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COULTER HMX Hematology Analyzer Service Manual

1. a 9 es se rf ses rs sells sen ses oi ee ese ed a ea ed mood 28D 2 e e 52 150 95 o m o 250 80 e 5 40 4 e e 80 HmX Hematology Analyzer HmX Hematology Analyzer with Autoloader Serial No 15 Call your Beckman Coulter Representative if 9596 of your graph points do not fall within 2 SDs LOG SHEETS This section contains these log sheets used in the diff comparison procedure Daily QC Worksheet Graph Point Summary Monthly QC Graphs Make photocopies as needed B 5 DIFF COMPARISON LOG SHEETS B 6 Date Specimen 1 Cycle Daily QC Worksheet For Manual Differential Check LY 0 0 1 2 Total gt _ 5 1 Tech NE LY 0 0 1 2 Total 5 Ref 1 NIM Specimen 2 Cycle NE LY 0 0 1 2 Total gt 2 Tech NE LY 0 0 1 2 Total X X 5 Ret 2 Graph Point GraphPoint HmX 1
2. Divide 2 Tech LY 0 0 BA 1 2 Total X Specimen 2 Cycle NE LY M0 E0 BA Record Results 2 63 6 30 03 4 4 ths adi Divide 2 7 slides using NCCLS H20 procedures 2slides of sample 1 2slides of sample 2 8 Give the slides to Techs A and B e 1 slide of sample 1 to Tech A The other slide of sample 1 to Tech B e 1 slide of sample 2 to Tech The other slide of sample 2 to Tech B B 2 PN 4237523A DIFF COMPARISON B PROCEDURE 9 Ask them for manual cell diffs NCCLS H20 10 Record the techs counts on the Daily QC Worksheet 11 Add the results for each parameter 12 Divide each parameter total by 2 Daily QC Worksheet For Manual Differential Check Date 5 17 99 Specimen 1 Cycle 1 SUI 2 Total 115 0 gt 5 Hmx1 57 5 Tech NE Record 1 BE 311 2 6 5 Total Mis 55 5 Specimen 2 Cycle 1 2 Total Record Results Divide 2 Graph Point GraphPoint 1 Ret b HmX 2_ Ref 2 COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Serial No 4237523A B 3 DIFF COMPARISON PROCEDURE 13 Calculate the graph points Daily QC Worksheet F Date 5 17 99 Specimen 1 Cycle NE 1 2 To
3. 368253 2 0 mL K EDTA GREINER Vacuette Brand Greiner No Volume Draw 454087 2 0 mL 454086 3 0 mL 457045 3 0 mL 454036 4 0 mL 457046 4 0 mL 457047 5 0 mL o d x L mm 13 x 75 13 x 75 16 x 75 13 x 75 16 x 65 16x 65 PN 4237523A SAMPLE TUBE SIZES JOHNS A 4 JOHNS See Labco listing A 5 LABCO Exetainer Brand Labco No Volume Draw o d x L mm EXPDL KE 1 1 0 mL 12 5 x 54 EXBGI KE 3e19 3 0 mL 12x 78 367860 4 0 mL Glass Vials GSPD KE 1 1 0 mL 12 5x 44 GSPD KE 2 2 0mL 12 5x 44 All lengths include caps LABO EXPRESS SERVICE L E S 4 mL plastic cap pierceable tube with a purple latex stopper LDM 4 mL plastic cap pierceable tube with a blue latex stopper 5 mL plastic cap pierceable tube with a blue latex stopper 5 mL glass tube with perforated plastic cap cover 12 x 75 mm 911213 5 mL plastic tube with perforated plastic cap cover 12 x 75 mm 920416 8 L I P TRI KE 4 No Volume Draw o d x L mm 38917 glass 4 0 mL 12 81 72110 plastic 4 0 mL 12x81 All lengths include cap 9 SARSTEDT Monovette brand plastic cap pierceable tube with red stop Volume Draw mL o d x L mm 2 7 mL 11 5 x 66 3 2 mL 16x65 PN 4237523A A 3 SAMPLE TUBE SIZES SHERWOOD MEDICAL 10 SHERWOOD MEDICAL S No 8881 311149 8881 311248 8881 314440 8881 311446 8881 311644 Volume Draw 2mL 3mL 3mL 5mL 7 mL 11 TERUMO Worldwide VENOJECTS tu
4. Parameter Units Mean Difference The greater of WBC x 103 cells uL 0 2 or 3 0 x 106 cells uL 0 05 or 2 0 Hgb g dL 0 2 or 2 0 MCV fL 2 0 Plt 103 cells uL 10 0 or 7 0 MPV 5 0 WBC Differential To determine accuracy of the WBC differential the binomial is set at a slope of 1 00 The 9596 confidence limits are based on the sum of the variances for an 800 cell reference differential and the total instrument count representing random and process error The reference document is the NCCLS H20 using an 800 cell count specification Linearity When tested using a stable sample having no interfering substances the COULTER HmX Hematology Analyzer values are equal to the expected values within the limits in Table 4 6 To get these same results subtract background counts from the HmX Hematology Analyzer values and take multiple readings at each point to eliminate statistical effects of imprecision Linearity of size measurements MCV and are tested using appropriate techniques Linearity limits apply only to directly measured parameters See Table 4 4 PN 4237523A 4 5 SPECIFICATIONS CHARACTERISTICS CBC AND DIFFERENTIAL PERFORMANCE SPECIFICATIONS Table 4 4 Linearity Limits Parameter Linearity Range Limits The greater of WBC x 10 cells uL 0 to 99 9 30 2 or 3 0 RBC x 108 cells uL 0 to 7 00 0 05 or 2 0 Hgb g dL 0 to 25 0 30 2 or 2 0 MCV fL 50 0 to 150 0 2 0 or 2 096 Pit
5. 55 91 ESC 91 20 4 4 20 56 X X 56 92 FS 92 21 5 5 21 57 Y Y 57 93 GS 93 22 6 6 22 58 7 7 58 94 5 94 23 7 7 23 59 59 95 US DEL 95 24 8 8 24 60 60 96 FNC3 FNC3 96 25 9 9 25 61 61 97 FNC2 FNC2 97 26 26 62 62 98 SHIFT SHIFT 98 27 27 63 63 99 CODEC CODEC 99 28 lt lt 28 64 NUL i 64 100 FNC4 29 29 65 SOH a 65 101 FNC4 CODEA CODEA 30 gt gt 30 66 STX b 66 102 FNC1 FNC1 FNC1 31 31 67 ETX C 67 103 START CODE A 32 32 68 EOT d 68 104 START CODE B 33 A 33 69 ENQ e 69 105 START CODE C 34 B B 34 70 ACK f 70 35 35 71 BEL g 71 7 2 Optical Characteristics at 670 nm 10 SE os Print Contrast Signal PCS 8096 minimum Reflectivity of Media RW 8096 minimum Reflectivity of Ink Rb 16 maximum No spots or voids no ink smearing Edge roughness is included in the bar and space tolerances Rw PCS x 10096 PN 4237523A BAR CODE SPECIFICATIONS BAR CODE LABELS 7 Bar code labels used in the system must be grade C or better according to American National Standards Institute s guidelines X3 182 1990 Label Specifications IMPORTANT Use of bar codes is an extremely accurate and effective method of data capture Certain features such as checksum digits maximize accuracy in reading Codabar NW7 Code 39 and Interleaved 2 of 5 labels In one study the use of checksum
6. 1 0 MILLIWATT MAXIMUM CLASS Il LASER PRODUCT AA Figure 5 3 Laser Safety Labels for Bar Code Reader on the HmX Hematology Analyzer CAUTION M Z e 2 lt 4237523 REPORTING OPTIONS Sample results can be printed on a Graphic Printer either in e Ticket format or e Graphic format 6 1 TICKET FORMAT ON A GRAPHIC PRINTER Autoprint format must be set to Ticket Format to get this report Sample reports are automatically printed when you select ALL NORMALS or ABNORMALS from the Auto Print option See Figure 6 1 for an example of a printed ticket format Note Batches are always printed in Graphic format To manually request a Ticket format printout press Ticket at the Run Samples screen Figure 6 1 Ticket Format ae 33196 Customized IDA 608 SAITB Mode Date 09 13 99 Sequence V Me dE n area Tar your laboratory H vi c PE E d RU ON worst ratto 1 B aT HM No Cycle uk Lp 12 1 data ei PAL AB a neu Definitive 7 i message 1 iO area Reporting units c te Operator can choose from e NORMAL RANGES Kiereicopie 091 1 WOME dt 10 6 RICHO 400 610 F 4 20 5 40 PLT a h US2 Retics 4 Wi FOE0 9 0 POW KF lg 51 i ww EU RE EM 12 TE EE ng n
7. 376 FIRMWARE 196 FIRMWARE ANALYSIS ALGORITHM RETICULOCYTE SOFTWARE BI DIREC HOST SOFTWARE DATA PACKAGE SOFTWARE Control set up Sample analysis set up System set up 1 5 OPTIONS Printers Up to two graphics printers can be added to your system to produce hard copy reports of sample data 1 6 REAGENTS Beckman Coulter recommends these reagents or their equivalents stated performance characteristics in this manual refer to the HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader using these reagents Diluent ISOTON or ISOTON 4 Japan only diluent is an isotonic electrolyte that e Dilutes the whole blood samples e Stabilizes cell membranes for accurate counting and sizing Conducts aperture current e Carries and focuses the sample stream in the flow cell to enable the WBC differential measurements Rinses the system between samples PN 4237523A 1 7 USE AND FUNCTION REAGENTS CBC Lytic Reagent LYSE S diff or LYSE S 4 Japan only lytic reagent is a lytic reagent used for the CBC mode It e Rapidly lyses erythrocytes RBCs freeing hemoglobin Hgb and reducing the size of cellular debris to a level that does not interfere with the leukocyte WBC count Causes a substantial conversion of the Hgb to a stable pigment the absorbance of which is directly proportional to the Hgb concentration over the clinical range Note If you use LY
8. JOHNS A 3 LABCO A 3 Exetainer Brand A 3 LABO EXPRESS SERVICE L E S A 3 LDM A 3 L LP A 3 SARSTEDT A 3 10 SHERWOOD MEDICAL A 4 11 TERUMO Worldwide A 4 PN 4237523A 4237523 B DIFF COMPARISON 1 B l INTRODUCTION B 1 B 2 PROCEDURE B 1 3 LOG SHEETS B 5 LIMITED WARRANTY REFERENCES REFERENCES 1 GLOSSARY GLOSSARY 1 INDEX 9 TRADEMARKS CONTENTS Xi ILLUSTRATIONS 11 HmX Hematology Analyzer 1 1 1 2 The HmX Hematology Analyzer with Autoloader 1 2 1 3 System Version Display 1 7 2 1 Reagent and Waste Container Tubing Connections 2 4 2 2 Interunit Connections 2 5 3 1 Coulter Method of Counting and Sizing 3 1 3 2 Flow Cell 3 2 3 3 Loading a Cassette 3 3 3 4 Reading a Bar Code Label 3 4 3 5 BSV 3 5 3 6 Baths Draining 3 6 3 7 Sample Flow 3 7 3 8 Erythrolyse II PAK LYSE and StabiLyse PAK PRESERVE Reagent Pumps 3 8 3 9 Aperture Baths and Vacuum Isolators 3 8 3 10 Sample Movement to the Flow Cell 3 9 3 11 Sweep Flow 3 11 3 12 Scatterplot DF 1 View 3 12 3 13 Scatterplot DF 2 View 3 13 3 14 Scatterplot DF 3 View 3 13 3 15 Scatterplot DF 5 View 3 14 3 16 Scatterplot DF 6 View 3 14 5 1 Laser Safety Label 5 2 5 2 Safety Labels the 5 3 53 Laser Safety Labels for Bar Code Reader on the HmX Hematology Analyzer 5 4 5 4 Laser Safety Labels for Bar Code Reader on the HmX Hematology Analyzer with Autoloader 5 4 6 1 Ticket Form
9. Quality Control in Hematology Symposium of the International Committee for Standardization in Haematology Lewis SM and Coster JF eds Academic Press London England 1975 Koepke JA Drug interference with leukocyte counting spurious leukopenia Drug Therapy 1974 79 Bull BS A statistical approach to quality control Quality Control in Hematology Symposium of the International Committee for Standardization in Haematology Lewis SM and Coster JF eds Academic Press London England 1975 PN 4237523A 4237523 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 Eckhoff RE An experimental indication of the volume proportional response of the Coulter Counter for irregularly shaped particles J Sci Inst 1967 44 648 649 Grover NB Naaman J Ben asson S and Dojanski E Electrical sizing of particles in suspension III Rigid spheroids and red blood cells Biophys J 1972 12 1099 1116 Waterman CS Atkinson EE Wilkins B Fischer CL and Kimsey SL Improved measurement of erythrocyte volume distribution by aperture counter signal analysis Clin Chem 1975 21 1201 1211 Kachel V and Ruhenstroth Bauer G Methodik and Ergebissne Optiseher Formfatorunter suchungen bei der Zellvolumenmessung nach Coulter Micros Acta 1976 75 419 423 Luke RG Koepke JA and Siegel RR The effect of immunosuppressive drugs and uremia on automated leukocyte
10. Ref 1 HmX 2 Ref 2 2 COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Serial No COULTER PN 4237523A DIFF COMPARISON B LOG SHEETS Graph Point Summary For Manual Differential Check Month Year LY MO E0 BA Day 2 SD 250 2SD 2SD 2 SD Graph Graph Graph Graph Graph Point Status Point Status Point Status Point Status Point Status 250 250 LY SD E Each graph point The mean for that column 250 0 The number of graph points 1 250 E0 Status W Within 2 SDs 250 BA H More than 2 SDs ABOVE the mean L More than 2 SDs BELOW the mean COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader BECKMAN Serial No COULTER PN 4237523A B 7 DIFF COMPARISON LOG SHEETS Monthly QC Graph z o zi kr id 2 CD 5 NE 250 150 15 25 LY 2 SD 1SD 1SD 25 SD 1SD 1SD 25 0 1250 150 15 25 BA 2 SD 150 15 25 C
11. 00 0 13 RBC 1012 cells L 2 31 6 59 0 00 0 03 Hgb g dL 8 00 17 50 0 00 0 05 MCV fL 69 60 125 60 0 01 0 82 RDW 11 04 26 50 0 06 0 32 Pit 109 cells L 10 0 715 0 0 80 10 72 MPV fL 5 60 10 8 0 02 0 24 Precision of the Differential Parameters Hematology Analyzer with Autoloader Evaluation of the Pair Difference Analysis for the five part differential was by subtraction of 38 paired test results given by the HmX Hematology Analyzer with Autoloader Primary Aspiration Mode See Table 4 20 4 13 4 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER WITH AUTOLOADER 4 14 Table 4 20 Imprecision Analysis Diff Parameters by Paired Sample HmX Hematology Analyzer with Autoloader Cell Type Mean Difference SD of Difference Lymphocyte 0 91 6 36 Monocyte 0 43 3 41 Neutrophil 0 09 1 18 Eosinophil 0 05 0 29 Basophil 0 45 2 27 Accuracy of CBC Parameters HmX Hematology Analyzer with Autoloader Evaluation of the CBC parameter accuracy was by subtraction of 69 paired test results given by the HmX Hematology Analyzer with Autoloader Primary Aspiration Mode and the HmX Hematology Analyzer with Autoloader Secondary Aspiration Mode Evaluation of the Five Part Differential Accuracy was by subtraction of 38 paired test results given by the HmX Hematology Analyzer with Autoloader Primary Aspiration Mode and the HmX Hematology Analyzer with Autoloade
12. Britt WB Flow system measurement of cell impedance properties Histochem Cytochem 1979 27 1 234 240 Leif RC Schwartz S Rodriguez CM Pell Fernandez L Groves M Leif SB Cayer M and Crews H Two dimensional impedance studies of BSA buoyant density separated human erythrocytes Cytometry 1985 6 1 13 21 Coulter WH et al Signal modulated apparatus for generating and detecting resistive and reactive changes in a modulated current path for particle classification and analysis U S Patent 3 502 974 March 24 1970 Fulwyler MJ Electronic separation of biological cells by volume Science 1965 150 910 911 Loken MR Sweet and Herzenberg LA Cell discrimination multiangle light scattering J Histochem Cytochem 1976 24 1 284 291 Miale JB Laboratory Medicine Hematology CV Mosby Company St Louis MO 4th ed 1972 22 Corash L Rheinschmidt M Lieu S Meers P and Brew E Fluorescence activated flow cytometry in the haematology clinical laboratory Cytometry 1988 Supplement 3 60 64 Friedman EW Reticulocyte counts how to use them what they mean Diagnostic Medicine 1984 7 6 29 33 Williams WJ et al Hematology McGraw Hill Inc New York NY 4th ed 1990 416 Brecher G New methylene blue as a reticulocyte stain Am J Clin Path 1949 19 895 896 Dorsey DB What can quality control do for hematology Am J Med Tech 1965 Mar Apr 150 153 Bull BS A statistical approach to quality control
13. FLOW Figure 3 7 Sample Flow pumps NG Ja AT CBC yti Go ae reagent EN L a ET em Mixing 69 bubble entry 2S o H e up 9009 m e Air pump 6966 for diff transfer Pauley 91 la to sample line SZ BSV CBC delivery Diluent i l AG SW in To WBC bath AS Diluent from large dispensers To RBC bath D a G UL 3 7 4237523 OPERATION PRINCIPLES SAMPLE FLOW 8 BSV rotates back Erythrolyse PAK LYSE reagent pumps send the diff lytic reagent to pick up and deliver the diff portion to the mixing chamber rupturing red cell membranes and dissolving cell debris in the process The StabiLyse PAK PRESERVE reagent pump dispenses diff leukocyte preservative It enters the mixing chamber to stabilize the leukocyte subpopulations See Figure 3 8 Figure 3 8 Erythrolyse Il PAK LYSE and StabiLyse PAK PRESERVE Reagent Pumps UST Mixes OFF C StabiLyse reagent pump Erythrolyse II reagent pumps 9 The vacuum isolators supply vacuum to th
14. Het 10 Mean Corpuscular Hemoglobin This is the weight of hemoglobin in the average erythrocyte count computed as Heb MCH PS x10 p2 RBC PN 4237523A 3 15 OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION Mean Corpuscular Hemoglobin Concentration MCHC This is the average weight of hemoglobin in a measured dilution computed as Hgb MCHC g dL g dL Het x 100 Red Distribution Width RDW RDW represents the size distribution spread of the erythrocyte population derived from the RBC histogram It is the coefficient of variation CV expressed in percent of the RBC size distribution Platelet Count This is the number of thrombocytes derived from the Plt histogram and multiplied by a calibration constant This number is expressed as Plt nx 10 cells uL Mean Platelet Volume MPV MPV is the average volume of individual platelets derived from the Plt histogram It represents the mean volume of the Plt population under the fitted Plt curve multiplied by a calibration constant and expressed in femtoliters Differential Counts Percentages The percentages of leukocytes from each category are derived from the scatterplot NE no of cells inside NE area LLLI x 100 no of cells inside NE LY MO LY no of cells inside LY area no of cells inside NE LY MO BA MO no of cells inside MO area LLLI x 100 no of cel
15. Operating Range The operating range is 0 100 percent reticulocytes Flagging Samples above or below the reportable range are flagged accordingly Instrument conditions that may interfere with the identification of reticulocytes are also flagged Refer to the Parameter Codes table in the Operator s Guide Limitations Prepare samples at ambient temperatures between 16 and 30 C 61 and 86 F Use air displacement pipettes to pipet whole blood and to transfer the blood stain mixture Repeated aspiration of Reagent A can cause pipette discoloration Also see Heading 4 8 INTERFERING SUBSTANCES 4 5 PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER Precision the CBC Parameters The tests described in this section were performed on the WBC differential and CBC subsystems as separate noninteractive entities This test condition is dictated in part by the need to use separately validated reference methods for evaluation of instrument accuracy and 4 8 PN 4237523A 4237523 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER clinical sensitivity For CBC parameters a Model S PLUS IV analyzer provided reference data The performance of this instrument had been independently validated against the following methods WBC RBC Plt Hgb Model ZBI CHANNELYZER analyzer Certified volumetric glassware Model ZBI CHANNELYZER analyzer Certified volumetric glassware M
16. Size is on the horizontal X axis and number is on the vertical Y axis Hz Hertz a unit of frequency ICSH Acronym for International Committee for the Standardization of Hematology i d Inner diameter IEC International Electrical Commission in Inch a unit of linear measurement In Vitro Outside of a living system as in a laboratory system or in an artificial container IQAP Interlaboratory Quality Assurance Program This quality control program offered only through Beckman Coulter compares your laboratory s instrument performance to the performance of similar instruments k Kilogram a unit of weight equal to 1 000 grams K3EDTA Tripotassium ethylenediaminetetraacetic acid L A code designating a low value Laser Light Amplification by Stimulated Emission of Radiation Two lasers are used in the instrument one for reading bar codes and one in the flow cell assessing white blood cells Ib Pound a unit of weight Light Scatter Analysis In the instrument monochromatic laser light using forward angle scatter analyzes the internal structure granularity and surface characteristics of white blood cells as each cell passes through the flow cell Linearity The ability of an instrument to recover expected results for directly measured parameters for such parameters as WBC RBC Hgb and Plt at varying levels of concentration within specified limits Lot Number A manufacturers code that identifies wh
17. a simple average result of a very large number of samples population mean might be by using a small number of samples Baud A rate defining how many data bits per second are transferred during communications between two pieces of equipment BSV Blood Sampling Valve A three sectioned valve that separates the aspirated sample into three parts for analysis in red cell bath white cell bath and flow cell Btu British Thermal Unit Calibration A procedure to standardize the instrument for accuracy by determining its deviation from calibration references and applying any necessary correction factors Calibration Factors Called CAL FAC on the CBC Calibration screen These are values the system uses to fine tune instrument accuracy Carryover The amount in percent of WBC RBC Hgb and Plt remaining in diluent following the cycling of a blood sample CBC Complete Blood Count All blood parameters that the instrument measures except for the leukocyte differential parameters Cell Control A preparation made of human blood with stabilized cells and surrogate material It is used for daily instrument QC Check Valve A one way valve that routes liquid or air through the Diluter PN 4237523A GLOSSARY 1 GLOSSARY CLIA Clinical Laboratory Improvement Amendments Closed Vial Sampler CVS In the instrument a carousel cap piercing mechanism for the closed vial mode cm Abbreviation for centimeter a unit of lin
18. cleaning manual aspirator tip A bubble blood detector bar code reader Diluter The Diluter is the primary mechanical operating unit of the system It aspirates pipets dilutes mixes lyses and senses Analyzer Systems Control Module This module controls the timing and sequencing of the operating cycles As it receives pulses and raw data from both the CBC and VCS diff diluters it counts measures and computes parameters It then sends this information to the DMS Electronic Power Supply This unit supplies the necessary power for all instrument functions Pneumatic Power Supply This unit supplies all air pressures and vacuums needed to operate the system PN 4237523A Data Management System DMS USE AND FUNCTION OPTIONS The DMS controls instrument operation displays stores and recalls sample data and allows the operator to perform quality control and calibration procedures It stores patient and quality control data on the hard drive and allows bidirectional communication with a host computer The System Version screen Figure 1 3 displays the version number of the enabled software and the features If a feature is not enabled the system displays Figure 1 3 System Version Display Sample Analysis Controls Diluter Functions Special Functions Diagnostics Set UP HmX SYSTEM VERSION 1 XXX DMS SOFTWARE INSTRUMENT SOFTWARE SAMPLE HANDLER SOFTWARE DIGIBOARD SOFTWARE DILUTER TABLE
19. digits detected 97 of misread errors Use checksums to provide protection against occasional misread errors caused by problems such as damaged or misapplied labels If you must use bar codes without checksums it is recommended that you verify each bar code reading to assure correct patient identification See Figure 7 1 for bar code label specifications Figure 7 1 Bar Code Label Specifications Leading edge of label 0 045 0 045 1 0 055 1 1 t 0 300 0 005 Label width min maximum 1 1 Y minimum 0 40 You must leave at least 1 8 50 you see tube contents Placement indicator X 0 100 0 0301 0 040 0 030 10 narrow element width leading quiet zone Maximum thickness of label adhesive 0 006 0 003 checksum stop character 4237523 r First bar line parallel to leading edge within 0 002 All subsequent bar lines parallel to first bar line within 0 001 Human readable code 630 370 Code area Start character data digits 0 062 10X min Trailing quiet zone Label length gt 7 3 BAR CODE SPECIFICATIONS BAR CODE READER Code Related Specifications See Table 7 2 for code related specifications Table 7 2 Code Related Specifications Code Interleaved 2 of 5 Codabar NW7 Code 39 Code 128 NE width 0 010 0
20. gt 20 Parameter Mean Difference SD of Difference 0 5 lt 1 5 Both requirements must be met Accuracy PN 4237523A Reticulocyte parameter accuracy is the sum of the variables of linearity and imprecision for the test and the comparator method using specimens covering the reportable range The reference method for reticulocyte counting is described in the NCCLS document H16 P n 4 000 or its pertinent successor document Analysis is based on the differences diff Run 2 instrument Reference 4 7 4 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER Limits over the clinical range for a minimum of 50 specimens from a general hospital population of no more than 3096 specimens with abnormally elevated Reticulocyte values gt 4 are Parameter Mean Difference SD of Difference RET96 1 0 lt 1 5 Limits over the clinical range for minimum of 50 specimens with the following characteristics are e Greater than 50 abnormally elevated values gt 4 e greater than 5 of 50 specimens have values gt 20 Parameter Mean Difference SD of Difference 0 00 30 00 41 5 53 0 Both requirements must be met Reportable Range Table 4 7 shows the reportable range for the HmX Hematology Analyzer with Reticulocyte method Table 4 7 Reportable Range Parameter Range Mean Difference Reticulocyte 0 2 30 0 0 3
21. mean definition GLOSSARY 1 baud definition GLOSSARY 1 bidirectional communication with host computer 1 7 Blood Sampling Valve BSV definition GLOSSARY 1 Brilliant Cresyl Blue dye 1 5 INDEX 1 INDEX 2 INDEX Btus definition GLOSSARY 1 special requirements 2 2 C cable connections location 2 5 calibration definition GLOSSARY 1 stability 4 4 calibration factors definition GLOSSARY 1 calibrator description 1 9 recommended 4 2 carryover definition GLOSSARY 1 performance specifications 4 7 cassette identified by bar code label 3 3 loading 3 3 movement 3 3 transporting specimens 3 3 Caution definition ii CBC analysis 3 1 definition GLOSSARY 1 lytic reagent description 1 8 CDRH approved labels 5 1 cell classification 3 10 cell control See controls cell counting 3 10 channels Plt histogram 3 11 RBC histogram 3 11 characteristics performance 4 8 check valves definition GLOSSARY 1 checksums important to use 7 3 cleaning agent container tubing connections 2 3 COULTER CLENZ cleaning agent 1 8 description 1 8 recommended 4 2 clearing reagent reticulocytes See ReticPrep reagent kit CLIA complexity category 1 3 definition GLOSSARY 2 clinical sensitivity performance characteristics 4 11 closed vial mode See Primary mode cm definition GLOSSARY 2 Codabar bar code 4 3 7 1 Code 128 bar code 4 3 7 1 Code 128 characters 7 1 Code 39 bar code 4 3 7 1 cod
22. or any copy Limited Warranty Beckman Coulter warrants that the software will substantially conform to the published specifications for the Product in which it is contained provided that it is used on the computer hardware and in the operating system environment for which it was designed Should the media on which your software arrives prove defective Beckman Coulter will replace said media free of charge within 90 days of delivery of the Product This is your sole remedy for any breech of warranty for this software Except as specifically noted above Beckman Coulter makes no warranty or representation either expressed or implied with respect to this software or its documentation including quality performance merchantability or fitness for a particular purpose No Liability for Consequential Damages In no event shall Beckman Coulter or its suppliers be liable for any damages whatsoever including without limitation damages for loss of profits business interruption loss of information or other pecuniary loss arising out of the use of or inability to use the Beckman Coulter Product software Because some states do not allow the exclusion or limitation of liability for consequential damages the above limitation might not apply to you General This agreement constitutes the entire agreement between you and Beckman Coulter and supersedes any prior agreement concerning this Product software It shall not be modified except by written
23. screen is Special Functions gt Set Up System Set Up Reagents To select a menu item highlight it then press or press the alphabetic key on the keyboard that corresponds to the letter displayed in black within the name of the menu item _ indicates a key such as Enter indicates to press and release the first key listed then press and release the next key listed J indicates to press and hold the first key listed then press the next key PN 4237523A INTRODUCTION LIST OF ICONS LIST OF ICONS Read this section if you 3 Read this section if you have a HmX Hematology have a HmX Analyzer with Hematology Analyzer Autoloader COMPUTER PROGRAM STATEMENT About the HmX Hematology Analyzer Computer Program HmX Hematology Analyzer Computer Program Version 1 0 Copyright 1999 Beckman Coulter Inc Rights Reserved This Computer program is protected by international copyright laws and unauthorized copying use distribution transfer or sale is a violation of those laws that may result in civil or criminal penalties This computer program may also be subject to additional restrictions contained in a license granted by Beckman Coulter Inc to the authorized user of this computer program or to the authorized owner or other authorized user of the system onto which this computer program is installed Any violation of the license provisions may result in additional civil penalties including an inj
24. 020 0 010 Scaling 0 010 0 020 0 010 0 020 Factor 1 538 WE NE ratio 2 2 to 3 1 N A 2 21 to 3 1 N A Intercharacter No 0 010 Min gt NE N A Data digits 2 to 16 3 to 16 to 16 3 to 8 with 3 to 16 HEMOGARD tubes According to American National Standard for bar code specifications that yield 10 characters per inch at NE 0 0065 Printing Methods Photographic thermal transfer dot matrix and laser printer 1 2 BAR CODE READER Description The HmX Hematology Analyzer uses a visible laser type reader containing a Class II laser operating at a wavelength of 670 nm with a maximum power output of 1 mW Settings and Defaults Table 7 3 lists the available settings for the bar code reader and the default setting for each feature To change a setting call your Beckman Coulter Representative The default setting appears in bold typeface Table 7 3 Bar Code Reader Settings and Defaults Feature Interleaved 2 of 5 Codabar NW7 Code 39 Code 128 Code Type Enabled Disabled Enabled Disabled Enabled Disabled Enabled Disabled Fixed Length N A Enabled Disabled Enabled Disabled Enabled Disabled Code Length No 1 0 2 4 6 8 10 12 3 4 5 6 7 8 9 10 3 4 5 6 7 8 9 10 3 4 5 6 7 8 9 10 14 16 11 12 13 14 15 16 11 12 13 14 15 16 11 12 13 14 15 16 Code Length 2 0 2 4 6 8 10 12 N A N A N A 14 16 Check Digit Enabled Disabled Enabled Disabled E
25. 1 HGB 100 g dl MV 91 f 1 29 3 1 WT 3 7 102 MX 125 1 MV 89 8 fL FOR 34 1 MH 26 7 L p BAR 27 OH Y MH 297 L gil 33 Qu RDW 137 H 141 1 7 1073 uL RETR 24 MR 0 4 10 3 ul RETE 10 6 uL tO 0 2 10 3 uL BAR 02 1073 uL JORMAL RANGES WC 05 07 RBC M 0 50 0 70 0 50 0 70 5 7 NEE ME 05 07 0 5 07 0 5 0 7 0 5 0 7 LYZ MF 05 07 0 5 07 0 5 0 7 WOR M 05 017 0 5 07 05 00 FOR 05 07 0 5 0 7 BAS 05 07 MCHCHF 0 5 0 7 ROW 0 5 0 7 NER 0 5 0 7 LYE 0 5 0 7 0 50 0 70 F 0 50 0 70 NOt MF 0 5 0 7 RETE 5000 7000 f 5000 7000 EOR MF 0 5 0 7 BAR 0 5 0 7 Microscopic Diff Neut Meta Band Myelo Lymph Pro Mono Blast Los Baso NR Toxic Gran RBC Morph Aniso Baso Stip Macro Sphero Micro Target Hypo Po PLT Est Poi Comments Sig Rev Date PN 4237523A 6 3 REPORTING OPTIONS GRAPHIC FORMAT 6 4 PN 4237523A BAR CODE SPECIFICATIONS IMPORTANT Inaccurate reading by the scanner could occur if you use bar code labels for specimen tubes that do not conform to the specifications given in this appendix Only use bar code labels that comply with these specifications 1 14 BAR CODE LABELS A bar code consists of black lines bars and white lines spaces called elements They are narrow elements NE and wide elements WE and the code determines their arrangements The HmX Hematology Analyzer and HmX Hematology An
26. 103 cells uL 0 to 999 10 0 or 7 0 MPV fL 5 0 to 20 0 5 0 Mode to Mode Matching Minor differences between the Primary cap pierce or autoloader and Secondary manual modes are due to differences in the flow characteristics of the aspiration pathways Additionally flow characteristics vary between samples Verification of the minor mode to mode differences seen on the HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader requires elimination of effects of carryover and within mode precision in testing For these reasons the specification is based on the average values for 10 normal bloods measured in triplicate three consecutive measurements When verification is performed according to this protocol differences between the averages of the two modes do not exceed the following limits in Table 4 5 Table 4 5 Mode to Mode Matching Parameter Limits The greater of x 10 cells uL 30 4 or 5 0 RBC x 106 cells uL 30 2 or 2 0 Hgb g dL 30 3 or 2 0 Plt x 103 cells uL 20 0 or 7 0 Data collected using blind paired samples has demonstrated that variability observed in the paired samples between Primary and Secondary modes is similar to the variability observed within a mode Background Counts Background count for the WBC differential is X100 total counts collected from all regions of the scatterplot For CBC parameters background count see Table 4 6 Table 4 6 Background Counts fo
27. 4 1 Dimensions 4 1 Power 4 1 Installation Category 4 1 Input Dedicated Line 4 1 Consumption 4 1 Pneumatic Supplies 4 1 Pressure 4 1 Vacuum 4 2 Temperature Ambient Operating Range for Patient Samples 4 2 Humidity 4 2 Recommended Reagents 4 2 Reagent Usage 4 2 Recommended Commercial Controls 4 2 Recommended Calibrator 4 2 Recommended Anticoagulant 4 3 Minimum Sample Volume Required 4 3 Tube Sizes for Closed Vial Mode 4 3 Recommended Bar Code Labels 4 3 DMS Storage 4 3 Patient Results 4 3 Controls 4 3 Conditions of Measurement 4 3 Hemoglobin Measurement 4 3 Aperture Size 4 4 Electronic Stability 4 4 Throughput 4 4 4 20 SOFTWARE SPECIFICATONS 4 4 Date Format 4 4 43 CBC AND DIFFERENTIAL PERFORMANCE SPECIFICATIONS 4 4 Precision 4 4 Accuracy 4 5 CBC 4 5 WBC Differential 4 5 Linearity 4 5 Mode to Mode Matching 4 6 Background Counts 4 6 Carryover 4 7 4 4 RETICULOCYTE PERFORMANCE SPECIFICATIONS 4 7 Precision 4 7 Accuracy 4 7 Reportable Range 4 8 Operating Range 4 8 Flagging 4 8 Limitations 4 8 4237523 45 PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER 4 8 Precision of the CBC Parameters 4 8 Imprecision Analysis by Paired Sample of the Differential Parameters 4 10 Accuracy of CBC Parameters 4 10 Accuracy of Differential Parameters 4 11 Clinical Sensitivity 4 11 4 6 PERFORMANCE CHARACTERISTICS HEMATOLOGY ANALYZER WITH AUTO
28. 4 4 hemoglobin 4 3 units 3 14 method history 1 4 mg definition GLOSSARY 4 mil definition GLOSSARY 4 mL definition GLOSSARY 4 mm definition GLOSSARY 4 MO derivation 3 17 formula 3 17 listing 1 2 MO derivation 3 16 formula 3 16 listing 1 2 mode definition GLOSSARY 5 mode Primary definition GLOSSARY 5 mode Secondary definition GLOSSARY 6 mode to mode matching definition GLOSSARY 5 performance specifications 4 6 monocyte number See MO monocyte percent See MO morphologic abnormalities 4 12 MPV derivation 3 16 formula 3 16 interfering substances 4 17 listing 1 2 voting 3 10 MSDS how to order 1 9 mW definition GLOSSARY 5 INDEX 7 INDEX 8 INDEX N definition GLOSSARY 5 NCCLS definition GLOSSARY 5 derivation 3 17 formula 3 17 listing 1 2 derivation 3 16 formula 3 16 listing 1 2 neutrophil number See NE neutrophil percent See NEW CAL FACTOR definition GLOSSARY 5 new methylene blue dye used in ReticPrep reagent A 1 8 used to measure reticulocytes 1 5 nm definition GLOSSARY 5 normal range reticulocytes 4 16 bar code 4 3 7 1 0 o d definition GLOSSARY 5 OLD CAL FACTOR definition GLOSSARY 5 opacity definition GLOSSARY 5 open drain 2 2 open vial mode See Secondary mode operating range reticuloctyes 4 8 operation principles 3 1 optical characteristics bar code labels 7 2 options printers 1 7 outlier defi
29. 4237523A 1 The appropriate aspiration pump pulls the sample into the BSV Figure 3 5 e 125 pL in the open vial mode 185 pL in the closed vial mode Figure 3 5 BSV ASPIRATION 28 diff loop 1 6 uL RBC 28 uL WBC loop 3 5 OPERATION PRINCIPLES SAMPLE FLOW 2 baths drain into the waste chamber Figure 3 6 Figure 3 6 Baths Draining 10 eod AM eo sd IE Ale Waste ls vv 9 chamber M J1 AJE WBC 4 bath L it hes o E Hgb lamp Pe L1 le inr Hgb Sau preamp o ot a 3 Figure 3 7 applies to steps 3 through 7 The BSV rotates to segment three portions of the sample 1 6 pL for the bath dilution 28 uL for the WBC bath dilution 28 pL for the WBC diff The air pump transfers the diff portion to the sample line v Dispensers send diluent to the BSV to pick up and dilute the RBC and WBC portions The CBC lytic reagent pumps send the CBC lytic reagent LYSE S III or LYSE S 4 to the WBC bath It lyses the RBCs and converts the hemoglobin into a stable compound 7 Mixing bubbles enter both baths 3 6 PN 4237523 OPERATION PRINCIPLES 3 SAMPLE
30. A SHEETS MSDS 1 10 PN 4237523A INSTALLATION 2 1 GENERAL CAUTION Possible system damage could occur if you improperly uncrate the system install it or set it up Keep the system in its packaging until your Beckman Coulter Representative uncrates it for installation and set up Your instrument is tested before it is shipped from the factory International symbols and special handling instructions on the cartons tell the carrier how to handle this electronic system Carefully inspect all cartons when they arrive If you see any sign of mishandling or damage file a claim with the carrier immediately If the system is insured separately file a claim with the insurance company 2 2 SPECIAL REQUIREMENTS The system is intended for installation and operation in a conventional clinical laboratory setting Because the components are interrelated you must determine the system location and layout before your local Beckman Coulter Representative arrives to install the system Consider the following special requirements Space and Accessibility In addition to the space required for the individual components and their interconnection consider e Comfortable working height e Access to the rear of the system for maintenance and service Allow gt 30cm 12 in behind gt 30cm 12 in on the sides Electrical Input This system requires independent protected circuit ground path capable of carrying the f
31. CES 1 repipetter dispenser used with ReticPrep reagent B 1 8 reportable range reticulocyte parameters 4 8 reporting units 3 14 reproducibility definition GLOSSARY 6 See also precision requirements installation instrument accessibility 2 1 power input 2 1 room temperature 2 2 space needed 2 1 RET description 3 17 interfering substances 4 17 listing 1 3 RET description 3 17 interfering substances 4 17 listing 1 3 Retic C cell control description 1 9 ReticPrep method 3 2 ReticPrep reagent kit 1 8 PN 4237523A 4237523 reticulocytes accuracy 4 7 4 15 analysis 1 5 clearing reagent 1 8 control 1 9 derivation 3 17 flagging 4 8 formula 3 17 interfering substances 4 17 limitations 4 8 minimum sample volume 4 3 normal range 4 16 number See operating range 4 8 percent See performance characteristics 4 15 performance specifications 4 7 precision 4 7 4 15 reagents 1 8 reagents recommended 4 2 reference interval 4 16 reportable range 4 8 sample flow 3 9 scatterplots 3 13 room temperature ambient operating 4 2 special requirements 2 2 specifications 4 2 See also temperature or ambient temperature S safety definitions ii material safety data sheets 1 9 using lasers 5 1 sample flow CBC and diff 3 5 normal 3 5 reticulocyte 3 9 sample handler 1 6 sample transport 3 3 3 4 sample tube sizes A 1 sample volume minimum required 4 3 samp
32. COULTER HmxX Hematology Analyzer COULTER HmxX Hematology Analyzer with Autoloader Reference 00000 916191612 4237523A July 1999 COULTER CORPORATION A Beckman Coulter Company Miami Florida 33196 2500 USA LEGAL NOTICES 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 e 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
33. GRAM STATEMENT xvii USE AND FUNCTION 1 1 11 INTENDED USE 1 1 General 1 1 Parameters 1 2 CLIA Complexity Categories 1 3 12 QUALITY CONTROL QC 1 3 13 METHOD HISTORY 1 4 Development 1 4 Hemoglobinometry 1 4 Differential Measurement 1 5 Volume Analysis 1 5 Conductivity Analysis 1 5 Light Scatter Analysis 1 5 Reticulocyte Retic Analysis 1 5 Analysis 1 5 14 SYSTEM COMPONENTS 1 6 Main Unit 1 6 Sample Handler 1 6 Diluter 1 6 Analyzer Systems Control Module 1 6 Electronic Power Supply 1 6 Pneumatic Power Supply 1 6 Data Management System DMS 1 7 15 OPTIONS 1 7 Printers 1 7 1 6 1 7 1 8 REAGENTS 1 7 Diluent 1 7 CBC Lytic Reagent 1 8 HmxX 1 8 LYSE 1 8 PAK PRESERVE 1 8 ReticPrep Reagent Kit 1 8 Reagent A 1 8 Reagent B 1 8 Cleaning Agent 1 8 CONTROLS AND CALIBRATOR 1 9 Controls 1 9 Calibrator 1 9 MATERIAL SAFETY DATA SHEETS MSDS 1 9 INSTALLATION 2 1 2 1 2 2 253 GENERAL 2 1 SPECIAL REQUIREMENTS 2 1 Space and Accessibility 2 1 Electrical Input 2 1 Ambient Temperature and Humidity 2 2 Ventilation 2 2 Air Conditioning 2 2 Drainage 2 2 Date Format 2 3 INTERUNIT CONNECTIONS 2 3 Reagent and Waste Connections 2 3 Power and Signal Cables 2 5 OPERATION PRINCIPLES 5 1 3 1 3 2 3 3 3 4 GENERAL PRINCIPLES 3 1 CBC Analysis 3 1 Differential Analysis 3 1 Effect of Re
34. ICS 4 INTERFERING SUBSTANCES Plt Very small red blood cells near the upper threshold cell fragments clumped platelets as with oxalate or heparin platelet fragments or cellular debris near the lower platelet threshold 6 57 58 59 MPV Known factors that interfere with the Plt count and shape of the histogram or known effects of EDTA 60 61 62 63 Het Known factors that interfere with the parameters used for computation RBC and MCV MCH Known factors that interfere with the parameters used for computation Hgb and RBC MCHC Known factors that interfere with the parameters used for computation Hgb RBC and MCV Diff Parameters Known factors that affect the WBC count as listed above or high triglycerides that affect lysing 6 Reticulocytes Erythrocyte inclusions stained by New Methylene Blue if sufficiently numerous within a sample and some hemoglobinopathies SS SC might affect the accuracy of the reticulocyte enumeration PN 4237523A 4 17 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 4 18 4237523A LASER SAFETY 5 1 LASER SAFETY PRECAUTIONS The HmX Hematology Analyzer uses two lasers laser bar code reader A helium neon laser in the diff module TTM for analyzing the WBC differential and Retic counts WARNING The laser in the diff module TTM can damage both the instrument and your eyes if you do not use it safely Follow the instructions and procedures in this ma
35. LOADER 4 13 Precision of the CBC Parameters 4 13 Precision of the Differential Parameters HmX Hematology Analyzer with Autoloader 4 13 Accuracy of CBC Parameters HmX Hematology Analyzer with Autoloader 4 14 4 7 RETICULOCYTE PERFORMANCE CHARACTERISTICS 4 15 Imprecision Analysis by Replication 4 15 Accuracy 4 15 Reference Interval 4 16 4 8 INTERFERING SUBSTANCES 4 16 WBC 4 16 RBC 4 16 Hgb 4 16 4 16 RDW 4 16 Plt 4 17 4 17 Hct 4 17 4 17 4 17 Diff Parameters 4 17 Reticulocytes 4 17 5 LASER SAFETY 5 1 5 1 LASER SAFETY PRECAUTIONS 5 1 5 2 GENERAL LASER SAFETY WARNINGS 5 1 53 WARNING LABELS 5 1 6 REPORTING OPTIONS 6 1 6 1 TICKET FORMAT ON A GRAPHIC PRINTER 6 1 6 2 GRAPHIC FORMAT 6 2 PN 4237523A ix BAR CODE SPECIFICATIONS 7 1 7 1 7 2 7 3 BAR CODE LABELS 7 1 Optical Characteristics at 670 nm 10 7 2 Label Specifications 7 3 Code Related Specifications 7 4 Printing Methods 7 4 BAR CODE READER 7 4 Description 7 4 Settings and Defaults 7 4 BAR CODE DECODER 7 5 Normal Operation 7 5 HmX Hematology Analyzer 7 5 HmX Hematology Analyzer with Autoloader 7 5 SAMPLE TUBE SIZES A 1 1 2 4 5 8 9 BECKMAN COULTER 1 BECTON DICKINSON A 1 Worldwide A 1 U S A A 1 Europe 2 U K and Australia A 2 Japan A 2 GREINER A 2 Vacuette Brand A 2
36. MCH MCHC RDW Plt MPV PDW White Blood Cell leukocyte Count Neutrophil percent Neutrophil number Lymphocyte percent Lymphocyte number Monocyte percent Monocyte number Eosinophil percent Eosinophil number Basophil percent Basophil number Red Blood Cell erythrocyte count Hemoglobin concentration Hematocrit Mean Corpuscular Volume Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration Red Cell Distribution Width Platelet count Mean Platelet Volume Platelet Distribution Width Plateletcrit PN 4237523A 1 2 4237523 Reticulocyte percent Reticulocyte number QUALITY CONTROL QC USE AND FUNCTION In the USA the PDW and Pct parameters are Not for Diagnostic Use The value for PDW is used as an internal check on the reported platelet parameters Plt and MPV 2 3 Unless otherwise stated all parameter results are shown in the US unit format throughout the manuals CLIA Complexity Categories See Table 1 1 for the CLIA complexity categories of the HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader Table 1 1 CLIA Complexity Table Analyte CDC Test Analyte Category Identifier System Code Hematocrit Hct Moderate 2514 10254 Hemoglobin Hgb Moderate 2515 10254 Platelet count Plt Moderate 4908 10254 Red blood cell count erythrocyte count RBC Moderate 5502 10254 Reticulocyte Moderate 5506 10078
37. N 26 FP 203 12 8 Reference H20 Abnormal 1 FN 26 TP 27 3 7 Total 178 52 230 TN True Negative FP False Positive FN False Negative Blasts 0 07 x 10 cells L TP True Positive 4 12 4237523A 4 6 4237523 PERFORMANCE CHARACTERISTICS HEMATOLOGY ANALYZER PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER WITH AUTOLOADER WITH AUTOLOADER Precision of the CBC Parameters The results of replicate precision testing n 31 for each parameter measured by the test instrument are given in Table 4 18 SPECIFICATIONS CHARACTERISTICS Table 4 18 Imprecision Analysis by Replication WHOLE BLOOD HmX Hematology Analyzer with Autoloader Parameter Units Mean 0 CV WBC x 109 cells L 10 44 0 11 RBC x 1012 cells L 4 98 0 025 Hgb g dL 14 39 0 04 MCV fL 85 90 0 65 RDW 12 34 0 15 Pit 10 cells L 321 60 11 86 MPV fL 9 15 0 13 The results of Pair Difference analysis for 69 paired clinical blood specimens are given in Table 4 19 Evaluation of the Pair Difference analysis of the CBC parameter was by subtraction of 69 paired test results given by the HmX Hematology Analyzer with Autoloader Primary Aspiration Mode Table 4 19 Imprecision Analysis by Paired Sample HmX Hematology Analyzer with Autoloader Clinical Range Parameter Units Low High Mean Diff 0 WBC x 10 cells L 1 10 55 20 0
38. NDEX 9 INDEX 10 INDEX range linearity 4 6 operating reticulocytes 4 8 reportable reticulocytes 4 8 RBC cell size 3 11 counting 3 10 derivation 3 15 formula 3 15 histogram 3 11 interfering substances 4 16 listing 1 2 sizing 5 10 voting 3 10 RBC counting and sizing 3 11 and WBC Hgb module 1 6 RDW derivation 3 16 formula 3 16 interfering substances 4 16 listing 1 2 voting 3 10 Reagent A description 1 8 function 3 2 Reagent B description 1 8 function 3 2 reagent tubing connections 2 3 length 2 3 reagents CBC lytic reagent LYSE S III LYSE 5 4 1 8 cleaning agent COULTER CLENZ connections 2 3 container placement 2 3 description 1 7 diff lytic reagent Erythrolyse ID 1 8 diluent ISOTON 5 4 1 7 effect of 3 2 erythrocyte lytic reagent Erythrolyse 1 8 HmxX Pak 1 8 leukocyte preservative StabiLyse Pak Lyse Erythrolyse 1 8 Pak Preserve StabiLyse 1 8 Reagent A 1 8 Reagent B 1 8 recommended 4 2 ReticPrep reagent kit 1 8 types used 1 7 red blood cell See RBC red cell count See RBC Red Cell Distribution Width See RDW REF values definition GLOSSARY 6 reference interval reticulocytes 4 16 reference manual conventions used xvi icons description xvii introduction to your manuals xv symbols meaning xvii using the manuals xv reference range diff comparison B 1 differential parameters 4 10 references recommended REFEREN
39. ON CONVENTIONS Chapter 3 Operation Principles Contains the descriptions of the Coulter Method the normal sample flow through the instrument how counting and sizing are accomplished and how the parameters are derived Chapter 4 Specifications Characteristics Details the instrument and performance specifications the performance characteristics and the interfering substances Chapter 5 Laser Safety Describes laser safety precautions and the location of the laser related labels Chapter 6 Reporting Options Shows examples of printouts you can select from your graphic printer Chapter 7 Bar Code Specification Describes the specifications for bar code labels to be used with the system Appendices The appendices provide reference material on the following topics e Tube Sizes Diff Comparison References Lists the references by number as used throughout this manual Glossary Contains the definitions for words and terms used in the set of manuals Index Contains terms and where you can easily locate information about them in this manual CONVENTIONS This manual uses the following conventions xvi ITALICS indicate screen messages such as RESET THE SYSTEM or Press any hey Bold indicates gt amenu item such as Run Samples gt ora function such as F3 Run The software path to access the needed function or screen appears in a series separated by double arrow heads For example the path to the REAGENTS set up
40. OULTER Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader SS BECKMAN Serial No COULTER 5 8 4237523 LIMITED WARRANTY This instrument when purchased from Beckman Coulter Inc or from an authorized distributor or subsidiary company is warranted against defects in materials and workmanship for a period of one 1 year from date of the original invoice to the customer for this instrument or for longer periods if purchased This warranty is limited to the repair and replacement of parts which prove to be defective during the warranty period This warranty is not valid for parts damaged lost or which fail because of accident fire theft acts of nature storms floods etc negligence of the use of chemicals which have a deleterious effect This warranty is conditioned upon Beckman Coulter Inc retaining the unqualified option of replacing parts up to and including an entire instrument This warranty will not extend to any repairs or modifications made to the instrument by some party other than Beckman Coulter Inc or a party authorized to do so by Beckman Coulter Inc Also this warranty sh
41. SE S III diff lytic reagent you must use ISOTON III diluent If you use LYSE S 4 lytic reagent you must use ISOTON 4 diluent HmX Pak contains the PAK LYSE Erythrolyse II erythrocyte lytic reagent and the PAK PRESERVE StabiLyse leukocyte preservative used for the differential measurement PAK LYSE The PAK LYSE also called the diff lytic reagent while maintaining leukocytes WBCs in near native state e Dilutes the blood samples Rapidly lyses erythrocytes RBCs e Reduces cellular debris to an insignificant level PAK PRESERVE The PAK PRESERVE preserves the leukocytes WBCs in near native state It allows the leukocytes to be differentiated into their subpopulations through the volume conductivity and light scatter measurements ReticPrep Reagent Kit The COULTER ReticPrep reagent kit see package insert includes two reagents Reagent A and Reagent B Use these reagents when preparing samples for reticulocyte analysis Follow the preparation instructions supplied with the kit Reagent A Reagent A is a specially formulated New Methylene Blue dye that stains the reticulum Reagent B Reagent B is a clearing reagent that removes hemoglobin from the cell without removing the precipitated stain RNA complex keeping the cell and its membranes intact Reagent B needs to be used with the repipetter dispenser available from Beckman Coulter Inc Cleaning Agent COULTER CLENZ cleaning age
42. White blood cell count leukocyte count WBC Moderate 7002 10254 White blood cell differential WBC Diff Moderate 7001 10254 QUALITY CONTROL QC Your laboratory can use these QC techniques with the HmX Hematology Analyzer e Daily instrument checks Commercial controls e Xs Analysis e Patient sample review e Interlaboratory comparison IQAP Quality Assurance QA can include a combination of these methods to provide complete QC Beckman Coulter manufactures commercial controls for monitoring performance of CBC and differential parameters as well as monitoring flow cell alignment gains and VCS for flow cell volume conductivity and light scatter You can perform manual differentials as a measure of good QC practice or as recommended by your laboratory state or federal protocol 1 3 USE AND FUNCTION METHOD HISTORY 1 3 14 METHOD HISTORY Development W H Coulter 1956 describes the Coulter Principle A suspension of blood cells is passed thru a small orifice simultaneously with an electric current The individual blood cells passing thru the orifice introduce an impedance change in the orifice determined by the size of the cell The system counts the individual cells and provides cell size distribution The number of cells counted per sample is approximately 100 times greater than the usual microscope count to reduce the statistical error by a factor of approximately 10 times This substantia
43. agents 3 2 Retic Analysis 3 2 SPECIMEN TRANSPORT HmX HEMATOLOGY ANALYZER WITH AUTOLOADER 3 3 SPECIMEN TRANSPORT HmX HEMATOLOGY ANALYZER 3 4 SAMPLE FLOW 3 5 Normal Sample Flow 3 5 Retic Sample Flow 3 9 PN 4237523A 3 5 COUNTING AND SIZING 3 10 Red and White Blood Cell Counting 3 10 Routine Counting 3 10 Extended Counting 3 10 Coincidence Correction 3 10 Triplicate Counting Voting 3 10 Sweep Flow 3 11 Pulse Editing 3 11 RBC Count and Size Distribution 3 11 Plt Count and Size Distribution 3 11 Plt Fitting Process 3 12 Scatterplot Development 3 12 Differential Related 3 12 Retic Related 3 13 Retic Parameters 3 14 Derived and Computed Parameters 3 14 3 6 CONCENTRATION MEASUREMENT 3 14 3 7 PARAMETERS AND THEIR DERIVATION 3 14 White Blood Cell WBC Count 3 15 Red Blood Cell RBC 3 15 Hemoglobin Hgb Concentration 3 15 Mean Corpuscular Volume MCV 3 15 Hematocrit Hct 3 15 Mean Corpuscular Hemoglobin MCH 3 15 Mean Corpuscular Hemoglobin Concentration MCHC 3 16 Red Distribution Width RDW 3 16 Platelet Plt Count 3 16 Mean Platelet Volume MPV 3 16 Differential Counts 3 16 Percentages 3 16 Absolute Numbers 3 17 Reticulocyte Retic Parameters 3 17 Reticulocyte Percent RET 3 17 Reticulocyte Absolute Number RET 3 17 4237523A vii 4 SPECIFICATIONS CHARACTERISTICS 4 1 4 1 INSTRUMENT SPECIFICATIONS
44. agreement dated subsequent to the date of this agreement signed by an authorized Beckman Coulter representative Beckman Coulter is not bound by any provision of any purchase order receipt acceptance confirmation correspondence or otherwise unless Beckman Coulter specifically agrees to the provision in writing This agreement is governed by the laws of the State of Florida COULTER TRADEMARKS m The BECKMAN COULTER logo 5C CHANNELYZER COULTER COULTER CLENZ COULTER COUNTER Erythrolyse ISOTON LATRON LIN C LYSE S Retic C ReticPrep S CAL S PLUS Stabilyse and ZBI are trademarks of Beckman Coulter Inc All other trademarks service marks products or services are trademarks or registered trademarks of their respective holders PN 4237523A Reference PN 4237523 Operator s Guide PN 4237519 PN 4237521 Autoloader Special Procedures and Troubleshooting PN 4237520 PN 4237522 Autoloader Host Specifications PN 4237518 Master Index PN 4237524 PN 4237525 Autoloader COULTER HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader Documentation Use and Function Installation Operation Principles Specifications Characteristics Laser Safety Reporting Options Bar Code Specifications Sample Tube Sizes Diff Comparison References Glossary Index System Overview Startup and Controls Sample Analysis e Data Review Shutdown Set Up Referen
45. al Pop Normal PLT Pop US1 5 8 10730 RBE 275 10 BLT 169 L 10 3 uL HGB 10 0 E g dl 93 US2 Retics Pom ao od sit Nao t 4 3 3 107371 ROW 13 7 H wg 12 qun 1073 uL RETX x 73 4 RETH 1076 uL mon Wwe SI3 BAH 0 2 167 37ut SUSPECT FLAGS 514 1 515 lt Basophilia X 1 Hypochr omia 516 5 S17 Re tics NORMAL RANGES Microscopie i KE bn Japan p 05 D dup oo d in Blast 3 0 Beso vit 5 Toxic Gran RBC Morph 50 0 50 0 Aniso Baso Stip 5000 Macro Sphero 2 y Micro Target 2 5 2 Hypo poly PLT Est Limits are set Pate MA Coments in Action Limits _ Ser Diff box 6 2 PN 4237523 REPORTING OPTIONS 6 GRAPHIC FORMAT Figure 6 3 Graphic Narrow Small Page Format 12 16 99 08 15 39 Dr Roth City Labs SN000001 OPR 590 W 20th Street 305 885 0131 Metropolis FL RBC PLT RELE A m 50 100 200 300 fL 1 0 30 WBC ape 0 U M DF 1 Cass Pos 1 DATE TIME CBCHDiff 89235974072 06 14 89 15 47 47 082 Jones John Sequence 000012 06 14 99 15 20 Black STAT 06 25 1959 N Call Results Sample is a redraw Abnormal WBC Pop Abnormal RBC Pop Normal PLT Pop 80548 ie 3 75 100 169 57
46. all be effective only upon written notice of the defect to Beckman Coulter Inc or its authorized distributor within five 5 days after occurrence of said defect This warranty shall apply only to use of the instrument at a location within a state of the United States and in Canada and shall not apply to use of the instrument at a location outside the continental limits of the United States including any territory possession military or government facility therein and in any other Country foreign to the United States Upon request of the purchaser Beckman Coulter Inc can undertake to arrange for special warranty service upon agreed written terms only at a location where this warranty does not apply No other warranty of any kind is made expressed or implied COULTER BECKMAN COULTER CORPORATION A Beckman Coulter Company Miami Florida 33196 PN 4237523A REFERENCES m l Corash L Platelet Sizing Techniques Biological Significance and Clinical Applications Current Topics in Hematology New York New York Alan R Lise Inc 1983 2 Threate GA Andrados C Ebbe S and Brecher G Mean Platelet Volume The Need for a Reference Method 1984 81 769 772 3 Thompson CB Diaz DD Quinn PG Lapins M Kurtz SR and Valeri CR The Role of Anticoagulant in the Measurement of Platelet Volumes AJCP 1983 327 332 4 Coulter WH High speed automatic blood cell counter and cell size analyzer Paper presented at Nati
47. alled in the Triple Transducer Module TTM safety fixture the laser presents no radiation hazard to users and complies with 21 CFR 1040 See Figure 5 1 Figure 5 2 Figure 5 3 and Figure 5 4 5 1 LASER SAFETY WARNING LABELS Figure 5 1 Laser Safety Label THIS PRODUCT COMPLIES WITH THE REQUIREMENTS OF 21 CFR 1040 10 MANUFACTURED BY COULTER CORPORATION 11800 S W 147 AVE MIAMI FL 33196 2500 DATE OF MANUFACTURE MONTH YEAR 041993 ae g 0 0 m un z Sod Right side view PN 4237523A LASER SAFETY 5 WARNING LABELS Figure 5 2 Safety Labels on the TTM LASER RADIATION WHEN OPEN AND INTERLOCK DEFEATED AVOID DIRECT EYE EXPOSURE 72 uniphase 1096 Mellon Avenue Manteca CA 95337 MODEL MANUFACTURED SERIAL NO DAN 0008 n 4 AVOID DIRECT EYE EXPOSURE THIS LASER DOES NOT COMPLY WITH 21 CFR 1040 USE ONLY AS A COMPONENT SEE INSTALLATION INSTRUCTIONS PATENT NOS MADE 4352 185 4631 727 IN 4750 182 4864 583 USA 4237523A 5 3 5 4 LASER SAFETY WARNING LABELS DO NOT STARE INTO BEAM 670 nm DIODE LASER
48. alyzer with Autoloader accept four bar code symbologies Code 399 bar code Codabar NW7 Interleaved 2 of 5 e Code 128 Only one of these types Codabar or NW7 can be active at the same time The NW7 code used on the instrument is the same as the Codabar symbology with a checkdigit IMPORTANT Inaccurate reading by the scanner could occur if you use the characters listed below in your bar code label Do not use the following Code 128 characters Subset Character values A 0 64 95 101 102 B 0 95 100 102 C 102 Table 7 1 contains Code 128 characters Table 7 1 Code 128 Characters Value CodeA CodeB CodeC Value CodeA CodeB Code C Value CodeA CodeB CodeC 0 Space Space 00 1 01 2 gt 02 03 4 04 5 05 6 amp amp 06 7 07 8 08 9 09 10 B 10 4237523A 7 1 BAR CODE SPECIFICATIONS BAR CODE LABELS Table 7 1 Code 128 Characters Continued Value CodeA CodeB Code C Value CodeA C Value Code A CodeC 11 11 47 0 0 47 83 063 S 83 12 12 48 48 84 064 t 84 13 13 49 0 0 49 85 85 14 14 50 50 86 SYN V 86 15 15 51 S S 51 87 ETB w 87 16 0 0 16 52 T T 52 88 CAN x 88 17 1 1 17 53 0 U 53 89 EM y 89 18 2 2 18 54 V V 54 90 SUB 2 90 19 3 3 19 55
49. analyzer WARNING Risk of operator 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 7 99 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 4237523A iii REVISION STATUS 4237523 4237523 m LEGAL NOTICES REVISION STATUS iii CONTENTS v INTRODUCTION xv HOW TO USE YOUR COULTER HmX HEMATOLOGY ANALYZER AND HmX HEMATOLOGY ANALYZER WITH AUTOLOADER DOCUMENTATION SET xv ABOUT THIS MANUAL xv CONVENTIONS xvi LIST OF ICONS xvii COMPUTER PRO
50. at 6 1 6 2 Graphic Wide Large Page Format 6 2 6 3 Graphic Narrow Small Page Format 6 3 7 1 Bar Code Label Specifications 7 3 Xii PN 4237523A xiii 1 1 4 1 4 2 4 3 4 4 4 5 4 6 4 7 4 8 4 9 4 10 4 11 4 12 4 13 4 14 4 15 4 16 4 17 4 18 4 19 4 20 4 21 4 22 4 23 4 24 4 25 7 1 7 2 7 3 Complexity Table 1 3 Precision Specifications 4 4 Precision WBC Differential Parameters 4 5 CBC Accuracy Limits 4 5 Linearity Limits 4 6 Mode to Mode Matching 4 6 Background Counts for CBC Analysis 4 6 Reportable Range 4 8 Imprecision Analysis by Replication WHOLE BLOOD HmX Hematology Analyzer 4 9 Imprecision Analysis by Paired Sample HmX Hematology Analyzer 4 9 Imprecision Analysis Diff Parameters by Paired Sample HmX Hematology Analyzer 4 10 Imprecision Analysis Diff Parameters by Replication HmX Hematology Analyzer 4 10 Reference Range Diff Parameters for 160 Subjects HmX Hematology Analyzer 4 10 Accuracy Analysis by Compared Specimens HmX Hematology Analyzer 4 11 Accuracy Analysis Diff Parameters by Compared Specimens HmX Hematology Analyzer 4 11 Flagging Criteria H2O Method 4 12 Morphologic Abnormalities HmX Hematology Analyzer 4 12 Clinical Sensitivity for Morphologic Abnormals HmX Hematology Analyzer 4 12 Imprecision Analysis by Replication WHOLE BLOOD HmX Hematology Analyzer with Autoloader 4 13 Imprecis
51. ate with the instrument EDTA Ethylenediaminetetraacetic acid Expiration Date The last day when you can use a lot number of a reagent control or calibrator FAC 96 DIFF In CBC calibration the percentage difference between the old OLD CAL FAC and the new NEW CAL FAC calibration factors Field Area on a screen for entering data Whenever you move a cursor you are moving it from field to field Flags Codes which appear such as H L R next to parameter results These indicate possible abnormal conditions Flow Cell A device through which white cells flow one cell at a time to be simultaneously assessed for cell volume conductivity opacity and light scatter ft Foot or feet a unit of linear measurement fL Femtoliter a unit of volumetric measurement equal to 10 15 meter Function Key Any of the keys labeled F1 to F12 You use these to command system and individual screen processes g Gram a unit of weight gal Gallon a unit of volumetric measurement H A code representing a high value Hemoglobinometry Measurement of hemoglobin in the blood In Beckman Coulter instruments this is done by comparing the amount of light that passes through a diluted lysed sample in which the released Hgb has been chemically converted with the amount of light that passes through a blank GLOSSARY 3 GLOSSARY Hg Mercury Histogram A graph showing the relative number and distribution of particles
52. bes with lavender rubber stoppers 4 Y 573DK 272505 273505 274505 206505 202505 Volume Draw 3mL 2mL 3mL 4mL 5mL 7 mL o d x L mm 10 25 x 50 10 25 x 64 13x 75 13 x 75 16 x 75 o d x L mm l6x75 10 25 x 50 10 25 x 65 10 25 x 85 13 x 75 16 x 75 PN 4237523A DIFF COMPARISON 1 INTRODUCTION You can perform manual differentials as a measure of good QC practice or as recommended by your laboratory state and federal protocols At the end of this appendix are blank log sheets used in the procedure B 2 PROCEDURE 1 Collect two different normal blood samples Follow NCCLS H3 A2 procedures The samples must be e Collected in K3EDTA with 1 5 mg mL of anticoagulant to blood Maintained at room temperature Within the reference range of NE 40 to 72 LY 17 to 45 MO 4 to 12 EO 10 0 01 e Analyzed between 30 minutes 5 hours after draw Draw 2 Label the samples 4237523A B 1 DIFF COMPARISON PROCEDURE 3 Cycle each sample two times Print the results for your logbook Record your results on the Daily QC Worksheet Add the results for each parameter Divide each parameter total by 2 Daily QC Worksheet For Manual Differential Check xs ov TAB Specimen 1 Cycle LY 0 0 BA 1 Sil als 20 20 2 Bila 32 9 6 3 8 Record Results
53. cell control description 1 9 A A definition GLOSSARY 1 accessibility instrument installation requirements 2 1 accuracy CBC parameters 4 5 4 10 4 14 definition GLOSSARY 1 differential parameters 4 5 4 11 4 14 limits 4 5 performance characteristics 4 10 4 11 4 14 4 15 performance specifications 4 5 4 7 reticulocyte parameters 4 7 4 15 air conditioning special requirements 2 2 algorithm definition GLOSSARY 1 ambient temperature instrument 2 2 patient samples 4 2 See also temperature or room temperature Analyzer description 1 6 dimensions 4 1 ANSI definition GLOSSARY 1 anticoagulant recommended 4 3 aperture size 4 4 ASCII definition GLOSSARY 1 aspiration how it occurs 3 5 assay values definition GLOSSARY 1 ASTM definition GLOSSARY 1 INDEX average value definition GLOSSARY 1 derivation 3 17 formula 3 17 listing 1 2 derivation 3 16 formula 3 16 listing 1 2 background count definition GLOSSARY 1 specifications 4 6 bar code acceptable 4 3 7 1 Codabar 4 3 7 1 Code 128 4 3 7 1 Code 128 characters 7 1 Code 39 4 3 7 1 Interleaved 2 of 5 4 3 7 1 labeling 4 3 labels 7 1 NWT 4 3 7 1 reader 7 4 reading 3 3 3 4 recommended 4 3 specifications 7 1 bar code reader description 7 4 settings and defaults 7 4 barrier protection recommendation ii basophil number See basophil percent See BA96 batch definition GLOSSARY 1 batch
54. ces Index Calibration Reproducibility and Carryover Cleaning Procedures Adjust Replace Procedures Troubleshooting Index Defines the contents of records transmitted from a HmX Hematology Analyzer to a host computer Combined index for the Operator s Guide Special Procedures and Troubleshooting and Reference manuals Come visit us at www beckmancoulter com Copyright Beckman Coulter Inc 1999 All Rights Reserved Printed on Recycled Paper COULTER COULTER CORPORATION A Beckman Coulter Company Miami Florida 33196 2500 USA
55. counts Am J Clin Path 1971 56 503 507 Koepke JA Drug interference with leukocyte counting spurious leukopenia Drug Therapy 1974 79 Dale NL and Schumacher HR Platelet satellitism new spurious results with automated instruments Lab Med 1982 13 300 304 Kjeldsberg CR and Hershgold EJ Spurious thrombocytopenia JAMA 1974 227 628 630 Brittin GM Brecher Johnson and Stuart J Spurious macrocytosis of antibody coated red cells Am J Clin Path 1969 52 237 241 Hattersley PG Gerard PW Caggiano V and Hash DR Erroneous values on the COULTER COUNTER Model 5 due to high titer cold autoagglutinins Am J Clin Path 1971 55 442 446 Nosanchuk JS Roark ME and Wanser C Anemia masked by triglyceridemia Am J Clin Path 1974 62 838 839 Brittin GM Brecher G Johnson CA and Stuart J Spurious macrocytosis of antibody coated red cells Am J Clin Path 1969 52 237 241 Nosanchuk JS Roark ME and Wanser C Anemia masked by triglyceridemia Am J Clin Path 1974 62 838 839 Waterman CS Atkinson EE Wilkins B Fischer CL and Kimsey SL Improved measurement of erythrocyte volume distribution by aperture counter signal analysis Clin Chem 1975 21 1201 1211 Fales W Water distribution in blood during sickling of erythrocytes Blood 1978 51 703 709 Kjeldsberg CR and Hershgold EJ Spurious thrombocytopenia JAMA 1974 227 628 630 Dale NL Schumacher HR Platelet satellitism new spurious results
56. ct reading Using these two methods minimizes any chance of misidentification PN 4237523A 7 5 BAR CODE SPECIFICATIONS BAR CODE DECODER 7 6 PN 4237523A SAMPLE TUBE SIZES The closed vial sampling system has been tested with the following collection devices BECKMAN COULTER 5C cell control tubes 13 x 62 mm control tubes A 2 BECTON DICKINSON Worldwide VACUTAINERS collection tubes with lavender rubber stoppers are unless otherwise noted BD No Volume Draw o d x L mm 6405 6564 2 5 mL 13x 75 6385 3mL 10 25 x 64 6458 3 5 mL 16 x 75 6545 4 mL 16x 75 6452 Europe 4 5 mL 13x75 6452 U S A 5 mL 13x 75 VACUTAINER tubes with HEMOGARD closure All tubes are 13 x 75 mm U S A BD No Volume Draw Content 367650 3 0 mL K3EDTA 367651 2 0 mL K3EDTA 367653 5 0 mL K3EDTA 367658 5 0 mL K3EDTA 367661 3 0 mL K3EDTA 367662 5 0 mL K3EDTA 368261 2 0 mL 368262 3 0 mL K EDTA Also available in South America PN 4237523A A 1 SAMPLE TUBE SIZES GREINER A 3 A 2 Europe BD No Volume Draw Content 367652 3 0mL K3EDTA 367654 4 5 mL K3EDTA 367656 4 0 mL K EDTA 367657 4 5 mL K3EDTA 367663 4 0 mL K3EDTA 367664 5 0 mL Na EDTA 368241 2 0 mL 368242 3 0 mL and Australia BD No Volume Draw Content 368247 2 0mL K EDTA 368248 3 0 mL K EDTA Japan BD No Volume Draw Content 367648 2 0 mL K EDTA 367649 2 0 mL K EDTA 367660 2 0 mL
57. cy current 1 5 LY derivation 3 17 formula 3 17 listing 1 2 LY derivation 3 16 formula 3 16 listing 1 2 lymphocyte number See LY lymphocyte percent See LY LYSE S 4 lytic reagent description 1 8 See also lytic reagent LYSE diff lytic reagent description 1 8 See also lytic reagent lytic reagent 1 4 3 2 CBC description 1 8 diff description 1 8 Erythrolyse II erythrocyte lytic reagent description 1 8 LYSE S 4 lytic reagent 1 8 PN 4237523A 4237523 LYSE S III diff lytic reagent 1 8 Pak Lyse 1 8 recommended 4 2 tubing connection 2 4 m definition GLOSSARY 4 Main Unit components 1 6 manual cell diffs diff comparison B 3 manuals for your instrument about your reference manual xv conventions used xvi how to use xv icons description xvii introduction to your manuals xv symbols meaning xvii using the manuals xv material safety data sheets MSDS how to order 1 9 MCH derivation 3 15 formula 3 15 interfering substances 4 17 listing 1 2 MCHC derivation 3 16 formula 3 16 interfering substances 4 17 listing 1 2 MCV derivation 3 15 formula 3 15 interfering substances 4 16 listing 1 2 voting 3 10 mean definition GLOSSARY 4 Mean Corpuscular Hemoglobin See MCH Mean Corpuscular Hemoglobin Concentration See MCHC Mean Corpuscular Volume See MCV Mean Platelet Volume See MPV INDEX measurement aperture size 4 4 conditions 4 3 electronic stability
58. cyte volume analysis using low frequency current has been used since 1967 18 It has been evaluated as a possible adjunct to the differential white cell count 10 20 21 22 Conductivity Analysis Cell walls act as conductors to high frequency current As the current passes through the cell walls and through each cell interior it detects differences in the insulating properties of cell components The current characterizes the nuclear and granular constituents and the chemical composition of the cell 23 24 25 Light Scatter Analysis Beckman Coulter s experience in flow cytometry dates back decades to Fulwyler s pioneering use of light scatter for cell 1 26 Loken et al and Jovin et al discuss the relationship of particle size and refractivity to the angle of light scattered from a laser beam Reticulocyte Retic Analysis PN 4237523A Reticulocytes are immature nonnucleated erythrocytes retaining a small network of basophilic organelles comprised of RNA and protoporphyrin The enumeration of reticulocytes provides a simple effective means to determine red cell production and regeneration 28 29 50 31 The most common means of measuring reticulocytes is to use supravital dyes such as New Methylene Blue or Brilliant Cresyl Blue These dyes precipitate and aggregate the basophilic substances within the reticulocyte resulting in a granular staining pattern easily seen with light microscopy Anal
59. d Thom R Electrical sizing and counting of platelets in whole blood Med Biol Engr 1973 73 447 454 15 Von Behrens WE Mediterranean macrothrombocytopenia Blood 1975 46 2 199 208 16 Paulus JM Platelet size in man Blood 1975 46 3 321 336 17 International Committee for Standardization in Haematology Recommendations for reference method for haemoglobinometry in human blood ICSH Standard EP 6 2 1977 and specifications for international haemiglobincyanide reference preparation ICSH Standard EP 6 3 1977 J Clin Path 1978 31 2 139 143 18 Gauthier J et al Human leukocytes their size distribution and mean corpuscular volume Can Med Assoc J 1967 97 793 796 4237523A REFERENCES 1 19 20 21 22 23 24 25 26 24 28 29 30 31 32 33 34 35 36 2 REFERENCES Hughes Jones NC et al Differential leucocyte counts by volume distribution analysis Brit Haemat 1974 28 1 148 England JM et al A semi automatic instrument for estimating the differential leucocyte count Biomed Engr 1975 10 8 303 304 Wycherley PA and O Shea MJ Abridged differential leucocyte counts provided by a Coulter Channelyzer in a routine haematology laboratory J Clin Path 1978 31 3 271 274 Oberjat TE Zucker RM Cassen B Rapid and reliable differential counts on dilute leukocyte suspensions J Lab Clin Med 1970 76 3 518 522 Hoffman RA and
60. e baths to pull the sample through the apertures for the cell counts The unit counts and sizes RBCs and Plts at the RBC aperture and WBCs at the WBC aperture It measures hemoglobin photometrically through the WBC bath See Figure 3 9 Figure 3 9 Aperture Baths and Vacuum Isolators Vacuum isolators 0 00 0000 999 e soli Waste chamber DB WBC aperture aperture bath Hgb lamp Hgb photometer card 3 8 PN 4237523 OPERATION PRINCIPLES 3 SAMPLE FLOW 10 The unit does the WBC differential in the triple transducer module TTM at the flow cell aperture Sample pressure to the mixing chamber pushes the sample through the flow cell for the diff analysis See Figure 3 10 Figure 3 10 Sample Movement to the Flow Cell Vented waste Sample pressure Flow c7 cell Sheath tank ct Sheath fluid is gt sample 1l Thecycle finishes The mixing chamber drains into its waste chamber CBC baths drain into the waste chamber Theunit cleans the baths and flow cell The waste chambers drain Retic Sample Flow CAUTION Using undiluted whole blood can clog multiple components of the instrument and might require a service call to clean the components when the HmX He
61. e related specifications for bar code labels 7 4 codes definition GLOSSARY 2 coefficient of variation definition GLOSSARY 2 coincidence correction 3 10 definition GLOSSARY 2 collection diff comparison B 1 complete blood count See CBC complexity category 1 3 components system description 1 6 system dimensions 4 1 conditions of measurement 4 3 conductivity analysis definition GLOSSARY 2 description 1 5 connections interunit 2 5 location 2 4 2 5 power cable 2 5 reagent 2 3 signal cable 2 5 waste 2 3 container waste capacity 2 2 connection 2 3 control disk definition GLOSSARY 2 control quality 1 3 PN 4237523A 4237523 controls 5C cell control 1 9 cell definition GLOSSARY 1 descriptions 1 9 LATRON control 1 9 LATRON primer 1 9 LIN C linearity control 1 9 recommended 4 2 Retic C cell control 1 9 conventions used in the manual xvi COULTER CLENZ cleaning agent See cleaning agent Coulter method 3 1 Coulter principle 1 4 counting and sizing 3 10 differential 3 12 platelets 3 11 3 11 WBC 3 12 current high frequency 1 5 low frequency 1 5 used in the Coulter Principle 1 4 current XB batch definition GLOSSARY 2 cursor definition GLOSSARY 2 CV definition GLOSSARY 2 CVS definition GLOSSARY 2 D daily QC worksheet diff comparison B 2 Data Management System See DMS data sheets material safety how to order 1 9 date f
62. e with the flow of air Conditioning Compensate for system generated heat in air conditioned environments with an additional 5 000 Btus Drainage 2 2 CAUTION Incomplete drainage and overflow into the vacuum system can occur if the waste line is longer than the recommended length Contact your Beckman Coulter Representative if you need to increase the length of the waste line supplied with the system The maximum waste line length is 3 7 m 12 ft WARNING Biohazardous contamination can occur from contact with the waste container and its associated tubing if not handled with care Avoid skin contact Clean up spills immediately Dispose of the contents of the waste container in accordance with local environmental regulations and with acceptable laboratory procedures The waste line supplied with the instrument can be connected to either Adrain less than 76 cm 30 in above the floor e waste container with a recommended minimum capacity of 20 L 5 gal If you use an open drain mechanically secure the waste tube into the drain so the tube cannot accidentally come out of the drain This prevents spillage PN 4237523A INSTALLATION 2 INTERUNIT CONNECTIONS Date Format Choose which of the following date formats fits your location e European DD MM YY Japanese YY MM DD e U S MM DD YY Your Beckman Coulter Representative installs your selection at installation 23 INTERUNIT CONNECTIONS Reagen
63. e year entered displayed is 00 to 89 the system assumes the year is in the range of 2000 to 2089 e 90 to 99 the system assumes the year is in the range of 1990 to 1999 CBC AND DIFFERENTIAL PERFORMANCE SPECIFICATIONS Precision Precision is specified as a coefficient of variation CV based on at least 31 replicate determinations of the same sample See Table 4 1 Table 4 1 Precision Specifications Parameter CV WBC at 4 0 15 0 x 103 cells uL 2 5 RBC at 3 0 6 0 x 106 cells uL 2 0 at 12 0 18 0 g dL 1 5 MCV at 80 0 100 0 fL 2 0 RDW at 12 0 15 0 2 5 at 200 500 x 103 cells uL 5 0 MPV at 7 0 12 0 fL 3 0 Precision of the WBC differential parameters is specified at 9596 confidence limits See Table 4 2 PN 4237523A SPECIFICATIONS CHARACTERISTICS 4 CBC AND DIFFERENTIAL PERFORMANCE SPECIFICATIONS Table 4 2 Precision WBC Differential Parameters Parameter 9596 Confidence Limits LY at 31 WBC at 4 0 x 10 cells uL 3 0 MO at 8 WBC at 4 0 x 10 cells uL 2 0 NE at 57 WBC at 4 0 x 103 cells uL 3 0 0 at 3 WBC at 4 0 x 103 cells uL 1 0 BA at 1 WBC at 4 0 x 103 cells uL 1 0 Accuracy is defined as agreement between test and reference values at point within the operating range CBC Accuracy is referenced to a COULTER S PLUS series instrument See Table 4 3 Table 4 3 CBC Accuracy Limits
64. ear measurement equal to 0 01 meter Codes On the screen and printouts symbols such as R R that further explain the sample results See the Parameter Codes Table in the Operator s Guide for more explanation Coefficient of Variation CV An expression in percent of data spread as related to the mean CV SD Mean 100 Coincidence More than one cell within the aperture sensing boundaries at the same time The system senses these as one large cell rather than as two distinct cells so it generates one large pulse Conductivity Analysis In the flow cell high frequency electromagnetic energy probes white cell content to measure nuclear size density and granularity Control Disk A data diskette that contains the assay values for the lot number of the control being used Current Batch The Xg batch that the instrument is accumulating data on right now Cursor On a computer screen a place shown by a little blinking indicator or by a highlighted area The cursor shows where you can select an option or type in information CV Coefficient of Variation An expression in percent of data spread as related to the mean CV SD Mean 100 CVS Closed Vial Sampler In the instrument a carousel cap piercing mechanism for the closed vial mode Data Management System DMS Computer software that controls instrument operation It displays stores and recalls sample data a
65. en restarted This sequence continues until all tubes in the cassette have been sampled The Autoloader continues rocking and moves the cassette along the bed to the unloading area Once the cassette has reached the fourth pierce position the second cassette is lowered and placed on the rocker bed 3 3 SPECIMEN TRANSPORT HmX HEMATOLOGY ANALYZER At the DMS instruct the instrument to run a sample in the Primary mode e Check that the Ready light is green to indicate the system is ready to process a sample e Manually mix the sample Read the bar code label on the sample tube Hold the sample tube with the bar code label facing the instrument in front of the reader See Figure 3 4 Figure 3 4 Reading a Bar Code Label gt the bar code label was read successfully the system beeps and a green light appears If a red light appears instead the bar code label was not read successfully wait and try again Insert the sample tube into the carousel The red light appears indicating the system is busy The sample is rotated to the piercing position The needle pierces the sample tube Sample is aspirated 3 4 PN 4237523A OPERATION PRINCIPLES SAMPLE FLOW e After aspiration the needle is retracted The sample tube is ejected from the carousel Sample analysis occurs Ready light is green to indicate another sample can be processed 3 4 SAMPLE FLOW Normal Sample Flow PN
66. en the reagent was manufactured m Meter a unit of linear measurement Mean Arithmetic average of a group of data mg Milligram a unit of weight equal to 0 001 gram mil A unit of linear measurement equal to 0 001 inch mL Milliliter a unit of volumetric measurement equal to 10 liter mm Millimeter a unit of linear measurement equal to 0 001 meter 4 GLOSSARY 4237523A 4237523 GLOSSARY Mode 1 The way you choose to run a sample closed vial primary mode or open vial secondary mode 2 The number or set of numbers that occur most frequently as shown by histogram peaks Mode to Mode Matching Agreement among patient results in open and closed vial modes See Chapter 4 for specifics mW Milliwatt a unit of power equal to 0 001 watt N or n Number NCCLS National Committee for Clinical Laboratory Standards NEW CAL FACTOR Values the system calculates as you go through the calibration procedure that makes mean values equal the reference values nm Nanometer a unit of linear measurement equal to 10 9 meter o d Outer diameter OLD CAL FACTOR Values the system has been using and still is using as you go through the calibration procedure Opacity For white blood cells analyzed in a flow cell using high frequency measurement Subtracting the volume measurement from the conductivity measurement yields cell opacity Outlier Control results that fall outside the expected
67. ert and enter them on the CBC calibration screen Reproducibility This procedure checks that the system gives similar results within established limits every time it measures the same sample It is also called precision Scatter Light scatter analysis Scatterplot A two dimensional display of three dimensional white cell data SD Standard Deviation A measurement of deviation from the mean Secondary Mode In the instrument the open vial mode of sampling Shift Consecutive values that abruptly move and maintain a constant level Solenoid An electronically controlled valve that routes vacuum pressure air or liquids Standard Deviation SD A measurement of deviation from the mean Stop Bit A computer code that indicates the end of a character Suspect Flags Messages generated by the instrument algorithm to denote abnormal WBC and or Plt populations Sweep Flow A steady stream of diluent that flows behind the RBC aperture during sensing periods to keep RBCs from swirling back into the sensing zone and becoming incorrectly sensed as platelets Time out After a predetermined time of no operator input the instrument reverts to a waiting state the compressor turns off and the DMS screen blanks If input to a prompt is not received in a predetermined amount of time a time out occurs and the system displays SELECT FUNCTION Trend Values that continue to increase or decrease gradually over a period of ti
68. factor PARAMETERS AND THEIR DERIVATION Mathematical expressions in this section are in US units of measurement You can change parameter units to any of four International Systems of Units or the Japanese system by using the Reporting Units screen See the Heading Reporting Units in the Operator s Guide PN 4237523A OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION White Blood Cell WBC Count This is the number of leukocytes measured directly multiplied by the calibration constant and expressed as 3 x 10 cells uL WBC n Red Blood Cell RBC This is the number of erythrocytes measured directly multiplied by the calibration constant and expressed as 6 T 10 cells uL RBC Hemoglobin Hgb Concentration Weight mass of hemoglobin determined from the degree of absorbance found through photocurrent transmittance is Hgb g dL Constant log Reference Sample T Mean Corpuscular Volume MCV This is the average volume of individual erythrocytes derived from the RBC histogram The system e Multiplies the number of RBCs in each channel by the size of the RBCs in that channel e Adds the products of each channel between 36 fL and 360 fL e Divides that sum by the total number of RBCs between 36 fL and 360 fL Multiplies by a calibration constant and expresses MCV in femtoliters Hematocrit Hct This is the relative volume of packed erythrocytes to whole blood computed as RBC x MCV
69. g oegi Stet lo Ci MEM 03 E RETEN 0 000 1 000 0 08 1 800 i 513 sk 1 54 o le 15 Retics 1 16 Retics 0 le 517 Retics 1 Japan o fo i 1 1 1 1 ium Limits are set in Action Limits PN 4237523A 6 1 REPORTING OPTIONS GRAPHIC FORMAT 6 2 GRAPHIC FORMAT Autoprint format must be set to Graphic Format to get this report Sample reports are automatically printed when you select ALL NORMALS or ABNORMALS from the Auto Print option Note Batches are always printed in Graphic format To manually request a Graphic format printout press Print at the Run Samples screen Figure 6 2 shows a graphic format report with a wide width large font page format Figure 6 3 shows a graphic format report with a narrow width small font page format Figure 6 2 Graphic Wide Large Page Format Customized area for your ee laboratory 12 16 99 08 18 06 Roth City Labs 5 000001 OPR 590 W 20th Street 805 88920131 Metropolis FL RBC PLT Cycle 0 100 200 300 fL T t Entered from ae A worklist NATAT al ass Pos N 108 1 DATE TIME 006601 CBC Diff 89235974072 06 14 99 15 47 47 Reporting units ID 2 ie John Sequence 000012 4 99 15 20 Operator can i 81556 1989 M eM Results Sample is a redraw choose from Abnormal Pop Abnorm
70. gram 3 11 interfering substances 4 17 listing 1 2 voting 3 10 Plt counting and sizing 3 11 Pneumatic Power Supply description 1 6 pressure specifications 4 1 power cable connections 2 5 consumption 4 1 electrical input 2 1 input 4 1 installation category 4 1 specifications 4 1 power supplies description 1 6 precautions definition ii laser safety 5 1 precision by replication 4 10 CBC parameters 4 4 4 8 4 13 definition GLOSSARY 5 differential parameters 4 4 4 10 4 13 limits 4 5 pair analysis 4 10 performance characteristics 4 8 4 13 INDEX performance specifications 4 7 replicate 4 9 reticulocyte parameters 4 7 4 15 See also reproducibility prediluted samples minimum sample volume required 4 3 preservative leukocyte See Pak Preserve pressure specifications 4 1 Primary mode definition GLOSSARY 5 principles of analysis 3 1 principles of operation 3 1 printers 1 7 printing methods bar code labels 7 4 psi definition GLOSSARY 5 pulse editing description 3 11 pulses height 3 1 number 3 1 pump 3 8 Erythrolyse erythrocyte lytic reagent 3 8 Pak Lyse 3 8 Pak Preserve 3 8 StabiLyse leukocyte preserve 3 8 purge definition GLOSSARY 5 Q QC daily worksheet B 6 definition GLOSSARY 5 diff comparison B 1 manual differentials B 1 monthly graph B 7 techniques 1 3 XB 1 5 quality control 1 3 definition GLOSSARY 6 See also QC R radiation hazards 5 1 I
71. he aperture at the same time When cells coincide however the analyzer counts only one pulse Because the frequency of coincidence is proportional to the actual count the system easily corrects results for coincidence Triplicate Counting Voting The HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader use triplicate counting strict voting criteria and proprietary flagging algorithms to confirm parameter results prior to reporting After coincidence correction the system compares the data from the three count periods then votes and rejects any questionable data Voting occurs for WBC RBC Plt MCV RDW and MPV If the system finds disagreement among all the count periods or some other internal criteria are not met the system displays and prints a total voteout code instead of the parameter result IMPORTANT In rare instances especially for specimens where fibrin cell fragments or other debris are likely to occur such as pediatric and oncology specimens a transient or partial aperture blockage may not be detected by any of these methods Therefore verify flagged results for accuracy and review any result which exceeds your laboratory action limits Beckman Coulter uses triplicate counting and voting to maximize the accuracy of the results PN 4237523A OPERATION PRINCIPLES COUNTING AND SIZING Sweep Flow The sweep flow is a steady stream of diluent that flows behind the RBC aperture during the sens
72. hecked that the Plt count per period is greater than 20 x 10 cells pL the computer smooths the histogram from each count and finds a maximum point and two minimum points in each histogram It uses a least squares method for a log normal curve to fit a portion of the histogram between the two minimum points It then checks that each of the fitted curves is positive has a mode between 3 and 15 fL and has a PDW greater than approximately 2096 It votes on Plt MPV and PDW derived from the fitted curves These fitted curves have a range of 0 to 70 fL If any of the criteria above are not met an R flag appears next to Plt and MPV For no fit conditions the computer derives the Plt count from the portion of the histograms between the two minimum points then votes on Plt MPV and PDW derived from the raw data Scatterplot Development The system performs a series of operations on the stored digital raw data values to identify subpopulations and calculate percentage values It also produces the scatterplot displays for visual representation of the WBC and Reticulocyte RBC populations A scatterplot is a two dimensional graphic display of the results of the volume conductivity and scatter measurements Largest concentration is indicated on the scatterplot display by intensity Differential Related The discriminant function DF 1 scatterplot Figure shows lymphocyte monocyte neutrophil and eosinophil populations The basophil populat
73. in the closed vial mode is 1 mL with the proper proportion of blood to anticoagulant 125 pL of whole blood in the open vial mode 125 pL of dilution for prediluted samples gt 50 pL of whole blood is mixed with 100 pL of diluent e For 50 pL of whole blood is mixed with 4 drops of Reagent A A portion of this dilution is then mixed with 2 mL of Reagent B Tube Sizes for Closed Vial Mode Tubes and tube devices that fall within these ranges Diameter 10 16 mm Length 47 77 mm Capacity 2 7 mL e Beckman Coulter control and calibration tubes e tubes are listed in Appendix A Recommended Bar Code Labels Codabar or NW7 Code 399 bar code Code 128 Interleaved 2 of 5 DMS Storage Patient Results 5 000 sets plus all Sample Analysis screen displays Controls 20 files with 100 runs per file Conditions of Measurement Hemoglobin Measurement Wavelength 525nm Bandwidth 60 nm PN 4237523A 4 3 4 SPECIFICATIONS CHARACTERISTICS SOFTWARE SPECIFICATONS 4 2 4 3 4 4 Aperture Size Aperture Diameter Length RBC 50 um 60 pm WBC 100 um 75 pm Electronic Stability The change in calibration of the electronic measurement system is less than 1 per month when it is measured in accordance with this manual and is compared at monthly intervals Throughput 75 samples per hour optimal 30 samples per hour optimal for Retics SOFTWARE SPECIFICATONS Date Format For two digit date entries if th
74. ing periods B This keeps cells from swirling back into the sensing zone Because these swirling cells A would be peripherally sensed their pulse height would be similar to Plt pulse heights See Figure 3 11 Figure 3 11 Sweep Flow A B To waste Cell Cell Sensing b zone 7 d CR L 9 J4 1 T Sensing s Swirling A effect Sweep sweep flow flow Pulse Editing When cells pass through the aperture near the edge or at an angle rather than at the center they create atypical pulses Pulse editing technology eliminates atypical pulses from the analysis because they distort the true size of the cell This prevents atypical pulses from influencing size measurements RBC Count and Size Distribution During RBC sensing pulses that represent cells from 36 fL to 360 fL are classified as RBCs and are sorted by size into 256 channels to build the RBC histogram Using a system of moving averages the computer smooths the histogram curve PIt Count and Size Distribution During RBC sensing pulses that represent cells from 2 to 20 fL are classified as platelets The system automatically extends the sensing time if platelet accumulation is below a predetermined level The system sorts the Plt pulses by size into 64 channels to build the Plt histogram PN 4237523A 3 11 OPERATION PRINCIPLES COUNTING AND SIZING 3 12 PIt Fitting Process Having c
75. inition GLOSSARY 6 timing and sequencing 1 6 transmission to host computer 1 7 transport system operation 3 3 3 4 trend definition GLOSSARY 6 triple transducer module definition GLOSSARY 6 laser labels 5 3 view 5 3 where differential is measured 3 9 TIM definition GLOSSARY 6 laser 5 1 See also triple transducer module tube sizes specifications 4 3 tubing reagent container connections 2 3 waste container connection 2 3 U UL definition GLOSSARY 6 units of measurement 3 14 unpacking of instrument 2 1 US units used in manuals 1 3 use and function 1 1 definition GLOSSARY 6 Vac definition GLOSSARY 6 vacuum specifications 4 2 VCS definition GLOSSARY 7 VCS technology 1 5 ventilation 2 2 volume analysis description 1 5 volume minimum sample needed 4 3 voting 3 10 definition GLOSSARY 7 W W definition GLOSSARY 7 Warning definition ii waste container capacity 2 2 connections 2 3 use of 2 2 waste line connections 2 2 length 2 2 WBC counting 3 10 derivation 3 15 differential analysis description 3 1 formula 3 15 interfering substances 4 16 listing 1 2 sizing 3 10 voting 3 10 WBC counting and sizing 3 12 weighted moving average 1 5 white blood cell See WBC PN 4237523A 4237523 white cell count See WBC whole blood minimum sample volume 4 3 worksheets See log sheets X X definition GLOSSARY 7 XB analysis def
76. inition GLOSSARY 7 method history 1 5 QC technique 1 3 Y year format 4 4 Z zap definition GLOSSARY 7 INDEX INDEX 13 INDEX 14 INDEX PN 4237523A BECKMAN COULTER INC CUSTOMER END USER LICENSE AGREEMENT This Product contains software that is owned by Beckman Coulter Inc or its suppliers and is protected by United States and international copyright laws and international trade provisions You must treat the software contained in this Product like any other copyrighted material This license and your right to use the Product terminate automatically if you violate any part of this agreement This is a license agreement and not an agreement for sale Beckman Coulter hereby licenses this Software to you under the following terms and conditions You May l Usethis software in the computer supplied to you by Beckman Coulter 2 Maintain one copy of this software for backup purposes the backup copy shall be supplied by Beckman Coulter 3 After written notification to Beckman Coulter transfer the entire Product to another person or entity provided you retain no copies of the Product software and the transferee agrees to the terms of this license agreement You May Not 1 Use or transfer copies of this Software except as provided in this license agreement 2 Alter merge modify or adapt this Software in any way including disassembling or decompiling 3 Loan rent lease or sublicense this Software
77. ion Analysis by Paired Sample HmX Hematology Analyzer with Autoloader 4 13 Imprecision Analysis Diff Parameters by Paired Sample HmX Hematology Analyzer with Autoloader 4 14 Accuracy Analysis by Compared Specimens HmX Hematology Analyzer with Autoloader 4 14 Imprecision Analysis by Replication 4 15 Imprecision Analysis by Paired Samples 4 15 Accuracy Analysis by Compared Specimens 4 15 Reference Intervals 4 16 Code 128 Characters 7 1 Code Related Specifications 7 4 Bar Code Reader Settings and Defaults 7 4 PN 4237523A 4237523 INTRODUCTION How to use your COULTER HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader Documentation set This introductory section contains the following topics e About this Manual Conventions ist of Icons HOW TO USE YOUR HmX HEMATOLOGY ANALYZER AND HmX HEMATOLOGY ANALYZER WITH AUTOLOADER DOCUMENTATION SET Use the Reference manual for in depth information about what the instrument does the methods it uses its specifications and information on installation safety and software options Use the Special Procedures and Troubleshooting Manual to run a calibration perform reproducibility and carryover checks and to clean replace or adjust a component of the instrument The troubleshooting tables appear at the back of the manual Use the Operator s Guide for the day to day running of your instrumen
78. ion is behind the upper right quadrant of the lymphocyte O population For purposes of the display the axes are labeled Volume and DF 1 DF 1 is derived primarily from the light scatter measurement Volume is determined by the low frequency impedance measurement Figure 3 12 Scatterplot DF 1 View PN 4237523A OPERATION PRINCIPLES 3 COUNTING AND SIZING DF 2 Figure 3 13 is another perspective of the five differential populations and is derived from conductivity DF 2 displays WBC volume on the y axis and conductivity on the x axis This display shows the lymphocyte monocyte and granulocyte populations The granulocyte population includes the neutrophils basophils and eosinophils DF 3 Figure 3 14 displays the same data as DF 2 with the eosinophil and primary neutrophil populations gated out Basophil lymphocyte and monocyte cell populations easier to see with this display Figure 3 13 Scatterplot DF 2 View Figure 3 14 Scatterplot DF 3 View WBC WBC mH lt lt lt DF 3 Retic Related DF 5 Figure 3 15 shows mature red cells and reticulocytes Cell volume is plotted on the y axis and laser light scatter characteristics are plotted on the x axis This graph shows the mature red blood cell population and the reticulocyte population DF 6 Figure 3 16 is derived primarily from reticulocyte conductivity DF 6 displays Retic volume on the y axis and conducti
79. ion of differences SD expresses the inclusive errors of imprecision and bias PN 4237523A SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER Table 4 13 Accuracy Analysis by Compared Specimens HmX Hematology Analyzer Clinical Range Parameter Units Low High Mean Diff SD WBC x 10 cells L 0 50 45 80 0 22 0 39 RBC x 1012 cells L 1 98 5 88 0 06 0 07 Hgb g dL 7 30 17 80 0 02 0 24 Hct 21 00 51 30 0 60 0 82 MCV fL 68 80 120 30 0 26 1 32 MCH pg 22 50 42 10 0 35 0 68 MCHC g dL 30 40 36 20 0 49 0 93 RDW 11 40 26 00 0 59 0 30 x 109 cells L 7 10 628 00 2 24 15 20 MPV fL 5 30 14 90 0 27 0 27 Accuracy of Differential Parameters PN 4237523A The HmX Hematology Analyzer was evaluated in a typical clinical laboratory environment using both normal subjects and hospitalized subjects The reference method with which the HmX Hematology Analyzer was compared is described in NCCLS publication H20 Because of the unsuitability of regression analysis accuracy is expressed as the mean difference between reference method H20 values and the HmX Hematology Analyzer values for 203 normal subjects The scatter of the data conformed to the limits of a binomial distribution envelope Table 4 14 gives the mean difference percent Table 4 14 Accuracy Analysis Diff Parameters by Compared Specimens HmX Hematology Analyzer Cell Type Mean Diffe
80. ity 0 to 9596 without condensation Recommended Reagents ISOTON III Cor ISOTON 4 Japan only diluent for CBC dilutions rinsing and diff sheath flow LYSE S III diff or LYSE S 4 Japan only lytic reagent for WBC counting and Hgb determination HmxX Pak reagents for diff analysis ReticPrep reagents for preparing reticulocyte analysis samples COULTER CLENZ cleaning agent for both modes Reagent Usage Cycle Diluent CBC Lyse Diff Lyse Diff Preserve Cleaner Closed Vial 53 mL 1 1 mL 0 6 mL 0 13 mL Open Vial 60 mL 1 1 mL Start Up 360 mL 7 9 mL 6 5 mL 2 2 mL Shut Down 15 mL 0 mL 0 mL New Reagent Prime 220 mL 30 mL 22 mL 12 mL 80 mL Recommended Commercial Controls These controls are all available from Beckman Coulter Inc 5 cell control for CBC and differential parameters e LATRON control for volume conductivity and light scatter parameters used with LATRON primer e Retic C cell control for Reticulocyte parameter e LIN C control for reportable range of the instrument Recommended Calibrator S CAL calibrator kit 4 2 4237523A SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Recommended Anticoagulant salt of EDTA is the preferred anticoagulant Beckman Coulter used K3EDTA for the data collection and verification of claims Minimum Sample Volume Required 185 uL of whole blood in the closed vial mode gt The minimum sample volume per tube
81. l improvement in precision over previous methods helped to establish the erythrocyte count as a sensitive index of erythropoietic dyscrasia particularly when considered together with Hct and measurements gt The COULTER COUNTER Model S analyzer was the first instrument that automated simultaneous multiparameter measurements on blood Brittin et al Gottmann and Hamilton and Davidson reviewed the performance and clinical value of the Model 5 5 7 8 Refinements of the COULTER COUNTER analyzer to provide accurate size volume distribution data led to a reawakening of interest in pathological erythrocyte size distribution first aroused by Price Jones in 1922 9 10 Among the advantages offered by the Coulter method of counting and sizing was the ability to derive an accurate Hct measurement by summing the electronic volume of erythrocytes England et al speculated that electronic Hct measurements did not have the trapped plasma error of centrifugal Hct measurements Bull et al described the use of a COULTER COUNTER analyzer for counting thrombocytes 2 This method useful as it was depended on preparing thrombocyte rich plasma to avoid counting erythrocytes as thrombocytes Mundschenk et al and Schulz and Thom discussed the possibility of counting thrombocytes in the presence of erythrocytes and classifying them by size 1 14 Electronic refinements in the Model S PLUS enhanced the accuracy of the hydrodynamic method Von Behren
82. le prediluted minimum sample volume 4 3 S CAL calibrator kit description 1 9 INDEX scatter definition GLOSSARY 6 scatter light 1 5 scatterplot definition GLOSSARY 6 development 3 12 DF1 3 12 DF2 3 13 DF3 3 13 DF5 3 14 DF6 3 14 SD standard deviation definition GLOSSARY 6 Secondary mode definition GLOSSARY 6 shift definition GLOSSARY 6 signal cable connections 2 5 size distribution Plt 3 11 RBC 3 11 sizing of cells method description 3 10 software specifications 4 4 solenoid definition GLOSSARY 6 space and accessibility 2 1 space needed 2 1 special requirements 2 1 specifications bar code 7 1 instrument 4 1 performance 4 4 software 4 4 specimen flow 3 5 minimum sample volume 4 3 transport 3 3 3 4 tube sizes 4 3 StabiLyse leukocyte preservative description 1 8 pump 3 8 See also Pak Preserve standard deviation SD definition GLOSSARY 6 stop bits definition GLOSSARY 6 storage diff comparison B 1 INDEX 11 INDEX 12 INDEX storing samples DMS 4 3 suspect flags definition GLOSSARY 6 sweep flow definition GLOSSARY 6 description 3 11 system components 1 6 system layout 2 1 systems control module 1 6 T temperature ambient 2 2 operating specification 4 2 See also ambient or room temperature thrombocyte 1 4 See also Plt throughput specifications 4 4 ticket format description 6 1 example 6 1 time out def
83. le electronic pulse For counting the vacuum used to pull the diluted suspension of cells through the aperture must be at a regulated volume The number of pulses correlates to the number of particles The height of the electrical pulse is proportional to the cell volume 7 38 39 40 Differential Analysis As the sample prepared for differential analysis streams through the flow cell Figure 3 2 these three measurements occur simultaneously on each individual white cell to classify it Low frequency current measures volume e High frequency current senses cellular internal content through measuring changes in conductivity e Light from the laser bouncing off the individual WBC cells characterizes cellular surface shape and reflectivity PN 4237523A 3 1 OPERATION PRINCIPLES GENERAL PRINCIPLES Figure 3 2 Flow Cell Waste 1 Sheath fluid upper circuit Aperture 8 Sheath fluid lower circuit 1 Sample Effect of Reagents The conductive diluent must affect cells minimally if at all Both lytic reagents must destroy erythrocytes without significantly affecting leukocytes They must work rapidly to satisfy the speed with which the system works The leukocyte preservative must e Provide clear separation of the white blood cell populations e Preserve leukocytes in their near native state for accurate cytometric measurement Retic Analysis The Coulter Reticulocyte Method is a t
84. logy Analyzer Your Beckman Coulter Representative makes these connections when installing and qualifying your system for subsequent use Make sure all connections are properly seated and fastened For example check all wire clips or screws on cable connectors and make sure they are fully clipped or screwed in Figure 2 2 Interunit Connections Main Unit Computer LCD Display Digital Communication box connector 1 Graphic Printer Power cord Keyboard 2 5 INSTALLATION INTERUNIT CONNECTIONS 2 6 PN 4237523A OPERATION PRINCIPLES 3 1 GENERAL PRINCIPLES CBC Analysis The Coulter method accurately counts and sizes cells by detecting and measuring changes in electrical resistance when a particle such as a cell in a conductive liquid passes through a small aperture See Figure 3 1 Figure 3 1 Coulter Method of Counting and Sizing Vacuum Aperture current N Internal electrode External electrode SN Detail of Sample Blood cell aperture beaker suspension J Aperture Aperture tube Each cell suspended in a conductive liquid diluent acts as an insulator As each cell goes through the aperture it momentarily increases the resistance of the electrical path between the submerged electrodes on either side of the aperture This causes a measurab
85. ls inside NE LY BA EO no of cells inside EO area no of cells inside NE LY BA BA no of cells inside BA area eee x 100 no of cells inside NE LY 3 16 4237523A OPERATION PRINCIPLES 3 PARAMETERS AND THEIR DERIVATION Absolute Numbers The absolute numbers of leukocytes in each category are computed from the WBC count and the differential percentage parameters NE 10 cells uL x WBC count LY 10 cells wL TA x WBC count 10 cells LL mez x WBC count EO 10 cells uL WBC count 10 cells uL 52 x WBC count Reticulocyte Retic Parameters A graphic display of cell populations in a scatterplot form is available for reporting A flag indicates the sample needs further investigation Results then should be interpreted by a physician or other qualified medical professional Reticulocyte Percent This is the number of reticulocytes per 100 RBCs This parameter is directly measured and reported as 96 a percentage of RBCs Reticulocyte Absolute Number This is the absolute number of reticulocytes It is calculated from the reticulocyte percent and red cell RBC count It is expressed as the number of reticulocytes per liter and reported in the same units selected by the user for RBC x Count 100 On the HmX Hematology Analyzer you can enter the red cell count man
86. lysis by Paired Sample of the Differential Parameters Table 4 10 shows imprecision by pair analysis using normal blood for 194 paired observations Table 4 10 Imprecision Analysis Diff Parameters by Paired Sample HmX Hematology Analyzer Cell Type Mean Difference SD of Difference Lymphocyte 0 08 0 84 Monocyte 0 07 1 23 Neutrophil 0 01 1 26 Eosinophil 0 01 0 66 Basophil 0 01 0 53 Table 4 11 shows precision by replication 31 times with a single specimen Table 4 11 Imprecision Analysis Diff Parameters by Replication HmX Hematology Analyzer Cell Type Mean Percentage Standard Deviation Lymphocyte 38 30 1 29 Monocyte 14 38 0 86 Neutrophil 43 22 0 55 Eosinophil 3 65 0 28 Basophil 0 34 0 15 The reference range normal values for 160 subjects is given in Table 4 12 Table 4 12 Reference Range Diff Parameters for 160 Subjects HmX Hematology Analyzer Cell Type Lower Higher 96 Lower Absolute Higher Absolute Lymphocyte 20 50 45 50 1 30 2 90 Monocyte 5 50 11 70 0 31 0 83 Neutrophil 43 00 65 00 2 20 4 80 Eosinophil 0 90 2 90 0 05 0 22 Basophil 0 25 1 00 0 02 0 06 Accuracy of CBC Parameters Evaluation of accuracy by subtraction of paired test results given for COULTER HmX Hematology Analyzer and for COULTER S PLUS IV analyzer for 194 specimens is given in Table 4 13 The magnitude of the mean differences expresses accuracy The dispers
87. matology Analyzer is in the Retic Mode Manually dilute the blood before introducing the sample to the instrument for aspiration when it is in the Retic Mode Placing the instrument in the Retic Mode allows the sample to flow directly to the mixing chamber and flow cell of the triple transducer module TTM When in this mode the sample MUST be manually diluted and prepared before being aspirated by the instrument PN 4237523A 3 9 OPERATION PRINCIPLES COUNTING AND SIZING 3 5 COUNTING AND SIZING Red and White Blood Cell Counting Routine Counting Each bath has one aperture The regulated vacuum draws a precise volume of sample dilution through each aperture At each aperture the system counts cells in three consecutive periods of 4 seconds each During each counting period the analyzer gathers and amplifies the cell pulses It also checks that WBC and RBC data accumulations are above a predetermined low cut off value Pulses from the RBC bath that represent cells as 36 fL or greater are classified as red cells Pulses from the WBC bath that represent cells as 35 fL or greater are classified as white cells Both counts then go to the computer for coincidence correction and voting Extended Counting If accumulations are too low the unit extends the sensing period This ensures that the size distribution curves accurately reflect the true cell population Coincidence Correction Occasionally more than one cell goes through t
88. me five or more consecutive values TTM Triple Transducer Module the module that contains the laser and makes the diff measurements uL Microliter a unit of volumetric measurement UL Underwriters Laboratory um Micrometer a unit of linear measurement V Volt a unit of electrical potential Vac Volts of alternating current 6 GLOSSARY 4237523A GLOSSARY VCS Volume Conductivity and Scatter along with opacity the white cell measurements taken in the HmX Analyzer flow cell Voting In Beckman Coulter hematology instruments the system compares the three counts for WBC Plt and If the unit finds disagreement among all count periods or other internal criteria are not met the DMS displays a total voteout W Watt a unit of power X See mean Analysis A method of quality control that automatically compares patient indices MCHC with known target values It is used to monitor automated instruments in hematology Zap Multiple Aperture Zap under Special Functions fills the baths with cleaning agent and activates a series of quick electronic burns that rid apertures of any accumulated protein The Zap function then rinses the apertures and baths and readies the instrument for continued operation PN 4237523A GLOSSARY 7 GLOSSARY 8 GLOSSARY 4237523A 4237523 Symbols uL definition GLOSSARY 6 um definition GLOSSARY 6 Numerics 5C
89. nabled Disabled N A Check Digit Output Enabled Disabled Enabled Disabled Enabled Disabled N A Check Digit Type N A AIM 16 MOD 16 N A N A Coulter NW7 Intercharacter Gap N A Enabled Disabled Enabled Disabled N A Start Stop Match N A Enabled Disabled N A N A 7 4 PN 4237523A BAR CODE SPECIFICATIONS v BAR CODE DECODER Table 7 3 Bar Code Reader Settings and Defaults Continued Feature Interleaved 2 of 5 Codabar NW7 Code 39 Code 128 Start Stop Output N A Enabled Disabled N A N A Narrow Margins Enabled Disabled Enabled Disabled Enabled Disabled Enabled Disabled 1 3 BAR CODE DECODER Normal Operation Hematology Analyzer a The decoder e Turns the scanner ON for a maximum of 1 second e Decodes information from the scanner Beeps Turns the scanner OFF Transmits the decoded data or no read message to the sample handler The sample handler Flashes the green light to signal you to place the sample tube in the entry slot HmX Hematology Analyzer with Autoloader The decoder Turns the scanner ON for a maximum of 1 5 seconds Decodes information from the scanner Turns the scanner OFF Transmits the decoded data or no read message to the sample handler IMPORTANT Use bar code labels with checksum capabilities checksums verify the number is correct Also whenever possible enable the fixed length option as another way of ensuring a corre
90. nd allows you to communicate with the instrument Defaults Original settings in the DMS You can change these to tailor operation to your situation Definitive Flags Labels displayed when results exceed limits your laboratory set for indicating such conditions as leukopenia anemia thrombocytosis and so forth DELTA DIFF For CBC calibration the absolute difference between the mean and the reference values for WBC RBC Hgb MCV Plt and MPV DF Displays Discriminant Function DIFF scatterplots as seen in two dimensions from two angles of the distributional cube See the Operator s Guide for explanation and examples 2 GLOSSARY 4237523A 4237523 GLOSSARY Diff Leukocyte differential parameters items and processes relating to them 2 Onthe REPRODUCIBILITY screen the difference between the minimum and maximum results for each parameter 3 the Startup and System test screens diff psi difference between sheath pressure and sample pressure Differential Analysis Analysis of individual WBCs with VCS technology to differentiate and group them into subpopulations Diluter Primary operating unit of the instrument It aspirates pipets dilutes mixes lyses and senses dL Deciliter a unit of volumetric measurement equal to 0 1 liter DMS Data Management System Computer software that controls instrument operation It displays stores and recalls sample data and allows you to communic
91. nition GLOSSARY 5 P Pak Lyse description 1 8 pumps 3 8 tubing connection 2 4 Pak Preserve 3 8 description 1 8 pump 3 8 tubing connection 2 4 parameter derivation 3 14 parameter measurement conductivity 3 14 structure and shape 3 14 parameters definition GLOSSARY 5 derivation 3 14 determined by the system 1 2 formulas 3 14 interfering substances 4 16 listing 1 2 parity definition GLOSSARY 5 patient population definition GLOSSARY 5 patient sample review QC technique 1 3 Pct listing 1 2 PDW listing 1 2 performance characteristics 4 8 accuracy CBC parameters 4 10 4 14 accuracy differential parameters 4 11 4 14 accuracy reticulocytes 4 15 Autoloader model 4 13 clinical sensitivity 4 11 precision CBC parameters 4 8 4 13 precision differential parameters 4 10 4 13 precision reticulocytes 4 15 reticulocytes 4 15 performance specifications accuracy 4 5 4 7 background counts 4 6 carryover 4 7 CBC and differential parameters 4 4 linearity 4 5 mode to mode matching 4 6 PN 4237523A 4237523 operating range 4 8 precision 4 4 4 7 reportable range reticulocytes 4 8 reticulocytes 4 7 p8 definition GLOSSARY 5 physical specifications instrument 4 1 pipettes recommended 4 8 platelet count 1 4 See also Plt Platelet Distribution Width See PDW plateletcrit See Pct Plt cell size 3 11 count 1 4 derivation 3 16 fitting process 3 12 formula 3 16 histo
92. nt cleans and rinses the internal surfaces of the Diluter components Daily use prevents protein buildup and eliminates routine aperture bleaching 1 8 PN 4237523A 1 7 1 8 4237523 USE AND FUNCTION CONTROLS AND CALIBRATOR CONTROLS AND CALIBRATOR Controls COULTER 5C cell control monitors the CBC and differential parameters LATRON primer prepares the tubing and instrument components for the LATRON control LATRON control monitors the performance of the volume conductivity and light scatter measurements Retic C cell control monitors the Reticulocyte parameters LIN C linearity control verifies the reportable range of the instrument s CBC parameters Calibrator The S CAL calibrator kit calibrates Primary mode CBC parameters and is an acceptable alternative to the whole blood reference method of calibration S CAL calibrator meets the requirements recommended by the International Committee for the Standardization of Hematology ICSH The diff retics measurement device is calibrated for optimum performance at the factory MATERIAL SAFETY DATA SHEETS MSDS To obtain an MSDS for reagents used on the HmX Hematology Analyzer 1 IntheUSA either call Coulter Customer Operations 800 526 7694 or write to Coulter Corporation Attn MSDS Requests P O Box 169015 Miami FL 33116 9015 2 Outside the USA call your Coulter Representative 1 9 1 USE AND FUNCTION MATERIAL SAFETY DAT
93. nual to safely use the instrument and prevent damage In its design and manufacture of the HmX Hematology Analyzer Beckman Coulter has complied with the requirements governing the use and application of a laser as stipulated in regulatory documents issued by the U S Department of Health and Human Services e Center for Devices and Radiological Health CDRH In compliance with these regulatory documents every measure has been taken to ensure the health and safety of users and laboratory personnel from the possible dangers of laser use 5 2 GENERAL LASER SAFETY WARNINGS WARNING Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure Do not attempt to remove the laser or to open it If removal is required it must be done only by your Beckman Coulter Representative To ensure your safety HmX Hematology Analyzer lasers are covered with protective shields held in place by tamper proof screws Do not attempt to remove these shields This instrument contains components dangerous to the operator If any attempt has been made to defeat a safety feature or if this instrument fails to perform as listed in this manual disconnect power and call your Beckman Coulter Representative 5 3 WARNING LABELS PN 4237523A CDRH approved labels are placed near or on those covers that when removed might expose one to laser radiation Note As inst
94. odel ZBI CHANNELYZER analyzer Certified volumetric glassware NCCLS method H15 A NCCLS packed cell volume method H7 A For WBC differential parameters the reference values were provided by the method described in NCCLS publication H20 using an 800 cell count The results of replicate precision testing n 31 for each parameter measured by the test instrument are given in Table 4 8 Table 4 8 Imprecision Analysis by Replication WHOLE BLOOD HmX Hematology Analyzer Parameter Units Mean SD CV WBC 109 cells L 5 15 0 10 1 04 x 1012 cells L 4 55 0 06 1 32 Hgb g dL 13 07 0 12 0 92 MCV fL 86 1 1 1 1 28 RDW 12 56 0 21 1 67 Pit 109 cells L 206 7 8 78 4 25 MPV fL 9 69 0 15 1 55 Table 4 9 lists the results of Pair Difference analysis for 194 paired clinical blood specimens Table 4 9 Imprecision Analysis by Paired Sample Hematology Analyzer Clinical Range Parameter Units Low High Mean Diff 0 WBC 109 cells L 0 4 46 8 0 01 0 20 RBC x 1012 cells L 2 06 5 92 0 00 0 04 Hgb g dL 7 2 17 7 0 01 0 13 Hct 22 1 53 1 0 10 0 68 MCV fL 67 8 123 9 0 15 1 26 MCH pg 21 8 41 6 0 35 0 37 MCHC g dL 30 7 36 6 0 04 0 67 RDW 11 0 26 4 0 00 0 28 x 109 cells L 1 0 710 0 0 51 11 85 fL 8 6 15 0 0 01 0 93 4 9 4 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER 4 10 Imprecision Ana
95. on to your manuals xv symbols meaning xvii using the manuals xv drainage 2 2 dyes for measuring reticulocytes 1 5 3 2 E earth ground 2 1 editing pulses description 3 11 EDTA definition GLOSSARY 3 recommended anticoagulant 4 3 electrical input 2 1 electronic power supply 1 6 electronic stability 4 4 environmental requirements 2 1 derivation 3 17 formula 3 17 listing 1 2 EO derivation 3 16 formula 3 16 listing 1 2 eosinophil number See EO eosinophil percent See EO equivalence mode to mode 4 6 erythrocyte See RBC erythrocyte count 1 4 erythrocyte lytic reagent recommended 4 2 See also Pak Lyse erythrocyte size distribution 1 4 Erythrolyse II erythrocyte lytic reagent description 1 8 pumps 3 8 See also Pak Lyse expiration date definition GLOSSARY 3 extension cord 2 2 F FAC DIFF definition GLOSSARY 3 fans 2 2 field definition GLOSSARY 3 fitting process Plt description 3 12 5C cell control description 1 9 fL definition GLOSSARY 3 flagging 4 8 flags definition GLOSSARY 3 flow cell definition GLOSSARY 3 flow cell module See triple transducer module flow cytometry 1 5 formulas parameters 3 14 ft definition GLOSSARY 3 function keys definition GLOSSARY 3 G g definition GLOSSARY 3 PN 4237523A 4237523 gal definition GLOSSARY 3 glossary GLOSSARY 1 graph points diff comparison B 4 graphics format descri
96. onal Electronics Conference Chicago IL 1956 October 3 5 Brecher Schneiderman M and Williams GZ Evaluation of electronic red blood cell counter Am J Clin Path 1956 26 1439 1449 6 Brittin GM Brecher and Johnson CA Evaluation of the COULTER COUNTER Model S Am J Clin Path 1969 52 6 679 689 7 Gottmann AW Multiple hematologic analyses by means of a COULTER COUNTER Model S Paper presented at International Symposium of Standardization of Hematological Methods Fondazione Carlo Erbe Milan Italy November 9 and 10 1970 Symposium proceedings published in Haematologica Latina 1969 8 Hamilton PJ and Davison RL The interrelationships and stability of Coulter S determined blood indices J Clin Path 1973 26 700 705 9 Bessman JD and Johnson RK Erythrocyte volume distribution in normal and abnormal subjects Blood 1975 46 3 369 379 10 Price Jones C The diameters of red cells in pernicious anaemia and in anaemia following haemorrhage J Path Bact 1922 25 487 504 11 England JM Walford DM and Waters DAW Re assessment of the reliability of the haematocrit Brit J Haemat 1972 23 247 256 12 Bull BS Schneiderman MA and Brecher G Platelet counts with the COULTER COUNTER Am J Clin Path 1965 44 6 678 688 13 Mundschenk DD Connelly DP White JG and Brunning RD An improved technique for the electronic measurement of platelet size and shape J Lab Clin Med 1976 88 2 301 315 14 Schulz J an
97. or established range Parameters Components of blood that the instrument measures and reports Parity Methods of detecting errors in data handling The computer generates a parity bit such that the sum of the bits and the parity bit are odd or even for each data word Patient Population A large number of patient sample results for Xg Analysis used to give fairly consistent average results for each of the three red blood cell indices MCV MCH and MCHC pg Picogram a unit of gravimetric measurement psi Pounds per square inch a unit of pressure measurements Precision Ability of the instrument to reproduce similar results when a sample is run repeatedly Precision of the instrument is CV based on at least 31 replicate determinations of the same sample Precision of the closeness of test results when repeated analyses of the same material are performed Also called reproducibility Primary Mode Closed vial sampling mode in the instrument Purge An option that clears clogs and bubbles from apertures and flow cell QC Quality Control A comprehensive set of procedures your laboratory sets up to ensure that the instrument is working accurately and precisely GLOSSARY 5 GLOSSARY Quality Control QC A comprehensive set of procedures your laboratory sets up to ensure that the instrument is working accurately and precisely REE VALUES Reference values for CBC calibration You find these on the calibrator package ins
98. ormat 4 4 defaults definition GLOSSARY 2 definitions GLOSSARY 1 definitive flags definition GLOSSARY 2 delivery inspection 2 1 INDEX DELTA DIFF definition GLOSSARY 2 derivation of parameters 3 14 DF displays definition GLOSSARY 2 scatterplot description 3 12 example 3 12 DF2 scatterplot description 3 13 example 3 13 DF3 scatterplot description 3 13 example 3 13 DF5 scatterplot description 3 14 example 3 14 DF6 scatterplot description 3 14 example 3 14 diff definition GLOSSARY 3 diff comparison calculations B 2 daily QC worksheet B 2 graph points B 4 QC B 1 diff leukocyte preservative description 1 8 See also Pak Preserve diff lytic reagent description 1 8 recommended 4 2 See also Pak Lyse diff module laser 5 1 See also triple transducer module or TTM diff parameters derivation 3 16 formulas 3 16 interfering substances 4 17 listing 1 2 differential analysis 3 1 definition GLOSSARY 3 interfering substances 4 17 differential counts 3 16 differential measurement 1 5 INDEX 3 INDEX 4 INDEX diluent description 1 7 ISOTON 4 1 7 ISOTON III 1 7 recommended 4 2 tubing connection 2 4 diluter definition GLOSSARY 3 description 1 6 dimensions 4 1 dL definition GLOSSARY 3 DMS definition GLOSSARY 2 description 1 7 storage 4 3 documentation for your instrument about your reference manual xv conventions used xvi icons description xvii introducti
99. ption 6 2 example 6 2 ground path 2 1 H H definition GLOSSARY 3 Hct derivation 3 15 formula 3 15 interfering substances 4 17 listing 1 2 measurement 1 4 hematocrit See Hct hemoglobin See Hgb hemoglobin measurement 1 8 4 3 hemoglobinometry definition GLOSSARY 3 description 1 4 Hg definition GLOSSARY 4 Hgb concentration 3 15 derivation 3 15 description 3 15 formula 3 15 interfering substances 4 16 listing 1 2 measurement 1 8 4 3 high frequency current 1 5 histograms definition GLOSSARY 4 history of methods 1 4 Pak description 1 8 tubing connections 2 3 humidity 2 2 4 2 Hz definition GLOSSARY 4 INDEX i d definition GLOSSARY 4 ICSH definition GLOSSARY 4 IEC definition GLOSSARY 4 Important definition ii imprecision See precision in vitro definition GLOSSARY 4 in definition GLOSSARY 4 inspection delivery 2 1 installation category 4 1 requirements 2 1 instrument accessibility 2 1 characteristics 4 8 4 13 components 1 6 delivery inspection 2 1 dimensions 4 1 electrical input requirements 2 1 installation special requirements 2 1 layout 2 1 location 2 1 performance specifications 4 4 physical specifications 4 1 unpacking 2 1 view 1 1 1 2 intended use of instrument 1 1 interfering substances 4 16 Interleaved 2 1 5 bar code 4 3 7 1 interunit connections 2 5 introduction to your manuals xv IQAP definition GLOSSARY 4 type of q
100. r CBC Analysis Parameter Counts WBC x 103 cells uL 0 4 RBC x 106 cells uL lt 0 0 Hgb g dL lt 0 1 Plt x 103 cells uL 3 0 4 6 PN 4237523A SPECIFICATIONS CHARACTERISTICS RETICULOCYTE PERFORMANCE SPECIFICATIONS Carryover 4 4 The effect of sample A on the values obtained for the next sample sample B is less than 2 096 when the analysis is based on 10 determinations and when calculated carryover 100 where is the error in due to carryover RETICULOCYTE PERFORMANCE SPECIFICATIONS Precision Within Run Imprecision total system Validation limits for 31 separately prepared dilutions of the same specimen are Limits Whichever is greater SD Limit CV Limit 1 00 0 23 lt 23 1 00 4 00 lt 0 23 lt 17 4 01 15 00 lt 0 68 lt 15 Run to Run Precision Validation of paired imprecision for reticulocytes is based upon the differences of Run 1 and Run 2 specimens The limits over the clinical range of a minimum of 50 specimens from a general hospital population of no more than 3096 abnormally elevated reticulocyte specimens Retic gt 4 are as follows Parameter Mean Difference SD of Difference RET 0 4 lt 0 8 Paired imprecision limits over the clinical range for minimum of 50 specimens with the following characteristics are e Greater than 50 abnormally elevated values 2496 e No greater than 5 of 50 specimens have values
101. r Secondary Aspiration Mode See Table 4 21 Table 4 21 Accuracy Analysis by Compared Specimens HmX Hematology Analyzer with Autoloader Clinical Range Parameter Units Low High Mean Diff SD WBC x 10 cells L 1 10 55 20 0 07 0 12 RBC x 1012 cells L 2 31 6 59 0 04 0 04 Hgb g dL 8 00 17 50 0 12 0 08 MCV fL 69 60 125 60 0 07 1 07 RDW 11 04 26 50 0 04 0 28 x 10 cells L 10 0 715 0 10 86 11 57 MPV fL 5 60 10 8 0 03 0 30 Lymphocyte 11 5 67 1 0 61 4 85 Monocyte 1 50 26 20 0 35 3 00 Neutrophil 31 40 74 40 0 48 4 07 Eosinophil 0 00 9 00 0 08 0 36 Basophil 0 00 1 7 0 15 0 64 PN 4237523A SPECIFICATIONS CHARACTERISTICS RETICULOCYTE PERFORMANCE CHARACTERISTICS RETICULOCYTE PERFORMANCE CHARACTERISTICS Imprecision Analysis by Replication Imprecision is stated in terms of standard deviation SD The SD was determined by replicate testing using 31 dilutions of the same whole blood specimen The test was repeated at three different reticulocyte levels See Table 4 22 Table 4 22 Imprecision Analysis by Replication Statistic Level Level Il Level Ill Mean 0 22 1 54 6 72 SD 0 05 0 20 0 47 n 31 31 31 Table 4 23 shows paired samples imprecision analysis Table 4 23 Imprecision Analysis by Paired Samples Criteria Mean Minimum Maximum A Test 1 2 2596 0 2096 2 2596 B Test 2 2 3196 0 3096 2 3196 Diffe
102. rence Lymphocyte 1 19 Monocyte 0 51 Neutrophil 0 23 Eosinophil 0 47 Basophil 0 18 Clinical Sensitivity The ability of the HmX Hematology Analyzer to flag abnormal specimens was compared to the performance of the NCCLS publication H20 using an 800 cell count method using the reference limits listed in Table 4 15 Except for nucleated red cells absolute count values were used 4 11 4 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS HmX HEMATOLOGY ANALYZER Table 4 15 Flagging Criteria H20 Method Cell Type Reference Range x 10 cells L Reference Range Blast Meta Myelo Promyelo gt 0 1 2 0 Nucleated red cell 20 02 2 0 Lymphs variant forms 20 7 N A Bands left shift gt 0 9 6 Table 4 16 lists the numbers of morphologic abnormalities that were studied Table 4 16 Morphologic Abnormalities HmX Hematology Analyzer Abnormality Type Number of Cases Granulocytosis 43 Granulopenia 10 Lymphocytosis 22 Lymphopenia 34 Monocytosis 42 Eosinophilia 16 Basophilia 13 Metamyelocytes 26 Myelocytes 1 Promyelocytes 3 Blasts 13 Nucleated red cells 17 The clinical sensitivity for morphologic abnormals is shown in Table 4 17 Table 4 17 Clinical Sensitivity for Morphologic Abnormals HmX Hematology Analyzer HmX Hematology Analyzer HmX Hematology Analyzer Criteria Negative Positive Total Reference H20 Normal 177 T
103. rence A B 0 06 N A N A SD of Differences 0 43 N A N A 145 Test 1 vs Test 2 Accuracy PN 4237523A Accuracy is shown by analysis of paired tests using clinical specimens The analysis used the conventional calculation method for Mean Difference and Standard Deviation of differences SD Accuracy is defined as the degree of agreement between the reference method NCCLS 16 and the HmX Hematology Analyzer Clinical specimens with values covering the expected range of performance were used Table 4 24 displays the results of the accuracy analysis Table 4 24 Accuracy Analysis by Compared Specimens Criteria Mean Minimum Maximum A HmX Hematology Analyzer Reticulocyte Counter 3 4396 0 3 26 50 B Reference 3 2696 0 1296 24 0696 Difference A B 0 1996 N A N A SD of Differences 1 0196 N A N A COULTER HmxX Hematology Analyzer analysis based on 145 clinical specimens 4 15 4 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 4 8 4 16 Reference Interval Reference intervals normal range for the HmX Hematology Analyzer are divided into two groups based on sex The resulting minimum and maximum values of the laboratory normal range are shown in Table 4 25 Table 4 25 Reference Intervals Parameter Low High n Retic Male 0 696 2 6096 100 Retic Female 0 696 2 60 128 INTERFERING SUBSTANCES A salt of EDTA is the preferred anticoagulant Beckman Coulter
104. s and Paulus also cited the feasibility of counting thrombocytes by the Coulter method 16 Hemoglobinometry The lytic reagent used for the complete blood count CBC parameters prepares the blood so the system can count leukocytes and sense the amount of hemoglobin The lytic reagent rapidly and simultaneously destroys the erythrocytes and converts a substantial proportion of the hemoglobin to a stable pigment while it leaves leukocyte nuclei intact The absorbance of the pigment is directly proportional to the hemoglobin concentration of the sample The accuracy of this method equals that of the hemiglobincyanide method the reference method of choice for hemoglobinometry recommended by the International Committee for Standardization in Hematology 1 5 17 PN 4237523A USE AND FUNCTION METHOD HISTORY Differential Measurement The COULTER VCS established WBC differential technology using three measurements individual cell volume high frequency conductivity and laser light scatter The combination of low frequency current high frequency current and light scattering technology provides abundant cell by cell information that is translated by the instrument into conventional stained film leukocyte categories Correlation between the frequency of the different cell types using stained film microscopy and this system is greater than 0 9 for lymphocytes and granulocytes and 0 7 for mononuclear cells Volume Analysis Electronic leuko
105. t Read the System Overview chapter to become familiar with the different parts of your system Then go through the detailed step by step procedures of start up running controls and samples reviewing data and shutdown Use the Host Specifications Manual to locate information about transmission to a host computer Use the Master Index to locate a subject in your documentation set See the Documentation page on the back cover of this manual for the contents of each manual It can help you to determine quickly which manual contains the information you need ABOUT THIS MANUAL Your COULTER HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader Reference manual provides in depth information about what the instrument does the methods it uses its specifications and information on installation safety and software options This manual covers the total HmX system Use this manual for reference if you have a HmX Hematology Analyzer or a HmX Hematology Analyzer with Autoloader This information 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 calibrator and controls used and a short description of the major components and options Chapter 2 Installation Contains the instrument requirements the diagrams of the reagent tubing connections and the interunit cable connections PN 4237523A XV INTRODUCTI
106. t and Waste Connections CAUTION Possible reagent siphoning effect and priming problems could occur if a reagent container is placed above the level of the Diluter Place the reagent containers at the same level as the system or below IMPORTANT Possible incorrect platelet counts can be reported due to bubbles in the line and reagent priming problems could occur if the reagent tubing lengths are too long Do not exceed 8 ft from the rear of the system to any reagent container Figure 2 1 shows the tubing connections from the instrument to the reagent and to the waste containers The pak lyse pak preservative and lytic reagent are placed at the correct level on the counter beside the unit Be sure to keep all reagent lines isolated from anything electrical PN 4237523A 2 3 INSTALLATION INTERUNIT CONNECTIONS Figure 2 1 Reagent and Waste Container Tubing Connections From From lytic A diluent reagent B From From cleaner ak From Pak To yse preserve waste n 5 2 Lytic Pak Pak reagent lyse preserve PAYA 7 OtO 0 COULTER JN Waste Diluent Cleaner 2 4 4237523 INSTALLATION 2 INTERUNIT CONNECTIONS Power and Signal Cables Figure 2 2 shows interunit connections of the power and signal cables that are supplied with the HmX Hemato
107. tal gt 5 HmX1 d MGE IO j e Tech 1 2 Total 5 Z Ref Specimen 2 Cycle 1 2 Total i HmX2 Tech 1 2 Total gt 5 Ref 2 Graph Point HmX1 Ref 2 GraphPoint COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Au Serial No 14 Record the graph points on these log sheets Graph Point Summary Monthly QC Graphs For your first month use Zero as the mean e These values 15 250 3 26 6 52 3 23 6 46 126 2 52 0 95 1 90 0 40 0 80 4 4237523 B 3 PN 4237523A DIFF COMPARISON B SHEETS After you accumulate values for 31 days calculate your own laboratory s mean and standard deviations Graph Point Summary For Manual Differential Check Month Year NETS BAT M0 raph raph Point Status Point Status Point Status Point Status Point Status 3 m 06 W 25 W 52 W 0 W 2 W 7 W Monthly QC Graph H1 w fu Month Year 1999 12 Tm NE 250 6 52 e ES w N e o a N LY 250 6 46 e 5 m co e
108. the cassettes in the loading bay see Figure 3 3 Figure 3 3 Loading a Cassette At the DMS instruct the instrument to run samples in the Primary mode The right lift platform beneath the stacked cassettes rises and the bottom cassette is deposited on the rocker bed e platform lowers the cassette to the level of the rocker bed where it is rocked back and forth mixing the samples e The cassette moves along the bed while rocking until the first tube reaches the piercing station The cassette stops moving forward but continues rocking gt bar code scanner reads the Cassette Position label and the tube label gt cassette continues rocking The Autoloader stops if the Cassette Position label is not read Ifthe labels are read the bed is brought forward into the piercing position The needle pierces the tube e After aspiration the needle is retracted 3 3 OPERATION PRINCIPLES SPECIMEN TRANSPORT HmX HEMATOLOGY ANALYZER bed resumes rocking bar code scanner reads the Cassette Position label and the tube label a second time Jfboth bar code scans are identical the Autoloader continues to rock and moves the cassette until the next available tube has reached the piercing station gt the bar code scans are not identical the Autoloader stops No data is available for the sample The Autoloader continues sampling at the next available tube wh
109. uality control 1 3 ISOTON 4 diluent description 1 7 See also diluent ISOTON III diluent description 1 7 See also diluent INDEX 5 INDEX 6 INDEX K k definition GLOSSARY 4 anticoagulant used in data collection 4 3 definition GLOSSARY 4 keyboard cable connection 2 5 L L definition GLOSSARY 4 labels bar code specifications 7 1 CDRH approved 5 1 laser safety location on instrument 5 2 5 3 5 4 laser warning 5 1 safety 5 1 specifications 7 3 labels bar code dimensions 7 3 recommended 4 3 specifications 7 3 laboratory setting 2 1 laser definition GLOSSARY 4 labels 5 1 safety 5 1 latex LATRON See LATRON control LATRON control description 1 9 LATRON primer description 1 9 layout 2 1 Ib definition GLOSSARY 4 leukocyte volume 1 5 See also WBC leukocyte preservative description 1 8 recommended 4 2 See also Pak Preserve light scatter analysis definition GLOSSARY 4 description 1 5 limitations reticulocyte parameters 4 8 limits accuracy 4 5 accuracy reticulocytes 4 8 background count 4 6 linearity 4 6 mode to mode matching 4 6 precision 4 5 precision reticulocytes 4 7 LIN C linearity control description 1 9 linearity control 1 9 definition GLOSSARY 4 limits 4 5 performance specifications 4 5 ranges 4 6 log sheets B 5 daily QC worksheet B 6 graph point summary B 7 monthly QC graph B 7 lot number definition GLOSSARY 4 low frequen
110. ually via data base query if you want the absolute number result For more information see the heading Cycling Retic Samples in the Operator s Guide 4237523A 3 17 OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION 3 18 4237523A SPECIFICATIONS CHARACTERISTICS 4 1 INSTRUMENT SPECIFICATIONS Dimensions Component Height Width Depth Weight HmX Hematology Maximum 61 5 cm 61 7 cm 94 5 Analyzer 84 84 cm 25 10 in 25 20 in 210 Ib 33 40 in Minimum 80 2 cm 32 75 in Computer 41 2 cm 17 8 cm 41 9 cm 9 7 k 16 2 in 7 0 in 16 5 in 21 5 Ib LCD Display 41 9 cm 40 4 cm 19 6 cm 7 34 k 16 5 in 15 9 in 7 7 in 16 3 1b Keyboard 3 6 cm 40 4 cm 18 0 cm 2 8 k 1 4 in 15 9 in 7 1 in 6 2 1b Graphic Printer 13 2 cm 43 2 cm 33 0 cm optional 5 2 in 17 0 in 13 0 in 16 5 Ib Power Installation Category Category II per IEC 1010 1 Input Dedicated Line 100 120 Vac 50 60 Hz 220 240 50 60 Hz Consumption 1440 W This includes the system and all peripherals Pneumatic Supplies Pressure 60 psi 55 0 65 0 30 psi 26 0 34 0 Sheath low psi 5 8 6 2 Diff psi 0 1 1 0 4237523 4 1 SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Vacuum In inches of Hg at sea level Low 5 94 6 06 High 17 0 28 0 Temperature Ambient Operating Range for Patient Samples Ambient operating temperature 16 to 32 C 60 to 90 F Humid
111. ull current of the circuit confirmed third wire earth ground Afemale outlet gt For the 110 120 V 60 Hz model it needs to furnish 120 10 Vac 60 Hz 15 single phase input power gt For the 220 240 V model it needs to furnish 220 240 10 Vac 50 60 Hz 8 A single phase input power PN 4237523A 2 1 INSTALLATION SPECIAL REQUIREMENTS CAUTION Either of these two hazards can occur if you use an extension cord e Introduction of electrical interference can occur and cause instrument performance problems frequent lock ups and resets or e Overheating melting and burning of the extension cord can occur Plug the primary power cable directly into the electrical outlet Position the system close enough to an electrical outlet so you do not need to use an extension cord Do not use an extension cord CAUTION Possible damage can occur if you use a power strip that is not compatible with your instrument If you plan to use a power strip other than the one recommended by Beckman Coulter call your Beckman Coulter Representative to be sure that your power strip is compatible with your instrument Ambient Temperature and Humidity Operate the system in a room with a temperature between 16 and 32 60 and 90 F and humidity no higher than 9596 without condensation Ventilation Air Arrange for the ventilation fan on the rear panel to be at least 12 cm 5 in from any walls or obstructions that could interfer
112. unction and damages Please refer to the computer program or system agreement or to the computer program or system documentation for the terms and conditions of that license PN 4237523A xvii INTRODUCTION COMPUTER PROGRAM STATEMENT xviii PN 4237523A USE AND FUNCTION 1 1 INTENDED USE General The COULTER HmX Hematology Analyzer Figure 1 1 and the HmX Hematology Analyzer with Autoloader Figure 1 2 are quantitative automated hematology analyzers and leukocyte differential cell counters For In Vitro Diagnostic Use in clinical laboratories The purpose of the HmX Hematology Analyzer is to separate the normal patient with all normal system generated parameters from the patient who needs additional studies These studies include further measurements of cell size and cell distribution biochemical investigation or any other test that helps diagnose the abnormality Figure 1 1 The HmX Hematology Analyzer Main Unit Computer LCD Display Graphic Printer PN 4237523A 1 1 USE AND FUNCTION INTENDED USE Figure 1 2 The HmX Hematology Analyzer with Autoloader Graphic Printer 1 2 Parameters Main Unit Computer The systems measure these hematologic parameters of whole blood specimens WBC NE LY LY MO MO EO EO BA BA RBC Hgb Hct MCV
113. used K3EDTA for the data collection and verification of claims Use of other anticoagulants can yield misleading results The presence of certain interfering substances as listed in this section can also yield misleading results WBC Certain unusual RBC abnormalities that resist lysing nucleated RBCs fragmented WBCs any unlysed particles greater than 35 fL very large or aggregated platelets as when anticoagulated with oxalate or heparin specimens containing fibrin cell fragments or other debris such as pediatric and oncology specimens 42 43 44 RBC Very high WBC count high concentration of very large platelets agglutinated RBCs RBCs smaller than 36 fL specimens containing fibrin cell fragments or other debris such as pediatric and oncology specimens gt 46 Hgb Very high WBC count severe lipemia heparin certain unusual RBC abnormalities that resist lysing or anything that increases the turbidity of the sample such as elevated levels of triglycerides MCV Very high WBC count high concentration of very large platelets agglutinated RBCs RBC fragments that fall below the 36 fL threshold or rigid 48 49 50 51 RDW Very high WBC count high concentration of very large or clumped platelets as in blood anticoagulated with oxalate or heparin RBCs below the 36 fL threshold two distinct populations of RBCs RBC agglutinates or rigid 5 22 53 54 55 PN 4237523A SPECIFICATIONS CHARACTERIST
114. vity on the x axis This graph shows the mature red blood cell population and the reticulocyte population PN 4237523A 3 13 OPERATION PRINCIPLES Hgb CONCENTRATION MEASUREMENT 3 6 3 7 3 14 Figure 3 15 Scatterplot DF 5 View Figure 3 16 Scatterplot DF 6 View RBC oH DF 5 Retic Parameters The system makes three measurements as each cell passes through the flow cell aperture The low frequency impedance measurement which defines the cell s volume The high frequency impedance measurement which indicates the cell s internal conductivity The light scatter measurement which indicates the cell s structure and shape Derived and Computed Parameters From directly measured parameters the computer derives e and RDW from the RBC histogram e MPV and Plt count from the Plt histogram From derived and directly measured parameters the computer computes Hct MCH and MCHC Hgb CONCENTRATION MEASUREMENT After the WBC dilution is lysed the system shines a beam of white light through the WBC aperture bath and then through an optical filter This transmittance of light 525 nm wavelength through a standard path length of Hgb solution is compared to the transmittance of such light in the same way through a reagent blank The system converts this ratio to absorbance It then converts absorbance to Hgb values in g dL using a calibration
115. volumes AJCP 1983 327 332 Nosanchuk JS Roark ME and Wanser C Anemia masked by triglyceridemia Am J Clin Path 1974 62 838 839 Miale JB Laboratory Medicine Hematology 3rd Edition 1967 CV Mosby pages 592 595 4237523 Accuracy Ability of the instrument to agree with a predetermined reference value at any point within the operating range A Ampere a unit of electric current Algorithm A particular procedure for performing an analysis ANSI ANSI Acronym for American National Standards Institute ASCII Acronym for American Standard Code for Information Interchange Assay Values Values of all parameters in a control established by extensive assay of that control ASTM Acronym for American Society for Testing and Materials Average Value A value determined by adding a set of results and dividing by the number of results Usually referred to as the simple arithmetic mean Background Count Measure of the amount of electrical or particle interference Batch An group of 20 patient samples used for monitoring and MCHC as an automatic QC procedure or a group of patient results that you specify in Database Query for group printing and or transmitting to a host computer Batch Mean The mean or average of a set of samples For Analysis the batch mean is a value based on a statistical averaging technique and is a type of weighted moving average It is used to estimate what
116. with automated instruments Lab Med 1982 13 300 304 REFERENCES 3 54 55 56 57 58 59 60 61 62 63 64 65 4 REFERENCES Waterman CS Atkinson EE Wilkins B Fischer CL and Kimsey SL Improved measurement of erythrocyte volume distribution by aperture counter signal analysis Clin Chem 1975 21 1201 1211 Fales W Water distribution in blood during sickling of erythrocytes Blood 1978 51 703 709 Zucker Franklin D and Karpatkins S Red cell and platelet fragmentation in idiopathic autoimmune thrombocytopenic purpura NE J Med 1977 297 517 523 Akwari AM Ross DW and Stass SA ASCP 1982 77 220 221 Dale NL and Schumacher HR Platelet satellitism new spurious results with automated instruments Lab Med 1982 13 300 304 Kjeldsberg CR and Hershgold EJ Spurious thrombocytopenia JAMA 1974 227 628 630 Richardson Jones A Mean platelet volume clinical utility and the variables of measurement 1986 Coulter Electronics Inc Hialeah Florida Corash L Platelet Sizing Techniques biological significance and clinical applications Current topics in hematology New York New York Alan R Lise Inc 1983 Threate GA Andrados C Ebbe S and Brecher G Mean Platelet Volume The need for a reference method 1984 81 769 772 Thompson CB Diaz DD Quinn PG Lapins M Kurtz SR and Valeri CR The role of anticoagulant in the measurement of platelet
117. wo step sample preparation followed by analysis in the HmX Hematology Analyzer Retic Mode using volume conductivity and scatter VCS technology First a supravital dye New Methylene Blue in a special solution Reagent A is incubated with whole blood samples The dye precipitates the basophilic RNA network found in reticulocytes Then when added to the samples a hypotonic clearing reagent Reagent B clears hemoglobin and unbound stain from the cells After the treatment and if viewed in a wet prep microscopically mature erythrocytes appear as clear slightly spherical cells Reticulocytes have the same characteristics but with darkly stained reticulum 3 2 PN 4237523 3 2 4237523 OPERATION PRINCIPLES SPECIMEN TRANSPORT HmX HEMATOLOGY ANALYZER WITH AUTOLOADER Stained reticulocytes differ from mature erythrocytes RBCs and other cell populations by light scatter direct current measurements and opacity characteristics SPECIMEN TRANSPORT HmX HEMATOLOGY ANALYZER WITH AUTOLOADER Samples in the loading bay are automatically transported mixed aspirated and analyzed Sample tubes which can be identified by bar code labels are loaded into five tube cassettes Cassettes and the tube position in the cassette are identified by bar code labels on the cassette You can load up to 25 samples in the HmX Hematology Analyzer with Autoloader at one time These are the normal steps in specimen transport in an Autoloader e Place
118. ysis Dennis B Dorsey MD proposed in 1963 that the relatively constant blood cell indices could be used to follow the performance of hematology instrumentation Brian Bull MD improved the technique and named it Analysis Xg Analysis uses a weighted moving average of patient sample results because Koepke said that QC materials ideally should be similar in structure and in reactivity to the patient constituent being measured and therefore freshly drawn patient blood samples seem to be the most appropriate QC material 3 gt Bull explains The analyser sic is considered to be in control when the and MCHC determined on a batch of 20 patients by use of the algorithm are within 3 of the expected mean indices of the population 36 1 5 1 USE AND FUNCTION SYSTEM COMPONENTS 1 4 1 6 SYSTEM COMPONENTS Main Unit The Main Unit includes Asample handler e A Diluter for Thecomplete blood count CBC gt Leukocyte differential analysis DIFF or Reticulocyte analysis An Analyzer Systems Control Module Electronic Power Supply and Pneumatic Power Supply Sample Handler All HmX Hematology Analyzer instruments have 14 gt An automated cassette based transport for Primary mode HmX Hematology Analyzer with Autoloader OR e An automated closed vial Primary mode of a rotary cap piercer HmX Hematology Analyzer open vial Secondary mode that uses a self

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