Mindray BC-3000 Plus Hematology Analyzer User manual [gb]

Download

BC-3000 Plus

Auto Hematology Analyzer

Operation Manual

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;

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

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

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 injury of human health.

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.

III

Company Contact

Manufacture: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Address:

Phone:

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,

Nanshan, Shenzhen, P.R.China,518057

+86 755 26582479 26582888

Fax:

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

Address:

Phone:

Fax:

+86 755 26582500 26582501

Eiffestraβe 80, 20537 Hamburg Germany

0049-40-2513175

0049-40-255726

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

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

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

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 Y our 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

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

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 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

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

D Communication ......................................................................................D-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.

z 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

Plus

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

learn about how the BC-3000 Plus works

learn about how to install the BC-3000 Plus

learn about how to define/adjust system settings

learn about how to use the BC-3000 Plus 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-3000 Plus

learn about how to maintain/service the BC-3000 Plus

learn about the meanings of the error messages and how to

correct the problems

learn about the technical specifications of the BC-3000 Plus

see the summary of all safety messages included in this

manual

learn about the communication protocol of the BC-3000 Plus

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 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 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

FOR IN VITRO DIAGNOSTIC USE

1-6

Using This Manual

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

1-7

Using This Manual

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.

1-8

Using This Manual

(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

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 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

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

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

Understanding Your Analyzer

Figure2-2 Back view

1 --- RS-232 Port1 2 --- Parallel Port 3 --- RS-232 Port2 4 --- Keyboard interface 5 --- Power Interface of Floppy Disk Drive 6 --- Safety labeling 7 --- Diluent inlet 8 --- Diluent sensor connector 9 --- Rinse sensor connector 10 --- Waste outlet 11 --- Rinse inlet 12--- Power switch 13--- Equipotentiality

14--- WEEE labeling

2-4

Understanding Your Analyzer

Figure2-3 Inside front of the analyzer

1 --- Elevator motor 2 --- Sample probe 3 --- Probe wipe 4 --- WBC shielding box 5 --- RBC shielding box 6 --- Aspirate key

2-5

Understanding Your Analyzer

Figure2-4 Inside right of the analyzer

1 --- Valve8 2 --- Volumetric metering unit 3 --- Vacuum chamber 4 --- Valve13 5 --- Valve14 6 --- Valve12 7 --- Valve11 8 --- Valve10 9 --- Valve2 10 --- Valve9 11 --- 50ul and 2.5ml motor 12 --- 10ml motor 13 --- 2.5ml syringe 14 --- 50ul syringe 15 --- 10ml syringe 16 --- Valve6 17 --- Valve4 18 --- Valve3 19 --- Valve1 20 --- Valve5 21 --- Valve15 22 --- Valve16 23 --- Valve17 24 --- Valve7 25 --- Valve18

2-6

Understanding Your Analyzer

Figure2-5 Inside left of the analyzer

1 --- Fluid pump 2 --- Gas pump 3 --- Pressure chamber

2-7

Understanding Your Analyzer

2.3.1 LCD

The LCD is located on the front panel of the analyzer. 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 Figure2-6 shows. You can press the

key to start the selected run cycle or dispense diluent.

Figure2-6 Sample probe and aspirate key

1.Sample Probe 2. Aspirate Key

2-8

Understanding Your Analyzer

 Built-in keypad

The 23-key keypad is located below the LCD, as Figure2-7 shows.

Figure2-7 Built-in keypad

 PS/2 keyboard

The analyzer can also be controlled by an external PS/2 keyboard that should be connected

to the analyzer’s keyboard interface. See the table below for the correspondence between

the keypad keys and the keyboard keys and for their functions.

Keypad PS/2 keyboard Function

[MENU] [Esc] To enter/exit the system menu.

[PRINT] [P]or [p] To print out data by the recorder or printer.

[DEL] [Delete] or [Del] To delete data and characters.

[ENTER] [Enter] To confirm or execute an operation.

[↑][↓][←][→] [↑][↓][←][→] To move the cursor.

[0]...[9] [0]...[9] To enter digits.

[PgUp][PgDn] [PageUp] [PageDown] To scroll screen.

[Flush] / To unclog the apertures.

[FEED] / To advance the recorder paper.

[MAIN] /

To go back to the “Count” screen.

[DILUENT] [D]or [d] To enter the dispensing diluent state.

[STARTUP] / To execute the startup procedure (flushing the

fluidic lines and checking background).

[ID] [ I ]or [i] To call out the screen to enter patient information.

/ Alphanumeric keys and

other function keys.

To enter alphanumeric data or initiate a function.

2-9

Understanding Your Analyzer

2.3.3 Recorder

The thermal recorder is located on the front panel. You can use it to print out analysis reports

and other interested information.

2.3.4 Keyboard Interface

A PS/2 keyboard can be connected here.

2.3.5 Serial Ports

The analyzer provides two RS-232 ports, one for connecting the scanner and the other for

connecting a computer (host).

2.3.6 Parallel Port

The analyzer provides a parallel port to connect a printer or a floppy disk drive (a floppy disk

drive is needed to upgrade the system software; the drive can only be connected by a

Mindray-supplied cable).

2.3.7 Power Supply for the Floppy Disk Drive

It supplies power to the connected floppy disk drive. Only the drive power cable supplied by

Mindray can be used.

2.3.8 Power Indicator

The power indicator tells you whether the analyzer is on, off or in the screen saver mode.

2.3.9 Printer（Optional）

An external printer can be connected to the parallel port at the back of the analyzer. You can

use it to print out a detailed report and other interested information.

2.3.10 Scanner（Optional）

A bar-code scanner can be connected to the RS-232 port 1 of the analyzer. You can use it to

scan the bar-coded sample IDs into the analyzer.

z Be sure to use the printer and/or scanner of the specified model.

2-10

Understanding Your Analyzer

2.4 Instrument Software

2.4.1 Main Screen

After finishing the startup procedure, the analyzer enters the “Count” screen, which is the

screen to be used most frequently, hence the name “Main screen”. The main screen is shown

in Figure2-8.

Error message area

Title area

Menu area

Error Message Area

Status area

Analysis area

Help area

Figure2-8 “Count” screen

The Error Message area displays error messages one by one, alternating every two

seconds.

Title Area

The Title area displays the title of the current screen, which, in case of Figure2-8, is “Count”.

Status Area

 System Status Area

The System Status area displays whether this analyzer is ready for the next analysis. When it displays “Ready”, it means this analyzer is ready and you can proceed to analyze the next sample. When it displays “Waiting”, it means the analyzer is not ready for the next run yet. When it displays “Running”, it means this analyzer is analyzing a sample.

2-11

Understanding Your Analyzer

 Count Mode Area

The Count Mode area displays in which analysis (count) mode, whole blood or prediluted,

the next sample is to be analyzed.

 Transmission status

A live animation is displayed in this area when the transmission is in process.

 System Time Area

The System Time area displays the system time (in the 24-hour format).

Analysis Result Area

The Analysis Result area displays the analysis result, including sample ID, analysis time of

the current sample.

Menu Area

When you press [MENU], this area displays the system menu.

Help Area

The Help area reminds you how to proceed to the next step.

2.4.2 System Menu

Press the [MENU] button and the system menu, shown in the figure below, will pop up.

Figure2-9 System menu

The system menu contains 9 programs. The programs followed by “

sub-menus. See the figure below for the fully expanded menu.

2-12

”s have further

Count

Sample Mode

Understanding Your Analyzer

Review

Quality Control

Setup

Sample Review

Search Review

Search Histogram Review

L-J Analysis

X Analysis

X-R Analysis

X-B Analysis Limit

Count Time

Password

Ref. range Transmission Date & Time

L-J/X/X-R Edit L-J/X/X-R Count L-J/X/X-R Graph

L-J/X/X-R Table

Samples/Batch

Start/Stop

X-B Graph

X-B Table

General

Man

Woman

Sample Table Review

Sample Histogram ReviewSearch Table Review

File 1 File 2 File 3 File 4 File 5 File 6 File 7 File 8 File 9

Service

Calibration

Help

Shutdown

Gain

Auto Clean Time

Reagent Exp. Date

Report Title

Parameter Units

Other Setting

Maintenance

System Status

Valve Test

System Test

Prepare to Ship

Error Message

Manual Calibration

Auto Calibration

Fresh Blood

Child

Neonate

Figure 2-10 Fully expanded system menu

2-13

Understanding Your Analyzer

You can select the desired program as instructed below.

If you want to… Select…

analyze samples

select an appropriate analysis mode

review sample results

run the QC program

customize system software

maintain/service the analyzer

calibrate the analyzer

look for help

shut down the analyzer

Count Sample Mode Review Quality Control Setup Service Calibration Help Shutdown

2-14

Understanding Your Analyzer

2.5 Reagents, Controls and Calibrators

Because the analyzer, reagents (diluent, rinse, lyse, probe cleanser and E-Z cleanser),

controls, and calibrators are components of a system, performance of the system depends on

the combined integrity of all components. You should only use the Mindray-specified reagents

(see Appendix B Specifications), which are formulated specifically for the fluidic system of

your analyzer in order to provide optimal system performance. Do not use the analyzer with

reagents from multiple suppliers. In such use, the analyzer may not meet the performance

specified in this manual and may provide unreliable results. All references related to reagents

in this manual refer to the reagents specifically formulated for this analyzer.

Each reagent package must be examined before use. Inspect the package for signs of

leakage or moisture. Product integrity may be compromised in packages that have been

damaged. If there is evidence of leakage or improper handling, do not use the reagent.

z Store and use the reagents as instructed by instructions for use of the

reagents.

z When you have changed the diluent, rinse or lyse, run a background to see

if the results meet the requirement.

z Pay attention to the expiration dates and open-container stability days of all

the reagents. Be sure not to use expired reagents.

z After installing a new container of reagents, keep the reagents still for a

while before using them.

2.5.1 Diluent

The diluent is formulated to meet the following requirements:

 To dilute the blood samples;

 To provide the blood cells with an environment similar to the blood plasma;

 To maintain the cell volume of each red blood cell and platelet during the count and

sizing portion of the measurement cycle;

 To provide a conductive medium for impedance counting of white and red blood cells

and platelets.

2-15

Understanding Your Analyzer

2.5.2 Lyse

The lyse is formulated to meet the following requirements:

 To rapidly break down red blood cell walls, release the hemoglobin from the cell, and

reduce the size of cellular debris to a level that does not interfere with white blood cell

counting.

 To convert hemoglobin to a complex whose absorbance is determined by the

hemoglobin concentration.

2.5.3 Rinse

The rinse is formulated to rinse the baths and metering tubes and to provide proper meniscus

formation in the metering tubes and maintain it during each measurement cycle.

2.5.4 E-Z Cleanser

The E-Z (enzymatic) cleaner is an enzyme-based isotonic, cleaning solution and wetting

agent formulated to clean the fluidic lines and baths.

2.5.5 Probe Cleanser

The probe cleanser is an alkaline cleaning solution formulated to clean the fluidic lines,

apertures and baths.

2.5.6 Controls and Calibrators

The controls and calibrators are used to verify accurate operation of and calibrate the

analyzer.

The controls are commercially prepared whole-blood products used to verify that the analyzer

is functioning properly. They are available in low, normal, and high levels. Daily use of all

levels verifies the operation of the analyzer and ensures reliable results are obtained. The

calibrators are commercially prepared whole-blood products used to calibrate the analyzer.

Read and follow the instructions for use to use the controls and calibrators. All references

related to controls and calibrators in this manual refer to the controls and calibrators reagents

specifically formulated for this analyzer. You should buy those controls and calibrators from

Mindrayor Mindray-authorized distributors.

2-16

3 Understanding the System

Principles

3.1 Introduction

The two independent measurement methods used in this analyzer are:

 the Coulter method for determining the WBC, RBC, and PLT data;

 the colorimetric method for determining the HGB.

During each analysis cycle, the sample is aspirated, diluted and mixed before the

determination for each parameter is performed.

3-1

Understanding the System Principles

3.2 Aspiration

This analyzer can process two types of blood samples – whole blood samples and prediluted

blood samples.

If you are to analyze a whole blood sample, you can simply present the sample to the sample

probe and press the aspirate key to aspirate 13µL of the sample into the analyzer.

If you are to analyze a capillary blood sample, you should first manually dilute the sample (20 μL of capillary sample needs to be diluted by 0.7mL of diluent) and then present the

pre-diluted sample to the sample probe and press the aspirate key to aspirate 0.3ml of the

sample into the analyzer.

3-2

Understanding the System Principles

3.3 Dilution

Usually in blood samples, the cells are too close to each other to be identified or counted. For

this reason, the diluent is used to separate the cells so that they are drawn through the

aperture one at a time as well as to create a conductive environment for cell counting.

Moreover, red blood cells usually outnumber white blood cells by 1,000 times. For this reason,

lyse needs to be added to the sample to eliminate the red cells before the WBC counting.

When analyzing a whole blood sample, this analyzer aspirates 13µL of the sample and

follows the procedure presented in Figure3-1 to dilute it before proceeding to the actual

analysis.

13uL of Whole blood sample

3.5mL of diluent

About 1:269 dilution

0.5mL of lyse

About 1:308 dilution for

the WBC/HGB analysis

15.6uL

About 2.6mL of diluent

About 1:44872 dilution for

the RBC/PLT analysis

Figure3-1 How a whole blood sample is diluted

3-3

Understanding the System Principles

When analyzing a prediluted sample, you should first collect 20μL of capillary sample and

dispense 0.7mL of diluent from this analyzer to predilute it. Then the analyzer aspirates 0.3ml

of the pre-diluted sample for further dilution, as Figure3-2 shows.

20uL of capillary blood sample

0.7mL of diluent

1:36 dilution

0.3mL

2.9 mL of diluent

About 1:384 dilution

24.8uL

0.36 mL of lyse

About 2.8mL of diluent

About 1:428 dilution for

WBC/HGB measurement

About 1:43355 dilution

for RBC/PLT

measuremen

Figure3-2 How a capillary sample is diluted

3-4

Understanding the System Principles

3.4 WBC/HGB Measurement

3.4.1 Volumetric Metering

An accurate cell count cannot be obtained unless the precise volume of diluted sample that

passes through the aperture during the count portion of the analysis cycle (the count cycle) is

known. This analyzer uses a volumetric metering unit to control the count cycle and to ensure

that a precise volume of sample is analyzed.

The metering unit controlling the WBC count cycle consists of a metering tube with two

optical sensors mounted on it. This tube ensures that a precise amount of diluted sample is

measured during each count cycle. The exact amount is determined by the distance between

the two optical sensors. The rinse is used to create a meniscus in the metering tube. The

count cycle starts when the meniscus reaches the upper sensor and stops when the

meniscus reaches the lower sensor. The amount of time required for the meniscus to travel

from the upper sensor to the lower sensor is called the WBC Count Time and is measured in

seconds. At the end of the count cycle, the measured count time is compared to the

pre-defined reference count time (see Chapter 5.3 for details). If the former is less than or

greater than the latter by 2 seconds or more, the analyzer will report a WBC bubble or WBC

Clog error. Seeing the error message, you can refer to Chapter 11 Troubleshooting Your Analyzer for solutions.

Upper sensor

Lower sensor

1 Empty when start 2 Liquid surface fall down through the

volumeritc tube

Upper sensor

Lower sensor

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

4 Counting end when the liquid surface pass the lower sensor

Upper sensor

Lower sensor

Upper sensor

Lower sensor

Figure3-3 Volumetric metering process

3-5

Understanding the System Principles

3.4.2 Measurement Principles

 WBC measurement

WBCs are counted and sized by the Coulter method. This method is based on the

measurement of changes in electrical resistance produced by a particle, which in this case is

a blood cell, suspended in a conductive diluent as it passes through an aperture of known

dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an

electrical pathway. As each particle passes through the aperture, a transitory change in the

resistance between the electrodes is produced. This change produces a measurable

electrical pulse. The number of pulses generated signals the number of particles that passed

through the aperture. The amplitude of each pulse is proportional to the volume of each

particle. Each pulse is amplified and compared to the internal reference voltage channels,

which only accepts the pulses of a certain amplitude. If the pulse generated is above the

WBC threshold, it is counted as a WBC.

Figure3-4

 HGB measurement

HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the

WBC bath where it is bubble mixed with a certain amount of lyse, which converts hemoglobin

to a hemoglobin complex that is measurable at 525 nm. An LED is mounted on one side of

the bath and emits a beam of light, which passes through the sample and a 525nm filter, and

then is measured by a photo-sensor that is mounted on the opposite side. The signal is then

amplified and the voltage is measured and compared to the blank reference reading

3-6

Understanding the System Principles

(readings taken when there is only diluent in the bath). The HGB is calculated per the

following equation and expressed in g/L.

HGB(g/L) = Constant×Log

(Blank Photocurrent/Sample Photocurrent)

3.4.3 Derivation of WBC-Related Parameters

 WBC

WBC (10

passing through the aperture. Note that when you observe NRBCs (nucleated red blood

cells), which do not react with the lyse and can be mistaken by the analyzer for white cells, in

the microscope, be sure to correct the system-generated result by the following formula,

/ L) is the number of leukocytes measured directly by counting the white blood cells

WBC'WBC

＝ ×

where WBC represents the system-generated white cell number, NRBC the number of

NRBCs counted in 100 white cells and WBC′ the corrected white cell number.

 WBC differentia

With the help of the diluent and lyse, this analyzer can size the white cells into three

sub-populations - lymphocytes, mid-sized cells (including monocytes, basophils and

eosinophils ) and granulocytes. Based on the WBC histogram, this analyzer calculates Lymph％, Mid％ and Gran％ as follows and express the results in percents.

Lymph% ×

Mid% ×

Gran% ×

100

NRBC100

＋

100

PGPMPL

100

PGPMPL

100

PGPMPL

L/10

where PLT = particles in the lymphocyte region(

L/10

3-7

)

L/10

PM = particles in the mid size region(

PG = particles in the granulocyte region(

Having achieved the three parameters above, this analyzer proceeds to calculate the

Lymph# , Mid# and Gran# per the following equations and express them in

)

L/10

Understanding the System Principles

 WBC histogram

Besides the parameters mentioned above, this analyzer also presents a WBC histogram, whose x-coordinate represents the cell volume（fL）and y-coordinate represents the number

of the cells. The histogram is presented in the Analysis area of the “Count” screen when the

analysis is done. You can also review the histograms of the stored patient results (see

Chapter 7 Reviewing Sample Results).

The first three discriminators of the WBC histogram can be adjusted in case you are not

satisfied with the result. Note that you cannot adjust them if the WBC result is less than 0.5

or out of the operating range.

#Lymph

#Mid

100

#Gran

100

WBC%Lymph

100

WBC%Mid

WBC%Gran

3.4.4 HGB

Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L) as

follows.

HGB(g/L)=Constant×Log

(Blank Photocurrent/Sample Photocurrent)

3-8

Understanding the System Principles

3.5 RBC/PLT Measurement

3.5.1 Volumetric Metering

An accurate cell count cannot be obtained unless the precise volume of diluted sample that

passes through the aperture during the count cycle is known. This analyzer uses a volumetric

metering unit to control the count cycle and to ensure that a precise volume of sample is

analyzed for the measurement.

The metering unit controlling the RBC/PLT count cycle consists of a metering tube with two

optical sensors mounted on it. This tube ensures that a precise amount of diluted sample is

measured during each count cycle. The exact amount is determined by the distance between

the two optical sensors. The rinse is used to create a meniscus in the metering tube. The

count cycle starts when the meniscus reaches the upper sensor and stops when the

meniscus reaches the lower sensor. The amount of time required for the meniscus to travel

from the upper sensor to the lower sensor is called the RBC Count Time and is measured in

seconds. At the end of the count cycle, the measured count time is compared to the

pre-defined reference count time (see Chapter 5.3 for details). If the former is less than or

greater than the latter by 2 seconds or more, the analyzer will report a RBC bubble or RBC

Clog error. Seeing the error message, refer to Chapter 11 Troubleshooting for solutions.

Upper sensor

Lower sensor

1 Empty when start 2 Liquid surface fall down through the

volumeritc tube

Upper sensor

Lower sensor

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

4 Counting end when the liquid surface pass the lower sensor

Upper sensor

Lower sensor

Upper sensor

Lower sensor

Figure3-5 Volumetric metering process

3-9

Understanding the System Principles

3.5.2 Measurement Principles

 RBC/PLT measurement

RBCs/PLTs are counted and sized by the Coulter method. This method is based on the