROS 60 is ready for the next analysis MICROS 60 CS CT Note If the instrument has not been in operation for 1 2 hour and an analysis cycle is initiated the ABX MICROS 60 will start a HGB Reference cycle The message PLEASE WAIT will be displayed on the LCD screen Once the HGB reference cycle is complete the message CLOSE TUBE HOLDER DOOR will appear If any results are out of their acceptable ranges Control
126. is service function will allow the operator to prime reagents either individually or all at once depending on the type of system you have Separate Reagents or Minipak e From the Service Menu select 3 PRIME REAGENTS There are 2 types of ABX MICROS 60 systems 1 BOTTLE SYSTEM Separate reagents The prime reagents sub menu will indicate 1 ALL REAGENTS 2 DILUENT 3 LYSE 4 CLEANER e Press the ENTER key to access this sub menu for bottled units Select the reagent or reagents to be primed then press the ENTER key to start the prime cycle 2 PACK SYSTEM ABX Minipak all reagents contained in 1 pack Diluent Lyse and Cleaner The Prime reagents sub menu will indicate 1 CHANGE PACK 2 CAPACITY 3 PRIME PACK e Press the ENTER key to access this sub menu Select either Changing the Pack if the present pack is low or Priming the current pack if the cycles are sufficient Step by Step instructions will be given on the display when installing a Minipak RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting Prime Reagents continued MICROS 60 CS CT Note When priming reagents or pack verify that Reagent is being primed View the Chambers for reagent priming Verfiy that reagent is coming in and draining out of the chambers when a cycle is initiated Verify that there are No Air Bubbles in the reagent lines when priming
127. ity of the instrument All peripheral devices should be IEC compatible 2 1 Limited garantee The duration of guarantee is stipulated in the Sales conditions associated with the purchase of this instrument To validate the guarantee ensure the following is adhered to 1 The system is operated under the instructions of this manual 2 Only software or hardware specified by HORIBA ABx is installed on the instrument This software must be the original copyrighted version 3 Services and repairs are provided by an HORIBA ABX authorized technician using only HORIBA ABX approved spare parts 4 The electrical supply of the laboratory follows the national regulations 5 Specimens are collected and stored in normal conditions 6 Reagents used are those specified in this user manual 7 Proper tools are used when maintenance or troubleshooting operations are performed Introduction MICROS 60 CS CT or an authorised representative HORIBA ABX cannot guarantee this product in terms of specification latest revision and latest documentation Further information may be obtained from your authorised representative If this instrument has been supplied to you by anyone other than HORIBA ABX 2 2 Safety precautions The following parts must not be handled or checked by the user Electrical power supply bottom of the instrument Electronic components Operator injury may occur from an electric shock Electronic components
128. laboratory s protocol when neu tralizing and disposing of waste Please refer to the MSDS associated with the reagent S A au capital de 44 000 000 Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B latest version documents on www horiba abx com ABX Miniclean O Exclusive use Micros Micros CRP Hematology Devices for in vitro dagnostic use 15 01 05 A95A00031C 0403010 1L a CE easi HORIBA ABX BP 7290 34184 Montpellier cedex 4 France 1 Functions Enzymatic solution with proteolytic action for the cleaning of HORIBA ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance character istics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproduc ibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual Conservation amp Expiration Storage conditions Stored at 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label Measurements principles amp results Directions for use see Section Reagent Location and connec tion in the instrument User Manual
129. lder and close the tube holder door 8 The calibration cycle will automatically begin if and only if Auto Start was selected in the instrument configuration If not press the lt START gt key RABO43EEN section 6 Maintenance and Troubleshooting Micros 60 O 9 Run the calibrator to the number of replicates select in Step 4 Results automatically print when last sample has been completed 10 Check for New or Rejected coefficients If New and PASSED continue with Quality Control If Rejected and FAILED perform a Concentrated Cleaning and re run Calibration 11 If Calibration is rejected a second time call your local HORIBA ABX Technical Support Representative 4 6 Quality Control With QC Smart Card 1 For MINOTROL Follow the Control Package insert for mixing and Handling instructions 2 Place the Quality Control Smart Card in the reader if applicable If not Refer to Section 4 Calibration and Quality Control 2 4 Q C Analysis 3 From the Main Menu select lt 2 gt QC then lt 1 gt AUTOMATIC if reader is present 4 Confirm the OP Lot Exp date and Level of Control 5 Mix the Control level selected REMOVE CAP place it into the tube holder and close the tube holder door 6 The Quality control cycle will automatically begin if and only if Auto Start was selected in the instrument configuration If not press the lt START gt key 7 The results
130. less population and or geographical location studies are known MICROS 60 CS CT Important Numerous factors can contribute to constant Morphology flagging If you are experiencing constant flagging see Section 8 Maintenance and Troubleshooting Morphology flags Also see Section 1 Specifications 4 Limitations 4 3 Known Interfering substances PLT This CHG LAB LIMITS sub menu allows the operator to adjust the Morphology flag percentages to the specific needs of the pupulation and or geographical location All the Morphology flag percentages can be adjusted from 0 01 to 25 00 If you Lower the present Default percentages of the flags you will make the flagging criteria More Sensitive and may increase your flagging alarms on sample analysis If you Raise the present Default percentages of the flags you will make the flagging criteria Less Sensitive and may decrease your flagging alarms on sample analysis Platelet Flags Factory Default adjustment values are as indicated SCL 8 00 SCH 8 00 MIC 8 00 To enter into the Flag Limits menu from the Chg Lab Limits menu use the Down arrow key to 4 FLAG LIMITS 1 Press the ENTER key to enter into this sub menu as indicated on the display 2 Use the Down arrow key to select the Morphology flag that you would like to edit 3 Once your selection has been made press the ENTER key
131. lets due to poor collection techniques or platelet Satellitosis caused by EDTA activation of Immunoglobulins may cause a Low platelet count and or an elevated WBC count These types of specimens should be re collected in Sodium citrate anticoagulant and re analyzed For Platelets Only RABO43EEN section 1 Specifications I7 Micros 60 MICROS 60 CS CT Important Blood Samples collected in EDTA will not maintain a stable Mean Platelet Volume Platelets collected in EDTA will swell with Time and Temperature Giant Platelets that exceed the Upper Thresholding of the Platelet channels may not be counted as platelets Consequently these larger platelets will not be included in the instrument s calculations of the Mean Platelet Volume Agglutinated Red Blood cells May trap Platelets causing an erroneuos MPV result The presence of Aggultinated erythrocytes may be detected by observing abnormal MCH and MCHC values and by careful examination of a stained blood smear Very Small Erythrocytes Microcytes Erythrocyte fragments Schizocytes and White Blood cell fragments may interfere with the proper sizing and counting of the Platelets Chemotherapy May also affect the Sizing of Platelets O 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 the Lysing action may interfer with an accurat
132. libration and Quality Control Instrument Configuration SETUP MENU OVERVIEW 2 7 MEMORY CARD Patient samples Only 17 1 RESULTS OPTIONS 3 7 1 Memo On Off 18 7 2 Running patient samples 18 1 1 Reprint results 3 7 3 Transmission of results 19 1 2 Printout 3 7 4 Print List 19 1 3 Units 4 7 5 Reprint one result TR ONE 20 1 4 Printer selection 5 7 6 Reprint all results TR ALL 20 1 5 Temperature printout 5 7 7 Print From to 20 1 6 Print limits 5 7 8 Clear Card 21 1 7 Print LMG results 6 2 CHANGE LABORATORY LIMITS 6 2 1 Results Low limits 6 2 2 Results High limits T 2 3 Print Limits and Flag values 7 2 4 Morphology Flag limits 9 3 SPECIAL FUNCTIONS 10 3 1 Change Operator 11 3 2 Change Password 11 3 3 Startup cycle 12 3 4 Autocleaning frequency 12 3 5 Print Instrument configuration 13 3 6 Buzzer audible signal 14 3 7 Sample Identification mode 14 3 8 Analysis Cycle Start mode 14 4 DATE AND TIME 15 4 1 Change Time 15 4 2 Change the Date format 15 4 3 Change the date 15 5 HOST COMPUTER OPTIONS 16 5 1 Host communications 16 5 2 Baud rate 16 5 3 Transmission Send 17 6 BARCODE SETUP 17 RAB043EEN section 5 Instrument Configuration Micros 60 Menu Setup 1 REPRINT RESULTS 2 WITHOUT HISTO 2 PRINTOUT lt PRINTER 9 S 6 PRINT LIMITS Y N 4 INTER 2 2 RESERVED 2 4 STANDARD 2 HIGH LIMITS 4 FLAG LIMITS CHG OP 2 CHG PASSWORD EA 3 STARTUP C
133. lock e Possible contaminated Reagent s e Possible Hgb blank reference voltage e Possible dirty Aperture e Possible WBC chamber not filling e Possible Lyse flow error e Possible Tube cap debris in T fitting below WBC chamber e Possible debris in Hgb measurement pathway e Possible Hgb blank reference failure e Possible dirty Aperture e Possible dirty chamber e Possible Leakage from syringe block e Possible dirty Aperture e Poor calibration e Possible Leakage from syringe block e Possible dirty Aperture e Possible dirty chamber e Possible Leakage from syringe block e Incorrect sample mixing e Perform a Concentrated cleaning re run Startup e Remove and flush out sample probe e Check 3 syringe block abd call HORIBA ABX Technical support e Check and or replace Reagent s if necessary re run Startup e Call HORIBA ABX Technical support for assistance e Perform a Concentrated cleaning re run Sample e Check for diluent in chamber during cycle call HORIBA ABX Technical support e Check and or replace Lyse reagent e Call HORIBA ABX Technical support for assistance e Perform a Concentrated cleaning re run Sample e Call HORIBA ABX Technical support for assistance e Perform a Concentrated cleaning re run Sample e Perform a Concentrated cleaning re run Sample e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Perform a Concentrated cleaning re run Sampl
134. lue for both RBC s and PLT s O The RBC and PLT Histograms are determined by Thersholding of the electronical pulses These pulses are then Grouped according to size by Channeling the pulses into the correct size category The electronic pulses are smoothed Mathematically and plotted on a graph Pulse Height Cells passing through the perture creating electronic umber of Cells Pulses Grouped according to the Number of cells and the Size of the cells Cell Size umber of Cells Pulses are electronicall calculated and smoothed to show the RBC Distributio curve Cell Size umber of Cells Pulses are electronicall calculated and smoothed to show the PL Distribution curve Cell Size RABO43EEN section 2 Description 4 Technology Description amp Technology O RBC Histogram is an Electronic Distribution and Mathematical calculation of the RBC s placed into 256 Channels of Volumetric sizing from 30fl to 300fl PLT Histogram is an Electronic Distribution and Mathematical calculation of the PLT s placed into 128 Channels of Volumetric sizing from 2fl to a Mobile Threshold between the High end Platelets to the Low end Red Blood Cell Thresholds fl fentaliters A Microscopic volumetric unit of measurement This is a 3 dimentional measurement used to determine the volume of Microscopic particles O The Hemoglobin measurement is based on a STARTUP cycle This cycle includes a Hemoglobin Blank
135. ly maintained Should any variation of Quality Control results outside the Assayed ranges occur after calibration it is Highly suggested that you contact your local HORIBA ABX Technical Support Representative before Manually editing the calibration coefficients Changing Callpration Coemicients When in the Coefficients menu manually editing the calibration coefficients is performed by selecting 7 CALIB COEFF The LCD screen on the ABX MICROS 60 will then ask for the password which allows the operator to enter into and edit the coefficients The display will state as indicated RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control A specific password is required to enter into the coefficients menu Enter the password 123 or the password that has been defined by the operator in the set up menu See Section 5 Instrument Configuration 3 Special functions 3 2 Change Password The Instrument Default password is normally set to 123 before any operator intervention After entering the password press the ENTER key and the following menu will be displayed as indicated To Edit any coefficient in this menu place the cursor next the the coefficient to be edited by press the Up or Down arrow keys Once you have selected the coefficient to be edited follow the steps indicated 1 Once the coefficient has been selected press the ENTER key The followi
136. m 50 to 60Hz without modification 1 ON OFF SWITCH 2 FUSE HOLDER 3 MAIN SUPPLY PLUG 4 RS232 OUTPUT 5 PRINTER OUTPUT If the instrument has to be connected to a laboratory computer use the plug 4 RS232 9 8 Printer 20 MICROS 60 CS CT Caution It is mandatory to connect a printer which fulfills the following conditions the printer is recommended by an HORIBA ABX authorized technician the printer is compatible with IEC standarts the printer is a listed printer Introduction 9 9 Reagent priming When the ABX MICROS 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 required 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 AKEY 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 Install the reagent bottle and carry out a PRIME cycle to clear the reagent line of air bub
137. make sure that the Memo card sub menu is selected for 2 MEMO OFF 3 Press the ENTER key once you have made your selection MICROS 60 CS CT Note If the STANDARD ID Mode was previously select before turning the memo card function On the ID mode will automatically change to US MODE 18 7 2 Running Patient Samples 1 Place the sample into the tube holder and close the tube holder door to start the cycle if and only if Auto Start has been selected in the SPECIAL Menu 8 START MODE 1 AUTO Or Place the sample into the tube holder and press the START key if and only if Manual Start has been selected in the SPECIAL Menu 8 START MODE 2 MANUAL 2 Enter the sample identification Up to 13 Alphanumeric characters Use the Number keys to enter the numbers directly Use the Up and Down arrow keys to select each Alpha character then press the ENTER key after each Alphabetical selection 3 After the sample identification has been entered the analyzer checks to see if there is a memory card present in the card reader lf the memory card has not been inserted a message will appear on the display as indicated Insert the memory card and press the ENTER key If the operator inserts a Quality Control or a Calibrator Smard card instead of a memory card a message will appear on the display as indicated Remove the card insert a memor
138. mits may vary based upon the Applications for intended use The 2 CHG LAB LIMITS sub menu will allow the operator to access and edit some of the following sub menu functions such as Changing the Low parameter Laboratory limits Changing the High parameter Laboratory limits Printing the Current Laboratory limits Changing all Morphology Flag limits From the Set up Menu select 2 CHG LAB LIMITS then press the ENTER key to enter into the Chg Lab Limits sub menu As shown on the display 1 Use the Up or Down arrow keys to select the 1 LOW LIMITS sub menu as indicated on the display 2 1 Results Low Limits 2 Press the ENTER key to enter into the parameter Low Limits sub menu as indicated on the display RABO43EEN section 5 Instrument Configuration Instrument Configuration Results Low Limits continued 3 Select 1 WBC LOW and Press the ENTER key to edit the WBC Low value as indicated on the display 4 Enter the New value with the Number keys and use the Decimal key for placing the decimal point in the correct order 5 Once you have entered the correct value press the ENTER key to accept the change The display will return to the LOW LIMITS Menu as indicated 6 Use the Up or Down arrow keys to select the next Low Parameter to be edited 7 Repeat Steps 4 through 6 to edit the remaining Low parameters
139. n their specified ranges Calibration is complete 8 Run Quality Control and verify that all 3 levels of control results are within their specified ranges Verify that all control parameter results are without Flags H L and for HGB RABO43EEN section 4 Calibration and Quality Control 6 Micros 60 1 2 Calibration Passed In order for ABX MICROS 60 to Pass Calibration the data must meet the statistical criteria which contain 2 conditions 1 The Coefficient of Variations must be within their limits as indicated in the table below 2 The difference between the Target value and the Mean for each parameter calibrated must be less than 20 COEFFICIENT of Variation Limits Parameters WBC RBC HGB HCT PLT MPV CV 2295 lt 20 lt 15 lt 2 0 lt 5 0 lt 3 0 Passed Calibration printout is as indicated CALIBRATION DATE 01 20 2002 TIME 09 48 OPERATOR ABC LOT MCAL212 WBC 10 2 9 3 9 7 10 0 9 9 9 8 9 9 9 9 1 0 0 0 1 09 CURRENT 1 09 STATUS OK RAB043EEN section 4 Calibration and Quality Control Calibration amp Quality Control MICROS 60 CS CT the first calibration sample is not included in the statistical calculations This first sample is considered as a Calibrator material Prime 1 Note The P to the right of RUN 1 indicates that Once the calibration information has printer out the screen will indicate Press
140. new reagent using the following steps through the instrument Menus From the Main Menu select 4 SERVICE 3 PRIME then select the reagent or reagents that need to be primed 1 All Reagents 2 Diluent 3 Lyse 4 Cleaner MICROS 60 CS CT Warning Never pour Reagent from one container into another Any type of Contamination present in the old reagent will affect the New reagent Unacceptable Background counts will most likely occur especially for PLT s Platelets Always use the reagent Caps provided with the instrument to prevent Reagent pollution or oxidation Check the Waste container Empty the Waste when necessary and follow the Waste disposal guide lines according to your Local and or National regulations MICROS 60 CS CT Note If your Local or National Organizations require Waste Neutralization before disposal Waste Liquids of the ABX MICROS 60 can be Neutralized by using the following procedure For 20 Liters of waste liquid add 50ml of Sodium Hydroxide solution at 2009 L Then add 100ml of Ammonium Persulfate at 500g L prepared daily Or add 50ml of Sodium Hydroxide at 2009 L then add 500ml of Sodium Hypochlorite solution Bleach at 30 of full strength 1 2 Reagent Level Checks Minipak Units All Reagents and a Waste bladder are contained in One Minipak When a Reagent Pack runs low the instrument will display a message stating that the reagent pack is low
141. ng menu will be displayed as indicated 2 Enter the New coefficient derived from using the following formula at the bottom of this page 3 Once New coefficient has been entered press the ENTER key to accept the coefficient The diaplay will return to the Calibrate Coefficient Menu with the new coefficient displayed as indicated Parameter Target value 4 Continue to use the Up or Down arrow keys to select the next coefficient to be edited Use the same formula below to calculate the remaining coefficients 5 Repeat steps 1 through 3 for each remaining coefficient Once all New coefficients have been entered press the Escape ESC key until you return to the Main Menu MICROS 60 CS CT Important After manually editing the calibration coefficients it is Highly recommended to run Quality Control Verify that all levels of control material are within their specified parameter ranges Verify that there are no error flags H L for HGB associated with all levels of Quality control results MICROS 60 CS CT Note PCT and PDW are not available These in the United States parameters are Strictly used for research and investigational purposes Only Calibration Coefficients are as listed WBC RBC HGB HCT PLT MPV RDW COEFF PDW COEFF X Current parameter coeffieicet New parameter coefficient Parameter Mean value RAB043EEN section 4 Cali
142. ng procedure Do Not remove the instrument protection cover Power OFF the analyzer Disconnect the main power cable from the back power cord receptacle on the analyzer Pull open the little flap marked 250V fuse Remove the fuses from their holding receptacle Check for the correct ohms on each fuse Use only Slow blow internal fuses Use only fuses having the following characteristics e for 100 120Vac supply 1A 250V SB e for 220 240Vac supply 1A 250V SB 5 2 Input Output Label Waste Connect the waste output line to the Waste position fitting Note the Waste label for Waste output Only Diluent Connect the Diluent input line to the Diluent position fitting Note the Diluent label for Diluent input Only Lyse Connect the Clear tubing marked with a MINILYSE label to a straw and place it into the Lyse reagent container Miniclean Connect the Blue tubing marked with a MINICLEAN label to a straw and place it into the Miniclean reagent container RS 232 output connection Used only by HORIBA ABX qualified Engineers Printer connection Do Not connect any printer which has not been recommended by a HORIBA ABX qualified Engineer 5 3 Identification Label at MICROS 60 ET 10 Introduction 6 Intended Use The ABX MICROS 60 CT CS is a fully automated Microprocessor controlled Hematology analyzer used for in vitro diagnostics testing of Whole Blood specimens
143. nts 2 2 Operating Temperature Humidity 2 3 Dimensions and Weight 2 4 Wastes 2 5 Minimum Sample Volume 2 6 Dilution Ratios 2 7 Counting Aperture Diameter 2 8 Hemoglobin Measurement 3 Summary of Performance Data V1 6 3 1 Precision Reproducibility 3 2 Precision Claims 3 3 Precision Repeatability 00ON YO O00a10adaNa OOOO A A A AA ADN 3 4 Linearity 3 5 Carry over 3 6 Normal Ranges 10 3 7 Accuracy 11 3 8 Leucocytes Differential count 11 3 9 Sample stability study 1 4 Limitations 12 4 1 Maintenance 12 4 2 Blood Specimens 12 4 3 Known Interfering Substances 14 5 Reagent Specifications 19 5 1 General Recommendations 19 6 Waste Handling Procedure 20 7 Reagent Consumption 20 RABO43EEN section 1 Specifications Micros 60 1 Technical Specifications V1 6 e WBC RBC and PLT Histograms e Quantitative Flags e Parameter selection by choice of Software MICROS 60 CS CT blood counts and requires No manual operations for aspirating blood dilutions measuring calculations print outs and computer transfer of data The parameters are given according to the Internal Setup Note The ABX MICROS 60 CS CT performs automated 1 1 Parameters 5 Parameters RBC Red Blood Cells HCT Hematocrit RBC Distribution Curve ABX MICROS 60 CS CT 8 8 Parameters RBC Red blood cells HCT Hematocrit MCH Mean Corpuscular Hemoglobin PLT Platelets 2 RABO43EEN section 1 Specifications
144. o retain the results on the card 4 When you have completed this function press the Escape ESC key until you return to the MAIN MENU RABO43EEN section 5 Instrument Configuration 2 1 Micros 60 22 RAB043EEN section 5 Instrument Configuration Maintenance amp Troubleshooting 1 MAINTENANCE 2 1 1 Overview 3 1 2 Daily Maintenance 3 1 3 Service Functions 4 1 4 Instrument Cycles 7 1 5 Technician Functions 8 1 6 Automatic Cleaning 8 2 TROUBLESHOOTING 8 2 1 Overview 8 2 2 Problem Identification 8 2 3 Troubleshooting parameters 9 2 4 Troubleshooting System operations 13 2 5 Troubleshooting ERROR messages 14 3 SOFTWARE MENU OVERVIEW 16 4 QUICK OPERATIONS REFERENCE 18 RABO43EEN section 6 Maintenance and Troubleshooting Micros 60 Menu Service 4 SERVICE 1 ALL REAGENTS 2 DILUENT 3 LYSE 4 CLEANER PACK UNIT 1 CHG PACK 2 CAPACITY 3 PRIME PACK i RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting 1 Maintenance 1 1 Overview One of the principle factors contributing to accurate and reliable results is a well mainteined instrument The ABX MICROS 60 is designed to keep this maintenance automatically to a minimum providing that the operator is aware of its schedule This section of the manual will describe the daily and periodic maintenance procedures 1 2 Daily Maintenance These cleaning
145. o the operator before during or after a specific operational function HORIBA ABX B P 7290 Rue du caduc e Parc Eurom decine 34184 MONTPELLIER Cedex 04 FRANCE Tel 33 467 14 15 16 Fax 33 467141517 Micros 60 2 Warning and precautions User manual must be enterely read and understood prior to the installation and functioning of the instrument The user always operates with full Knowledge and appreciation of instrument warnings alarms and flags Should the user requires training in complement to information provided in User manual please contact your HORIBA ABX representative Always refer to labeling and HORIBA ABX instructions in order to avoid to compromised system integrity The ABX MICROS 60 responds to the standards and directives named in the Declaration of Conformity added at the beginning of this manual MICROS 60 CS CT The reagents and accessoiries stipulated by HORIBA ABX have been validated in accordance with the European Directive for in vitro medical devices 98 79 CE The use of any other reagents and accessories may place at risk the performance of the instrument engaging the Users responsability In this case HORIBA ABX takes no responsability for the device nor for the results rendered Disposal gloves eyes protection and lab coat must be worm by the operator Local or national regulations must be applied in all the operations Portable mobile telephones should not be used in proxim
146. omplete The second group of parameter results can be displayed by pressing the Up arrow key when in the results display Indentification 1 US Mode sample Identification can be reviewed on the LCD screen in the RESULTS menu by moving the Up or Down Arrow keys as shown 2 Standard Mode The Patient Run can be reviewed on the LCD screen in the RESULTS menu by moving the Up or Down Arrow keys as shown OFlags The PLT and WBC flags can be reviewed on the LCD screen in the RESULTS menu by moving the Up or Down Arrow keys as shown O RABO43EEN section 3 Startup and Sample Run Startup and Sample Run MICROS 60 CS CT Note The Last sample result run can be displayed again at any time before running the next analysis From the Main Menu select 1 RESULTS Use the Up and Down arrow keys to view any part of the Last sample results RESULTS TIME 09 25 DATE 01 20 2002 ID SMITH_1234567 SEQ 27 STARTUP PASSED PLT Page z 7 5 10 mm 3 l um 80 100 4 90 10 mm 3 F l 6 Pg 26 5 35 5 15 0 g dl 11 0 l 1 g dl 37 5 33 5 43 9 35 0 0 11 0 16 0 287 10 mm 150 8 um 6 5 17 0 WBC Flags LYM 393 20 0 45 0 i 2 10 mm 1 2 3 2 MON 7 3 4 0 10 0 4 10 mm 0 3 0 8 GRA 53 4 43 0 76 0 i 0 10 mm 1 2 6 8 WBC RBC PLT
147. on 1 sheet of paper starting from left to right in a line form are not available with the use of the memory card All sample results are printed individually on a separate sheet of paper To enter into the Reprint All sub menu from the MEMO CARD Menu use the Down arrow key to 5 TR ALL as indicated 1 Place the Memory card in the reader 2 Select 5 TR ALL then press the ENTER key All complete results from the memory card will be printed out A MICROS 60 CS CT Note If you selected 5 TR ALL by error remove the memory card from the reader and press the Escape ESC key Wait until the printer has stopped before continuing through the sub menu 7 7 Reprint From To TR FROM TO This memory card sub menu will allow the operator to print out a specified group of sample results starting from a specified number and ending with a specified number 1 Place the Memory card in the reader 2 From the Memo Card Menu select 3 PRT LIST Wait until all the Sample Identification list is completely printed out 3 From the Memo Card Menu select 6 TR FROM TO and press the ENTER key RABO43EEN section 5 Instrument Configuration Instrument Configuration The Display will indicate 4 Select 7 BEGIN and press the ENTER key to access this sub menu 5 Review the printed list and enter the beginning MEMO number that you wish to start with as indi
148. on the commercial control blood The information printed out will contain all the necessary statistical data for each level The levels can be selected individually or all at once MICROS 60 CS CT Quality Control Statistical data at the end of each 1 Important It is highly recommended to print out all month for hard copy verification of control data Each File printout contains the following information File Name Blood Level Lot of the Control Expiration date of the control Date and Time of the print data request Date and Time of each control run Operator and Parameter results of each control run the Reference Assay Mean Upper and Lower limits the Actual Mean results of the total control runs the 2 Standard Deviation value and the Percent Coefficient of Variation Select Statistics 1 From the Q C Menu select 4 STATISTICS then press the ENTER key to enter into the sub menu as indicated on the display 2 Use the Down arrow key to select one of 3 levels to be printed out or select ALL to print out a 3 levels Selection will be indicated on the display 3 Once your selection has been made press the ENTER key to print out the statistical data The display will state as indicated 20 RABO43EEN section 4 Calibration and Quality Control Calibration amp Quality Control 5 When the statistical data has been printed out it will state as indicated below 6
149. ontpellier cedex 4 France 1 Functions This reagent is used on HORIBA ABX blood cell counters to lyse red blood cells and determine hemoglobin concentration Measurement procedure to be followed in using the device Principle of the method specific analytical performance character istics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproduc ibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual Conservation amp expiration Storage conditions Stored at 15 C 59 F to 30 C 86 F away from light Expiration date label refer to expiration date reagent packaging Measurements principles amp results Directions for use see Section Maintenance amp Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Workflow in the instrument User Manual Performance data see Section Specifications in the instrument User Manual a Modifications from Index A to B Company name change FORM 0866 rev 1 S A au Capital de 44 000 000 Euros RCS Montpellier 328 031 0
150. ount of the actual WBC s When NRBC s are present in the WBC count the formula for correcting the WBC parameter is as followed Counted WBC s x 100 Corrected WBC 100 of NRBC s 100 WBC 14 Non lysed Red Cells In particularly rare instances the erythrocytes in the blood sample may not completely lyse when lysing reagent is added in the WBC Chamber These non lysed Red blood cells may be detected on the WBC Histogram with an L1 Alarm or as an elevated baseline on the Left leading edge of the Lymphocytes population in the WBC Histogram Non lysed erythrocytes will also 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 WBC counts Leukemia A very low WBC count may result in this disease state because of possible increased fragility of the leukocytes leading to some destruction of these cells during counting These white cell fragments will also interfere with the white cell partial differential parameters LYM and MON and GRA and A suspiciously 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 Cytotoxins and Immunosuppressive drugs may increase the fragility of the leukocyte
151. procedures are required daily to maintain optimum performance of your ABX MICROS 60 MICROS 60 CS CT Warning Failure to perform any of these recommended cleaning procedures can result in decreased reliability of your system It Is important that you monitor your analyzer for the types of specimens that may cause pre mature cleaning other than routine O Atthe beginning of each business day a Startup cycle must be performed This can be done either automatically or just by pressing the STARTUP key on the front of the instrument panel which ever the system has been set up for in Section 5 Instrument Configuration 3 Special functions 3 3 Startup Cycle At the end of each business day a Standby cycle should be performed Press the STANDBY key on the front of the instrument panel to start the cycle This cycle takes about 1 minute Once the Standby cycle is complete you may Power Off the instrument or leave it in the standby mode Overnight MICROS 60 CS CT Important The Standby mode introduces MINICLEAN into the chambers for the enzymatic cleaning of Protein build up on the counting chambers and apertures This Standby cycle is a very important step in daily maintenance O This Automatic cleaning cycle is automatically performed when the number of analysis cycles has been reached to initiate the auto clean cycle This cleaning frequency cycle can be programmed by the operator to
152. r Blood sample MICROS 60 CS CT Important It is highly recommended that you use the ABX MINOCAL Calibration product when calibrating the ABX MICROS 60 analyzer This product is specifically designed for use with the ABX MICROS 60 analyzer Call your local HORIBA ABX Customer Service Representative for information and ordering of this specialized product 2 Known Calibration Coefficients can be directly entered by selecting a Calibration Menu option MICROS 60 CS CT Important Before performing an instrument Calibration it is mandatory to 1 perform a Concentrated Cleaning to ensure the cleanliness of the Counting Chambers and Apertures 2 Run a Blank Cycle to assure that all the Background values are at their lowest possible limits See Section 3 Startup and Sample Run 1 4 Instrument Startup Background Limits 3 Run Reproducibility on a Fresh Normal patient blood sample 10 times and calculate the Coefficient of Variation CV for WBC RBC HGB HCT PLT and MPV Note the Percent CV s in this section of the Manual These 3 factors will ensure a clean and precise instrument when calibrating If your ABX MICROS 60 does not pass a Background or Reproducibility check contact your local HORIBA ABX Technical Support representative To enter into the Calibration Menu from the Main Menu select 3 CALIBRATION The following menu will be displayed on the LCD screen as shown 1 1 Calibration
153. r Availability Parameter setup availability options MICROS 60 CS CT 5 CS CT 8 CS CT 16 CS CT 18 Parameters MICROS 60 CS CT Note PCT and PDW have not been established as indications for this product in the United States The use of PCT and PDW should be restricted to Research Use Only 12 Introduction 8 Presentation The ABX MICROS 60 which is small in size has 9 main parts 1 The Electrical supply 2 The Electronic Main board 3 The Dilution Pneumatics 4 The Control panel including a key pad and LCD screen 5 ACap piercing mechanism 6 AReagent compartment 7 A Printer that prints out results and Distribution curves 8 A Smart Card Reader optional for Quality Control result records and Patient result records 9 A Barcode reader optional for a direct entry of the Alphanumerical identifications 8 1 Micros 60 Models Available The ABX MICROS 60 is available in 4 different models as indicated e The ABX MICROS 60 OT This model is an Open Tube unit Without a Smart Card reader The operator must remove the cap from the blood collection tube before analyzing any sample e The ABX MICROS 60 OS This model is an Open Tube unit With a Smart Card reader The Smart Card reader gives the operator the ability to record results and perform automated Quality Control The operator must remove the cap from the blood collection tube before analyzing any sample e The ABX
154. ratory working practices when handling specimens Wear protective gear Gloves Lab coats Safety glasses or Face shields and follow other biosafety practices as specified in OSHA Bloodborne Pathogen Rule 29 CFR Part 1910 1030 or other equivalent biosafety procedures MICROS 60 CS CT WARNING Whilst every effort is taken by HORIBA ABX to investigate and indicate all known interference s it is by no means possible to guarantee that all interference s have been identified At all times results should be validated and communicated only once all information relating to the patient has been assessed and taken into account When collecting blood specimens Venous blood is recommended but Arterial blood may also be used in extreme cases Blood collection must 4 1 Maintenance be placed in Vacuum or atmospheric sample collection tubes In this Manual specific Start up Shutdown and Maintenance procedures are listed The Maintenance procedures listed in this manual are mandatory for the proper use and operation of continued the ABX MICROS 60 Sample Collection and mixing MICROS 60 CS CT Note For USA Only For additional information on collecting venous and capillary samples refer to NCCLS document H3 A4 and NCCLS document H4 A4 sept 1999 MICROS 60 CS CT Caution Failure to execute any of these maintenance procedures may result in Decreased Reliability of the system High
155. re 9 Once the cleaning cycle is complete perform a Backflush cycle From the SERVICE Menu select 1 BACKFLUSH then press the ENTER key to start the cycle 10 Perform the Backflush 2 more times 11 Once the backflush cycles are complete press the Escape ESC key until you return to the Main Menu 12 Press the STARTUP key to run a startup Verify that Background results are within their limits 13 Re run Quality Control and verify that the results are within the Assay limits listed on the control Assay sheet that comes with the controls 14 If the problem still persists repeat steps 1 through 11 again MICROS 60 CS CT Note If the problem still persists after the second cleaning call your local HORIBA ABX Technical Support Representative
156. re are 3 options in the Printout Menu as followed Results printed out WITH HISTOGRAMS Results printed out WITHOUT HISTOGRAMS Results printed out WITHOUT RBC HISTOGRAM RABO43EEN section 5 Instrument Configuration Micros 60 O Printout continued From the Results Menu use the Down arrow key to select 3 UNITS 2 Use the Up or Down arrow keys to make your selection of the 3 OPTIONS as indicated 1 Use the Down arrow to move the cursor on the display to select the Units required for your applications as indicated on the display MICROS 60 CS CT The Units are as listed Note The Printout WITHOUT RBC HISTOGRAMS option is Highly 71 STANDARD used in the United States and recommended on the CITIZEN Model in most European countries printer This option gives less print 2 SI used in some European countries and time on the Citizen printer in Research Laboratories 3 INTER 1 are used Internationally but Not in the United States 3 Press the ENTER key once you have made 4 INTER 2 are used Internationally but Not your selection in the United States 1 3 Units 2 Once your selection has been made press the ENTER key to accept your choice This sub menu allows the operator to select between 4 different Units of Measurement These Units vary from Country to Country and are designed for International applications The choices are listed on the c
157. re the future Note if performance changes call HORIBA ABX representative your Composition amp handling precautions Composition Potassium Cyanide lt 0 1 Sodium Azide o o lt 0 1 A ieee a lt 25 Potassium chloride lt 20 A A tine Aoeeeseoe lt 20 Quaternary ammonium salt lt 20 pH 10 2 0 4 T 20 C Resistivity 131 6 Q T 20 C Description aqueous solution limpid Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested The product can be absorbed through an open wound or inhalation Please refer to the MSDS associated with the reagent Special precautions Avoid contact with acid and aqueous acid en vironment extremely toxic cyanide acid vapour can be formed Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Specimen collec tion and Mixing in the instrument User Manual Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal Follow your laboratory s protocol when neu tralizing and disposing of waste Please refer to the MSDS associated with the reagent Latest version documents on www horiba abx com HORIBA GROUP ABX Minidil O Exclusive use Micros Hematology Devices for in vitro dagnostic use 15 01 05 A95A00021B 0801010 10L 10L
158. rform a Concentrated cleaning re run Sample e Call HORIBA ABX Technical support for assistance e Perform a Concentrated cleaning re run Sample e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Call HORIBA ABX Technical support for assistance e Call HORIBA ABX Technical support for assistance e Perform a Concentrated cleaning re run Sample e Check 3 syringe block for leakage and call HORIBA ABX Technical support e Call HORIBA ABX Technical support for assistance e Call HORIBA ABX Technical support for assistance e Call HORIBA ABX Technical support for assistance e Select 4 Service 5 Mechanic 5 Pressure syringe check operation 10 RABO43EEN section 6 Maintenance and Troubleshooting e Startup Failed check reagents High Background counts e No results in analysis e Suspiciuos patient results e QC results are outside of the acceptable limits e Poor Repeatability Troubleshooting e Possible dirty Aperture e Possible Partial blockage in sample probe e Possible Leakage from syringe block e Possible contaminated Reagent s e Possible dirty Aperture e Possible RBC chamber not filling e Possible dirty Aperture e Possible dirty chamber e Possible Leakage from syringe block e Possible dirty Aperture e Poor calibration e Possible Leakage from syringe block e Possible dirty Aperture e Possible dirty chamber e Possible Leakage from syringe block
159. ros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future Performance data see Section Specifications in the instrument User Manual Note if performance representative changes call your HORIBA ABX Composition amp handling precautions Composition Potassium Chloride lt 20 Sodium Azide scseeee lt 0 1 AAA a E lt 25 pH 7 2 0 1 T 20 C Resistivity 63 7 6 Q T 20 C Description Limpid and odourless aqueous solution Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Introduction in the instrument User Manual Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see section Specifications in the instru ment user manual Please refer to the MSDS associated with the reagent Latest version documents on www horiba abx com HORIBA GROUP ABX Lysebio O Exclusive use Micros Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 Hematology Devices for in vitro dagnostic use 15 01 05 A95A00011B 0906012 1L 0906013 0 4L 1L a vo C par HORIBA ABX BP 7290 34184 M
160. ros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future r Performance data see Section Specifications in the instrument User Manual Note if performance representative changes call your HORIBA ABX Composition amp handling precautions Composition Sodium fluoride lt 3 Sodium Azide lt 0 1 Sodium Hydroxyde lt 1 Dimethylourea 0 1 pH Resistivity 7 0 0 1 T 20 C 60 6 Q T 20 C Description Limpid and odourless aqueous solution Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Preparation before analysis and Startup in the instrument User Manual Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Installation in the instrument User Manual Please refer to the MSDS associated with the reagent Latest version documents on www horiba abx com HORIBA GROUP ABX Minilyse O Exclusive use Micros Hematology Devices for in vitro dagnostic use 15 01 05 A95A00024B 0701010 1L a CE easi HORIBA ABX BP 7290 34184 Montpellier cedex 4 France 1 Functions Erythrocyte lysing reagent for white bloo
161. s Performance data see Section Specifications in the instrument R2 Erythrocyte lysing agent for white blood cell counting and dif User Manual ferentiation and hemoglobin determination on HORIBA ABX blood Note if performance changes call your HORIBA ABX cell counters representative R3 Buffered isotonic solution for the determination and the dif ferentiation of blood cells and the measurement of hematocrit on HORIBA ABX blood cell counters 4 Composition amp Handling precautions Measurement procedure to be followed in using the device Principle of the method specific analytical performance character R1 Organic Buffer siete eee eeeeeeees lt 20 istics analytical sensitivity diagnostic sensitivity analytical Proteolytic enzyme lt 1 specificity diagnostic specificity accuracy repeatability reproduc pH 9 6 0 4 T 20 C ibility including control of known relevant interference limits of Resistivity 72 2 Q T 20 C detection limitations of the method and information about the use A Rear of available reference measurement procedures and materials by Description Colorless liquid the user see Section Specifications in the instrument User R2 Potassium cyanide lt 0 03 Manual Quaternary Ammonium salt lt 20 pH 10 0 5 T 20 C 2 Conservation amp Expiration pore AAA O Description Colorless liquid Storage conditions Stored at 18 C 65 F to 25 C 77 F
162. s indicated below 4 Press any key to exit the function If any of these sensors remain at O when the mechanism has been moved call your local HORIBA ABX Technical Support Representative for assistance with this issue 5 To access any other mechanical function place the cursor by the mechanism and press the ENTER key to access that specific function The display will step you through the function 6 Press the Escape ESC key to exit any function O LCD Contrast Adjustment The LCD Contrast can be adjusted as followed 1 from the Mechanic Menu select 7 CHG CONTRAST then press the ENTER key to access that function as indicated RABO43EEN section 6 Maintenance and Troubleshooting Maintenance amp Troubleshooting LCD Contrast adjustment continued 2 Press the UP arrow key to increase the contrast or press the DOWN arrow key to reduce the contrast 3 When the contrast is set press the ENTER key to accept the change in contrast MICROS 60 CS CT Note The Contrast Menu can be accessed at any time from any other menu Press and hold the Delete DEL key and Period key simultaneously The contrast menu will appear for adjustment Park This Service function allows the operator to place the Vacuum Waste syringe in a position so that the instrument can be placed in storage or shutdown for a long period of time From the Mechanic Menu select 8
163. s and Normal Patient samples perform the following steps 1 Rerun the Control or patient sample 2 Clean the system see Section 6 Maintenance and Troubleshooting Service functions Concentrated Cleaning Re run the sample 3 Open a New vial of Control material 4 Call your local HORIBA ABX Technical Support Representative before re Calibrating the system 3 Running Samples 3 1 Sample Identification Run the Quality Control blood all 3 levels and verify that the results are within their specified limits Run the patient blood samples Follow the steps listed 1 Mix the blood sample gently and thoroughly 2 Rotate the Tube Holder to the position desired for the sample 3 Press the ID key and enter the patient Identification if US Mode is selected in set up Press the ID key and enter the Run if Standard Mode is select in set up 4 Mix and place the sample into the tube holder Close the tube holder door The analysis will begin if the system is set for Auto Start in the set up menu Press the START key on the front panel if the system is set for Maual Start in the set up menu RABO43EEN section 3 Startup and Sample Run Micros 60 3 2 Automatic Cleaning Cycle The ABX MICROS 60 will perform an Automatic cleaning cycle once the analysis cycles have reached the programmed cycle limit set in the Set up Menu The standard Default automatic cycle limit is se
164. s to view as indicated 1 STARTUP the number of Startup cycles that the instrument has ran 2 STANDBY the number of Standby cycles that the instrument has ran 3 CBC the number of analysis cycles that the instrument has ran From the Service Menu select 6 CYCLES then press the ENTER key to access this menu as indicated RABO43EEN section 6 Maintenance and Troubleshooting Micros 60 1 5 Technician Functions This Service function allows the operator to work with HORIBA ABX Technical Support in resolving checking and or adjusting some Technical interventions on the ABX MICROS 60 This Service Menu is mainly used by the Engineers to make adjustment in the technical areas of the analyzer A MICROS 60 CS CT Note This Technician Functions Menu can be accessed only by a special password When troubleshooting your instrument in this area call your local HORIBA ABX Technical Support Representative for the special password and instructions in this menu area 1 6 Automatic Cleaning This Service function allows the operator select a Cleaning cycle at any time that they wish to clean the instrument This cleaning cycle is the same cycle as the programmed cleaning cycle frequency See Section 5 Instrument Configuration 3 Special Functions 3 4 Autocleaning Frequency From the Service Menu select 8 AUTO CLEAN then press the ENTER key to start the cleaning cycle The di
165. s which may cause low WBC counts RABO43EEN section 1 Specifications Cryoglobulins Increased levels of Cryoglobulins that may be associated with Myeloma Carcinoma Leukemia Macroglobulineima Lymphoproliferative disorders Mestastic turmors Auto immune disorders Infections Idiopathic disease Aneurism Pregnancy Thromboembolic phenomena Diabetes etc which can elevate the WBC RBC and PLT counts along with the HGB value The specimen can be warmed up to 37 C and re analyzed immediately If warming the specimen has no effect on the count a Manual WBC RBC and or PLT count can be performed Increased Turbidity may also be seen in cases where the red blood cells are resistant to the lysing action This condition will cause a falsely elevated Hemoglobin result but may be detected by observing the abnormal MCH and MCHC values also the increased baseline on the Left leading edge of the WBC Histogram Erroneous Hemoglobin results will also 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 Hemoglobin value Specifications Red Blood cell Agglutination May produce erroneous HCT and MCV values Red blood cells agglutination may be detected by observing abnormal MCH and MCHC values as well as examination of a stained blood smear in such cases Manual Laboratory methods may be required to obtain an a
166. sk you if you want EXIT QC as indicated on the display 5 Press the ENTER key and the analyzer will state that control blood results were not stored on the QC Smart card as indicated on the display 18 After pressing any key the analyzer returns you to the Q C menu as indicated on the display Valid Q C If the QC is accepted and validated the index is increased on the QC Smart card and the ABX MICROS 60 internal index is increased as well O Invalid Q C If the QC is rejected and not validated the following message appears on the display Results are not stored on the QC Smart Card at the time of exit 2 4 Q C Analysis Without Q C Smart Card 1 Remove the Minotrol Quality Control blood from the refrigerator and bring it to room temperature 2 From the Q C Menu select 2 ANALYSIS This menu will allow the operator to run a control level blood as a normal analysis cycle Without the use of a Smart Card but with specific LMG Thresholds for control level bloods Independant from the Temperature 3 The ABX MICROS 60 will display a menu which will ask you for a LOT and show a current lot number if any as indicated 4 Enter a Lot number anywhere from 1 to 10 Alphanumeric characters Use the Number keys to enter the numbers directly Use the Up or Down arrow keys to select each Alpha character pressing the ENTER key after each Alpha entry
167. splay will indicate that a cleaning cycle is in progress and the duration time may vary depending on the revision of software on the unit MICROS 60 CS CT Important This Auto Clean cycle is a short cycle and may not provide enough cleaning action for Fibrin clots in the apertures and or chambers If this is the case a Concentrated Cleaning is highly recommended A 2 Troubleshooting 2 1 Overview Your ABX MICROS 60 may occasionally require troubleshooting if e System operations are faulty e The Background count is unacceptably high e Your Quality Control values are out of range or patient results are suspicious e g consistently high RBC counts or the inability to verify results by manual methods e Percision is poor e Calibration is drifting 2 2 Problem Identification The first step in any troubleshooting session is to identify the source of the system malfunction e System operation e Percision e Quality Control e Calibration These steps should be carried out in sequence as described below O The ABX MICROS 60 software identifies most of the mechanical or hydraulic problems A Mechanical problem gives an alarm message and stops the current cycle in progress A Hydraulic problem can be noted by parameter and or morphology flags The Waste sensor also gives an error message if a hydraulic problem exists If this is the case Power OFF the ABX MICROS 60 Power ON
168. t XEA 317 A AABX MICROS 60 CT pack installation kit XEA 335 A Two different printers are available according to the country specifications Printer European model 230V 50 60Hz XAA 398 A Printer US model 120V 50 60HZ XAA 399 A Introduction 9 3 Package content The ABX MICROS 60 CT boxes contain the following parts ABX MICROS 60 CT Printer User s manual english RABO43EEN ABX MICROS 60 CT power cable european DACO11A or ABX MICROS 60 CT power cable US DACO12A The ABX MICROS 60 CT bottle installation kit EA 317 A includes Reagent straw L 270 mm XEAO17A 3 Diluent Waste male connector EACO19A 2 O ring 6x1 5 FAA036A 2 Rubber stopper 2 holes FBLOO1A 1 ABX MICROS 60common installation kit XEA312A 1 The ABX MICROSCT pack installation kit XEA 335 A includes Sampling needle ABX MICROS 60 CT GBCO52AS 1 O ring 0 74x1 02 FAAO54A 2 15 Micros 60 9 5 Visual checks 2 5 1 Mechanical check Diag 9 2 Diag 9 3 Diag 9 4 Diag 9 5 16 Using the key from the installation kit unloosen the locker as shown on the Diag 9 2 below Open the pneumatic protection door MICROS 60 CS CT Do not open or close the Arne front door when the door of the piercing mechanism is open Unscrew the 5 cover fixation screws and remove the cover pull it backward and lift it up to the rear of the instrument Diag 9 3 Push the white plastic
169. t at 50 analysis cycles per day This Cleaning cycle number can be changed in the Set up menu See Section 5 Instrument Configuration 3 Special functions 3 4 Autocleaning frequency The Operator has the option of changing this cleaning frequency number to allow for cleaning intervals dependant on the number of blood samples run during each day When an Automatic cleaning cycle begins a message will appear on the LCD screen stating The Operator may also request an AutoClean at any time needed From the Main Menu select 4 SERVICE then 8 AUTO CLEAN 3 3 End of the Day Rinsing It is necessary to run a STANDBY Shutdown cycle at the end of each day Press the STANDBY key on the front panel The ABX MICROS 60 performs a complete cleaning with the enzymatic detergent Miniclean and puts the system into a Standby mode The ABX MICROS 60 can then be switched OFF at the end of the working day or left in this Standby mode until the next working day It also may be left in the Standby mode between long breaks during the day MICROS 60 CS CT Important When the ABX MICROS 60 is left in the Standby Mode it is mandatory to perform a STARTUP cycle before returning to any analysis cycles 6 RABO43EEN section 3 Startup and Sample Run Startup and Sample Run 4 Results When an analysis cycle is complete Results are displayed and printed out according to the Set up of the Instrument
170. t the limits These limits Are not Quality Control limits These limits are the ones that were established in the set up menu See Section 5 Instrument Configuration 2 Change Laboratory Limits 2 1 2 2 Result Low Limits and Result High Limits Verify your control results with the Assay sheet that comes with the control material Verify that each Control level parameter is within its assayed limits To enter into the Q C menu from the Main Menu select 2 Q C then press the ENTER key The menu will displayed as indicated e2 2 Q C Automatic 1 Remove the Minotrol Quality Control blood from the refrigerator and bring it to room temperature 2 From the Q C Menu select 1 AUTOMATIC This menu will move the operator through the automatic quality control process once the Smart Card is inserted Operator selection Lot identification Expiration date etc will be displayed between each step of the process 3 Insert the Quality Control Smart Card into the card reader with a firm push until you here it click into place RABO43EEN section 4 Calibration and Quality Control Micros 60 A NT A et Aan ats O Q C Automatic With Q C Smart Card continued The first step that takes place is that the ABX MICROS 60 checks for the presence of a CARD READER lf a Card Reader is not present or if there is a technical failure with the present reader the Q C PROGRAM will be
171. tant Temperature differences during transportation Allow your reagents to return to Room Temperature before use to avoid Gas bubble emissions Never pour the remaining quantity of a reagent perviously being used into the New reagent replacing it This will eliminate any Cross Contamination to the New Reagent Never leave a reagent container Open during use Use the appropriate Caps provided with the instrument Order New Reagent caps if lost or Misplaced Do Not use the instrument operational caps when reagents are left off the instrument Clean any reagent spillage with water as soon as possible in order to prevent Crystallization of the reagent and Oxidation of the metal parts of the instrument Never pour reagents into the Laboratory waste water drainage system Follow Local National regulations for Chemical waste disposal Apply neutralization procedures when necessary It is Necessary to Flush the reagent lines with Distilled water then dry them when the instrument is going to be shipped to any location or will be left without operating for an extended period of time Contact your Local HORIBA ABX SERVICE CENTER for more information about this procedure These reagents are used for Invitro out side the body diagnostics All these reagents are Manufactured by HORIBA ABX Rue du Caduc e Parc Eurom decine 34184 MONTPELLIER CEDEX FRANCE Tel 83 467 141516 Fax
172. telet results with these specific flags should be re verified by Platelet Rich Plasma PRP analysis and or Manual Platelet Counts RABO43EEN section 3 Startup and Sample Run Startup and Sample Run O The ABX MICROS 60 CS CT16 and CS CT18 has a system of WBC Differential flags alerting the operator to the possible presence of Pathological cells Abnormal volume distribution histograms or Abnormal elevated populations such as the excessive presence of Eosinophils and Basophils 1 Flag L1 indicates an abnormal number of cells in comparison with the Lymphocytes in the 30fl to 60fl zone The pathological elements which may be found in this area will include Platelet aggregates Nucleated Red blood cells Atypical Lymphocytes This flag corresponds to the number of cells counted in the first 5 channels out of the total number of Lymphocytes 2 The M2 flag indicates an excessive number of cells in the 130fl to 160fl zone The Pathological elements which may be found in this area will include Lymphoblasts Myelocytes Abnormal Lymphocytes Basophilia too Many Basophils This flag corresponds to the number of cells counted in the detection zone in comparison to the total number of Granulocytes 3 The G1 flag indicates an excessive number of cells in the 160fl to 220fl zone The pathological elements which may be found in this area will include Eosinophilia too many
173. thout a Barcode Reader is a simple and easy task Just press the ID key on the front panel to enter the sample ID The Identification menu will be displayed on the LCD as indicated The sample Identification can be entered using up to 13 Alphanumeric Numbers and or Letters characters Letters can be entered by using the Up and Down arrow keys Von the front panel Press the ENTER key after each Alpha character entry The Number keys can be used up to 13 consecutive characters if No alpha characters are used before pressing the ENTER key The sample Identification will be held in Memory until the cycle is complete US Mode ldentification With a Barcode Reader is performed by pressing the ID key on the front panel MICROS 60 CS CT Important The Barcode Reader is a special setup function in the system configuration Before using this setup the Barcode Reader must be configured on the Main Circuit board of the ABX MICROS 60 If you require a Barcode Reader for sample Identification please contact your local HORIBA ABX Service Representative for Installation and setup of this device Place the sample in front of the reader so that the Label can be identified When the reading is complete a Beep tone is heard and the label identification will be displayed on the LCD screen Press the ENTER key to save the current identification or press the Escape ESC key to
174. tifiers 3 FORMAT ABX with character identifiers 4 TR OFF Transmission Off 1 Use the Down arrow key to select 7 HOST COMM Press the ENTER key to access the Host Comm sub menu as indicated 2 Select one of the 4 different output options and press the ENTER key to accept that specific output format 5 2 Baud Rate This sub menu allows the operator to select the rate of transmitted data to the host computer There are 5 different rates to select from 1 300 2 1200 3 2400 4 4800 5 9600 1 Use the Down arrow key to select 2 BAUD RATE Press the ENTER key to access the Baud Rate sub menu as indicated on the next page RABO43EEN section 5 Instrument Configuration Instrument Configuration Baud Rate continued 2 Use the Down arrow key to select one of 5 different transmission rates for your specific applications then press the ENTER key to accept that rate 5 3 Transmission Send This sub menu will allow the operator to send the last sample results in memory to the Host computer as a transmission acceptance verification This function is mainly used to verify transmission from the ABX MICROS 60 to a host computer To enter into the Transmission sub menu from the Host Options Menu use the Down arrow key to 3 TRANSMISSION as indicated on the display 1 Press the ENTER key to send the last sample results
175. to edit that value which is indicated 4 Use the Number keys and the Decimal key for placing the decimal point in the correct order Once you have entered the correct number press the ENTER key to accept the New value The display will return to the Flag Limits menu as indicated 5 Use the Up or Down arrow keys to select the next Flag Limit to be edited 6 Repeat Steps 3 through 5 to edit the remaining Flag Limits if necessary 7 Once you have edited the necessary Flag Limits press the Escape ESC key to exit back to the Chg Lab Limits Menu as indicated on the Display RABO43EEN section 5 Instrument Configuration Micros 60 WBC Morphology Flags MICROS 60 CS CT Important The WBC Morphology flags may also be adjusted by the operator according to the populations of samples to be analyzed Hospitals Reference Laboratories and Outpatient facilities have different flagging criteria depending on the areas of specialty Note the area of Specialty before making any adjustments Factory Default adjustment values are as indicated L1 8 00 M2 8 00 G1 15 00 G3 8 00 1 From the Flag Limits Menu use the Down arrow key to option 4 L1 press the ENTER key to edit the L1 value as indicated 2 Press the ENTER key to edit the flag value as indicated 3 Use the Number keys and the Decimal key for placin
176. to select 6 PRINT LIMITS Y N then press the ENTER key The display will indicate the selection RABO43EEN section 5 Instrument Configuration Micros 60 Print Limits continued The asterisk indicates the current state 1 Use the Up or Down arrow keys to select 1 YES print With limits 2 NO print Without limits then press the ENTER key to accept the change 1 7 Print LMG Results MICROS 60 CS CT Note This Menu function is available Only on ABX MICROS 60 16 and 18 parameter systems This sub menu allows the operator to have the option of printing out the 3 part Differential results with the results printout To enter into the Print LMG results sub menu from the Results Menu use the Down arrow key to select 7 PRINT LMG Y N then press the ENTER key The display will indicate the selection The asterisk indicates the current state 1 Use the Up or Down arrow keys to select 1 YES print With LMG results 2 NO print Without LMG results then press the ENTER key to accept the change 2 Change Laboratory Limits MICROS 60 CS CT Note Laboratory Limits are commonly known as Normal Patient Ranges These Limits will vary with Population and or Geographical location The Default limits set on the ABX MICROS 60 are based on a study of Normal Healthy and Drug free individuals Your li
177. to the Host computer The transmission should be complete if the output format was set up correctly 6 Barcode Setup This sub menu will allow the operator to select the types of Barcode labels to be read by the reader Turning the Checksum ON or OFF gives the operator this capability once the Barcode reader has been installed correctly From the SETUP Menu use the Down arrow key to select 6 BARCODE as indicated 1 Press the ENTER key to access the CHECKSUM Yes or No sub menu 2 Press the ENTER key to accept the change MICROS 60 CS CT Important The Barcode Reader is a special setup function in the system configuration Before using this setup the Barcode Reader must be configured on the Main Circuit board of the ABX MICROS 60 If you require a Barcode Reader for sample Identification please contact your local HORIBA ABX Service Representative for Installation and setup of this device MICROS 60 CS CT Important Verify that the US MODE has been selected in the SPECIAL Menu under the sub menu 7 ID MODE The Barcode reader will only work with this mode selected 7 Memory Card This menu will allow the operator to have the option of storing Patient samples on a Memory card or having the Memory card function turned Off This Memory card option allows the operator to store up to 60 patient results on the card if the instrument has a card reader installed R
178. to the next entry as indiated Change Target values 5 The next screen will indicate changing the WBC Target value 6 Press the ENTER key and enter the new target value for WBC from the Calibration Assay sheet as indicated 7 Press the ENTER key to save the new target value and move to the next entry as indiated 8 The next screen will indicate changing the RBC Target value Repeat Steps 6 through 8 for RBC HGB HCT PLT and MPV When the MPV target value has been entered the next screen that will appear will ask if you want to change the number of samples to be run for calibration A Calibration Reminder MICROS 60 CS CT Note The number of samples you can run for calibration is a Minimum of 3 and a Maximum of 11 In order for the instrument to provide the best mathematical data for a good calibration a Minimum of 6 sample runs is highly recommended for quality statistical calibration data O Change Number of Calibration Samples After all the Target values have been entered the next screen will indicate 9 Press the ENTER key to change the number of samples The next screen will indicate entering the sample number 10 Press the ENTER key and enter the number of samples you wish to run for calibration or press the Escape ESC key if the number of samples desired is already present The LCD will now state as indicated 11
179. tronic pulse to be generated which is amplified measured and then mathematically calculated to create a numerical value First the 28 3ul Diluted Blood sample is diluted in an Electrolytic Diluent e ectronic current conducting fluid mixed then pulled through a Calibrated micro aperture There are two electrodes that are placed on each side of the aperture and a constant electronic current passes between them As the Blood cells pass through the aperture they create resistance Impedence in the electronic field between the two electrodes Since the Current is constant and remains unchanged the Larger the cell is the more resistance it has The Smaller the cell is the less resistance it has The Voltage which measures the cells is proportional to the cell size The Larger the cell the higher the voltage will be The Smaller the cell the lower the voltage will be These Electronic Voltages vary in pulse size as cells pass through the aperture The Pulses are then Channeled according to pulse size The pulses are then Thresholded grouped then mathematically calculated to create a Numerical value for the determination of RBC s and PLIT s A certain amount of cells will pass through the Calibrated Micro aperture within a specific time frame They are then measured by pulse height Thresholded grouped by size and Mathematically calculated along with the Calibration Coefficient to give a final numerical va
180. ue The cleaning cycle will begin and a cleaning time will be displayed This time will vary depending on the revision of software that is currently on the analyzer e This concentrated cleaning cycle involves different cycles Backflush Aspiration Rinsing which allow a good cleaning of the chambers and apertures After this procedure is complete perform a STARTUP cycle to verify that the background parameters are within their limits 4 Once the Startup cycle has passed sample analysis may begin MICROS 60 CS CT Important Severe Fibrin clots in the chambers and apertures may require this conecntrated cleaning procedure to be run more that once with 3 Backflushes before the cleaning cycle and 8 Backflushes after the cleaning cycle to ensure the dislodging of any clot prior to sample analysis Micros 60 O Mechanical Checks This service function will allow the operator to move through a sub menu full of mechanical movements that will allow them to select a specific mechanism for function verification If the operator suspects a specific mechanical failure they may then verify it in this menu From the Service Menu use the Down arrow to select 5 MECHANIC then press the ENTER key to access these sub menus as indicated There are 9 mechanical functions in this sub menu 1 SENSORS Needle and Carriage This allows the operator to check the homing sensors of the Sample probe an
181. uld be disposed of in accordance with local legislation and should be treated as being contaminated with blood The appropriate biological precautions should be taken If any doubt please contact your HORIBA ABX representative service department 3 7 Transportation and Storage Conditions Storage temperature 20 C 50 C MICROS 60 CS CT A Caution Prior to the shipping of an instrument by transporter whatever the destination an external decontamination of the instrument must be carried out Introduction 4 Graphics and Symbols O lt O ME ACE NT LOT E CAL ON O Switch off position Switch on position Alternative current Manufacturer In Vitro Diagnostic Medical Device the Declaration of conformity Caution consult accompanying documents Biological risks Reagent Up This product conforms to the EEC directives and standarts named in Fragile Handle with care Keep dry Do not stack e Batch code x Temperature limitation Use by REF Catalogue number Calibrator Ci Consult Instructions before use Control Content MICROS 60 CS CT All graphics including screens and printouts Ground A photographs are for illustrations purposes only and are not contractual Micros 60 5 Labels 5 1 Main power label In order to replace the 2 1A Fuses located under the power plug connection on the back of the analyzer carry out the followi
182. y set at 1 00 It can be edited by entering into the Calibration Menu and selecting 2 COEFFICIENTS 1 CALIB COEFF enter the password 123 or the password that has been defined by the operator in the set up menu See Section 5 Instrument Configuration 3 Special functions 3 2 Change Password The Instrument Default password is normally set to 123 before operator intervention Press the ENTER key and the following menu will be displayed as indicated 1 Select the number 7 key on the key pad or use the Down arrow key to select the RDW coefficient as indicated on the display 2 Once the RDW coefficient has been selected press the ENTER key to edit the coefficient as indicated on the display 3 Enter the RDW coefficient value which has been calculated from the comparison study Press the ENTER key to accept the new value 4 Press the Escape ESC key until you return to the Main Menu RDW Calibration form a Quality Control Standard The RDW may also be calibrated by using a Known Quality Control Standard DEFINITION A Quality Control Standard is defined as a Commercial blood product which has been specifically developed and Assayed with set parameter Target values and ranges This product is designed to precisely measure the accuracy and linearity of the analyzer 1 Take the ABX Minotrol Controls and bring them to room temperature Gently and thoroughly

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