BC-2800 Auto Hematology Analyzer Operation Manual（V1.0）

Copyright Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns all rights to this unpublished work and intends to maintain this work as confidential. Mindray may also seek to maintain this work as an unpublished copyright. This publication is to be used solely for the purposes of reference, operation, maintenance, or repair of Mindray equipment. No part of this can be disseminated for other purposes.

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All information contained in this publication is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material. This publication may refer to information and protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties.

Content of this manual is subject to changes without prior notice.

PROPERTY OF SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. ALL RIGHTS RESERVED Responsibility on the manufacturer party Mindray is responsible for safety, reliability and performance of this equipment only in the condition that:

• all installation, expansion, change, modification and repair of this equipment are conducted by Mindray qualified personnel;

• applied electrical appliance is in compliance with relevant National Standards;

Auto Hematology Analyzer Operation Manual（V1.0）

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Note This equipment is not intended for family usage. This equipment must be operated by skilled/trained clinical personnel.

Warning It is important for the hospital or organization that employs this equipment to carry out a reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury of human health.

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the substitution upon it of parts or accessories not approved by Mindray or repaired by anyone other than a Mindray authorized representative.

This warranty shall not extend to any instrument which has been subjected to misuse, negligence or accident; any instrument from which Mindray's original serial number tag or product identification markings have been altered or removed, or any product of any other manufacturer.

Return Policy Return Procedure In the event that it becomes necessary to return a unit to Mindray, the following procedure should be followed:

1.

Obtain return authorization. Contact the Mindray Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Return shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial number,

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Auto Hematology Analyzer Operation Manual（V1.0）

and a brief description of the reason for return.

2.

Freight policy. The customer is responsible for freight charges when equipment is shipped to Mindray for service (this includes customs charges).

Company Contact Address:

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 P.R.China

Free hot line:+86 800 830 3312 Phone:

+86 755 26582888

Fax:

+86 755 26582680

Auto Hematology Analyzer Operation Manual（V1.0）

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Safety Symbols

Symbol

Warning Condition

Action

Consider all materials Wear standard laboratory attire, glove and follow safe controls, calibrators, or laboratory procedures when

Biohazard: (specimens,

components that contain or have contacted handling any material in the human blood) as being potentially laboratory. infectious.

Probe Hazard: The probe is sharp

Avoid

any

unnecessary

contact with the probe and and may contain biohazardous materials, probe area. including controls and calibrators.

NOTE:

Indicate

information

of

to

the

importance

operator in

the

procedure to be performed. This heading is also used to indicate specific sample handling techniques that are helpful in operating the instrument.

CAUTION: Indicate to the operator information of importance that could result in damage to the instrument or affect the test due to improper operation if these instructions are not followed.

WARNING: Indicate to the operator information regarding potential hazards that may cause personal harm to the operator if these instructions are not followed.

Auto Hematology Analyzer Operation Manual（V1.0）

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（1）

（2）

（3）

（1） WARNING To avoid electrical shock, be sure to disconnect the power supply before maintaining this device.

（2） BIOHAZARD Consider waste that contain or have contacted human blood as being potentially infectious. Wear laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory.

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Auto Hematology Analyzer Operation Manual（V1.0）

（3） Equipotentiality.

（4）

（4） WARNING To avoid being injured, do not put hand under the motor when the machine is running.

Auto Hematology Analyzer Operation Manual（V1.0）

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（5）

（6）

（5）and（6） WARNING To avoid electrical shock, be sure to disconnect the power supply before maintaining this device.

FOR IN VITRO DIAGNOSTIC USE

BATCH CODE

USE BY

CE MARK

DATE OF MANUFACTURE 4

Auto Hematology Analyzer Operation Manual（V1.0）

MANUFATURER

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

SERIAL NUMBER

Auto Hematology Analyzer Operation Manual（V1.0）

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MANUFATURER

AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

SERIAL NUMBER

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Content

Content Chapter 1

Introduction ... 1-1

1.1

Foreword ... 1-1

1.2

General ... 1-2

1.3

System Introduction ... 1-3

1.4

Principles of Operation... 1-6

1.5

Specifications ... 1-11

1.6

System Operation ... 1-15

1.7

Operation Summary... 1-22

Chapter 2

Installation ... 2-1

2.1

Unpacking ... 2-1

2.2

Installation Requirements ... 2-2

2.3

Installation ... 2-3

2.4

Loading Recording Paper ... 2-6

2.5

Installing Printer ... 2-8

2.6

Installing Scanner (optional)... 2-9

Chapter 3

Sample Analysis ... 3-1

3.1

Preparing to Start ... 3-1

3.2

Power-up ... 3-3

3.3

Entering Count Screen ... 3-4

3.4

Entering Sample Information ... 3-7

3.5

Preparing Samples... 3-15

3.6

Sample Analysis... 3-17

3.7

Background Check ... 3-25

3.8

Shutdown ... 3-26

Chapter 4

Quality Control ... 4-1

4.1

QC with Controls... 4-2

4.2

X-B Analysis ... 4-12

Chapter 5

Calibration ... 5-1

5.1

Introduction ... 5-1

5.2

Preparing for Calibration... 5-2 Auto Hematology Analyzer Operation Manual（V1.0）

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Content

5.3

Manual Calibration ... 5-3

5.4

Calibration Using Calibrators ... 5-8

5.5

Calibration Using Fresh Blood ... 5-15

Chapter 6

Sample Review ... 6-1

6.1

Histogram Mode ... 6-2

6.2

Review in Table Mode ... 6-5

Chapter 7

Setup ... 7-1

7.1

Password ... 7-1

7.2

Editing Settings... 7-4

Chapter 8

Maintenance ... 8-1

8.1

Regular Maintenance ... 8-1

8.2

System Maintenance... 8-3

8.3

System Status... 8-16

8.4

System Self-Test... 8-18

8.5

Log... 8-22

8.6

System Configuration... 8-24

8.7

Printing Management... 8-25

8.8

Adjusting Sample Probe and Probe Wipe Block ... 8-27

Chapter 9

Troubleshooting ... 9-1

9.1

Error Codes... 9-2

9.2

Solutions ... 9-3

Appendix A

Communication ... A-1

A.1

Connection...A-1

A.2

Setting Transmission Parameters ...A-1

A.3

Transmission ...A-2

A.4

Transmission Date Format ...A-2

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Auto Hematology Analyzer Operation Manual（V1.0）

Introduction

Chapter 1

Introduction

1.1 Foreword This manual covers all the instructions related to the operation and general maintenance of the BC-2800 Auto Hematology Analyzer. To ensure this analyzer performs in the best way, please carefully read and comprehend the contents of this manual and operate/maintain this analyzer exactly as instructed. This manual includes a detailed description of this analyzer, the specifications given by the manufacturer, methods to install, calibrate and maintain this analyzer, and measures to be taken when errors occur. It also presents the working principle of this analyzer and the recommended reagents. Operation notes, limits and potential hazards are stressed where appropriate. This chapter mainly deals with the following contents: General Introduces how this manual is organized and presents a brief introduction of all the chapters. System introduction Briefly introduces the main factors of this analyzer, including functions, accessories and optional parts. Principles of operation Introduces how the analyzer functions. Specifications Presents the specifications of this analyzer. System operations Describes the key functions, display areas and system menu and presents a brief introduction of how to operate this analyzer.

Auto Hematology Analyzer Operation Manual（V1.0）

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Introduction

1.2 General See Table 1-1 for the organization of this manual and brief introductions of the chapters. Table 1-1 Organization of the BC-2800 operation manual Chapters

Contents

Chapter 1 Introduction

Introduces

organization

of

this

manual,

system introduction, principles of operation, specifications,

system

operations

and

requirements

and

operation summary. Chapter 2 Installation

Introduces

installation

steps. Chapter 3 Sample Analysis

Introduces how to analyze samples on this analyzer.

Chapter 4 Quality Control

Introduces how to run the QC program on this analyzer.

Chapter 5 Calibration

Introduces how to calibrate this analyzer.

Chapter 6 Sample Review

Introduces how to review, search and print the saved sample analysis results.

Chapter 7 Setup

Introduces how to set date, time and other system settings.

Chapter 8 Service

Introduces how to maintain this analyzer and replace the reagents.

Chapter 9 Troubleshooting

Introduces how to deals with the reported errors.

Appendix A Communication

1-2

Communication protocol.

Auto Hematology Analyzer Operation Manual（V1.0）

Introduction

1.3 System Introduction 1.3.1 Name and Intended Use The full name of this analyzer is BC-2800 Auto Hematology Analyzer. It is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories. Note The purpose of this analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies. It determines the following 19 hematological parameters and presents 3 histograms of blood specimens. Table 1-2 Parameters and histograms Group

Parameter

Abbreviation

WBC Group

White Blood Cell or leukocyte

WBC

Lymphocyte

Lymph#

Mid-sized cell

Mid#

Granulocyte

Gran#

Lymphocyte percentage

Lymph%

Mid-sized cell percentage

Mid%

Granulocyte percentage

Gran%

WBC histogram HGB Group

Hemoglobin Concentration

HGB

RBC Group

Hemoglobin Concentration

RBC

Hematocrit

HCT

Mean Corpuscular (erythrocyte)

MCV

Volume Mean

Cell

(erythrocyte)

MCH

(erythrocyte)

MCHC

Hemoglobin Mean

Cell

Hemoglobin Concentration Red

Blood

Cell

(erythrocyte)

RDW-CV

Distribution Width Coefficient of Variation

Auto Hematology Analyzer Operation Manual（V1.0）

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Introduction

Red

Blood

Cell

(erythrocyte)

RDW-SD

Distribution Width Standard Deviation RBC histogram PLT Group

Platele

PLT

Mean Platelet Volume

MPV

Platelet Distribution Width

PDW

Plateletcrit

PCT

PLT histogram

1.3.2 Classifications CE: General In vitro diagnostic medical devices

1.3.3 Supplementary Data Mindray aperiodically issues and delivers supplementary documents pertaining to operation or maintenance of this instrument. Be sure to read and observe these documents carefully and precisely as well as insert them into this manual for convenient reference。

1.3.4 Service Assistance If this analyzer does not operate properly, follow the directions in Chapter 9, Troubleshooting. If the error cannot be corrected by the recommended methods, contact the Mindray Customer Service Department or the distributor

1.3.5 Reagents, Calibrators and Controls The reagents, controls, calibrators, and analyzer are components of a whole system and must be used as one. Be sure that any products to be used have been tested and certified by the manufacturer. Mindray recommends the reagents described in Chapter 1.5.10 Reagents. Do not use the reagents or controls from different suppliers, or else the analyzer may not perform as promised and even be damaged. Each reagent should be examined prior to its application. Product integrity may be compromised in damaged containers. If a package appears damaged, inspect the inside for signs of leakage or moisture and find them, do not use the reagent. Read the user’s instructions of the reagents and operate as instructed when using the reagents. otherwise specified, reagents must be stored and used at room temperature. 1-4

Auto Hematology Analyzer Operation Manual（V1.0）

Unless

Introduction

Note To properly and safely use the reagents, be sure to read the tags on the package and the supplied data sheet.

1.3.5.1

Reagents

1. Diluent Besides diluting the blood sample, the diluent provides an environment similar to blood plasma to keep the sizes of blood cells unchanged within a certain period of time and serves as a conductive media for blood cells analysis. 2. Lyse The lyse can rapidly break down the red blood cell membranes and reduce cellular debris to a size small enough so that it does not interfere with white blood cell analysis. White cells can then be segregated into three sub-populations for differential analysis.The absorbency of the lyse-hemoglobin mixture is determined by the hemoglobin. 3. Rinse The rinse is a detergent used to wash the tubing and wet the volumetric tube. 4. E-Z Cleanser The Enzymatic Cleanser is an enzyme based, isotonic cleaning solution and wetting agent used to rinse the tubing and bath. This cleanser will not damage the plastic parts of the analyzer. 5. Probe Cleanser The probe cleanser is used to maintain the analyzer.

1.3.5.2

Calibrators and Controls

Calibrators and controls are whole blood products manufactured to calibrate and verify the operation of instruments. The “calibrators” and “controls” that appear in the rest of this manual refer to the calibrators and controls to be used on this analyze only. You shall order them only from Mindray customer service department or the distributor.

Auto Hematology Analyzer Operation Manual（V1.0）

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Introduction

1.4 Principles of Operation 1.4.1 Measuring Principle This analyzer adopts the Coulter Principle to count WBC, RBC and PLT cells and to draw their corresponding histograms. The Hemoglobin concentration (HGB) is obtained by the colorimetric method. The result of the rest parameters are derived from those (see Chapter 1.4.4, Derivation of Parameters).

1.4.2 Dilution Usually in blood specimens, the cells are too close to each other to be identified or measured. For this reason, the diluent is used to separate the cells so that they are drawn through the aperture one at a time as well as to create a conductive environment for blood analysis. This analyzer can processes two types of blood samples – whole blood samples (see Chapter 2.5.1 Preparing Whole Blood Samples) and prediluted blood samples (see Chapter 2.5.2 Preparing Prediluted Samples). When analyzing a whole blood sample, this analyzer aspirates 13μL of the sample and follow the procedure presented in Figure 1-1 to dilute it before proceeding to the actual analysis.

Figure 1-1 How a whole blood sample is diluted

1-6

Auto Hematology Analyzer Operation Manual（V1.0）

Introduction

When analyzing a prediluted sample, the operator should first collect 20μL capillary specimen and dispense 1.6mL diluent from this analyzer to predilute the specimen. Then the operator should present the prediluted sample to the analyzer, which will aspirate 0.7ml of the sample for further dilution, as Figure 1-2 shows.

Figure 1-2 How a prediluted sample is diluted After reacting with the diluent and lyse, the cells mainly fall into the following three volume ranges: WBC:

30～350

fL

RBC:

25～250

fL

PLT:

2～30

fL

1.4.3 Control of Sample Volume This analyzer employs an optical volumetric metering system to determine the sample volume aspirated through the aperture. Each count cycle, as shown in Figure 1-3, starts when the liquid surface passes the upper sensor of the volumetric tube and ends till the lower sensor is reached. If bubbles or an abnormal flow rate is detected, the system will alarm the operator for errors. When this happens, see Chapter 9 Troubleshooting for the solutions. Auto Hematology Analyzer Operation Manual（V1.0）

1-7

Introduction

Upper sensor

Upper sensor

Lower sensor

Lower sensor

1 Empty when start

2 Liquid surface fall down through the volumeritc tube

Upper sensor

Upper sensor

Lower sensor

Lower sensor

3 Counting start when the liquid surface pass the upper sensor.

4 Counting end when the liquid surface pass the lower sensor

Figure 1-3 How sample volume is controlled

1.4.4 Derivation of Parameters 1.4.4.1

WBC 9

WBC(10 / L) is the number of leukocytes measured directly by counting the white blood cells passing through the aperture. Note that when you observe in the microscope NRBCs (nucleated red blood cells), which do not react with the lyse and can be mistaken by the analyzer for white cells, be sure to correct the system-generated result by the following formula,

WBC '＝WBC ×

100 100＋NRBC

where WBC represents the system-generated white cell number, NRBC the number of NRBCs counted in 100 white cells and WBC′ the corrected white cell number.

1.4.4.2

WBC differential

With the help of the diluent and lyse, this analyze can size the white cells into three sub-populations - lymphocytes, mid-sized cells, and granulocytes. Lymphocytes are the largest white cells whose sizes are 30fL～85fL. Granulocytes are the smallest white cells whose sizes are above 125fL. Between them are the mid-sized cells whose sizes are 85fL～125fL. 1-8

Auto Hematology Analyzer Operation Manual（V1.0）