Mindray BC-2800 Operator's Manual

BC-2800

Auto Hematology Analyzer

Operator’s Manual

© 2005-2009 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.

For this Operator’s Manual, the issued date is 2009-06.

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called

Mindray) owns the intellectual property rights to this Mindray product and this manual. This

manual may refer to information protected by copyright or patents and does not convey any

license under the patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written

permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other

derivative work of this manual in any manner whatsoever without the written permission of

Mindray is strictly forbidden.

, are the trademarks, registered or otherwise, of Mindray in China and

other countries. All other trademarks that appear in this manual are used only for

informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable

for errors contained herein or for incidental or consequential damages in connection with the

furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product,

only if:

 all installation operations, expansions, changes, modifications and repairs of this product

are conducted by Mindray authorized personnel;

 the electrical installation of the relevant room complies with the applicable national and

local requirements; and

 the product is used in accordance with the instructions for use.

I

z It is important for the hospital or organization that employs this equipment

to carry out a reasonable service/maintenance plan. Neglect of this may
result in machine breakdown or personal injury.

z Be sure to operate the analyzer under the situation specified in this manual;

otherwise , the analyze r will not w ork normall y and the ana lysis resul ts will
be unreliable, which would damage the analyzer components and cause
personal injury.

z This equipment must be operated by skilled/trained clinical professionals.

II

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR

FITNESS FOR ANY PARTICULAR PURPOSE.

Definitions

 Main unit: Integrated facilities which implement the specified function separately.

Generally speaking, the main unit should include power supply, control system and

some functional modules.

 Accessories: Materials connected to the main unit to extend or implement specified

function.

 Consumables: Disposable or short-life parts which should be replaced each time after

use or periodically

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 use of parts or accessories not approved

by Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or

unauthorized service people.

 Malfunction of the instrument or part whose serial number is not legible enough.
 Others not caused by instrument or part itself.

The standard warranty period is as below:

 Main unit: 18 months from shipment
 Accessories: 15 months from shipment
 Consumables: N/A

III

Return Policy

Return Procedure

In the event that it becomes necessary to return this product or part of this product to Mindray,

the following procedure should be followed:

1. Return authorization: Contact the international Customer Service Department and obtain

a Return Materials Authorization number. This number must appear on the outside of the

shipping container. Returned shipments will not be accepted if the number is not clearly

visible. Please provide the model number, serial number, and a brief description of the

reason for return.

2. Freight policy: The customer is responsible for freight charges when this product is

shipped to Mindray for service (this includes customs charges).

3. Return address: Please send the part(s) or equipment to the address offered by the

international Customer Service Department.

Company Contact

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

E-mail Address:

Fax:

EC-Representative: Shanghai International Holding Corp. GmbH(Europe)

Address:

Tel:

[e-mail]

[phone] 26582888

Tel:

[phone] 26582500

Eiffestraβe 80, Hamburg 20537, Germany

0049-40-2513175

Fax:

0049-40-255726

IV

Table of Contents

1 Using This Manual................................................................................... 1-1

1.1 Introduction ............................................................................................ 1-1

1.2 Who Should Read This Manual ............................................................. 1-2

1.3 How to Find Information......................................................................... 1-3

1.4 Conventions Used in This Manual ......................................................... 1-4

1.5 Special Terms Used in This Manual....................................................... 1-5

1.6 Symbols ................................................................................................. 1-6

2 Understanding Your Analyzer.................................................................2-1

2.1 Introduction ............................................................................................ 2-1

2.2 Intended Use.......................................................................................... 2-2

2.3 User Interface......................................................................................... 2-3

2.3.1 LCD ............................................................................................. 2-6

2.3.2 Input Devices .............................................................................. 2-6

2.3.3 Recorder...................................................................................... 2-8

2.3.4 Keyboard Interface...................................................................... 2-8

2.3.5 Serial Ports.................................................................................. 2-8

2.3.6 Parallel Port................................................................................. 2-8

2.3.7 Power Supply for the Floppy Disk Drive ..................................... 2-8

2.3.8 Power Indicator ........................................................................... 2-8

2.3.9 Optional Devices ......................................................................... 2-8

2.4 Instrument Software............................................................................... 2-9

2.4.1 Main Screen................................................................................ 2-9

2.4.2 Screen saver............................................................................. 2-10

2.4.3 System Menu ............................................................................ 2-11

2.5 Reagents, Controls and Calibrator....................................................... 2-13

2.5.1 Diluent....................................................................................... 2-13

2.5.2 Lyse........................................................................................... 2-13

2.5.3 Rinse......................................................................................... 2-14

2.5.4 E-Z Cleanser ............................................................................. 2-14

2.5.5 Probe Cleanser ......................................................................... 2-14

2.5.6 Controls and Calibrator ............................................................. 2-14

3 Understanding the System Principles................................................... 3-1

3.1 Introduction ............................................................................................ 3-1

3.2 Aspiration ............................................................................................... 3-2

3.3 Dilution ................................................................................................... 3-3

3.4 WBC/HGB Measurement....................................................................... 3-4

3.4.1 Volumetric Metering .................................................................... 3-4

3.4.2 Measurement Principles.............................................................. 3-5

1

Table of Contents

3.4.3 Derivation of WBC-Related Parameters ..................................... 3-6

3.4.4 HGB............................................................................................. 3-7

3.5 RBC/PLT Measurement ......................................................................... 3-8

3.5.1 Volumetric Metering .................................................................... 3-8

3.5.2 Measurement Principles.............................................................. 3-9

3.5.3 Derivation of RBC-Related Parameters...................................... 3-9

3.5.4 Derivation of PLT-Related Parameters ..................................... 3-11

3.6 Wash .................................................................................................... 3-12

4 Installing Your Analyzer .......................................................................... 4-1

4.1 Introduction ............................................................................................ 4-1

4.2 Installation Requirements....................................................................... 4-2

4.2.1 Space Requirements ................................................................... 4-2

4.2.2 Power Requirements................................................................... 4-2

4.2.3 General Environment .................................................................. 4-3

4.3 Unpacking .............................................................................................. 4-4

4.3.1 Unpacking and Inspecting the Analyzer...................................... 4-4

4.3.2 How to move the analyzer........................................................... 4-4

4.4 Installation Procedure ............................................................................ 4-5

4.4.1 Connecting Regents.................................................................... 4-5

4.4.2 Installing Recorder Paper............................................................ 4-9

4.4.3 Connecting the Keyboard.......................................................... 4-10

4.4.4 Connecting the Printer (Optional) ............................................. 4-10

4.4.5 Connecting the Bar-Code Scanner (Optional) .......................... 4-10

4.5 Starting the Analyzer ............................................................................ 4-11

5 Customizing the Analyzer Software....................................................... 5-1

5.1 Introduction ............................................................................................ 5-1

5.2 Password ............................................................................................... 5-2

5.2.1 Entering the Administrator Password .......................................... 5-2

5.2.2 Resuming the Common User Password..................................... 5-3

5.3 Editing Settings ...................................................................................... 5-4

5.3.1 Reagent....................................................................................... 5-5

5.3.2 Printing and Communication Settings ......................................... 5-6

5.3.3 Date and Time........................................................................... 5-11

5.3.4 Gain........................................................................................... 5-13

5.3.5 Count......................................................................................... 5-16

5.3.6 Reference Range ...................................................................... 5-20

5.3.7 Auto Maintain ............................................................................ 5-23

5.3.8 Other Settings ........................................................................... 5-25

6 Operating Y our Analyzer.........................................................................6-1

6.1 Introduction ............................................................................................ 6-1

6.2 Initial Checks.......................................................................................... 6-2

2

Table of Contents

6.3 Power-on................................................................................................ 6-3

6.4 Daily Quality Control .............................................................................. 6-4

6.5 Selecting Analysis Mode ........................................................................ 6-5

6.6 Sample Collection and Handling............................................................ 6-6

6.6.1 Whole Blood Samples................................................................. 6-6

6.6.2 Prediluted Samples..................................................................... 6-7

6.7 Running Whole Blood Samples ............................................................. 6-9

6.7.1 Entering Sample Information ...................................................... 6-9

6.7.2 Running the Samples................................................................ 6-15

6.7.3 Special Functions...................................................................... 6-16

6.8 Running Prediluted Samples ............................................................... 6-19

6.8.1 Entering Sample Information .................................................... 6-19

6.8.2 Running the Samples................................................................ 6-24

6.8.3 Special Functions...................................................................... 6-25

6.9 Shutdown ............................................................................................. 6-28

7 Reviewing Sample Results..................................................................... 7-1

7.1 Introduction ............................................................................................ 7-1

7.2 Browsing All Sample Results ................................................................. 7-2

7.2.1 Browsing in the Histogram Mode................................................ 7-2

7.2.2 Browsing in the “Table” mode...................................................... 7-7

7.3 Searching for Interested Sample Results ............................................ 7-17

7.3.1 Starting a Search....................................................................... 7-17

7.3.2 Reviewing search result in the “Table” mode ............................ 7-19

7.3.3 Reviewing Search Result in the “Histogram” Mode.................. 7-29

8 Using the QC Programs.......................................................................... 8-1

8.1 Introduction ............................................................................................ 8-1

8.2 QC With Controls ................................................................................... 8-2

8.2.1 QC Editing................................................................................... 8-2

8.2.2 Running the Controls .................................................................. 8-6

8.2.3 Reviewing QC Results .............................................................. 8-10

8.3 X-B Analysis ......................................................................................... 8-15

8.3.1 QC Editing................................................................................. 8-15

8.3.2 Running X-B Analysis................................................................ 8-18

8.3.3 Reviewing X-B Results.............................................................. 8-18

9 Using the Calibration Programs.............................................................9-1

9.1 Introduction ............................................................................................ 9-1

9.2 When to Calibrate .................................................................................. 9-2

9.3 How to Calibrate..................................................................................... 9-3

9.3.1 Preparing Your Analyzer.............................................................. 9-3

9.3.2 Calibration Using Calibrator Program ......................................... 9-4

9.3.3 Fresh Blood Calibration............................................................. 9-10

3

Table of Contents

9.3.4 Manual Calibration Program ..................................................... 9-17

10 Maintaining Your Analyzer....................................................................10-1

10.1 Introduction .......................................................................................... 10-1

10.2 General Guidelines .............................................................................. 10-2

10.3 Using the “Maintenance” Program ....................................................... 10-3

10.3.1 Diluent Prime............................................................................. 10-4

10.3.2 Rinse Prime............................................................................... 10-5

10.3.3 Lyse Prime ................................................................................ 10-6

10.3.4 Zap Aperture ............................................................................. 10-7

10.3.5 Flush Aperture........................................................................... 10-8

10.3.6 Probe Cleanser Cleaning.......................................................... 10-9

10.3.7 E-Z Cleanser Cleaning............................................................ 10-11

10.3.8 Lyse Test ................................................................................. 10-13

10.3.9 Clean Bath .............................................................................. 10-15

10.3.10 Drain Bath............................................................................. 10-16

10.3.11 Drain Tubing ......................................................................... 10-18

10.3.12 Clean Probe Wipe................................................................. 10-19

10.3.13 Prepare to Ship..................................................................... 10-21

10.4 Using the “Status” Program................................................................ 10-23

10.5 Using the “Self-test” Program ............................................................ 10-24

10.5.1 Testing the Fluidic System ...................................................... 10-25

10.5.2 Testing Motors and Recorder/Printer ...................................... 10-25

10.5.3 Testing Valves ......................................................................... 10-26

10.5.4 Testing A/D Interrupt................................................................ 10-27

10.6 Log ..................................................................................................... 10-28

10.7 Viewing System Configuration ........................................................... 10-30

10.8 Printing Management......................................................................... 10-31

10.9 Calibrating Sample Probe Position .................................................... 10-32

10.10 Replacing the Probe Wipe ................................................................. 10-36

10.11 Replacing the Filter of the Vacuum Chamber.................................... 10-37

10.12 Maintaining Recorder ......................................................................... 10-39

11 Troubleshooting Your Analyzer............................................................ 11-1

11.1 Introduction .......................................................................................... 11-1

11.2 Errors without available error messages ............................................. 11-2

11.3 Errors indicated by error messages..................................................... 11-3

12 Appendices .............................................................................................. A-1

A Index.........................................................................................................A-1

B Specifications ..........................................................................................B-1

4

Table of Contents

C Precautions, Limitations and Hazards...................................................C-1

D Communication (8ID communication protocol)....................................D-1

E Communication (15ID communication protocol)..................................E-1

5

1 Using This Manual

1.1 Introduction

This chapter explains how to use your operator’s manual, which is shipped with your

BC-2800 auto hematology analyzer and contains reference information about the BC-2800

and procedures for operating, troubleshooting and maintaining the analyzer. Read this

manual carefully before operating your analyzer and operate your analyzer strictly as

instructed in this manual.

z Operate your analyzer strictly as instructed in this manual.
z All illustrations in this manual are provided as examples only. They may not

necessarily reflect your analyzer setup or data displayed and must not be
used for any other purpose.

1-1

Using This Manual

1.2 Who Should Read This Manual

This manual contains information written for clinical laboratory professionals to

 learn about the BC-2800 hardware and software;

 customize system settings;

 perform daily operating tasks;

 perform system maintenance and troubleshooting.

1-2

Using This Manual

1.3 How to Find Information

This operator’s manual comprises 11 chapters and 4 appendices. Refer to the table below to

find the information you need.

If you want to … See …

learn about the intended use and parameters of the BC-2800

learn about the hardware and software of the BC-2800

learn about how the BC-2800 works

learn about how to install the BC-2800

learn about how to define/adjust system settings

learn about how to use the BC-2800 to perform your daily

operating tasks

learn about how to review the saved analysis results

learn about how to use the quality control programs

Chapter 2 Understanding
Y our Analyzer
Chapter 2 Understanding
Y our Analyzer
Chapter 3 Understanding the
System Principles
Chapter 4 Installing Your
Analyzer
Chapter 5 Customizing the
Analyzer Software
Chapter 6 Operating Your
Analyzer
Chapter 7 Reviewing Sample
Results
Chapter 8 Using the QC

learn about how to calibrate the BC-2800

learn about how to maintain/service the BC-2800

learn about the meanings of the error messages and how to

correct the problems

learn about the technical specifications of the BC-2800

see the summary of all safety messages included in this

manual

learn about the communication protocol of the BC-2800

1-3

Programs
Chapter 9 Using the
Calibration Programs
Chapter 10 Maintaining Your
Analyzer
Chapter 11 Troubleshooting
Y our Analyzer
Appendix B Specifications
Appendix C Precautions,
Limitations and Hazards
Appendix D Communication

Using This Manual

1.4 Conventions Used in This Manual

This manual uses certain typographical conventions to clarify meaning in the text:

 All capital letters enclosed in [ ] indicate a key name (either on the built-in keypad or the

external keyboard), such as [ENTER].

 All capital, bold and italic letters indicate a special operation defined in the following

section, such as SELECT.

 Bold letters included in “ ” indicate text you can find on the screen, such as “Prepare to

ship”.

 Bold letters indicate defined screen areas/fields, such as System Status area, or

chapter titles, such as Chapter 1 Using This Manual.

All illustrations in this manual are provided as examples only. They may not necessarily

reflect your analyzer setup or data displayed.

1-4

Using This Manual

1.5 Special Terms Used in This Manual

When you read … It means …

CLICK

ENTER

DELETE

to press the arrow keys ([←][→] [↑][↓]) as needed to move the

cursor to a certain software button on screen and press

[ENTER].

to press the arrow keys ([←][→] [↑][↓]) as needed to move

cursor to the desired edit box and use the built-in keypad or

the external keyboard to enter the desired characters or digits.

Note that besides the numeric keys you may also use the

[PgUp] or [PgDn] keys to enter digits; or to scan the number

using the bar-code scanner.

to press the arrow keys ([←][→] [↑][↓]) as needed to move the

cursor to the character or digit to the left of the one you want to

delete and press [DEL]; or to press the arrow keys

([←][→][↑][↓]) as needed to move the cursor to the character

or digit to the right of the one you want to delete and press

[BackSpace] on the external keyboard.

to move the cursor to the character or digit you want to change

MODIFY

SELECT from “ ** ”

pull-down list

SELECT

and re-enter the desired one using either the built-in keypad or

the external keyboard.

to press the arrow keys ([←][→] [↑][↓]) as needed to move the

cursor to the desired edit box and press [ENTER] to display

the pull-down list and press [↑] or [↓] to move the cursor to the

desired item and press [ENTER] to select it.

to press the arrow keys ([←][→] [↑][↓]) as needed to the

desired item and press [ENTER].

z This analyzer adopts a fixed decimal point. You can enter the digits without

bothering to look for the [.] on the external keyboard.

1-5

Using This Manual

1.6 Symbols

You will find the following symbols in this manual.

When you see… Then…

read the statement below the symbol. The statement is

You may find the following symbols on the analyzer or the reagents.

When you see… It means…

alerting you to an operating hazard that can cause

personnel injury.

read the statement below the symbol. The statement is

alerting you to a possibility of analyzer damage or unreliable

analysis results.

read the statement below the symbol. The statement is

alerting you to information that requires your attention.

read the statement below the symbol. The statement is

alerting you to a potentially biohazardous condition.

EQUIPOTENTIALITY

CAUTION, CONSULT ACCOMPANYING

DOCUMENTS.

BIOLOGICAL RISK

HIGH VOLTAGE

ALTERNATING CURRENT

USE BY

1-6

Using This Manual

SERIAL NUMBER

IN VITRO DIAGNOSTIC

DATE OF MANUFACTURE

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

THE DEVICE IS FULLY CONFORMANCE

WITH THE COUNCIL DIRECTIVE

CONCERNING IN VITRO DIAGNOSTIC

MEDICAL DEVICES 98/79/EC.

MANUFACTURER

AUTHORISED REPRESENTATIVE IN THE

EUROPEAN COMMUNITY

IRRITATING SUBSTANCE

THE FOLLOWING DEFINITION OF THE

WEEE LABEL APPLIES TO EU MEMBER

STATES ONLY: THE USE OF THIS SYMBOL

INDICATES THAT THIS PRODUCT SHOULD

NOT BE TREATED AS HOUSEHOLD

WASTE. BY ENSURING THAT THIS

PRODUCT IS DISPOSED OF CORRECTLY,

YOU WILL HELP PREVENT BRINGING

POTENTIAL NEGATIVE CONSEQUENCES

TO THE ENVIRONMENT AND HUMAN

HEALTH. FOR MORE DETAILED

INFORMATION WITH REGARD TO

1-7

Using This Manual

RETURNING AND RECYCLING THIS

PRODUCT, PLEASE CONSULT THE

DISTRIBUTOR FROM WHOM YOU

PURCHASED THE PRODUCT.

1-8

Using This Manual

（4）

（3）

（2）

（1）

Figure 1-1 Back of the analyzer

(1)

Equipotentiality.

（2）

 Connect only to a properly earth grounded outlet;

 To avoid electric shock, disconnect power cord prior to removing or replacing fuse;

 Replace fuse only with the type and rating specified.

（3）

Biological risk.

（4）

The following definition of the WEEE label applies to EU member states only: The use of this

symbol indicates that this product should not be treated as household waste. By ensuring that

1-9

Using This Manual

this product is disposed of correctly, you will help prevent bringing potential negative

consequences to the environment and human health. For more detailed information with

regard to returning and recycling this product, please consult the distributor from whom you

purchased the product.

（5）

Figure 1-2 Warning label

（5）

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

1-10

Using This Manual

（6）

Figure 1-3 Warning label

（6）

To avoid electrical shock, disconnect the power supply before maintaining this device.

1-11

Using This Manual

（7）

（7）

High Voltage

Figure 1-4 High voltage warning label

1-12

2 Understanding Your Analyzer

2.1 Introduction

The BC-2800 Auto Hematology Analyzer is a quantitative, automated hematology analyzer

and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories.

2-1

Understanding Your Analyzer

2.2 Intended Use

z 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.

The analyzer is used for the quantitative determination of a maximum of 19 parameters and 3

histograms of blood samples.

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%

Red Blood Cell or erythrocyte RBC

Hemoglobin Concentration HGB

Mean Corpuscular (erythrocyte) Volume MCV

Mean Cell (erythrocyte) Hemoglobin MCH

Mean Cell (erythrocyte) Hemoglobin Concentration

MCHC

Red Blood Cell (erythrocyte) Distribution Width

Coefficient of Variation

Red Blood Cell (erythrocyte) Distribution Width

Standard Deviation

Hematocrit HCT

Platelet PLT

Mean Platelet Volume MPV

Platelet Distribution Width PDW

Plateletcrit PCT

White Blood Cell Histogram WBC Histogram

Red Blood Cell Histogram RBC Histogram

Platelet Histogram PLT Histogram

2-2

RDW-CV

RDW-SD

2.3 User Interface

Understanding Your Analyzer

Figure 2-1 Front view

1 ---- LCD 2 ---- Keypad

3 ---- Recorder 4 ---- Power indicator

5 ---- Aspirate key 6 ---- Sample probe

2-3

Understanding Your Analyzer

Figure 2-2 Back view

1 --- Power switch 2 --- Equipotentiality

3 --- Waste outlet(Red) 4 --- Lyse inlet(Orange)

5 --- Rinse inlet(Blue) 6 --- Diluent inlet(Green)

2-4

Understanding Your Analyzer

Figure 2-3 Left view

1 --- RS-232 port1 2 --- Parallel port

3 --- RS-232 port2 4 --- Power Interface of Floppy Disk Drive

5 --- Keyboard interface

2-5

Understanding Your Analyzer

2.3.1 LCD

The LCD is located on the front panel of the analyzer, as Figure 2-4 shows. It displays all

alphanumeric and graphic data.

2.3.2 Input Devices

The input devices include the aspirate key, built-in keypad and PS/2 keyboard.

 Aspirate key

The aspirate key is located behind the sample probe, as Figure 2-4 shows. You can press the

key to start the selected run cycle or dispense diluent.

Figure 2-4 Sample probe and aspirate key

1.Sample probe 2. Aspirate key

2-6