Mindray BC-2800 User manual

BC-2800
Auto Hematology Analyzer
Operator’s Manual

I
© 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.

II
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 personal injury.
zBe sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.
zThis equipment must be operated by skilled/trained clinical professionals.

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.
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

IV
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: [e-mail]
Tel: [phone] 26582888
Fax: [phone] 26582500
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: [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 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
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....................................................................... 3-4
3.4.1 Volumetric Metering .................................................................... 3-4
3.4.2 Measurement Principles.............................................................. 3-5

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2
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
4Installing 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
5Customizing 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
6Operating Your Analyzer.........................................................................6-1
6.1 Introduction ............................................................................................ 6-1
6.2 Initial Checks.......................................................................................... 6-2

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3
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
7Reviewing 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
8Using 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
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
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

Table of Contents
4
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
AIndex.........................................................................................................A-1
BSpecifications ..........................................................................................B-1

Table of Contents
5
CPrecautions, Limitations and Hazards...................................................C-1
DCommunication (8ID communication protocol)....................................D-1
ECommunication (15ID communication protocol)..................................E-1

1-1
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.
zOperate your analyzer strictly as instructed in this manual.
zAll 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.

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-2800 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 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 Chapter 2 Understanding
Your Analyzer
learn about the hardware and software of the BC-2800 Chapter 2 Understanding
Your Analyzer
learn about how the BC-2800 works Chapter 3 Understanding the
System Principles
learn about how to install the BC-2800 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-2800 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-2800 Chapter 9 Using the
Calibration Programs
learn about how to maintain/service the BC-2800 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-2800 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-2800 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
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
USE BY

Using This Manual
1-7
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

Using This Manual
1-8
RETURNING AND RECYCLING THIS
PRODUCT, PLEASE CONSULT THE
DISTRIBUTOR FROM WHOM YOU
PURCHASED THE PRODUCT.