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Beckman Coulter Coulter LH 700 Series Reference

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COULTER LH 750 System
PN 4277248DD (January 2013)
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.
*SYSTEM RUN*
04/30/96
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12:30:18
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STATUS : READY
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ALERT:
TEST MODE
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MODE: C/D/R
ASPIRATIONS/TUBE 01
VII
MAIN MENU
BLOOD DETECT: ON
VIII
PRIME
CLEAR
START
ALARM
DRAIN RINSE
STOP PREMIX
APERT
APERT
READY
CONT
RESET
F
1
2
3
ID
START UP
POWER ON
4
5
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SHUT DOWN
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POWER OFF
N
7
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9
T
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CE
0
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R
NEC
MultiSync LCD 1700m+
Reference

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  • Page 1 VIII PRIME CLEAR START ALARM DRAIN RINSE STOP PREMIX APERT APERT READY CONT RESET START UP POWER ON SHUT DOWN POWER OFF MultiSync LCD 1700m+ PN 4277248DD (January 2013) Beckman Coulter, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 U.S.A.

  • Page 2: Warnings And Precautions

    This equipment is used in a manner other than specified. Operate the instrument as instructed in the Product Manuals. r You introduce software that is not authorized by Beckman Coulter into your computer. Only operate your system’s computer with software authorized by Beckman Coulter.

  • Page 3: Revision Status

    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.beckmancoulter.com and download the most recent manual or system help for your instrument.
  • Page 4 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.beckmancoulter.com and download the most recent manual or system help for your instrument.

  • Page 5: Table Of Contents

    CONTENTS WARNINGS AND PRECAUTIONS, ii REVISION STATUS, iii CONTENTS, v INTRODUCTION, xiii HOW TO USE YOUR COULTER LH 750 SERIES SYSTEM HARD-COPY MANUALS, xiii ABOUT THIS MANUAL, xiv ONLINE HELP SYSTEM, xiv CONVENTIONS, xiv USE AND FUNCTION, 1-1 INTENDED USE, 1-1 INDICATIONS FOR USE, 1-1 Parameters, 1-2 QUALITY CONTROL (QC), 1-3...

  • Page 6: Contents

    CONTENTS CONTROLS AND CALIBRATOR, 1-9 Controls, 1-9 Calibrator, 1-9 REAGENTS, 1-9 Diluent, 1-10 CBC Lytic Reagent, 1-10 LH Series PAK Reagent System, 1-10 The LH Series RETIC PAK Reagent Kit, 1-10 Cleaners, 1-11 MATERIAL SAFETY DATA SHEETS (MSDS), 1-11 INSTALLATION, 2-1 GENERAL, 2-1 SPECIAL REQUIREMENTS: HARDWARE, 2-1 Space and Accessibility, 2-1...
  • Page 7 CONTENTS 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 MEASUREMENT OF HEMOGLOBIN CONCENTRATION, 3-12 DATAPLOT DEVELOPMENT, 3-13 Two-Dimensional (2D) DataPlots, 3-13 Three-Dimensional (3D) DataPlots, 3-13 PARAMETERS AND THEIR DERIVATION, 3-14 Summary of Parameter Derivations, 3-14...
  • Page 8 CONTENTS SPECIFICATIONS/CHARACTERISTICS, 4-1 PHYSICAL SPECIFICATIONS, 4-1 Dimensions, 4-1 Power, 4-1 Input, 4-1 Consumption, 4-1 PERFORMANCE SPECIFICATIONS--LH 700 Series, 4-1 Precision, 4-1 Within-Run Precision, 4-1 Accuracy, 4-2 Accuracy Qualification, 4-2 Accuracy, CBC, 4-2 Accuracy, WBC Differential, 4-3 Accuracy, Reticulocyte, 4-3 Linearity, 4-3 Background, 4-4 Carryover, 4-4 Operating and Reportable Ranges, 4-4...
  • Page 9 CONTENTS BAR-CODE SYMBOLOGY OVERVIEW, 4-14 Character Set, 4-15 Symbology Type, 4-15 Fixed or Variable Length, 4-15 Self-Checking, 4-15 Start Code, Stop Code, 4-15 Check Character, Checksum Algorithm, 4-15 Quiet Zone, Quiet Area, 4-15 BAR CODES AND THE LH 700 Series, 4-16 Checksum Algorithm, 4-16 Bar-Code Symbologies Supported by the LH 700 Series, 4-16 Interleaved 2-of-5, 4-16...
  • Page 10 CONTENTS REFERENCES, REFERENCES-1 GLOSSARY, GLOSSARY-1 INDEX, INDEX-1 BECKMAN COULTER, INC. CUSTOMER END USER LICENSE AGREEMENT, 1 TRADEMARKS, 3 PN 4277248DD...
  • Page 11 CONTENTS ILLUSTRATIONS COULTER LH 700 Series, 1-1 Corrected WBC, 1-4 Illustration of the ten light scatter regions, 1-5 NRBC signature position on Differential Dataplot, 1-6 NRBC location on WBC histogram, 1-6 Space for tower-type computers, 2-1 Space for Small Form Factor (SFF)-type computers, 2-2...
  • Page 12 CONTENTS TABLES Description of Pneumatic/Hydraulic Connections, 2-6 Effect of Directly-Measured Parameters on the Red Cell Indices, 3-21 Within-Run Precision, 4-2 Accuracy, CBC, 4-2 Accuracy Tolerance Limits, WBC Differential, 4-3 Accuracy, Reticulocyte, using a predicate hematology analyzer, 4-3 Linearity Limits, 4-4 Operating and Reportable Ranges, 4-5 CBC Sample Stability, Room Temperature‡, 4-6 CBC Sample Stability, Cold Temperature‡, 4-6...

  • Page 13: Introduction

    INTRODUCTION This introductory section contains the following topics: How to use your COULTER LH 750 System hard-copy manuals About this manual Online Help System Conventions HOW TO USE YOUR COULTER LH 750 SERIES SYSTEM HARD-COPY MANUALS Use the Getting Started booklet to see an overview of the system hardware and software. This document comes with your LH 750 System.

  • Page 14: About This Manual

    INTRODUCTION ABOUT THIS MANUAL ABOUT THIS MANUAL Your LH 750 System Reference Guide is a source of information for the day-to-day operation of your instrument. This information is organized as follows: Chapter 1, Use and Function Contains the intended use of the instrument, a brief history of the methods used, the reagents, calibrators and controls used, and a short description of the major components.

  • Page 15: Use And Function

    WBC differential or any other definitive test that helps diagnose the patient’ s condition. Figure 1.1 COULTER LH 700 Series * S Y S T E M R U N * 0 4 / 3 0 / 9 6...

  • Page 16: Parameters

    USE AND FUNCTION INDICATIONS FOR USE Parameters The system determines these hematologic parameters of whole-blood specimens: White Blood Cell or leukocyte count Red Blood Cell or erythrocyte count Hemoglobin concentration Hematocrit (relative volume of erythrocytes) Mean Corpuscular (erythrocyte) Volume Mean Corpuscular (erythrocyte) Hemoglobin MCHC Mean Corpuscular (erythrocyte) Hemoglobin Concentration Red Cell (erythrocyte volume) Distribution Width...

  • Page 17: Quality Control (Qc)

    USE AND FUNCTION QUALITY CONTROL (QC) QUALITY CONTROL (QC) Your laboratory can use these QC techniques with the LH 700 Series: Daily instrument checks Commercial or Patient Controls Delta checks XB Analysis Extended QC XM Analysis Interlaboratory Quality Assurance Program (IQAP) Quality Assurance includes routine maintenance and service in conjunction with the use of controls and calibrators.

  • Page 18: Corrected Wbc Counts

    USE AND FUNCTION METHOD HISTORY 10, 11 by size. Electronic refinements in the Model S-PLUS enhanced the accuracy of the hydrodynamic method. Von Behrens and Paulus have also cited the feasibility of counting 12, 13 thrombocytes by the Coulter method. Corrected WBC Counts White Blood Cell count results from the CBC analysis.

  • Page 19: Conductivity Analysis

    USE AND FUNCTION METHOD HISTORY Conductivity Analysis Cell walls act as conductors to high-frequency current. The current, while passing through the cell walls and through each cell interior, detects differences in the insulating properties of cell components. The current characterizes the nuclear and granular constituents and the 20,21,22 chemical composition of the cell interior.

  • Page 20: Nrbc Enumeration

    USE AND FUNCTION METHOD HISTORY NRBC Enumeration The NRBC Enumeration is achieved through the combined use of impedance and VCS technology and a proprietary algorithm. The first step in NRBC enumeration is the identification of particles in the NRBC signature position in the differential data plot.

  • Page 21: Coulter Intellikinetics Application

    USE AND FUNCTION METHOD HISTORY dataplot and the WBC histogram are consistent with NRBCs, the NRBC count is derived from the WBC histogram. COULTER IntelliKinetics Application The LH 700 Series utilizes the COULTER IntelliKinetics application. Control of reaction kinetics is extremely important to ensure the best performance of the automated white cell differential and reticulocyte analysis.

  • Page 22: System Components

    You install software that is not an original copyrighted version. Operate the instrument as instructed in your product documentation. Only operate your system’s computer with software authorized by Beckman Coulter. Only use software that is an original copyrighted version to prevent virus contamination The LH Workstation is not for use as a general purpose personal computer.

  • Page 23: Hardware Options

    Beckman Coulter reagents. Because Beckman Coulter cannot guarantee the performance of the instrument using reagents not manufactured by Beckman Coulter, please be advised that the warranty on the instrument is conditioned upon the use of Beckman Coulter reagents. PN 4277248DD...

  • Page 24: Diluent

    USE AND FUNCTION REAGENTS Diluent Beckman Coulter diluents, including LH Series diluent and ISOTON 4 diluent, are isotonic electrolyte solutions that: Dilute whole-blood samples. Stabilize cell membranes for accurate counting and sizing. Conducts aperture current. Rinse instrument components between analyses.

  • Page 25: Cleaners

    MATERIAL SAFETY DATA SHEETS (MSDS) To obtain an MSDS for Beckman Coulter reagents used on the LH 700 SeriesLH 700 Series: On the internet, go to www.beckmancoulter.com and select MSDS from the Customer Support dropdown menu.
  • Page 26 USE AND FUNCTION MATERIAL SAFETY DATA SHEETS (MSDS) 1-12 PN 4277248DD...

  • Page 27: Installation

    Possible system damage can occur if you uncrate the instrument, install it or set it up. Keep the instrument in its packaging until your Beckman Coulter Representative uncrates it for installation and setup. Your instrument is tested before it is shipped from the factory. International symbols and special handling instructions printed on the shipping cartons tell the carrier how to handle this electronic instrument.

  • Page 28: Electrical Input

    INSTALLATION SPECIAL REQUIREMENTS: HARDWARE Figure 2.2 Space for Small Form Factor (SFF)-type computers 33 cm (13 in.) 27.9 cm (11 in.) 25.4 cm (10 in.) 38 cm (15 in.) 30 cm (13 in.) 44.5 cm (17.5 in.) 68.6 cm 76.2 cm (27 in.) 88.9 cm (30 in.)

  • Page 29: Ambient Temperature And Humidity

    Incomplete waste chamber drainage and eventual waste chamber overflow into the vacuum system can occur if the waste line is too long. Contact your Beckman Coulter Representative if you need to increase the length of the waste line supplied with the instrument.

  • Page 30: Interunit Connections

    Figure 2.3 shows the interunit connections of the power and signal cables, highlighting the DB-25 pin connector, if being used. Your Beckman Coulter Representative makes these connections when installing the instrument. Figure 2.3 Rear of instrument and accessories with DB-25 pin for tower-type computers...

  • Page 31: Pneumatic/Hydraulic Tubing Connections

    INSTALLATION INTERUNIT CONNECTIONS Figure 2.4 Rear of instrument with DB 9-Pin Connector Note: The DB 9-pin connector on the computer base, designated as COM 1, is located beside the video display connector. Pneumatic/Hydraulic Tubing Connections CAUTION Possible reagent siphoning effect and priming problems can occur if a reagent container is placed above the level of the Analyzer.

  • Page 32: Pneumatic/Hydraulic Connections

    INSTALLATION INTERUNIT CONNECTIONS Figure 2.5 Pneumatic/Hydraulic Connections Back of diluter 30 PSI 5 PSI WASTE LEVEL SENSOR RETIC RETIC PACK PACK DILUENT WASTE LYSE CLEAR STAIN PRESERVE LYSE CLEANER Retic clear Retic stain lyse Diluent Waste Cleaning preserve agent Power supply lyse 30 PSI...

  • Page 33: Operation Principles

    OPERATION PRINCIPLES COULTER METHOD CBC Analysis The Coulter method counts and sizes cells by detecting and measuring changes in electrical resistance when a particle (such as a cell) in a conductive liquid goes through a small aperture. See Figure 3.1. Figure 3.1 Coulter Method of Counting and Sizing VACUUM INTERNAL...

  • Page 34: Effect Of Reagents

    OPERATION PRINCIPLES AUTOMATIC ASPIRATION MODE Effect of Reagents The conductive diluent must affect cells minimally, if at all. Both lytic reagents must destroy erythrocytes without significantly affecting leukocytes. They must work rapidly to satisfy the speed with which the system works. The leukocyte preservative must Provide clear separation of the white blood cell populations, and Preserve leukocytes in their near-natural state for accurate cytometric measurement.

  • Page 35: Transport System

    OPERATION PRINCIPLES AUTOMATIC ASPIRATION MODE Figure 3.2 Transport System * S Y S T E M R U N * 0 4 / 3 0 / 0 1 1 2 : 3 0 : 1 8 A n a l y z e r S T A T U S : R E A D Y T E S T M O D E A L E R T :...

  • Page 36: Aspiration

    OPERATION PRINCIPLES AUTOMATIC ASPIRATION MODE 11. After the last tube in the cassette is aspirated, the cassette continues along the rocker bed and is deposited onto the unloading bay platform. The left platform lifts the cassette into the exit bay, where up to 12 cassettes can be stacked. Aspiration At the sampling station, after the cap is pierced: A pump draws a maximum of 300 µL (LH 700 Series only) or 550 µL (LH 700 Series...

  • Page 37: Reticulocyte (Retic)

    OPERATION PRINCIPLES AUTOMATIC ASPIRATION MODE After aspiration of the blood sample, the sliding plate of the diff segment valve (shear valve) moves, aligning the reagent input and output ports with the diff segment isolated in the stationary plate of the valve. The diff lytic reagent pump dispenses diff lytic reagent, displacing the reagent in the diff heater.

  • Page 38: Cbc Sensing System

    OPERATION PRINCIPLES AUTOMATIC ASPIRATION MODE In addition, the instrument activates the blood/stain pump to remove residual stained blood from the lines and activates the retic clearing solution pump to rinse the retic chamber and associated tubing. CBC Sensing System Vacuum, equal to 6 in. of mercury, draws a precise volume of suspension from each bath through the three apertures.

  • Page 39: 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. Tamper-proof screws secure the protective housing; they can only be removed with a special tool.

  • Page 40: Backwash And Rinse

    OPERATION PRINCIPLES MANUAL ASPIRATION MODE Figure 3.4 Triple Transducer Module with Protective Housing Cut Away LASER ON LAMP LASER RADIATION WHEN OPEN AND INTERLOCK DEFEATED. ELECTROMAGNETIC AVOID DIRECT EYE EXPOSURE. SHIELD LASER RADIATION IS EMITTED FROM THIS APERTURE AVOI D EXPOSURE 1096 Mellon Avenue Manteca, CA 95337 MODEL...

  • Page 41: Counting And Sizing

    OPERATION PRINCIPLES COUNTING AND SIZING The Manual mode of operation is like the Automatic mode except: Before you run the sample, you enter the sample identification number by performing any of the following-- Scanning the bar-code label on the tube Entering the ID number on the Numeric Keypad Entering the ID number in the bar-code field on the LH Workstation from its keyboard.

  • Page 42: Coincidence Correction

    OPERATION PRINCIPLES COUNTING AND SIZING Coincidence Correction Occasionally, more than one cell passes through the aperture at the same time. When cells coincide, the Analyzer counts only one pulse. As the frequency of coincidence is proportional to the actual count, the system automatically corrects results for coincidence. Voting To prevent data errors due to statistical outliers or obstructions that may block an aperture, the Analyzer votes on the data from all of the apertures, and rejects any questionable data.

  • Page 43: Rbc Size Distribution

    OPERATION PRINCIPLES COUNTING AND SIZING Figure 3.5 Sweep Flow WASTE SENSING ZONE CELL CELL SENSING ZONE SWIRLING EFFECT SWEEP FLOW SWEEP FLOW RBC Size Distribution After editing, the RED/WHITE PROCESSOR converts the three sets of both the RBC and WBC pulses. It converts each pulse to a number that corresponds to the size of the cell. The Analyzer Microcontroller card (AMC) reads this data and generates histograms.

  • Page 44: Measurement Of Hemoglobin Concentration

    INTFC card where it is digitized. The digital information is sent to the Analyzer computer, then to the Workstation. A significant refinement of the Beckman Coulter systems is the introduction of a reagent blank into the cuvette during each operating cycle. After the percent transmittance is...

  • Page 45: Dataplot Development

    It also produces the DataPlot displays for visual representation of the WBC Diff and Reticulocyte/RBC membership and density. In the LH 750, the Beckman Coulter AccuGate algorithm uses adaptive contouring methods designed for finding optimal separation between overlapping clusters of data. The AccuGate algorithm provides a statistical analysis tool that discovers the overlapping populations using nonlinear separation techniques.

  • Page 46: Parameters And Their Derivation

    OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION On the WBC differential DataPlot the axes are: Volume = green RLS (rotated light scatter) = red OP (opacity) = blue On the Retic DataPlot the axes are: Volume = green LLS (linear light scatter) = red OP (opacity) = blue PARAMETERS AND THEIR DERIVATION Mathematical expressions in this section are in U.S.

  • Page 47: Derived From Wbc Histogram

    OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION Derived From WBC Histogram Parameter Derived From NRBC% WBC Histogram and VCS Technology Calculated Parameter MCHC DIFF# parameters RET# NRBC# White Blood Cell (WBC) Count WBC is the number of leukocytes measured directly, multiplied by the calibration factor. This number is expressed as 10 3 WBC = n...

  • Page 48: Mean Corpuscular Volume (Mcv)

    OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION Mean Corpuscular Volume (MCV) MCV is the average volume of individual erythrocytes derived from the RBC histogram. The system multiplies the number of RBCs in each channel by the size of the RBCs in that channel.

  • Page 49: Differential (Diff)

    OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION NRBC # (Nucleated Red Blood Cells) A parameter that is calculated from the NRBC % and the total WBC count. NRBC # represents the total number of nucleated Red Blood Cells. NRBC (10 cells µL) = NRBC% / 100 x WBC count Differential (Diff) Diff Percentages (DIFF%) The percentages of leukocytes from each category are derived from the DataPlot.

  • Page 50: Reticulocyte (Retic) Parameters

    OPERATION PRINCIPLES PARAMETERS AND THEIR DERIVATION Reticulocyte (Retic) Parameters Retic Percent (RET%) Number of reticulocytes per 100 RBCs. This parameter is directly measured and reported as %, a percentage of RBCs.The RET% is calculated as the ratio of reticulocytes to the total number of red cells;...

  • Page 51: Xb Analysis

    OPERATION PRINCIPLES XB ANALYSIS XB ANALYSIS Studies (Bull 1974, Koepke 1981) indicate that the red cell indices (MCV, MCH, and MCHC) 39,40 of patient populations are stable over time. This stability characteristic of the indices is the basis of a quality-control technique called XB Analysis. In a manually implemented system, population means (target values) are established by analyzing as large a sample as possible, at least 250, but ideally 1,000 blood samples.

  • Page 52: Adjusting Initial Xb Target Values

    If the XB indices are still out-of-limits, you should investigate the instrument and reagent systems associated with the directly-measured parameter(s) as indicated by Table 3.1 and call your Beckman Coulter Service Representative. 3-20 PN 4277248DD...

  • Page 53: Xm Analysis

    OPERATION PRINCIPLES XB ANALYSIS Table 3.1 Effect of Directly-Measured Parameters on the Red Cell Indices Index Directly-Measured Parameter Increased Decreased Increased Decreased Increased Decreased HIGH NORMAL NORMAL NORMAL NORMAL NORMAL NORMAL HIGH HIGH MCHC HIGH HIGH HIGH See the Glossary for terms used with the XB Analysis. XM Analysis XM Analysis is a quality-control method that uses an Exponentially Weighted Moving Average (EWMA) of CBC, Diff, NRBC and Reticulocyte Parameters and compares them with...
  • Page 54 OPERATION PRINCIPLES XB ANALYSIS 3-22 PN 4277248DD...

  • Page 55: Specifications/Characteristics

    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 conformance to specifications.

  • Page 56: Accuracy

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE SPECIFICATIONS--LH 700 Series Table 4.1 Within-Run Precision Parameter @ Approximate Level Limit ≤1.7% CV 9 to 11 x 10 cells/µL ≤0.8% CV 4.5 to 5.5 x 10 cells/µL ≤0.8% CV 14 to 16 g/dL ≤0.8% CV 80 to 90 fL ≤2.2% CV 12 to 14% ≤3.3% CV...

  • Page 57: Accuracy, Reticulocyte

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE SPECIFICATIONS--LH 700 Series Table 4.2 Accuracy, CBC ±0.2 ±3.0% MCV* ±2.0% ±0.5 ±5.0% ±10 ±7.0% ±5.0% *Due to the effect of temperature on red cell size, the specification applies to a temperature range of 70 to 80 degrees F . Accuracy, WBC Differential Accuracy of the WBC differential should be determined by comparison against either or both of two comparator methods.

  • Page 58: Background

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE SPECIFICATIONS--LH 700 Series Table 4.5 Linearity Limits Limits (mean difference or % Parameter Linearity Range difference, whichever is greater) 0.00 to 100.0 ±0.2 or 3.0% WBC x 10 cells/µL 100.1 to 400.0 ±9% 0.00 to 8.00 ±0.05 or 2.0% RBC x 10 cells/µL Hgb g/dL...

  • Page 59: Mode-To-Mode Comparison

    *National Committee for Clinical Laboratory Standards is now the Clinical and Laboratory Standards Institute (CLSI). 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. PN 4277248DD...

  • Page 60: Sample Stability

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE CHARACTERISTICS Sample Stability The following tables show the average results for specimens from five normal donors collected in K EDTA‡. The specimens were stored at room temperature and cold temperature. For this study, room temperature was 72 - 73º (22 - 23ºC) and cold temperature was 37 - 39ºF (3 - 4ºC).

  • Page 61: Retic Sample Stability, Room Temperature

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE CHARACTERISTICS Table 4.10 DIFF% Sample Stability, Cold Temperature‡ Hours 56.63 34.92 6.32 1.76 0.37 58.08 34.96 5.05 1.65 0.27 58.71 33.57 5.80 1.63 0.29 60.58 31.41 6.33 1.47 0.22 61.00 31.14 6.43 1.11 0.32 *Results analyzed @ Room Temperature Table 4.11 DIFF# Sample Stability, Room Temperature‡...

  • Page 62: Wbc Differential Flagging Stability

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE CHARACTERISTICS Table 4.14 RETIC Sample Stability, Cold Temperature‡ Hours RETIC% RETIC# 1.771 0.078 103.87 0.356 1.900 0.084 103.92 0.354 1.874 0.083 103.94 0.347 1.957 0.086 105.48 0.357 1.907 0.084 104.63 0.360 1.670 0.074 106.86 0.360 1.644 0.073 104.70 0.345 1.674 0.074...

  • Page 63: Nrbc Paired Sample Imprecision

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE CHARACTERISTICS Table 4.17 Differential Suspect Flagging at Room Temperature Sample # 1 hour 4 hour 8 hour 16 hour 24 hour Imm Ne 1 Imm Ne 1 Imm Ne 1 Imm Ne 1 Mo Blast, Imm Ne 1, Imm Ne 2 Imm Ne 2 *Indicates that there were no flags present.

  • Page 64: Nrbc Accuracy Characteristics

    (NCCLS H20A) and a predicate hematology analyzer. All NRBC % results > 2 and < 15 will be flagged with an R symbol. Beckman Coulter, Inc. recommends a slide review as per your individual laboratory protocol. The presence of this flag does not affect the correction of the white blood cell count in the presence of NRBC's.

  • Page 65: Temperature

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE CHARACTERISTICS Table 4.23 Normal Population Study (Continued) 13.30 12.09 15.19 248.65 169.06 397.10 x 10 cells/µL 9.31 7.54 11.24 59.78 41.71 73.74 28.67 18.39 44.42 7.89 4.69 12.66 2.96 0.75 8.06 0.62 0.17 1.37 3.74 1.47 7.06 x 10 cells/µL 1.84 0.65...

  • Page 66: Sample Type

    SPECIFICATIONS/CHARACTERISTICS PERFORMANCE CHARACTERISTICS Sample Type Anticoagulated human whole blood Recommended Anticoagulant EDTA or K EDTA Sampling Modes Aspiration Automatic cap-piercing, whole blood Manual, open vial, whole blood and diluted specimens. Test/Cycle CBC/DIFF CBC/RETIC CBC/DIFF/RETIC RETIC Throughput, Automatic Mode Typical throughput performance is described for samples with elevated parameter levels. Approximate throughput performance data, not including sample preparation, is: LH 750 Sample/hour...

  • Page 67: Pneumatic Supplies (Internally Regulated)

    Known Interfering Substances Misleading results can occur if the specimen is not properly collected, stored or transported. Beckman Coulter 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.

  • Page 68: Nrbc

    The presence of a majority or NRBC that are very small or very large may result in a false negative condition. If an NRBC% is reported as zero and there are any suspect messages or parameter codes, Beckman Coulter, Inc. recommends a slide review per your laboratory protocol.

  • Page 69: Character Set

    SPECIFICATIONS/CHARACTERISTICS BAR-CODE SYMBOLOGY OVERVIEW A symbology is defined by the following characteristics: Character Set This refers to the range of data characters that can be encoded for a specific symbology. There are essentially three types: Numeric—The symbology can encode only numeric characters. Alphanumeric—Can encode the full alpha and numeric characters of the ASCII character set.

  • Page 70: Bar Codes And The Lh 700 Series

    Interleaved 2-of-5 labels. Use checksums to provide protection against occasional misread errors caused by problems such as damaged or misapplied labels. If you must use bar codes without checksums, Beckman Coulter recommends that you verify each bar-code reading to assure correct patient identification. Bar-Code Symbologies Supported by the LH 700 Series Interleaved 2-of-5 Interleaved 2-of-5 is a high density, continuous numeric symbology.

  • Page 71: Codabar

    SPECIFICATIONS/CHARACTERISTICS BAR CODES AND THE LH 700 Series Codabar Codabar has a character set of 16 characters. It is a discrete, self-checking symbology and is most commonly used in libraries and blood banks. NW-7 NW-7 is similar to Codabar. It uses numeric characters only and a different checksum algorithm.

  • Page 72: Bar-Code Label Specifications

    Possible misidentified results. For accurate reading by the scanner, it is important that bar-code labels for specimen tubes adhere strictly to the specifications given in this section. Labels that meet these specifications are available from Beckman Coulter. Optical Characteristics at 880 nm ±10% and 633 nm ±10% Print Contrast Signal (PCS): 80% min.

  • Page 73: Label Dimensions And Data

    SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS Label Dimensions and Data The dimensional and data specifications are illustrated in Figure 4.1, Bar-Code Label Specifications. Table 4.24, Bar-Code Label Specifications, explains the specifications called out in Figure 4.1, Bar-Code Label Specifications. Figure 4.1 Bar-Code Label Specifications LEADING EDGE OF LABEL FIRST BAR LINE (SEE SPEC.

  • Page 74: Acceptable Bar Codes

    If you must use bar codes without checksums, Beckman Coulter recommends that you verify each bar-code reading to assure correct patient identification. Maintain the bar-code printer. To achieve the maximum number of digits on the bar-code labels, higher density symbols should be used.

  • Page 75: Checksum Algorithm

    Interleaved 2-of-5 labels. Use checksums to provide protection against occasional misread errors caused by problems such as damaged or misapplied labels. If you must use bar-codes without checksums, Beckman Coulter recommends that you verify each bar-code reading to assure correct patient identification.

  • Page 76: Codabar

    SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS This number is the value of the checksum character. Determine whether total number of characters (message plus checksum) is odd or even. If odd, add a leading nonsignificant zero to the message to produce an even number of characters as required by the symbology.

  • Page 77: Nw7 Decoding

    SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS Examples: MESSAGE VALUE 2+3+4+7+1+3 = 20 20 ÷ 16 = 1, REMAINDER 4 The value 4 corresponds to character 4; therefore, the checksum is 4 and the final decoded message is 2347134. MESSAGE VALUE 11+11+13+13+15+15+15+15 = 108 108 ÷...
  • Page 78 SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS Checksum Technique: The start and stop digits are not used as part of the checksum calculation. The Checksum digit immediately precedes the stop digit. Weighted modulus 11 calculation method DIGIT POSITION (Right Justified) WEIGHT (1) WEIGHT (2) Example 1: Message 011529007 Use weight (1): (9 x 0) + (10 x 1) + (8 x 5) + (4 x 2) + (5 x 9) + (3 x 0) + (6 x 0) + (2 x 7) = 124...

  • Page 79: Code 39 Bar Code

    SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS Code 39 Bar Code This code uses three to 16 data digits with checksum enabled. Use of a 3 digit bar code without checksum enabled is not allowed. The value assigned to each of the characters is: Table 4.28 Code 39 Character Value Table: CHARACTER VALUE...

  • Page 80: Code 128

    SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS Code 128 This code uses four to 16 data digits on the LH 700 Series and four to 11 data digits for the SlideMaker bar-code label printing. The checksum character immediately precedes the stop character. The checksum character used with Code 128 must conform to the AIM USS 128 checksum generation procedure.
  • Page 81 SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS VALUE CODE A CODE B CODE C < < > > 4-27 PN 4277248DD...
  • Page 82 SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS VALUE CODE A CODE B CODE C 4-28 PN 4277248DD...
  • Page 83 SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS VALUE CODE A CODE B CODE C FNC 3 FNC 3 FNC 2 FNC 2 SHIFT SHIFT CODE C CODE C CODE B FNC 4 CODE B (A) FNC 4 CODE A CODE A (A) FNC 1 FNC 1 FNC 1 (A) START...
  • Page 84 SPECIFICATIONS/CHARACTERISTICS BAR-CODE LABEL SPECIFICATIONS 4-30 PN 4277248DD...

  • Page 85: Hazards

    If removal is required, it must be done only by a Beckman Coulter Representative. All service and maintenance of the laser must be done at the Beckman Coulter factory by trained personnel. If removal is required, it must be done by a Beckman Coulter Representative.

  • Page 86: Laser Warning Label, Protective Housing Cut Away

    HAZARDS LASER WARNING LABELS Figure 5.1 Laser Warning Label, Protective Housing Cut Away LASER ON LAMP LASER RADIATION WHEN OPEN AND INTERLOCK DEFEATED. ELECTROMAGNETIC AVOID DIRECT EYE EXPOSURE. SHIELD LASER RADIATION IS EMITTED FROM THIS APERTURE AVOI D EXPOSURE 1096 Mellon Avenue Manteca, CA 95337 MODEL FLOW...

  • Page 87: Bar-Code Reader

    LASER RADATION WHEN OPEN CLASS 1 LASER PRODUCT AND INTERLOCK DEFEATED. Manufactured: AVOID DIRECT EYE EXPOSURE. DATE BECKMAN COULTER, INC. 250 S. KRAEMER BLVD. BREA, CA 92821 2427796 VIII BAR-CODE READER Figure 5.3 Bar-Code Reader Laser Warning Label Location, Protective Housing Cut Away...

  • Page 88: Bar-Code Reader Laser Warning Label Location, Protective Housing On

    HAZARDS BAR-CODE READER Figure 5.4 Bar-Code Reader Laser Warning Label Location, Protective Housing On L a s e r r a d i a t i o n e m i s s i o n i n d i c a t o r ( L E D ) C A U T I O N L a s e r r a d i a t i o n w h e n o p e n a n d i n t e r l o c k d e f e a t e d .

  • Page 89: Handheld Scanner

    European Union. For products under the requirement of WEEE directive, please contact your dealer or local Beckman Coulter office for the proper decontamination information and take back program which will facilitate the proper collection, treatment, recovery, recycling, and safe disposal of device.
  • Page 90 HAZARDS DISPOSAL OF ELECTRICAL INSTRUMENTATION PN 4277248DD...
  • Page 91 REFERENCES Coulter WH. High speed automatic blood cell counter and cell size analyzer. Paper presented at National Electronics Conference, Chicago, IL, 1956; October 3. Brecher G, Schneiderman M and Williams GZ. Evaluation of electronic red blood cell counter. Am J Clin Path, 1956; 26:1439-1449. Brittin GM, Brecher G and Johnson CA.
  • Page 92 REFERENCES 20. Hoffman RA and Britt WB. Flow-system measurement of cell impedance properties. J Histochem Cytochem, 1979; 27(1):234-240. 21. Leif RC, Scwartz S, Rodriguez CM, Peel-Fernandez L, Groves M, Leif SB, Cayer M and Crews H. Two-dimensional impedance studies of BSA buoyant density separated human erythrocytes.
  • Page 93 Hematology Analzyers: A Critical Evaluation, 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.
  • Page 94 REFERENCES 54. Bancroft A. J., Abel E. W. , Mclaren M. , Belch 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 GLOSSARY µL Microliter, a unit of volumetric measurement equal to one millionth of a liter. µm Micrometer, a unit of linear measurement equal to one millionth of a meter. Ampere, a unit of electric current. Accuracy Ability of the instrument to agree with a predetermined reference value. Action Limits Values established by your laboratory to flag results requiring action.
  • Page 96 GLOSSARY AutoCollation A Workstation feature that automatically combines results of different test modes (CBC/Diff and Retic) analyzed from a sample with an identical patient or sample ID. The different test modes must be performed within a predetermined time. Automatic Aspiration The closed-vial method of running a sample.
  • Page 97 GLOSSARY Batch Mean The mean or average of a set of samples. For Xb and XM Analysis, the batch mean is a value based on a statistical averaging technique and is a type of "weighted moving average." It is used to estimate what a simple average result of a very large number of samples (population mean) might be by using a small number of samples.
  • Page 98 GLOSSARY CLSI Clinical and Laboratory Standard Institute formerly known as the National Committee for Clinical Laboratory Standards (NCCLS). Centimeter, a unit of linear measurement. Codes On windows and printouts, symbols, such as -----, ++++, :::::, appear with or in place of sample or control results because of irregularities. A code can only be generated by the instrument.
  • Page 99 GLOSSARY Definitive Messages Definitive messages appear in a separate area of the screen display, printout, and host transmission. Definitive messages such as Anisocytosis, Leukopenia, etc, are laboratory-defined. Definitive messages are defined based on numeric limits generated by your laboratory. If results exceed the limits, the Workstation generates a message.
  • Page 100 GLOSSARY Extended QC - Random error is Extended QC’ s measurement of imprecision. Random Error Extended QC - Systematic error is Extended QC’ s measurement of bias. A systematic error is Systematic Error defined as the deviation of the mean from the target value. Extended QC - Total Total Error is Extended QC’...
  • Page 101 Any host or laboratory computer system. Instrument The Analyzer and Diluter portion of the LH 700 Series. IQAP Beckman Coulter Inc. provides this program, which statistically compares your (Interlaboratory 5C Cell control and Retic-C Cell control data to a group of other laboratories' Quality Assurance control recovery data with the same control lot number.
  • Page 102 GLOSSARY LY % (Lymphocytes) A WBC differential parameter result from the Diff sample analysis. The percent (%) is measured directly using VCS technology. no. of cells inside LY area LY % = x 100 no. of cells inside NE+LY+MO+EO+BA Meter, a unit of linear measurement. Manual aspiration The open-vial method of running a sample.
  • Page 103 GLOSSARY Modes (Test) Use Default Type on the Command Center to specify the test mode. It determines how the LH 700 Series processes data. Mode-to-Mode Agreement between patient results in Automatic aspiration mode and Manual Matching aspiration mode. MPV (Mean Platelet MPV is the mean cell volume for platelets.
  • Page 104 GLOSSARY Operator ID A 16-character identifier that uniquely identifies the processor of the samples. If you forget your user name or password, contact your lab administrator. The user name works with your password to uniquely identify you to the system. Also called: operator ID.
  • Page 105 GLOSSARY Pending List 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.
  • Page 106 GLOSSARY Predilute Diltion of a sample prior to analysis on the analyzer. The Predilute mode on the LH 700 Series may be used to dilute specimens that exceed the reportable range, or to run a citrated tube when clumped platelets are suspected. The Predilute mode runs in the CBC test mode via manual aspiration only.
  • Page 107 GLOSSARY Reportable range This range represents the clinical limits of values that have been tested and found to be accurate, precise, and linear. Reportable range can be the same as the linear range, but it is usually a subset of the linear range. Reproducibility A procedure to check that the system gives consistent results (within established limits) every time it measures the same sample.
  • Page 108 GLOSSARY SD (Standard A measure of deviation from the mean. Deviation) Σ( − − Secondary Mode The open-vial method of running a sample. You immerse the aspirator tip in the sample. The instrument automatically aspirates the sample. If the instrument fails to aspirate automatically, you can press and release the activator to aspirate the sample.
  • Page 109 GLOSSARY Synovial Fluid Joint fluid. Test (Modes) The LH 700 Series has five different test modes. The test mode determines how the LH 700 Series processes data. For example, in the CBC test mode the LH 700 Series performs a basic complete blood count on whole-blood samples. The test mode appears as a field on the QA Results &...
  • Page 110 GLOSSARY WBC (White Blood White Blood Cell count results from the CBC analysis. The WBC count is Cell) adjusted for interfering substances when appropriate. No further correction of WBC is required. Interfering substances include, but are not limited to NRBC, giant platelets, platelet clumps, unlysed RBCs and RBC fragments.
  • Page 111 INDEX Hgb, 4--1 Plt, 4--1 A (definition), GLOSSARY--1 RBC, 4--1 accessibility, 2--1 Retic, 4--1 Accuracy WBC, 4--1 (definition), GLOSSARY--1 Background Results (definition), GLOSSARY--2 accuracy, 4--1 Bar Code Symbology Overview, 4--14 CBC, 4--1 bar codes, 4--14, 4--16, 4--18 of reticulocyte parameters, 4--1 acceptable, 4--18...
  • Page 112 INDEX sample stability, 4--1 Delta Check (definition), GLOSSARY--5 CDC (definition), GLOSSARY--3 Density (definition), GLOSSARY--5 CEE (definition), GLOSSARY--3 diff Cell Control (definition), GLOSSARY--3 parameters, 4--1 characteristics, 4--18 Diff (Differential) performance, 4--18 (definition), GLOSSARY--5 Characters (definition), GLOSSARY--3 diff parameters Check Valve (definition), GLOSSARY--3 sample stability, 4--1...
  • Page 113 INDEX bar-code, dimensions, 4--18 bar-code, specifications, 4--18 handheld scanner, 4--14, 4--16 Laser (definition), GLOSSARY--7 bar codes overview, 4--14 leukocyte, GLOSSARY--16 handheld scanner,bar codes overview, 4--16 Levey-Jennings Control Chart (definition), HCT, GLOSSARY--6 GLOSSARY--7 HCT (Hematocrit) Field, GLOSSARY--6 LH 750 System, 4--1 hematocrit, GLOSSARY--6 performance specifications,...
  • Page 114 INDEX monocytes, GLOSSARY--8 percent, GLOSSARY--2, GLOSSARY--5, MPV (Mean Platelet Volume), GLOSSARY--9 GLOSSARY--7, GLOSSARY--8, MRV, GLOSSARY--9 GLOSSARY--9, GLOSSARY--13 MSCV, GLOSSARY--9 performance specifications, 4--1 mW (definition), GLOSSARY--9 accuracy, 4--1 carryover, 4--1 CBC linearity, 4--1 mode-to-mode comparison, 4--1 n (definition), GLOSSARY--9 operating range, 4--1 name, GLOSSARY--6, GLOSSARY--7...
  • Page 115 INDEX RBC indices,MCV, GLOSSARY--8 startup, GLOSSARY--2, GLOSSARY--6 RDW, GLOSSARY--12 automatic cycles, GLOSSARY--2 RDW (Red Cell Distribution Width) Field, status bar (definition), GLOSSARY--14 GLOSSARY--12 Stop Bit (definition), GLOSSARY--14 read, GLOSSARY--6 Suspect Flags (definition), GLOSSARY--14 Hgb voltages fields, GLOSSARY--6 Sweep Flow (definition), GLOSSARY--14 Record (definition), GLOSSARY--12...
  • Page 116 INDEX XB Analysis (definition), GLOSSARY--16 XM Analysis (definition), GLOSSARY--16 6-INDEX PN 4277248DD...
  • Page 117 BECKMAN COULTER, INC. CUSTOMER END USER LICENSE AGREEMENT This Product contains software that is owned by Beckman Coulter, Inc. or its suppliers and is protected by United States and international copyright laws and international trade provisions. You must treat the software contained in this Product like any other copyrighted material.
  • Page 119 TRADEMARKS Beckman Coulter, the stylized logo, and COULTER 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...
  • Page 120 COULTER LH 700 SERIES SYSTEM HARD-COPY DOCUMENTATION Host Transmission Specifications for transmitting to a host computer. PN 4277303 Available in hard copy by request. Reference Use and Function • Installation • Operation Principles • Specifications/Characteristics • PN 4277248 Precautions/Hazards • References • Glossary • Index Available in hard copy by request.

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