Mindray BC-3000 Plus User manual

BC-3000 Plus
Auto Hematology Analyzer
Operation Manual

I
Copyright
© 2003-2005 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operation Manual, the issued Date is 2005-10 (Version: 1.1).
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 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.
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, rent, adaption and translation of this manual
in any manner whatsoever without the written permission of Mindray is strictly forbidden.
,are the registered trademarks or trademarks owned by Mindray in China
and other countries. All other trademarks that appear in this manual are used only for
editorial purposes without the intention of improperly using them. They are the property of
their respective owners.
Responsibility on the Manufacturer Party
Contents of this manual are subject to changes without prior notice.
All information contained in this manual 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 manual.
Mindray is responsible for safety, reliability and performance of this product only in the
condition that:
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;

II
the product is used in accordance with the instructions for use.
zThis equipment must be operated by skilled/trained medical professionals.
zIt 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 injury of human health.

III
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.
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:
any Mindray product which has been subjected to misuse, negligence or accident;
any Mindray product from which Mindray's original serial number tag or product
identification markings have been altered or removed;
any product of any other manufacturer.
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. 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. Returned shipments will not be accepted if the Mindray
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
Customer Service department.

IV
Company Contact
Manufacture: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen, P.R.China,518057
Phone: [phone] 26582888
Fax: [phone] 26582501
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg Germany
Phone: [phone]
Fax: [phone]

1
Table of Contents
1Using 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
2Understanding Your Analyzer................................................................. 2-1
2.1 Introduction ............................................................................................ 2-1
2.2 Intended Use.......................................................................................... 2-2
2.3 User Interfaces....................................................................................... 2-3
2.4 Instrument Software............................................................................. 2-11
2.5 Reagents, Controls and Calibrators..................................................... 2-15
3Understanding 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....................................................................... 3-5
3.5 RBC/PLT Measurement ......................................................................... 3-9
3.6 Wash .................................................................................................... 3-13
4Installing Your Analyzer ..........................................................................4-1
4.1 Introduction ............................................................................................ 4-1
4.2 Installation Requirements....................................................................... 4-2
4.3 Unpacking .............................................................................................. 4-4
4.4 Installation Procedure ............................................................................ 4-6
4.5 Starting the Analyzer ............................................................................ 4-16
5Customizing the Analyzer Software.......................................................5-1
5.1 Introduction ............................................................................................ 5-1
5.2 Print........................................................................................................ 5-2
5.3 Count time.............................................................................................. 5-6
5.4 Password ............................................................................................... 5-8
5.5 Transmission........................................................................................ 5-14
5.6 Setting system time (Date & Time) ...................................................... 5-19
5.7 Gain...................................................................................................... 5-21

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2
5.8 Auto Clean Time .................................................................................. 5-26
5.9 Reagent Exp. Date............................................................................... 5-27
5.10 Report Title （external keyboard required）....................................... 5-29
5.11 Parameter Units ................................................................................... 5-31
5.12 Other .................................................................................................... 5-34
6Operating Your Analyzer.........................................................................6-1
6.1 Introduction ............................................................................................ 6-1
6.2 Initial Checks.......................................................................................... 6-2
6.3 Power-on................................................................................................ 6-3
6.4 Daily Quality Control .............................................................................. 6-4
6.5 Sample Collection and Handling............................................................ 6-5
6.6 Running Whole Blood Samples ............................................................. 6-8
6.7 Running Prediluted Samples ............................................................... 6-17
6.8 Shutdown ............................................................................................. 6-26
7Reviewing Sample Results .....................................................................7-1
7.1 Introduction ............................................................................................ 7-1
7.2 Browsing All Sample Results ................................................................. 7-2
7.3 Searching for Interested Sample Results ............................................ 7-17
8Using the QC Programs..........................................................................8-1
8.1 Introduction ............................................................................................ 8-1
8.2 “L-J Analysis” Program........................................................................... 8-2
8.3 “XAnalysis ” Program ........................................................................ 8-15
8.4 “X-R Analysis” program....................................................................... 8-28
8.5 “X-B Analysis” Program........................................................................ 8-39
9Using the Calibration Programs.............................................................9-1
9.1 Introduction ............................................................................................ 9-1
9.2 When to calibrate ................................................................................... 9-2
9.3 How to Calibrate..................................................................................... 9-3
10 Maintaining Your Analyzer....................................................................10-1
10.1 Introduction .......................................................................................... 10-1
10.2 General Guidelines .............................................................................. 10-2
10.3 Using the “Maintenance” Program....................................................... 10-4
10.4 Using the “System Status” Program................................................... 10-24
10.5 Using the “Valve Test” Program ......................................................... 10-26
10.6 Using the “System Test” Program ...................................................... 10-27
10.7 Using the “Prepare to ship” Program ................................................. 10-28
10.8 Using the “Error Message” Program.................................................. 10-31
10.9 Calibrating Sample Probe Position .................................................... 10-33
10.10 Replacing the Probe Wipe. ................................................................ 10-37

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3
10.11 Replacing the Filter of the Vacuum Chamber .................................... 10-38
10.12 Using the [Flush] key ......................................................................... 10-39
10.13 Using the [Startup] key....................................................................... 10-40
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
AIndex ......................................................................................................A-1
BSpecifications .........................................................................................B-1
CPrecautions, Limitations and Hazards ...................................................C-1
DCommunication ......................................................................................D-1

1-1
1 Using This Manual
1.1 Introduction
This chapter explains how to use your BC-3000 Plus operation manual, which is shipped with
your BC-3000 Plus hematology analyzer and contains reference information about the
BC-3000 Plus 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.
zBe sure to operate your analyzer strictly as instructed in this manual.

Using This Manual
1-2
1.2 Who Should Read This Manual
This manual contains information written for clinical laboratory professionals to:
learn about the BC-3000 Plus hardware and software;
customize system settings;
perform daily operating tasks;
perform system maintenance and troubleshooting.

Using This Manual
1-3
1.3 How to Find Information
This operation 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-3000
Plus
Chapter 2 Understanding
Your Analyzer
learn about the hardware and software of the BC-3000 Plus Chapter 2 Understanding
Your Analyzer
learn about how the BC-3000 Plus works Chapter 3 Understanding the
System Principles
learn about how to install the BC-3000 Plus Chapter 4 Installing Your
Analyzer
learn about how to define/adjust system settings Chapter 5 Customizing the
Analyzer Software
learn about how to use the BC-3000 Plus to perform your daily
operating tasks
Chapter 6 Operating Your
Analyzer
learn about how to review the saved analysis results Chapter 7 Reviewing Sample
Results
learn about how to use the quality control programs Chapter 8 Using the QC
Programs
learn about how to calibrate the BC-3000 Plus Chapter 9 Using the
Calibration Programs
learn about how to maintain/service the BC-3000 Plus Chapter 10 Maintaining Your
Analyzer
learn about the meanings of the error messages and how to
correct the problems
Chapter 11 Troubleshooting
Your Analyzer
learn about the technical specifications of the BC-3000 Plus Appendix B Specifications
see the summary of all safety messages included in this
manual
Appendix C Precautions,
Limitations and Hazards
learn about the communication protocol of the BC-3000 Plus Appendix D Communication

Using This Manual
1-4
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.

Using This Manual
1-5
1.5 Special Terms Used in This Manual
When you read … It means …
CLICK
to press the arrow keys ([←][→] [↑][↓]) as needed to move the
cursor to a certain software button on screen and press
[ENTER].
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 in using the bar-code scanner.
DELETE
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.
MODIFY
to move the cursor to the character or digit you want to change
and re-enter the desired one using either the built-in keypad or
the external keyboard.
SELECT from “ ** ”
pull-down list
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.
SELECT
to press the arrow keys ([←][→] [↑][↓]) as needed to the
desired item and press [ENTER].
zThis analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.

Using This Manual
1-6
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
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.
You may find the following symbols on the analyzer or the reagents.
When you see… It means…
EQUIPOTENTIALITY
CAUTION, CONSULT ACCOMPANYING
DOCUMENTS.
BIOLOGICAL RISK
HIGH VOLTAGE
ALTERNATING CURRENT
FOR IN VITRO DIAGNOSTIC USE

Using This Manual
1-7
BATCH CODE
USE BY
SERIAL NUMBER
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

Using This Manual
1-8
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.

Using This Manual
1-9
5 6
Figure1-1 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 this product is disposed of correctly, you will help prevent bringing potential negative
(1)
(2)
(3)
(4)

Using This Manual
1-10
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.