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- Frank`s Hospital Workshop

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1. Level eei check Connect nical Bent Probe Yes Yes OK error Switched Expiration i message Switched on Press ON OFF on date switch Temperature Yes Yes Yes OK Paper Failed No See Startuj Probe feed iP Reagents motion M Drain OK OK Yes iy nam T M See Start OK Y Y z 5 ee Startu Printout i pe agi ics Ses Replacing F Sop p E transmission Contact a See Heading 8 6 Rinse rinter Configuration eagents nep raeng A 1 Beckman Coulter System i roubleshootin Container gt Ok See Heading 8 6 representativa Procedures a Ok Calibration System vera Troubleshooting Procedures Poor v See Chapter 7 E N Flags Calibration Incorrect l results Instrument Interpretive flags messages Flags AN 2 a All parameters RBC PLT HCT HGB WBC DIFF WBC WBC WBC OK OK OK Reproducibilit RBC RBC RBC Yes OK OK OK Calibrated Calibrated Calibrated Calibrated PIt PIt PIt OK OK OK See Chapter 6 See Chapter 6 See Chapter 6 See Chapter 6 See Chapter 6 Reviewing Results Reviewing Results Reviewing Results Reviewing Results Reviewing Results Hgb Hgb Hgb OK OK OK 4 OK S m a OK h ee Heading See Chapt See Heading 6 3 6 4 6 Reviewing Flags Generated Interpretive Results by the Instrument Messages PN 4237615B D 1 TROUBLESHOOTING FLOWCHART TROUBLESHOOTING FLOWCHART D 2
2. Parameter Correlation r WBC 20 95 RBC 20 95 Hgb 20 95 3 5 3 SPECIFICATIONS CHARACTERISTICS PERFORMANCE SPECIFICATIONS Table 3 4 Accuracy Specifications Continued Parameter Correlation r Het gt 0 95 PIt 0 95 Carryover Carryover Table 3 5 is assessed by analyzing whole blood with high values followed by a whole blood sample with low values Each sample is run consecutively in triplicate Carryover is calculated as follows Low 1 Low 3 x 100 High 1 Low 3 Carryover Table 3 5 Carryover Specifications Parameter Carryover WBC lt 2 0 RBC lt 2 0 Pit lt 2 0 Hgb lt 2 0 Reportable Range The reportable range Table 3 6 is the range of results that the instrument displays prints and transmits Results between the linear range and the reportable range will be flagged Table 3 6 Reportable Range Parameter Units Reportable Range WBC 103 uL 0 0 100 0 RBC 106 uL 0 00 10 00 Pit 108 uL 0 0 1500 0 Hct 0 0 80 0 Hgb g dL 0 0 30 0 3 6 PN 4237615B 3 3 PN 4237615B PERFORMANCE CHARACTERISTICS Reproducibility SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS Reproducibility was measured twice to show precision at two levels of WBC counts one relatively lower than the other Table 3 7 shows the precision values based on 20 replicate samples that were analy
3. R 51 IDENTIFICATION NUMBER 1009 To display the DIFF percentage AEE AME PN values do not select DISPLAY DIFF NABLE A M PCT PDW O Note Regardless of what you select here the percentage and absolute count both print on the report 3 Press e to exit and save the changes A 16 ENABLING ATL IMM PCT AND PDW Do this procedure to enable ATL IMM Pct and PDW results 1 Beginning at the Main menu select SETUP gt gt OTHERS IDENTIFICATION MODE A 28 PN 4237615B INSTRUMENT SETUP A RESETTING THE MANUAL SAMPLE ID NUMBER AND INSTRUMENT SEQUENCE NUMBER TO 1 2 Move the cursor to the ENABLE ATL IMM PCT PDW feature IDENTIFICATION MODE 02 27 00 16 05 MANUAL ID MODE Li AUTONUMBERING MODE ti BAR CODE WITH CHECKSUM x SEQUENCE NUMBER 51 IDENTIFICATION NUMBER 1009 RESET TIME 07 30 AM i 3 Press e 4 Press to save and exit A 17 RESETTING THE MANUAL SAMPLE ID NUMBER AND INSTRUMENT SEQUENCE NUMBER TO 1 The instrument sequence number which indicates the number of cycles analyzed is instrument generated and is independent of the sample ID The sequence number automatically resets to 1 at the reset time shown which can be user defined Do this procedure to reset the manual sample ID number and instrument sequence number to one 1 Beginning at the Main menu select SETUP gt gt OTHERS I
4. No Start Stop equality check but transmission AD 1213 Start Stop equality check but no transmission TADl2Zi Start Stop equality check and transmission F 6 PN 4237615B F 7 See Table F7 1 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS Table F 7 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels BARCODE SPECIFICATIONS F Number of Characters Check Digit or No Check Digit With Check Digit No Check Digit Fixed Digit Test Labels Read this label first then ONE of Read this label first then ONE of the other labels below the other labels below t4ADCO 4AC s Ill Il Ill Il 4ACl2S0404 4ACllD4D4 1236 Ill ll Ill 4ACl230606 4ACl1D6D6s 123457 Ill Il Ill s 4ACcl208082 4AC110808 12345670 i WAL TUE IL 4 4C0131010 401110104 1224567895 B Ill Il Ill 4ACISIZlZ 4ACIIIlZl1Z 123456789012 13 or 14 jj HI II LL WL PN 4237615B F 7 BARCODE SPECIFICATIONS 1 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS Table F 7 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels Continued 15 or 16 AC01316165 tAClll l z lz34567850123452 3 to 15 or 4 to TT ay OTT 15 AC1304165 S h01104165 Note Variable Length Characters are NOT recommended for Interleav
5. A Beckman Coulter Service Representative will install your instrument and printer DEFAULT CONFIGURATION Your instrument was configured prior to installation Table A 1 shows the default configuration information Table A 1 Instrument Default Settings Feature Default Settings To Change the Setting Date format Time format Reporting unit Language MM DD YY AM PM US ENGLISH Do Selecting the Date Format Do Selecting the Time Format Do Heading A 7 REPORTING UNIT SELECTION Do Heading A 4 LANGUAGE AND USA FIELD SELECTION Sample ID mode AUTONUMBERING Do Heading A 14 SELECTING THE SAMPLE IDENTIFICATION ID MODE Barcode with checksum YES Do Heading A 18 SELECTING BARCODE WITH CHECKSUM Display DIFF NO Do Heading A 15 DISPLAYING DIFF OR DIFF Enable ATL IMM PCT and PDW NO Do Heading A 16 ENABLING ATL IMM PCT AND PDW Operator OP1 OP2 OP3 and OP4 Do Defining the Operator Daily workload CBC runs per day 10 Do Heading A 20 CHANGING THE CBC DIFF runs per day 10 DAILY WORKLOAD Autoclean frequency 75 Do Heading A 19 AUTO CLEAN FREQUENCY SETTING Printer configuration Paper length in 11 Do Heading A 10 PRINTER Patient range printout YES CONFIGURATION Messages printout YES DiffPlot amp Histogram Flags NO Histogram Thresholds NO Print raw values NO Zoomed print screen NO Disable printer NO Print format OPT
6. Interfering Substance Het RBC agglutination May produce erroneous Hct and MCV values RBC agglutination may be detected by observing abnormal MCH and MCHC values and by examining the stained blood film Use the manual method to obtain an accurate Hct value MCV RBC agglutination May produce an erroneous MCV value RBC agglutination may be detected by observing abnormal MCH and MCHC values and by examining the stained blood film Use the manual method to obtain an accurate MCV value Excessive numbers of large platelets This condition and or the presence of an excessively high WBC count may interfere with the accurate determination of the MCV value Carefully examine the stained blood film to detect the problem MCH MCH is determined according to the Hgb value and the RBC count which means that anything listed as an interfering substance for Hgb and or RBC will impact MCH and may cause erroneous MCH values MCHC MCHC is determined according to the Hgb and Hct values which means that anything listed as an interfering substance for Hgb and or Het will impact MCHC and may cause erroneous MCHC values RDW RDW is determined according to the RBC count and may be impacted by the following conditions e Agglutinated RBCs May cause a falsely low RBC count and erroneous RDWs Blood samples containing the agglutinated RBC may be detected by observing abnormal MCH and MCHC values and by examining the stained blood
7. The DIFF Patient Ranges are now changed to reflect the new values you entered Repeat steps 3 and 4 as needed to change additional values for the patient range you selected in step 2 PN 4237615B INSTRUMENT SETUP LABORATORY LIMITS SETUP A 7 Repeat steps 2 through 6 to change the other patient ranges if required 8 Press to exit Action Ranges PN 4237615B Your laboratory can set three separate action ranges If a result is outside the selected action range the result will be flagged HH for results above the upper limit and LL for results below the lower limit CBC and DIFF action ranges are initially set to the default values shown in Tables A 3 and A 4 If you want to change the action ranges For CBC do Changing CBC Action Ranges For DIFE do Changing DIFF Action Ranges Changing CBC Action Ranges Table A 5 shows the default action ranges for CBC parameters Table A 5 CBC Default Action Ranges CBC Range Parameter Low Limit High Limit Unit WBC 2 0 15 0 103 uL RBC 2 50 7 00 106 uL Hgb 8 5 20 0 g dL Het 25 0 60 0 MCV 70 120 fL MCH 25 0 35 0 pg MCHC 28 0 38 0 g dL RDW 7 0 25 0 Plt 70 500 103 uL MPV 5 0 12 5 fL Pct 0 1 0 6 PDW 5 0 25 0 A 13 INSTRUMENT SETUP LABORATORY LIMITS SETUP 1 Beginning at the Main menu select SETUP LAB LIMITS ACTION RANGES CBC 2 Press select the
8. position Y 1 Beginning at the Main Menu select DIAGNOSTICS HARDWARE SYSTEMS HARDWARE RESET 2 The instrument resets components to a home position Checking the Valves Contact a Beckman Coulter representative for assistance with this procedure Checking the Motors Contact a Beckman Coulter representative for assistance with this procedure 8 7 REPLACEMENT PROCEDURES Replacing Reagents At Startup the instrument compares the quantity of reagent remaining in each bottle container to the daily workload settings to determine if there is enough reagents for the day For additional information see Heading A 20 CHANGING THE DAILY WORKLOAD If the instrument determines that the reagent may run out before the end of the daily workload a REAGENT LOW LEVEL message is displayed after Startup You can either replace the reagent bottle immediately see Replacing Fix WBC Lyse Hgb Lyse and Rinse Reagents ox Replacing the Diluent Reagent or you can perform analyses until the specific reagent message REAGENT LOW LEVEL XXXXX where XXXXX represents the reagent name appears PN 42376158 8 15 REPLACEMENT PROCEDURES DIAGNOSTICS 8 16 Figure 8 5 shows the reagent bottles containers Figure 8 5 Reagent Bottle Location IMPORTANT Risk of instrument error if reagent is poured from one container to another Never pour reagents from one container to another Particle
9. Count 1 200 in the WBC BASO bath Differential Acquisition 25uL ACsT 5diff Fix 1 000uL Final 35 C 95 F with Differential WBC ACeT 5diff Diluent 1 000uL 1 80 Count in the DIFF bath Hgb Measurement 10yuL ACeT 5diff Diluent 1700uL Preliminary 35 C 95 F in the First After removin 1 170 ER g dilution 1 250 AT Sdiff Diluent 400uL ACT Sdiff Hgb Lyse 400uL RBC and Plt Count 42 5uL of the AC T 5diff Diluent 2 500uL Secondary 35 C 95 F in the RBC bath 1 170 dilution 1 58 8 Note The primary ane 1 170x dilution 1 170 is made First 1 58 8 in the First Dilution Hgb ane Final bath 1 10 000 PARAMETER DEVELOPMENT The AC T 5diff hematology analyzer uses duplicate counting criteria voting criteria and proprietary flagging information to confirm the parameter result prior to reporting it To obtain an RBC count result the instrument compares the data from the two 5 second count periods then votes and rejects any questionable data RBC count Number of cells counted per unit volume x Calibration coefficient The RBC count is displayed and printed as RBC N x 106 cells pL Note cells uL is the US unit format Other formats are available See Heading A 7 REPORTING UNIT SELECTION 2 13 2 OPERATION PRINCIPLES PARAMETER DEVELOPMENT RBC Histogram In addition to being counted red blood cells are categorized according to size from 30 fL to 300 fL by a 256 channel pulse height analyzer
10. Table A 2 Reporting Unit Format INSTRUMENT SETUP A REPORTING UNIT SELECTION Reporting Unit Parameter US SI 1 12 S13 SI4 WBC 103 uL 109 L 109 L 103 uL 109 L RBC 106 uL 1012 L 1012 L 106 uL 1012 L Pit 108 uL 109 L 109 L 103 uL 109 L Het L L L L L L L L Hgb g dL g L g L g dL mmol L MCV fL fL fL fL fL MCH pg pg pg pg fmol MCHC g dL g L g L g dL mmol L RDW MPV fL fL fL fL fL Pct PDW DIFF ratio DIFF 103 uL 109 L 109 L 103 uL 103 uL Do this procedure to select a reporting unit format 1 Beginning at the Main menu select SETUP UNITS PN 4237615B A 7 INSTRUMENT SETUP LABORATORY LIMITS SETUP 2 Move the cursor to the desired report unit format 02 27 00 16 05 3 Press e to select the format 4 Press to save and exit A 8 LABORATORY LIMITS SETUP The instrument provides the ability to define three separate sets of flagging criteria e Range 1 selects Patient Range 1 and Action Range 1 e Range 2 selects Patient Range 2 and Action Range 2 e Range 3 selects Patient Range 3 and Action Range 3 This means that if you select Range 2 the sample results will be reported and flagged according to Patient Range 2 and Action Range 2 Remember these range associations when establishing your laboratory limits and when selecting a range for analysis Patient Ranges Your laborator
11. The instrument does not generate a flag or alarm if you use an expired material 3 Verify that the expiration date is correct e Ifit is correct go to step 4 e Ifitis not correct enter the correct date a Move the cursor to the EXP DATE field b Move the cursor under the number you want to replace 90 009 c Enter the number d Press 9 when you are finished editing the expiration date Note If you need to change the date format do Date Setup 7 4 PN 4237615B CALIBRATION v AUTO CALIBRATION 4 Verify that the target values are correct e Ifthey are correct move to CONTINUE and press 9 e If they are not correct enter the correct target values a Move the cursor to TARGET Move the cursor under the number you want to replace The cursor should be flashing which indicates that you can edit the number C000 009 c Enter the number d Press 9 when you are finished editing the target values e Repeat steps b through d to edit additional target values if necessary f After modifying the target values move to CONTINUE and press 9 The calibration results chart is displayed Note To exit the Auto calibration screen at any time press o Running Calibration Calibration passes when e The CV is within the limits defined in Heading A 13 CALIBRATION SETUP The percentage of difference between the target and the mean value is less than 20 1 Beginning at the Main
12. accordance with local legislation 3 4 PN 4237615B 3 2 PERFORMANCE SPECIFICATIONS SPECIFICATIONS CHARACTERISTICS PERFORMANCE SPECIFICATIONS The stated performance specifications apply to an instrument that has been properly maintained as indicated in Chapter 8 DIAGNOSTICS and one that uses only the recommended reagents listed in Recommended Reagents Reproducibility Reproducibility Table 3 2 is based on 20 consecutive replicate runs from one normal fresh whole blood sample without flags Table 3 2 Reproducibility Specifications Parameter CV Test Level WBC lt 2 0 10 0x103 uL RBC 2 096 5 00x108 pL Hgb lt 1 0 15 0 g dL Het lt 2 0 45 0 Pit lt 5 0 300 0x103 uL Linearity Linearity Table 3 3 is assessed on serially diluted material Each dilution is analyzed four times Table 3 3 Linearity Specifications Difference Parameter Units Linearity Range Whichever is Greater WBC 103 uL 0 4 to 90 0 0 2 or 3 RBC 108 uL 0 23 to 7 70 0 05 or 2 Plt 103 uL 4 to 1 000 10 or 6 Hgb g dL 0 to 22 9 0 3 or 2 Het 1 8 to 55 9 2 Or 3 56 0 to 63 8 5 or 5 Accuracy Accuracy Table 3 4 is assessed by duplicate analysis of clinical specimens when compared to an automated hematology analyzer that has been properly calibrated and maintained according to the manufacturers recommendation PN 4237615B Table 3 4 Accuracy Specifications
13. count will also be flagged 3 Ifthe mobile threshold cannot be 2 18 25u 30 positioned between 18fL and 25fL the threshold is placed at Figure 6 6 Mobile Threshold Cannot Be the 18fL position an SCH Positioned in the Standard Region schistocytes flag is generated A and the Plt count is flagged Suspected abnormalities include the presence of schistocytes and or the presence of Pit aggregates See Figure 6 7 The Plt result is not reliable Verify the result by an alternative method 3 18 25y 30 Figure 6 7 Mobile Threshold Cannot Be Positioned 2 18 250 30 6 10 PN 4237615B REVIEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT 6 Table 6 2 CBC Histogram Flags Continued Histogram Flag Illustrations of Histogram Flags Description Pit SCL An SCL small cell flag indicates the continued presence of small cells in the 2fL and j 3fL regions Rerun the sample and verify the results Suspect or Detailed Flag Format As described in Types of Flag Printout Formats the two types of flag printout formats are Suspect and Detailed formats Suspect Flag Format If the DIFFPLOT AND HISTOGRAM FLAGS option is not selected default setting on the instrument s printer configuration screen the flags are reported displayed and printed in the Suspect format as follows DB prints as DB e The DIFF flag replaces the SL SL1 NL MN UM LN UN and NE fla
14. fL definition GLOSSARY 1 flags definition 6 3 WBC defined 6 8 definition 6 2 definition 6 2 action range 6 12 ATL definition 6 3 6 7 6 11 BASO definition 6 8 INDEX 3 INDEX CBC histogram 6 8 DB definition 6 3 6 4 6 11 definition 6 1 GLOSSARY 1 DIFF definition 6 3 DIFF definition 6 11 DIFF definition 6 3 DiffPlot 6 3 format types 6 1 H definition 6 12 HH definition 6 12 HISTO definition 6 11 IMM definition 6 3 6 7 6 11 L definition 6 12 LL definition 6 12 LN definition 6 3 6 6 MACRO definition 6 9 MB definition 6 8 MIC definition 6 10 MICRO definition 6 9 MN definition 6 3 6 5 NE definition 6 3 6 7 NL definition 6 3 6 5 patient range 6 12 R definition 6 2 reject 6 3 review definition 6 2 SCL definition 6 11 SL definition 6 3 6 4 SL1 definition 6 3 6 5 types 6 1 UM definition 6 3 6 6 UN definition 6 3 6 6 V definition 6 3 voteout definition 6 3 WBC BA definition 6 11 flowcell rinsing procedure 8 13 flowcell lamp replacement 8 29 G 8 definition ABBREVIATIONS 1 gal definition ABBREVIATIONS 1 GR definition ABBREVIATIONS 1 grounding requirements 3 1 INDEX 4 H H flag definition 6 12 hardware reset function 8 15 procedure 8 15 hardware system troubleshooting 8 15 hazards operational list 4 2 Het definition ABBREVIATIONS 1 interfering substances 3 10 header report
15. the result will be indicated as follows Ifthe result is below the lower limits of the instrument the result will be reported as 0 For example if the WBC is less than 0 1x10 pL WBC is reported as 0 0 e Ifthe result is outside the limits at which the parameter can be calculated the result is replaced by Ifthe result is above the instruments linear range the result is flagged with or if the result is above the instruments reportable range the result is replaced by In addition related parameters may also be flagged or replaced Hemoglobin Errors Hgh Blank Error The instrument establishes a reference blank reading and compares each sample blank to the reference result If the blank differs from the reference by more than an allowable amount the Hgb MCH and MCHC results are flagged with a review R flag If three consecutive samples produce a Hgb blank error the Hgb MCH and MCHC results are replaced by on the third sample Hgh Read Error The instrument reads each sample three times If the difference among the three readings exceeds a predefined limit the Hgb MCH and MCHC results are flagged with a voteout V flag PN 4237615B REVIEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT Voteout Flag The instrument performs two counts on the WBC RBC Hct and Plt If the results for the two counts differ by more than a predefined limit the WBC RBC Hct and Plt results are flagged with
16. 02 0 90 HPV 9 1 fL 6 0 1f 0 EON 0 10 103 uL 0 00 0 50 PCT 0 2 a 0 1 0 86 BAM 0 13 107 pl 0 00 0 20 PDW 15 8 a 7 0 749 0 ATLH 0 07 105 yuL 0 00 0 20 IMME 0 02 103 uL 0 00 70 20 CFL Microscopic Examination Neutrophils Metamyelocytes nisocytasis __ Retics Bands Z Myelacytes Hypocromia Sad Rate Lymphocyte Promyelocytes Polychromasia L7 Monocytes Blast Poikliocytosis Eosinophils ZZ Atyp Lymph Microcytosis Basophils NRBC E MESES Macracytosis i i Comments o ooo uuo Requested by LL Reviewed by H i 7615083B Printing Results for Last Sample Analyzed There are two ways you can print results for the last sample analyzed e Ifthe run screen is displayed press e Ifthe run screen is not displayed beginning at the Main menu select SETUP PRINTER PRINT LATEST RESULT 5 10 PN 4237615B RUNNING SAMPLES 5 SHUTDOWN Auto Clean An auto clean automatic cleaning is performed by the instrument after a specified number of samples is analyzed You can set the frequency from 1 to 75 see Heading A 19 AUTO CLEAN FREQUENCY SETTING 9 4 SHUTDOWN At the end of each day do this procedure to rinse the instrument and place it in a stand by mode 1 Press e The instrument cycles Rinse reagent for cleaning and goes into a stand by mode 2 When Shutdown is complete e Allow the instrument to remain in stand by mode OR Turn the instrument off Note
17. 16 05 WBC 121 ENTER TO SAVE COEFICIENTS ESCAPE TO REJECT RDW 0 34 MPV 1 00 9 Perform a quality control check to verify calibration with the AC T 5diff Control material Table 7 1 Calibration Factors Range Calibration Factor Minimum Maximum WBC 90 200 RBC 160 290 Hgb 25 0 55 0 Hct 160 290 PIt 180 400 RDW 0 1 0 9 1 13 7 CALIBRATION PRINTING CALIBRATION FACTORS 7 5 PRINTING CALIBRATION FACTORS Do this procedure to print the calibration factors 1 Beginning at the Main Menu select CALIBRATION gt PRINT CAL FACTORS CALIBRATION 2 Press to print DATE 02 24 00 TIME 10 52 17 CALI BRATION DATE 02 24 00 An example of a Calibration report is OPERATOR PAT shown here LOT 4 CX292 EXP DATE 03 15 00 TARGET VALUES WBC 104 105 uL RBC 440 105 uL HGB 13 6 g dL HCT 367 PLT 255 108 ul CURR WBC 121 RBC 204 HGB 42 1 HCT 208 PLT 268 RDW 0 34 3 Keepa copy of the printout for your records 7 14 PN 4237615B 8 1 8 2 GENERAL MAINTENANCE DIAGNOSTICS 8 This chapter details the AC T 5diff analyzer maintenance procedures that are your responsibility Also included is a troubleshooting guide to help solve possible instrument problems Failure to properly execute the maintenance procedures in this chapter may compromise instrument performance Perform maintenance procedures either on a time schedule or on an instrume
18. 4 Shutdown 8 5 System Cleaning 8 5 SYSTEM RESET CYCLE 8 9 COMPONENT LOCATIONS 8 10 SYSTEM TROUBLESHOOTING PROCEDURES 8 12 Diluter System 8 12 Backflush 8 12 Bath and Flowcell Rinse 8 13 Draining the Baths and or the Diluent Reservoir 8 14 Hardware System 8 15 Hardware Reset 8 15 Checking the Valves 8 15 Checking the Motors 8 15 REPLACEMENT PROCEDURES 8 15 Replacing Reagents 8 15 Viewing Reagent Levels 8 16 Replacing the Diluent Reagent 8 17 Replacing Fix WBC Lyse Hgb Lyse and Rinse Reagents 8 21 Priming the Reagents 8 26 Replacing the Waste Container 8 27 Replacing the Flowcell Lamp 8 29 SYSTEM ERRORS 8 34 What Error Messages Mean 8 34 TROUBLESHOOTING GUIDES 8 36 INSTRUMENT SETUP A 1 INSTALLATION A 1 DEFAULT CONFIGURATION A 1 CHANGES TO INSTRUMENT SETUP A 2 LANGUAGE AND USA FIELD SELECTION A 2 PASSWORD SETUP A 3 PN 4237615B A 6 A T A 8 A 9 A 10 A 11 A 12 A 13 A 14 A 15 A 16 A 17 A 18 A 19 A 20 A 21 A 22 PN 4237615B CONTENTS DATE TIME SETUP A 4 Date Setup A 4 Selecting the Date Format A 4 Selecting the Time Format A 5 Setting a New Date and Time A 5 REPORTING UNIT SELECTION A 7 LABORATORY LIMITS SETUP A 8 Patient Ranges A 8 Changing CBC Patient Ranges A 9 Changing DIFF Patient Ranges A 11 Action Ranges A 13 Changing CBC Action Ranges A 13 Changing DIFF Action Ranges A 15 SETTING FLAG SENSITIVITY AND
19. 61 F to 93 F If you keep the instrument at a temperature less than 10 C 50 F allow the instrument to remain at the ambient operating temperature for one hour before use PN 4237615B 3 1 SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Altitude Range The instrument can be operated at any altitude up to 3 000 meters 9 800 feet Recommended Location Place the instrument on a clean level bench allowing at least 20cm 8 in of space behind the instrument for ventilation Electromagnetic Environment Check The instrument produces less than the acceptable level of electromagnetic interference when properly placed Electromagnetic interferences are limited to levels that allow the correct operation of other instruments conforming to their placement If there is a problem ensure that the instrument is not placed near electromagnetic fields or short wave emissions such as radar X ray machines scanners and so forth Recommended Reagents Beckman Coulter recommends these reagents e ACeT 5diff Diluent e ACeT 5diff Fix e ACeT 5diff WBC Lyse e ACeT 5diff Hgb Lyse and e ACeT 5diff Rinse See Heading 1 3 REAGENTS for additional information about these reagents Recommended Controls ACeT 5diff Control is the recommended control See Heading 1 2 CONTROLS AND CALIBRATORS for additional information Recommended Calibrator ACeT 5diff Cal Calibrator is the recommended calibrator See Heading 1 2 CON
20. 8 5 when to do 8 5 SYSTEM ERROR RUN SYSTEM RESET CYCLE 8 35 system reset cycle description 8 9 when required 8 9 system setup report printing A 22 T TABLE OF EXPECTED RESULTS definition GLOSSARY 2 tabs INDEX 8 manual dividers xx temperature ambient operating range 3 1 instrument not achieved 8 36 TEMPERATURE OUT OF RANGE 8 35 THE PRINTER IS DISCONNECTED SWITCHED OFF OR HAS NOT BEEN SELECTED 8 35 thresholds description 2 4 Thrombocytopenia triggering condition 6 14 Thrombocytosis triggering condition 6 14 time changing A 5 format selecting A 5 TIMEOUT OVERFLOW ON RS232 8 35 training checklist E 1 troubleshooting dilution problems 8 36 electrical problems 8 37 flowchart D 1 guide 8 36 mechanical problems 8 37 optical problems 8 37 pneumatic problems 8 37 power problems 8 36 printer problems 8 37 procedures 8 12 reagent problems 8 37 results problems 8 37 sampling problems 8 36 Startup problems 8 36 U U S See reporting units USER PASSWORD 8 35 V Vac definition ABBREVIATIONS 2 valves checking 8 15 Vds definition ABBREVIATIONS 2 verification definition GLOSSARY 2 W warning PN 4237615B definition 4 1 8 4 warning labels See labels waste output connector location 1 4 waste container replacement 8 27 waste sensor 8 27 waste sensor function 8 27 location 8 27 WBC definition ABBREVIATIONS 2 interfering substances
21. A 21 Hgb definition ABBREVIATIONS 1 interfering substances 3 9 Hgb Lyse reagent description 1 8 replacement procedure 8 21 HH flag definition 6 12 host RS 232 connector location 1 4 Hypochroma triggering condition 6 13 Hz definition ABBREVIATIONS 1 IMM description 2 20 display print setup A 28 immature granulocytes See IMM important definition 4 1 INCORRECT DATE ENTRY 8 34 INCORRECT TIME ENTRY 8 34 installation by Beckman Coulter representative A 1 instrument component locations 8 10 default configuration A 1 dimensions 3 1 features 1 6 illustration 1 1 intended use 1 1 limitations 3 8 PN 4237615B purpose 1 1 reported parameters 1 1 setup changes what to do after A 2 weight 3 1 where to place it 3 2 interpretive messages definition 6 12 triggering conditions 6 13 L L definition ABBREVIATIONS 1 L flag definition 6 12 labels serial number location 1 4 warning and caution location 1 4 laboratory limits description A 8 setup procedure A 8 lamp See flowcell lamp language selecting display language A 2 Large immature cell triggering condition 6 13 LCD definition 1 2 ABBREVIATIONS 1 location illustration 1 2 LED definition 1 2 ABBREVIATIONS 1 green function 1 2 green location illustration 1 2 red function 1 2 red location illustration 1 2 Left Shift triggering condition 6 13 Leukocytosis triggering condition 6 13 Leukopenia triggering co
22. A 23 cycle count description A 34 viewing A 34 D DATA NOT SAVED VALUE OUT OF RANGE 8 34 date changing A 5 format selecting A 4 setup procedure A 4 debris description 2 19 default configuration instrument A 1 definition GLOSSARY 1 delete button location 1 3 function 1 3 DIFF syringe function 8 11 location 8 11 Diluent reagent description 1 8 input connector location 1 4 replacement procedure 8 17 diluent reservoir draining procedure 8 14 diluent tank function 8 10 location 8 10 diluter system troubleshooting procedures 8 12 dilution ratios 3 2 summary 2 13 dL definition ABBREVIATIONS 1 DRAIN TIMEOUT 8 34 drainage syringe function 8 10 location 8 10 draining procedures PN 4237615B INDEX baths 8 14 diluent reservoir 8 14 E EDTA definition ABBREVIATIONS 1 enter button location 1 3 function 1 3 ENTER AN IDENTIFICATION 8 34 environmental protection requirements 3 4 EO description 2 19 interfering substances 3 11 eosinophil See EO Eosinophilia triggering condition 6 13 error messages definition 8 34 list 8 34 See also individual messages Erythrocytosis triggering condition 6 14 escape button location 1 3 function 1 3 expiration date definition GLOSSARY 1 F femtoliter definition GLOSSARY 1 field definition GLOSSARY 1 fields how to de select 1 12 how to select 1 12 Fix reagent description 1 8 replacement procedure 8 21
23. B 4 PN 4237615B MANUAL CALIBRATION C 1 ANALYSIS PROCEDURE Use a material with known reference values as your calibrator 1 Be sure you have done Heading 7 2 PRE CALIBRATION CHECKS 2 Prepare your material as needed 3 Present the well mixed material to the probe so that the tip is well into the tube and press the aspirate switch 4 Record the results on the calibration worksheet CALIBRATION WORKSHEET Sample Number WBC RBC Hgb Het Pit MEAN A ASSIGNED VALUE B ABSOLUTE DIFFERENCE C CALIBRATION REQUIRED CURRENT CALIBRATION FACTOR D NEW CALIBRATION FACTOR E A E B A xD 9 Repeat steps 3 and 4 ten more times for a total of 11 runs PN 4237615B C 1 MANUAL CALIBRATION CALCULATIONS PROCEDURE 6 Do Heading C 2 CALCULATIONS PROCEDURE C 2 CALCULATIONS PROCEDURE 1 Calculate the mean for each parameter using samples 2 through 11 on the worksheet Write this number into row A on the worksheet 2 Copy your calibrator material s assigned value to the worksheet Write this number into row B on the worksheet 3 Calculate the absolute difference between the assigned value and the mean value calculated in step 1 Write this number into row C of the worksheet C 2 PN 4237615B C 3 PN 4237615B MANUAL CALIBRATION CALCULATING NEW CALIBRATION FACTORS Determine if cal
24. DIAGNOSTICS 8 SYSTEM TROUBLESHOOTING PROCEDURES 2 The instrument performs a backflush Bath and Flowcell Rinse You can rinse the instrument s baths and or flowcell with AC T 5diff Diluent Rinse the baths if you have excessive flagging on CBC parameters e Rinse the flowcell to remove bubbles from the flowcell or if you have excessive flagging on DIFF parameters 12 07 99 16 05 Beginning at the Main Menu select DIAGNOSTICS gt gt DILUTER SYSTEMS gt RINSE 2 FLOWCELL 2 Select BATHS or FLOWCELL 3 The instrument rinses the selected component PN 4237615B 8 13 SYSTEM TROUBLESHOOTING PROCEDURES DIAGNOSTICS 8 14 Draining the Baths and or the Diluent Reservoir Do this procedure if there is a problem with the baths and or the diluent reservoir A 1 Beginning at the Main menu select DIAGNOSTICS DILUTER SYSTEMS gt gt DRAIN BATHS From the Drain Baths menu select one of the following options RINSE FIRST DILUTION DIFF WBC BASO RBC PLT ALL BATHS DILUENT RESERVOIR Note If you select ALL BATHS or DILUENT RESERVOIR a status bar appears to show progress For the other options the red LED illuminates when the function is in progress PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES Hardware System Hardware Reset Hardware Reset initializes the mechanical assemblies and resets instrument components such as motors to a normal or home
25. ENTER AN An ID is required to run an Enter the sample ID IDENTIFICATION analysis in the Manual ID mode INCORRECT DATE ENTRY Value entered is not a valid date Enter a valid date INCORRECT TIME ENTRY Time entered is not a valid time Enter a valid time NO ACK CHARACTER There is a problem with the Verify that the protocol set up in the host RECEIVED ON RS232 communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer NO DILUENT CHECK Diluent reservoir is unable to fill Check the diluent level If necessary do LEVEL Replacing the Diluent Reagent NO ENQ CHARACTER There is a problem with the Verify that the protocol set up in the host RECEIVED ON RS232 communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer PRINTER ERROR CHECK PAPER An error indication has been sent from the Printer to the instrument usually a paper out message 1 Ensure there is paper in the Printer 2 Referto the Printer user s manual for additional information REAGENT LOW LEVEL The calculated reagent level forthe Check the reagent level If necessary do REAGENT NAME specified reagent indicates no Replacing the Diluent Reagent and or reagent Replacing Fix WBC Lyse Hgb Lyse and Rinse Reagents REAGENTS LOW LEVEL This message is given at the end Monitor the reagent levels If necessary of start
26. FIRE HAZARD REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE FOR SAFETY REASONS EQUIPMENT REQUIRES CONNECTION TO PROTECTIVE EARTH GROUND A sepu BIOHAZARDOUS MATERIAL REFER TO PRODUICT REFERENCE MANUAL FOR PROPER HANDLING CAUTION ALL COVERS PANELS MUST BE SECURED IN PLACE PRIOR TO INSTRUMENT OPERATION REFER TO PRODUCT REFERENCE MANUAL FOR PROPER INSTALLATION 2429555 1 4 PN 4237615B Modes USE AND FUNCTION INTENDED USE The instrument has two modes of analysis CBC and CBC DIFE For information on the parameters of each mode see Parameters Parameters CBC Mode Table 1 1 lists the 12 parameters analyzed in the CBC mode Table 1 1 CBC Parameters Parameter Definition WBC White Blood Cell or leukocyte count RBC Red Blood Cell or erythrocyte count Hgb Hemoglobin concentration Het Hematocrit relative volume of erythrocytes within the whole blood sample MCV Mean Corpuscular erythrocyte Volume MCH Mean Corpuscular erythrocyte Hemoglobin MCHC Mean Corpuscular erythrocyte Hemoglobin Concentration RDW Red Cell erythrocyte Distribution Width Pit Platelet or thrombocyte count MPV Mean Platelet Volume PDWt Platelet Distribution Width Pctt Plateletcrit tPct and PDW are derived parameters and are For Research Use Only Not for use in diagnostic procedures i USE AND FUNCTION INTENDED USE CBC DIFF Mode Table 1 2 lists the
27. Menu press CALIBRATION AUTOCALIBRATION PN 4237615B 7 5 CALIBRATION AUTO CALIBRATION 7 6 2 Move the cursor to CONTINUE and press e AUTOCALIBRATION 02 27 00 16 05 WBC RBC HGB HCT PLT 10 4 440 13 6 13 7 255 204 42 1 208 268 The Autocalibration table is displayed RUN AT LEAST 3 SAMPLES AND PRESS ENTER TO CALIBRATE C CV 3 Prepare the calibrator according to the package insert LN 4 Open the A eT 5diff Cal Calibrator vial AE 9 Present the vial to the sampling probe 1 and ensure that the probe is deep inside the vial press the aspirate switch e PN 4237615B CALIBRATION AUTO CALIBRATION 6 When the red LED remains illuminated remove the vial and replace the cap on the calibrator When the green LED remains illuminated the instrument is ready for the next analysis IMPORTANT Risk of erroneous results if the calibrator is not continuously mixed between each analysis Continue mixing the calibrator between each analysis 7 Mix the calibrator between each analysis 8 When analysis ends the result is displayed 9 Each result used by the instrument for the statistical calculation is selected If you want to discard a result from the calculation highlight the result and press e PN 4237615B 1 1 7 CALIBRATION AUTO CALIBRATION ATTENTION It is recommended that you run the calibrator at least five times to achiev
28. Risk of contamination If you do not properly shield yourself while decontaminating the instrument you may become contaminated To prevent possible biological contamination you must use appropriate barrier protections safety glasses a lab coat gloves and so forth when performing this procedure 9 When the message POUR 3 mL OF EXTENDED CLEANING REAGENT INTO BATHS appears dispense 3 mL of the 196 to 296 chlorine solution into each bath Close the right door Press Allow the instrument to complete the cleaning procedure Note It takes about 5 minutes for the cycle to complete The system will automatically flush to remove the chlorine solution that you dispensed in step 5 Auto Clean An auto clean automatic cleaning is performed by the instrument after a specified number of samples are analyzed You can set the frequency from 1 to 75 see Heading A 19 AUTO CLEAN FREQUENCY SETTING 8 4 DILUTER SYSTEMS 12 07 99 16 05 i POUR 3 ml OF EXTENDED CLEANING REAGENTS INTO BATHS PRESS ENTER KEY TO CONTINUE CYCLE IN PROGRESS PN 4237615B DIAGNOSTICS 8 CLEANING PROCEDURES Shutdown At the end of each day do Shutdown to rinse the instrument and place it in a stand by mode 1 Press e The instrument cycles Rinse reagent for cleaning and goes into a stand by mode 2 When Shutdown is complete Allow the instrument to remain in stand by mo
29. THRESHOLDS A 17 PRINTER CONFIGURATION A 18 Configuring the Instruments Printer Settings A 18 Printing Options A 20 ENTERING EDITING THE INSTITUTIONAL HEADER A 21 PRINTING A SYSTEM SETUP REPORT A 22 CALIBRATION SETUP A 23 Changing CV Limits A 23 Defining the Operator A 25 SELECTING THE SAMPLE IDENTIFICATION ID MODE A 27 DISPLAYING DIFF OR DIFF A 28 ENABLING ATL IMM PCT AND PDW A 28 RESETTING THE MANUAL SAMPLE ID NUMBER AND INSTRUMENT SEQUENCE NUMBER TO 1 A 29 SELECTING BARCODE WITH CHECKSUM A 30 AUTO CLEAN FREQUENCY SETTING A 31 CHANGING THE DAILY WORKLOAD A 32 REAGENT VOLUMES SETUP A 33 VIEWING THE CYCLE COUNT A 34 xi CONTENTS xii LOG SHEETS B 1 ACTION LOG B 2 MAINTENANCE LOG B 3 REAGENT LOG B 4 MANUAL CALIBRATION C 1 C l ANALYSIS PROCEDURE C 1 C 2 CALCULATIONS PROCEDURE C 2 C 3 CALCULATING NEW CALIBRATION FACTORS C 3 Calibration Worksheet C 4 TROUBLESHOOTING FLOWCHART D 1 D 1 TROUBLESHOOTING FLOWCHART D 1 TRAINING CHECKLIST E 1 E INSTALLATION E 1 E2 GENERAL E l E 3 SAMPLE HANDLING E 1 E 4 INSTRUMENT COMPONENTS E 1 E 5 SOFTWARE MENU E 1 E 6 REAGENTS E 1 E 7 INSTRUMENT SETUP CUSTOMIZATION E 2 E 8 CALIBRATION E 2 E 9 CONTROLS E 2 E 10 SYSTEM OPERATION OVERVIEW E 2 E 11 DAILY PROCEDURES E 2 E 12 SPECIAL PROCEDURES E 3 E 13 MAINTAINING AND SERVICING THE INSTRUMENT E 3 E l4 PAPERWORK E 3 BARCODE SPECIFICATIONS F 1 El OVERV
30. action range 02 27 00 16 05 1 2 or 3 to be changed ACTION RANGES 1 70 500 5 0 125 0 6 The range number is displayed as ACTION RANGES X where X is the number 2 2 8 2 7 25 28 7 3 Move the cursor to the value to be changed 4 Edit the value 0999 0099 5 Press to save The CBC Action Ranges are now changed to reflect the new values you entered A 14 PN 4237615B PN 4237615B INSTRUMENT SETUP LABORATORY LIMITS SETUP 6 Repeat steps 3 and 4 as needed to change additional values for the action range you selected in step 2 7 Repeat steps 2 through 6 to change the other action ranges if required 8 Press to exit Changing DIFF Action Ranges Table A 6 shows the default action ranges for DIFF parameters Table A 6 DIFF Default Action Ranges DIFF Range Parameter Low Limit High Limit Unit NE 45 0 85 0 LY 15 0 55 0 M0 1 0 12 0 E0 0 0 8 0 BA 0 0 5 0 ATL 0 0 5 0 IMM 0 0 5 0 NE 1 50 9 00 103 uL LY 0 75 5 50 103 uL MO 0 00 1 10 103 uL EO 0 00 0 60 103 uL BA 0 00 0 30 103 uL ATL 0 00 0 60 103 uL IMM 0 00 0 60 103 uL A 15 A INSTRUMENT SETUP LABORATORY LIMITS SETUP A 16 Beginning at the Main menu select SETUP LAB LIMITS ACTION RANGES DIFF Press to select the action range 1 2 or 3 to be changed The range number is displaye
31. compartment door 9 Remove the empty bottle from the reagent compartment eee Hi eee WBC Lyse PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES 6 Remove the bottle stopper assembly from the reagent you are replacing 1 Uncapa new reagent bottle Af 8 Putthe cap from the new container onto the empty container 9 Properly dispose of the empty bottle PN 4237615B 8 23 DIAGNOSTICS REPLACEMENT PROCEDURES 10 Insert the stopper assembly tube into the new bottle gt ll 11 Tighten the stopper assembly onto the bottle to ensure an adequate seal T 12 Put the new reagent bottle in the reagent compartment ACeT 5diff Rinse is shown here 8 24 PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES 13 Close the reagent compartment door 14 Enter the lot number from the new reagent container LEVEL CHANGE 12 07 99 16 05 AM DILUENT 93 CHANGE EIX FIX ENTER LOT NUMBER AND PRESS ENTER TO CONTINUE LOT 00102D0002 CHANGE ALL C000 099 PN 4237615B 8 25 DIAGNOSTICS REPLACEMENT PROCEDURES 8 26 15 Press 9 This primes the reagent you replaced and updates the level indicator Note Due to priming the reagent level may not be displayed as 10096 ATTENTION If an instrument error occurs during the prime cycle of a reagent replacement procedure th
32. doing calibration is done during calibration and recorded with the calibration results 1 Beginning at the Main menu select SETUP OTHERS gt CALIBRATION gt gt DEFINE OPERATOR 02 27 99 16 05 DEFINE OEPRATOR OPERATOR 1 LIAM OPERATOR 2 PAT OPERATOR 3 OP3 OPERATOR 4 OP4 2 Move the cursor to the Operator ID you want to edit 3 Press 9 The cursor becomes a flashing underscore to let you edit the field 4 Edit the operator definition by entering up to eight alphanumeric characters e Press or 0 to display alpha characters C000 e099 e Enter numbers at the numeric keypad PN 42376158 A 25 INSTRUMENT SETUP CALIBRATION SETUP 9 Press 9 to accept the changes and to move to the next operator field 6 Repeat steps 2 through 5 until all operators have been defined DEFINE OPERATOR 2 27 99 16 05 OPERATOR 1 TAMMY OPERATOR 2 PATRICK OPERATOR 3 OP3 OPERATOR 4 OP4 7 Press to save and exit A 26 PN 4237615B INSTRUMENT SETUP A SELECTING THE SAMPLE IDENTIFICATION ID MODE A 14 SELECTING THE SAMPLE IDENTIFICATION ID MODE Before you analyze a sample a sample ID is required You can manually enter the sample ID scan the barcode ID from the sample tube using the optional barcode reader or have the instrument automatically assign auto number the sample ID Ifyou select Manual you are required to enter an ID before running the sample Enter a sample
33. flowcell incorporates a 60pm aperture for cellular volume analysis and a 42m measurement area for light absorbance Focused Flow Impedance Focused flow impedance technology measures the electrical resistance of a cell as it passes through the aperture in the flowcell The change in resistance is directly proportional to the volume of the cell 2 3 2 OPERATION PRINCIPLES ACV TECHNOLOGY Absorbance Cytochemistry As a cell passes through the optical portion of the flowcell light is scattered in all directions A sensor detects only forward scattered light The optical measurement is derived as a function of the amount of light lost due to diffraction and absorbance as compared to full transmission when no cell is present The collected signals are converted into voltage pulses and are processed The magnitude of the voltage pulses are proportional to the physical and chemical characteristics of the cells being analyzed Light absorbance is related to cellular contents granularity nuclear content and so forth after cytochemical staining These measurements provide the information for lymphocytes monocytes neutrophils and eosinophils and their precursors Signal Processing The signals from the flowcell aperture and from the optical measurement are correlated by a window of time The optical pulse must be detected within 100 to 300 microseconds of the impedance pulse otherwise the signal is rejected The output signals from
34. limits defined in Heading A 13 CALIBRATION SETUP The percentage of difference between the target and the mean value is less than 20 Forced Calibration Calibration is forced required when e The CV is not within the limits defined in Heading A 13 CALIBRATION SETUP The percentage of difference between the target and the mean value is greater than 20 The out of range CV is highlighted on the display Figure 7 1 and a flag HH or LL is printed next to the calibration factor Figure 7 1 Out of Range Calibration Factors AUTOCALIBRATION 12 07 99 16 05 CALIBRATION FAILED PRESS ENTER TO FORCE CALIBRATION ESCAPE TO RETURN 127 197 38 97 207 4 245 198 1266 _ 166 _ 10 3 4 41 13 3 38 0 218 0 70 0 58 0 34 0 70 3 44 PN 4237615B 7 9 CALIBRATION AUTO CALIBRATION 7 10 Decide if you want to save the new calibration factors or if you want to quit calibration and save the previous factors e Ifyou want to save the new factors go to step 2 e Ifyou want to quit calibration and save the previous factors press o Do not continue to step 2 Press to force calibration using the new factors Enter the user password and press e AUTOCALIBRATION 12 07 99 16 05 38 3 226 38 0 219 37 9 217 207 245 138 5 38 0 218 0 70 3 44 PN 4237615B CALIBRATION MANUAL CALIBRATION FACTOR ADJUSTMENT 4 The calibration report is pri
35. low level of cellular complexity they absorb less light As a result band cells tend to appear in the region between the neutrophils and the monocytes Blast Cells Blast cells are generally larger than monocytes and have similar absorbance When blast cells are present they are generally located above the monocytes which means they will be included in the IMM cell count Small blasts will be located between the normal lymphocyte and monocyte populations 9 90 PN 4237615B SPECIFICATIONS CHARACTERISTICS 3 1 INSTRUMENT SPECIFICATIONS Dimensions and Weight See Figure 3 1 WARNING Risk of operator injury if only one person lifts the instrument The instrument has no lifting handles and it weighs more than one person should lift Therefore to prevent injury at least two people following necessary safety precautions should lift the instrument together Figure 3 1 Instrument Dimensions and Weight 81 0 Ib 37 0 Kg Power Supply From 100 Vac to 240 Vac From 50 Hz to 60 Hz Consumption 200 watts maximum Installation Category The instrument is designed to be safe for transient voltages according to Installation Category II and Pollution Degree 2 Grounding Requirements To protect against electrical shock the wall ground earth plug must be correctly connected to the laboratory grounding electricity installation Temperature Ambient Operating The ambient operating temperature is 16 C to 34 C
36. parameters numeric results e Non replacement flags appear next to the parameter results Up to two of these flags can be displayed for a parameter Types of Flag Printout Formats The system provides two printout formats for reporting the DiffPlot and histogram flags on the patient report Suspect and Detailed Ifthe DIFFPLOT AND HISTROGRAM FLAGS print option is not selected samples are flagged using the Suspect format Note This is the default setting Ifthe DIFFPLOT AND HISTOGRAM FLAGS print option is selected samples are flagged using the Detailed format For additional information on print options see Configuring the Instrument s Printer Settings For additional information on flag printout formats see Suspect or Detailed Flag Format PN 4237615B 6 1 REVIEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT 6 3 6 2 Interpretive Messages Definition Interpretive messages are triggered from the flagging limits established by your laboratory These messages indicate possible pathological disorders For details see Heading 6 4 INTERPRETIVE MESSAGES FLAGS GENERATED BY THE INSTRUMENT The following sections define these general instrument generated flags e Results Exceeding Instrument Capacity e Hemoglobin Errors e Voteout Flag e WBC Count Flag e DiffPlot Flags e CBC Flags and e Patient Ranges and Action Ranges Results Exceeding Instrument Capacity If a result exceeds instrument capacity
37. sample is pulled from the tube into the sample probe Depending on the selected mode of operation the AC T 5diff analyzer aspirates either 30uL CBC mode or 53pL CBC DIFF mode of sample The volume of sample aspirated into the sample probe is sufficient to make all the dilutions needed to develop parameter results in the selected mode of operation The aspirated sample is then partitioned as it is distributed into the designated baths Figure 2 5 shows the sample partitioning that occurs in the CBC DIFF mode Notice there are three aliquots of the aspirated whole blood sample that will be used to make dilutions Figure 2 6 shows the sample partitioning that occurs in the CBC mode Notice there are only two aliquots of the aspirated whole blood sample that will be used to make dilutions in this mode of operation The DIFF aliquot is not needed in the CBC mode To ensure sample integrity the sample aliquot at the tip of the probe is never used to make a dilution it is discarded into the Rinse bath PN 4237615B 2 5 OPERATION PRINCIPLES SAMPLE ANALYSIS OVERVIEW Figure 2 5 Sample Partitions Inside the Probe CBC DIFF Mode Diluent Air bubble Not used DIFF dilution WBC BASO dilution Not used Dilution RBC PLT HGB first dilution Figure 2 6 Sample Partitions Inside the Probe CBC Mode Diluent Air bubble Not used WBC BASO dilution RBC PLT HGB first dilution Not used 7616056
38. the DiffPlot e Reject UM upper monocyte e DB debris LN lower neutrophil SL small lymphocytes e UN upper neutrophil e SLI small lymphocytes 1 NE neutrophil eosinophil NL neutrophil lymphocyte e ATL atypical lymphocytes MN monocyte neutrophil MM immature cells See Table 6 1 for additional information PN 42376158 6 3 6 REVIEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT Table 6 1 Definition of DIFF Flags DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities The system R next to all detects a problem DIFF with volume and parameters Debris DB Absorbance absorbance measurements in the flowcell More than 5096 of the pulses were rejected DB Occurs when the DB is displayed Plt aggregates number of pulses and printed in Increased Plt count in the DB region WBC flag area exceeds the DBZ RBCs resistant to limit lysis stroma Default values NRBCs 100 or 120 Reagent particles contamination SL Occurs when the R next to Small lymphocytes umher o NE NE Pit aggregates particles that are LY95 LY counted in the SL M0 MO NRBCs region is higher E0 EO RBCs resistant to than the SL limit ATL ATLA lysis stroma Default values IMM IMM 100 or 50 SL displayed particles and printed in Debris WBC flag area Absorbance 6 4 PN 4237615B FLAGS GENERATED BY THE INSTRU
39. the top cover a Place the top cover on the instrument b Fasten the three hex screws to secure the cover to the instrument frame c Replace the left door and fasten the four hex screws to secure the door to the instrument frame d Close the right door 12 After closing all doors and replacing all covers plug the instrument into the power source 13 Turn the instrument on and verify instrument performance by running a fresh whole blood sample 8 33 8 DIAGNOSTICS SYSTEM ERRORS 8 8 SYSTEM ERRORS What Error Messages Mean 8 34 Table 8 2 lists errors messages that may appear on the instrument Table 8 2 Error Messages Message Probable Cause Suggested Action AT LEAST 3 TAGGED At least 3 results are required for Run at least three results for calculation RESULTS REQUIRED calibration calculations and less results to be generated than 3 have been run BATH ENCLOSURE DOOR If a cycle is attempted while the 1 Close the door OPENED right side door is open this 2 Do Heading 8 4 SYSTEM RESET message is generated CYCLE DATA NOT SAVED VALUE The value typed in is not an Re enter the data OUT OF RANGE acceptable value It may be out of an expected range or an incorrect data type DRAIN TIMEOUT Problems with draining 1 Do Heading 8 4 SYSTEM RESET CYCLE 2 fthe problem persists contact a Beckman Coulter representative
40. their native size Figure 2 14 is an example of a Plt histogram with a normal Plt size distribution Figure 2 14 Typical Pit Histogram 30fL Interference on the Lower End of the Platelet Distribution Curve Particles that are approximately platelet size can interfere with the platelet histogram and count Small particles such as micro bubbles or dust can interfere at the low end If the number of pulses in the 2 to 3 fL region is higher than the predefined limits an SCL flag appears to alert the operator that a significant number of small cells or interference such as micro bubbles are present PN 42376158 2 15 OPERATION PRINCIPLES PARAMETER DEVELOPMENT Microcytic Interferences on the Upper End of the Platelet Distribution Curve Microcytic red blood cells can intrude at the upper end of the platelet distribution curve If the sample contains microcytes the AC T 5diff analyzer may be able to successfully eliminate the influence of this interference by repositioning the variable threshold and excluding the microcytes Parameter Results Obtained Using the PIt Histogram Plt Count The AC T 5diff hematology analyzer uses duplicate counting criteria voting criteria and proprietary flagging information to confirm the parameter result prior to reporting it To obtain a Plt count result the instrument compares the data from the two 5 second count periods then votes and rejects any questionable data Plt count Number of cells coun
41. used a brief description of the major components and how to work with the software Chapter 2 OPERATION PRINCIPLES Contains the descriptions for cell counting and voting and how the parameters are derived Chapter 3 SPECIFICATIONS CHARACTERISTICS Details instrument specifications characteristics and interfering substances e Chapter 4 PRECAUTIONS HAZARDS Provides information about key safety issues and contains information on biological hazards and hazards pertaining to moving parts Chapter 5 RUNNING SAMPLES Provides information on how to run patient blood samples PN 42376158 xvii INTRODUCTION ABOUT THIS MANUAL xviii Chapter 6 REVIEWING RESULTS Provides information on reviewing flagged sample results Chapter 7 CALIBRATION Provides procedures for calibrating the instrument including manually adjusting the calibration factors Chapter 8 DIAGNOSTICS Provides information about special procedures and troubleshooting procedures for the instrument Includes topics such as a maintenance schedule cleaning and replacement procedures and what error messages mean Appendix A INSTRUMENT SETUP Provides procedures on customizing the instruments settings such as date time reporting units laboratory limits and others Appendix B LOG SHEETS Contains log sheets for your laboratory s use Appendix C MANUAL CALIBRATION Provides a procedure for manually calibrating the instrument Appendix D TROUBLESHOOTI
42. 00 5 00 109 uL 0 00 0 30 107 uL 0 20 70 20 10 uL O 102 ni 6 00 70 20 Microscopic Examination Area 1 of the report See Printing Options Area 2 of the report See Printing Options Area 3 of the report See Printing Options Header See Heading A 11 ENTERING EDITING THE INSTITUTIONAL HEADER Date See Heading A 6 DATE TIME SETUP PN 4237615B e 0 Patient information Written or typed by the operator after the report is printed Time See Heading A 6 DATE TIME SETUP Flags See Chapter 6 REVIEWING RESULTS Parameter See Parameters Neutrophils Metamyelocytes 5 1 Anisocytasis 111 Retics Bands LLL Myelacytes Hypoeroeia ied Rate Lyaphocytes Proayelocytes Lo Poiychroessia Monocytes Plast Mi party fa EEG veis rela a PIDE MUE bt g perenne Pacrocytosis CM ees Comments Uu Reguested bys Reviewed by RCM eu R ARE 76150688 Sample ID Result Displayed in the See Heading A 14 selected format See SELECTING THE SAMPLE Heading A 7 REPORTING IDENTIFICATION ID UNIT SELECTION MODE Reporting unit See Heading A 7 REPORTING UNIT SELECTION Range See Heading A 8 LABORATORY LIMITS SETUP Other flagging information and interpretive messages if any e A 19 INSTRUMENT SETUP PRINTER CONFIGURATION A 20 Printing Options There are three report printing options The opt
43. 1 calibrator definition GLOSSARY 1 recommended 3 2 calibrators recommended 1 7 carryover definition GLOSSARY 1 performance characteristics 3 8 performance specifications 3 6 caution definition 4 1 caution labels See labels CBC INDEX 2 definition ABBREVIATIONS 1 CBC parameters excessive flagging what to do if 8 13 CBC DIFF mode button 1 3 CBC DIFF parameters excessive flagging what to do if 8 13 cell control definition GLOSSARY 1 recommended 1 7 results not acceptable 5 7 characteristics definition GLOSSARY 1 See also performance characteristics cleaning procedures auto clean 8 4 extended cleaning 8 2 for inside of instrument 8 2 for outside of instrument 8 2 system cleaning 8 5 cm definition ABBREVIATIONS 1 coefficient of variation CV definition GLOSSARY 1 Cold agglutinin triggering condition 6 13 components resetting to home position 8 15 configuration report printing A 22 contamination risk 8 4 control definition GLOSSARY 1 recommended 3 2 control panel definition of each button 1 3 function 1 2 location illustration 1 2 conventions definition GLOSSARY 1 used in this manual xix counting assembly function 8 10 location 8 10 counting syringe function 8 11 location 8 11 cursor arrows 1 11 how to move 1 11 cursor keys PN 4237615B button location 1 3 function 1 3 CV definition GLOSSARY 1 CV limits changing A 23 defaults
44. 26 parameters analyzed in the CBC DIFF mode Table 1 2 CBC DIFF Parameters Parameter Definition WBC White Blood Cell or leukocyte count NE Neutrophil percentage NE Neutrophil number LY Lymphocyte percentage LY Lymphocyte number MO Monocyte percentage MO Monocyte number E0 Eosinophil percentage EO Eosinophil number BA Basophil percentage BA Basophil number IMM t Immature cell percentage IMM t Immature cell number ATL t Atypical lymphocyte percentage ATL t Atypical lymphocyte number RBC Red Blood Cell or erythrocyte count Hgb Hemoglobin concentration Het Hematocrit relative volume of erythrocytes within the whole blood sample MCV Mean Corpuscular erythrocyte Volume MCH Mean Corpuscular erythrocyte Hemoglobin MCHC Mean Corpuscular erythrocyte Hemoglobin Concentration RDW Red Cell erythrocyte Distribution Width Plt Platelet or thrombocyte count MPV Mean Platelet thrombocyte Volume PDWt Platelet Distribution Width Pett Plateletcrit tDerived parameters are For Research Use Only Not for use in diagnostic procedures Features Features of the instrument include automated calibration one button aspiration with probe wipe 12 or 26 parameter analysis with histograms and DiffPlots and alphanumeric or barcode patient sample identification Reports Patient sample reports are printed based on your instrument setup 1 6 PN 423
45. 3 6 Reportable Range 3 6 3 7 Reproducibility Characteristics From a Normal Sample with a Low Normal WBC Count 3 7 3 8 Reproducibility Characteristics From a Normal Sample with a High Normal WBC Count 3 7 3 9 Accuracy Characteristics 3 8 3 10 Carryover Characteristics 3 8 3 11 Interfering Substances 3 9 6 1 Definition of DIFF Flags 6 4 6 2 CBC Histogram Flags 6 8 6 3 Patient Range and Action Range Flags 6 12 6 4 WBC Interpretive Messages from Action Ranges 6 13 6 5 WBC Interpretive Messages from DiffPlot 6 13 6 6 RBC Interpretive Messages from Action Ranges 6 13 6 7 RBC Interpretive Messages from Flag Sensitivity 6 14 xiv PN 4237615B 6 8 6 9 6 10 6 11 7 1 8 1 8 2 8 3 A l A 2 A 3 A 4 A 5 A 6 A T A 8 A 9 El E2 E3 E4 E5 E6 E7 PN 4237615B CONTENTS Plt Interpretive Messages from Action Ranges 6 14 Plt Interpretive Messages from the Plt Histogram 6 14 Interpretive Messages from a Combination of WBC RBC PIt Action Ranges 6 14 NRBCs and PLATELET AGGREGATES Interpretive Messages 6 15 Calibration Factors Range 7 13 Maintenance Schedule 8 1 Error Messages 8 34 Troubleshooting Guide 8 36 Instrument Default Settings A 1 Reporting Unit Format A 7 CBC Default Patient Ranges A 9 DIFF Default Patient Ranges A 11 CBC Default Action Ranges A 13 DIFF Default Action Ranges A 15 Default CV Limits A 23 Daily Workload Runs by Mode A 32 Default Reagent Volumes A 33 Default Barcode S
46. 3 9 WBC Lyse reagent description 1 8 replacement procedure 8 21 whole blood definition GLOSSARY 2 workload daily changing A 32 defaults A 32 description A 32 WRITE ERROR RS232 8 35 X XXX NOT REACHING HOME 8 35 PN 4237615B INDEX INDEX 9 INDEX INDEX 10 PN 4237615B TRADEMARKS m ACeT and Beckman Coulter are trademarks of Beckman Coulter Inc All other trademarks service marks products or services are trademarks or registered trademarks of their respective holders PN 4237615B BECKMAN COULTER ACeT 5diff Hematology Analyzer Documentation Operator s Guide Use and Function Operation Principles Specifications Characteristics e PN 4237615 Precautions Hazards Running Samples Reviewing Results Calibration e Diagnostics Instrument Setup Log Sheets Manual Calibration e Troubleshooting Flowchart Training Checklist e References Glossary e Abbreviations Index Host Transmission Specification Defines requirements for interfacing the instrument to a host computer PN 4277065 Come visit us at www beckmancoulter com O un Copyright Beckman Coulter Inc 2000 CO ULI El t All Rights Reserved 6 COULTER CORPORATION SEA Printed on Recycled Paper A Beckman Coulter Company COULTER e Miami Florida 33196 2500 USA
47. 615B INTENDED USE 1 1 General 1 1 Purpose 1 1 Instrument Description 1 1 Control Panel 1 3 Back Panel 1 4 Warning and Caution Labels 1 4 Modes 1 5 Parameters 1 5 CBC Mode 1 5 CBC DIFF Mode 1 6 Features 1 6 Reports 1 6 CONTROLS AND CALIBRATORS 1 7 Cell Controls 1 7 Calibrator 1 7 REAGENTS 1 7 ACeT 5diff Diluent 1 8 ACeT 5diff Fix 1 8 ACeT 5diff WBC Lyse 1 8 ACeT 5diff Hgb Lyse 1 8 ACeT 5diff Rinse 1 8 Waste Handling Procedures 1 9 Neutralizing the Waste and Treating for Biohazards 1 9 Handling Expired Reagents 1 10 PRINTER 1 10 RANGES 1 10 CONTENTS um CONTENTS vi 1 6 1 7 1 8 WORKING WITH THE SOFTWARE 1 11 Moving the Cursor 1 11 Selecting Menu Items 1 11 Erasing Saved Text 1 12 Selecting De selecting Software Fields 1 12 PRESENTING SAMPLES TUBES OR VIALS AND STARTING ANALYSIS 1 13 ORDERING MATERIAL SAFETY DATA SHEETS MSDS 1 13 OPERATION PRINCIPLES 2 1 2 1 2 2 2 3 2 4 2 5 2 6 OVERVIEW 2 1 MEASUREMENT PRINCIPLES 2 1 Coulter Principle 2 1 Aperture Sensor System 2 1 Applying the Coulter Principle 2 2 ACV TECHNOLOGY 2 3 Dual Focused Flow DFF 2 3 Flowcell 2 3 Focused Flow Impedance 2 3 Absorbance Cytochemistry 2 4 Signal Processing 2 4 Thresholds 2 4 WBC BASO METHODOLOGY 2 5 SAMPLE ANALYSIS OVERVIEW 2 5 Aspiration 2 5 Dilution 2 6 CBC Mode 2 7 CBC DIFF Mode 2 7 Delivery 2 7 SAMPLE ANAL
48. 7615B USE AND FUNCTION CONTROLS AND CALIBRATORS 1 2 CONTROLS AND CALIBRATORS Cell Controls A eT 5diff Control is available in three levels low normal and high to provide a stable reference control for use with this instrument Calibrator ACeT 5diff Cal Calibrator is a recommended alternative to the whole blood reference method of calibration and is traceable to reference methods and materials Use ACeT 5diff Cal Calibrator to ensure accurate instrument measurements for WBC RBC Plt Hct and Hgb 1 3 REAGENTS Beckman Coulter recommends these reagents ACeT 5diff Diluent ACeT 5diff Fix ACeT 5diff WBC Lyse ACeT 5diff Hgb Lyse and AC T 5diff Rinse These reagents are Registered by the AFSSAPS Agence Francaise de s curit sanitaire des produits de sant and are For In Vitro Diagnostic Use Manufactured by Coulter Corporation Inc Miami Florida USA and distributed by Beckman Coulter France SA 33 rue des Vanesses BP 50359 Villepinte 95942 Roissy CDG Cedex All stated performance characteristics in this manual are based on the use of the ACeT 5diff analyzer with the above referenced reagents Refer to the reagents bottle container label for detailed information such as stability before using the reagent ATTENTION The open container stability on the reagent labeling applies only to the reagent when connected to the instrument with approved reagent pickups and caps For information on handling rea
49. 9 Label will not read if scanner is programmed to default condition 123123A Codabar PN 4237615B F 3 BARCODE SPECIFICATIONS BARCODE SCANNER CONFIGURATION F 5 BARCODE SCANNER CONFIGURATION To restore the barcode scanner to default settings read each bar code from top to bottom on each column of Table F4 until all bar codes are read Bar codes with S and will sound multiple beeps when read Other codes will only sound a single beep Table F 4 Barcode Scanner Configuration Sheet feag MN Ail WL ll CPO BCL21212 III m H1 N f MN MI ADEC Il AM TUI ATDAAS Il B3EHAASFF ll F 4 PN 4237615B BARCODE SPECIFICATIONS E CODE 39 AND CODABAR BARCODE SCANNER OPTIONS F6 CODE 39 AND CODABAR BARCODE SCANNER OPTIONS e For Code 39 see Table E5 Code 39 Barcode Scanner Options e For Codabar see Table E6 Codabar Barcode Scanner Options Table F 5 Code 39 Barcode Scanner Options Read ONE of the labels below to set Check Digit control option AB113 Code 39 No Check Digit control f4ABl3 Code 39 Check Digit control PN 4237615B F 5 BARCODE SPECIFICATIONS CODE 39 AND CODABAR BARCODE SCANNER OPTIONS Table F 6 Codabar Barcode Scanner Options Read ONE of the labels below to set Start Stop Equality option check 4D1113 No Start Stop equality check nor transmission AD1123
50. 9 0099 2 Move the cursor by pressing o Or 5 12 PN 4237615B RUNNING SAMPLES 5 ENTERING THE SAMPLE IDENTIFICATION ID 3 Repeat steps 1 and 2 until you have entered the sample ID 4 Press 9 when the ID is complete The ID of the current sample appears in the Analyzing field and the ID of the next sample appears in the Next ID field 5 Do Running Whole Blood Samples Scanning the Sample ID with the Barcode Reader The barcode reader is optional If your system is equipped with a barcode reader you can scan the sample ID into the system ATTENTION Beckman Coulter recommends that you verify each barcode reading to ensure correct sample identification eS A 1 Locate the barcode on the sample tube label PN 42376158 5 13 RUNNING SAMPLES ENTERING THE SAMPLE IDENTIFICATION ID IMPORTANT Risk of sample mis identification if the entire barcode is not captured with the barcode reader especially with Interleaved 2 of 5 barcode format Position the barcode reader over the label to capture the entire barcoded sample ID Otherwise part of the sample ID may not be scanned resulting in mis identification Pass the barcode reader over the barcode label on the sample tube 2 Pass the barcode reader over the barcode label on the sample tube The ID of the current sample appears in the Analyzing field and the ID of the next sample appears in the Next ID field 3 Verify each barcode reading
51. A Using the Sequential Dilution System SDS technique the instrument makes a series of dilutions in a series of baths Figure 2 7 Figure 2 7 Bath Assembly 2 6 Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath PN 4237615B OPERATION PRINCIPLES SAMPLE ANALYSIS OVERVIEW CBC Mode After aspiration in the CBC mode aliquots of the whole blood sample are distributed as follows Figure 2 5 e The 3pL sample aliquot at the tip of the probe is discarded into the Rinse bath as the exterior of the sample probe is rinsed ensuring sample integrity e lOgL of sample is delivered to the First Dilution Hgb bath for use in preparing the primary RBC PIt dilution and for measuring the Hgb value e lOgLofsample is delivered to the WBC BASO bath for the WBC BASO count e 7yuL of remaining sample is discarded into the Rinse bath CBC DIFF Mode After aspiration in the CBC DIFF mode aliquots of the whole blood sample are distributed as follows Figure 2 6 e The 3pL sample aliquot at the tip of the probe is discarded into the Rinse bath as the exterior of the sample probe is rinsed ensuring sample integrity e lOgLofsample is delivered to the First Dilution Hgb bath for use in preparing the primary RBC PIt dilution and for measuring the Hgb value e 10uL of sample is delivered to the WBC BASO bath for the WBC BASO count e 25nL of sample is delivered to the DIFF bath for development of the D
52. After doing Shutdown you must do a Startup before operating the instrument again 5 5 ENTERING THE SAMPLE IDENTIFICATION ID Three methods are available for entering sample IDs on this instrument auto numbering manual and barcode optional For details on selecting the sample ID mode see Heading A 14 SELECTING THE SAMPLE IDENTIFICATION ID MODE ATTENTION If the system is set up for a manual ID and no sample ID has been entered the analysis cycle will not start Auto Numbering If your instrument is configured to the Autonumbering ID mode the instrument automatically assigns a sample ID from 1 to 99999 and increments the number before each analysis If you want to override the current autonumber and enter another sample ID do this procedure PN 42376158 5 11 RUNNING SAMPLES ENTERING THE SAMPLE IDENTIFICATION ID A 1 Enter the sequence number in the Next ID field C000 099 2 Press 9 when the ID is complete 3 Do Running Whole Blood Samples The ID of the current sample appears in the upper left corner of the screen and the ID of the next sample appears in the Next ID field Manual Sample ID If your instrument is configured for Manual ID entry do this procedure to enter a sample identification You can enter up to 16 alphanumeric characters in the sample ID e A 1 Press Q or 0 to scroll through the available alpha characters or enter the number at the numeric keypad 099
53. BECKMAN COULTER ACeT 5diff Hematology Analyzer Operator s Guide Mo OM Do 9 9 S08 T o PN 4237615B July 2000 COULTER CORPORATION A Beckman Coulter Company Miami Florida 33196 2500 USA READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS CAUTIONS and IMPORTANTS alert you as follows WARNING Might cause injury CAUTION Might cause damage to the instrument IMPORTANT Might cause misleading results CAUTION System integrity might be compromised and operational failures might occur if This equipment is used in a manner other than specified Operate the instrument as instructed in the Product Manuals e You introduce software that is not authorized by Beckman Coulter into your computer Only operate your system s computer with software authorized by Beckman Coulter e You install software that is not an original copyrighted version Only use software that is an original copyrighted version to prevent virus contamination Beckman Coulter Inc urges its customers to comply with all national health and safety standards such as the use of barrier protection This may include but it is not limited to protective eyewear gloves and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer WARNING Risk of opera
54. CEDURES DIAGNOSTICS 8 18 LN 4 Unscrew the stopper assembly from the container 9 Uncap a new diluent container 6 Putthe cap from the new container onto the empty container 7 Properly dispose of the empty container 8 Insert the stopper assembly tube into the new container 9 Tighten the stopper assembly onto the container to ensure an adequate seal PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES IMPORTANT Risk of instrument error if the diluent container is further than 80cm 31 5 in below the instrument Be sure the diluent container is no more than 80cm 31 5 in below the instrument 10 Put the new container no more than 80 cm 31 5 in below the instrument 11 Enter the lot number from the new reagent container C000 9000 PN 4237615B 8 19 DIAGNOSTICS REPLACEMENT PROCEDURES 8 20 12 Press 9 This primes the Diluent and updates the level indicator Note Due to priming the reagent level may not be displayed as 10096 ATTENTION If an instrument error occurs during the prime cycle of a reagent replacement procedure the reagent is not fully primed and the instrument will not permit sample analysis If the error occurs 1 Press to acknowledge the error 2 Run Heading 8 4 SYSTEM RESET CYCLE 3 Manually prime the reagent as instructed in Priming the Reagents PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES Rep
55. D 2 PN 42376158 TRAINING CHECKLIST E 1 INSTALLATION L Install the instrument according to the instructions in the service manual E 2 GENERAL L Describe the intended use of the instrument including the parameters analyzed displayed and printed L Review the Operator s Guide and reference materials as needed E 3 SAMPLE HANDLING C Review the requirements for specimen collection sample handling storage and mixing for venous and microcollection samples E 4 INSTRUMENT COMPONENTS Identify and locate the following instrument components CL On Off switch L Aspirate switch L Reagent compartment LC Sampling probe L Diluter assembly L Baths 5 C Diluent Reservoir L Printer E5 SOFTWARE MENU Describe the software menu options J Main Menu L Calibration L Reagents C Diagnostics m Setup E 6 REAGENTS Identify and locate each reagent and provide replacement instructions QO ACT 5diff Diluent LJ AcsT 5diff Fix LJ ACT 5diff Rinse L AcsT 5diff WBC Lyse QO ACT 5diff Hgb Lyse PN 42376158 E 1 TRAINING CHECKLIST INSTRUMENT SETUP CUSTOMIZATION E 7 INSTRUMENT SETUP CUSTOMIZATION Review and assist as needed QO Date Time QO Units QO Lab Limits e US e Patient ranges e SH e Action ranges e 12 e Flags Sensitivity e SI3 e Thresholds e 3 4 Q Host Setup Q Printer Q Others e Host Configuration e Printer Configuration e Calibration e Sending Configuration e Print Setup Report e Identif
56. DENTIFICATION IDENTIFICATION MODE 02 27 00 16 05 MODE MANUAL ID MODE D AUTONUMBERING MODE M BAR CODE WITH CHECKSUM m SEQUENCE NUMBER 51 IDENTIFICATION NUMBER 1009 RESET TIME 07 30 AM m PM v eren DIFF 1 NABLE ATL IMM PCT PDW PN 4237615B A 29 INSTRUMENT SETUP SELECTING BARCODE WITH CHECKSUM 2 Highlight RESET and press 9 3 Press o exit and save the changes A 18 SELECTING BARCODE WITH CHECKSUM If you are using the optional barcode reader do this procedure to select or de select the barcode checksum Note The barcode with checksum default is selected which is recommended 1 Beginning at the Main menu select SETUP OTHERS IDENTIFICATION MODE 2 Move the cursor to the checksum field 3 Press amp IDENTIFICATION MODE 02 27 00 16 05 MANUAL ID MODE o BAR CODE WITH CHECKSUM amp RESET IDENTIFICATION NUMBER 009 RESET TIME 07 30 AM PM DISPLAY DIFF O ENABLE ATL IMM PCT POW 0O 4 Press o exit and save the changes A 30 PN 4237615B INSTRUMENT SETUP A AUTO CLEAN FREQUENCY SETTING A 19 AUTO CLEAN FREQUENCY SETTING The instrument automatically performs an autoclean cycle after a specified number of analyses The default number of analyses is 75 You can change this number to be any number from 1 to 75 For example if you want the instrument to run the autoclean cycle after 50 anal
57. Digit Checksum 9 Always Enabled Not Enabled Always Always Enabled Available Enabled Enabled Start Stop Equality Check Not Not Enabled Not Not Not Available Available Available Available Available Start Stop Equality Output Not Not Disabled Not Not Not Available Available Available Available Available Code 128 provides excellent density alphanumeric characters and good security Recommend using this symbology if using barcodes for the first time and if compatible with other bar code systems used in your lab 9p increased sample identification integrity always use Check Digit Checksum umber of characters for 2 of 5 can be programmed for other lengths including variable length However the variable length is NOT recommended for 2 of 5 due to the possibility of capturing a partial read of the bar code label F 2 PN 4237615B BARCODE SPECIFICATIONS E BARCODE LABEL TEST PAGES F 4 BARCODE LABEL TEST PAGES See Tables E2 and E3 Table F 2 Test Labels With the Check Digit Checksum l 345ABCDE l 34567 Code 128 EAN 8 Reads 123456770 l z3ABCZ Llzs4567 890125 Code 39 EAN 13 If this label is read with Check Digit Reads 12345678901228 disabled the last character is also displayed lz345e78323 01z Interleaved 2 of 5 Reads 11 characters with Check Digit or reads 12 characters without Check Digit Table F 3 Test Labels Without the Check Digit lz3ABC Code 3
58. E MESSAGES 6 1 Flags 6 1 Definition 6 1 Types of Flags 6 1 Types of Flag Printout Formats 6 1 Interpretive Messages 6 2 Definition 6 2 FLAGS GENERATED BY THE INSTRUMENT 6 2 Results Exceeding Instrument Capacity 6 2 Hemoglobin Errors 6 2 Hgb Blank Error 6 2 Hgb Read Error 6 2 Voteout Flag 6 3 WBC Count Flag 6 3 DiffPlot Flags 6 3 CBC Flags 6 8 Suspect or Detailed Flag Format 6 11 Suspect Flag Format 6 11 Detailed Flag Format 6 12 Patient Ranges and Action Ranges 6 12 INTERPRETIVE MESSAGES 6 12 WEC Interpretive Messages 6 13 RBC Interpretive Messages 6 13 Plt Interpretive Messages 6 14 Combination WBC RBC PIt Interpretive Messages 6 14 7 CALIBRATION 7 1 7 1 12 7 3 7 4 7 5 PN 4237615B GENERAL 7 1 Recommended Calibration Conditions 7 1 When to Calibrate 7 1 When to Verify Calibration 7 1 PRE CALIBRATION CHECKS 7 1 AUTO CALIBRATION 7 3 Calibration Setup 7 3 Running Calibration 7 5 Interpreting Calibration Results 7 9 Forced Calibration 7 9 MANUAL CALIBRATION FACTOR ADJUSTMENT 7 11 PRINTING CALIBRATION FACTORS 7 14 CONTENTS 8 DIAGNOSTICS 8 1 8 1 8 2 8 3 8 4 8 5 8 6 8 7 8 8 8 9 A l A 2 A 3 A 4 A 5 GENERAL MAINTENANCE 8 1 MAINTENANCE SCHEDULE 8 1 CLEANING PROCEDURES 8 2 Cleaning the Outside of the Instrument 8 2 Cleaning the Inside of the Instrument 8 2 Extended Cleaning Procedure 8 2 Auto Clean 8
59. ER 2 Move the cursor to where you want to enter information INSTITUTIONNAL HEADER 12 07 99 16 05 HEADER 1 HECKMAN COULTER INC CORE LAB HEADER 2 11800 SW 147 AVE HEADER 3 MIAMI FL 33196 HEADER 4 305 380 3800 3 Press 9 The cursor becomes a flashing underscore to let you edit the field 4 Enter the header text e Press or 0 to display alpha characters C000 90909 Enter numbers at the numeric keypad PN 42376158 A 21 INSTRUMENT SETUP PRINTING A SYSTEM SETUP REPORT 9 Press 9 to accept your changes and to move the cursor to the next line 6 Repeat steps 2 through 5 as needed 7 Press to exit A 12 PRINTING A SYSTEM SETUP REPORT After changing the instrument s setup print a system setup report which details your instruments setup configuration Keep the report for your records Note Regarding printing reagent lot numbers only the lot numbers for the reagents currently in use will print 1 Beginning at the Main menu select SETUP OTHERS PRINT SYSTEM SETUP 2 The system setup report prints Note It may take several minutes to print this report consists of several pages 3 Keep the system setup report for your records A 22 PN 4237615B INSTRUMENT SETUP A CALIBRATION SETUP A 13 CALIBRATION SETUP Changing CV Limits This feature allows you to set the upper limits of the CVs for each parameter used in calculating the CV When c
60. FF RUNS PER DAY 40 NUMBER OF CBC RUNS PER DAY 10 3 Change the number of runs 0009 90009 PN 4237615B INSTRUMENT SETUP REAGENT VOLUMES SETUP A 4 Press to save D Press to exit A 21 REAGENT VOLUMES SETUP This feature defines the initial volumes of each reagent bottle container This information is used to calculate reagent consumption based on the number of analyses performed and to determine the reagent volume remaining in each reagent bottle container Table A 9 shows the default volumes for each reagent Table A 9 Default Reagent Volumes Reagent Standard Volume mL Minimum Maximum Diluent 20 000 1 000 30 000 Fix 1 000 100 5 000 WBC Lyse 1 000 100 5 000 Hgb Lyse 400 100 2 000 Rinse 1 000 100 5 000 ATTENTION Default values Table A 9 are based on the bottle container volume for Beckman Coulter recommended reagents Changing these values may cause reagents to run out without displaying a REAGENT LOW LEVEL message 1 Beginning at the Main menu select SETUP OTHERS REAGENT VOLUMES REAGENT VOLUMES 02 27 00 16 05 DILUENT RINSE FIX WBC LYSE HGB LYSE STANDARD VOLUME ml A 33 INSTRUMENT SETUP VIEWING THE CYCLE COUNT 2 Move the cursor to the value to be changed 3 Edit the values 0099 099 4 Press 9 to save the changes and to move the cursor to the next field 9 Repeat steps 2 through 4 to change other reage
61. ICS 8 SYSTEM RESET CYCLE 19 Turn the instrument on The power on sequence should now perform a startup and background cycle This sequence also establishes a Hgb blank reference which is used ina blank check during normal sample analysis 8 4 SYSTEM RESET CYCLE The System Reset Cycle performs a general rinse draining and initialization of mechanical assemblies Do a System Reset Cycle e Ifthe instrument halts due to error e After an emergency stop of the instrument e When the instrument reports a faulty operation e When prompted by the instrument eS A 1 Beginning at the Main Menu select DIAGNOSTICS SYSTEM RESET CYCLE 2 The instrument is reset PN 42376158 8 9 DIAGNOSTICS COMPONENT LOCATIONS 8 5 COMPONENT LOCATIONS See the following figures for component locations Figure 8 1 View of the Pneumatics Area Right Side Figure 8 2 Bath Assembly Figure 8 3 View Behind Motherboard Left Side and Figure 8 4 Motherboard Figure 8 1 View of the Pneumatics Area Right Side Sampling syringe distributes portions of the specimen into the dilution baths and takes the sample from the first dilution and distributes it into the RBC bath Drainage syringe drains the baths bubbles the mixtures and trans
62. ID by entering numbers at the numeric keypad or by selecting alpha characters using or 0 e Ifyou select Autonumbering the ID number is automatically incremented by 1 from the previously assigned number each time a sample is analyzed Do this procedure to select the sample ID mode manual or autonumber that you will use If you want to use the optional barcode reader you do not have to do this procedure 1 Beginning at the Main menu select SETUP OTHERS IDENTIFICATION MODE 2 Move the cursor to Manual ID Mode or Autonumbering Mode IDENTIFICATION MODE 02 27 00 16 05 MANUAL ID MODE Li AUTONUMBERING MODE ti BAR CODE WITH CHECKSUM m SEQUENCE NUMBE R 51 IDENTIFICATION NUMBER 1009 RESET TIME 07 30 AM f PM DISPLAY DIFF O ENABLE ATL IMM PCT PDW 3 Press e 4 Press e to exit and save the changes PN 4237615B A 27 INSTRUMENT SETUP DISPLAYING DIFF OR DIFF A 15 DISPLAYING DIFF OR DIFF Do this procedure to select how you want the DIFF results displayed on the sample results screen DIFF is the default setting 1 Beginning at the Main menu select SETUP gt gt OTHERS IDENTIFICATION MODE 2 Select the DIFF display option To display the DIFF absolute IDENTIFICATION MODE 02 27 00 16 05 counts move the cursor to KUTONUMBERING MODE n BAR CODE WITH CHECKSUM x DISPLAY DIFF and press em SEQUENCE NUNE
63. IEW F 1 Definition F 1 PN 4237615B E2 E3 E4 E5 E6 E7 CONTENTS BARCODE LABELS F 1 Symbologies F 1 BARCODE SPECIFICATIONS F 1 BARCODE LABEL TEST PAGES F 3 BARCODE SCANNER CONFIGURATION F 4 CODE 39 AND CODABAR BARCODE SCANNER OPTIONS F 5 I 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS F 7 REFERENCES REFERENCES 1 LIST OF REFERENCES REFERENCES 1 GLOSSARY GLOSSARY 1 DEFINITIONS GLOSSARY 1 ABBREVIATIONS ABBREVIATIONS 1 LIST OF ABBREVIATIONS ABBREVIATIONS 1 INDEX INDEX 1 TRADEMARKS ILLUSTRATIONS 1 1 ACeT 5diff Analyzer 1 1 1 2 Outside View of the Instrument 1 2 1 3 Control Panel Buttons 1 3 1 4 Back Panel 1 4 1 5 Warning and Caution Labels on the Instrument 1 4 21 Coulter Principle 2 2 2 2 Dual Focused Flow Process 2 3 2 3 Signal Processing 2 4 2 4 BASO Thresholds 2 5 2 5 Sample Partitions Inside the Probe CBC DIFF Mode 2 6 2 6 Sample Partitions Inside the Probe CBC Mode 2 6 2 7 Bath Assembly 2 6 2 8 Sample Delivery Using Tangential Flow 2 7 2 9 Bath Assembly 2 8 2 10 Bath Assembly 2 10 211 Flowcell Operation 2 11 2 12 DiffPlot Regions 2 12 2 13 Typical RBC Histogram 2 14 2 14 Typical Plt Histogram 2 15 2 15 Area of the Plt Histogram Used to Determine the PDW Parameter Result 2 16 2 16 Areas Used to Determine WBC and BASO Parameter Results 2 17 2 17 DiffPlot Regions 2 18 PN 4237615B xiii CONTENTS 3 1 Instrument Dimensions and Weight 3 1 3 2
64. IEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT CBC Flags There are three types of CBC flags e WBC BASO histogram flags e RBC histogram flags and e Plt histogram flags See Table 6 2 for additional information Table 6 2 CBC Histogram Flags Histogram Flag Illustrations of Histogram Flags Description WBC BASO WBC Figure 6 1 WBC BASO Histogram Flags CBC Mode Determined from the ratio of the cells counted between the 0 channel and BAI Indicates the presence of an abnormal number of cells in comparison to leukocytes Plt aggregates and NRBCs may be found in this region Default value 3 5 or 999 particles Mono CBC DIFF Mode Baso BASO MB Figure 6 2 WBC BASO Histogram Flags Generated when the percentage of basophils found in the BA channel is above the percentage of the LY MO NE raw count found on the DIFF channel If the BASO exceeds 50 a BASO flag is generated The basophils are not taken away from the DiffPlot LY MO NE populations s displayed and printed instead of the BA and BA 6 8 PN 4237615B FLAGS GENERATED BY THE INSTRUMENT Table 6 2 CBC Histogram Flags Continued REVIEWING RESULTS Histogram Flag Illustrations of Histogram Flags Description RBC MICRO Figure 6 3 MICRO and MACRO Regions MICRO and MACRO flags are and or on RBC Histogram generated when the percentage of MACRO cells count
65. ION 1 Patient ranges 1 CBC See Table A 3 DIFF See Table A 4 Do Changing CBC Patient Ranges Do Changing DIFF Patient Ranges Action ranges 1 CBC See Table A 5 DIFF See Table A 6 Do Changing CBC Action Ranges Do Changing DIFF Action Ranges A 1 INSTRUMENT SETUP CHANGES TO INSTRUMENT SETUP A 3 CHANGES TO INSTRUMENT SETUP Any time you change the instrument setup print a setup report for your records See Heading A 12 PRINTING A SYSTEM SETUP REPORT A 4 LANGUAGE AND USA FIELD SELECTION Do this procedure to select the language in which you want the instruments software to be displayed and or to select the USA field ATTENTION The USA field must be selected on all instruments installed in the United States In conjunction with the selection of Pct PDW ATL and IMM parameters the USA field controls the activation of the message In USA Pct PDW ATL and IMM are for Research Use Only 1 Beginning at the Main menu select SETUP gt OTHERS LANGUAGE 2 Move the cursor to the desired option LANGUAGE 02 27 00 16 05 ENGLISH ft FRENCH OU GERMAN ITALIAN O USA y 3 Press e to select the language 4 Press to return to the previous menu A 2 PN 4237615B A 5 PN 4237615B PASSWORD SETUP A user password is required to Change calibration factors Configure RS 232 host transmission Change the user password Change c
66. ISH 2 FRENCH 3 GERMAN 4 SPANISH 5 ITALIAN MENU TREE 7615022B xxi MENU TREE xxii xxii PN 4237615B USE AND FUNCTION 1 1 INTENDED USE General The Beckman Coulter ACeT 5diff Figure 1 1 ACeT 5diff Analyzer hematology analyzer Figure 1 1 isa 26 parameter fully automated hematology analyzer including a five part leukocyte differential counter Of the 26 reported parameters e 20 parameters are For In Vitro Diagnostic Use WBC RBC Hgb Hct MCV MCH MCHC RDW Plt MPV NE NE LY96 LY MO96 MO EO EO BA and BA 6 parameters are qualitative and are For Research Use Only Not for use in diagnostic procedures Pct PDW IMM IMM ATL and ATL Purpose The purpose of the AC T 5diff hematology analyzer is to identify normal patient results with all normal system generated parameters and to flag or identify patient results that require additional studies Instrument Description Figure 1 2 shows the outside of the instrument Figure 1 3 shows the control panel Figure 1 4 shows the back panel Figure 1 5 shows the warning and caution labels on the instrument WARNING Risk of operator injury when covers and doors are not closed and secured in place before you operate the instrument Ensure that all covers and doors are closed and secured before operating the instrument PN 4237615B 1 1 USE AND FUNCTION INTENDED USE 1 2 Figure 1 2 Ou
67. MENT REVIEWING RESULTS Table 6 1 Definition of DIFF Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities SL1 Occurs when the May trigger Plt aggregates number of interpretive NRBCs particles in the SL messages region is higher NRBCs Plt RBCs resistant to than the SL1 aggregates and ysis stroma number limit and NRBCs plus Pit Small abnormal when the aggregates lymphocytes percentage of SL1 is displayed particles inthe SL ang printed in region relative to the WBC flag the lymphocyte area Abasorbaneg region exceeds the SL1 percentage limit Default values 5 or 45 particles NL Occurs when the R next to Small Neutrophils number of NE NE without granules particles in the NL LY and LY and or slight separation region Tv nuclear is above the limits NL Is displayed segmentation g set and printed in L 5 WBC flag area Lymphocytes with g Default values 3 segment nuclei Orto particles Neutrophils with weak membranes smudge smear cells MN Occurs when the R next to Monocytes with number of ATL ATL granules or particles in the MN IMM and hyperbasophilic separation region jyaye monocytes o keii the limits Replaces NE Immature So NEZ MO and neutrophils with Default values MO with non segmented Absorbance 100 or 120 particles MN is displayed and printed in
68. Monocytes are typically large cells with a kidney shaped nucleus and agranular cytoplasm These cells neither scatter nor absorb large amounts of light and therefore are positioned in the lower end of the absorbance axis Due to their size the monocytes are clearly positioned high on the volume axis Figure 2 17 Very large monocytes may be found in the IMM immature cell region Eosinophil Eos With the reagent action eosinophils are the most intensely stained for optical separation Due to the staining and their size the eosinophils will show higher absorbance than the neutrophils but will be of similar volume Figure 2 17 Debris Platelets and debris from erythrocyte lysis represent the background debris population located in the lower region of the DiffPlot PN 4237615B 2 19 2 OPERATION PRINCIPLES PARAMETER DEVELOPMENT Table 2 8 Immature White Blood Cells Immature Cell Type Definition Immature Granulocytes Immature granulocytes are detected by their larger volume and by the presence of granules that increase the intensity of the scattered light Due to their increased volume and similar absorbance promyelocytes myelocytes and metamyelocytes are located above the neutrophil population and are typically counted as IMM cells IMM cells are included in the reported neutrophil value Band Cells Band cells are typically larger or of similar size to the neutrophils however due to their
69. NG FLOWCHART Provides supplemental troubleshooting information Appendix E TRAINING CHECKLIST Summarizes what must be done after the instrument is installed Appendix E BARCODE SPECIFICATIONS Defines the specifications that barcode labels must meet for use with the instrument REFERENCES Lists references used in this manual GLOSSARY Defines terminology used in this manual ABBREVIATIONS Defines abbreviations used in this manual INDEX Provides page numbers for indexed information PN 4237615B INTRODUCTION CONVENTIONS CONVENTIONS This manual uses the following conventions GRAPHICS Main Ment refers to the initial menu displayed on the instrument after MAIN MENU 12 07 99 16 05 Startup 1 RUN SAMPLES 2 CALIBRATION gt 3 REAGENTS gt 4 DIAGNOSTICS gt 5 SETUP gt When instructed to make a menu selection the text appears in bold with two symbols to distinguish the menu path For example if instructed to choose Calibration then Autocalibration the text will appear as CALIBRATION AUTOCALIBRATION Bold font indicates a menu option such as SETUP Italics font indicates screen text displayed on the instrument such as Calibration Passed Bold italics font indicates a heading name within this document For example you may be instructed to do the Startup procedure which would appear as Do Startup Instrument refers to the AC T 5diff hematology analyzer A Note contains
70. Reviewed by 76150838 PN 42376158 3 3 SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Measurements and Computation Impedance for WBC Plt RBC and BA e Photometry for Hgb using cyanmethemoglobin method with 550nm diode light source Impedance and light absorbance for NE LY MO EO ATL and IMM Computation from stored data that was directly measured for Hct MCV MCH MCHC RDW MPV Pct and PDW Counting Aperture Diameters WBC BASO 80 pm DIFF 60 pm RBC Plt 50 pm Reagent Consumption Table 3 1 shows the instruments reagent consumption by cycle Table 3 1 Reagent Consumption by Cycle in mL Approximate Cycle Reagent Duration Diluent WBC Lyse Rinse Fix Hgb Lyse CBC 20 5 2 1 0 9 5 0 4 60 sec CBC DIFF 25 6 2 1 0 9 1 0 0 4 60 sec Startupt 62 0 2 1 3 7 1 0 1 4 3 min 40 sec Shutdown 25 5 14 z 1 0 2 min 45 sec Prime Diluent 35 5 B 2 min 30 sec Prime Rinse 25 8 1 min 20 sec Prime Fix 25 8 T 1 min 30 sec Prime WBC Lyse 25 8 lt 1 min 20 sec Prime Hgb Lyse 2 5 x 4 2 1 min Prime All Reagents 23 7 16 0 16 0 16 0 4 2 3 min 20 sec Autoclean 12 5 B 6 0 z 1 min 35 sec System Reset Cycle 24 0 1 4 1 0 1 min 25 sec tFor one background count only The maximum is three indicates not applicable Environmental Protection Removal and recycling of this instrument must be done by a properly qualified laboratory in
71. S 2 RINSE 3 DRAIN BATHS 4 EXTENDED CLEANING HARDWARE SYSTEMS 2 MOTORS 3 VALVES 4 TRAVERSE SERVICE POSITION SERVICE PASSWORD REQUIRED SET DATE TIME 1 TIME FORMAT 2 DATE FORMAT 3 SET DATE amp TIME LAB LIMITS 1 PATIENT RANGES 2 ACTION RANGES 3 FLAGS SENSITIVITY 4 THRESHOLDS HOST SETUP 1 HOST SETUP CONFIGURATION 2 SENDING CONFIGURATION 3 SENDING OPTIONS 4 VARIABLE FORMAT SETUP 5 SEND LATEST RESULT PRINTER 1 PRINTER CONFIGURATION 2 INSTITUTIONNAL HEADER 3 PRINT LATEST RESULT OTHERS 1 CALIBRATION 2 IDENTIFICATION MODE 3 AUTOCLEAN FREQUENCY 4 CHANGE PASSWORD 5 LANGUAGE 6 REAGENT VOLUMES 7 CYCLE COUNTS 8 PRINT SYSTEM SETUP 9 SEND SETUP RINSE 1 BATHS 2 FLOWCELL DRAIN BATHS 2 FIRST DILUTION 3 DIFF 4 WBC BASO 5 RBC PLT 6 ALL BATHS 7 DILUENT RESERVOIR MOTORS 2 TRAVERSE 3 SAMPLING SYRINGE 4 DRAINING SYRINGE 5 COUNTING SYRINGE 6 FLOWCELL SYRINGES 7 DILUTION SYRINGES VALVES 2 12TO 16 3 17 AND 18 4 20TO 26 5 27TO 31 PATIENT RANGES ACTION RANGES 1 CBC 2 DIFF VARIABLE FORMAT SETUP 1 NUMERICAL RESULTS 2 FLAGS AND MESSAGES 3 HISTOGRAMS AND THRESHOLDS 4 PATIENT FILE CALIBRATION 1 CV LIMITS 2 DEFINE OPERATOR LANGUAGE 1 ENGL
72. STRUMENT SETUP A DATE TIME SETUP Selecting the Time Format Do this procedure to select a time format 1 Beginning at the Main Menu select SETUP gt gt DATE TIME gt gt TIME FORMAT 2 Select the desired time format TIME FORMAT 1 27 00 16 05 AM PM HJ 24H u 3 Press to save and exit Setting a New Date and Time Do this procedure to enter a new date and time into the instrument 1 Beginning at the Main Menu select SETUP gt DATE TIME gt gt SET DATE amp TIME SET DATE amp TIME 1 27 00 16 05 PLEASE ENTER NEW DATE AND TIME MM DD YY 01 27 00 HH MN SS 16 05 21 AM PM s PN 4237615B A 5 INSTRUMENT SETUP DATE TIME SETUP A 6 Enter the correct date and press 9 The cursor moves to the time field e Enter the correct time and press The cursor moves to the AM PM field unless you are using the 24 hour time format If you are using the 24 hour time format go to step 5 If you are using the AM PM time format select AM or PM for the current time a Move the cursor to the desired option b Press e Press to save and exit PN 4237615B A 7 REPORTING UNIT SELECTION By selecting a reporting unit you are selecting the format in which numeric results are reported You can choose from these reporting units US SII e SI2 e SI3 e SI4 Table A 2 shows the reporting unit formats for each parameter
73. Sample Report 3 3 5 1 Sample Report 5 10 6 1 WBC BASO Histogram Flags CBC Mode 6 8 6 2 WBC BASO Histogram Flags CBC DIFF Mode 6 8 6 3 MICRO and MACRO Regions on RBC Histogram 6 9 6 4 Plt Flags 6 10 6 5 Mobile Threshold Positioned in the Standard Regions Between 18fL and 25fL 6 10 6 6 Mobile Threshold Cannot Be Positioned in the Standard Region 6 10 6 7 Mobile Threshold Cannot Be Positioned 6 10 7 1 Out of Range Calibration Factors 7 9 8 1 View of the Pneumatics Area Right Side 8 10 8 2 Bath Assembly 8 11 8 3 View Behind Motherboard Left Side 8 11 8 4 Motherboard 8 12 8 5 Reagent Bottle Location 8 16 8 6 Waste Sensor Alarm Unit Location 8 27 A l Sample Results Report Areas Defined A 19 D 1 Troubleshooting Flowchart D 1 TABLES 1 1 CBC Parameters 1 5 1 2 CBC DIFF Parameters 1 6 2 1 ACeT 5diff Analyzer Measurement Technologies 2 1 2 2 Technical Characteristics for Obtaining RBC and Platelet Counts 2 8 2 3 Technical Characteristics for the Measurement of the Hemoglobin 2 9 2 4 Characteristics Required to Obtain WBC BASO Results 2 10 2 5 Technical Characteristics for Acquisition of the DiffPlot 2 12 2 6 Summary of Dilutions 2 13 2 7 DiffPlot Regions Defined 2 19 2 8 Immature White Blood Cells 2 20 3 1 Reagent Consumption by Cycle in mL 3 4 3 2 Reproducibility Specifications 3 5 3 3 Linearity Specifications 3 5 3 4 Accuracy Specifications 3 5 3 5 Carryover Specifications 3 6
74. TININ MCHC gt MCHC HH MICROCYTOSIS MCV lt MCV LL 6 13 l6 REVIEWING RESULTS INTERPRETIVE MESSAGES Table 6 6 RBC Interpretive Messages from Action Ranges Continued Message Triggering Condition MACROCYTOSIS MCV gt MCV HH ERYTHROCYTOSIS RBC gt RBC HH HH means above the action range LL means below the action range Table 6 7 RBC Interpretive Messages from Flag Sensitivity Message Triggering Condition MICROCYTE MICRO gt MICRO Flag Sensitivity limit MACROCYTE MACRO gt MACRO Flag Sensitivity limit Pit Interpretive Messages Table 6 8 lists platelet interpretive messages from Action Ranges Table 6 9 lists platelet interpretive messages from the Plt histogram Table 6 8 Pit Interpretive Messages from Action Ranges Message Triggering Condition THROMBOCYTOSIS Plt gt Pit HH THROMBOCYTOPENIA Pit Pit LL MACROPLATELETS MPV gt 11 HH means above the action range LL means below the action range Table 6 9 Pit Interpretive Messages from the Plt Histogram MESSAGE Triggering Condition MICROCYTOSIS Derived from Plt histogram SCHISTOCYTE Derived from Plt histogram SMALL CELL Derived from Plt histogram Combination WBC RBC PIt Interpretive Messages e Table 6 10 lists interpretive messages from a combination of WBC RBC PIt Action Ranges Table 6 11 lists conditions causing NRBCS and PLATELET AGGREGATES interpretive
75. TROLS AND CALIBRATORS for additional information Recommended Anticoagulant The recommended anticoagulant is KEDTA with the proper proportion of blood to anticoagulant as specified by the tube manufacturer Sample Volume Aspirated e 30 pL of whole blood is aspirated in the CBC mode 53 pL of whole blood is aspirated in the CBC DIFF mode Dilution Ratios WBC BASO 1 200 DIFF 1 80 RBC PIt 1 10 000 Hgb 1 250 3 2 PN 4237615B SPECIFICATIONS CHARACTERISTICS 3 INSTRUMENT SPECIFICATIONS Throughput The instrument can process up to 60 samples per hour in either mode CBC or CBC DIFE The instrument achieves nominal throughput when used in a routine laboratory environment with samples having normal hematology parameters Depending on sample mix and workflow conditions slightly higher or lower throughput might be observed Sample Stability Sample stability is based on an average of 20 clinical normal and abnormal whole blood samples e CBC parameters are stable up to 48 hours at room temperature DIFF parameters are stable up to 24 hours at room temperature Sample Identification You can enter a sample ID using the instruments control panel setup the instrument to autonumber the IDs or scan the tube s barcode label with the optional hand held barcode reader Output The instrument can transmit startup sample and control data to a host computer The Sample Results screen shows the sample identification numb
76. The pulse height analyzer uses a number of thresholds to sort the particles into several size volume categories and to develop a size distribution curve of the particles The RBC distribution curve shows cells in their native size Figure 2 13 is an example of an RBC histogram with a normal RBC size distribution Figure 2 13 Typical RBC Histogram 30 300 7616036A Parameter Results Obtained Using the RBC Histogram Hct measurement The height of the pulse generated by the passage of a cell through the aperture is directly proportional to the volume of the analyzed red blood cell The hematocrit Hct is the sum of all the digitized pulses Hct is displayed and printed as percentage Note is the US unit format Other formats are available See Heading A 7 REPORTING UNIT SELECTION MCV calculation The MCV Mean Cell Volume is calculated using the Hct and the RBC count The MCV is displayed and printed in femtoliters fL Note fL is the US unit format Other formats are available See Heading A 7 REPORTING UNIT SELECTION RDW calculation The RDW Red cell Distribution Width is an index of the variation or spread in the size of the red blood cells The study of the RBC distribution detects erythrocyte anomalies linked to anisocytosis and enables the clinician to follow the evolution of the width of the curve relative to the cell number and average volume Displayed and printed as a percentage RDW is calculated using
77. Volume and count RBC count platelet count and hematocrit 2 2 MEASUREMENT PRINCIPLES Coulter Principle In the AC T 5diff analyzer the Coulter Principle is used to analyze the final RBC PIt dilution and the WBC BASO dilution This electronic method of counting and sizing particles is based on the fact that cells which are poor conductors of electricity will interrupt a current flow The impedance variation generated by the passage of non conductive cells through a small calibrated aperture is used to determine the count number of particles and size volume of the particles passing through the aperture within a given time period Aperture Sensor System The RBC PIt aperture sensor system determines the cell count and size of red blood cells and platelets The WBC BASO aperture sensor system determines the cell count and size of white blood cells Additionally the differentiation between basophils and other white blood cells is related to the AC T 5diff WBC Lyse specific lytic action on the white blood cells in WBC BASO bath To sense particles using the Coulter Principle Figure 2 1 a current flow is established so changes in that flow can be monitored In this sensing system an electrode is placed on each side of the aperture The most visible electrode is referred to as the counting head These electrodes are the conductive metallic housings attached to the front of the RBC and WBC BASO baths The second electrode refer
78. WBC flag area nuclei band cells PN 4237615B 6 5 6 REVIEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT Table 6 1 Definition of DIFF Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities UM Occurs when the R next to Large monocytes number of NE NE Hyperbasophilic particles in UM MO Moy monocytes region is above the IMM i EE o and Myelocytes limits set IMMZ o Promyelocytes Default values 3 1 1 or 999 T Reis Large blasts gt articles and printed in p WBC flag area LN Occurs when the R next to all Neutrophil number of WBC DIFF degradation due to particles in the LN parameters improper storage or region is above the N is displayed sample age limits set and printed in Plt aggregates 5 Default values WBC flag area RBCs resistant to gt 2 5 or 999 lysis stroma particles Reagent contamination UN Occurs when the R next to Large neutrophils number of NE NE Immature particles in the UN IMM IMM granulocytes region is above the MES limits set aa n Metamyelocytes ri s E Default values WBC flag ard Myelocytes 3 1 1 or 999 Promyelocytes gt Debris DB Absorbance particles 6 6 PN 4237615B REVIEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT Table 6 1 Definition of DIFF Flags Continued DiffPlot Region Suspected Flag DiffPlo
79. YSIS 2 8 RBC and Platelet Analysis 2 8 Parameter Results Obtained from the RBC Plt Dilution 2 9 Hgb Measurement 2 9 WBC Count and Differential 2 10 Parameter Results Obtained from the WBC BASO Dilution 2 11 Differential 2 11 Parameter Results Obtained from the DIFF Dilution 2 12 Dilution Summary 2 13 PN 4237615B 2 7 CONTENTS PARAMETER DEVELOPMENT 2 13 RBC Parameters 2 13 RBC Count 2 13 RBC Histogram 2 14 Parameter Results Obtained Using the RBC Histogram 2 14 MCH and MCHC Calculations 2 15 Plt Parameters 2 15 Interference on the Lower End of the Platelet Distribution Curve 2 15 Microcytic Interferences on the Upper End of the Platelet Distribution Curve 2 16 Parameter Results Obtained Using the Plt Histogram 2 16 Hgb Determination 2 17 WBC Count BASO Count and DiffPlot Development 2 17 WBC Count 2 17 BASO Count 2 17 DiffPlot Development 2 18 3 SPECIFICATIONS CHARACTERISTICS 3 1 3 1 3 2 PN 4237615B INSTRUMENT SPECIFICATIONS 3 1 Dimensions and Weight 3 1 Power 3 1 Supply 3 1 Consumption 3 1 Installation Category 3 1 Grounding Requirements 3 1 Temperature Ambient Operating 3 1 Altitude Range 3 2 Recommended Location 3 2 Electromagnetic Environment Check 3 2 Recommended Reagents 3 2 Recommended Controls 3 2 Recommended Calibrator 3 2 Recommended Anticoagulant 3 2 Sample Volume Aspirated 3 2 Dilution Ratios 3 2 Throughput 3 3 Sample Stability 3 3 Sample Identifica
80. a voteout V flag Ifthe WBC result is flagged with a V then the DIFF number results are also flagged with a V Ifthe RBC result is flagged with a V then the MCV MCH MCHC and RDW results are replaced by e Ifthe Hct result is flagged with a V then the MCV and MCHC results are replaced by Ifthe Plt counts votes out then the Plt result is flagged with a V WBC Count Flag During the data collection for the DiffPlot the instrument also determines the WBC count from the flowcell The WBC flag DIFF or DIFF is reported e Ifthe WBC count from the flowcell exceeds the WBC count from the WBC BASO bath by more than a predefined amount DIFF is displayed e Ifthe WBC count from the flowcell is less than the WBC count from the WBC BASO bath by more than a predefined amount DIFF is displayed e When a DIFF or a DIFF flag occurs the WBC count and all DIFF parameters are flagged with an Note The comparison between the WBC count from the WBC BASO bath and the WBC count from the flowcell will not be performed when the sample is analyzed in the CBC mode or when this option is disabled in setup DiffPlot Flags When populations in the DiffPlot exceed the limits set for that region a review R flag will occur on the DIFF parameter related to that region If the R flag occurs on a DIFF parameter further investigate the result Twelve different flags may occur related to the position of the populations within
81. aced If so do Replacing the Waste Container Printer Check At the beginning of each day be sure the printer is ready to print 1 Besure there is an adequate paper supply in the printer e Ifso go to step 2 e Ifnot add paper according to the printers user manual 2 Press the printers ON OFF switch until the control LEDs are on J Besure the printer is properly configured See Heading A 10 PRINTER CONFIGURATION for details PN 4237615B 5 1 RUNNING SAMPLES BEFORE ANALYSIS Startup Startup During Power Up When you turn on the instrument Startup is automatically done if the unit has been put in Shutdown If you want to do Startup again do Startup After Power Up 1 Turn the instrument on The instrument performs the Startup routine a rinse cycle followed by a background count which is an analysis cycle on reagent without any blood specimen Upon completion of the Startup cycle the instrument displays and prints the results IMPORTANT Risk of erroneous results if the instrument s heating devices have not reached 35 C 95 F Allow the instrument to warm to BACKGROUND COUNT IN PROGRESS e 35 C 95 F This may take several minutes to do Keep the right door closed 2 Review the Startup results e If Startup passed go to Specimen Collection and Mixing If Startup failed go to step 3 5 2 PN 4237615B RUNNING SAMPLES 5 BEFORE ANALYSIS 3 If the backgr
82. alibration CV limits and Force calibration INSTRUMENT SETUP PASSWORD SETUP Do this procedure to change the password The default user password is 123 Beginning at the Main menu select SETUP OTHERS CHANGE PASSWORD Enter the current user password and press 9 l The current password is displayed Enter the new user password up to four characters Note If you make a mistake press o C000 Press to save the changes Press to return to the previous screen A 3 A INSTRUMENT SETUP DATE TIME SETUP A 6 DATE TIME SETUP You can set the current date and time according to your laboratory s requirements Date Setup There are three date formats from which you can choose e DD MM YY Format example 11 01 00 for January 11 2000 e MM DD YY Format example 01 11 00 for January 11 2000 e YY MM DD Format example 00 01 11 for January 11 2000 Note DD represents the day of the month such as 11 for the 11th MM represents the month such as 02 for February YY represents year such as 99 for 1999 or 00 for 2000 Selecting the Date Format Do this procedure to select a date format 1 Beginning at the Main Menu select SETUP gt DATE TIME gt DATE FORMAT DATE FORMAT 02 27 00 16 05 DD MM YY MM DD YY W YY MM DD 2 Move the cursor to the desired format 3 Press amp 4 Press to save and exit A 4 PN 4237615B IN
83. alibration CV results are not within these limits an HH flag appears next to the CV value Table A 7 shows the default CV limits Note The default values are selected for optimal performance It is strongly recommended that you consult a Beckman Coulter representative prior to changing the CV limits The default limits are defined for a system that has been correctly maintained and for a system using Beckman Coulter recommended reagents and calibrators Table A 7 Default CV Limits CV Limits Default Minimum Maximum WBC 2 1 3 RBC 2 1 3 Hgb 1 1 2 Het 2 1 3 Plt 5 3 7 Note A user password is required for this procedure 1 Beginning at the Main menu select SETUP OTHERS gt gt CALIBRATION gt gt CV LIMITS 2 Enter the user password and press 9 PN 42376158 A 23 INSTRUMENT SETUP CALIBRATION SETUP 3 Move the cursor to the value you want to edit CV LIMITS 1 27 00 16 05 WBC CV LIMIT 2 0 RCB CV LIMIT 2 0 0 HCT CV LIMIT 2 0 0 PLT CV LIMIT 5 4 Edit the value 0099 5 Press to save the value entered and to move to the next field 6 Repeat steps 3 through 5 as needed 7 Press Esc exit A 24 PN 4237615B INSTRUMENT SETUP A CALIBRATION SETUP Defining the Operator An operator ID is associated with performing calibration functions You can change the code used to identify the operator on the screen The selection of the operator
84. and are detected on the WBC histogram with an WBC flag or as an elevated baseline on the lymphocytes Non lysed RBCs will cause a falsely elevated WBC count Multiple myeloma The precipitation of proteins in multiple myeloma patients may cause elevated WBC counts Leukemia A very low WBC count may result in this disease state due to the possible fragility of the leukocytes some of these cells may be destroyed during counting WBC fragments will also interfere with the WBC DIFF parameters Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of the leukocytes which may cause low WBC counts Cryoglobulins Increased levels of cryoglobulin that may be associated with myeloma carcinoma leukemia macroglobulinemia lymphoproliferative disorders metastic tumors autoimmune disorders infections aneurysm pregnancy thromboembolic phenomena diabetes and so forth which can elevate the WBC RBC or Plt counts and the Hgb concentration The specimen must be warmed to 37 C 99 F in a water bath for 30 minutes and reanalyzed immediately analyzer or manual method Agglutinated WBCs Leukoagglutination RBCt Agglutinated RBCs May cause a falsely low RBC count Blood samples containing the agglutinated RBCs may be suspected by elevated MCH and MCHC values and shown by examination of the stained blood film Cold agglutinins IgM immunoglobulins elevated in cold agglutinin disease may lower RBC and Plt counts
85. and increase MCV Hgb Turbidity of the blood sample Any number of physiologic and or therapeutic factors may produce falsely elevated Hgb 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 e Elevated WBC An extremely elevated WBC will cause excessive light scatter If this occurs 1 Use the reference manual methods 2 Centrifuge the diluted sample 3 Measure the supernatant fluid with a spectrophotometer e Elevated lipids Elevated lipids in the blood sample will give the plasma a milky appearance This condition can occur with hyperlipidemia hyperproteinemia as in gammapathies and hyperbilirubinemia Accurate hemoglobin determinations can be achieved by using reference manual methods and a plasma bank e Increased turbidity This may be seen in cases where the RBCs are resistant to lysing This condition will cause a falsely elevated Hgb result but may be detected by observing the abnormal MCH MCHC values and the increased baseline on the leading edge of the WBC histogram Erroneous Hgb results will cause the results of MCH and MCHC to also be erroneous e Fetal bloods The mixing of fetal and maternal blood may produce a falsely elevated Hgb value PN 4237615B 3 9 3 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES Table 3 11 Interfering Substances Continued Parameter
86. ansmission screen matches the the host computer protocol expected by the host computer USER PASSWORD A password is required to perform Enter the user password the requested action WRITE ERROR RS232 There is a problem with the Verify that the protocol set up in the host communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer XXX NOT REACHING Motor did not reach home sensor 1 Do Hardware Reset HOME 2 Do Heading 8 4 SYSTEM RESET Note XXX name of CYCLE motor 8 Ifthe problem persists contact a Beckman Coulter representative PN 4237615B 8 35 8 DIAGNOSTICS TROUBLESHOOTING GUIDES 8 9 TROUBLESHOOTING GUIDES Troubleshoot instrument problems by using Table 8 3 Appendix D TROUBLESHOOTING FLOWCHART Table 8 3 Troubleshooting Guide For additional information see Problem Area Situation Probable Cause Suggested Action Power Power will not Power cord loose or Ensure that the power cord is properly turn on not securely connected connected Instrument is turned Turn the instrument on off No voltage or wrong Ensure the voltage is on and that the outlet voltage at laboratory is the correct Vac power outlet Defective power Contact a Beckman Coulter representative switch or blown fuse Startup Startup failed 1 Verify the reagents are not expired three times Replace reagent if necessary See R
87. atches a raised square 9 Remove the lamp a PN 4237615B Use a 2 mm hex key to loosen the two screws a few turns Separate the metal bracket from the lamp and cable assembly Save the metal bracket and screws Turn the lamp counterclockwise to remove it from its housing 8 31 8 DIAGNOSTICS REPLACEMENT PROCEDURES 6 Discard the old lamp assembly IMPORTANT Risk of compromising output of the new lamp if the surface is smudged Fingerprints or other smudges on the lamp can affect output Do not touch the surface of the lamp 7 Using care not to touch the surface of the lamp a Insert the new lamp assembly inside the housing b Place the bracket with wings up on the housing c Turn the lamp assembly clockwise until secure d Reinstall the two screws removed in step 5 e Reconnect the lamp to the Power Supply Plug the instruments power cord into the electrical outlet 8 32 Verify correct operation a Turn the instrument on b While the instrument is performing a startup and background check look to see that the new lamp is lighted e fitis go to step 10 e fitis not then troubleshoot the system to determine the problem PN 4237615B PN 4237615B DIAGNOSTICS REPLACEMENT PROCEDURES 10 When the startup routine is done turn the instrument off and unplug it from the power outlet 11 Replace
88. ater to prevent the buildup of corrosive deposits Pay particular attention to the sample probe area Clean up spills promptly Cleaning the Inside of the Instrument Le IN EZ AS If corrosive deposits are evident clean the inside of the instrument with a damp cloth and distilled water Be careful not to wipe contaminants into the baths Extended Cleaning Procedure Do this procedure to clean the baths with a 196 to 296 solution of sodium hypochlorite Ifyou suspect a clog or fibrin When directed by a Beckman Coulter representative Supplies needed Q One 5mL syringe Q 50mL ofa 1 to 2 chlorine solution produced from high quality fragrance free sodium hypochlorite 8 2 PN 4237615B PN 4237615B DIAGNOSTICS CLEANING PROCEDURES e A 1 Prepare a 196 to 2 chlorine solution using high quality fragrance free sodium hypochlorite For example Ifusing 4 high quality fragrance free sodium hypochlorite dilute with an equal part of distilled water e Ifusing 1096 to 12 high quality fragrance free sodium hypochlorite dilute by adding 10 parts distilled water to 1 part of the 1096 to 1296 high quality fragrance free sodium hypochlorite 2 Beginning at the Main Menu select DIAGNOTICS DILUTER SYSTEMS EXTENDED CLEANING Vir AE AS 3 Open the right door 4 Press 9 to continue or press o to exit 8 3 8 DIAGNOSTICS CLEANING PROCEDURES LN WARNING
89. blood Volume A T 5diff Fix Volume AC T 5diff Diluent Final dilution ratio Reaction temperature Incubation duration Measurement Characteristics Method of analysis Aperture diameter Diameter of the flow Injection duration Data accumulated Volume injected 25uL 1000uL 1000uL 1 80 35 C 95 F 12 seconds Impedance with hydrofocus 60um 42um 15 seconds 12 seconds 72uL Parameter Results Obtained from the DIFF Dilution From these measurements a DiffPlot is developed with optical transmission absorbance on the X axis and volume on the Y axis Figure 2 12 shows the DiffPlot regions From the DiffPlot four out of five leukocyte white blood cell populations are determined lymphocytes monocytes neutrophils and eosinophils In a typical whole blood sample the basophil population determined in the WBC BASO bath is very small compared to the other four white blood cell populations Figure 2 12 DiffPlot Regions Absorbance PN 4237615B 2 7 PN 4237615B Dilution Summary OPERATION PRINCIPLES PARAMETER DEVELOPMENT Table 2 6 summarizes the dilution characteristics required to obtain CBC and CBC DIFF parameter results Table 2 6 Summary of Dilutions RBC Parameters RBC Count Technical Whole Blood Reagent Dilution Reaction Characteristics Volume Reagent s Volume Ratio Temperature WBC Count and BASO 10pL ACeT 5diff WBC Lyse 2 000pL Final 35 C 95 F
90. ckman Coulter recommends that you do the calibration procedure e At ambient operating temperature of 16 C to 34 C 61 F to 93 F e Using AC T 5diff Cal Calibrator as an alternative to whole blood When to Calibrate Calibrate your instrument During installation before analyzing samples e After service has been performed on the instrument e As instructed by a Beckman Coulter representative When to Verify Calibration Verify calibration of your instrument e As required by your laboratory procedures and as required by local or national regulations e When cell controls such as ACeT 5diff Control exceed the manufacturers defined acceptable limits In the normal process of tracking data for an extended period of time your laboratory can decide to recalibrate the instrument for a given parameter Never adjust to a specific value based on an individual sample result 1 2 PRE CALIBRATION CHECKS Before beginning calibration it is important that you do these pre calibration checks 1 Determine if there is enough reagents to complete the entire procedure e Ifnot do Replacing Reagents e Ifso go to step 2 PN 4237615B 7 1 CALIBRATION PRE CALIBRATION CHECKS 1 2 Verify that the instrument has been shut down for at least 30 minutes in the past 24 hours Ifnot do Extended Cleaning Procedure e Ifso go to step 3 Do Startup Do Running Cell Controls to Verify Calibration e If th
91. considered an important and is noted in the text as IMPORTANT Importants appear where needed throughout this manual Attention An ATTENTION provides additional information to be considered when performing a procedure 4 2 SAFETY PRECAUTIONS Electronic WARNING Risk of personal injury from electronic shock Electronic components can shock and injure you To prevent possible injury or shock do not tamper with the instrument and do not remove any components covers doors panels and so on unless otherwise instructed within this document Biological WARNING Risk of personal injury or contamination If you do not properly shield yourself while using or servicing the instrument you may become injured or contaminated To prevent possible injury or biological contamination you must wear proper laboratory attire including gloves a laboratory coat and eye protection Use care when working with pathogenic materials Be sure that you have a procedure available to decontaminate the instrument provide ventilation and dispose of waste liquid and sharps Refer to the following publications for further guidance on decontamination e Biohazards Safety Guide 1974 National Institute of Health e Classifications of Etiological Agents on the Basis of Hazards 3d ed June 1974 Center for Disease Control U S Public Health Service Moving Parts WARNING Risk of personal injury Operating the instrument with doors and or covers ope
92. d as ACTION RANGES X where X is the number 02 27 00 16 05 ACTION RANGES 1 NE LY MO EO BA ATL 1 50 IMM O Move the cursor to the value to be changed Edit the value 0999 0099 Press to save The DIFF Action Ranges are now changed to reflect the new values you entered PN 4237615B INSTRUMENT SETUP A SETTING FLAG SENSITIVITY AND THRESHOLDS 6 Repeat steps 3 and 4 as needed to change additional values for the patient range you selected in step 2 7 Repeat steps 2 through 6 to change the other action ranges if required 8 Press to exit A 9 SETTING FLAG SENSITIVITY AND THRESHOLDS ATTENTION This procedure must be done by a Beckman Coulter representative The instrument flags a sample if the sample results exceed specific criteria defined within the software The values used to position the thresholds which separate different cell populations and determine if a flag should be triggered are selected to provide optimal population separation and flagging under normal operating conditions Contact a Beckman Coulter representative if you need to modify any of these values PN 4237615B A 17 INSTRUMENT SETUP PRINTER CONFIGURATION A 10 PRINTER CONFIGURATION ATTENTION Ensure that the printer is in Draft mode so that printouts such as patient result reports are formatted correctly Refer to the printer s user manual for information on setti
93. de OR Turn the instrument off Note After doing Shutdown you must do a Startup before operating the instrument again System Cleaning Do this procedure to clean the system after analyzing a contaminated sample Tools Supplies Needed 0 500mL of a 196 to 2 chlorine solution produced from high quality fragrance free sodium hypochlorite Deionized water Absorbent paper Distilled water Oooo 2 containers such as beakers or flasks that can each hold more than 500mL of liquid and can be placed in front of the reagent compartment when the door is open LN 1 Do Extended Cleaning Procedure PN 42376158 8 5 DIAGNOSTICS CLEANING PROCEDURES 8 6 In one container prepare approximately 500mL of a 1 to 2 chlorine solution using high quality fragrance free sodium hypochlorite For example Ifusing 4 high quality fragrance free sodium hypochlorite dilute with an equal part of distilled water e Ifusing 10 to 12 high quality fragrance free sodium hypochlorite dilute by adding 10 parts distilled water to 1 part of the 10 to 12 high quality fragrance free sodium hypochlorite Pour 500mL of distilled water into the other container Remove all reagent pickup tube assemblies from their containers including Diluent Place all reagent pickup tube assemblies in the chlorine solution Beginning at the Main Menu select REAGENTS PRIME gt gt ALL REAGENTS Chlor
94. e Note The background count limits are WBC 0 3 x 105 02 RBC 0 03 x 10 pL3 Hgb 0 3 g dL Plt 7 0 x 103 pL3 a Do Startup After Power Up b IfStartup continues to fail contact a Beckman Coulter representative If the system determines that there is insufficient reagent to complete the days work a REAGENT LOW LEVEL message appears Identify the low reagent and change it according to Replacing Reagents OR Continue and change the reagent when the specific reagent low message is displayed PN 4237615B RUNNING SAMPLES 5 BEFORE ANALYSIS Specimen Collection and Mixing LN IMPORTANT Risk of erroneous results if the specimen collection tube is not filled to the quantity required by the tube manufacturer Fill the specimen collection tube as required 1 Using KjEDTA as the anticoagulant collect the required amount of venous specimen according to the tube manufacturers requirements Note You can collect blood into a microcontainer with a minimum volume of 100pL for analysis on this instrument 2 Mix the blood specimen gently and thoroughly before analysis Running Cell Controls to Verify Calibration Before analyzing patient samples ensure that the system is within acceptable operating limits by analyzing three levels low normal and high of cell control material The cell control for the AC T 5diff hematology analyzer is AC T 5diff Control AN 1 Press to select the d
95. e When the green LED remains illuminated the instrument is ready for the next analysis 8 The sample results appear on the screen and print according to ID 1007 instrument setup Hob HCT MCV MCH MCHC RDW PLT ANALYZING NEXT ID 1008 PN 4237615B 12 07 99 16 05 12 3 H 64 1 27 8 5 6 1 0 CBC DIFF 1 RUNNING SAMPLES AFTER ANALYSIS 9 IfAutonumbering is on the instrument is ready to run the next sample If Autonumbering is off enter the next sample ID manually or with the optional barcode reader 5 3 AFTER ANALYSIS Results When analysis is completed the instrument displays the results and prints the report Figure 5 1 is an example of a sample report If flags appear on the results see Chapter 6 REVIEWING RESULTS Figure 5 1 Sample Report BECKMAN COULTER INC 1 i 11800 SW 147 AVE KIAMI FLORIDA DATE 93 02 00 TIME 16 04 28 SEQ 90 Patient Name Pen 1 ID 46 DOB 7 Age OFR ID i 8 i Range 1 Range 1 UBC 4 9 L 10 pL 5 0 1 0 NE 41 8 x 40 0 70 0 RBC 5 11 10 ul 4 00 5 00 Ly 25 4 x 25 0 55 0 HGB 14 3 a dL 13 0 17 0 0 8 x 5 0 712 0 HCT 46 4 40 0 760 0 E0 2 1 H X 0 8 2 0 ney 91 fL 70 7 100 BA 2 6 H X 0 1 2 0 MEH 31 9 pq 25 0 35 0 ATL 1 4 X 0 0 240 MCHC 35 0 g dL 30 0 18 0 Im 0 4 x 0 0 2 0 RDW 12 2 10 0 20 0 NER 3 02 102 uL 2 00 5 00 LYN 1 24 i03 yL 1 00 3 00 PLT 206 107 uL 125 7410 MOM 0 40 107 pL 0
96. e control is within expected ranges run samples Calibration is not necessary if the cell control is within the expected ranges If the control is not within expected ranges do Heading 7 3 AUTO CALIBRATION Calibration is required if the cell control is not within the defined limits PN 4237615B CALIBRATION v AUTO CALIBRATION 7 3 AUTO CALIBRATION When calibration verification fails calibrate the instrument using this procedure Calibration Setup 1 Select the operator a Beginning at the Main Menu AUTOCALIBRATION 02 27 00 16 05 select CALIBRATION gt gt H EXP DATE 04 05 00 AUTOCALIBRATION to access the Autocalibration screen TARGET VALUES b Move the cursor to the required 367 PT gss 005 190 operator ID Press e C Note To change an operator ID definition do Defining the Operator 2 Verify that the lot number is correct e fitis correct go to step 3 e Ifitis not correct enter the correct lot number a Move the cursor to the Lot field b Press 9 The cursor should be flashing on the first digit of the lot number to indicate that you can edit the numbers or letters c Press or 0 to display the letters and press a number button to enter that number 0999 0099 d Press 9 when you are finished editing the lot number PN 4237615B 7 3 CALIBRATION AUTO CALIBRATION ATTENTION It is important that you verify the expiration date
97. e reagent is not fully primed and the instrument will not permit sample analysis If the error occurs 1 Press to acknowledge the error 2 Run Heading 8 4 SYSTEM RESET CYCLE 3 Manually prime the reagent as instructed in Priming the Reagents Priming the Reagents The function primes reagents into the instrument Do this procedure after service has been performed on the instrument ATTENTION This function does not reset the reagent cycle Do not do this procedure to change reagents 1 Beginning at the Main Menu select REAGENTS gt PRIME IMPORTANT Risk of unacceptable background results Initiating two Hgb Lyse or WBC Lyse prime cycles back to back causes excessive foaming in the waste chamber which may produce interference that might cause unacceptable background results Run a blank cycle before repeating a Hgb Lyse or WBC Lyse prime cycle 2 Select the desired option PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES 3 The instrument primes the selected reagent s Replacing the Waste Container WARNING Risk of biohazardous condition if the waste sensor alarm battery is not promptly replaced when needed The waste sensor alarm uses a 9 V alkaline battery for operation The waste sensor unit will alert you that the battery needs to be replaced If the waste container is not full and the alarm chirps beeps at regular intervals immediately replace the old battery with a new 9 V alka
98. e the best calibration 10 Repeat steps 4 through 8 until at least three but no more than eleven calibrator samples have been analyzed The instruments autocalibration module performs statistics on these results to obtain the best possible calibration factors Note After three runs the instrument calculates calibration statistics 11 To accept the calibration factors press 9 If calibration passed CALIBRATION PASSED is displayed 12 Update the calibration factors or exit without updating To exit without updating the calibration factors press o To update the calibration factors a Press 9 b Enter the user password and press c When calibration is completed 4 38 3 226 o 3 380 press j 4 879 A mE CALIBRATION COMPLETE 255 The calibration report is printed PRESS ESCAPE TO ENT 203 NEW AUTOCALIBRATION 12 07 99 16 05 Be sure to keep a copy for your 07 DAE records ae 0 70 3 44 7 8 PN 4237615B CALIBRATION v AUTO CALIBRATION Interpreting Calibration Results The calibration table shows e TARGT Target values of calibration material NEW Reflects the new calibration factor calculated from the data e CURR Reflects the calibration factor currently being calculated e MEAN Reflects the mean of the results e CV Reflects the coefficient of variation Calibration passes when e The CV is within the
99. e three separate sets of flagging criteria Range 1 selects Patient Range 1 and Action Range 1 Range 2 selects Patient Range 2 and Action Range 2 Range 3 selects Patient Range 3 and Action Range 3 This means that if you select Range 2 the sample results will be reported and flagged according to Patient Range 2 and Action Range 2 Remember these range associations when establishing your laboratory limits and when selecting a range for analysis 1 10 PN 4237615B USE AND FUNCTION WORKING WITH THE SOFTWARE 1 6 WORKING WITH THE SOFTWARE When working with the instruments software be sure you understand the basics of e Moving the Cursor Selecting Menu Items e Erasing Saved Text and Selecting De selecting Software Fields Moving the Cursor To move the software cursor press the appropriate cursor key Q 0 or Selecting Menu Items There are two ways to select a menu item e Press the number on the numeric keypad that corresponds to the menu MAIN MENU 12 07 99 16 05 item you want to select For example to select CALIBRATION i 2 CALIBRATION from the Main Menu press at 3 REAGENTS 4 DIAGNOSTICS the numeric keypad 5 SETUP OR Highlight the menu item by pressing Q or 0 then press 9 For example to select CALIBRATION from the Main Menu press 0 and 9 PN 4237615B 1 11 i USE AND FUNCTION WORKING WITH THE SOFTWARE Erasing Saved Text There may be times when y
100. ed 2 of 5 Barcodes To increase sample identification integrity use fixed length characters with Check Digit If the test label fails to read reset the scanner by turning the instrument off then on and repeating the programming sequence F 8 PN 4237615B REFERENCES m LIST OF REFERENCES l Coulter WH High speed automatic blood cell counter and cell size analyzer Paper presented at National Electronics Conference Chicago IL 1956 October 3 PN 42376158 REFERENCES 1 REFERENCES LIST OF REFERENCES REFERENCES 2 PN 4237615B DEFINITIONS PN 4237615B accuracy Ability of the instrument to agree with a predetermined reference value at any point within the operating range closeness of a result to the true accepted value agglutination clump background count Measure of the amount of electrical or particle interference blank cycle Runs diluent through the system to clean it out calibration A procedure to standardize the instrument by determining its deviation from calibration references and applying any necessary correction factors calibration factors These are correction factors that the system uses to fine tune instrument accuracy calibrator A substance traceable to a reference method for preparation or material used to calibrate graduate or adjust measurement carryover The amount in percent of blood cells of Hgb remaining in diluent following the cycling of a blood samp
101. ed in the microcytic MACRO 1 1 MICRO 1 1 MICRO and macrocytic MACRO regions compared to the total number of RBCs are above the established limits set by your laboratory Thresholds RBC1 and RBC2 define the MICRO and MACRO regions and are calculated based on the standard deviation of a normal RBC population Default value 5 for MICRO and 7 5 for MACRO Note MICRO and MACRO flags will be activated in software version 1 0 and higher PN 4237615B 6 9 6 REVIEWING RESULTS FLAGS GENERATED BY THE INSTRUMENT Table 6 2 CBC Histogram Flags Continued Histogram Flag Illustrations of Histogram Flags Description Pit Mic Figure 6 4 Pit Flags The Plt histogram has 256 channels and between 2fL and 30fL A mobile SCH threshold at 25fL by default Figure 6 4 moves according to the presence of microcytic RBCs present in the Plt analysis region Plt flags generate when the following three conditions occur 1 Ifthe mobile threshold can be 3 25 30 positioned in the standard region between 18fL and 25fL the MIC Figure 6 5 Mobile Threshold Positioned Microcytes flag will be shown in in the Standard Regions Between 18fL the PIt alarm region See and 25fL Figure 6 5 The Plt result is reliable 2 Ifa valley is not detected by the 18fL threshold the threshold is placed at the 18fL position and a MIC flag is generated If the interference is significant the Plt
102. eplacing Reagents 2 Do Startup again 3 Do Extended Cleaning Procedure Temperature not Instrument did not Wait 5 minutes to allow the instrument to reached reach operating reach the operating temperature temperature If the problem persists contact a Beckman Coulter representative Control 1 Do Extended Cleaning Procedure verification out of 2 Rerun the control acoeptanie mits 3 Run a new vial of control 4 Calibrate the instrument Sampling Sample probe not Motor Contact a Beckman Coulter representative working properly Dilution Traverse motion Motor problem 1 Ensure there is enough reagent in each bath 2 Ifthe problem persists contact a Beckman Coulter representative Sample distribution Pneumatic syringe problem Analyze a sample and check that specimen is correctly distributed into the baths See Aspiration Drain and rinse Pneumatic syringe problem Drain the baths See Draining the Baths and or the Diluent Reservoir 2 Rinse the baths See Bath and Flowcell Rinse 3 Ifthe problem persists contact a Beckman Coulter representative 8 36 PN 4237615B Table 8 3 Troubleshooting Guide Continued DIAGNOSTICS TROUBLESHOOTING GUIDES Problem Area Situation Probable Cause Suggested Action Results Poor Bent sample probe Contact a Beckman Coulter representative reproducibility Poor precision Bent sample probe Con
103. er sample results and any result flags The instrument prints a report Figure 3 2 Figure 3 2 Sample Report BECKMAN COULTER INC 11800 SW 147 AVE RIAMI FLORIDA DATE 03 02 00 TIME 16 04 28 SEQ 90 Patient Name ID 46 DOB 7 Aga OFR ID 8 Range 1 Range 1 WBC 4 9 LO 109 uL 5 0 11 0 NE 41 8 40 0 70 0 Ree 95 11 104 suL 4 00 6 00 LY 25 4 x 25 0 55 0 HGB 14 3 a dL 13 0 17 0 o 84 x 5 0 712 HET 46 4 0 0 760 0 EQ 2 1 H X 9 8 2 0 ney 91 TL 70 100 BA 2 6 H X 0 1 72 0 MEH 21 9 pq 25 0 35 0 ATL 1 4 0 0 2 6 MCHC 38 0 g dL 30 0 738 0 IM 0 4 0 0 72 0 RDW 12 2 10 0 20 0 NER 3 02 103 pL 2 00 5 00 LYN 1 24 i03 gL 1 00 3 00 PLT 206 i107 uL 128 410 MOM 0 40 103 uL 0 02 0 90 PV 9 1 fL 6 0 711 0 EON 0 10 PCT 0 2 x 0 1 40 8 BAM 0 13 1037uL 0 00 0 20 PDW 15 8 x 7 0 719 0 ATLH 0 07 103 uL 0 00 0 20 IMME 0 02 10 uL 0 00 0 20 1 1 1 1 1057p 0 00 0 30 Microscopic Examination 1 Neutrophils Metamyelocytes 1 nisocytasis Retics 1 Bands Z Myelacytes Hypocromia Sad Rate C Lymphocyte Promyelocytes Polychromasia 1 Monocytes Foikliocytosis 1 Microcytosis Blast Eosinophil Z Atyp Lymph Basophils NRBC E Macracytosis Comments Requested by
104. esired analysis mode CBC or CBC DIFF The mode selected appears on the screen PN 42376158 5 5 RUNNING SAMPLES BEFORE ANALYSIS 2 Enter the cell control number as the sample ID e0 0009 GS LN 3 Mix each control according to the instructions in the cell control package insert Inspect the vial s contents to ensure that all cells are uniformly distributed if not repeat this step 4 Present the cell control vial to the T 1 sample probe and press the aspirate switch The LEDs flash during sample e aspiration 5b When the red LED illuminates remove the cell control tube from the probe When the green LED remains illuminated the instrument is ready for the next analysis 5 6 PN 4237615B PN 4237615B RUNNING SAMPLES BEFORE ANALYSIS Repeat steps 1 through 5 until you have run all three levels of cell control Review the control results to ensure they are within the acceptable ranges e Ifso then you are ready to analyze patient samples See Heading 5 2 ANALYSIS If not go to step 8 When control results are not within the acceptable ranges a Rerun the control If results are still outside the acceptable ranges do step b b Clean the system See Diluter System c Rerun the control If the results are still outside the acceptable ranges do step d d Analyze a new cell control vial If the results are still out
105. ettings F 2 Test Labels With the Check Digit Checksum F 3 Test Labels Without the Check Digit F 3 Barcode Scanner Configuration Sheet F 4 Code 39 Barcode Scanner Options F 5 Codabar Barcode Scanner Options F 6 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels F 7 XV CONTENTS xvi PN 42376158 INTRODUCTION m HOW TO USE YOUR AC T 5diff HEMATOLOGY ANALYZER MANUALS e ABOUT THIS MANUAL CONVENTIONS e GRAPHICS e SYMBOLS and e MENU TREE HOW TO USE YOUR ACT 5diff HEMATOLOGY ANALYZER MANUALS Use this Operators Guide to find information about This introductory section contains the following topics Getting started Running your instrument e Reviewing results Performing special procedures such as cleaning replacing or adjusting an instrument component e Troubleshooting problems Determining what the instrument does e Understanding how to safely operate the instrument e Powering up the instrument Customizing the setup and Running controls and samples Use the Host Transmission Specification manual PN 4277065 to find out information about interfacing your AC T 5diff analyzer to your laboratory s host computer ABOUT THIS MANUAL The information in this manual is organized as follows Chapter 1 USE AND FUNCTION Contains the intended use of the instrument a brief history of the methods used by the instrument the reagents calibrators and controls
106. fers by vacuum the DIFF specimen from the mixing bath towards to the injector on the optical bench Diluent tank holds the necessary diluent for an analysis cycle prevents diluent degassing as it is being aspirated by the syringes and is vacuum filled by the counting syringe Counting assembly receives the different rinsings and dilutions regulates the temperature of dilutions and provides the dilutions for WBC BASO RBC PIt and Hgb Sampling traverse 8 10 ensures probe positioning for the sample stages and distribution and supports the sampling syringe PN 4237615B PN 4237615B Figure 8 2 Bath Assembly Figure 8 3 View Behind Motherboard Left Side 000000 Rinse bath DIFF bath RBC bath WBC BASO bath DIAGNOSTICS COMPONENT LOCATIONS First Dilution Hgb bath Optical bench ensures the support and adjustment of the flowcell lamp and optical and electronic elements DIFF syringe assembly e injects the diluted sample into the flowcell and e injects the interior and exterior sheath into the flowcell Reagent syringe assembly e ensures correct reagent delivery gt Lysing reagent for Hgb ACeT 5diff Hgb Lyse Rinsing reagent AC T 5diff Rinse Lysing reagent for DIFF ACeT 5diff Fix Lysing reage
107. film e Nutritional deficiency or blood transfusion May cause elevated RDW results due to iron cobalamin and or folate deficiencies Plt Very small RBCs microcytes RBC fragments schizocytes and WBC fragments May interfere with the proper counting of platelets and cause elevated Pit counts Agglutinated RBCs May trap platelets causing an erroneously low Plt count The presence of agglutinated RBCs may be detected by observing abnormal MCH and MCHC values and by examining the stained blood film Excessive numbers of large platelets May cause an erroneously low Plt count since these large platelets may exceed the upper threshold for the Plt parameter are not counted Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells which may cause low Plt counts Use the manual reference method to obtain an accurate Plt count Hemolysis Hemolysed specimens contain RBC stroma which may elevate Plt count ACD acid citrate dextrose blood Blood anticoagulated with ACD may contain clumped PIt which could depress the Pit count Plt Agglutination Clumped platelets may cause a decreased Plt count and or elevated WBC count WBC SL and SL1 flags may be generated Reanalyze the specimen as follows 1 Recollect the specimen in sodium citrate anticoagulant to prevent platelet agglutination 2 Reanalyze the specimen for only the Plt count 3 Correct the final Plt result for the effect of
108. g hemoglobin Table 2 3 Technical Characteristics for the Measurement of the Hemoglobin Dilution Characteristics Volume of whole blood 10uL Volume AC T 5diff diluent 1700uL Preliminary dilution ratio 1 170 Volume of the 1 170 dilution removed 42 5uL for making the RBC PIt dilution Additional volume of AC T 5diff diluent 400uL Volume of AC T 5diff Hgb Lyse 400uL Final dilution for Hgb determination 1 250 Reaction temperature 35 C 95 F Measurement Characteristics Method of analysis Spectrophotometry Wavelength 550nm PN 4237615B 2 9 OPERATION PRINCIPLES SAMPLE ANALYSIS WBC Count and Differential The WBC count is determined twice using two different methodologies e The reference WBC count is the count obtained in the WBC BASO bath Figure 2 10 The WBC count and the BASO count are determined simultaneously Asecond WBC count is determined in the flowcell during acquisition of the DiffPlot The dilution analyzed in the flowcell is prepared in the DIFF bath Figure 2 10 The WBC counts from the two methodologies are compared and if they exceed the defined limits will be flagged Figure 2 10 Bath Assembly Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath Table 2 4 summarizes the technical characteristics required to obtain WBC and BASO results Table 2 4 Characteristics Required to Obtain WBC BASO Results Dilution Characteristics Volume of who
109. ge on the printout L Result is below the patient limit set by your laboratory and may generate an interpretive message on the printout HH Result is above the action limit set by your laboratory and may generate an interpretive message on the printout LL Result is below the action limit set by your laboratory and may generate an interpretive message on the printout INTERPRETIVE MESSAGES ATTENTION Interpretive messages indicate a possible pathological disorder and should be used for assisting with quickly and efficiently screening abnormal samples and for diagnosis It is recommended that your laboratory use suitable reference methods to confirm diagnoses The interpretive messages print in the flag area on the patient report Tables 6 4 through 6 11 list interpretive messages and triggering conditions Only one DIFF interpretive message can be displayed for each DIFF parameter The message generated from the absolute count for that parameter takes priority For example if a relative LYMPHOPENIA LY lt LY LL and an absolute LYMPHOCYTOSIS LY gt LY HH occur only the LYMPHOCYTOSIS message will be displayed The following sections define e WBC Interpretive Messages e RBC Interpretive Messages e Plt Interpretive Messages and e Combination WBC RBC PIt Interpretive Messages PN 4237615B PN 4237615B REVIEWING RESULTS INTERPRETIVE MESSAGES WBC Interpretive Messages e Table 6 4 lists WBC interp
110. gent waste see Waste Handling Procedures and Replacing the Waste Container PN 4237615B Ter i USE AND FUNCTION REAGENTS ACeT 5diff Diluent WARNING Risk of explosion if sodium azide is not properly flushed down the drain with large volumes of water Sodium azide preservative may form explosive compounds in metal drain lines See National Institute for Occupational Safety and Health Bulletin Explosive Azide Hazards 8 16 76 When disposing of reagents down the drain flush with large volumes of water Used for counting and differentiating blood cells AC T 5diff Diluent is clear and odorless Composed of stabilized saline solution containing an organic buffer and less than 0 1 sodium azide AC T 5diff Diluent e Dilutes whole blood samples e Stabilizes cell membranes for accurate counting and sizing e Conducts aperture current and e Rinses instrument components between analyses Handle as indicated in this manual To be used at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACeT 5diff Fix Used to lyse erythrocytes fix leukocytes and differentially stain granules of monocytes neutrophils and eosinophils AC T 5diff Fix is a deep blue aqueous solution that smells like alcohol AC T 5diff Fix is composed of an alcohol solution containing propylene glycol a formic dye buffers alkaline salts wetting agents and an aldehyde preservative Handle as indicated in t
111. gents procedure 8 26 when to do 8 26 print button 1 3 function 1 3 printer configuration procedure A 20 connector location 1 4 daily printer check 5 1 prints incorrectly what to do if 8 37 required model 1 10 settings A 18 PRINTER ERROR CHECK PAPER 8 34 PN 4237615B Q quality control QC definition GLOSSARY 2 R R flag description 6 3 range association 1 10 button location 1 3 description 1 10 function 1 3 reportable 3 6 RBC interfering substances 3 9 stable RBCs and unstable Plts what to do if 8 37 RDW interfering substances 3 10 reagent log sample B 4 REAGENT LOW LEVEL 8 17 8 21 8 34 A 32 REAGENT LOW LEVEL REAGENT NAME 8 34 REAGENT LOW LEVEL X A 32 reagent syringe function 8 11 location 8 11 reagents consumption by cycle 3 4 location 8 16 priming procedure 8 26 recommended 1 7 3 2 replacement procedures 8 15 volume setup procedure A 33 volumes default A 33 when to replace 8 21 replacing the waste container 8 27 report system setup A 22 See also sample report reportable range Het 3 6 Hgb 3 6 Plt 3 6 RBC 3 6 WBC 3 6 reporting units formats available A 7 selection procedure A 7 PN 4237615B INDEX reproducibility definition GLOSSARY 2 performance characteristics 3 7 performance specifications 3 5 poor what to do if 8 37 results exceeding instrument capacity 6 2 review flag description 6 3 Rinse reagent description 1 8 replaceme
112. gs IMM prints as IMM e ATL prints as ATL e The WBC BA flag replaces the DIFF DIFF WBC MB and BASO flags The HISTO flag replaces the MICRO MACRO SCL MIC and SCH flags The flags will be printed on the patient report in the area labeled SUSPECT For example when the option is not selected flags on the patient sample report may be shown as SUSPECT WBC WBC BA DB DIFF IMM AIL RBC HISTO PLT HISTO For additional information about the DIFFPLOT AND HISTOGRAM FLAGS print option see Configuring the Instrument s Printer Settings PN 42376158 6 11 REVIEWING RESULTS INTERPRETIVE MESSAGES 6 4 6 12 Detailed Flag Format If the DIFFPLOT AND HISTOGRAM FLAGS option is selected on the instruments printer configuration screen the DiffPlot and histogram flags are reported displayed and printed in the detailed format For example when the option is selected flags on the patient sample report may be shown as FLAGS WBC WBC DB SL UM IMM ATL RBC MICRO PLT MIC For additional information about the DIFFPLOT AND HISTOGRAM FLAGS print option see Configuring the Instrument s Printer Settings Patient Ranges and Action Ranges Table 6 3 shows the four flags that can be generated based on patient ranges and action ranges Table 6 3 Patient Range and Action Range Flags Flag Description H Result is above the patient limit set by your laboratory and may generate an interpretive messa
113. his manual To be used at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACeT 5diff WBC Lyse Used to lyse red blood cells for the leukocyte count and to differentiate poly nuclear basophils AC T 5diff WBC Lyse is a colorless aqueous solution It is composed of an acidic solution containing a lytic agent Handle as indicated in this manual To be used at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACeT 5diff Hgb Lyse Used to lyse blood cells and to determine hemoglobin concentration AC T 5diff Hgb Lyse is a clear aqueous solution and is composed of potassium cyanide at 0 035 a quarternary ammonium salt and a saline phosphate buffer containing less than 0 196 sodium azide Handle as indicated in this manual To be used at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACeT 5diff Rinse 1 8 Used as a rinsing agent AC T 5diff Rinse is a transparent liquid composed of an enzymatic solution with proteolytic action Handle as indicated in this manual To be used at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging PN 4237615B USE AND FUNCTION I REAGENTS Waste Handling Procedures Consult the material safety data sheets MSDS for additional reagent information To order an MSDS see Heading 1 8 ORDERING MATERIAL SAFETY DATA SHEETS MSDS Ne
114. ibility of electrical shock when instrument is plugged in to the power source Before continuing unplug the ACeT 5diff analyzer from the electrical outlet Tab Symbols Tabs divide this document into four sections reference operation special procedures and troubleshooting and appendices Each tab reflects a unique symbol Symbol Definition Pd d A Identifies the reference section pE CM Identifies the operating instructions section 2 Identifies the special procedures and troubleshooting section 7 NS NS PECES Identifies the appendices section PN 4237615B MENU TREE The functions of the instrument are programmed into its software PN 4237615B MAIN MENU 1 RUN SAMPLES 2 CALIBRATION 3 REAGENTS 4 DIAGNOSTICS 5 SETUP CALIBRATION 2 CAL FACTORS 3 PRINT CAL FACTORS 4 REPRODUCIBILITY gt gt REAGENTS 1 LEVEL CHANGE 2 DAILY WORKLOAD 3 PRIME DIAGNOSTICS 2 MINI PRIME 3 DILUTER SYSTEMS 4 HARDWARE SYSTEMS 5 SERVICE SETUP 2 UNITS 3 LAB LIMITS 4 HOST SETUP 5 PRINTER 6 OTHERS Consult a Beckman Coulter representative before selecting this option Service password required PRIME 2 FIX 3 WBC LYSE 4 HGB LYSE 5 RINSE 6 ALL REAGENTS 7 UNPRIME ALL DILUTER SYSTEM
115. ibration is necessary by comparing the absolute difference from row C to your material s calibration criteria table e Ifthe absolute difference is less than the value in your material s calibration criteria table no calibration is required e Ifthe absolute difference is between the values found in your material s calibration criteria table do Heading C 3 CALCULATING NEW CALIBRATION FACTORS Ifthe absolute difference is greater than the value found in your material s calibration criteria table eliminate possible instrument problems and possible calibrator deterioration If you determine calibration may be needed contact a Beckman Coulter Representative before calibrating CALCULATING NEW CALIBRATION FACTORS Do Heading 7 4 MANUAL CALIBRATION FACTOR ADJUSTMENT Record these factors into row D on the worksheet C 3 C MANUAL CALIBRATION CALCULATING NEW CALIBRATION FACTORS Calibration Worksheet Sample Number ae e Ce e eo A samples 2 through 11 C B A E B A xD PN 4237615B C 4 TROUBLESHOOTING FLOWCHART D D 1 TROUBLESHOOTING FLOWCHART See Figure D 1 for troubleshooting information Figure D 1 Troubleshooting Flowchart Instrument operation mode Analysis cycle Check Check Instrument Instrument Printer Reagents a startup alarms Sampling FS C Dilution
116. ication Mode e Sending Options e Institutional Header e Autoclean Frequency e Variable Format Setup e Print Latest Results e Change Password e Send Latest Results e Language e Reagent Volumes e Cycle Counts E 8 CALIBRATION L Review the instrument s pre calibration status L Review recommendations and frequency L Locate and discuss procedure for future use E 9 CONTROLS Review and assist as needed LJ Importance of quality control L Control handling techniques CL Running controls L Stability E 10 SYSTEM OPERATION OVERVIEW CQ Sample flow and distribution Sample aspiration volume Q Sample dilution CQ Sampling probe CQ Results displayed printed Q Printer operation QO RUO parameters USA only E 11 DAILY PROCEDURES Q Startup procedure and Q Sample ID manual Q Running samples background tests autonumbering or barcode Q Sample results 0 Parameter flags and codes O Irregular sample results Q Shutdown procedure E 2 PN 42376158 TRAINING CHECKLIST SPECIAL PROCEDURES E 12 SPECIAL PROCEDURES Review and assist as needed C General maintenance C Cycle counter C Cleaning procedures C Reagent replacement C Waste container Q Flowcell lamp replacement replacement E 13 MAINTAINING AND SERVICING THE INSTRUMENT C Importance of general maintenance C Telephone troubleshooting availability and its importance for minimizing downtime C Service procedures and expectation
117. iffPlot e 5yL of remaining sample is discarded into the Rinse bath Delivery In the CBC and the CBC DIFF modes each aliquotted sample is delivered to its appropriate bath using a tangential flow Figure 2 8 of reagent which mixes the diluted sample and minimizes viscosity problems Figure 2 8 Sample Delivery Using Tangential Flow Probe ay Reagent X input Tangential flow Mixing bath 7616002A PN 42376158 2 7 2 OPERATION PRINCIPLES SAMPLE ANALYSIS 2 6 SAMPLE ANALYSIS RBC and Platelet Analysis The RBC Plt dilution analyzes red blood cells and platelets This dilution is prepared in two stages the primary first dilution and the secondary last dilution The primary dilution is made in the First Dilution Hgb bath and the secondary dilution is made in the RBC bath Figure 2 9 Table 2 2 summarizes the technical characteristics required to obtain RBC and Platelet results Figure 2 9 Bath Assembly Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath Table 2 2 Technical Characteristics for Obtaining RBC and Platelet Counts Dilution Characteristics Primary Dilution for RBC and Pit Initial volume of whole blood Volume A eT 5diff diluent Primary dilution ratio Secondary Dilution for RBC and Plt Volume of primary dilution Volume A eT 5diff diluent Secondary dilution ratio Final dilution for RBC and Plt results React
118. ine solution will now be pulled into the instrument through the reagent pickup tubes PN 4237615B DIAGNOSTICS 8 CLEANING PROCEDURES 7 When priming is complete remove the reagent pickup tube assemblies from the chlorine solution and wrap the tubes in absorbent paper 8 Beginning at the Main Menu select REAGENTS PRIME gt ALL REAGENTS The chlorine solution will now be drained from the system 9 Place the container with the distilled water in front of the reagent compartment 10 Beginning at the Main Menu select REAGENTS PRIME ALL REAGENTS The distilled water will now be pulled in to rinse the system 11 When priming is complete select ALL REAGENTS again to ensure that the distilled water is removed from the system 12 Press the aspirate switch to run a blank cycle PN 4237615B 8 7 DIAGNOSTICS CLEANING PROCEDURES 8 8 13 Re connect the reagent pickup tube assemblies to their respective containers 14 Be sure each pickup tube cap is properly tightened 15 Place the reagent containers in their respective compartments locations 16 Beginning at the Main Menu select REAGENTS PRIME gt ALL REAGENTS 17 Inspect the reagent lines to ensure there are no air bubbles present If air bubbles are present repeat step 16 18 Turn the instrument off and leave it off for about five seconds Ai PN 4237615B DIAGNOST
119. information that is important to remember or helpful when performing a procedure Motherboard refers to the main card board in the instrument RBC bath is sometimes referred to as RBC PIt bath ACeT 5diff Rinse reagent is sometimes referred to as Rinse AC T 5diff Fix reagent is sometimes referred to as Fix ACeT 5diff Hgb Lyse reagent is sometimes referred to as Hgb Lyse AC T 5diff WBC Lyse reagent is sometimes referred to as WBC Lyse AC T 5diff Diluent reagent is sometimes referred to as Diluent All graphics including screens and printouts are for illustration purposes only and must not be used for any other purpose PN 4237615B Xix INTRODUCTION SYMBOLS SYMBOLS Safety Symbols Safety symbols alert you to potentially dangerous conditions These symbols together with text apply to specific procedures and appear as needed throughout this manual Symbol Warning Condition Action LN Biohazard Consider all materials specimens reagents controls and calibrators and so forth and areas these materials come into contact with as being potentially infectious Wear standard laboratory attire and follow safe laboratory procedures when handling any material in the laboratory AE Probe hazard The probe is sharp and may contain biohazardous materials such as controls and calibrators Avoid any unnecessary contact with the probe and probe area AS Electrical shock hazard Poss
120. ion temperature Measurement Characteristics Method of analysis Aperture diameter Count vacuum Count period 10pL 1700pL 1 170 42 5uL 2500pL 1 58 8 1 170 x 1 58 8 1 10 000 35 C 95 F Coulter Principle 50um 200mb 5 9in Hg 2x5 seconds 2 8 PN 4237615B OPERATION PRINCIPLES 2 SAMPLE ANALYSIS Parameter Results Obtained from the RBC PIt Dilution This final 1 10 000 RBC Plt dilution is used to Determine the RBC count e Develop the RBC histogram which is needed to obtain the Hct MCV and RDW results e Determine Plt count Develop the Plt histogram which is needed to obtain MPV Pct and PDW results Hgb Measurement Hemoglobin is determined from the dilution in the First Dilution Hgb bath Figure 2 9 This dilution is prepared in two stages the primary first dilution and the secondary last dilution The primary dilution is made and 42 5yL of that dilution is removed for making the RBC PIt dilution AC T 5diff Hgb Lyse and additional Diluent are added to make the final 1 250 dilution The Hgb concentration is based on the transmittance of light through the optical part of the First Dilution Hgb bath using a spectrophotometric technique at a wavelength of 550nm The transmittance of the sample dilution is compared to the transmittance of a reagent blank The system calculates the Hgb using the blank and sample readings Table 2 3 summarizes the technical characteristics required for measurin
121. ion you choose determines which areas Figure A 1 will print on the report e Option 1 prints report areas 1 2 and 3 Option 2 prints report areas 1 and 2 Option 3 prints report area 1 Do this procedure to configure the printer 1 Beginning at the Main menu select SETUP gt gt PRINTER gt gt PRINTER CONFIGURATION PRINTER CONFIGURATION 02 27 00 16 05 PAPER LENGTH INCHES AREA PRINTING 5 5 OPTION 1 6 O OPTION 20 1 OPTION 3 11 12 PATIENT RANGE PRINTOUT MESSAGES PRINTOUT DIFFPLOT amp HISTOGRAM FLAGS HISTOGRAM THRESHOLDS PRINT RAW VALUES ZOOMED PRINT SCREEN DISABLE PRINTER 2 Move the cursor to the parameter you want to select or de select 3 Press at an empty box to make the selection To de select that box select something else 4 Repeatsteps 2 and 3 as needed 5 Press to save and exit Note If paper length is changed turn the printer off then on to activate the new length so the form feeds correctly PN 4237615B INSTRUMENT SETUP A ENTERING EDITING THE INSTITUTIONAL HEADER A 11 ENTERING EDITING THE INSTITUTIONAL HEADER Do this procedure to define the header that will appear on the sample reports You can enter up to four lines of text with 32 characters per line 1 Beginning at the Main menu select SETUP gt gt PRINTER INSTITUTIONAL HEAD
122. lacing Fix WBC Lyse Hgb Lyse and Rinse Reagents Replace a reagent e when it is empty or when REAGENT LOW LEVEL appears Do this procedure to replace Fix WBC Lyse Hgb Lyse or Rinse reagents To replace Diluent do Replacing the Diluent Reagent GS A 1 Beginning at the Main Menu select REAGENTS LEVEL CHANGE Note If a reagent level indicates 0 you must replace that reagent 2 Move the cursor to the CHANGE bar next to reagent you want to replace or select LEVEL CHANGE 42 07 99 16 05 DILUENT CHANGE ALL and press 9 SSS 00 CHANGE SSS 93 For example if you wanted to WBC LYSE in change the Fix reagent move the HGB LYSE j E eum M 9196 cursor to the Fix CHANGE bar and RINSE 88 press 9 CHANGE ALL Note If you select CHANGE ALL do Replacing the Diluent Reagent and the following procedure PN 42376158 8 21 DIAGNOSTICS REPLACEMENT PROCEDURES 8 22 ATTENTION Do not enter the lot number at this time If you do priming will start before the reagent container is replaced 3 The lot number prompt appears for the selected reagent For example if you are replacing the Fix this screen would appear Do not enter the lot number at this time LEVEL CHANGE 12 07 99 16 05 AM DILUENT FIX FIX ENTER LOT NUMBER AND PRESS ENTER TO CONTINUE LOT 00102D0002 93 CHANGE CHANGE ALL 4 Open the reagent
123. le cell control A preparation made of human blood with stabilized cells and surrogate material used for daily instrument quality control characteristics See performance characteristics coefficient of variation An expression in percent of data SD spread related to the mean CV SD mean x100 control A substance used for monitoring the performance of an analytical process or instrument conventions A standard style or format used in a manual CV See coefficient of variation default An original factory setting expiration date The last day that you can use that specific lot number of reagent control or calibrator fL Abbreviation for femtoliter femtoliter One quadrillionth 1015 of a liter field An area on a screen for entering data flags On printouts letters or symbols that appear next to parameter results to indicate specific conditions For additional information see Heading 6 2 FLAGS AND INTERPRETIVE MESSAGES linearity The ability of an instrument to recover expected results reference values or calculated values for such parameters as WBC RBC Hgb and Plt at varying levels of concentration of these parameters within specified limits lot number A manufacturer s code that identifies when the product such as a reagent was manufactured mean Arithmetic average of a group of data operating range Range of results over which the instr
124. le blood 10uL Volume AC T 5diff WBC Lyse 2 000uL Dilution ratio 1 200 Reaction temperature 35 C 95 F Measurement Characteristics Method of analysis Coulter Principle Aperture diameter 80um Count vacuum 200mb 5 9in Hg Count period 2x6 seconds 9 10 PN 4237615B OPERATION PRINCIPLES 2 SAMPLE ANALYSIS Parameter Results Obtained from the WBC BASO Dilution The final 1 200 dilution is used to e Determine the WBC count and Develop the WBC BASO histogram which is needed to obtain the BASO count Differential Twenty five microliters 25pL of whole blood is delivered to the DIFF bath in a flow of AC T 5diff Fix reagent which lyses the red blood cells stabilizes the WBC in their native forms and differentially stains the lymphocytes monocytes neutrophils and eosinophils with eosinophils staining most intensely The solution is then stabilized with Diluent for three seconds and transferred to the measuring bath See Figure 2 11 Each cell is measured in absorbance cytochemistry and resistivity volume Figure 2 11 Flowcell Operation 2 Second focused flow for optical detection pit A 8S 1 Primary focused flow for impedance PN 4237615B 2 11 OPERATION PRINCIPLES SAMPLE ANALYSIS Table 2 5 summarizes the technical characteristics required for acquisition of the DiffPlot Table 2 5 Technical Characteristics for Acquisition of the DiffPlot Dilution Characteristics Volume of whole
125. limits o o and so forth o o Delete deletes the entered information o ee 9 000 O O O DOC Enter executes a function or enters O O O p data C x d J Range selects the flagging range to be N used 75800A Cursor keys move the cursor on the screen and allow you to scroll through the alphabet when entering information Numeric keypad allows you to enter numbers for dates values limits sample IDs and to select menu items Period Allows you to enter the decimal number separator and to select de select software options 1 3 i USE AND FUNCTION INTENDED USE Back Panel Figure 1 4 shows the instruments back panel Figure 1 4 Back Panel Serial number label Barcode reader connector Printer connector Host RS 232 C Output connector Power supply cord connector Waste output connector eococooc e Diluent input connector a OR Sio o S Warning and Caution Labels Pay close attention to the labels on the instrument Figure 1 5 Figure 1 5 Warning and Caution Labels on the Instrument 100 240 VOLTS HZ AMPS WATTS COULTER MADE IN FRANCE AUTOMATED DIFFERENTIAL CELL COUNTER FOR IN VITRO DIAGNOSTIC USE _ TO REDUCE THE RISK OF ELECTRICAL SHOCK DO NOT REMOVE THE COVER OR BACK REFER SERVICING TO QUALIFIED SERVICE PERSONNEL ELECTRIC SHOCK HAZARD DISCONNECT UNIT FROM POWER SOURCE PRIOR TO SERVICING FOR CONTINUED PROTECTION AGAINSTR
126. line battery to ensure correct operation of the waste sensor alarm There is a waste sensor alarm unit mounted on Figure 8 6 Waste Sensor Alarm Unit Location back of the instrument Figure 8 6 As the waste container fills there is a float on the sensor that triggers the alarm which then emits a continuous intermittent beep until the waste container cap is removed If you need to move the waste sensor alarm closer to the waste container gently pull the alarm unit from the back of the instrument Do this procedure when the waste sensor alarm sounds or as needed AN 1 Carefully remove the cap with waste sensor attached from the waste container PN 4237615B 8 27 DIAGNOSTICS REPLACEMENT PROCEDURES 2 Replace the waste container according to your laboratory guidelines 3 Insert the waste sensor float into the new waste container and properly secure the cap WARNING Risk of personal injury if waste is not neutralized before the waste container is capped Non neutralized waste contents may produce gas which can build up pressure in a capped container Neutralize waste contents after removing the waste container and before capping it for disposal 4 Do Neutralizing the Waste and Treating for Biohazards 8 28 PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES Replacing the Flowcell Lamp Do this procedure when the flowcell lamp fails or e when instruc
127. llustration 1 2 ASTM definition ABBREVIATIONS 1 AT LEAST 3 TAGGED RESULTS REQUIRED 8 34 ATL display print setup A 28 attention definition 4 1 Atypical Lymphocyte triggering condition 6 13 auto clean frequency 8 4 frequency setting procedure A 31 when performed 5 11 BA interfering substances 3 11 backflush function 8 12 procedure 8 12 background count definition GLOSSARY 1 limits 5 3 5 4 band cells description 2 20 barcode labels default settings F 2 specifications F 1 symbologies list of F 1 barcode reader connector location 1 4 entering sample ID 5 13 barcode definition F 1 INDEX 1 INDEX basophil See BA Basophilia triggering condition 6 13 BATH ENCLOSURE DOOR OPENED 8 34 baths cleaning bleaching procedure 8 2 draining procedure 8 14 location illustration 8 11 rinsing procedure 8 13 blank cycle definition GLOSSARY 1 blast cells description 2 20 Blasts triggering condition 6 13 bleaching See cleaning procedures blocked apertures removing blockage 8 12 bps definition ABBREVIATIONS 1 C calibration auto calibration 7 3 definition GLOSSARY 1 forced required 7 9 manual 7 11 C 1 number of runs 7 8 passing requirements 7 9 pre calibration checks 7 1 printing calibration factors 7 14 report example 7 14 requirements 7 1 running 7 5 setup procedures 7 3 A 23 verification out of limit what to do it 8 36 calibration factors definition GLOSSARY
128. low voltage which the amplification circuit increases so that the electronic system can better analyze the pulses and eliminate the background noise Applying the Coulter Principle The AC T 5diff analyzer makes several dilutions of an aspirated whole blood sample The RBC Plt dilution begins in the First Dilution Hgb bath but is actually analyzed in the RBC bath The final dilution in the RBC bath is used to determine the cell count and size of red blood cells and platelets The WBC BASO aperture sensor system is directly responsible for determining the cell count and size of white blood cells The differentiation between basophils and other white blood cells is also related to the AC T 5diff WBC Lyse specific lytic action on these white blood cells Thresholds which are electronically set size limits exclude unwanted particles such as debris from the analysis Particles above the threshold are analyzed and particles below the threshold are excluded PN 4237615B 2 3 PN 4237615B OPERATION PRINCIPLES ACV TECHNOLOGY ACV TECHNOLOGY In the DIFF bath 25pL of whole blood is mixed with 1 000pL of AC T 5diff Fix reagent for 12 seconds then stabilized with 1 000pL of ACT 5diff Diluent for an additional 3 seconds This reaction lyses the red blood cells preserves the leukocytes at their original size and differentially stains the lymphocytes monocytes neutrophils and eosinophils with eosinophils staining most intensely The instr
129. lues for a control material used for quality control parameters Usually EXPECTED reported on package insert shipped with the control material can be a separate RESULTS assay sheet verification Procedure to analyze cell controls or whole blood with known values to determine if your results are within expected range whole blood Non diluted blood blood and anticoagulant only GLOSSARY 2 PN 4237615B LIST OF ABBREVIATIONS pL microliter ACD acid citrate dextrose ANSI American National Standards Institute ASTM American Society for Testing and Materials BA basophil bps bits per second CBC complete blood count cm centimeter CV coefficient of variation DIFF differential dL deciliter EDTA ethylenediaminetetraacetic acid EO eosinophil fL femtoliter ft foot or feet g gram gal gallon GR granulocyte Het hematocrit Hgb hemoglobin Hz hertz L liter LCD liquid crystal display LED light emitting diode LY lymphocyte m meter MCH mean corpuscular hemoglobin MCHC mean corpuscular hemoglobin concentration MCV mean corpuscular volume mL milliliter mm millimeter MO monocyte MPV mean platelet volume MSDS material safety data sheet mW milliwat n number PN 4237615B ABBREVIATIONS 1 ABBREVIATIONS LIST OF ABBREVIATIONS NCCLS National Committee for Clinical Laboratory Standards NE neu
130. mber of basophils may interfere with an accurate monocyte count Interfering substances pertaining to WBC also pertain to the MO and MO EO E0 BA BA The eosinophil cell count is derived from the WBC count The presence of abnormal granules degranulated areas toxic granules and so forth may interfere with the eosinophil count Interfering substances pertaining to WBC also pertain to the EO and EO The basophil cell count is derived from the WBC count Interfering substances pertaining to WBC also pertain to the BA and BA tThe RBC dilution contains all formed elements in the blood erythrocytes leukocytes and platelets During the counting of the RBCs platelets are not counted if their size falls below the RBC minimum threshold Blood samples collected in EDTA will not maintain a stable MPV because platelets swell depending on the time post collection and PN 4237615B storage temperature 3 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 3 12 PN 4237615B PRECAUTIONS HAZARDS 4 1 DEFINITIONS Warnings Anything that can cause user injury is considered a hazard and is noted in the text as WARNING Warnings appear where needed throughout this manual Cautions Anything that can cause instrument damage is considered a caution and is noted in the text as CAUTION Cautions appear where needed throughout this manual Importants Anything that can cause misleading results or data corruption is
131. messages Table 6 10 Interpretive Messages from a Combination of WBC RBC PIt Action Ranges Message Triggering Condition PANCYTOPENIA WBC lt WBC LL and RBC lt RBC LL and Pit lt Pit LL HH means above the action range LL means below the action range 6 14 PN 4237615B REVIEWING RESULTS INTERPRETIVE MESSAGES Table 6 11 NABCs and PLATELET AGGREGATES Interpretive Messages Message Triggering Condition PLT AGGREGATES Plt lt 150x103 mm and WBC voteout DB and PDW gt 20 or DB and MPV gt 10 or DB and Plt lt 150x103 mm3 or DB and WBC Voteout WBC and PDW gt 20 or WBC and MPV gt 10 or WBC and Plt lt 150x108 mm3 NRBCS SL or SL and WBC Voteout or WBC and WBC Voteout or SL1 and WBC Voteout NRBCS amp PLATELET If none of the individual conditions defined for VRBCS or PLATELET AGGREGATES AGGREGATES occur and WBC or SL1 or WBC Voteout occur PN 4237615B 6 15 l6 REVIEWING RESULTS INTERPRETIVE MESSAGES 6 16 PN 4237615B CALIBRATION 7 1 GENERAL Calibration is a procedure to standardize the instrument by determining its deviation if any from calibration references and to apply any necessary correction factors There are two calibration modes available on this instrument e Auto calibration which uses calibration blood samples Manual calibration where known calibration factors can be directly entered Recommended Calibration Conditions Be
132. n can cause personal injury When you operate the instrument be sure all covers and doors are closed PN 4237615B 4 1 PRECAUTIONS HAZARDS OPERATIONAL HAZARDS 4 3 OPERATIONAL HAZARDS Safety symbols alert you to potentially dangerous conditions These symbols together with text apply to specific procedures and appear as needed throughout this manual Symbol Warning Condition Action Biohazard Consider all materials Wear standard laboratory attire and follow safe le specimens reagents controls laboratory procedures when handling any calibrators and so forth and areas material in the laboratory these materials come into contact with as being potentially infectious T Er Probe hazard The probe is sharp Avoid any unnecessary contact with the probe and may contain biohazardous and probe area materials such as controls and calibrators NN Electrical shock hazard Possibility Before continuing unplug the AC T 5diff N Er of electrical shock when analyzer from the electrical outlet instrument is plugged into the power source 4 2 PN 42376158 RUNNING SAMPLES Bj 9 1 BEFORE ANALYSIS Do the following procedures e Waste Container Level Check e Printer Check e Startup e Specimen Collection and Mixing and Running Cell Controls to Verify Calibration Waste Container Level Check At the beginning of each day check the waste container to determine if it needs to be repl
133. ndition 6 13 limits background count 5 3 5 4 linearity definition GLOSSARY 1 performance specifications 3 5 LL flag definition 6 12 log sheets B 1 action B 2 maintenance B 3 reagent B 4 lot number definition GLOSSARY 1 PN 4237615B INDEX LY description 2 19 interfering substances 3 11 lymphocytes See LY Lymphocytosis triggering condition 6 13 Lymphopenia triggering condition 6 13 m definition ABBREVIATIONS 1 MACRO flag definition 6 9 Macrocyte triggering condition 6 14 Macrocytosis triggering condition 6 14 Macroplatelets triggering condition 6 14 maintenance log sheet B 3 schedule 8 1 material safety data sheet See MSDS MB flag definition 6 8 MCH interfering substances 3 10 MCHC interfering substances 3 10 MCV interfering substances 3 10 mean definition GLOSSARY 1 menu selecting menu items 1 11 messages See interpretive messages MIC flag definition 6 10 MICRO flag definition 6 9 Microcyte triggering condition 6 14 Microcytosis triggering condition 6 13 6 14 mL definition ABBREVIATIONS 1 mm definition ABBREVIATIONS 1 MO description 2 19 interfering substances 3 11 monocyte See MO Monocytosis triggering condition 6 13 motherboard function 8 12 INDEX 5 INDEX location 8 12 screws securing in place 8 12 motors checking 8 15 MPV interfering substances 3 11 MSDS definition ABBREVIATIONS 1 how to order 1 13 mW defini
134. ng the printer to Draft mode A 18 Configuring the Instrument s Printer Settings Configure the printer settings including Paper length inches 5 5 6 11 or 12 Area printing options 1 through 3 Patient range printout prints normal ranges Messages printout prints interpretive messages DiffPlot amp histogram flags prints and displays the full format DiffPlot and histogram flags Histogram thresholds prints and displays the threshold positions on the WBC RBC and Plt histograms Print Raw Values prints raw data Select this option only for troubleshooting purposes not for routine operation Zoomed Print Screen allows large printout of screen display Disable printer Does not print the results and does not sound a printer alarm Figure A 1 is an example of a sample results printout PN 4237615B Figure A 1 Sample Results Report Areas Defined DATE i BECKMAN 11800 SW 147 AVE i 2 00 L DOB 8 ie e ange Patient N Oo 107 yL 3 0 Mts NE 41 8 104 ub 4 00 6 02 TA 25 6 g dl P o 717 0 HQ b 60 0 EQ 2 i _ H 00 B 2 4 H 25 ATL 1 4 q dL 30 0 736 9 Im 0 4 x 10 0 20 0 NER 3 02 LYN 1 24 107 pL 2 25 re MOM 0 40 0 EOM 0 10 Ont 40 5 RAH 0 13 a 7 0 19 0 ATLE 0 07 Imma 0 02 ULTER INC Ht INSTRUMENT SETUP PRINTER CONFIGURATION A FLORIDA o TIME 16 04 28 Range i 40 0 770 0 25 0 55 0 12 0 2 0 2 0 2 0 2 0 10 uL 2
135. nt cycle schedule Mark the maintenance dates on your calendar CAUTION Incorrectly performed maintenance procedures can damage the ACT 5diff analyzer Do not attempt to do any procedures not included in this manual Contact a Beckman Coulter representative for service and maintenance beyond the scope of what is documented in this manual MAINTENANCE SCHEDULE See Table 8 1 Table 8 1 Maintenance Schedule Maintenance Procedure Frequency Situation Startup Daily Automatically occurs when you O turn on the instrument Shutdown Daily Do Heading 5 4 SHUTDOWN to e clean the instrument Calibration As needed or when required by your laboratory or regulatory agency Replace reagents When empty or when there is not enough to complete your daily workload REAGENT LEVEL LOW message appears on the instrument Extended cleaning As needed Poor instrument performance Replace sampling probe As needed System Reset Cycle After an emergency stop of the instrument or when a faulty operation has been detected PN 4237615B 8 1 DIAGNOSTICS CLEANING PROCEDURES 8 3 CLEANING PROCEDURES WARNING Risk of biohazardous conditions Utilize appropriate barrier protection when performing these procedures as the instrument may contain biohazardous material Cleaning the Outside of the Instrument L 2 N E AS Clean the outside of the instrument with a damp cloth and distilled w
136. nt for WBC BASO AC T 5diff WBC Lyse Diluent AC T 5diff Diluent Q Counting syringe e ensures the vacuum for the WBC and BASO counts e ensures the vacuum for the RBC and Plt counts and e ensures the vacuum for filling the diluent tank with diluent 8 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES Figure 8 4 Motherboard Motherboard e amplifies processes and counts the resistive signals and DIFF optical signals the RBC signal the Pit signal and the WBC BASO signal e measures hemoglobin e pilots the motorized components e manages user interface control panel buttons printer host interface and barcode reader and processes data and calculates results Screws that secure the motherboard to the frame Cables that must not be pinched or damaged when the motherboard door is opened Latch that holds Motherboard open ATTENTION When opening the Motherboard support panel use care not to disconnect or damage the electric cables 8 6 SYSTEM TROUBLESHOOTING PROCEDURES Diluter System Backflush The backflush feature pushes pressure through the rear of the apertures to remove blockages Do this procedure if you suspect the apertures are blocked iA S N N Fa DILUTER SYSTEMS 12 07 99 16 05 1 Beginning at the Main Menu select DIAGNOSTICS gt gt DILUTER SYSTEMS gt DRAIN BATHS BACKFLUSH 4 EXTENDED CLEANING 8 12 PN 4237615B
137. nt procedure 8 21 rinsing procedures baths 8 13 flowcell 8 13 S safety precautions biological 8 4 list of 4 1 while performing maintenance or service 8 4 sample analysis after what to do 5 10 before what to do 5 1 procedure 5 8 sample ID available methods 5 11 entering A 27 mode selection A 27 scanning with barcode reader 5 13 sample identification See sample ID sample probe malfunctioning 8 36 sample report header A 21 printout example A 19 samples entering IDs 3 3 number processed per hour 3 3 presenting to the sample probe 1 13 stability of 3 3 sampling syringe function 8 10 location 8 10 sampling traverse function 8 10 location 8 10 Schistocyte triggering condition 6 14 INDEX 7 INDEX SCL flag definition 6 11 SD standard deviation definition GLOSSARY 2 serial number label location 1 4 Shutdown button 1 3 cycle definition GLOSSARY 2 function 1 3 procedure 5 11 SI 1 See reporting units SI 2 See reporting units SI 3 See reporting units SI 4 See reporting units Small cell triggering condition 6 14 software cursor See cursor software fields See fields software menu See menu specifications See performance specifications specimen collection requirements 5 5 limitations 3 8 mixing requirements 5 5 Startup button 1 3 failure 8 36 function 1 3 when to do 5 2 startup cycle definition GLOSSARY 2 symbols safety xx tab xx system cleaning procedure
138. nt volumes if necessary 6 Press to exit A 22 VIEWING THE CYCLE COUNT Beginning at 1 the instrument counts the number of cycles run after the software is installed for e CBC DIF e CBC e Startup e Shutdown and e System Reset Cycle Do this procedure to review the number of cycles analyzed by the instrument A 34 PN 4237615B INSTRUMENT SETUP A VIEWING THE CYCLE COUNT 1 Beginning at the Main menu select SETUP gt OTHERS CYCLE COUNTS 2 The number of analyzed cycles is displayed CYCLE COUNTS 1 27 00 16 05 CBC DIFF 1395 CBC 144 STARTUP 100 SHUTDOWN 43 SYSTEM RESET 31 3 Press to exit PN 4237615B A 35 INSTRUMENT SETUP VIEWING THE CYCLE COUNT A 36 PN 4237615B PN 4237615B This Appendix contains these Log Sheets Action Log Maintenance Log Reagent Log Photocopy these log sheets as needed B 1 LOG SHEETS ACTION LOG ACTION LOG Action Log Activity Serial No Lab BECKMAN COULTER AC T 5diff Analyzer B 2 PN 4237615B LOG SHEETS B MAINTENANCE LOG MAINTENANCE LOG Maintenance Log Date By Activity Serial No Lab BECKMAN COULTER AC T 5diff Analyzer PN 4237615B B 3 LOG SHEETS REAGENT LOG REAGENT LOG Reagent Log Date Opened Lot Number Expiration Date Who Changed it Serial No Lab BECKMAN COULTER ACeT 5diff Analyzer A COULTER
139. nted Forced Calibration prints on the report as shown in this example CALIBRATION TIME 10 52 17 AM DPERATOR PAT FORCED CALIBRATION OT 4 CX292 103 uL 108 uL g dL 103 uL 5 Press to exit the calibration chart table 7 4 MANUAL CALIBRATION FACTOR ADJUSTMENT If you know the calibration factors you can change them to achieve calibration Do this procedure if you want to change the calibration factors 1 Beginning at the Main Menu select CALIBRATION gt gt CAL FACTORS 2 Enter the user password and press 9 The Cal Factors screen appears PN 4237615B CAL FACTORS 02 27 00 16 05 121 204 7 CALIBRATION MANUAL CALIBRATION FACTOR ADJUSTMENT 7 12 Move the cursor to the parameter whose factor you want to change Enter the new factors Table 7 1 shows the calibration factors ranges for each parameter ee0 90009 Note RDW can be calibrated by means of calibration factors These coefficients are incremented to 0 3 by default RDW is calculated based on the following formula RDW result RDW coefficient x RDWcalculated Press Repeat steps 3 through 5 as needed When you are finished entering new factors press e PN 4237615B PN 4237615B CALIBRATION MANUAL CALIBRATION FACTOR ADJUSTMENT 8 Save the calibration factors by pressing 9 or reject the calibration factors by pressing B CAL FACTORS 02 27 00
140. orrelation r WBC 0 99 RBC 0 99 Hgb 0 99 Het 0 99 Plt 0 98 NE 0 99 LY 0 99 MO 0 88 E0 0 98 Carryover Carryover Table 3 10 was assessed by analyzing whole blood with high values followed by a whole blood sample with low values Each sample was run consecutively in triplicate Carryover is calculated as follows Carryover Lonte Low x 100 High 1 Low 3 Table 3 10 Carryover Characteristics Parameter Units Low Level High Level Carryover WBC 103 uL 1 5 54 6 0 0096 RBC 108 uL 2 0 8 1 0 1696 PIt 103 uL 35 5 818 0 0 45 Hgb g dL 6 3 25 4 0 26 3 4 LIMITATIONS Maintenance Failure to properly execute the maintenance procedures in Chapter 8 DIAGNOSTICS may compromise the instruments reliability Blood Specimens If any abnormal test result including flagged results or results outside the normal range occur use reference methods or other standard laboratory procedures to verify the results For additional information see Heading 3 5 INTERFERING SUBSTANCES 3 8 PN 4237615B SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 3 5 INTERFERING SUBSTANCES Table 3 11 shows a list of known limitations of automated blood cell counters that use impedance and light absorbance as measurement principles Table 3 11 Interfering Substances Parameter Interfering Substance WBC Unlysed RBCs In rare instances the erythrocytes in the blood sample may not completely lyse
141. ot regions Table 2 8 defines immature white blood cells Table 2 7 DiffPlot Regions Defined Region Definition Neutrophil Neut Neutrophils with their cytoplasmic granules and segmented nuclei scatter light according to their morphological complexity A hypersegmented neutrophil gives an increased optical response when compared to a young neutrophil population The higher the complexity of the cell the further to the right they appear in the DiffPlot Figure 2 17 Lymphocyte Lymph Lymphocytes typically being small with regular shape are smaller in volume and lower in absorbance than the other cells and are positioned in the lower region of the DiffPlot Figure 2 17 Normal lymphocyte populations typically have a homogeneous volume with a Gaussian bell shaped distribution Large lymphocytes reactive lymphoid forms stimulated lymphocytes and plasma cells are found in the upper portion of the lymphocyte region Figure 2 17 The lower area of the lymphocyte zone is normally empty however when small lymphocytes are present a population may exist in this area Figure 2 17 The presence of platelet aggregates is indicated by a distribution pattern that moves from the DiffPlot origin into the lymphocyte region Figure 2 17 NRBC cytoplasmic membranes lyse like those of mature erythrocytes The small nuclei that remain appear in the debris and small lymphocyte regions Figure 2 17 Monocyte Mono
142. ou need to erase saved text Move the cursor to the line of text where you want to delete information Press The cursor becomes a flashing underscore which means you can now edit the field Move the underscore to the character you want to delete Press o to backspace and delete Press 9 to save the changes Selecting De selecting Software Fields Some software screens allow you to select activate or de select deactivate certain software features 1 Move the cursor to the desired field PN 4237615B USE AND FUNCTION PRESENTING SAMPLES TUBES OR VIALS AND STARTING ANALYSIS 2 Press e AUTOCALIBRATION 02 27 00 16 05 For example 7001 is selected on the j LOT CX294 EXP DATE 04 05 00 Autocalibration screen shown here TARGET VALUES Note 10 4 RBC 4 40 HGB 13 6 36 7 PLT 255 v selected CONTINUE not selected 1 7 PRESENTING SAMPLES TUBES OR VIALS AND STARTING ANALYSIS Some procedures in this manual require you to present a tube or vial to the instrument and start analysis The following information describes how Present the tube or vial to the aspirate probe T Ensure that the probe is well inside the tube or 1 vial contents and press the aspirate switch During aspiration the red and green LEDs flash K e When the red LED remains illuminated e remove the tube or vial from the probe When the g
143. ound counts are not within acceptable limits after the first Startup cycle the instrument automatically performs Startup up to two more times If Startup fails after the third attempt a STARTUP FAILED message appears on the screen and on the report for every cycle Note The background count limits are WBC 0 3 x 103 pL RBC 0 03 x 10 aL Hgb 0 3 g dL Plt 7 0 x 10 pL3 a Do Startup After Power Up b If Startup continues to fail contact a Beckman Coulter representative If the system determines that there is insufficient reagent to complete the days work a REAGENT LOW LEVEL message appears Identify the low reagent and change it according to the procedures in Replacing Reagents OR Continue and change the reagent when the specific reagent low message is displayed Startup After Power Up Do this procedure if you want to run Startup after the instrument has already gone through the initial Startup routine at power up 1 Press PN 42376158 5 3 RUNNING SAMPLES BEFORE ANALYSIS Review the Startup results If Startup passed go to Specimen Collection and Mixing e If Startup failed go to step 3 If the background counts are not within acceptable limits after the first Startup cycle the instrument automatically performs Startup up to two more times If Startup fails after the third attempt a STARTUP FAILED message appears on the screen and on the report for every cycl
144. re correct sample identification F 2 BARCODE LABELS Symbologies The AC T 5diff analyzer accepts six barcode symbologies e Code 128 e Code 39 e Codabar e Interleaved 2 of 5 e EAN 8 and EAN 13 ATTENTION The scanner uses Code 128 symbology for programming Therefore the following Code 128 characters must not be used in any of the barcodes used to identify the sample and F3 BARCODE SPECIFICATIONS Barcode labels to be used with the AC T 5diff analyzer must meet the following specifications Maximum number of usable characters in barcode label 16 Minimum PCS Print Contrast Signal 1596 at 670 nm e Maximum resolution of scanner 0 1 mm 4 mils Maximum label length 66 mm 2 6 inches e Code 128 barcode labels must meet European Standard EN 799 e Code 39 barcode labels must meet European Standard EN 800 e Codabar barcode must meet European Standard EN 798 Interleaved 2 of 5 I 2 of 5 barcode labels must meet European Standard EN 801 EAN 8 barcode labels must meet EAN European Article Numbering Specifications EAN 13 barcode labels must meet EAN European Article Numbering Specifications PN 42376158 F 1 BARCODE SPECIFICATIONS BARCODE SPECIFICATIONS Table E1 shows default barcode settings for each symbology Table F 1 Default Barcode Settings Setting Code 1289 Code 39 Codabar 12 of 5 EAN8 EAN 13 Character Length 1 to 16 1 to 16 3 to 16 119 7 12 Check
145. red to as the bath electrode is not as conspicuous This electrode is located inside the bath The aperture is located between the counting head and the bath electrode PN 42376158 2 1 OPERATION PRINCIPLES MEASUREMENT PRINCIPLES 2 2 Figure 2 1 Coulter Principle Solution to be analyzed Vacuum constant Current costant Volts Analyzing electronic circuit Electrodes gt Time 7616035A When the count circuit is activated and an electronically conductive reagent is in the RBC or WBC BASO bath an electric current continuously passes through the aperture Current moving between the two electrodes establishes the electronic flow through the aperture Once a sample is aspirated an aliquot of that aspirated sample is diluted with reagent an electrolyte and is delivered to the RBC or WBC BASO bath using tangential flow which ensures proper mixing of the dilution When the cells suspended in the conductive reagent are pulled through a calibrated aperture the electrical resistance between the two electrodes increases proportionately with the cell volume Figure 2 1 The resistance creates a pulse that is sensed and counted as a particle by the instrument The amount of resistance amplitude of each pulse is directly related to the size of the particle that produced it The generated pulses have a very
146. reen LED remains illuminated the instrument is ready for the next analysis 1 8 ORDERING MATERIAL SAFETY DATA SHEETS MSDS To obtain an MSDS for reagents used on the ACeT 5diff analyzer l Inthe USA either call Beckman Coulter Customer Operations 800 526 7694 or write Beckman Coulter Inc Attn MSDS Requests PO Box 169015 Miami FL 33116 9015 2 Outside the USA contact a Beckman Coulter representative PN 42376158 1 13 1 USE AND FUNCTION ORDERING MATERIAL SAFETY DATA SHEETS MSDS 1 14 PN 4237615B OPERATION PRINCIPLES 2 1 OVERVIEW The A eT 5diff analyzer is a fully automated hematology analyzer providing a complete WBC five part differential which is determined simultaneously by the ACV Absorbance Cytochemistry and Volume Technology and WBC BASO methodologies The ACV Technology uses absorbance cytochemistry and focused flow impedance The WBC BASO methodology uses differential lysis impedance technology and differential thresholds See Table 2 1 Table 2 1 ACeT 5diff Analyzer Measurement Technologies Fluid Dynamics Technology Measurements Output Dual Focused Flow ACV Technology Light absorbance of Lymphocytes monocytes cytochemically stained neutrophils eosinophils cells immature cells and atypical lymphocytes Volume aperture Differential lysis using the Volume and count WBC count basophil Coulter Principle percentage and basophil count Volume aperture Coulter Principle
147. retive messages from Action Ranges e Table 6 5 lists WBC interpretive messages from the DiffPlot Table 6 4 WBC Interpretive Messages from Action Ranges Printed Message Triggering Condition LEUCOCYTOSIS WBC gt WBC HH LEUCOPENIA WBC lt WBC LL LYMPHOCYTOSIS LY gt LY HH or LY gt LY HH LYMPHOPENIA LY lt LY LL or LY lt LY LL NEUTROPHILIA NE gt NE HH or NE gt NE HH NEUTROPENIA NE lt NE LL or NE lt NE LL EOSINOPHILIA EO gt EO HH or E0 gt E0 HH MONOCYTOSIS MO gt MO HH or MO gt MO HH BASOPHILIA BA gt BA HH or BA gt BA HH LARGE IMMATURE IMM gt IMM HH or IMM gt IMM HH CELLS ATYPICAL ATL gt ATL HH or ATL gt ATL HH LYMPHOCYTE MYELEMIA NE gt NE HH and IMM gt IMM HH BLASTS BA gt BA HH and IMM gt IMM HH and UM H means above the patient range HH means above the action range LL means below the action range Table 6 5 WBC Interpretive Messages from DiffPlot Message Triggering Condition LEFT SHIFT MN or NL and UN RBC Interpretive Messages e Table 6 6 lists RBC interpretive messages from Action Ranges e Table 6 7 lists RBC interpretive messages from Flag Sensitivity Table 6 6 RBC Interpretive Messages from Action Ranges Message Triggering Condition ANEMIA Hgb lt Hgb LL ANISOCYTOSIS RDW gt RDW HH HYPOCHROMA MCHC lt MCHC LL COLD AGGLU
148. s E 14 PAPERWORK C Log sheets Appendix B CQ Purpose of documenting Ensure customer service daily procedures controls telephone number is clearly reagents and noted maintenance Q Complete this training Q Attach a copy of control QO Attach copy of Setup Report to checklist installer and results all levels to this this checklist customer Customer should checklist keep this in laboratory logbook Q Complete atraining certificate C Review Factory Calibration Complete the RUO Certification if applicable and leave it data form PN 4277094 and return with the customer it to Beckman Coulter Inc customers in USA only Install date Training date OPERATOR BECKMAN COULTER REPRESENTATIVE Name Name Print Print Title Title Signature Signature Thank you for purchasing the BECKMAN COULTER ACeT 5diff hematology analyzer PN 4237615B E 3 E TRAINING CHECKLIST PAPERWORK E 4 PN 42376158 BARCODE SPECIFICATIONS F 1 OVERVIEW Use the information in this appendix to test troubleshoot and reprogram your barcode scanner IMPORTANT Risk of sample mis identification if your barcode labels do not meet the specifications stated in this appendix Use only barcode labels that meet the stated specifications Definition A barcode consists of black lines bars and white lines spaces called elements ATTENTION Beckman Coulter recommends that you verify each barcode reading to ensu
149. s at the bottom of the old container can contaminate the new reagent which will cause unacceptable background results especially for platelets Viewing Reagent Levels Do this procedure to view a reagent level LN 1 Beginning at the Main Menu select REAGENTS LEVEL CHANGE Note If a reagent level indicates 0 you must replace that reagent Do Replacing Fix WBC Lyse Hgb Lyse and Rinse Reagents or Replacing the Diluent Reagent LEVEL CHANGE 12 07 99 16 05 DILUENT 93 93 92 91 88 CHANGE CHANGE CHANGE CHANGE CHANGE CHANGE ALL 2 Press to exit PN 4237615B DIAGNOSTICS 8 REPLACEMENT PROCEDURES Replacing the Diluent Reagent Replace the Diluent e when it is empty or when REAGENT LOW LEVEL appears LN 1 Beginning at the Main Menu select REAGENTS LEVEL CHANGE Note If a reagent level indicates 096 you must replace that reagent 2 Move the cursor to the CHANGE bar next LEVEL CHANGE 12 07 99 16 05 DILUENT FIX WBC LYSE HGB LYSE RINSE to Diluent and press 93 93 92 91 88 CHANGE ALL ATTENTION Do not enter the lot number at this time If you do priming will start before the reagent container is replaced 3 The lot number prompt appears for Diluent Do not enter the lot number at this time PN 4237615B 8 17 REPLACEMENT PRO
150. side the acceptable ranges do step e e Recalibrate the system See Heading 7 3 AUTO CALIBRATION and rerun the control e If the results are still outside the acceptable ranges contact a Beckman Coulter representative e f your cell control results are within the acceptable ranges you are ready to analyze patient samples in Heading 5 2 ANALYSIS 5 7 5 RUNNING SAMPLES ANALYSIS 5 2 ANALYSIS Running Whole Blood Samples A 1 Verify that the sample ID in the Next ID field is correct e Ifso go to step 2 Ifnot enter the sample ID as instructed in Heading 5 5 ENTERING THE SAMPLE IDENTIFICATION ID 2 Ifyou want to change the sample analysis mode from what is currently ID 1007 12 07 99 16 05 123 H 64 1 selected press 27 8 5 6 The current analysis mode and range are displayed on the bottom right of the screen ANALYZING NEXT ID 1008 CBC DIFF 1 3 Ifyou want to change the Range from what is currently selected press until the desired flagging range appears 4 Mix the sample according to your laboratory s protocol 5 8 PN 4237615B RUNNING SAMPLES 5 ANALYSIS 9 Remove the cap from the sample tube according to your laboratory s protocol Vf AE 6 Present the sample to the probe and 1 press the aspirate switch The LEDs flash during sample aspiration 7 When the red LED remains illuminated remove the tube from the prob
151. t Region Affected Description Flags Abnormalities NE Occurs when the R next to Young eosinophils nun Ber pI IMM and Giant particles the NE jy hypersegmented separation region neutrophils is above the limits Replaces NE ee g set NE E0 and on with E 3 Default values EO with intracytoplasmic a material agranular NE is displayed POBIFIODRS and printed in WBC flag area ATL Occurs when a ATLis displayed Large lymphocytes significantly large and printed in Reactive population is WBC flag area lymphocytes located in the ATL May be enmubred region isplaved and imulate E l displaye lymphocytes z ATL flag is printed as gt triggered from the ATL and Plasma cells Patient Limits and ATL the interpretive message Atypical Lymphocyte is Absorbance triggered from the Action Limits Default values 2 or 0 2x109 L IMM Occurs when a IMM is Large monocytes significantly large displayed and Hyperbasophilic population of cells printed in WBC monocytes is located in UN flag area UM and channel May be Myelocytes Q 127 regions metamyelocytes 5 displayed and promyelocytes IMM flag is printed as 2 triggered from the IMM and Large blasts Patient Limits and IMM Large neutrophils Debris DB Absorbance the interpretive message Large Immature Cell is triggered from the Action Limits Default values 2 or 0 2x109 L PN 4237615B 6 7 6 REV
152. tact a Beckman Coulter representative Stable RBCs and Bent sample probe Contact a Beckman Coulter representative unstable Plts Printer Printer does not Printer may be turned Turn the printer on work off Printer may not be Refer to the printer user s manual setup or connected properly Printer does not Printer may not bein Put the printer in Draft Mode print results Draft Mode correctly Reagents Not enough reagent in Do Replacing Reagents the bottle container Waste sensor Waste container is full Do Replacing the Waste Container alarm beeps Incorrect Defective stepper Motor alarms are Do Hardware Reset mechanical motors triggered operation Current cycle stops Incorrect Leaks or Reagent alarms are 1 Do Heading 8 4 SYSTEM RESET pneumatic blockages triggered CYCLE operation Current cycle stops 2 Do Bath and Flowcell Rinse 3 Do Priming the Reagents Incorrectoptical Defective optical Specific flags 1 Do Heading 8 4 SYSTEM RESET Operation parts Hgb blank cycle CYCLE Dirty optical measurements are 2 Do Bath and Flowcell Rinse parts outside acceptable 3 Do Priming the Reagents limit Incorrect Incorrect main Instrument would not Ensure correct voltage from power source electrical supply voltage initialize operation means not applicable PN 4237615B 8 37 8 DIAGNOSTICS TROUBLESHOOTING GUIDES 8 38 PN 4237615B A 1 A 2 PN 4237615B INSTALLATION INSTRUMENT SETUP
153. ted by a Beckman Coulter representative Tools Supplies needed L Hex keys 2 mm and 3 mm QO Flowcell lamp ALAS N 1 Turn the instrument off 2 Unplug the instrument from its power source PN 42376158 8 29 DIAGNOSTICS REPLACEMENT PROCEDURES 8 30 Remove the side and top covers of the instrument Remove the four hex screws securing the left door to the instrument frame Set screws aside for use later In the left compartment remove the hex screw from the upper front corner Open the right door and remove the hex screw in the upper front corners At the rear of the instrument remove the three hex screws that secure the top cover to the instrument frame Carefully remove the top cover and set it aside PN 4237615B DIAGNOSTICS REPLACEMENT PROCEDURES WARNING Risk of personal injury due to hot surfaces within the instrument Use care when working in this area Some of the surfaces may be very hot and can burn you 4 Disconnect the lamp from the Power Supply a Locate the lamp and the connector on the left side of the optical bench Disconnect the lamp from the Power Supply Note how the existing lamp is seated e The metal bracket holding the lamp is keyed to ensure proper positioning e There are two different notches one is a semi circle that matches a circular raised area and the other is a square notch that m
154. ted per unit volume x Calibration coefficient Plt count is displayed and printed as Plt Nx10 cells pL Note pL is the US unit format Other formats are available See Heading A 7 REPORTING UNIT SELECTION MPV Measurement The MPV Mean Platelet Volume is measured directly from analysis of the platelet distribution curve The MPV is displayed and printed in femtoliters fL Pct Calculation The Pct plateletcrit is calculated according to the formula Pit 10 gL x MPV fL 10 000 PDW Calculation PDW Platelet Distribution Width is calculated from the Plt histogram as the width of the curve between S1 and S2 Pct As shown in Figure 2 15 S1 and S2 are placed so that gt 15 of the platelets occur between 2fL and S1 gt 15 of the platelets occur between S2 and the variable upper threshold gt The PDW result is determined on the platelets between S1 and S2 Figure 2 15 Area of the Pit Histogram Used to Determine the PDW Parameter Result e ge 55 0 oe ae 1 S2 7615002A PN 4237615B OPERATION PRINCIPLES 2 PARAMETER DEVELOPMENT Hgb Determination The hemoglobin Hgb released by the lysis of the red blood cells combines with the potassium cyanide to form a stable cyanmethemoglobin compound This compound is measured through the optical part of the First Dilution Hgb bath using a spectrophotometric technique at a wavelength of 550nm Transmittance of the sample dilu
155. the focused flow impedance and the light absorbance measurements are combined to define the WBC differential population clusters See Figure 2 3 Figure 2 3 Signal Processing Debris Absorbance Thresholds Most of the population partition thresholds are fixed and give the limits of the morphological normality of leukocytes Changes in the morphology of a population are expressed on the DiffPlot by a shifting of the corresponding population Volume and absorbance thresholds are used to detect shifting populations 9 4 PN 4237615B OPERATION PRINCIPLES 2 WBC BASO METHODOLOGY 2 4 WBC BASO METHODOLOGY In the WBC BASO bath 1OpnL of whole blood is mixed with 2 000pL of AC T 5diff WBC Lyse reagent This reaction lyses the red blood cells and specifically differentiates between the basophils and other leukocytes by volume The instrument maintains the reagents and reaction at a regulated temperature of 35 C 95 F Using a constant vacuum the instrument then pulls the sample through an 80pm aperture As each cell passes through the aperture a pulse is generated proportional to the cellular volume The total leukocyte count and basophil percentage are determined by specific thresholds on the WBC BASO histogram Figure 2 4 Figure 2 4 BASO Thresholds BA1 BA2 BA3 BASO 2 5 SAMPLE ANALYSIS OVERVIEW 0 Aspiration When the sample probe is immersed in a whole blood sample and the aspirate switch is pressed
156. the sodium citrate dilution PN 4237615B SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES Table 3 11 Interfering Substances Continued Parameter Interfering Substance MPVt Giant platelets May exceed the upper threshold of the Plt parameter and may not be counted as platelets Consequently these larger platelets will not be included in the instrument s calculation of MPV Very small RBCs microcytes RBC fragments schizocytes and WBC fragments May interfere with the proper counting of platelets Agglutinated RBCs May trap platelets causing an erroneous MPV result You may be able to detect the presence of agglutinated RBCs by observing abnormal MCH and MCHC values and by examining the stained blood film Chemotherapy May also affect the sizing of platelets NE NE The neutrophil count is derived from the WBC count The presence of excessive eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may interfere with an accurate neutrophil count LY LY The lymphocyte count is derived from the WBC count The presence of erythroblasts certain parasites and RBCs that are resistant to lysis may interfere with an accurate LY count Interfering substances pertaining to WBC also pertain to the LY and LY MO MO The mononuclear cell count absolute is derived from the WBC count The presence of large lymphocytes atypical lymphocytes blasts and an excessive nu
157. the standard deviation SD of the RBC population and the MCV RDW KSD MCV where K System constant SD Calculated standard deviation based on the red cell distribution MCV Mean Cell Volume of the red cells PN 4237615B OPERATION PRINCIPLES 2 PARAMETER DEVELOPMENT MCH and MCHC Calculations e MCH calculation The MCH Mean Cell Hemoglobin is calculated from the Hgb value and the RBC count and describes the average weight of hemoglobin in a red cell The calculation for MCH is Hgb MCH pg REC x 10 Note pg is the US unit format Other formats are available See Heading A 7 REPORTING UNIT SELECTION e MCHC calculation The MCHC Mean Cell Hemoglobin Concentration is calculated using the Hgb and Hct values and describes the average concentration of hemoglobin in the red blood cells The calculation for MCHC is MCHC g dL H x 100 Hct Note g dL is the US unit format Other formats are available See Heading A 7 REPORTING UNIT SELECTION Pit Parameters Platelet counting and sizing is also done in the RBC bath Thresholds separate the platelet pulses which are much smaller from the red blood cell pulses Platelets are also categorized according to size by a 256 channel pulse height analyzer A pulse height analyzer uses a number of thresholds to sort the particles into several size volume categories and to develop a size distribution curve of the particles The Plt distribution curve shows cells in
158. tion 3 3 Output 3 3 Measurements and Computation 3 4 Counting Aperture Diameters 3 4 Reagent Consumption 3 4 Environmental Protection 3 4 PERFORMANCE SPECIFICATIONS 3 5 Reproducibility 3 5 Linearity 3 5 Accuracy 3 5 Carryover 3 6 Reportable Range 3 6 vii CONTENTS vili 3 3 3 4 3 5 PERFORMANCE CHARACTERISTICS 3 7 Reproducibility 3 7 Accuracy 3 8 Carryover 3 8 LIMITATIONS 3 8 Maintenance 3 8 Blood Specimens 3 8 INTERFERING SUBSTANCES 3 9 PRECAUTIONS HAZARDS 4 1 4 1 4 2 4 3 DEFINITIONS 4 1 Warnings 4 1 Cautions 4 1 Importants 4 1 Attention 4 1 SAFETY PRECAUTIONS 4 1 Electronic 4 1 Biological 4 1 Moving Parts 4 1 OPERATIONAL HAZARDS 4 2 RUNNING SAMPLES 5 1 5 1 5 2 5 3 5 4 5 5 BEFORE ANALYSIS 5 1 Waste Container Level Check 5 1 Printer Check 5 1 Startup 5 2 Startup During Power Up 5 2 Startup After Power Up 5 3 Specimen Collection and Mixing 5 5 Running Cell Controls to Verify Calibration 5 5 ANALYSIS 5 8 Running Whole Blood Samples 5 8 AFTER ANALYSIS 5 10 Results 5 10 Printing Results for Last Sample Analyzed 5 10 Auto Clean 5 11 SHUTDOWN 5 11 ENTERING THE SAMPLE IDENTIFICATION ID 5 11 Auto Numbering 5 11 Manual Sample ID 5 12 Scanning the Sample ID with the Barcode Reader 5 13 PN 4237615B CONTENTS 6 REVIEWING RESULTS 6 1 6 1 6 2 6 3 6 4 GENERAL 6 1 FLAGS AND INTERPRETIV
159. tion ABBREVIATIONS 1 Myelemia triggering condition 6 13 n definition ABBREVIATIONS 1 NCCLS definition ABBREVIATIONS 2 NE description 2 19 interfering substances 3 11 Neutropenia triggering condition 6 13 neutrophil See NE Neutrophilia triggering condition 6 13 nm definition ABBREVIATIONS 2 NO ACK CHARACTER RECEIVED ON RS232 8 34 NO DILUENT CHECK LEVEL 8 34 NO ENQ CHARACTER RECEIVED ON RS232 8 34 Nucleated RBC triggering condition 6 15 numeric keypad button location 1 3 function 1 3 0 ON OFF switch location 1 2 operating range definition GLOSSARY 1 operator ID defining A 25 optical bench function 8 11 location 8 11 P Pancytopenia triggering condition 6 14 parameters INDEX 6 analyzed CBC parameters 1 5 analyzed CBC DIFF parameters 1 6 definition GLOSSARY 1 password changing A 3 default A 3 patient ranges default CBC A 9 default DIFE A 11 description A 8 performance characteristics accuracy 3 8 carryover 3 8 definition GLOSSARY 1 reproducibility 3 7 performance specifications accuracy 3 5 carryover 3 6 definition GLOSSARY 2 linearity 3 5 reproducibility 3 5 Pg definition ABBREVIATIONS 2 Plt interfering substances 3 10 Plt aggregate triggering condition 6 15 power consumption 3 1 power supply 3 1 will not turn on what to do if 8 36 power supply cord connector location 1 4 precision definition GLOSSARY 2 poor what to do if 8 37 priming rea
160. tion is compared with the transmittance of a reagent blank The system calculates the Hgb using both the blank and sample readings The final Hgb result represents absorbance value obtained x coefficient of calibration Hgb is displayed and printed as Hgb N g dL Note g dL is the US unit format Other formats are available See Heading A 7 REPORTING UNIT SELECTION WBC Count BASO Count and DiffPlot Development WBC Count The AC T 5diff hematology analyzer uses duplicate counting criteria voting criteria and proprietary flagging information to confirm the parameter result prior to reporting it To obtain a WBC count result the instrument compares the data from the two 5 second count periods then votes and rejects any questionable data This is the reference WBC count which is reported A second WBC count is determined in the flowcell during acquisition of the DiffPlot WBC count number of cells per unit volume x coefficient of calibration BASO Count Differentiation between basophils and other leukocytes is obtained by means of the AC T 5diff WBC Lyse specific lytic action See Figure 2 16 In Figure 2 16 basophils are located in the area between the thresholds labeled and 8 One hundred percent 10096 of the leukocytes is represented by the total number of nucleated particles plus the basophils within the area between the thresholds labeled 0 and 9 The basophil percentage is calculated from the number of particles e
161. to ensure correct sample identification PN 4237615B REVIEWING RESULTS 6 6 1 GENERAL Patient sample results are generated from sample analysis There may be instances when a patient sample result is flagged or a parameter number is replaced by a flag Carefully review all patient sample results especially results with flags and or messages For details see Heading 6 3 FLAGS GENERATED BY THE INSTRUMENT and Heading 6 4 INTERPRETIVE MESSAGES IMPORTANT Risk of result inaccuracy if a transient or partial blockage is not detected by the instrument In rare instances especially for samples where fibrin or other debris is likely to occur such as pediatric or oncology samples a transient or partial blockage may not be detected by the instrument Therefore verify flagged results for accuracy and review any result that exceeds your laboratory s limits 6 2 FLAGS AND INTERPRETIVE MESSAGES Flags Definition A flag is a symbol set of symbols or letters generated by the instrument to signal that a certain parameter requires additional attention Flags can be Linked to a result when it exceeds the normal limits Linked to a problem in the morphology of the blood cell population Linked to instrument operation For details see Heading 6 3 FLAGS GENERATED BY THE INSTRUMENT Types of Flags This instrument uses two types of flags replacement and non replacement flags e Replacement flags also called codes replace a
162. tor injury if all covers are not secured in place prior to instrument operation or you attempt to replace a part without carefully reading the replacement instructions Do not attempt to replace any component until you carefully read the instructions for replacing the component IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor and if it is not presently under a Beckman Coulter service maintenance agreement Beckman Coulter cannot guarantee that the product is fitted with the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product If you purchased this product from a third party and would like further information concerning this topic call your Beckman Coulter Representative Initial Issue 03 00 Software version 0 11 Issue B 07 00 Software version 1 0 This document applies to the latest software listed and higher versions When a subsequent software version changes the information in this document a new issue will be released PN 4237615B iii REVISION STATUS iv PN 4237615B REVISION STATUS INTRODUCTION xvii HOW TO USE YOUR AC T 5diff HEMATOLOGY ANALYZER MANUALS xvii ABOUT THIS MANUAL xvii CONVENTIONS xix GRAPHICS xix SYMBOLS xx Safety Symbols xx Tab Symbols xx MENU TREE xxi 1 USE AND FUNCTION 1 1 l l 1 2 1 3 1 4 1 5 PN 4237
163. trophil nm nanometer pg picogram Pit platelet RBC red blood cell RDW red cell distribution width SD standard deviation Vac volts of alternating current Vdc volts of direct current WBC white blood cell ABBREVIATIONS 2 PN 4237615B Symbols definition 6 3 BASO definition 6 8 WBC definition 6 8 definition 6 2 444 definition 6 2 uL definition ABBREVIATIONS 1 A abbreviations list of ABBREVIATIONS 1 ACeT 5diff Cal Calibrator See calibrators ACeT 5diff Control See cell controls ACeT 5diff Diluent See diluent reagent See reagents ACeT 5diff Fix See Fix reagent 1 7 See reagents ACeT 5diff Hgb Lyse See Hgb Lyse reagent See reagents ACeT 5diff Rinse See reagents See Rinse reagent ACeT 5diff WBC Lyse See reagents See WBC Lyse reagent accuracy definition GLOSSARY 1 performance characteristics 3 8 performance specifications 3 5 ACD definition ABBREVIATIONS 1 action log B 2 action ranges default CBC A 9 default DIFF A 11 description A 13 agglutination definition GLOSSARY 1 altitude range 3 2 PN 4237615B INDEX m Anemia triggering condition 6 13 Anisocytosis triggering condition 6 13 ANSI definition ABBREVIATIONS 1 anticoagulant recommended 3 2 aperture DIFF diameter 3 4 RBC diameter 3 4 WBC BA diameter 3 4 See also blocked apertures aspirate probe function 1 2 location illustration 1 2 aspirate switch function 1 2 location i
164. tside View of the Instrument LCD liquid crystal display screen Control panel allows you to interface with the instrument See Control Panel for details Door to reagents allows you to access the reagent bottles on board Top cover Door to pneumatics allows you to access the hydraulic parts for maintenance procedures Note The system will not operate when this door is open Aspirate switch allows you to start an analysis cycle Aspirate sample probe aspirates sample or control material from tubes or vials Green LED light emitting diode indicates the instrument is ready Red LED indicates the instrument is busy ON OFF switch PN 4237615B PN 4237615B USE AND FUNCTION INTENDED USE Control Panel Use the control panel buttons Figure 1 3 to setup and operate the instrument Figure 1 3 Control Panel Buttons eo ia ooo gt Startup performs a prime and rinsing procedure followed by a background count Shutdown performs a cleaning 6 eeo 9 typically done at the end of the day The eoe P instrument remains in stand by mode with lt e e e the Rinse SON e e 6 o S 9 Escape exits a function without d executing it and goes to the previous screen TUEEIIm 9 6 amp Mode allows you to select CBC and OU oeo OO CBC DIFF modes eoo R N Q C2 Print allows you to print the last sample NN DEINEN result calibration results laboratory
165. ument displays prints and transmits data parameter A component of blood that the instrument measures and reports performance characteristics Actual performance of the instrument GLOSSARY 1 GLOSSARY DEFINITIONS performance specifications Targeted performance of the instrument based on established ranges and parameters precision A measure of reproducibility precision is the ability of the instrument to reproduce similar results when a sample is repeatedly run Precision of the instrument is a CV or an SD for DIFF parameters based on replicate determinations of the same sample Precision shows the closeness of test results when repeated analyses of the same material are performed quality control QC A comprehensive set of procedures a laboratory establishes to ensure that the instrument is working accurately and precisely reproducibility This procedure checks that the system gives similar results within established limits every time it measures the same sample A so called precision SD standard deviation A measure of variation within a group of samples or within a population shutdown cycle Cleans the instrument s fluidic lines and apertures to help prevent residue buildup specifications See performance specifications startup cycle Ensures that the instrument is ready to run includes performing a background test TABLE OF Assigned va
166. ument maintains the reagents and reaction at a regulated temperature of 35 C 95 F The lymphocytes monocytes neutrophils and eosinophils each have a unique nuclear and morphologic structure and staining intensity and therefore absorb light differently Each stained cell is individually focused by the Dual Focused Flow DFF system and transported through the flowcell using sample pressure and diluent sheath flow Dual Focused Flow DFF DFF Figure 2 2 fluid dynamics uses a hydrodynamic focusing process to focus individual cells or particles in a stream of diluent The focused sample stream of the ACeT 5diff analyzer is about 40pm in diameter DFF uses the sheath fluid to surround and force cells suspended in diluent to pass one at a time through the center of the flowcell The first sheath flow focuses the sample through the impedance aperture The second sheath flow maintains the focused flow of cells as they exit the aperture into the optical flowcell Hydrodynamic focusing in the flowcell enables accurate and rapid cell by cell measurements on a large number of individual cells Figure 2 2 Dual Focused Flow Process Optical Aperture window Sample dilution Sheath Sample stream 1 injector Sheath Sample Sheath stream 2 stream fluid Flowcell Sequential analyses for cell volume impedance and light absorbance are performed in the flowcell A total of 72pL of sample is injected through the flowcell for 15 seconds The
167. up if there is not enough reagent left to complete the daily workload that has been set up do Replacing the Diluent Reagent and or Replacing Fix WBC Lyse Hgb Lyse and Rinse Reagents PN 4237615B Table 8 2 Error Messages Continued DIAGNOSTICS SYSTEM ERRORS Message Probable Cause Suggested Action SYSTEM ERROR RUN During a cycle a system error of 1 Do Heading 8 4 SYSTEM RESET SYSTEM RESET CYCLE the following type has caused the CYCLE system to stop 2 Ifthe problem persists note the error e A motor has not returned to its message and contact a Beckman home sensor when expected Coulter representative Adrain problem has been detected at one of the two drain sensors e The right side door has been opened during a cycle losing temperature control at the baths e A mechanical problem TEMPERATURE OUT OF The temperature in the counting 1 Ensure the sure right side door is RANGE bath compartment is outside of closed the acceptable range 2 Wait a few minutes 3 Ifthe problem persists contact a Beckman Coulter representative THE PRINTER IS No or incorrect communication 1 Ensure the cable is properly DISCONNECTED between Printer and instrument connected SWITCHED OFF OR 2 Ensure the Printer is turned on P 3 Ensure the Printer is online or selected TIMEOUT OVERFLOW ON There is a problem with the Verify that the protocol set up in the host RS232 communication or handshaking to tr
168. utralizing the Waste and Treating for Biohazards Do this procedure before capping the waste container for disposal WARNING Risk of personal injury if waste is not neutralized before the waste container is capped Non neutralized waste contents may produce gas which can build up pressure in a capped container Neutralize waste contents after removing the waste container and before capping it for disposal 1 For20L of waste liquid add the following to the waste container a 50mL of Sodium Hydroxide solution 200g L to prevent gas from forming b 250mL of Sodium Hypochlorite solution 1296 available chlorine to treat waste for biohazards 2 Cap the waste container and firmly tighten the cap to prevent waste contents from escaping 3 Dispose of the waste container according to your laboratory s guidelines PN 4237615B 1 9 USE AND FUNCTION PRINTER Handling Expired Reagents Do this procedure to eliminate cyanides from expired AC T 5diff Hgb Lyse 1 For 1L of reagent add a 50mL of Sodium Hydroxide solution 200g L b 100mL of freshly prepared Ammonium Persulfate solution 500g L or 50mL of Sodium Hydroxide solution 500g L c 500mL of Sodium Hypochlorite solution 30 available chlorine 2 Dispose of expired reagents according to your laboratory s guidelines 1 4 PRINTER Use the printer supplied or approved by Beckman Coulter 1 5 RANGES The instrument provides the ability to defin
169. value to be changed Edit the value Press to save The CBC Patient Ranges are now changed to reflect the new values you entered Repeat steps 3 and 4 as needed to change additional values for the patient range you selected in step 2 PN 4237615B PN 4237615B INSTRUMENT SETUP LABORATORY LIMITS SETUP 7 Repeat steps 2 through 6 to change the other patient ranges if required 8 Press to exit Changing DIFF Patient Ranges Table A 4 shows the default patient ranges for DIFF parameters Table A 4 DIFF Default Patient Ranges DIFF Range Parameter Low Limit High Limit Unit NE 50 0 80 0 LY 25 0 50 0 M0 2 0 10 0 E0 0 0 5 0 BA 0 0 2 0 ATL 0 0 2 0 IMM 0 0 2 0 NE 2 00 8 00 103 uL LY 1 00 5 00 103 uL MO 0 10 1 00 103 uL EO 0 00 0 40 103 uL BA 0 00 0 20 103 uL ATL 0 00 0 20 103 uL IMM 0 00 0 20 103 uL 1 Beginning at the Main menu select SETUP LAB LIMITS PATIENT RANGES DIFF A 11 A INSTRUMENT SETUP LABORATORY LIMITS SETUP A 12 Press to select the patient range 1 2 or 3 to be changed The range number is displayed as PATIENT RANGES X where X is the number 02 27 00 16 05 PATIENT RANGES 1 NE LY MO EO BA ATL IMM 2 00 Move the cursor to the value to be changed Edit the value C000 0009 Press to save
170. xisting in the area between the thresholds labeled and 6 Figure 2 16 Figure 2 16 Areas Used to Determine WBC and BASO Parameter Results 9 eo e basophils PN 42376158 2 17 OPERATION PRINCIPLES PARAMETER DEVELOPMENT BASO count number of cells per unit volume x coefficient of calibration in percentage relative to the number of counted cells BASO plus WBC nuclei BASO BA t SO coun WBC x WBC count DiffPlot Development The DiffPlot analysis on the ACeT 5diff hematology analyzer is based on three essential principles Dual Focused Flow DFF fluid dynamics which is a process by which individual cells or particles are focused in a stream of diluent hydrodynamic focusing The volume measurement Coulter Principle The measurement of transmitted light with zero degree 0 angle which permits a response proportional to the internal structure of each cell and its absorbance From these measurements a DiffPlot is developed with optical transmission absorbance on the X axis and volume on the Y axis See Figure 2 17 Figure 2 17 DiffPlot Regions Absorbance The study of the DiffPlot permits the clear differentiation of four out of five leukocyte populations In a typical whole blood sample the basophil population is very small when compared with the other four white cell populations 9 18 PN 4237615B OPERATION PRINCIPLES PARAMETER DEVELOPMENT Table 2 7 defines the DiffPl
171. y can define three separate patient ranges If a result is outside the selected patient range the result will be flagged e H for results above the upper limit and e L for results below the lower limit A 8 PN 4237615B INSTRUMENT SETUP A LABORATORY LIMITS SETUP CBC and DIFF patient ranges are initially set to the default values shown in Tables A 3 and A 4 If you want to change the patient ranges e For CBC do Changing CBC Patient Ranges e For DIFE do Changing DIFF Patient Ranges Changing CBC Patient Ranges Table A 3 shows the default patient ranges for CBC parameters Table A 3 CBC Default Patient Ranges CBC Range Parameter Low Limit High Limit Unit WBC 4 0 11 0 103 uL RBC 4 00 6 20 106 uL Hgb 11 0 18 8 g dL Het 35 0 55 0 MCV 80 100 fL MCH 26 0 34 0 pg MCHC 31 0 35 0 g dL RDW 10 0 20 0 Plt 150 400 103 uL MPV 6 0 10 0 fL Pct 0 2 0 5 PDW 8 0 18 0 1 Beginning at the Main menu select SETUP gt gt LAB LIMITS PATIENT RANGES CBC PN 4237615B A 9 INSTRUMENT SETUP LABORATORY LIMITS SETUP A 10 Press to select the patient range 1 2 or 3 to be changed The range number is displayed as PATIENT RANGES X where X is the number 02 27 00 16 05 1 6 1 5 1 3 3 2 PATIENT RANGES 1 ioc Oo oo SARS ooo 150 400 MPV 6 0 10 0 02 705 PDW 8 0 718 0 Move the cursor to the
172. yses then you would change the number to 50 Do this procedure to change the autoclean frequency 1 Beginning at the Main menu select SETUP gt gt OTHERS gt gt AUTOCLEAN AUTOCLEAN FREQUENCY 1 27 00 16 05 FREQUENCY AUTOCLEAN FREQUENCY 75 2 Edit the number from 1 to 75 0999 e099 3 Press 9 to save the changes 4 Press to exit and save the changes PN 4237615B A 31 INSTRUMENT SETUP CHANGING THE DAILY WORKLOAD A 20 CHANGING THE DAILY WORKLOAD You can enter the daily workload approximate number of CBC and CBC DIFF analyses performed each day which the instrument will use to perform a reagent capacity check at the end of a Startup to determine if there is enough reagent to last throughout a workday Table A 8 shows the default workload values for the CBC and CBC DIFF modes A 32 If the instrument determines that there is not enough reagent to complete the day s work a REAGENT LOW LEVEL message is displayed You can either determine which reagent is low and change the reagent or continue working until the specific REAGENT LOW LEVEL X message is displayed X refers to the specific reagent Table A 8 Daily Workload Runs by Mode Mode Default Minimum Maximum CBC 10 1 500 CBC DIFF 40 1 500 1 Beginning at the Main Menu select REAGENTS gt gt DAILY WORKLOAD 2 Move the cursor to the appropriate field DAILY WORKLOAD 1 27 00 16 05 NUMBER OF CBC DI
173. zed consecutively on the same instrument from one normal fresh whole blood sample with a low normal WBC and without flags Table 3 8 shows the precision values based on 20 replicate samples analyzed consecutively on the same instrument from one normal fresh whole blood sample with a high normal WBC and without flags Table 3 7 Reproducibility Characteristics From a Normal Sample with a Low Normal WBC Count Parameter Mean Standard Deviation SD CV WBC 6 40 0 09 1 42 RBC 4 39 0 03 0 59 Hgb 13 80 0 06 0 44 Het 38 60 0 25 0 66 Plt 288 40 7 86 2 73 NE 60 8 0 73 1 21 LY 27 3 0 55 2 02 MO 8 10 0 49 6 09 E0 3 30 0 32 9 64 BA 0 60 0 12 20 21 Table 3 8 Reproducibility Characteristics From a Normal Sample with a High Normal WBC Count Parameter Mean Standard Deviation SD CV WBC 12 50 0 18 1 41 RBC 5 17 0 03 0 61 Hgb 16 80 0 06 0 33 Het 48 90 0 32 0 64 Plt 173 60 4 05 2 33 NE 85 20 0 31 0 36 LY 7 70 0 37 4 80 MO 5 30 0 17 3 30 E0 0 90 0 14 15 10 BA 0 90 0 10 10 59 3 7 3 SPECIFICATIONS CHARACTERISTICS LIMITATIONS Accuracy Accuracy Table 3 9 for the CBC and DIFF parameters was defined as agreement between the comparator instrument and the A eT 5diff analyzer using clinical specimens covering the expected range of performance Table 3 9 Accuracy Characteristics Parameter C

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