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Beckman Coulter COULTER LH 750 System, Reference, Page: 7 / 120

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Beckman Coulter COULTER LH 750 System Reference Download Page 7

PN 4277248DD

vii

CONTENTS

3.4

COUNTING AND SIZING, 3-9
Red and White Blood Cell Counting, 3-9
Coincidence Correction, 3-10
Voting, 3-10
Pulse Editing, 3-10
Sweep Flow, 3-10
RBC Size Distribution, 3-11
Platelet Method, 3-11

3.5

MEASUREMENT OF HEMOGLOBIN CONCENTRATION, 3-12

3.6

DATAPLOT DEVELOPMENT, 3-13
Two-Dimensional (2D) DataPlots, 3-13
Three-Dimensional (3D) DataPlots, 3-13

3.7

PARAMETERS AND THEIR DERIVATION, 3-14
Summary of Parameter Derivations, 3-14

Measured Directly, 3-14
Derived From RBC or Plt Histogram, 3-14
Derived From WBC Histogram, 3-15
Calculated, 3-15

White Blood Cell (WBC) Count, 3-15
Red Blood Cell (RBC), 3-15
Hemoglobin (Hgb) Concentration, 3-15
Mean Corpuscular Volume (MCV), 3-16
Hematocrit (Hct), 3-16
Mean Corpuscular Hemoglobin (MCH), 3-16
Mean Corpuscular Hemoglobin Concentration (MCHC), 3-16
Red Cell Distribution Width (RDW), 3-16
Platelet (Plt) Count, 3-16
Mean Platelet Volume (MPV), 3-16
NRBC % (Nucleated Red Blood Cells), 3-16
NRBC # (Nucleated Red Blood Cells), 3-17
Differential (Diff), 3-17

Diff Percentages (DIFF%), 3-17
Diff Absolute Numbers (DIFF#), 3-17

Reticulocyte (Retic) Parameters, 3-18

Retic Percent (RET%), 3-18
Retic Absolute Number (RET#), 3-18
Immature reticulocyte fraction (IRF), 3-18
Mean reticulocyte volume (MRV), 3-18

3.8

XB ANALYSIS, 3-19

Adjusting Initial XB Target Values, 3-20

XM Analysis, 3-21
Extended QC, 3-21

Summary of Contents for COULTER LH 750 System

Page 1: ... SYSTEM RUN 04 30 96 12 30 18 STATUS READY ALERT MODE C D R BLOOD DETECT ON TEST MODE ASPIRATIONS TUBE 01 MAIN MENU VIII VII VI V IV III II I POWER ON POWER OFF START UP SHUT DOWN ALARM RESET READY PRIME APERT DRAIN RINSE CLEAR APERT CE 7 4 1 F 2 5 8 0 3 6 9 ID STOP PREMIX START CONT E N T E R NEC MultiSync LCD 1700m ...

Page 2: ...ooting To avoid injury r Keep doors covers and panels closed and secured in place while the instrument is in use r Take full advantage of the safety features of the instrument Do not defeat safety interlocks and sensors r Acknowledge and act upon instrument alarms and error messages r Keep away from moving parts r Report any broken parts to your Beckman Coulter Representative r Open remove and clo...

Page 3: ...System Reference Issue DA 08 09 Software version 2D1 Converted from Help Version 2D1 091732 Issue DB 11 10 Software Version 2D1 Updates were made to the company corporate address Issue DC 12 10 Software Version 2D1 Changes were made to r BAR CODES AND THE LH 700 Series r Checksum Algorithm r NW 7 r Code 128 USS 128 r BAR CODE LABEL SPECIFICATIONS r Acceptable Bar Codes r Codabar r NW7 Decoding Not...

Page 4: ... to the Hematology Tube List information Note Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page 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 to the Beckman Coulter website For labeling updates go to www ...

Page 5: ...ROL QC 1 3 1 4 METHOD HISTORY 1 3 Development 1 3 Corrected WBC Counts 1 4 Hemoglobinometry 1 4 Differential Measurement 1 4 Volume Analysis 1 4 Conductivity Analysis 1 5 Light Scatter Analysis 1 5 Reticulocyte Retic Analysis 1 5 NRBC Enumeration 1 6 COULTER IntelliKinetics Application 1 7 XB Analysis 1 7 XM Analysis 1 7 Extended QC 1 7 1 5 SYSTEM COMPONENTS 1 8 Power Supply 1 8 Diluter 1 8 Analyz...

Page 6: ...ning 2 3 Ventilation 2 3 Drainage 2 3 2 3 INTERUNIT CONNECTIONS 2 4 Power and Signal Cables 2 4 Changing 9 pin and 25 pin connectors 2 4 Pneumatic Hydraulic Tubing Connections 2 5 3 OPERATION PRINCIPLES 3 1 3 1 COULTER METHOD 3 1 CBC Analysis 3 1 Differential Analysis 3 1 Effect of Reagents 3 2 Reticulocyte Analysis 3 2 3 2 AUTOMATIC ASPIRATION MODE 3 2 Loading Specimens 3 2 Transporting Cassettes...

Page 7: ...ated 3 15 White Blood Cell WBC Count 3 15 Red Blood Cell RBC 3 15 Hemoglobin Hgb Concentration 3 15 Mean Corpuscular Volume MCV 3 16 Hematocrit Hct 3 16 Mean Corpuscular Hemoglobin MCH 3 16 Mean Corpuscular Hemoglobin Concentration MCHC 3 16 Red Cell Distribution Width RDW 3 16 Platelet Plt Count 3 16 Mean Platelet Volume MPV 3 16 NRBC Nucleated Red Blood Cells 3 16 NRBC Nucleated Red Blood Cells ...

Page 8: ...ERISTICS 4 5 Sample Stability 4 6 WBC Differential Flagging Stability 4 8 NRBC Paired Sample Imprecision 4 9 MCV Accuracy Characteristics 4 9 NRBC Accuracy Characteristics 4 10 Platelet Accuracy Characteristics 4 10 Reference Ranges 4 10 Temperature 4 11 Humidity 4 11 Storing Specimens 4 11 Venipuncture Specimens 4 11 Sample Type 4 12 Recommended Anticoagulant 4 12 Sampling Modes 4 12 Aspiration 4...

Page 9: ...4 16 Codabar 4 17 NW 7 4 17 Code 128 USS 128 4 17 Bar Code Tips 4 17 4 6 BAR CODE LABEL SPECIFICATIONS 4 18 General 4 18 Optical Characteristics at 880 nm 10 and 633 nm 10 4 18 Printing Method 4 18 Label Thickness 4 18 NE WE Ratio 4 18 Label Dimensions and Data 4 19 Acceptable Bar Codes 4 20 Extended Digit Bar Code 4 20 Checksum Algorithm 4 21 Interleaved 2 of 5 4 21 Codabar 4 22 NW7 Decoding 4 23...

Page 10: ...PN 4277248DD x CONTENTS REFERENCES REFERENCES 1 GLOSSARY GLOSSARY 1 INDEX INDEX 1 BECKMAN COULTER INC CUSTOMER END USER LICENSE AGREEMENT 1 TRADEMARKS 3 ...

Page 11: ...f instrument with DB 9 Pin Connector 2 5 2 5 Pneumatic Hydraulic Connections 2 6 3 1 Coulter Method of Counting and Sizing 3 1 3 2 Transport System 3 3 3 3 Triple Transducer Module with Protective Housing 3 7 3 4 Triple Transducer Module with Protective Housing Cut Away 3 8 3 5 Sweep Flow 3 11 4 1 Bar Code Label Specifications 4 19 5 1 Laser Warning Label Protective Housing Cut Away 5 2 5 2 Laser ...

Page 12: ...FF Sample Stability Room Temperature 4 7 4 12 DIFF Sample Stability Cold Temperature 4 7 4 15 NRBC Sample Stability Room Temperature 4 8 4 16 NRBC Sample Stability Cold Temperature 4 8 4 14 RETIC Sample Stability Cold Temperature 4 8 4 17 Differential Suspect Flagging at Room Temperature 4 9 4 18 Differential Suspect Flagging at Cold Temperature 4 9 4 19 NRBC Imprecision Characteristics Paired Sam...

Page 13: ...s available in hard copy by request Use the SlideMaker Operator s Guide for in depth information about what the SlideMaker does the methods it uses its specifications and information on installation safety and software as well as day to day operating and troubleshooting your SlideMaker This document is made up of procedures from the online Help system it is available in hard copy by request Use th...

Page 14: ...ow counting and sizing are accomplished and what the DataPlots show s Chapter 4 Specifications Characteristics Details the instrument and performance specifications the performance characteristics the interferring substances and the bar code label specifications s Chapter 5 Hazards Describes laser safety precautions and the location of the laser related labels s References s Glossary s Index hard ...

Page 15: ...The purpose of the LH 700 Series Figure 1 1 is to separate the normal patient with all normal system generated parameters from the patient who needs additional studies of any of these parameters These studies might include further measurements of cell size and platelet distribution manual WBC differential or any other definitive test that helps diagnose the patient s condition Figure 1 1 COULTER L...

Page 16: ...lobin MCHC Mean Corpuscular erythrocyte Hemoglobin Concentration RDW Red Cell erythrocyte volume Distribution Width Plt Platelet or thrombocyte count MPV Mean Platelet thrombocyte Volume LY Lymphocyte percent MO Monocyte percent NE Neutrophil percent EO Eosinophil percent BA Basophil percent LY Lymphocyte number MO Monocyte number NE Neutrophil number EO Eosinophil number BA Basophil number NRBC N...

Page 17: ...ctor of approximately 10 times This substantial 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 Hgb measurements 2 The COULTER COUNTER Model S analyzer was the first instrument that automated simultaneous multiparameter measurements on blood Brittin et al Got...

Page 18: ...c reagent used for the complete blood count CBC parameters prepares the blood so the system can count leukocytes and measure 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 h...

Page 19: ...culocyte resulting in a granular staining pattern easily seen with light microscopy 30 Reticulocyte immaturity is related to cell volume and light scatter Since more immature reticulocytes are larger contain more RNA and cause increased light scatter the cell volume and light scatter will increase with immaturity of the cell Figure 1 3 illustrates the IRF and MRV algorithms This figure is a repres...

Page 20: ...rated from VCS analysis of the cells Figure 1 4 NRBC signature position on Differential Dataplot Once particles have been identified in this region the LH 700 Series examines the far left region of the WBC histogram for the presence of particles Figure 1 5 NRBC location on WBC histogram If the VCS dataplot and the WBC histogram both indicate the presence of NRBCs then the combined information is f...

Page 21: ...The IntelliKinetics application working in concert with new algorithms provides the instrument with the best signals for analysis even when the laboratory environment varies throughout the day XB Analysis Dennis B Dorsey MD proposed in 1963 that the relatively constant blood cell indices could be used to follow the performance of hematology instrumentation 31 Brian Bull MD improved the technique a...

Page 22: ...zer LH Workstation The LH Workstation holds the data algorithms used to process the List Mode Data supplied by the Analyzer From the List Mode Data the Workstation computes Diff and Retic results develops the histograms and DataPlots and displays the results The Workstation stores the data and transmits it to the Printer and Host computer The LH Workstation is equipped with a mouse that allows ope...

Page 23: ... 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 Retic parameters Lin C linearity control identifies the reportable range of the instrument s CBC parameters Calibrator The S CAL calibrator kit is an acceptable alternative to the whole...

Page 24: ...gment the absorbance of which is directly proportional to the Hgb concentration over the clinical range LYSE S 4 Lytic reagent r Rapidly lyses erythrocytes RBCs freeing hemoglobin Hgb and reducing the size of cellular debris to a level that does not interfere with leukocyte WBC count r Causes a substantial conversion of the Hgb to a stable oxyhemoglobin based hemachromagen the absorbance of which ...

Page 25: ...aces of the instrument components Daily use prevents protein buildup and eliminates the need for routine aperture bleaching and blood sampling valve maintenance 1 9 MATERIAL SAFETY DATA SHEETS MSDS To obtain an MSDS for Beckman Coulter reagents used on the LH 700 SeriesLH 700 Series 1 On the internet go to www beckmancoulter com and select MSDS from the Customer Support dropdown menu 2 If you do n...

Page 26: ...PN 4277248DD 1 12 USE AND FUNCTION MATERIAL SAFETY DATA SHEETS MSDS ...

Page 27: ...al requirements Space and Accessibility In addition to the space required for the individual components consider r Comfortable working height r Access to perform service procedures Allow at least 46 cm 18 in for the rear doors plus sufficient room for work space Units can be moved to obtain additional work space Figure 2 1 Space for tower type computers CAUTION Possible system damage can occur if ...

Page 28: ...E CLEARANCE 25 cm 10 in 27 9 cm 11 in CLEARANCE 25 4 cm 10 in 38 cm 15 in LH 780 30 cm 13 in 76 2 cm 30 in 50 2 cm 19 75 in 25 4 cm 10 in 68 6 cm 27 in 44 5 cm 17 5 in 50 2 cm 19 75 in 45 7 cm 18 in 88 9 cm 35 in 30 cm 12 in CLEARANCE 61 cm 24 in 66 cm 26 in 38 1 cm 15 in 63 5 cm 25 in disc disc DVD RW NEC MultiSync LCD 1700m 45 2 cm 17 8 in 64 5 cm 25 4 in 64 8 cm 25 5 in CAUTION Introduction of ...

Page 29: ...ied with the system can be connected to either r An open drain suitable for biohazardous waste less than 76 cm 30 in above the floor r A waste container with a minimum capacity of 20 L 5 gal When using an open drain instead of a waste container r Mechanically secure the waste tube into the drain so the tube cannot accidentally come out of the drain This prevents spillage Be sure to dispose of wast...

Page 30: ...akes these connections when installing the instrument Figure 2 3 Rear of instrument and accessories with DB 25 pin for tower type computers Changing 9 pin and 25 pin connectors For LH 700 Series workstations the COM PORT can be configured to COM 1 or COM 6 The COM PORT depends on the workstation to be used Figure 2 4 Rear of instrument with DB 9 Pin Connector shows the connector location when usin...

Page 31: ... shows the updated tubing connections between the Diluter and the r Reagent containers r Waste container r Power Supply pressure and vacuum supplies CAUTION Possible reagent siphoning effect and priming problems can occur if a reagent container is placed above the level of the Analyzer Do not place reagent containers above the level of the Analyzer IMPORTANT Placing Reagent Paks in any location ot...

Page 32: ...ection 2 Retic clear connection 3 Retic stain connection 4 Pak preserve connection 5 Pak lyse connection 1 2 3 4 5 A WASTE LEVEL SENSOR DILUENT WASTE CBC LYSE RETIC CLEAR RETIC STAIN PACK PRESERVE PACK LYSE CLEANER VAC 30 PSI 5 PSI B Back of diluter LH Series RETIC PAK LH Series PAK Pak lyse Pak preserve CBC lyse Retic stain Retic clear 2 3 1 4 5 Power supply Diluent Waste 30 PSI 5 PSI VAC A B Cle...

Page 33: ...es one located on each side of the aperture This causes an electrical pulse that can be counted and sized While the number of pulses indicates particle count the size of the electrical pulse is proportional to the cell volume 35 36 37 38 Differential Analysis WBC differential analysis and classification occurs in the flow cell where r Low frequency current measures volume r High frequency current ...

Page 34: ...arkly stained reticulocytes Stained reticulocytes are differentiated from mature red cells and other cell populations by light scatter direct current measurements and opacity characteristics 3 2 AUTOMATIC ASPIRATION MODE The system automatically transports mixes aspirates and processes specimens Loading Specimens 1 The operator places specimen tubes which can be identified by bar code labels into ...

Page 35: ...g station If the bar code reader detects a discrepancy between the forward and return readings it makes an additional pass r If the bar code reader cannot read the cassette bar code label the Diluter stops posts a message on the Analyzer Diluter and Workstation displays backwashes the system then returns to the Ready state r If Cass Pos is the Positive Identifier and the bar code reader cannot rea...

Page 36: ... before sensing begins r At the beginning of the delivery any residual rinse in the Hgb cuvette drains into the waste chamber and the waste chamber drains r Diluent from the diluent dispensers drives the separated volumes of sample from the BSV to the baths r One volume of sample 1 6 µL is delivered with 10 mL of diluent to the RBC bath This dilution is used for RBC Plt counting and MCV Plt sizing...

Page 37: ...ring aspiration of the blood sample blood is pulled through two shear valves before it reaches the rear blood detector After aspiration of the blood sample the sliding plate of the retic segment value shear valve moves aligning the reagent input and output ports with the retic segment isolated in the stationary plate of the valve The stain pump dispenses retic stain through the retic segment valve...

Page 38: ...nk and sample The RBC and WBC raw data consists of counts wait time counts count time and channelyze time as well as histograms for each of the three apertures The PLT raw data consists of the histogram and channelyze time for each aperture The HGB raw data consists of two voltage measurements for the blank and two measurements for the sample The Analyzer then sends the raw data to the workstation...

Page 39: ...ut its protective housing to display the flow cell and label locations Figure 3 3 Triple Transducer Module with Protective Housing WARNING The laser beam can cause damage to your eyes and to the instrument Do not attempt to remove the laser from the Diluter module If removal is required it must be done only by a Beckman Coulter Representative VIII VII VI V IV III II I Located on back of unit CLASS...

Page 40: ...C diluent dispenser The WBC bath needs a larger rinse volume to r Remove RBC cell stroma after lysing r Remove remaining lytic reagent r Rinse above the 7 mL fill line r Rinse the hemoglobin cuvette 3 3 MANUAL ASPIRATION MODE TAMPER PROOF SCREWS ELECTROMAGNETIC SHIELD LASER ON LAMP FLOW CELL LASER 1096 Mellon Avenue Manteca CA 95337 MODEL MANUFACTURED SERIAL NO THIS LASER DOES NOT COMPLY WITH 21 C...

Page 41: ... During this delay the system conditions the electronics to perform the counting and sizing of the sample Regulated vacuum draws a precise volume of sample dilution through the apertures At each aperture the system gathers pulses for 4 seconds The RED WHITE PRE AMP cards amplify these pulses and the Analyzer screen displays them The system sends these pulses to the RED WHITE PROCESSOR card The RED...

Page 42: ...erture The computer derives the affected parameter by averaging the data from the two remaining apertures The data from at least two of the three apertures must be within an established statistical range of each other or the system totally votes out the parameter and histograms When a parameter totally votes out the system does not give any results for the affected parameter or for any parameters ...

Page 43: ...ugh the Communication Interface COMM INTFC card to the Workstation for display Platelet Method Pulses representing cells from 2 to 20 fL are classified as platelets The analyzer sorts the pulses into three 64 channel size distribution histograms Data collection occurs between a two second minimum up to 20 second maximum time in one second increments The data collection stops when at least 1500 cel...

Page 44: ...elet data plus data from the WBC and RBC histograms is further examined The PLT is R flagged when specific conditions indicate the confidence in the count is low These include the Research Use Suspect flags Low End Interference and High End Interference Additionally statistics and histograms are examined for the possible presence of Giant Platelets and Platelet Clumps It is possible to observe r A...

Page 45: ...guish the presence of even the faintest subpopulation The AccuGate algorithm can adapt to unusual population shifts and overlaps It can define highly irregular separation and signal the need for further analysis It can then make a subsequent analysis of the identified regions and correct deficiencies in separation In the DataPlots different colors represent different memberships types of cells Sha...

Page 46: ... in U S units of measurement Parameter units can be changed to other International System of Units SI through Setup on the LH Workstation Summary of Parameter Derivations Parameters are either r Measured directly r Derived from the RBC or Plt histogram r Calculated Measured Directly Derived From RBC or Plt Histogram Parameter Method RBC Coulter Principle WBC Coulter Principle Hgb Photometric Measu...

Page 47: ...obin Hgb Concentration The transmittance of light 525 nm wavelength through the lysed WBC solution in the hemoglobin cuvette is compared to the transmittance of the same light through a reagent blank The system converts this ratio to an Hgb value in g dL using a calibration factor Weight mass of hemoglobin determined from the degree of absorbance found through photocurrent transmittance is Paramet...

Page 48: ...ar Hemoglobin Concentration MCHC MCHC is the average weight of hemoglobin in a measured dilution computed by the formula MCHC g dL HGB HCT x 100 Red Cell Distribution Width RDW RDW is the size distribution spread of the erythrocyte population derived from the RBC histogram Expressed as coefficient of variation CV Platelet Plt Count Plt is the number of thrombocytes derived from the Plt histogram a...

Page 49: ...bsolute numbers of leukocytes in each category are computed from the WBC count and differential percentage parameters NE no of cells inside NE area no of cells inside NE LY MO EO BA 100 LY no of cells inside LY area no of cells inside NE LY MO EO BA 100 MO no of cells inside MO area no of cells inside NE LY MO EO BA 100 EO no of cells inside EO area no of cells inside NE LY MO EO BA 100 BA no of c...

Page 50: ...tio The IRF parameter is an indication of new reticulocyte synthesis It is calculated from the RET as the total number of reticulocyte events in the outermost light scattering region corresponding to immature reticulocytes relative to the total number of reticulocytes and is reported as this ratio The algorithm for calculating the IRF parameter is shown below Mean reticulocyte volume MRV The avera...

Page 51: ...ata by giving less weight to outliers and smoothes it by incorporating information from the previous patient batch in the analysis of the current batch As each sample is processed the mean of the previous set of samples is subtracted from each of the red cell indices The square root of this deviation difference between the means is stored After 20 samples have been processed the sum of the square ...

Page 52: ...s are greater than 1 5 or the mean values are greater than 3 different from the recommended target values there may be an instrument or population problem In this case repeat this procedure using the next 20 XB batches If the indices themselves are stable in a hospital population then any deviation from the Target Values and Action Limits may point to an instrument or reagent problem These problem...

Page 53: ...Quality Control Guidelines for the Medical laboratory known in Germany as Rili BÄK Rili BÄK Guidelines of the Federal Chamber of Physicians was first published in 1987 and amended in 1990 and 1993 covering clinical chemistry immunochemistry and other tests but not hematology In 2003 the guidelines were extended to include hematology Users can enable disable Extended QC Rules for 5C Cell control Ta...

Page 54: ...PN 4277248DD 3 22 OPERATION PRINCIPLES XB ANALYSIS ...

Page 55: ...r volume conductivity and light scatter technology Performance specifications stated apply only to an instrument that has been properly maintained as indicated in the COULTER LH 700 Series documentation using the recommended reagents If the average room temperature should change more than 5 5 C 10 F from the calibrating temperature verify calibration and recalibrate if necessary to ensure conforma...

Page 56: ...y was tested against a predicate hematology analyzer Table 4 2 lists the specifications for the mean difference and mean percent difference Table 4 1 Within Run Precision Parameter Approximate Level Limit WBC 9 to 11 x 103 cells µL 1 7 CV RBC 4 5 to 5 5 x 106 cells µL 0 8 CV Hgb 14 to 16 g dL 0 8 CV MCV 80 to 90 fL 0 8 CV RDW 12 to 14 2 2 CV Plt 280 to 320 x 103 cells µL 3 3 CV Plt 90 to 110 x 103...

Page 57: ...in Table 4 3 Accuracy Reticulocyte Accuracy was tested against a predicate hematology analyzer See Table 4 4 Linearity When tested using a stable material having no interfering substances the LH 700 Series value should be equal to the expected value within the limits given in Table 4 5 To minimize the effects of imprecision take multiple readings at each dilution point Subtract the background coun...

Page 58: ...ubsequent specimen as indicated by the specified limits listed above Operating and Reportable Ranges The operating ranges reflect the range of values over which the instrument displays prints and transmits results Values that are between the linear range and the operating range and values outside the reportable range are displayed printed and transmitted with an over linear range flag Values that ...

Page 59: ... Clinical and Laboratory Standards Institute CLSI 4 3 PERFORMANCE CHARACTERISTICS The information in this section describes typical performance for an instrument that has been properly maintained as indicated in the COULTER LH 700 Series documentation using the recommended reagents Table 4 6 Operating and Reportable Ranges Parameter Operating Range Reportable Range WBC 0 00 to 900 00 x 103 cells µ...

Page 60: ...3 65 86 8 13 87 249 2 8 76 8 8 76 4 485 13 69 87 9 14 17 247 7 8 68 16 8 94 4 468 13 65 88 5 14 38 256 0 8 78 24 8 81 4 462 13 61 89 5 14 59 261 0 8 96 Table 4 8 CBC Sample Stability Cold Temperature Hours WBC RBC Hgb MCV RDW PLT MPV 1 8 45 4 416 13 49 86 4 13 84 248 7 8 59 4 8 54 4 438 13 49 86 3 13 90 252 8 8 64 8 8 59 4 437 13 51 87 0 13 77 244 9 8 65 16 8 65 4 446 13 54 87 1 13 84 240 4 8 80 2...

Page 61: ... 0 49 0 10 0 02 24 5 71 2 48 0 51 0 09 0 02 Table 4 12 DIFF Sample Stability Cold Temperature Hours NE LY MO EO BA 1 5 45 2 32 0 54 0 11 0 02 4 5 50 2 40 0 50 0 11 0 03 8 5 59 2 43 0 44 0 11 0 03 16 5 72 2 45 0 36 0 10 0 02 24 5 81 2 35 0 42 0 11 0 02 36 5 94 2 20 0 43 0 09 0 01 48 5 77 2 16 0 46 0 06 0 02 Results analyzed Room Temperature Table 4 13 RETIC Sample Stability Room Temperature Hours R...

Page 62: ...d Temperature Hours RETIC RETIC MRV IRV 1 1 771 0 078 103 87 0 356 4 1 900 0 084 103 92 0 354 8 1 874 0 083 103 94 0 347 16 1 957 0 086 105 48 0 357 24 1 907 0 084 104 63 0 360 36 1 670 0 074 106 86 0 360 48 1 644 0 073 104 70 0 345 60 1 674 0 074 106 08 0 374 72 1 786 0 079 105 84 0 368 Results analyzed Room Temperature Table 4 15 NRBC Sample Stability Room Temperature Hours NRBC NRBC 1 0 00 0 00...

Page 63: ...mperature Sample 1 hour 4 hour 8 hour 16 hour 24 hour 1 Imm Ne 1 Imm Ne 1 Imm Ne 1 Imm Ne 1 Mo Blast Imm Ne 1 Imm Ne 2 2 Imm Ne 2 3 4 5 Indicates that there were no flags present Table 4 18 Differential Suspect Flagging at Cold Temperature Sample 4 hour 8 hour 16 hour 24 hour 36 hour 48 hour 1 Imm Ne 1 Imm Ne 1 Imm Ne 1 Imm Ne 1 Imm Ne 1 2 3 PLT Clumps 4 5 Indicates that there were no flags presen...

Page 64: ...ood specimens collected in a salt of EDTA Reference Ranges A Normal Range study was conducted to assess the Reference Ranges for the LH 700 Series Whole blood samples were collected from 131 donors males and females The selection of donors was consistent with guidelines stated in NCCLS C28 A Table 4 21 NRBC Accuracy Characteristics Compared Samples Parameter Units N Population Minimum Population M...

Page 65: ...thin 24 hours after collection if stored at 21 2 25 6 C 70 78 F r Stored between 2 and 8 C 35 6 and 46 4 F up to 24 hours after collection NOTE Also refer to any pertinent manufacturer s storage recommendations for the venipuncture and microcollection devices used in your lab RDW 13 30 12 09 15 19 Plt x 103 cells µL 248 65 169 06 397 10 MPV fL 9 31 7 54 11 24 NE 59 78 41 71 73 74 LY 28 67 18 39 44...

Page 66: ...throughput performance is described for samples with elevated parameter levels Approximate throughput performance data not including sample preparation is Sample Volume Aspirated Automatic cap piercing mode maximum 300 µL Manual open vial mode maximum 200 µL With optional LH SlideMaker 550 µL Waste 20 liter waste container CBC CBC DIFF CBC RETIC CBC DIFF RETIC RETIC LH 750 Sample hour CBC 110 CBC ...

Page 67: ...ter recommends that you follow NCCLS or equivalent procedures to ensure proper specimen collection storage and transport Always follow manufacturer s recommendations when using microcollection devices for capillary specimen collection All Misleading results can occur if specimens contain clots Always use good laboratory practices for inspecting specimens for clots and verifying results All Mislead...

Page 68: ... very large platelets auto agglutination Plt Giant platelets platelet clumps white cell fragments electronic noise very small red cells red cell fragments Hct Known interferences related to RBC and MCV MCH Known interferences related to Hgb and RBC MCHC Known interferences related to Hgb RBC and MCV NRBC Known interferences related to lyse resistant red cells platelet clumps giant platelets malari...

Page 69: ...iable length data Some should only be used as a fixed length to increase the security of data decoding Self Checking A self checking symbology has the ability to prevent character transposition due to a single printing defect Start Code Stop Code Start and Stop Codes are bar and space patterns that are placed at the beginning and end of the encoded data A start code indicates the beginning of the ...

Page 70: ...vices set to recognize labels of a specific length for example 12 digits Code 39 Also called 3 of 9 Code Code 39 was the first alphanumeric symbology developed It is a self checking discrete and variable length symbology The Health Industry Bar Code Council HIBCC has adopted the use of a check character for health care applications This is encouraged particularly where print quality is less than o...

Page 71: ... additional required dimensional tolerances You must use and print a checksum character and it must conform to the AIM USS 128 checksum generation procedure DO NOT use the following values as they are not recognized as valid values Bar Code Tips No bar code symbology is perfect You will occasionally get a read error Following are some tips to help you get the best performance from the symbology yo...

Page 72: ...diameter including the label is not greater than 13 3 mm r The label including adhesive 0 006 0 003 in NE WE Ratio Must remain constant over code length IMPORTANT 1 DO NOT use the following characters in Specimen or Patient identifiers There is a potential for Specimen or Patient misidentification to occur The system will substitute or omit these characters when the system in configured in a langu...

Page 73: ...ications Specification Called Out in Figure 4 1 Explanation 1 The first bar of the code B must be parallel to the label edge A within 0 002 2 All subsequent bar lines must be parallel to B within 0 001 3 The human readable code HRC does not include the checksum the dash in the HRC is not encoded in the bar code 4 The trailing quiet zone must be 0 250 minimum 5 The maximum label length is determine...

Page 74: ...ot tolerate any void or speck when using the 177 8 µm 0 007 in narrow element width r Print bar code patterns on labels to allow for a minimum of 10 times the narrow element width as the leading and trailing quiet zones If you are not using 16 digits on your label use a quiet zone of at least 6 35 mm 0 25 in on either side of the bar code label r Place the bar code label on the tube to ensure that...

Page 75: ...Inches Minimum µm Minimum Interleaved 2 of 5 with Checksum 3 to 15 0 010 254 0 2 21 to 3 1 11 Interleaved 2 of 5 without Checksum 4 to 16 0 010 254 0 2 21 to 3 1 10 NW7 with Checksum 3 to 11 0 010 254 0 3 1 8 12 to 16 0 007 177 8 3 1 Codabar with Checksum 3 to 11 0 010 254 0 3 1 8 12 to 16 0 007 177 8 3 1 Codabar NW7 without Checksum 4 to 11 0 010 254 0 3 1 9 12 to 16 0 007 177 8 3 1 Code 39 with ...

Page 76: ...4 61 9 70 Therefore the checksum is 9 and the final decoded message is 01256789 Codabar This code uses three to 16 data digits The value assigned to each of the characters is presented in the following table Table 4 26 Codabar Character Value Table The checksum technique is r The character value of a message is obtained from the above table and added together r This sum is divided by 16 and the re...

Page 77: ... The value assigned to each of the characters is presented in the following table Table 4 27 NW 7 Character Value Table The checksum technique is r The data digit value that is the difference between 11 and the Mod 11 sum of the weighted values of the data digits is used as the check digit The start and stop digits are not used as part of the checksum calculation r NW7 is made up of 1 start digit ...

Page 78: ... 8 Therefore the Checksum is 8 and the final decoded message is 0115290078 Example 2 Message 023229006 Use weight 1 9 x 0 10 x 2 7 x 3 8 x 2 4 x 2 5 x 9 3 x 0 6 x 0 2 x 6 122 122 11 11 remainder 1 When the remainder is 1 the calculation must be repeated using weight 2 Use weight 2 2 x 0 10 x 2 4 x 3 3 x 2 7 x 2 6 x 9 8 x 0 5 x0 9 x 6 160 160 11 14 remainder 6 When the remainder is 0 0 is the check...

Page 79: ...table and added together r This sum is divided by 43 and the remainder corresponds to the value of the checksum character Example 28 29 30 31 32 33 34 15 232 232 43 5 REMAINDER 17 17 H CHECKCHARACTER The value 17 corresponds to character H therefore checksum is H and the final decoded message is STUVWXYFH CHARACTER VALUE CHARACTER VALUE CHARACTER VALUE 0 0 F 15 U 30 1 1 G 16 V 31 2 2 H 17 W 32 3 3...

Page 80: ...r Code C Data 25 a Check character and a STOP character The value of the Start character C is 105 and the data character for 25 is 25 The weight of the first data character is one so the check character value is calculated as follows 105 25 x 1 130 where 105 and 25 are the values and 1 is the weight The checksum is equal to 130 modula 103 the remainder of 130 divided by 103 130 103 1 REMAINDER 27 ...

Page 81: ...13 13 14 14 15 15 16 0 0 16 17 1 1 17 18 2 2 18 19 3 3 19 20 4 4 20 21 5 5 21 22 6 6 22 23 7 7 23 24 8 8 24 25 9 9 25 26 26 27 27 28 28 29 29 30 30 31 31 32 32 33 A A 33 34 B B 34 35 C C 35 36 D D 36 37 E E 37 38 F F 38 39 G G 39 40 H H 40 41 I I 41 42 J J 42 43 K K 43 44 L L 44 VALUE CODE A CODE B CODE C ...

Page 82: ... 51 S S 51 52 T T 52 53 U U 53 54 V V 54 55 W W 55 56 X X 56 57 Y Y 57 58 Z Z 58 59 59 60 60 61 61 62 62 63 ___ ___ 63 64 NUL 64 65 SOH a 65 66 STX b 66 67 ETX c 67 68 EOT d 68 69 ENQ e 69 70 ACK f 70 71 BEL g 71 72 BS h 72 73 HT i 73 74 LF j 74 75 VT k 75 76 FF l 76 77 CR m 77 78 SO n 78 79 SI o 79 80 DLE p 80 VALUE CODE A CODE B CODE C ...

Page 83: ...85 86 SYN v 86 87 ETB w 87 88 CAN x 88 89 EM y 89 90 SUB z 90 91 ESC 91 92 FS 92 93 GS 93 94 RS 94 95 US DEL 95 96 FNC 3 FNC 3 96 97 FNC 2 FNC 2 97 98 SHIFT SHIFT 98 99 CODE C CODE C 99 100 CODE B FNC 4 CODE B A 101 FNC 4 CODE A CODE A A 102 FNC 1 FNC 1 FNC 1 A 103 START CODE A 104 START CODE B 105 START CODE C VALUE CODE A CODE B CODE C ...

Page 84: ...PN 4277248DD 4 30 SPECIFICATIONS CHARACTERISTICS BAR CODE LABEL SPECIFICATIONS ...

Page 85: ...ealth 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 3 LASER WARNING LABELS CDRH approved labels are placed near or on those covers that when removed might expose laser radiation Figure 5 1 shows the laser cover and the protective housing cut away This illustr...

Page 86: ...21 CFR 1040 TAMPER PROOF SCREWS ELECTROMAGNETIC SHIELD LASER ON LAMP FLOW CELL LASER 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 727 4750 182 4864 583 LASER RADIATION WHEN OPEN AND INTERLOCK DEFEATED AVOID DIRECT EYE EXPOSURE LASER RADIATION IS...

Page 87: ... users and complies with 21 CFR 1040 VIII VII VI V IV III II I Located on back of unit CLASS 1 LASER PRODUCT LASER RADATION WHEN OPEN AND INTERLOCK DEFEATED AVOID DIRECT EYE EXPOSURE THIS LASER PRODUCT CONFORMS TO THE PROVISIONS OF 21 CFR SUBCHAPTER J SECTIONS 1040 10 AND 1040 11 Manufactured DATE BY 2427796 BECKMAN COULTER INC 250 S KRAEMER BLVD BREA CA 92821 OPTICAL GLASS LENSES LASER RADIATION ...

Page 88: ... U B E 0 1 M A I N M E N U VIII VII VI V IV III II I 0 4 3 0 0 1 1 2 3 0 1 8 S T A T U S R E A D Y A L E R T M O D E C D R CAUTION LASER LIGHT DO NOT STARE INTO BEAM 670nm DIODE LASER 1 0 MILLIWATT MAXIMUM CLASS II LASER PRODUCT CAUTION Laser radiation when open and interlock defeated DO NOT STARE INTO BEAM L A S E R O N L A S E R L I G H T D O N O T S T A R E I N T O B E A M 6 7 0 n m D IO D E L ...

Page 89: ... Waste Electrical and Electronic Equipment WEEE Directive of the European Union The presence of this marking on the product indicates 1 1 that the device was put on the European Market after August 13 2005 and 2 2 that the device is not to be disposed via the municipal waste collection system of any member state of the European Union For products under the requirement of WEEE directive please cont...

Page 90: ...PN 4277248DD 5 6 HAZARDS DISPOSAL OF ELECTRICAL INSTRUMENTATION ...

Page 91: ...1965 44 6 678 688 10 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 11 Schultz J and Thom R Electrical sizing and counting of platelets in whole blood Med Biol Engr 1973 73 447 454 12 Von Behrens WE Mediterranean macrothrombocytopenia Blood 1975 46 2 199 208 13 Paulus JM Platelet si...

Page 92: ... EW Reticulocyte counts How to use them what they mean Diagnostic Medicine 1984 7 6 29 33 29 Williams WJ Beutler E Erslev AJ and Lichtman MA Hematology McGraw Hill Inc New York NY 4th ed 1990 416 30 Brecher G New methylene blue as a reticulocyte stain Am J Clin Path 1949 19 895 896 31 Dorsey DB What can quality control do for hematology Am J Med Tech 1965 Mar Apr 150 153 32 Bull BS A statistical a...

Page 93: ...n Lab Hematol 7 255 266 2001 47 Charie L Harrison P Smith C Cobb J Briggs C Machin S Accuracy in the Low Platelet Count Range A Comparison of Automated Platelet Counts on Beckman Coulter High Volume Hematology Analyzers with the ISLH ICSH Platelet Reference Method Lab Hematol 7 236 244 2001 48 Yee I Keeney M Johnson K Brown W Wolfe N Kaplan S White Blood Cell Flagging Rates of the Coulter LH 750 A...

Page 94: ...ch J J F Mean platelet volume is a useful parameter a reproducible routine method using a modified Coulter Thrombocytometer Platelets 11 379 387 2005 National Committee for Clinical Laboratory Standards has changed to Clinical and Laboratory Standards Institute CLSI ...

Page 95: ...ures and assists you in troubleshooting Also called ADMS DMS LH Workstation Algorithm A particular procedure for performing an analysis Analytical Station The Analyzer Diluter and Power Supply of the LH 700 Series Analyzer The Analyzer is a subsystem of the LH 700 Series that physically sits on top of the Diluter Analyzer Pulse A graphical display on the Analyzer screen that indicates the conditio...

Page 96: ...d sample lines with cleaning agent AutoSequencing A Workstation feature used with the ToDo list to automatically increment the identifiers you specify Patient ID Cass Pos sample ID and sequence number AutoStop A Workstation feature that instructs the instrument to stop processing based on specific criteria Average Value A value that is computed by dividing the sum of a set of values by the number ...

Page 97: ...r and cassette position number This identifier appears on bar code labels so that cassettes and positions are automatically read using a bar code reader Cassette The cassette is the carrier for the sample tubes patient control or special test used in Automatic aspiration mode where automatic loading mixing and sampling occurs Cassette Clips Clips that you permanently install in each opening of the...

Page 98: ...mits Values established by your laboratory to flag results requiring immediate action CSA Canadian Standards Association CSF Cerebrospinal fluid is a clear colorless non cellular fluid that circulates over the brain and spinal cord Cursor On the 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 information CV Coeffi...

Page 99: ... and mixes it Move the cursor over the illustration to see links to additional information dL Deciliter a unit of volumetric measurement equal to 0 1 liter DMS The computer hardware and software that controls instrument operation displays stores and recalls sample data automates QC and calibration procedures and assists you in troubleshooting Also called ADMS DMS LH 700 Series Workstation Double c...

Page 100: ...ppear to the right of a result A flag can be instrument generated R P or laboratory defined H L c a On windows and printouts the letters such as H L and R appear next to parameter results to indicate specific conditions Flow Cytometry A process for measuring the characteristics of cells or other biological particles as they pass through a measuring apparatus in a fluid stream Function Key One of t...

Page 101: ... A specific user name and password is assigned to the lab administrator in your laboratory Laser Light Amplification by Stimulated Emission of Radiation The instrument uses a laser for WBC Diff and Retic analysis Last Name Referes to the patient s last name The Workstation considers this field an optional identifier you can use for a sample This field appears blank unless you provide the informati...

Page 102: ...ically recalculates this value if HGB or HCT change MCHC g dL HGB HCT x 100 MCV Mean Corpuscular Volume The volume of the average red cell derived from the RBC histogram Mean Arithmetic average of a group of data Membership The different types of cells in a particular region regardless of the number of cells On DataPlots membership is represented showing different types of cells in different color...

Page 103: ...l to one thousandth of a watt n Number NCCLS National Committee for Clinical Laboratory Standards is now the Clinical and Laboratory Standard Institute CLSI NE Neutrophil A WBC differential parameter result from the Diff sample analysis The number is computed from the WBC count and the NE NE Neutrophil A WBC differential parameter result from the Diff sample analysis The percent is measured direct...

Page 104: ...um of the data bits for a data word are odd or even and stored in the parity bit for checking by the receiver of the data word Patient ID The Workstation considers this field an optional sample identifier Your laboratory may use it as a specific identifier for the patient such as the medical record or Social Security Number It is intended for laboratories that want to track results of several diff...

Page 105: ...ogram The portion of the Plt distribution curve between 0 fL and 36 fL PLT Platelet Platelet count results from the CBC analysis The system derives this parameter from the Plt histogram PLT n x cells µL Positive Identifier An identifier that is linked irrevocably to the date and time of instrument analysis on a sample and the sample results A positive identifier must be entered before a sample ana...

Page 106: ...omprehensive set of procedures your laboratory uses to ensure that the instrument is working accurately and precisely Ramp Test The ramp test is performed as part of the automatic startup cycles If any test value exceeds the reference value by 1 or more the test value appears in red on the Workstation screen and is flagged with an H high or L low RBC Red Blood Cell Red Blood Cell count results fro...

Page 107: ...ppear if the parameter was excluded as part of parameter selection in setup A computed value that represents the absolute number of reticulocytes The sample s RBC must be known to calculate this value RET Reticulocytes Reticulocyte count results from Retic analysis of samples or controls The percent is measured directly using VCS technology Rili BÄK Richtlinien der Bundesarztekammer Guidelines of ...

Page 108: ...ly move from one side of the mean to the other then maintain a constant level Contrast with trend A scheduled period of work SID Sample ID One of two possible positive identifiers for sample analysis The other possible positive identifier is Cass Pos Standard Deviation SD A measure of deviation from the mean Status Bar A horizontal bar that appears toward the bottom of the screen It displays short...

Page 109: ...of time Contrast with shift Tube Adapters Special holders that enable small tubes to fit in standard cassettes Two sizes of gray sleeve adapters accommodate 2 0 mL tubes and 3 0 mL tubes UL Underwriters Laboratory User Name A 16 character identifier that uniquely identifies the processor of the samples Also called operator ID UWBC UWBC Uncorrected WBC This field and parameter label do not appear o...

Page 110: ... particular test mode You can sort these lists by any column you choose Also called Worklist Pending List Work Order Work Order A feature of the Workstation that lets you view a list of samples the instrument has not yet processed You can view a list of all the unprocessed samples or a list of unprocessed samples for a particular test mode You can sort these lists by any column you choose Also cal...

Page 111: ...lue definition GLOSSARY 2 B BA GLOSSARY 2 BA Number Basophils Field GLOSSARY 2 BA Percent Basophils Field GLOSSARY 2 Background Count definition GLOSSARY 2 background limits 4 1 Diff 4 1 Hgb 4 1 Plt 4 1 RBC 4 1 Retic 4 1 WBC 4 1 Background Results definition GLOSSARY 2 Bar Code Symbology Overview 4 14 bar codes 4 14 4 16 4 18 acceptable 4 18 checksum algorithm 4 18 Codabar 4 18 Code 128 4 18 Code ...

Page 112: ...cient of Variation GLOSSARY 4 Cycle Counter definition GLOSSARY 4 cycling GLOSSARY 2 startup GLOSSARY 2 D Data Management System definition GLOSSARY 4 GLOSSARY 5 DataPlot definition GLOSSARY 4 Defaults definition GLOSSARY 4 Definitive Flags definition GLOSSARY 5 Delta Check definition GLOSSARY 5 Density definition GLOSSARY 5 diff parameters 4 1 Diff Differential definition GLOSSARY 5 diff paramete...

Page 113: ...4 14 4 16 bar codes overview 4 14 4 16 labels 4 18 bar code dimensions 4 18 bar code specifications 4 18 Laser definition GLOSSARY 7 leukocyte GLOSSARY 16 Levey Jennings Control Chart definition GLOSSARY 7 LH 750 System 4 1 performance specifications 4 1 limits 4 1 background 4 1 carryover 4 1 linearity 4 1 precision 4 1 linearity 4 1 definition GLOSSARY 7 limits 4 1 range 4 1 Lot Number definitio...

Page 114: ...nt Population definition GLOSSARY 10 PCT Plateletcrit GLOSSARY 10 PCV GLOSSARY 8 PDW Platelet Distribution Width GLOSSARY 10 Pending List GLOSSARY 11 percent GLOSSARY 2 GLOSSARY 5 GLOSSARY 7 GLOSSARY 8 GLOSSARY 9 GLOSSARY 13 performance specifications 4 1 accuracy 4 1 carryover 4 1 CBC linearity 4 1 mode to mode comparison 4 1 operating range 4 1 precision 4 1 Pericardial Fluid GLOSSARY 11 Periton...

Page 115: ...nition GLOSSARY 14 sizing of cells method description 3 1 sorting GLOSSARY 10 specifications 4 1 4 18 bar code label 4 18 instrument 4 1 performance 4 1 startup GLOSSARY 2 GLOSSARY 6 automatic cycles GLOSSARY 2 status bar definition GLOSSARY 14 Stop Bit definition GLOSSARY 14 Suspect Flags definition GLOSSARY 14 Sweep Flow definition GLOSSARY 14 T test GLOSSARY 11 GLOSSARY 12 GLOSSARY 15 precision...

Page 116: ...PN 4277248DD 6 INDEX INDEX X XB Analysis definition GLOSSARY 16 XM Analysis definition GLOSSARY 16 ...

Page 117: ...hat 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 war...

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Page 119: ...TER are trademarks of Beckman Coulter Inc and are registered with the USPTO All other trademarks service marks products or services are trademarks or registered trademarks of their respective holders Find us on the World Wide Web at www beckmancoulter com Made in USA ...

Page 120: ...Guide PN 4277299 Use And Function Installation Operation Principles Specifications characteristics Operating Procedures Cleaning Replacement Procedures References Available in hard copy by request s SlideStainer Operator s Guide PN 4277300 Use And Function Installation Operation Principles Specifications characteristics Operating Procedures Cleaning Replacement Procedures References Available in h...

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