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PN 4237523A

xiii

CONTENTS

TABLES

1.1

CLIA Complexity Table, 1-3

4.1

Precision Specifications, 4-4

4.2

Precision, WBC Differential Parameters, 4-5

4.3

CBC Accuracy Limits, 4-5

4.4

Linearity Limits, 4-6

4.5

Mode-to-Mode Matching, 4-6

4.6

Background Counts for CBC Analysis, 4-6

4.7

Reportable Range, 4-8

4.8

Imprecision Analysis by Replication WHOLE BLOOD - HmX Hematology Analyzer, 4-9

4.9

Imprecision Analysis by Paired Sample - HmX Hematology Analyzer, 4-9

4.10

Imprecision Analysis (Diff Parameters) by Paired Sample - HmX Hematology Analyzer, 4-10

4.11

Imprecision Analysis (Diff Parameters) by Replication - HmX Hematology Analyzer, 4-10

4.12

Reference Range (Diff Parameters) for 160 Subjects - HmX Hematology Analyzer, 4-10

4.13

Accuracy Analysis by Compared Specimens - HmX Hematology Analyzer, 4-11

4.14

Accuracy Analysis (Diff Parameters) by Compared Specimens - HmX Hematology

Analyzer, 4-11

4.15

Flagging Criteria - H2O Method, 4-12

4.16

Morphologic Abnormalities - HmX Hematology Analyzer, 4-12

4.17

Clinical Sensitivity for Morphologic Abnormals - HmX Hematology Analyzer, 4-12

4.18

Imprecision Analysis by Replication: WHOLE BLOOD - HmX Hematology Analyzer with

Autoloader, 4-13

4.19

Imprecision Analysis by Paired Sample - HmX Hematology Analyzer with Autoloader, 4-13

4.20

Imprecision Analysis (Diff Parameters) by Paired Sample - HmX Hematology Analyzer with

Autoloader, 4-14

4.21

Accuracy Analysis by Compared Specimens - HmX Hematology Analyzer with

Autoloader, 4-14

4.22

Imprecision Analysis by Replication, 4-15

4.23

Imprecision Analysis by Paired Samples, 4-15

4.24

Accuracy Analysis by Compared Specimens, 4-15

4.25

Reference Intervals, 4-16

7.1

Code 128 Characters, 7-1

7.2

Code-Related Specifications, 7-4

7.3

Bar-Code Reader Settings and Defaults , 7-4

Содержание HmX Hematology Analyzer

Страница 1: ...mpany Miami Florida 33196 2500 USA COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Reference AV OID EX PO SU RE LA SE R RAD IA TI ON EM IT TE D FR OM TH IS AP ER TU RE BECKMAN COULTER HmX COULTER HmX BECKMAN COULTER HmX COULTER HmX ...

Страница 2: ...l national health and safety standards such as the use of barrier protection This may include but it is not limited to protective eyewear gloves and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer WARNING Risk of operator injury if all covers are not secured in place prior to instrument operation or you attempt to replace a part without care...

Страница 3: ...ument 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 REVISION STATUS Initial Issue A 7 99 Software version 1 0 ...

Страница 4: ...PN 4237523A iv REVISION STATUS ...

Страница 5: ... USE 1 1 General 1 1 Parameters 1 2 CLIA Complexity Categories 1 3 1 2 QUALITY CONTROL QC 1 3 1 3 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 1 4 SYSTEM COMPONENTS 1 6 Main Unit 1 6 Sample Handler 1 6 Diluter 1 6 Analyzer Systems Control Mod...

Страница 6: ...e 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 2 3 INTERUNIT CONNECTIONS 2 3 Reagent and Waste Connections 2 3 Power and Signal Cables 2 5 3 OPERATION PRINCIPLES 3 1 3 1 GENERAL PRINCIPLES 3 1 CBC Analysis 3 1 Differential Analysis 3 1 Effect of Reagents 3 2 Retic Analysis 3 2 3 2 SPECIMEN TRANSPOR...

Страница 7: ...rameters 3 14 Derived and Computed Parameters 3 14 3 6 Hgb 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 Plate...

Страница 8: ...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 2 SOFTWARE SPECIFICATONS 4 4 Date Format 4 4 4 3 CBC AND DIFFERENTIAL PERFORMANCE SPECIFICATIONS 4 4 Precision 4 4 Accuracy 4 5 CBC...

Страница 9: ...rential 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 MCV 4 16 RDW 4 16 Plt 4 17 MPV 4 17 Hct 4 17 MCH 4 17 MCHC 4 17 Diff Paramet...

Страница 10: ... BAR CODE DECODER 7 5 Normal Operation 7 5 HmX Hematology Analyzer 7 5 HmX Hematology Analyzer with Autoloader 7 5 A SAMPLE TUBE SIZES A 1 A 1 BECKMAN COULTER A 1 A 2 BECTON DICKINSON A 1 Worldwide A 1 U S A A 1 Europe A 2 U K and Australia A 2 Japan A 2 A 3 GREINER A 2 Vacuette Brand A 2 A 4 JOHNS A 3 A 5 LABCO A 3 Exetainer Brand A 3 A 6 LABO EXPRESS SERVICE L E S A 3 A 7 LDM A 3 A 8 L I P A 3 A...

Страница 11: ...PN 4237523A xi CONTENTS B DIFF COMPARISON B 1 B 1 INTRODUCTION B 1 B 2 PROCEDURE B 1 B 3 LOG SHEETS B 5 LIMITED WARRANTY REFERENCES REFERENCES 1 GLOSSARY GLOSSARY 1 INDEX 9 TRADEMARKS ...

Страница 12: ... 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 on the TTM 5 3 5 3 Laser Safety Labels for Bar Code Reader o...

Страница 13: ...tology Analyzer 4 11 4 14 Accuracy Analysis Diff Parameters by Compared Specimens HmX Hematology Analyzer 4 11 4 15 Flagging Criteria H2O Method 4 12 4 16 Morphologic Abnormalities HmX Hematology Analyzer 4 12 4 17 Clinical Sensitivity for Morphologic Abnormals HmX Hematology Analyzer 4 12 4 18 Imprecision Analysis by Replication WHOLE BLOOD HmX Hematology Analyzer with Autoloader 4 13 4 19 Imprec...

Страница 14: ...PN 4237523A xiv CONTENTS ...

Страница 15: ... 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 You...

Страница 16: ...e references by number as used throughout this manual s Glossary Contains the definitions for words and terms used in the set of manuals s Index Contains terms and where you can easily locate information about them in this manual CONVENTIONS This manual uses the following conventions r ITALICS indicate screen messages such as RESET THE SYSTEM or Press any key r Bold indicates t a menu item such as...

Страница 17: ...g 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 v...

Страница 18: ...PN 4237523A xviii INTRODUCTION COMPUTER PROGRAM STATEMENT ...

Страница 19: ...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 Graphic Printer Computer LCD Display MIC TREEBLE BASS ON OFF VOLUME M...

Страница 20: ...hite Blood Cell leukocyte Count NE Neutrophil percent NE Neutrophil number LY Lymphocyte percent LY Lymphocyte number MO Monocyte percent MO Monocyte number EO Eosinophil percent EO Eosinophil number BA Basophil percent BA Basophil number RBC Red Blood Cell erythrocyte count Hgb Hemoglobin concentration Hct Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscula...

Страница 21: ...y 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 labo...

Страница 22: ...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 11 Bull et al described the use of a COULTER COUNTER analyzer for counting thrombocytes 12 This method useful as it ...

Страница 23: ...g use of light scatter for cell analysis 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 27 Reticulocyte Retic Analysis Reticulocytes are immature nonnucleated erythrocytes retaining a small network of basophilic organelles comprised of RNA and protoporphyrin The enumeration of reticulocytes provides a simp...

Страница 24: ...l 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 vacu...

Страница 25: ...valents All stated performance characteristics in this manual refer to the HmX Hematology Analyzer and HmX Hematology Analyzer with Autoloader using these reagents Diluent ISOTON III or ISOTON 4 Japan only diluent is an isotonic electrolyte that r Dilutes the whole blood samples r Stabilizes cell membranes for accurate counting and sizing r Conducts aperture current r Carries and focuses the sampl...

Страница 26: ...tes the blood samples r Rapidly lyses erythrocytes RBCs r 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 i...

Страница 27: ...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 1 8 MATERIAL SAF...

Страница 28: ...PN 4237523A 1 10 USE AND FUNCTION MATERIAL SAFETY DATA SHEETS MSDS ...

Страница 29: ... system Consider the following special requirements Space and Accessibility In addition to the space required for the individual components and their interconnection consider r Comfortable working height r Access to the rear of the system for maintenance and service Allow t 30 cm 12 in behind t 30 cm 12 in on the sides Electrical Input This system requires r An independent protected circuit r A gr...

Страница 30: ...f electrical interference can occur and cause instrument performance problems frequent lock ups and resets or r 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 CAUTION Possible damage can occur if you use a power strip...

Страница 31: ...k 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 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...

Страница 32: ...ECTIONS Figure 2 1 Reagent and Waste Container Tubing Connections Lytic reagent Pak lyse Pak preserve Waste Diluent Cleaner From lytic reagent From Pak lyse From Pak preserve From diluent From cleaner To waste W COULTER CLENZ Isoton III HmX Pak ...

Страница 33: ...resentative 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 Power cord LPT1 J1 LCD Display Graphic Printer CAUTION Computer Keyboard Digital Commu...

Страница 34: ...PN 4237523A 2 6 INSTALLATION INTERUNIT CONNECTIONS ...

Страница 35: ...cuum 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 37 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 ...

Страница 36: ... Method is a two 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 ...

Страница 37: ...n specimen transport in an Autoloader r Place the cassettes in the loading bay see Figure 3 3 Figure 3 3 Loading a Cassette r At the DMS instruct the instrument to run samples in the Primary mode r The right lift platform beneath the stacked cassettes rises and the bottom cassette is deposited on the rocker bed r The platform lowers the cassette to the level of the rocker bed where it is rocked ba...

Страница 38: ...ssette has reached the fourth pierce position the second cassette is lowered and placed on the rocker bed 3 3 SPECIMEN TRANSPORT HmX HEMATOLOGY ANALYZER r At the DMS instruct the instrument to run a sample in the Primary mode r Check that the Ready light is green to indicate the system is ready to process a sample r Manually mix the sample r Read the bar code label on the sample tube t Hold the sa...

Страница 39: ...el r Sample analysis occurs r The Ready light is green to indicate another sample can be processed 3 4 SAMPLE FLOW Normal Sample Flow 1 The appropriate aspiration pump pulls the sample into the BSV Figure 3 5 r 125 µL in the open vial mode r 185 µL in the closed vial mode Figure 3 5 BSV ASPIRATION 28 µL diff loop 28 µL WBC loop 1 6 µL RBC ...

Страница 40: ... r 28 µL for the WBC bath dilution r 28 µL for the WBC diff 4 The air pump transfers the diff portion to the sample line 5 Dispensers send diluent to the BSV to pick up and dilute the RBC and WBC portions 6 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 ba...

Страница 41: ... PRINCIPLES SAMPLE FLOW 3 Figure 3 7 Sample Flow Mixing bubble entry Air pump for diff transfer to sample line CBC lytic reagent pumps BSV CBC delivery Diluent in Diluent in To WBC bath To RBC bath Diluent from large dispensers ...

Страница 42: ... the leukocyte subpopulations See Figure 3 8 Figure 3 8 Erythrolyse II PAK LYSE and StabiLyse PAK PRESERVE Reagent Pumps 9 The vacuum isolators supply vacuum to the 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 Figu...

Страница 43: ...te chambers drain Retic Sample Flow 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 Sample pressure Sheath tank Vented waste Sheath fluid sample Flow cell Prepared CAUTION Using undiluted whol...

Страница 44: ...e 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 res...

Страница 45: ... 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 Plt Count an...

Страница 46: ...ween 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 graph...

Страница 47: ...hil populations gated out Basophil D lymphocyte b and monocyte c cell populations are easier to see with this display S 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 b and the reticulocyte population c DF 6 Figure 3 1...

Страница 48: ...t MCH and MCHC 3 6 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 ...

Страница 49: ...s is the average volume of individual erythrocytes derived from the RBC histogram The system r Multiplies the number of RBCs in each channel by the size of the RBCs in that channel r Adds the products of each channel between 36 fL and 360 fL r Divides that sum by the total number of RBCs between 36 fL and 360 fL r Multiplies by a calibration constant and expresses MCV in femtoliters Hematocrit Hct...

Страница 50: ...pressed as 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 MCHC g dL Hgb Hct 100 Pl...

Страница 51: ...Cs This parameter is directly measured and reported as a percentage of RBCs Reticulocyte Absolute Number RET This is the absolute number of reticulocytes It is calculated from the reticulocyte percent RET 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 On the HmX Hematology Analyzer you can enter the red ce...

Страница 52: ...PN 4237523A 3 18 OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION ...

Страница 53: ...zer Maximum 84 84 cm 33 40 in Minimum 80 2 cm 32 75 in 61 5 cm 25 10 in 61 7 cm 25 20 in 94 5 k 210 lb Computer 41 2 cm 16 2 in 17 8 cm 7 0 in 41 9 cm 16 5 in 9 7 k 21 5 lb LCD Display 41 9 cm 16 5 in 40 4 cm 15 9 in 19 6 cm 7 7 in 7 34 k 16 3 lb Keyboard 3 6 cm 1 4 in 40 4 cm 15 9 in 18 0 cm 7 1 in 2 8 k 6 2 lb Graphic Printer optional 13 2 cm 5 2 in 43 2 cm 17 0 in 33 0 cm 13 0 in 7 4 k 16 5 lb ...

Страница 54: ...mples COULTER CLENZ cleaning agent for both modes Reagent Usage Recommended Commercial Controls These controls are all available from Beckman Coulter Inc r 5C cell control for CBC and differential parameters r LATRON control for volume conductivity and light scatter parameters used with LATRON primer r Retic C cell control for Reticulocyte Retic parameter r LIN C control for reportable range of th...

Страница 55: ... samples t 50 µL of whole blood is mixed with 100 µL of diluent r For Retics 50 µL 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 r Tubes and tube devices that fall within these ranges Diameter 10 16 mm Length 47 77 mm Capacity 2 7 mL r Beckman Coulter control and calibration tubes r All tubes are li...

Страница 56: ...is in the range of 2000 to 2089 r 90 to 99 the system assumes the year is in the range of 1990 to 1999 4 3 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 Precision of the WBC differential parameters is specified at 95 confidence limits See Table 4 2 Aper...

Страница 57: ... 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 MPV are tested using appropriate techniques Linearity limits apply only to ...

Страница 58: ...exceed the following limits in Table 4 5 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 100 total counts collected from all regions of the scatterplot For CBC parameters background count s...

Страница 59: ... elevated reticulocyte specimens Retic 4 are as follows Paired imprecision limits over the clinical range for a minimum of 50 specimens with the following characteristics are r Greater than 50 abnormally elevated Retic values Retic 4 r No greater than 5 of 50 specimens have Retic values 20 Both requirements must be met Accuracy Reticulocyte parameter accuracy is the sum of the variables of lineari...

Страница 60: ...t 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 He...

Страница 61: ...method H15 A MCV 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 Table 4 8 Imprecision Analysis by Replication WHOLE BLOOD HmX Hematology Analyzer Parameter Units Mean SD CV WBC x 109 cells L 5 15 0 10 1 94 RBC x 1012 cells L 4 55 0 06 1 32 Hgb g dL 13 07 0 12 0 92 MCV f...

Страница 62: ...es accuracy The dispersion of differences SD expresses the inclusive errors of imprecision and bias 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 Imprecision Analysis Diff Parameters by Replication HmX ...

Страница 63: ...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 Table 4 13 Accuracy Analysis by Compared Specimens HmX Hematology Analyzer Parameter Units Clinical Range Mean Diff...

Страница 64: ...yelo Promyelo 0 1 2 0 Nucleated red cell 0 02 2 0 Lymphs variant forms 0 7 N A Bands left shift 0 9 6 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 Table 4 17 Cl...

Страница 65: ...oloader 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 Table 4 18 Imprecision Analysis by Replication WHOLE BLOOD HmX Hematology Analyzer with Autoloader Parameter Units Mean SD CV WBC x 109 cells L 10 44 0 11 1 05 RBC x 1012 cells L 4 ...

Страница 66: ... Autoloader Secondary Aspiration Mode See Table 4 21 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 Table 4 21 Accuracy Analysis by Compared Specimens HmX Hematology Analyzer with Autoloader Paramet...

Страница 67: ...cy is defined as the degree of agreement between the reference method NCCLS H16 P 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 COULTER HmX Hematology Analyzer analysis based on 145 clinical specimens Table 4 22 Imprecision Analysis by Replication Statistic Level I Level I...

Страница 68: ...ecimens containing fibrin cell fragments or other debris such as pediatric and oncology specimens 41 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 45 46 Hgb Very high WBC count severe lipemia heparin certain unusual RBC abnormal...

Страница 69: ...2 63 Hct 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 64 Reticulocytes Er...

Страница 70: ...PN 4237523A 4 18 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES ...

Страница 71: ...e 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...

Страница 72: ...RNING 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 Right side view 041993 ...

Страница 73: ...CLASS IIIa LASER PRODUCT CDRH 633 nm 4 mW LASER RADIATION AVOID EXPOSURE TO BEAM CLASS 3B LASER PRODUCT IEC CLASS IIIa LASER PRODUCT CDRH 633 nm 4 mW LASER RADIATION WHEN OPEN AND INTERLOCK DEFEATED 1096 Mellon Avenue Manteca CA 95337 MODEL MANUFACTURED SERIAL NO THIS LASER DOES NOT COMPLY WITH 21 CFR 1040 USE ONLY AS A COMPONENT SEE INSTALLATION INSTRUCTIONS MADE IN USA PATENT NOS 4352 185 4631 7...

Страница 74: ...DO NOT STARE INTO BEAM 670 nm DIODE LASER 1 0 MILLIWATT MAXIMUM CLASS II LASER PRODUCT CAUTION LASER LIGHT DO NOT STARE INTO BEAM 670 nm DIODE LASER 1 0 MILLIW ATT MAXIMUM CLASS II LASER PRODUCT CAUT ION LASER LIGHT DO NOT STARE INTO BEAM 670 nm DIODE LASER 1 0 MILLIWATT MAXIMUM CLASS II LASER PRODUCT CAUTION LAS ER LIG HT DO NO T STA RE INT O BE AM 670 nm DIO DE LAS ER 1 0 MIL LIW ATT MA XIM UM C...

Страница 75: ...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 Ê Ticket at the Run Samples screen Figure 6 1 Ticket Format Mode Cycle Reporting units Operator can choose from US1 US2 Retics SI1 SI2 SI3 SI4 SI5 Retics SI6 Retics SI7 Retics Japan Limits are s...

Страница 76: ...ally request a Graphic format printout press Ì 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 Cycle Reporting units Operator can choose from US1 US2 Retics SI1 SI2 SI3 SI4 SI5 Retics SI6 Retics SI7 Retics Ja...

Страница 77: ...PN 4237523A 6 3 REPORTING OPTIONS GRAPHIC FORMAT 6 Figure 6 3 Graphic Narrow Small Page Format ...

Страница 78: ...PN 4237523A 6 4 REPORTING OPTIONS GRAPHIC FORMAT ...

Страница 79: ...y 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 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...

Страница 80: ...8 54 V V 54 90 SUB z 90 19 3 3 19 55 W W 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 Z Z 58 94 RS 94 23 7 7 23 59 59 95 US DEL 95 24 8 8 24 60 60 96 FNC 3 FNC 3 96 25 9 9 25 61 61 97 FNC 2 FNC 2 97 26 26 62 62 98 SHIFT SHIFT 98 27 27 63 _ _ 63 99 CODE C CODE C 99 28 28 64 NUL 64 100 CODE B FNC 4 CODE B 29 29 65 SOH a 65 101 FNC 4 CODE A CODE A 30 30 66 STX b...

Страница 81: ... 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 Leading edge of label 0 055 0 005 0 100 0 030 0 062 630 370 Label length 10X min All subsequent bar lines parallel to first bar line within 0 001 ...

Страница 82: ...f 5 Codabar NW7 Code 39 Code 128 NE width 0 010 0 020 0 010 Scaling Factor 1 538 0 010 0 020 0 010 0 020 WE NE ratio 2 2 to 3 1 N A 2 21 to 3 1 N A Intercharacter gap No 0 010 Min NE N A Data digits 2 to 16 3 to 16 3 to 16 3 to 8 with HEMOGARD tubes 3 to 16 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 Dis...

Страница 83: ...ation from the scanner r Beeps r Turns the scanner OFF r Transmits the decoded data or no read message to the sample handler The sample handler r Flashes the green light to signal you to place the sample tube in the entry slot The decoder r Turns the scanner ON for a maximum of 1 5 seconds r Decodes information from the scanner r Turns the scanner OFF r Transmits the decoded data or no read messag...

Страница 84: ...PN 4237523A 7 6 BAR CODE SPECIFICATIONS BAR CODE DECODER ...

Страница 85: ...K3EDTA unless otherwise noted VACUTAINER tubes with HEMOGARD closure All tubes are 13 x 75 mm U S A Also available in South America BD No Volume Draw o d x L mm 6405 6564 2 5 mL 13 x 75 6385 3 mL 10 25 x 64 6458 3 5 mL 16 x 75 6545 4 mL 16 x 75 6452 Europe 4 5 mL 13 x 75 6452 U S A 5 mL 13 x 75 BD No Volume Draw Content 367650 3 0 mL K3EDTA 367651 2 0 mL K3EDTA 367653 5 0 mL K3EDTA 367658 5 0 mL K...

Страница 86: ... 0 mL K3EDTA 367664 5 0 mL Na2EDTA 368241 2 0 mL K2EDTA 368242 3 0 mL K2EDTA BD No Volume Draw Content 368247 2 0 mL K2EDTA 368248 3 0 mL K2EDTA BD No Volume Draw Content 367648 2 0 mL K2EDTA 367649 2 0 mL K2EDTA 367660 2 0 mL K3EDTA 368253 2 0 mL K2EDTA Greiner No Volume Draw o d x L mm 454087 2 0 mL 13 x 75 454086 3 0 mL 13 x 75 457045 3 0 mL 16 x 75 454036 4 0 mL 13 x 75 457046 4 0 mL 16 x 65 4...

Страница 87: ... 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 A 8 L I P All lengths include cap A 9 SARSTEDT Monovette brand plastic cap pierceable tube with red stop Labco No Volume Draw o d x L mm EXPDL KE 1 1 0 mL 12 5 x 54 EXBG1 KE 3e19 3 0 mL 12 x 78 367860 4 0 mL Glass Vials GSPD KE 1 1 0 mL 12 5 x 44 GSPD KE 2 2 0 mL 12 5 x 4...

Страница 88: ...pers S No Volume Draw o d x L mm 8881 311149 2 mL 10 25 x 50 8881 311248 3 mL 10 25 x 64 8881 314440 3 mL 13 x 75 8881 311446 5 mL 13 x 75 8881 311644 7 mL 16 x 75 T No Volume Draw o d x L mm Y 573DK Japan 3 mL 16 x 75 T 272SQS 2 mL 10 25 x 50 T 273SQS 3 mL 10 25 x 65 T 274SQS 4 mL 10 25 x 85 T 206SQS 5 mL 13 x 75 T 202SQS 7 mL 16 x 75 ...

Страница 89: ... sheets used in the procedure B 2 PROCEDURE 1 Collect two different normal blood samples Follow NCCLS H3 A2 procedures The samples must be r Collected in K3EDTA with 1 5 mg mL of anticoagulant to blood r Maintained at room temperature r Within the reference range of NE 40 to 72 LY 17 to 45 MO 4 to 12 EO 0 to 10 BA 0 to1 r Analyzed between 30 minutes and 5 hours after draw 2 Label the samples Draw ...

Страница 90: ...ides to Techs A and B r 1 slide of sample 1 to Tech A r The other slide of sample 1 to Tech B r 1 slide of sample 2 to Tech A r The other slide of sample 2 to Tech B 1 2 Daily QC Worksheet For Manual Differential Check Date ______________ Specimen 1 Cycle NE LY MO EO BA 1 2 Total Σ Tech NE LY MO EO BA 1 2 Total Σ Σ 2 HmX 1 Specimen 2 Cycle NE LY MO EO BA 1 2 Total Σ Σ 2 HmX 1 5 17 99 57 8 33 1 6 5...

Страница 91: ... LY MO EO BA 1 2 Total Σ Tech NE LY MO EO BA 1 2 Total Σ Graph Point COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Serial No ___________________ Σ 2 HmX 1 Σ 2 Ref 1 Σ 2 HmX 2 Σ 2 Ref 2 GraphPoint HmX 1 Ref 1 HmX 2 Ref 2 2 5 17 99 57 8 33 1 6 5 2 0 6 57 2 32 9 6 3 2 8 8 115 0 66 0 12 8 4 8 1 4 57 5 33 0 6 4 2 4 7 55 32 7 3 1 56 33 6 3 0 111 65 13 6 1 55 5 32 5 6 5 ...

Страница 92: ...eet Fo Date ______________ Specimen 1 Cycle NE LY 1 2 Total Σ Tech NE LY 1 2 Total Σ Specimen 2 Cycle NE LY 1 2 Total Σ Tech NE LY 1 2 Total Σ Graph Point COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloade Serial No ___________________ Σ 2 HmX 1 Σ 2 Ref 1 Σ 2 HmX 2 Σ 2 Ref 2 GraphPoint HmX 1 Ref 1 HmX 2 Ref 2 2 5 17 99 33 1 32 9 66 0 33 0 32 33 65 32 5 30 7 30 5 61 2 30...

Страница 93: ...4 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Σ 0 2 SD NE 2 SD LY 2 SD MO 2 SD EO Status W Within 2 SDs H More than 2 SDs ABOVE the mean L More than 2 SDs BELOW the mean 2 SD BA COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Serial No _________________ SD Σ Each graph point The mean for that column 2 The number of graph points 1 May 1999 6 52 6 46 2 52 1 90 ...

Страница 94: ...E LY MO EO BA 1 2 Total Σ Tech NE LY MO EO BA 1 2 Total Σ Specimen 2 Cycle NE LY MO EO BA 1 2 Total Σ Tech NE LY MO EO BA 1 2 Total Σ Graph Point COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Serial No ___________________ Σ 2 HmX 1 Σ 2 Ref 1 Σ 2 HmX 2 Σ 2 Ref 2 GraphPoint HmX 1 Ref 1 HmX 2 Ref 2 2 ...

Страница 95: ...oint Status Graph Point Status Graph Point Status 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 Σ 2 SD NE 2 SD LY 2 SD MO 2 SD EO Status W Within 2 SDs H More than 2 SDs ABOVE the mean L More than 2 SDs BELOW the mean 2 SD BA COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Serial No _________________ SD Σ Each graph point The me...

Страница 96: ... 5 6 7 4 4 3 2 1 0 1 2 3 4 3 2 1 0 1 2 3 4 LY MO NE EO BA Monthly QC Graph Month Year _____________________ COULTER HmX Hematology Analyzer COULTER HmX Hematology Analyzer with Autoloader Serial No _________________ 2 SD 1 SD 1 SD 1 SD 1 SD 1 SD 1 SD 2 SD 2 SD 2 SD 2 SD 2 SD 1 SD 1 SD 1 SD 1 SD 2 SD 2 SD 2 SD 2 SD ...

Страница 97: ...ot 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 shall 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...

Страница 98: ......

Страница 99: ...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 t...

Страница 100: ...ic separation of biological cells by volume Science 1965 150 910 911 27 Loken MR Sweet RG and Herzenberg LA Cell discrimination by multiangle light scattering J Histochem Cytochem 1976 24 1 284 291 28 Miale JB Laboratory Medicine Hematology CV Mosby Company St Louis MO 4th ed 1972 22 29 Corash L Rheinschmidt M Lieu S Meers P and Brew E Fluorescence activated flow cytometry in the haematology clini...

Страница 101: ...d instruments Lab Med 1982 13 300 304 44 Kjeldsberg CR and Hershgold EJ Spurious thrombocytopenia JAMA 1974 227 628 630 45 Brittin GM Brecher G Johnson CA and Stuart J Spurious macrocytosis of antibody coated red cells Am J Clin Path 1969 52 237 241 46 Hattersley PG Gerard PW Caggiano V and Hash DR Erroneous values on the COULTER COUNTER Model S due to high titer cold autoagglutinins Am J Clin Pat...

Страница 102: ...0 304 59 Kjeldsberg CR and Hershgold EJ Spurious thrombocytopenia JAMA 1974 227 628 630 60 Richardson Jones A Mean platelet volume clinical utility and the variables of measurement 1986 Coulter Electronics Inc Hialeah Florida 61 Corash L Platelet Sizing Techniques biological significance and clinical applications Current topics in hematology New York New York Alan R Lise Inc 1983 62 Threate GA And...

Страница 103: ...based on a statistical averaging technique and is a type of weighted moving average It is used to estimate what 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 ...

Страница 104: ...d Current Batch The 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 c...

Страница 105: ...tor FAC 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 c...

Страница 106: ...r 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 lb 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 cel...

Страница 107: ...at fall outside the expected 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 Analysis used to give fairly consistent av...

Страница 108: ...tion 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 RBC 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 se...

Страница 109: ...a 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 MCV MCH 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 ri...

Страница 110: ...PN 4237523A 8 GLOSSARY GLOSSARY ...

Страница 111: ...erture size 4 4 ASCII definition GLOSSARY 1 aspiration how it occurs 3 5 assay values definition GLOSSARY 1 ASTM definition GLOSSARY 1 average value definition GLOSSARY 1 B BA derivation 3 17 formula 3 17 listing 1 2 BA 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 ...

Страница 112: ...ULTER 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 code related spe...

Страница 113: ...nition GLOSSARY 2 definitions GLOSSARY 1 definitive flags definition GLOSSARY 2 delivery inspection 2 1 DELTA DIFF definition GLOSSARY 2 derivation of parameters 3 14 DF displays definition GLOSSARY 2 DF1 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...

Страница 114: ...mental requirements 2 1 EO 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 a...

Страница 115: ...idity 2 2 4 2 Hz definition GLOSSARY 4 I 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...

Страница 116: ...sis 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 workshe...

Страница 117: ... 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 measurement aperture size 4 4 conditions 4 3 electronic stability 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 ...

Страница 118: ...ription 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...

Страница 119: ... 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 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 defini...

Страница 120: ...Pak Lyse Erythrolyse II 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 meanin...

Страница 121: ...ansport 3 3 3 4 sample tube sizes A 1 sample volume minimum required 4 3 sample prediluted minimum sample volume 4 3 S CAL calibrator kit description 1 9 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 GLOS...

Страница 122: ...aser 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 V V definition GLOSSARY 6 Vac definition GLOSSARY 6 vacuum specifications 4 2 VCS definition GLOSSARY 7 VCS technology 1 5 v...

Страница 123: ...hite cell count See WBC whole blood minimum sample volume 4 3 worksheets See log sheets X X definition GLOSSARY 7 XB analysis definition GLOSSARY 7 method history 1 5 QC technique 1 3 Y year format 4 4 Z zap definition GLOSSARY 7 ...

Страница 124: ...PN 4237523A 14 INDEX INDEX ...

Страница 125: ... 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 w...

Страница 126: ......

Страница 127: ...ademarks or registered trademarks of their respective holders TRADEMARKS 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 ...

Страница 128: ... Sizes Diff Comparison References Glossary Index s Operator s Guide PN 4237519 PN 4237521 Autoloader System Overview Startup and Controls Sample Analysis Data Review Shutdown Set Up References Index s Special Procedures and Troubleshooting PN 4237520 PN 4237522 Autoloader Calibration Reproducibility and Carryover Cleaning Procedures Adjust Replace Procedures Troubleshooting Index s Host Specificat...

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