BC-3000 Plus Auto Hematology Analyzer Operation Manual

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;

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„

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

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This equipment must be operated by skilled/trained medical professionals.

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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 injury of human health.

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.

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.

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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:

+86 755 26582479 26582888

Fax:

+86 755 26582500 26582501

EC-Representative:

Shanghai International Holding Corp. GmbH(Europe)

Address:

Eiffestraβe 80, 20537 Hamburg Germany

Phone:

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 Interfaces... 2-3 2.4 Instrument Software ... 2-11 2.5 Reagents, Controls and Calibrators... 2-15

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... 3-5 3.5 RBC/PLT Measurement ... 3-9 3.6 Wash ... 3-13

4

Installing Your Analyzer ... 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 4.1

5

Customizing 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 1

Table of Contents 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

6

Operating 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

7

Reviewing 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

8

Using the QC Programs ... 8-1 8.1 Introduction ... 8-1 8.2 “L-J Analysis” Program... 8-2 8.3 “ X Analysis ” Program ... 8-15 8.4 “ X -R Analysis” program... 8-28 8.5 “X-B Analysis” Program... 8-39

9

Using the Calibration Programs ... 9-1 Introduction ... 9-1 9.2 When to calibrate ... 9-2 9.3 How to Calibrate... 9-3 9.1

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 2

Table of Contents 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

12

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 Appendices ...A-1 Index ...A-1 B Specifications ...B-1 C Precautions, Limitations and Hazards ...C-1 D Communication ...D-1 A

3

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.

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Be sure to operate your analyzer strictly as instructed in this manual.

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-3000 Plus 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 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

Chapter

Plus

Your Analyzer

learn about the hardware and software of the BC-3000 Plus

Chapter

2

Understanding

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

Chapter

operating tasks

Analyzer

learn about how to review the saved analysis results

Chapter 7 Reviewing Sample

6 Operating Your

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

Chapter 11 Troubleshooting

correct the problems

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

Appendix

manual

Limitations and Hazards

learn about the communication protocol of the BC-3000 Plus

Appendix D Communication

1-3

C

Precautions,

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 … CLICK

It means … 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

ENTER

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.

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

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

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

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to press the arrow keys ([←][→] [↑][↓]) as needed to the desired item and press [ENTER].

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 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

1-6

Using This Manual

6 5

(4)

(1) (2) (3)

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 1-9

Using This Manual 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.

1-10

Using This Manual

(5)

Figure1-2 Inside right of the analyzer

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

1-11

2 Understanding Your Analyzer 2.1 Introduction The BC-3000 Plus 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

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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 the following 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

RDW-CV

Coefficient of Variation Red Blood Cell (erythrocyte) Distribution Width

RDW-SD

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

Understanding Your Analyzer

2.3 User Interfaces

Figure2-1 Front view

1 ---- LCD

2 ---- Keypad

3 ---- Recorder

4 ---- Power indicator

5 ---- Aspirate key

6 ---- Sample probe

2-3