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BC-2800

Auto Hematology Analyzer

Operators Manual

2005-2009 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operators 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.

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


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

Be 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.

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

II

Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.

Definitions

Main unit: Integrated facilities which implement the specified function separately.
Generally speaking, the main unit should include power supply, control system and
some functional modules.

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


function.

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

Exemptions
Mindray's obligation or liability under this warranty does not include any transportation or
other charges or liability for direct, indirect or consequential damages or delay resulting from
the improper use or application of the product or the use of parts or accessories not approved
by Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

Malfunction or damage caused by improper use or man-made failure.

Malfunction or damage caused by unstable or out-of-range power input.

Malfunction or damage caused by force majeure such as fire and earthquake.

Malfunction or damage caused by improper operation or repair by unqualified or


unauthorized service people.

Malfunction of the instrument or part whose serial number is not legible enough.

Others not caused by instrument or part itself.

The standard warranty period is as below:

Main unit: 18 months from shipment

Accessories: 15 months from shipment

Consumables: N/A

III

Return Policy
Return Procedure
In the event that it becomes necessary to return this product or part of this product to Mindray,
the following procedure should be followed:
1.

Return authorization: Contact the international Customer Service Department and obtain
a Return Materials Authorization number. This number must appear on the outside of the
shipping container. Returned shipments will not be accepted if the number is not clearly
visible. Please provide the model number, serial number, and a brief description of the
reason for return.

2.

Freight policy: The customer is responsible for freight charges when this product is
shipped to Mindray for service (this includes customs charges).

3.

Return address: Please send the part(s) or equipment to the address offered by the
international Customer Service Department.

Company Contact
Manufacturer:
E-mail Address:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.


service@mindray.com.cn

Tel:

+86 755 26582479 26582888

Fax:

+86 755 26582934 26582500

EC-Representative:
Address:

Shanghai International Holding Corp. GmbH(Europe)


Eiffestrae 80, Hamburg 20537, Germany

Tel:

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

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


2.1
Introduction ............................................................................................ 2-1
2.2
Intended Use.......................................................................................... 2-2
2.3
User Interface......................................................................................... 2-3
2.3.1 LCD ............................................................................................. 2-6
2.3.2 Input Devices .............................................................................. 2-6
2.3.3 Recorder...................................................................................... 2-8
2.3.4 Keyboard Interface...................................................................... 2-8
2.3.5 Serial Ports.................................................................................. 2-8
2.3.6 Parallel Port................................................................................. 2-8
2.3.7 Power Supply for the Floppy Disk Drive ..................................... 2-8
2.3.8 Power Indicator ........................................................................... 2-8
2.3.9 Optional Devices ......................................................................... 2-8
2.4
Instrument Software ............................................................................... 2-9
2.4.1 Main Screen ................................................................................ 2-9
2.4.2 Screen saver ............................................................................. 2-10
2.4.3 System Menu ............................................................................ 2-11
2.5
Reagents, Controls and Calibrator....................................................... 2-13
2.5.1 Diluent ....................................................................................... 2-13
2.5.2 Lyse ........................................................................................... 2-13
2.5.3 Rinse ......................................................................................... 2-14
2.5.4 E-Z Cleanser ............................................................................. 2-14
2.5.5 Probe Cleanser ......................................................................... 2-14
2.5.6 Controls and Calibrator ............................................................. 2-14

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


3.1
Introduction ............................................................................................ 3-1
3.2
Aspiration ............................................................................................... 3-2
3.3
Dilution ................................................................................................... 3-3
3.4
WBC/HGB Measurement....................................................................... 3-4
3.4.1 Volumetric Metering .................................................................... 3-4
3.4.2 Measurement Principles.............................................................. 3-5
1

Table of Contents
3.4.3 Derivation of WBC-Related Parameters ..................................... 3-6
3.4.4 HGB............................................................................................. 3-7
3.5

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


3.5.1 Volumetric Metering .................................................................... 3-8
3.5.2 Measurement Principles.............................................................. 3-9
3.5.3 Derivation of RBC-Related Parameters ...................................... 3-9
3.5.4 Derivation of PLT-Related Parameters ..................................... 3-11

3.6

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

Installing Your Analyzer .......................................................................... 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
4.1

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


5.1
Introduction ............................................................................................ 5-1
5.2
Password ............................................................................................... 5-2
5.2.1 Entering the Administrator Password.......................................... 5-2
5.2.2 Resuming the Common User Password..................................... 5-3
5.3
Editing Settings ...................................................................................... 5-4
5.3.1 Reagent....................................................................................... 5-5
5.3.2 Printing and Communication Settings......................................... 5-6
5.3.3 Date and Time........................................................................... 5-11
5.3.4 Gain........................................................................................... 5-13
5.3.5 Count......................................................................................... 5-16
5.3.6 Reference Range ...................................................................... 5-20
5.3.7 Auto Maintain ............................................................................ 5-23
5.3.8 Other Settings ........................................................................... 5-25

Operating Your Analyzer ......................................................................... 6-1


6.1
Introduction ............................................................................................ 6-1
6.2
Initial Checks.......................................................................................... 6-2
2

Table of Contents
6.3

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

6.4

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

6.5

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

6.6

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


6.6.1 Whole Blood Samples................................................................. 6-6
6.6.2 Prediluted Samples ..................................................................... 6-7

6.7

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


6.7.1 Entering Sample Information ...................................................... 6-9
6.7.2 Running the Samples................................................................ 6-15
6.7.3 Special Functions ...................................................................... 6-16

6.8

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


6.8.1 Entering Sample Information .................................................... 6-19
6.8.2 Running the Samples................................................................ 6-24
6.8.3 Special Functions ...................................................................... 6-25

6.9

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

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


7.1
Introduction ............................................................................................ 7-1
7.2
Browsing All Sample Results ................................................................. 7-2
7.2.1 Browsing in the Histogram Mode ................................................ 7-2
7.2.2 Browsing in the Table mode...................................................... 7-7
7.3
Searching for Interested Sample Results ............................................ 7-17
7.3.1 Starting a Search....................................................................... 7-17
7.3.2 Reviewing search result in the Table mode ............................ 7-19
7.3.3 Reviewing Search Result in the Histogram Mode .................. 7-29

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


8.1
Introduction ............................................................................................ 8-1
8.2
QC With Controls ................................................................................... 8-2
8.2.1 QC Editing ................................................................................... 8-2
8.2.2 Running the Controls .................................................................. 8-6
8.2.3 Reviewing QC Results .............................................................. 8-10
8.3
X-B Analysis ......................................................................................... 8-15
8.3.1 QC Editing ................................................................................. 8-15
8.3.2 Running X-B Analysis................................................................ 8-18
8.3.3 Reviewing X-B Results.............................................................. 8-18

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


9.1
Introduction ............................................................................................ 9-1
9.2
When to Calibrate .................................................................................. 9-2
9.3
How to Calibrate..................................................................................... 9-3
9.3.1 Preparing Your Analyzer.............................................................. 9-3
9.3.2 Calibration Using Calibrator Program ......................................... 9-4
9.3.3 Fresh Blood Calibration............................................................. 9-10
3

Table of Contents
9.3.4 Manual Calibration Program ..................................................... 9-17

10

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


10.1 Introduction .......................................................................................... 10-1
10.2 General Guidelines .............................................................................. 10-2
10.3 Using the Maintenance Program ....................................................... 10-3
10.3.1 Diluent Prime............................................................................. 10-4
10.3.2 Rinse Prime............................................................................... 10-5
10.3.3 Lyse Prime ................................................................................ 10-6
10.3.4 Zap Aperture ............................................................................. 10-7
10.3.5 Flush Aperture........................................................................... 10-8
10.3.6 Probe Cleanser Cleaning .......................................................... 10-9
10.3.7 E-Z Cleanser Cleaning............................................................ 10-11
10.3.8 Lyse Test ................................................................................. 10-13
10.3.9 Clean Bath .............................................................................. 10-15
10.3.10 Drain Bath............................................................................. 10-16
10.3.11 Drain Tubing ......................................................................... 10-18
10.3.12 Clean Probe Wipe................................................................. 10-19
10.3.13 Prepare to Ship..................................................................... 10-21
10.4 Using the Status Program................................................................ 10-23
10.5 Using the Self-test Program ............................................................ 10-24
10.5.1 Testing the Fluidic System ...................................................... 10-25
10.5.2 Testing Motors and Recorder/Printer ...................................... 10-25
10.5.3 Testing Valves ......................................................................... 10-26
10.5.4 Testing A/D Interrupt................................................................ 10-27
10.6 Log ..................................................................................................... 10-28
10.7 Viewing System Configuration ........................................................... 10-30
10.8 Printing Management......................................................................... 10-31
10.9 Calibrating Sample Probe Position .................................................... 10-32
10.10 Replacing the Probe Wipe ................................................................. 10-36
10.11 Replacing the Filter of the Vacuum Chamber .................................... 10-37
10.12 Maintaining Recorder ......................................................................... 10-39

11

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


11.1 Introduction .......................................................................................... 11-1
11.2 Errors without available error messages ............................................. 11-2
11.3 Errors indicated by error messages ..................................................... 11-3

12

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

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

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

Table of Contents

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

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

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

Using This Manual

1.1 Introduction
This chapter explains how to use your operators 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.

Operate your analyzer strictly as instructed in this manual.

All illustrations in this manual are provided as examples only. They may not
necessarily reflect your analyzer setup or data displayed and must not be
used for any other purpose.

1-1

Using This Manual

1.2 Who Should Read This Manual


This manual contains information written for clinical laboratory professionals to

learn about the BC-2800 hardware and software;

customize system settings;

perform daily operating tasks;

perform system maintenance and troubleshooting.

1-2

Using This Manual

1.3 How to Find Information


This operators 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

Understanding

Your Analyzer
learn about the hardware and software of the BC-2800

Chapter

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

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

Chapter 6 Operating Your

operating tasks

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

Using

the

QC

Programs
learn about how to calibrate the BC-2800

Chapter

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

Chapter 11 Troubleshooting

correct the problems

Your Analyzer

learn about the technical specifications of the BC-2800

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-2800

Appendix D Communication

1-3

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

It means
to press the arrow keys ([][] [][]) as needed to move the

CLICK

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.

ENTER

Note that besides the numeric keys you may also use the
[PgUp] or [PgDn] keys to enter digits; or to scan the number
using the bar-code scanner.
to press the arrow keys ([][] [][]) as needed to move the
cursor to the character or digit to the left of the one you want to
delete and press [DEL]; or to press the arrow keys

DELETE

([][][][]) 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.
to press the arrow keys ([][] [][]) as needed to move the

SELECT from **
pull-down list

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

SELECT

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

DOCUMENTS.
BIOLOGICAL RISK

HIGH VOLTAGE

ALTERNATING CURRENT

USE BY

1-6

ACCOMPANYING

Using This Manual


SERIAL NUMBER

IN VITRO DIAGNOSTIC

DATE OF MANUFACTURE

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

THE DEVICE IS FULLY CONFORMANCE


WITH

THE

CONCERNING

COUNCIL
IN

VITRO

DIRECTIVE
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

WASTE.

TREATED
BY

AS

HOUSEHOLD

ENSURING

THAT

THIS

PRODUCT IS DISPOSED OF CORRECTLY,


YOU WILL HELP PREVENT BRINGING
POTENTIAL NEGATIVE CONSEQUENCES
TO THE ENVIRONMENT AND HUMAN
HEALTH.

FOR

INFORMATION
1-7

MORE
WITH

DETAILED

REGARD

TO

Using This Manual


RETURNING
PRODUCT,

AND

RECYCLING

THIS

CONSULT

THE

PLEASE

DISTRIBUTOR

FROM

WHOM

PURCHASED THE PRODUCT.

1-8

YOU

Using This Manual

3
2

Figure 1-1 Back of the analyzer

(1)
Equipotentiality.

Connect only to a properly earth grounded outlet;

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

Replace fuse only with the type and rating specified.

3
Biological risk.

4
The following definition of the WEEE label applies to EU member states only: The use of this
symbol indicates that this product should not be treated as household waste. By ensuring that
1-9

Using This Manual


this product is disposed of correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For more detailed information with
regard to returning and recycling this product, please consult the distributor from whom you
purchased the product.

Figure 1-2 Warning label

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

1-10

Using This Manual

Figure 1-3 Warning label

6
To avoid electrical shock, disconnect the power supply before maintaining this device.

1-11

Using This Manual

Figure 1-4 High voltage warning label

7
High Voltage

1-12

Understanding Your Analyzer

2.1 Introduction
The BC-2800 Auto Hematology Analyzer is a quantitative, automated hematology analyzer
and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories.

2-1

Understanding Your Analyzer

2.2 Intended Use

The purpose of this analyzer is to identify the normal patient, with all normal
system-generated parameters, and to flag or identify patient results that
require additional studies.

The analyzer is used for the quantitative determination of a maximum of 19 parameters and 3
histograms of blood samples.
White Blood Cell or leukocyte

WBC

Lymphocyte

Lymph#

Mid-sized cell

Mid#

Granulocyte

Gran#

Lymphocyte percentage

Lymph%

Mid-sized cell percentage

Mid%

Granulocyte percentage

Gran%

Red Blood Cell or erythrocyte

RBC

Hemoglobin Concentration

HGB

Mean Corpuscular (erythrocyte) Volume

MCV

Mean Cell (erythrocyte) Hemoglobin

MCH

Mean Cell (erythrocyte) Hemoglobin Concentration

MCHC

Red Blood Cell (erythrocyte) Distribution Width

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 Interface

Figure 2-1 Front view

1 ---- LCD

2 ---- Keypad

3 ---- Recorder

4 ---- Power indicator

5 ---- Aspirate key

6 ---- Sample probe

2-3

Understanding Your Analyzer

Figure 2-2 Back view

1 --- Power switch

2 --- Equipotentiality

3 --- Waste outlet(Red)

4 --- Lyse inlet(Orange)

5 --- Rinse inlet(Blue)

6 --- Diluent inlet(Green)

2-4

Understanding Your Analyzer

Figure 2-3 Left view

1 --- RS-232 port1

2 --- Parallel port

3 --- RS-232 port2

4 --- Power Interface of Floppy Disk Drive

5 --- Keyboard interface

2-5

Understanding Your Analyzer

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

2.3.2 Input Devices


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

Aspirate key

The aspirate key is located behind the sample probe, as Figure 2-4 shows. You can press the
key to start the selected run cycle or dispense diluent.

Figure 2-4 Sample probe and aspirate key

1.Sample probe

2. Aspirate key

2-6

Understanding Your Analyzer

Built-in keypad

The 18-key keypad is located below the LCD, as Figure 2-5 shows.

Figure 2-5 Build-in keypad

PS/2 keyboard

The analyzer can also be controlled by an external PS/2 keyboard that should be connected
to the analyzers keyboard interface. See Table 2-1 for the correspondence between the
keypad keys and the keyboard keys and for their functions.
Table 2-1 Key functions
Keypad

PS/2 keyboard

Function

[MENU]

[Esc]

Press it to enter/exit the system menu.

[PRINT]

[P] or [p]

Press it to print out data by the recorder or printer.

[HELP]

[H] or [h]

Press it to call out the analyzers on-line help.

[DEL]

[Delete] or [Del]

Press it to delete data and characters.

[ENTER]

[Enter]

Press it to confirm or execute an operation

[], [],

[], [],

Press them to move the cursor.

[], []

[], []

[F1], [F2], [F3],

[F1], [F2], [F3],

Press them to use various functions. See the rest of this

[F4], [F5]

[F4], [F5]

manual or the analyzers on-line help for details.

[PgUp][PgDn]

[PageUp]

Press them to scroll the screen.

[PageDown]
[MODE]

[Ctrl+A]

Switch to another analysis mode (works only in the


Count screen).

[DILUENT]

In the prediluted mode, press it if you want to dispense


diluent into the sample tube.

Other keys

Use them as needed. See the rest of this manual or the


analyzers on-line help for details.

2-7

Understanding Your Analyzer

2.3.3 Recorder
A thermal recorder is located on the front panel. It prints out analysis reports and other related
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
Mindraycan 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 Optional Devices

Printer

An external printer can be connected to the parallel port at the left side of the analyzer. You
can use it to print out a detailed report and other desired information.

Bar-code scanner

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 and reagent information into the analyzer.

Use the printer and scanner of the specified model.

2-8

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 is main screen.
Title Area

Count Mode Area

Error Message
Area

Help Area

Figure 2-6 Count screen

System Status Area

Reagent Status
Area

Title Area

The Title area displays the title of the current screen, which, in case of Figure 2-6, is Count.

Count Mode Area

The Count Mode area displays in which analysis (count) mode, the next sample is to be
analyzed. In case of Figure 2-6, the next sample is to be analyzed in the Whole Blood-All.

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.

System Time Area


2-9

Understanding Your Analyzer


The System Time area displays the system time.

Sample Information Area

The Sample Information area has two sub-areas, the upper titled Current sample and the
lower Next sample.
The Current sample refers to the sample, whose analysis result is displayed on the
Count screen. Its sample ID, time of analysis, analysis mode and patient information (name,
gender, age), are respectively displayed in the fields of the Current sample area.
The Next Sample refers to the sample to be analyzed next. Its sample ID and analysis
mode are displayed in the Next sample area.

Analysis Result Area

The Analysis Result area displays the analysis result, including histograms, of the current
sample.

Error Message Area

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

Reagent Status Area

The Reagents Status area displays how many counts the remaining reagents are enough for.
Note that when it displays 99 counts, it indicates the reagents are enough for over 99
counts and there is also enough space left in the waste container for the counts; when it
displays 0 counts, it indicates either at least one of the reagents is insufficient or the waste
container is full.

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 Screen saver


This analyzer will enter the screen saver if it has been idle at the Count screen for 10
minutes. When it happens, the sample probe will retract into the analyzer, the LCD will turn
dark and the power indicator will be flickering. You can press any key to resume the display
and reposition the sample probe.

2-10

Understanding Your Analyzer

2.4.3 System Menu


Press the [MENU] button and the system menu, shown in Figure 2-7 below, will pop up.

Figure 2-7 System menu


The system menu contains 7 programs. The programs followed by >s have further
sub-menus. See Figure 2-8 for the expanded menu.

Figure 2-8 Fully expanded system menu

2-11

Understanding Your Analyzer


You can select the desired program as instructed below.

If you want to

Select

analyze samples

Count

review sample results

Review

run the QC program

Quality Control

customize system software

Setup

maintain/service the analyzer

Service

calibrate the analyzer

Calibration

shut down the analyzer

Shutdown

2-12

Understanding Your Analyzer

2.5 Reagents, Controls and Calibrator


Because the analyzer, reagents (diluent, rinse, lyse, probe cleanser and E-Z cleanser),
controls, and calibrator 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. If other reagents are used, 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.

Store and use the reagents as directed by instructions for use of the
reagents.

When you have changed the diluent, rinse or lyse, run a background to see
if the results meet the requirement.

Pay attention to the expiration dates and open-container stability days of all
the reagents. Never use expired reagents.

After installing new reagents, let the reagents stand 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.

2.5.2 Lyse
The lyse is formulated to meet the following requirements:
2-13

Understanding Your Analyzer

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 bath 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 bath.

2.5.5 Probe Cleanser


The probe cleanser is an alkaline cleaning solution formulated to clean the fluidic lines,
apertures and bath.

2.5.6 Controls and Calibrator


The controls and calibrator 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. Controls and calibrators can be purchased from
Mindray or Mindray-authorized distributors.

2-14

Understanding the System


Principles

3.1 Introduction
The two independent measurement methods used in this analyzer are:

the impedance 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 going to analyze a whole blood sample, you can simply present the sample to the
sample probe and press the aspirate key to aspirate 13L of the sample into the analyzer.
If you are going to analyze a capillary blood sample, you should first manually dilute the
sample (20 L of capillary sample needs to be diluted by 1.6 mL of diluent) and then present
the pre-diluted sample to the sample probe and press the aspirate key to aspirate 0.7 mL 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.

3-3

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, as Figure 3-1 shows. 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 WBC
bubbles or WBC clog error. Seeing the error message, you can refer to Chapter 11
Troubleshooting Your Analyzer for solutions.

Figure 3-1 Volumetric metering process

3-4

Understanding the System Principles

3.4.2 Measurement Principles

WBC measurement

WBCs are counted and sized by the impedance method, as Figure 3-2 shows. 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 indicates 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 certain amplitude. If the
pulse generated is above the WBC threshold, it is counted as a WBC.

Figure 3-2 Impedance method of counting and sizing

HGB measurement

HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the
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 monochromatic light, whose central wavelength is 525nm, 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
(readings taken when there is only diluent in the bath). The HGB is calculated per the
following equation and expressed in g/L.

3-5

Understanding the System Principles


HGB(g/L) = ConstantLog 10 (Blank Photocurrent/Sample Photocurrent)

3.4.3 Derivation of WBC-Related Parameters

WBC

WBC (109/ L) is the number of leukocytes measured directly by counting the white blood cells
passing through the aperture.

WBC = n 109 / L
Note that NRBCs do not react with the lyse and can be mistaken by the analyzer for white
blood cells. If you observe NRBCs in the microscope, correct the system-generated result by
the following formula,

WBC'WBC

100
100NRBC

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% =

PL
PL + PM + PG
PM

100

100

PL + PM + PG
PG
PL + PM + PG

100

where PL = particles in the lymphocyte region( 10


PM = particles in the mid size region( 10

/L)

/L)

PG = particles in the granulocyte region( 10

/ L ).

Having achieved the three parameters above, this analyzer proceeds to calculate the
Lymph# , Mid# and Gran# per the following equations and express them in
3-6

10 9 / L .

Understanding the System Principles

Lymph# =

Lymph% WBC
100

Mid # =

Mid % WBC
100

Gran # =

Gran % WBC
100

WBC histogram

Besides the parameters mentioned above, this analyzer also presents a WBC histogram,
whose x-coordinate represents the cell volumefLand y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result 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.

3.4.4 HGB
Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L) as
follows.
HGB (g/L)=ConstantLog 10 (Blank Photocurrent/Sample Photocurrent)

3-7

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, as Figure 3-3 shows. 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 RBC
bubbles or RBC clog error. Seeing the error message, refer to Chapter 11 Troubleshooting
Your Analyzer for solutions.

Figure 3-3 Volumetric metering process

3-8

Understanding the System Principles

3.5.2 Measurement Principles

RBC/PLT measurement

RBCs/PLTs are counted and sized by the impedance method, as Figure 3-4 shows. 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 indicates
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 RBC/PLT lower threshold, it is counted as an RBC/PLT.

Figure 3-4 Impedance method of counting and sizing

3.5.3 Derivation of RBC-Related Parameters

RBC

RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes
passing through the aperture.

MCV

Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and
3-9

Understanding the System Principles


expresses the result in fL.
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows:

HCT =

RBC MCV
10

MCH =

HGB
RBC

MCHC =

HGB
100
HCT

Where the RBC is expressed in 1012/L, MCV in fL and HGB in g/L.

RDW-CV

Based on the RBC histogram, this analyzer calculates the CV (Coefficient of Variation) of the
erythrocyte distribution width.

RDW-SD

RDW-SD (RBC Distribution Width Standard Deviation, fL) is set on the 20% frequency level
with the peak taken as 100%, as Figure 3-5 shows.

Figure 3-5 RBC Distribution Width Standard Deviation

RBC Histogram

Besides the parameters mentioned above, this analyzer also presents an RBC histogram,
whose x-coordinate represents the cell volumefLand y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result 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 two discriminators of the RBC histogram can be adjusted in case you are not satisfied
with the result. Note that you cannot adjust them if the RBC result is less than 0.2 or out of the
operating range.

3-10

Understanding the System Principles

3.5.4 Derivation of PLT-Related Parameters

PLT

PLT (109/L) is measured directly by counting the platelets passing through the aperture.

MPV

Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL).

PDW

Platelet distribution width (PDW) is the geometric standard deviation (GSD) of the platelet
size distribution. Each PDW result is derived from the platelet histogram data and is reported
as 10 (GSD).

PCT

This analyzer calculates the PCT as follows and express it in .


Where the PLT is expressed in 109/L and the MPV in fL.

PCT =

PLT MPV
10000

PLT Histogram

Besides the parameters mentioned above, this analyzer also presents a PLT histogram,
whose x-coordinate represents the cell volumefLand y-coordinate represents the number
of the cells. The histogram is presented in the Analysis Result 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 two discriminators of the PLT histogram can be adjusted in case you are not satisfied
with the result. Note that you cannot adjust them if the PLT result is less than 10 or out of the
operating range.

3-11

Understanding the System Principles

3.6 Wash
After each analysis cycle, each element of the analyzer is washed.

The sample probe is washed internally and externally with diluent;

The bath is washed with diluent and rinse;

The metering tube is washed with rinse;

The rest of the fluidic system is washed by diluent.

3-12

Installing Your Analyzer

4.1 Introduction
This chapter introduces how to install the BC-2800. To ensure all system components
function correctly and to verify system performance, Mindray-authorized representatives will
handle the installation and initial software setup.

Installation by personnel not authorized or trained by Mindray may damage


your analyzer. Do not install your analyzer without the presence of
Mindray-authorized personnel.

4-1

Installing Your Analyzer

4.2 Installation Requirements


Before installation, you should ensure that the following space, power and environmental
requirements are met.

4.2.1 Space Requirements


Check the site for proper space allocation. In addition to the space required for the analyzer
itself, arrange for

at least 28 cm on each side, which is the preferred access to perform service


procedures;

at least 10 cm behind for cabling and ventilation;

enough room on or below the countertop to accommodate the diluent, rinse and waste
containers.

4.2.2 Power Requirements


Check the availability of a power outlet that meets the following requirements

Voltage: 100 to 240 VAC;

Frequency: 50/601 Hz

Power: 180VA

Fuse: 250V T4A

Make sure the analyzer is properly grounded.

Replace fuse only with the type and rating specified.

Make sure the electrical outlet meets the requirements.

Before connecting the power cord, make sure the power switch at the back
of the analyzer is placed in the off (O) position.

4-2

Installing Your Analyzer

4.2.3 General Environment

Operating temperature: 15 to 30 .

Relative humidity: 30% to 85%.

Atmospheric pressure: 60 kPa to 106 kPa.

The environment should be as free as possible from dust, mechanical vibrations, loud
noises, and electrical interference.

Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.

Do not place the analyzer in direct sunlight or in front of a source of heat or drafts.

Do not place the analyzer in a flammable or explosive environment.

Do not place any container on the top of the analyzer.

If the ambient temperature is outside the specified operating range, the


analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting Your Analyzer for
solutions.

4-3

Installing Your Analyzer

4.3 Unpacking
4.3.1 Unpacking and Inspecting the Analyzer
Your analyzer is tested before it is shipped from the factory. International symbols and special
handling instructions tell the carrier how to treat this electronic instrument. When you receive
your analyzer, carefully inspect the carton. If you see any signs of mishandling or damage,
contact Mindray customer service department or your local distributor immediately. When you
are sure the carton is fine, follow the steps below to unpack the analyzer:

Place the carton on the floor upright with the arrows on the side upwards;

Remove the tape and take out the accessory box. Check the accessories against the
packing list. Notify the Mindray customer service department or your local distributor
immediately if you find anything missing;

Open the main box and check the items inside against the packing list. Notify the
Mindray customer service department or your local distributor immediately if you find
anything missing;

Remove the top protective foam, carefully carry out the analyzer from the box and place
it on the countertop.

Remove the foam fixing the sample probe.

Retain the shipping carton and all the packing materials, as they can be
used for packaging if analyzer must be reshipped.

4.3.2 How to move the analyzer

If the carton is intact, you may use a plate and fork-lifter to move the analyzer for a short
distance.

If your analyzer has been used, do the Empty tubing procedure and shut it down
before moving it.

For a short - distance moving on a smooth ground, you may use a trolley to facilitate the
transportation.

During the moving process, protect the LCD and the sample probe from excessive force
and from contact with other objects.

Keep the analyzer upright during the moving process. Do not tilt or incline it.

Do your best to minimize the mechanical shock when moving the analyzer. After a
long-distance moving, check and tune the analyzer before using it.
4-4

Installing Your Analyzer

4.4 Installation Procedure

Dispose of reagents, waste, samples, consumables, etc. according to


government regulations.

The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

z
z

Use the specified reagents.


After installing new reagents, keep the reagents still for a while before using
them.

z
z

Never use expired reagents.


To prevent contamination, tighten the container caps when the installation is
finished.

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

4.4.1 Connecting Regents


On the back of the instrument you will find a fluidic connection equipped with 4 plastic plugs.
These plugs are closed by protection caps to prevent dust and the leaking of liquids during
transportation. Take off these caps by unscrewing them and keep them in a safe place for
future transportation.

Connecting the diluent container


1. Take out the diluent pickup tube (the one with a green connector) from the accessory box
4-5

Installing Your Analyzer


Figure 4-1;

Figure 4-1 Diluent container


2. Take out the diluent container and place it on or below the countertop;
3. Remove the container cap and insert the tube end that has no connector into the diluent
container and tighten the cap until properly secured, as Figure 4-2 shows;

Figure 4-2 Insert the tube end into the container


4. Locate the green fitting marked DILUENT in the lower right corner of the back of the
analyzer;
5. Plug the green connector of the tube into the fitting and turn it clockwise until properly
secured.

Connecting the rinse container


1. Take out the rinse pickup tube (the one with a blue connector) from the accessory box, as
Figure 4-3 shows;

4-6

Installing Your Analyzer

Figure 4-3 Rinse container


2. Take out the rinse container and place it on or below the countertop;
3. Remove the container cap and insert the tube end that has no connector into the rinse
container and tighten the cap until properly secured, as Figure 4-4 shows;

Figure 4-4 Insert the tube end into the container


4. Locate the blue fitting marked RINSE in the lower right corner of the back of the
analyzer.
5. Plug the blue connector of the tube into the fitting and turn it clockwise until properly
secured.

Connecting the lyse container


1. Take out the lyse pickup tube (the one with an orange connector) from the accessory box,
as Figure 4-5 shows;

4-7

Installing Your Analyzer

Figure 4-5 Lyse container


2. Take out the lyse container;
3. Remove the container cap and insert the tube end that has no connector into the
container and tighten the cap until properly secured, as Figure 4-6 shows;

Figure 4-6 Insert the tube into the container


4. Locate the orange fitting marked LYSE in the lower right corner of the back of the
analyzer;
5. Plug the orange connector of the tube into the fitting and turn it clockwise until properly
secured.

Connect the waste container


1. Take out the waste tube (the one with a red connector) from the accessory box;
2. Locate the red fitting marked WASTE in the lower right corner of the back of the
analyzer;
3. Plug the red connector of the tube into the fitting and turn it clockwise until properly
secured;
4. Prepare a container to receive the waste and place it on or below the countertop;
5. Insert the waste tube into the waste container.

4-8

Installing Your Analyzer

4.4.2 Installing Recorder Paper

Remove the protective paper between the recorder head and the roller
inside the recorder before installing recorder paper.

Follow the procedure below to install the recorder paper.


1.

Use the latch at the upper right corner of the recorder door to pull the door open.

2.

Insert a new roll into the compartment as shown below.

3.

Close the recorder door.

4.

Check if paper is installed correctly and the paper end is feeding from the top.

Paper roll

Figure 4-7 Installing recorder paper

Use only specified recorder paper. Otherwise, it may cause damage to the
recorder head, or the recorder may be unable to print, or poor print quality
may result.

Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.

Do not leave the recorder door open unless you install paper or remove
trouble.

Improper installation of recorder paper may jam the paper and/or result in
blank printout.

4-9

Installing Your Analyzer

4.4.3 Connecting the Keyboard


Take out the keyboard from the accessory kit and connect it to the keyboard interface marked
KB.

4.4.4 Connecting the Printer (Optional)


Follow the printers instructions for use to connect the printer to the parallel port.

4.4.5 Connecting the Bar-Code Scanner (Optional)


Follow the scanners instructions for use to connect the scanner to the serial port1.

Use the printer and scanner of the specified model.

4-10

Installing Your Analyzer

4.5 Starting the Analyzer


Take out the power cord from the accessory box. Plug the non-pronged end into the AC input
at the back of the analyzer and the pronged end into an electrical outlet. Place the power
switch at the back of the analyzer in the ON position (1) to turn on the analyzer. The power
indicator light will be illuminated and the screen will display Initializing. The analyzer will
sequentially initialize the file, hardware and fluidic systems and the whole initializing process
lasts about 4 to 7 minutes. When the initialization is finished, the analyzer will automatically
enter the Count screen.

4-11

Customizing the Analyzer Software

5.1 Introduction
The BC-2800 is a flexible laboratory instrument that can be tailored to your work environment.
You can use the Setup program to customize the software options as introduced in
Chapters 5.2 to 5.3.

5-1

Customizing the Analyzer Software

5.2 Password
The BC-2800 classifies users into two categories: common users (default) and administrators.
You need to enter the administrator password to adjust certain options such as Count,
Gain, etc.

5.2.1 Entering the Administrator Password


Press [MENU] to enter the system menu.

Figure 5-1 System menu


SELECT Setup Password ( Figure 5-1 ) to enter the Password screen ( Figure 5-2 ).

Figure 5-2 Password screen


ENTER 2826 and press [MENU], a message box will pop up to remind you of the current
password level, as Figure 5-3 shows, to remind you of the current password level,

5-2

Customizing the Analyzer Software

Figure 5-3 A message box to confirm the user level


CLICK Yes to confirm the password and exit to the system menu.

5.2.2 Resuming the Common User Password


Enter the Password screen and the default password is the common user password. Press
[MENU] again and a message box will pop up to remind you of the current password level, as
Figure 5-4 shows.

Figure 5-4 A message box to confirm the user level


CLICK Yes to confirm the password and exit to the system menu.

5-3

Customizing the Analyzer Software

5.3 Editing Settings


You can use the Settings menu to edit system settings.
Press [MENU] to enter the system menu. SELECT Setup Settings, as Figure 5-5 shows,
to enter the Settings screen, as Figure 5-6 shows.

Figure 5-5 System menu

Figure 5-6 Settings screen

This screen can be interpreted as follows:

Setting Groups area (on the left)

This area displays the visible or changeable setting groups. You can press [F1] to select the
desired group. The selected group is preceded by a .

Settings area (on the right)

You can change the settings of the items displayed in this area.

Help area (on the bottom)


5-4

Customizing the Analyzer Software


This area displays useful information to help you move to the next step.
At this screen, if you want to acquire help information, press [HELP]; if you want to return to
the system menu, press [MENU].

5.3.1 Reagent
You can select the Reagent group to change the settings regarding the reagents and the
waste, as Figure 5-7 shows.

Figure 5-7 Reagent settings

Selecting the Reagent group

Press [F1] to select the Reagent group.

Setting remaining volumes for reagents

You may set the remaining volumes for the diluent, rinse and lyse. When any of the entered
volumes is counted down to zero, the system will remind you to install a new container.
1. SELECT Diluent, Rinse or Lyse in the Remains field as needed;
2. ENTER the desired digits. See Table 5-1 for the valid reagent volumes.
Table 5-1 Valid reagent volumes
Diluent
Allowed range

About 0 to 30.0 L

Rinse
About 0 to 30.0 L

Lyse
About 0 to 999.0 mL

Entering the usable volume of the waste container

You may enter the usable volume of the waste container. When the system counts down the
entered volume to 0, it will alert you to empty the waste container. Follow the steps given
below to set the volume.
5-5

Customizing the Analyzer Software


1. SELECT Waste Container;
2. ENTER the desired digits.

Entering expiration dates of reagents

You can specify the expiration dates for the diluent, rinse and lyse. Once any of these
reagents is expired, the system will alert you to install a new container. Follow the steps given
below to enter the expiration dates.
1. SELECT Exp. Date;
2. ENTER the desired digits. You can use the bar-code scanner (if available) to scan the
bar-code of the reagents into the analyzer;
3. Note that open reagents are stable for 60 days. The entered expiration date should be
the open date + 60 days or the expiration date marked on the packaging of the reagent,
whichever is earlier.

Exiting the Reagent group

When you have finished changing all the desired reagent settings, you may
1. Press [F1] to select another setting group you want to change; or
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-8 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.

Figure 5-8 Saving changes


Note that if any entered value is beyond the valid range, a message box will pop up after you
have pressed [MENU]. CLICK Yes to close the message box and clear the invalid values.

Figure 5-9 A message box to remind you of the erroneous entry

5.3.2 Printing and Communication Settings


You can select the Print & comm. group to change the printing and communication settings

5-6

Customizing the Analyzer Software


to your own need, as Figure 5-10 shows.

Figure 5-10 Printing and communication settings

Selecting the Print & comm. group

Press [F1] to select the Print & comm. group.

Selecting the printing device

To select a printing device, SELECT Recorder or Printer from the Device drop-down
list, as Figure 5-10 shows.

Selecting the printing format

If you have selected the printer, you can choose either of the following printing formats.
1. Format1 - One page with histogram;
2. Format2 - One page without histogram.
To select a printing format, SELECT desired format from the Format drop-down list,
If you have selected the recorder, you can choose any of the following 4 printing formats.
1. Format1 - parameter values + histograms;
2. Format2 parameter values only;
3. Format3 - parameter values + histograms;
4. Format4 - parameter values only.
To choose the desired format, SELECT the desired format from the Format pull-down list,
as Figure 5-11 shows.

5-7

Customizing the Analyzer Software

Figure 5-11 Selecting printing format

Auto printing

The auto printing function refers to the analyzers ability to automatically print out the analysis
results once they are done. To activate this function, SELECT ON (or OFF) from the
Auto pull-down list, as Figure 5-12 shows.

Figure 5-12 Selecting auto-printing

Setting baud rate

To choose one of the four baud rates, 19200, 9600, 4800, 2400 and 1200, SELECT
the desired baud rate from the Baud drop-down list, as Figure 5-13 shows.

5-8

Customizing the Analyzer Software

Figure 5-13 Selecting baud rate

Selecting parity

To choose the Odd, Even or None (default) check, SELECT the desired check from the
Parity drop-down list, as Figure 5-14 shows.

Figure 5-14 Setting parity

Activating/deactivating handshake

If the Handshake function is activated, to start the transmission this analyzer will send a
handshake signal to an external computer and wait for the response. If the computer does not
respond, this analyzer will abort the transmission and give an alarm for the transmission error.
If the Handshake function is deactivated, this analyzer will transmit data to the external
computer regardless of the response. This function is deactivated by default.

5-9

Customizing the Analyzer Software


To activate or deactivate this option, SELECT Yes or No from the Handshake
drop-down list, as Figure 5-15 shows.

Figure 5-15 Setting handshake

Auto Communication

The auto communication function refers to the analyzers ability to automatically transmit the
analysis results to an external computer once they are done. To activate or deactivate this
function, SELECT On or Off from the Auto drop-down list in the Transmit field, as
Figure 5-16 shows.

Figure 5-16 Auto communication

Editing report titles (external keyboard needed)

To edit the title of an analysis report,


1. SELECT Recorder or Printer in the Report Title field, depending on the selected

5-10

Customizing the Analyzer Software


printing device;
2. ENTER the desired report title.

Exiting the Print & comm. group

When you have finished changing all the desired printing and transmission settings, you may
press [F1] to select another setting group you want to change; or press [MENU] and a
message box will pop up to remind you to save the changes, as Figure 5-17 shows. CLICK
Yes to save the changes and exit to the system menu; or CLICK No to exit to the system
menu without saving the changes.

Figure 5-17 Saving changes

5.3.3 Date and Time


You can select the Date & time group to set the system date and time, as Figure 5-18
shows. Follow the instructions given below to do so.

Figure 5-18 Setting date and time

Selecting the Date & time group

Press [F1] to select the Date & time group.

Setting the system date

1. SELECT Year, Month or Day;


2. ENTER the desired digits.
5-11

Customizing the Analyzer Software

Selecting the date format

You may choose one of the three formats YYYY-MM-DD, MM-DD-YYYY and
DD-MM-YYYY. To do so, SELECT the desired format from the Format drop-down list,
as Figure 5-19 shows.

Figure 5-19 Setting date format

Setting the system time

1. SELECT Hour, Minute or Second;


2. ENTER the desired digits.

Exiting the Date & time group

When you have finished changing all the desired date and time settings, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-20 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.

Figure 5-20 Saving changes

5-12

Customizing the Analyzer Software

5.3.4 Gain
You can select the Gain group to view or change (if you have the administrator password)
the WBC, RBC and HGB gains.

Figure 5-21 Setting gain

Selecting the Gain group

Press [F1] to select the Gain group, as Figure 5-21 shows.

Setting the WBC gain

When WBC histograms of most samples are similar to Figure 5-22, it implies too small a
WBC gain and you need to increase the gain appropriately.

Figure 5-22 WBC gain too small


When WBC histograms of most samples are similar to Figure 5-23, it implies too large a WBC
gain and you need to decrease the gain appropriately.

Figure 5-23 WBC gain too large

5-13

Customizing the Analyzer Software


To increase (or decrease) the gain
1. Enter the administrator password as introduced in Chapter 5.2.1.
2. At the Gain screen and ENTER the desired gain into the WBC (WB) , as Figure 5-24
shows, or WBC (PB), as Figure 5-25 shows.

Figure 5-24 Setting WBC (WB) gain

Figure 5-25 Setting WBC (PB) gain

Setting the RBC gain

When the difference between the actual MCV result and the expected result exceeds 6%,
you need to change the RBC gain.

5-14

Customizing the Analyzer Software


For example, assuming the expected MCV result is 90.0fL, while the actual analysis result is
82.0fL, then

ExpectedMCV
90.0
100%
100% = 109.8%
ActualMCV
82.0
You should adjust the RBC gain to 109.8% as close as possible. Follow the steps given below
to do so.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Gain group;
3. SELECT RBC, as Figure 5-26 shows;
4. ENTER the desired gain so that the adjustment becomes as close to 109.8% as possible.

Figure 5-26 Setting RBC gain

Setting the HGB gain

You may adjust the HGB gain to change the HGB blank voltage, which usually should be set
between 3.4 to 4.8V (4.5V recommended). Follow the steps given below to set the HGB gain.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Gain group;
3. SELECT HGB;
4. ENTER the desired gain so that the HGB blank voltage is between 3.4 to 4.8V, as Figure
5-27 shows.

5-15

Customizing the Analyzer Software

Figure 5-27 Setting HGB gain

Exiting Gain group

When you have finished changing all the desired gain settings, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-28 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.

Figure 5-28 Saving changes

5.3.5 Count
You can select the Count group to view or change (if you have the administrator password)
the parameter units and count time.

5-16

Customizing the Analyzer Software

Figure 5-29 Setting unit and count time

Selecting the Count group

Press [F1] to select the Count group, as Figure 5-29 shows.

Selecting parameter units

This analyzer provides multiple units for certain parameters. Refer to Table 5-2 for all the
selectable units of all parameters. The 19 parameters are divided into 11 groups based on
their units and you can only select unit for the first parameter of a group. Pay special attention
to the HGB group, which includes HGB, MCHC and MCH. When you select g/L or g/dL as the
unit of HGB, the default unit for MCH is pg; when you select mmol/L as the unit of HGB, the
default unit of MCH is fmol.
Table 5-2 Units of Parameters
Parameter

Display format

Unit

Remarks

***.*

10 /L

Default

***.*

10 /uL

Mid#

****

10 /uL

Gran#

***.*

/nL

Lymph%

**.*

Mid%

.***

***

g/L

Default

**.*

g/dL

**.*

mmol/L

WBC
Lymph#

Default

Gran%
HGB, MCHC

5-17

Customizing the Analyzer Software


*.**

1012/L

Default

*.**

106/uL

***

104/uL

*.**

/pL

**.*

Default

.***

L/L

***.*

fL

Default

***.*

um3

RDW-CV

**.*

Default

PLT

****

109 /L

Default

****

103 /uL

***.*

104 /uL

****

/nL

***.*

fL

Default

***.*

um3

PDW

**.*

Default

PCT

.***

Default

*.**

mL/L

*.***

pg

Default

**.**

fmol

RBC

HCT

MCV, RDW-SD

MPV

MCH

Follow the steps given below to select the units.


1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Count group;
3. SELECT the desired unit from the drop-down list of the desired parameter, as Figure
5-30 shows.

5-18

Customizing the Analyzer Software

Figure 5-30 Selecting parameter unit

Setting count time

If the WBC or RBC count time is inappropriately set, the system may give false alarms for
clogs or bubbles. When this happens, follow the steps given below to change the WBC or
RBC count time. Refer to the actual count time (see Chapter 10.5.1 for details) when editing
the count time. Follow the steps given below to set the count time.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Count group;
3. SELECT WBC or RBC, as Figure 5-31 shows;
4. ENTER the desired digits.

Figure 5-31 Setting count time

Exiting the Count group


5-19

Customizing the Analyzer Software


When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-32 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.

Figure 5-32 Saving changes

5.3.6 Reference Range


You can set a reference range for every parameter. The system will flag any analysis result
that exceeds this range with either an H or L. This analyzer divides the patients into 5 patient
groups, which are all listed in Table 5-3. The default ranges are given. Note that the default
ranges are for references only. Each laboratory is encouraged to establish its own
references.

Table 5-3 Demographic groups


Group
General

Gender

Age

Not specified, male or female.

Not specified.

Not specified.

12 years

Man

Male

12 years

Woman

Female

12 years

Child

Male or Female

28 days and 12 years

Neonate

Male or Female

28 days

The upper and lower limits of the reference ranges are visible to all users but changeable

5-20

Customizing the Analyzer Software


only to administrators, as Figure 5-33 shows. Follow the instructions below to set the ranges.

Figure 5-33 Reference range screen

Selecting patient group

Follow the steps given below to select the patient group you want.
1. At the Settings screen, press [F1] to select the Ref. Range group.
2. SELECT the combo box to the right of Group.

Figure 5-34 Selecting patient group


3. SELECT General, Man, Woman, Child or Neonate from the Group
pull-down list.

5-21

Customizing the Analyzer Software

Setting reference ranges (administrators only)

1. Enter the administrator password as introduced in Chapter 5.2.1;


2. At the Settings screen, press [F1] to select the Ref. Range group, as Figure 5-35
shows;
3. When you have finished selecting the patient group, SELECT the desired parameter and
ENTER the desired digits for the upper and lower limits;

Figure 5-35 Setting reference range


4. Press [F2] to save the changes. If the changes are successfully saved, a message box
shown in Figure 5-36 will pop up; CLICK the Yes to close the message box;

Figure 5-36 A message box to note data saved


5. If some entered limits are invalid, a message box shown in Figure 5-37 will pop up.
CLICK Yes and enter valid number again;
5-22

Customizing the Analyzer Software

Figure 5-37 A message box to remind you of the erroneous entry


6. If you want to resume the default settings, press [F4].

Exiting the Ref. Range group

When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] to exit to the system menu.

5.3.7 Auto Maintain


You can select Auto Maintain group to view or set the how many WB samples can be run
after perform auto maintaining.

Selecting Auto Maintain group

Press [F1] to select the Auto Maintain group.

Figure 5-38 Auto Maintain screen(1)


The screen displays:
1) how many WB samples had been run after auto-cleaning and how many WB
samples can be run between two auto-cleanings;
2) how many WB samples had been run and how long the analyzer run after soak by
probe cleanser
5-23

Customizing the Analyzer Software


3) how many WB samples had been run after probe wipe cleaning.
For more information about auto maintain, see Chapter 10 Maintaining Your Analyzer for
detail.

Change the WB samples can be run between two cleanings

1. Enter the administrator password as introduced in Chapter 5.2.1.


2. At the Settings screen, press [F1] to select the Auto Maintain group, as Figure 5-39
shows.
3. ENTER the desired digits.

Figure 5-39 Auto maintain screen(2)

Exiting the Auto Maintain group

When you have finished the changing, you may


1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-40 shows. CLICK Yes to save the changes and exit to the system menu; or
CLICK No to exit to the system menu without saving the changes.

Figure 5-40 Saving changes

5-24

Customizing the Analyzer Software

5.3.8 Other Settings


You can select the Other group to view or change other settings.

Selecting the Other group

Press [F1] to select the Other group.

Muting beeper

This analyzer beeps when an error occurs. You can mute the beeper by pressing any key or
leave it beeping until the errors are removed. If you prefer the former, SELECT Enabled
from the Any key to mute drop-down list ; if you prefer the latter, SELECT Disabled
from the Any key to mute drop-down list. See Figure 5-41 shows.

Figure 5-41 Selecting how to mute the beeper

Selecting LCD contrast

Follow the steps given below to adjust the LCD contrast.


1. SELECT LCD contrast, as Figure 5-42 shows;
2. ENTER the desired contrast (0 to 255).

5-25

Customizing the Analyzer Software

Figure 5-42 Select LCD contrast

Setting alarm time

Follow the steps given below to set for how long (2s to120s) the error messages listed in
Table 5-4 should be displayed on the screen.
Table 5-4 Error List
No.
1

Error
Communication Error

No.
2

Error
Scanner Error

No.
3

Error
Scanner
Communication Error

Environmental

Background Abnormal

HGB Error

WBC Bubbles

Temperature Abnormal
7

HGB Adjustment

WBC Clog

10

RBC Clog

11

RBC Bubbles

1. SELECT Alarm time(s), as Figure 5-43 shows;


2. ENTER the desired digits.

5-26

Customizing the Analyzer Software

Figure 5-43 Setting alarm time

Selecting PMB color (administrator password needed)

The PMB color refers to the background color of the screen when your analyzer is in the
prediluted mode. Follow the steps below to select the PMB color.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Other group;
3. SELECT Black (default) or Blue from the PMB color drop-down list, as Figure
5-44 shows.

Figure 5-44 Setting PMB color

Delete data information list

You can delete the information in the list of Dept., Sender, Tester and Checker stored
5-27

Customizing the Analyzer Software


in the edit window when input patient information.
1. Enter the administrator password as introduced in Chapter 5.2.1;
2. At the Settings screen, press [F1] to select the Other group;
3. SELECT Not Delete (default) or Delete All from the Info. In list of Dept., Sender
etc. drop-down list, as Figure 5-45 shows.

Figure 5-45 Delete the information

Exiting the Other group

When you have finished changing all the parameter units and count time settings you want to
change, you may
1. Press [F1] to select another setting group you want to change; or;
2. Press [MENU] and a message box will pop up to remind you to save the changes, as
Figure 5-46 shows. SELECT Yes to save the changes and exit to the system menu; or
SELECT No to exit to the system menu without saving the changes.

5-28

Customizing the Analyzer Software

Figure 5-46 Saving changes

5-29

Operating Your Analyzer

6.1 Introduction
This chapter provides step-by-step procedures for operating your analyzer on a daily basis.

Initial Checks

Power on

Daily Quality Control

Sample Collection and Handling

No

Whole Blood Mode


Yes
Run Whole Blood Samples

Shutdown

6-1

Run Prediluted Samples

Operating Your Analyzer

6.2 Initial Checks


Perform the following checks before turning on the analyzer.
1. Check and make sure the waste container is empty;
2. Check and make sure there are enough reagents;

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

Dispose of reagents, waste, samples, consumables, etc. according to


government regulations.

3. Checking tubing and power connections ;

Check and make sure the diluent, rinse and waste tubes are properly connected and not
bent;

Check and make sure the power cord of the analyzer is properly plugged into an
electrical outlet.

4. Checking the printer (optional) and recorder;


Check and make sure enough printer or recorder paper is installed. Check and make sure the
power cord of the printer is properly plugged into an electrical outlet. Check and make sure
the printer cable is properly connected to the analyzer.
5. Check keyboard connection.
Check and make sure the keyboard is properly connected to the keyboard interface (marked
KB) of the analyzer.

6-2

Operating Your Analyzer

6.3 Power-on
Place the power switch at the back of the analyzer in the ON position (1) to turn on the
analyzer. The power indicator light will be illuminated and the screen will display
Initializing.
The analyzer will sequentially initialize the file, hardware and fluidic systems and the whole
initializing process lasts 4 to 7 minutes, depending on how the analyzer was previously shut
down.
If any error occurs during the initialization, the analyzer will display the error messages in the
lower left corner of the screen. You should remove all the errors before running any sample.
See Chapter 11 Troubleshooting Your Analyzer for solutions.

Running samples with the abnormal background error present will lead to
unreliable results.

6-3

Operating Your Analyzer

6.4 Daily Quality Control


Before running any samples, run the controls. See Chapter 8 Using the QC Programs for
details.

6-4

Operating Your Analyzer

6.5 Selecting Analysis Mode


At the Count screen, press [MODE] to select one of the six analysis modes. The selected
mode will be displayed in the Count Mode area.
1. Whole - All
It means the sample to be analyzed is a whole blood sample and all the 19 parameters are to
be analyzed.
2. Whole - WBC/HGB
It means the sample to be analyzed is a whole blood sample and only the following
parameters are analyzed: WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran% and HGB,
plus the WBC histogram.
3. Whole -RBC/PLT
It means the sample to be analyzed is a whole blood sample and only the following
parameters are analyzed: RBC, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV,
PDW and PCT, plus the RBC and PLT histograms.
4. Prediluted - All
It means the sample to be analyzed is a prediluted blood sample and all the 19 parameters
are to be analyzed, plus 3 histograms.
5. Prediluted - WBC/HGB
It means the sample to be analyzed is a whole blood sample and only the following
parameters are analyzed: WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran% and HGB,
plus the WBC histogram.
6. Prediluted -RBC/PLT
It means the sample to be analyzed is a prediluted blood sample and only the following
parameters are analyzed: RBC, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV,
PDW and PCT, plus the RBC and PLT histograms.

6-5

Operating Your Analyzer

6.6 Sample Collection and Handling

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

Avoid direct contact with blood samples.

Do not re-use disposable products.

Use clean K2EDTA anticoagulant collection tubes, fused silica glass/plastic


test tubes and 20L borosilicate glass capillary tubes.

6.6.1 Whole Blood Samples


Collect and handle the whole blood sample as follows:
1. Collect venous blood with a K2EDTA (1.5 to 2.2mg/mL ) anticoagulant collection tube;
2. Rapidly and thoroughly mix the blood with the anticoagulant.

You should collect at least 2mL venous blood sample.

For the whole blood samples to be used for WBC differential or PLT count,
you shall store them at the room temperature and run them within 4 hours
after collection.

If you do not need the PLT, MCV and WBC differential results, you can store
the samples in a refrigerator (2 to 8) for 24 hours. You need to warm the
6-6

Operating Your Analyzer


refrigerated samples at room temperature for at least 30 minutes before
running them.

Mix any sample that has been prepared for a while before running it.

6.6.2 Prediluted Samples


Collect and handle the prediluted sample as follows:
1. Press [MENU] and SELECT Count to enter the Count screen;
2. Press [MODE] to select prediluted analysis mode (any mode preceded by Prediluted);
3. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 6-1 shows;

Figure 6-1 A message box showing you how to dispense diluent


4. Present a clean sample tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 6-2 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 0.7mL of diluent (the dispensing volume is controlled by the analyzer)
into the tube;

Figure 6-2 How to dispense diluent


5. When the dispensing is finished, press [ENTER] to close the message box;
6. Add 20L of capillary blood to the diluent and shake the tube to mix the sample.

6-7

Operating Your Analyzer

Keep dust from the prepared diluent.

When preparing a prediluted sample, only use lint-free tissue to wipe the
external wall of the capillary tube; do not use cotton balls.

After mixing the capillary sample with the diluent, wait 5 minutes before
running the sample.

Run the prediluted samples within 30 minutes after the mixing.

Mix any sample that has been prepared for a while before running it.

Evaluate predilute stability based on your laboratorys sample population


and sample collection techniques or methods.

6-8

Operating Your Analyzer

6.7 Running Whole Blood Samples


Press [MENU] and SELECT Count to enter the Count screen, as Figure 6-3 shows.

Figure 6-3 Count screen


Press [MODE] to select whole blood mode (any mode preceded by Whole blood);

Select proper reference range as instructed in Chapter 5.3.6 before running


the samples. Otherwise, the obtained results may be erroneously flagged.

When you save the next sample information, run sample analysis;
Otherwise, the input sample information cannot be displayed when
restarting the analyzer.

6.7.1 Entering Sample Information


You may enter sample information in any of the three modes, ID only, All info and Batch
edit, depending on which of the three configurations your analyzer has:

ID only

All Info

ID only and Batch edit.

ID only mode
To enter the sample ID of the next sample, you may

6-9

Operating Your Analyzer


At the Count screen, use the bar-code scanner (if available) to scan the sample ID into the
analyzer; or
At the Count screen, press [F1] to enter the ID window and ENTER the sample ID.

Figure 6-4 Next sample window


When you have finished entering the sample ID, you may press [MENU] and a dialog box will
pop up, as Figure 6-5 shows. To ignore the entered number, CLICK No; otherwise, CLICK
Yes.

Figure 6-5 Dialog box

6-10

Operating Your Analyzer

If you intend to do the background check instead of a patient sample, enter


0 into the ID box.

All info mode (external keyboard needed)

Entering Edit

At the Count screen, press [F1] and an edit window will pop up, as Figure 6-6 shows.

Figure 6-6 Entering sample information

Entering sample ID

ENTER the ID number in the ID box, or if you have the bar-code scanner installed, you can
simply scan the sample ID into the analyzer.

Selecting patient gender

SELECT the desired item from the Gender drop-down list, as Figure 6-7 shows. Note
that you can select blank in case you are not aware of the patient gender.

6-11

Operating Your Analyzer

Figure 6-7 How to select the patient gender


.

Entering the patient name

ENTER the patient name into the Name box.

Entering the patient age

This analyzer provides three ways for you to enter the patient age in years, in months and in
days.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
Days box.

Entering the chart number

ENTER the number of the patients medical chart into the Chart No. box.

Entering the bed number

ENTER the number of the patients bed into the Bed No. box.

Entering the department name

You can either directly ENTER the name of the department, from which the sample came,
into the Department box or SELECT the desired department from the Department
pull-down list (if there are previously saved departments in the list, as Figure 6-8 shows).
6-12

Operating Your Analyzer

Figure 6-8 Select department name

Entering the names of the sender, tester and checker

To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.

Exit edit

When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to the Count screen. If you do not want to save the entered
information, CLICK the No button to return to the Count screen without saving the
changes.

Batch Edit Mode (external keyboard needed)


If your analyzer is configured as Batch edit, you can continuously enter information of a
batch of samples. Follow the steps given below to do so.

Entering Edit

At the Count screen, press [F4] and an edit window will pop up, as Figure 6-9 shows.
Follow the instructions to enter the information of the first sample.

6-13

Operating Your Analyzer

Figure 6-9 Batch edit screen

Save

CLICK Save to save the changes.

Next/Prev

If you want to review the entered information of a specific sample, press the appropriate
arrow keys to CLICK Prev. or Next to review the previous or next sample until the desired
sample is reached.

Delete

If you want to delete the currently displayed sample information, CLICK Delete to complete
the deletion.

Exit

When you are done with the batch, CLICK Exit to exit to the Count screen. After a sample
is analyzed, its corresponding sample information will be automatically displayed in the
Current sample area.

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Operating Your Analyzer

6.7.2 Running the Samples

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

Do not re-use such disposable product as collection tubes, test tubes,


capillary tubes, etc.

Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.

When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.

1. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display Running and the analyzer
will start aspirating sample;
2. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
3. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be repositioned. And if the
auto print function is enabled, the analysis result will be automatically printed out;
4. Repeat the above steps on other samples.

If the analyzer detects WBC/RBC clogging or bubbles during the analysis,


the corresponding error messages will be displayed in the error message

6-15

Operating Your Analyzer


area and the results of all the related parameters will be invalidated. See
Chapter 11 Troubleshooting Your Analyzer for solutions.

If the ambient temperature is outside the specified operating range, the


analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting Your Analyzer for
solutions.

6.7.3 Special Functions


Recount (optional function)
If the system detects clog or bubbles during the analysis, or you dont satisfied with the result
and press [F5], a dialog box will pop up to ask you whether you want to have a re-count
(analyze this sample again), as Figure 6-10 shows.

Figure 6-10 Re-count dialog box


If you dont want to re-count this sample, CLICK No; otherwise, CLICK Yes to enter the
Re-count screen, as Figure 6-11 shows. This Re-count screen is similar to the Count
screen, except the lower sub-area of the Sample Information area is tiled Re-count as
opposed to Next sample. The sample ID remains unchanged.

6-16

Operating Your Analyzer

Figure 6-11 Re-count screen


Follow the previously introduced procedure to re-analyze the sample in question. The new
result will overwrite the old result while the sample information keeps unchanged.

Automatic saving of analysis results


This analyzer automatically saves a maximum of 10,000 sample results. When the maximum
number has been reached, the newest result will overwrite the oldest.

Parameter flags

If the analysis result is followed by an H or L, it means the analysis result has


exceeded the upper or lower limit of the reference range.

If you see *** as opposed to the result, it means the result is either unreliable or out of the
operating range.

If the WBC result is less than 0.5 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).

The result of the background check will not be flagged.

Histogram flags
The system will flag abnormal histograms.

Abnormal WBC histograms will be flagged by one of the markings: R1, R2, R3, R4 and

Rm.
R1: indicates abnormality on the left side of the lymphocyte hump and possible presence of
6-17

Operating Your Analyzer


platelet clumps, giant platelets, nucleated red cell, insolvable red cell, protein and lipoid
debris in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mid-sized cell area and
possible presence of abnormal lymphocyte, plasma cell, atypical lymphocyte, original
granulocytes in the sample and eosinophilia or basophilia.
R3: indicates abnormality between the mid-sized cell area and the granulocytes and possible
presence of immature granulocytes, abnormal sub-population in the sample, or eosinophilia.
R4: indicates abnormality on the right side of the granulocytes hump and netrophilia.
Rm: indicates at least two R flags.

Abnormal PLT histograms will be flagged by one of the markings: Pm, PS and PL.

Pm: indicates blur demarcation between the platelet and red blood cell area and possible
presence of large platelet, platelet coagulation, small red blood cell, cell debris or fibrin.
PS: indicates excessive small PLTs.
PL: indicates excessive large PLTs.

When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.

Adjusting histograms manually


If you are not satisfied with the obtained histograms, you can adjust them manually, provided
you have the administrator password. See Chapter 7 Reviewing Sample Results for
details.

6-18

Operating Your Analyzer

6.8 Running Prediluted Samples


Press [MENU] and SELECT Count to enter the Count screen, as Figure 6-12 shows.

Figure 6-12 Count screen in prediluted mode


Press [MODE] to select prediluted mode (any mode preceded by Prediluted).

Select proper reference range as instructed in Chapter 5.3.6 before running


the samples. Otherwise, the obtained results may be erroneously flagged.

6.8.1 Entering Sample Information


You may enter sample information in any of the three modes, ID only, All info and Batch
edit, depending on which of the three configurations your analyzer has:

ID only

All Info

ID only and Batch edit.

ID only
To enter the sample ID of the next sample, you may
At the Count screen, use the bar-code scanner (if available) to scan the sample ID into the
analyzer; or
At the Count screen, press [F1] to enter the ID window and ENTER the sample ID.
6-19

Operating Your Analyzer

Figure 6-13 Entering ID of the next sample


When you have finished entering the sample ID, you may press [MENU] and a dialog box will
pop up, as Figure 6-14 shows. To ignore the entered number, CLICK No; otherwise, CLICK
Yes.

Figure 6-14 Dialog box

If you intend to do the background check instead of a patient sample, enter


0 into the ID box.

6-20

Operating Your Analyzer

All info mode (external keyboard needed)

Entering Edit

At the Count screen, press [F1] and an edit window will pop up, as Figure 6-15 shows.

Figure 6-15 Entering sample information

Entering sample ID

ENTER the ID number in the ID box, or if you have the bar-code scanner installed, you can
simply scan the sample ID into the analyzer.

Selecting the patient gender

SELECT the desired item from the Gender drop-down list, as Figure 6-16 shows. Note
that you can select blank in case you are not aware of the patient gender.

6-21

Operating Your Analyzer

Figure 6-16 How to select the patient gender


.

Entering the patient name

ENTER the patient name into the Name box.

Entering the patient age

This analyzer provides three ways for you to enter the patient age in years, in months and in
days.
To enter the patients age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
Days box.

Entering the chart number

ENTER the number of the patients medical chart into the Chart No. box.

Entering the bed number

ENTER the number of the patients bed into the Bed No. box.

Entering the department name

You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list, as Figure 6-17 shows).
6-22

Operating Your Analyzer

Figure 6-17 Select department name

Entering the names of the sender, tester and checker

To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.

Exit edit

When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to the Count screen. If you do not want to save the entered
information, CLICK the No button to return to the Count screen without saving the
changes.

Batch Edit Mode (external keyboard needed)


If your analyzer is configured as Batch edit, you can continuously enter information of a
batch of samples. Follow the steps given below to do so.

Entering Edit

At the Count screen, press [F4] and an edit window will pop up, as Figure 6-21 shows.
Follow the instructions to enter the information of the first sample.

6-23

Operating Your Analyzer

Figure 6-18 Batch edit screen

Save

CLICK Save to save the changes.

Next/Prev

If you want to review the entered information of a specific sample, press the appropriate
arrow keys to CLICK Prev. or Next to review the previous or next sample until the desired
sample is reached.

Delete

If you want to delete the currently displayed sample information, CLICK Delete to complete
the deletion.

Exit

When you are done with the batch, CLICK Exit to exit to the Count screen. After a sample
is analyzed, its corresponding sample information will be automatically displayed in the
Current sample area.

6.8.2 Running the Samples

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

6-24

Operating Your Analyzer

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

Do not re-use such disposable product as collection tubes, test tubes,


capillary tubes, etc.

Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.

When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.

1. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display Running and the analyzer
will start aspirating sample;
2. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
3. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be repositioned. And if the
auto print function is enabled, the analysis result will be automatically printed out;
4. Repeat the above steps on other samples.

6.8.3 Special Functions


Recount (optional function)
If the system detects clog or bubbles during the analysis, or you dont satisfied with the result
and press [F5], a dialog box will pop up to ask you whether you want to have a re-count
(analyze this sample again), as Figure 6-19 shows.

Figure 6-19 Re-count dialog box


6-25

Operating Your Analyzer


If you dont want to re-count this sample, CLICK No; otherwise, CLICK Yes to enter the
Re-count screen. This Re-count screen is similar to the Count screen, except the lower
sub-area of the Sample Information area is tiled Re-count as opposed to Next sample.
The sample ID remains unchanged.
Follow the previously introduced procedure to re-analyze the sample in question. The new
result will overwrite the old result while the sample information keeps unchanged.

Automatic saving of analysis results


This analyzer automatically saves a maximum of 10,000 sample results. When the maximum
number has been reached, the newest result will overwrite the oldest.

Parameter flags

If the analysis result is followed by an H or L, it means the analysis result has


exceeded the upper or lower limit of the reference range.

If you see *** as opposed to the result, it means the result is either unreliable or out of the
operating range.

If the WBC result is less than 0.5 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).

The result of the background check will not be flagged.

Histogram flags
The system will flag abnormal histograms.

Abnormal WBC histograms will be flagged by one of the markings: R1, R2, R3, R4 and

Rm.
R1: indicates abnormality on the left side of the lymphocyte hump and possible presence of
platelet clumps, giant platelets, nucleated red cell, insolvable red cell, protein and lipoid
debris in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mid-sized cell area and
possible presence of abnormal lymphocyte, plasma cell, atypical lymphocyte, original
granulocytes in the sample and eosinophilia or basophilia.
R3: indicates abnormality between the mid-sized cell area and the granulocytes and possible
presence of immature granulocytes, abnormal sub-population in the sample, or eosinophilia.
R4: indicates abnormality on the right side of the granulocytes hump and netrophilia.
Rm: indicates at least two R flags.

Abnormal PLT histograms will be flagged by one of the markings: Pm, PS and PL.
6-26

Operating Your Analyzer


Pm: indicates blur demarcation between the platelet and red blood cell area and possible
presence of large platelet, platelet coagulation, small red blood cell, cell debris or fibrin.
PS: indicates excessive small PLTs.
PL: indicates excessive large PLTs.

When the PLT value is less than 100 109 / L, a manual count by the
microscope is recommended.

Adjusting histograms manually


If you are not satisfied with the obtained histograms, you can adjust them manually, provided
you have the administrator password. See Chapter 7 Reviewing Sample Results for
details.

6-27

Operating Your Analyzer

6.9 Shutdown
Perform the Shutdown procedure to shut down the analyzer daily.

To ensure stable analyzer performance and accurate analysis results,


perform the Shutdown procedure to shut down the analyzer after it has
been running continuously for 24 hours.

Shut down the analyzer strictly as instructed below.

1. Press [MENU] to enter the system menu and SELECT Shutdown, as Figure 6-20
shows;

Figure 6-20 Selecting the shutdown program


2. A message box will pop up to ask you to confirm the shutdown, as Figure 6-21 shows;

Figure 6-21 Shutdown message box


3. CLICK Yes and a window will pop up to instruct you how to shut down the analyzer, as
Figure 6-22 shows;

6-28

Operating Your Analyzer

Figure 6-22 Shutdown window

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

4. Present the E-Z cleanser to the sample probe and press the aspirate key. The analyzer
will aspirate the E-Z cleanser and automatically clean the fluidic lines and the bath. The
cleaning progress will be displayed on the screen, as Figure 6-23 shows;

Figure 6-23 Shutdown progress bar


5. When the cleaning is finished, place the switch at the back of the analyzer to OFF (O) to
turn off the analyzer;
6. Empty the waste container.

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

6-29

Operating Your Analyzer

Dispose of reagents, waste, samples, consumables, etc. according to


government regulations.

6-30

Reviewing Sample Results

7.1 Introduction
The analyzer automatically saves analysis results. Totally 10,000 results can be saved. You
can either browse all the saved sample results in general or search for the results of a
particular sample or samples.

7-1

Reviewing Sample Results

7.2 Browsing All Sample Results


To browse all the saved sample results, you can choose either of the following modes:

The Histogram mode.

In this mode, you can review both parameter values and histograms of the saved sample
results, one sample result per screen.

The Table mode.

In this mode, the sample results are presented in a columnar fashion without histograms
(namely you can only see the parameter values). One screen displays a maximum of 8
sample results.

7.2.1 Browsing in the Histogram Mode


Entering the Histogram mode
Press [MENU] to enter the system menu, and SELECT Review (Figure 7-1 ) to enter the
Review screen ( Figure 7-2 ).

Figure 7-1 System menu

Figure 7-2 Sample histogram review screen


7-2

Reviewing Sample Results

Browsing sample results


Press [] or [] to browse the preceding or following sample result; press [PgUp] or [PgDn]
to jump 8 locations (e.g. from location 1 to location 9).

Switching to the Table mode


To switch to the Table mode, press[]; to switch back to the Histogram mode,
press[]again.

Jumping to a sample result with known location


Press [F1] and a Goto window will pop up, as Figure 7-3 shows.

Figure 7-3 Goto window


ENTER the location into the Location box and press [ENTER] to jump to the desired
sample result.

Editing sample information (if configured)


Press [F2] to edit the sample information, Figure 7-4 shows.

7-3

Reviewing Sample Results

Figure 7-4 Editing sample information

ID

You cannot edit the sample ID of an analyzed sample.

Selecting gender

SELECT the desired item from the Gender drop-down list. Note that you can select blank
in case you are not aware of the patient gender.

Entering patient name

ENTER the patient name into the Name box.

Entering patient age

This analyzer provides three ways for you to enter the patient age in years, in months and
in days. The first way is designed for the patients no younger than one year; the second for
the patients older than one month and younger than one year; the third for the patients
younger than one month. You can choose only one of the three ways to enter the patient age.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
Days box.

Entering the chart number

ENTER the number of the patients medical chart into the Chart No. box.

7-4

Reviewing Sample Results

Entering the bed number

ENTER the number of the patients bed into the Bed No. box.

Entering the department name

You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list).

Entering the names of the sender, tester and checker

To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.

Yes button

When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to exit the edit window.

No button

If you do not want to save the entered information, CLICK the No button to return to exit the
edit window.

Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually after you
have entered the administrator password.
The first three discriminators of the WBC histogram are adjustable. Note that if the WBC
result is less than 0.5 or non-numeric (***), the WBC histogram is not adjustable.
The first two discriminators of the RBC histogram are adjustable. Note that if the RBC result
is less than 0.2 or non-numeric (***), the RBC histogram is not adjustable.
The first two discriminators of the PLT histogram are adjustable. Note that if the PLT result is
less than 10 or non-numeric (***), the PLT histogram is not adjustable.
For example, to move the third discriminator of the following WBC histogram, follow the
procedure below to do so.
7-5

Reviewing Sample Results

1. Press [ENTER] and the discriminator will become adjustable. See Figure 7-5;

Figure 7-5 WBC histogram with adjustable discriminators


2. Press [] or [] as needed to select the WBC histogram, as Figure 7-6 shows;

Figure 7-6 Adjusting discriminator (1)


3. Press [F3] to select the third discriminator, as Figure 7-7 shows;

Figure 7-7 Adjusting discriminator (2)


4. Press [] to move the third discriminator, as Figure 7-8 shows;

7-6

Reviewing Sample Results

Figure 7-8 Adjusting discriminator (3)


5. Press [ENTER] and a message box will pop up, as Figure 7-9 shows.

Figure 7-9 Saving changes


6. CLICK Yes to save the changes and return to the Review screen.

Printing sample results


Press [PRINT] to print out the current sample result.

7.2.2 Browsing in the Table mode


At the Histogram mode, press[]to switch to the Table mode, as Figure 7-10 shows.

Figure 7-10 Sample table review screen


The sample results are sequentially displayed on the screen, The Loc/Total displayed in the
7-7

Reviewing Sample Results


lower right corner of the screen indicates the location of the current sample result (the one
whose ID is backlit) and the total number of the sample results.

Browsing sample results


Press [] or [] to browse the preceding or following sample result; press [PgUp] or [PgDn]
to browse the preceding or following screen.

Switching to the Histogram mode


If you are interested in reviewing the histograms of the current sample result, press[]to
switch to the Histogram mode. To switch back to the Table mode, press [] again.

Jumping to a sample result with known location


Press [F1] and a Goto window will pop up, as Figure 7-11 shows.

Figure 7-11 Goto window


ENTER the location into the Location box and press [ENTER] to jump to the desired
sample result.

You can select certain desired samples for transmission or printing.

Selecting/deselecting a sample result

Press [] or [] to move the cursor to the desired sample result and press [ENTER] to select
it. The selected sample result will be marked with a *, as sample 117 in Figure 7-12 shows.

7-8

Reviewing Sample Results

Figure 7-12 Selecting a sample result


Press [ENTER] again to deselect the sample result. Once the sample is deselected, the *
will disappear, as Figure 7-13 shows.

Figure 7-13 Deselecting a sample result

Selecting/deselecting multiple sample results

Example1: To select the sample results of locations 1 to 5 (sample IDs:114 to 118 ), follow the
procedure below to do so:
1. Press [F2] to enter the Select window, as Figure 7-14 shows;

7-9

Reviewing Sample Results

Figure 7-14 Entering the Select window


2. ENTER the start position (00001) into the From box;
3. ENTER the end position (00005) into the To box;
4. CLICK Select and the lower left corner of the Select window will display Select
samples, as Figure 7-15 shows;

Figure 7-15 Selecting sample results of locations 1-5


5. CLICK Exit to return to the sample table review screen. The selected sample results
will be marked with *, as Figure 7-16 shows.

Figure 7-16 Reviewing the selected results


Example2: To deselect the sample results of locations 1 to 5, follow the procedure below to
do so:
1. Enter the start and end positions as instructed in steps 1 to 3 of Example1;
2. CLICK De-select and the lower left corner of the Select window will display
7-10

Reviewing Sample Results


De-select the results, as Figure 7-17 shows;

Figure 7-17 Deselecting the sample results of locations 1 to 5

3. CLICK Exit to return to the sample table review screen. The * above those sample
results will disappear, as Figure 7-18 shows.

Figure 7-18 Reviewing the deselected results


Example3: To select the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
1. Select the sample results of locations 1 to 5 as instructed in steps 1 to 4 of Example1;
2. Select the sample results of locations 7 to 8 as instructed in steps 1 to 4 of Example1;
3. CLICK Exit to return to the sample table review screen. The selected sample results
will be marked with *, as Figure 7-19 shows.

7-11

Reviewing Sample Results

Figure 7-19 Reviewing the selected results


Example4: To deselect the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
1. Deselect the sample results of locations 1 to 5 as instructed in steps 1 to 3 of Example2;
2. Deselect the sample results of locations 7 to 8 as instructed in steps 1 to 3 of Example2;
3. CLICK Quit to return to the sample table review screen. The * above those sample
results will disappear, as Figure 7-20 shows.

Figure 7-20 Reviewing the deselected results

Transmitting sample results to a host


You can transmit the selected or all sample results to an external computer (a host). Press
[F3] to enter the Transmit window, as Figure 7-21 shows.

7-12

Reviewing Sample Results

Figure 7-21 Transmit window

To transmit the selected sample results to a host, CLICK Selected;

To transmit all the sample results, CLICK All;

To stop a transmission, CLICK Stop;

To return to the sample table review screen, CLICK Exit.

Printing sample results


Select the sample results you want to print and press [PRINT]. A message box will pop up to
ask you to confirm the printing, as Figure 7-22 shows. CLICK Yes to print out all the
selected results; CLICK No to abort the printing.

Figure 7-22 Print message box

Special functions
To access the Special Functions screen, you must first select several (1 to 500) sample
results and then press [F5] to enter the Special Functions screen, as Figure 7-23 shows.

7-13

Reviewing Sample Results

Figure 7-23 Special functions screen open to all users


Two special functions are included in Special Functions screen Reprodu. and Trend.
The former is open to all users, as Figure 7-23 shows, while the latter to administrators only,
as Figure 7-24 shows.

Figure 7-24 Special functions screen only open to administrators

Reproducibility
See Figure 7-23 for the Special Functions screen open to all users. The screen consists of
two fields, the left displaying the available functions and the right displaying the 19
parameters and their reproducibility indices (Mean, Diff and CV).
If the selected samples are less than 3, the reproducibility indices are all 0. If the analysis
result of certain parameter is invalid (***), the corresponding index will also be invalid (***).

7-14

Reviewing Sample Results


Trend
After entering the administrator password, you can enter the Special Functions screen
open to administrators, as Figure 7-24 shows. Press [F1] to access the Trend, which
displays the WBC, RBC, PLT, HGB, MCV and RDW-CV trends of the selected sample results.
The six trends are displayed in two screens, three trends in one, as Figure 7-25 and Figure
7-26 show. You can press [][] to switch between the screens. The selected results are
sequentially presented in the trend, newest at the utmost left (No. 1).

Figure 7-25 Trend screen (1)

Figure 7-26 Trend screen (2)


At either screen, you can press [] or [] to view the results (displayed below the parameter
box) of every point presented in the graph. The current cursor position is displayed to the
right of No. and the time at which the sample was analyzed is displayed to the right of
Time. You can also press [PgUp] or [PgDn] to jump forward or backward by 20 samples.

7-15

Reviewing Sample Results


The trend is interpreted as follows:

The x-coordinate represents how many sample results have been selected. The
y-coordinate represents the analysis results of the displayed parameters.

For every parameter, the upper dash line of its trend represents the upper limit of the
expected range, 10% above the mean, of the analysis result. In case of WBC in Figure
7-25, the upper limit is 10.2.

For every parameter, the lower dash line of its trend represents the lower limit of the
expected range, 10% below the mean, of the analysis result. In case of WBC in Figure
7-25, the lower limit is 8.4.

For every parameter, its mean is displayed between the values of the upper dash line
and of the lower dash line. In case of WBC in Figure 7-25, the mean is 9.3.

For every parameter, the three numbers on the right of its trend represents:
Mean the mean value of the saved results
Diff standard deviation of the saved analysis results
CV - Coefficient of Variation
n

Mean =

i =1

X i Mean
Diff =
n 1

CV =

)2

Diff
100%
Mean

where n represents how many sample results are selected and Xi is the result of the ith
analysis. If the selected samples are less than 3, the three indices will all be 0. If the analysis
result of certain parameter is invalid (***), the three indices will also be invalid (***). Under
these two circumstances, the three values on the left of the trends are the parameters means
and expected ranges set by the user (see Chapter 5.3.6).
Every point in the graph is interpreted as follows:
The darkened square that falls between the upper dash line and the lower dash line is
within the expected range. Otherwise, it is not. The blank square represents the sample
analysis either ran into errors or the result is out of the display range.

7-16

Reviewing Sample Results

7.3 Searching for Interested Sample Results


7.3.1 Starting a Search
At the sample table review screen, press [F4] to enter the Search window, as Figure 7-27
shows.

Figure 7-27 Search window


To include a search condition, press [] or [] to move the cursor to the desired condition and
press [ENTER] to select the condition, as Figure 7-28 shows.

Figure 7-28 All search conditions are included

7-17

Reviewing Sample Results

To specify the name of the patient

ENTER the patient name into the Name box.

Selecting the patient gender

SELECT the desired item from the Gender drop-down list. Note that you can select blank
in case you are not aware of the patient gender.

Selecting the department

You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list,

Entering sample ID

ENTER the ID number into the ID box.

Entering the bed number

ENTER the number of the patients bed into the Bed No. box.

Entering the chart number

ENTER the number of the patients medical chart into the Chart No. box.

Entering the start and end date

ENTER the start date into the Start box; ENTER the end date into the End box.
CLICK Yes to start the search. The analyzer will search the saved sample results for
matches and report the conclusion at Search Result window, as Figure 7-29 shows. CLICK
Yes of the Search Result window to return to the searched sample review screen,. The
matches found are saved in a database called Searched and you can review them in either
the Table mode or the Histogram mode.

7-18

Reviewing Sample Results

Figure 7-29 Search Result window

7.3.2 Reviewing search result in the Table mode

For every search, the analyzer can display a maximum of 500 matches.

The matches will be deleted if you have run another sample (including
background check), or deleted a sample result, or restarted the analyzer
after the search.

Entering the Table mode


At the Review screen, press [] to select the Searched database and then press [] to
enter the Table screen, as Figure 7-30 shows.

7-19

Reviewing Sample Results

Figure 7-30 Table screen


The sample results are sequentially displayed on the screen, The Loc/Total displayed in the
lower right corner of the screen indicates the location of the current sample result (the one
whose ID is backlit) and the total number of the sample results matching the search
conditions.

Browsing sample results


Press [] or [] to browse the preceding or following sample result; press [PgUp] or [PgDn]
to browse the preceding or following screen.

Switching to the Histogram mode


If you are interested in reviewing the histograms of the current sample result, press [] to
switch to the Histogram mode. To switch back to the Table mode, press[] again.

Jumping to a sample result with known location


Press [F1] and a Goto window will pop up, as Figure 7-31 shows.

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Reviewing Sample Results

Figure 7-31 Goto window


ENTER the location into the Location box and press [ENTER] to jump to the desired
sample result.

You can select certain desired samples for transmission or printing.

Selecting/deselecting a sample result

Press [] or [] to move the cursor to the desired sample result and press [ENTER] to select
it. The selected sample result will be marked with a *, as sample 118 in Figure 7-32 shows.

Figure 7-32 Selecting a sample result


Press [ENTER] again to deselect the sample result. Once the sample is deselected, the *
will disappear, as Figure 7-33 shows.

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Reviewing Sample Results

Figure 7-33 De-selecting a sample result

Selecting/deselecting multiple sample results

Example1: To select the sample results of locations 1 to 5 (sample IDs:114 to118 ), follow the
procedure below to do so:
1. Press [F2] to enter the Select window, as Figure 7-34 shows;

Figure 7-34 Entering the Select window


2. ENTER the start position (00001) into the From box;
3. ENTER the end position (00005) into the To box;
4. CLICK Select and the lower left corner of the Select window will display Select
samples, as Figure 7-35 shows;

Figure 7-35 Selecting sample results of locations 1 to 5


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Reviewing Sample Results


5. CLICK Exit to return to the sample table review screen. The selected sample results
will be marked with *, as Figure 7-36 shows.

Figure 7-36 Reviewing the selected results


Example2: To deselect the sample results of locations 1 to 5, follow the procedure below to
do so:
1. Enter the start and end positions as instructed in steps 1 to 3 of Example1;
2. CLICK De-select and the lower left corner of the Select window will display
De-select the result, as Figure 7-37 shows;

Figure 7-37 Deselecting the sample results of locations 1 to 5


3. CLICK Exit to return to the sample table review screen. The * above those sample
results will disappear, as Figure 7-38 shows.

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Reviewing Sample Results

Figure 7-38 Reviewing the deselected results


Example3: To select the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
1. Select the sample results of locations 1 to 5 as instructed in steps 1 to 4 of Example1;
2. Select the sample results of locations 7 to 8 as instructed in steps 1 to 4 of Example1;
3. CLICK Exit to return to the sample table review screen. The selected sample results
will be marked with *, as Figure 7-39 shows.

Figure 7-39 Reviewing the selected results


Example4: To deselect the sample results of locations 1 to 5 and 7 to 8, follow the procedure
below to do so:
1. Deselect the sample results of locations 1 to 5 as instructed in steps 1 to 3 of Example2;
2. Deselect the sample results of locations 7 to 8 as instructed in steps 1 to 3 of Example2;

7-24

Reviewing Sample Results


3. CLICK Exit to return to the sample table review screen. The * above those sample
results will disappear, as Figure 7-40 shows.

Figure 7-40 Reviewing the deselected results

Transmitting sample results to a host


You can transmit the selected or all sample results to an external computer (a host). Press
[F3] to enter the Transmit window, as Figure 7-41 shows.

Figure 7-41 Transmit screen

To transmit the selected sample results to a host, CLICK Selected;

To transmit all the sample results, CLICK All;

To stop a transmission, CLICK Stop;

To return to the review screen, CLICK Exit.

7-25

Reviewing Sample Results

Printing sample results


Select the sample results you want to print and press [PRINT]. A message box will pop up to
ask you to confirm the printing, as Figure 7-42shows. CLICK Yes to print out all the selected
results; CLICK No to abort the printing.

Figure 7-42 Print message box

Special functions
To access the Special Functions screen, you must first select several (1 to 500) sample
results and then press [F5] to enter the Special Functions screen, as Figure 7-43 shows.

Figure 7-43 Special functions screen open to all users


Two special functions are included in this screen Reprodu. and Trend. The former is
open to all users, as Figure 7-43 shows, while the latter to administrators only, as Figure 7-44
shows.

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Reviewing Sample Results

Figure 7-44 Special functions screen only open to administrators

Reproducibility
See Figure 7-43 for the Special Functions screen open to all users. The screen consists of
two fields, the left displaying the available functions and the right displaying the 19
parameters and their reproducibility indices (Mean, Diff and CV).
If the selected samples are less than 3, the reproducibility indices are all 0. If the analysis
result of certain parameter is invalid (***), the corresponding index will also be invalid (***).
Trend
After entering the administrator password, you can enter the Special Functions screen
open to administrators, as Figure 7-44 shows. Press [F1] to access the Trend, which
displays the WBC, RBC, PLT, HGB, MCV and RDW-CV trends of the selected sample results.
The six trends are displayed in two screens, three trends in one, as Figure 7-45 and Figure
7-46 show. You can press [][] to switch between the screens. The selected results are
sequentially presented in the trend, newest at the utmost left (No. 1).

7-27

Reviewing Sample Results

Figure 7-45 Trend screen (1)

Figure 7-46 Trend screen (2)


At either screen, you can press [] or [] to view the results (displayed below the parameter
box) of every point presented in the graph. The current cursor position is displayed to the
right of No. and the time at which the sample was analyzed is displayed to the right of
Time. You can also press [PgUp] or [PgDn] to jump forward or backward by 20 samples.
The trend is interpreted as follows:

The x-coordinate represents how many sample results have been selected. The
y-coordinate represents the analysis results of the displayed parameters.

For every parameter, the upper dash line of its trend represents the upper limit of the
expected range, 10% above the mean, of the analysis result. In case of WBC in Figure
7-45, the upper limit is 10.2.

7-28

Reviewing Sample Results

For every parameter, the lower dash line of its trend represents the lower limit of the
expected range, 10% below the mean, of the analysis result. In case of WBC in Figure
7-45 , the lower limit is 8.4.

For every parameter, its mean is displayed between the values of the upper dash line
and of the lower dash line. In case of WBC in Figure 7-45, the mean is 9.3.

For every parameter, the three numbers on the right of its trend represents:
Mean the mean value of the saved results
Diff standard deviation of the saved analysis results
CV - Coefficient of Variation
n

Mean =

i =1

X i Mean
Diff =
n 1
CV =

)2

Diff
100%
Mean

where n represents how many sample results are selected and Xi is the result of the ith
analysis. If the selected samples are less than 3, the three indices will all be 0. If the analysis
result of certain parameter is invalid (***), the three indices will also be invalid (***). Under
these two circumstances, the three values on the left of the trends are the parameters means
and expected ranges set by the user (see Chapter 5.3.6).
Every point in the graph is interpreted as follows:
The darkened square that falls between the upper dash line and the lower dash line is
within the expected range. Otherwise, it is not. The blank square represents the sample
analysis either ran into errors or the result is out of the display range.

7.3.3 Reviewing Search Result in the Histogram Mode


Entering the Histogram mode
At the Review screen, press [] to select the Searched database and then press [] to
enter the Histogram screen, as Figure 7-47 shows.

7-29

Reviewing Sample Results

Figure 7-47 Searched histogram screen

Browsing sample results


Press [] or [] to browse the preceding or following sample result; press [PgUp] or [PgDn]
to jump 8 locations (e.g. jumping from location 1 to location 8 ).

Switching to the Table mode


To switch to the Table mode, press []; to switch back to the Histogram mode, press
[] again.

Jumping to a sample result with known location


Press [F1] and a Goto window will pop up, as Figure 7-48 shows.

Figure 7-48 Goto window


7-30

Reviewing Sample Results


ENTER the location into the Location box and press [ENTER] to jump to the desired
sample result.

Editing sample information


Press [F2] to edit the sample information, as Figure 7-49 shows.

Figure 7-49 Editing sample information

ID

You cannot edit the sample ID of an analyzed sample.

Selecting gender

SELECT the desired item from the Gender drop-down list. Note that you can select blank
in case you are not aware of the patient gender.

Entering patient name

ENTER the patient name into the Name box.

Entering patient age

This analyzer provides three ways for you to enter the patient age in years, in months and
in days. The first way is designed for the patients no younger than one year; the second for
the patients older than one month and younger than one year; the third for the patients
younger than one month. You can choose only one of the three ways to enter the patient age.
To enter the patient age in years: ENTER the desired number, an integer from 0 to 200, into
the Years box.
To enter the patient age in months: ENTER the desired number, an integer from 0 to 12, into
the Months box.
7-31

Reviewing Sample Results


To enter the patient age in days: ENTER the desired number, an integer from 0 to 31, into the
Days box.

Entering the chart number

ENTER the number of the patients medical chart into the Chart No. box.

Entering the bed number

ENTER the number of the patients bed into the Bed No. box.

Entering the department name

You can either directly ENTER the name of the department, from which the sample came,
into the Dept box or SELECT the desired department from the Dept pull-down list (if
there are previously saved departments in the list).

Entering the names of the sender, tester and checker

To enter the name of the person who sent the sample for analysis, enter the name into the
Sender box or SELECT the desired name from the Sender pull-down list (if there are
previously saved names in the list); to enter the name of the person who is to run (or has run)
the sample, enter the name into the Tester box or SELECT the desired name from the
Tester pull-down list (if there are previously saved names in the list) ; to enter the name of
the person who is to review the sample results, enter the name into the Reviewer box, or
SELECT the desired name from the Checker pull-down list (if there are previously saved
names in the list). All the three pull-down lists are capable of saving 30 entered names.

Yes button

When you have finished entering all the desired sample information, CLICK the Yes button
to save the changes and return to exit the edit window.

No button

If you do not want to save the entered information, CLICK the No button to return to exit the
edit window.

Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually after you
have entered the administrator password.
The first three discriminators of the WBC histogram are adjustable. Note that if the WBC
result is less than 0.5 or non-numeric (***), the WBC histogram is not adjustable.
The first two discriminators of the RBC histogram are adjustable. Note that if the RBC result
7-32

Reviewing Sample Results


is less than 0.2 or non-numeric (***), the RBC histogram is not adjustable.
The first two discriminators of the PLT histogram are adjustable. Note that if the PLT result is
less than 10 or non-numeric (***), the PLT histogram is not adjustable.
For example, to move the third discriminator of the following WBC histogram, follow the
procedure below to do so.
1. Press [ENTER] and the discriminator will become adjustable. See Figure 7-50;

Figure 7-50 WBC histogram with adjustable discriminators


2. Press [] or [] as needed to select the WBC histogram, as Figure 7-51 shows;

Figure 7-51 Adjusting discriminator (1)


3. Press [F3] to select the third discriminator, as Figure 7-52 shows;

Figure 7-52 Adjusting discriminator (2)


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Reviewing Sample Results


4. Press [] to move the third discriminator, as Figure 7-53 shows;

Figure 7-53 Adjusting discriminator (3)


5. Press [ENTER] and a message box will pop up, as Figure 7-54 shows.

Figure 7-54 Saving changes


CLICK Yes to save the changes and return to the Review screen.

Printing sample results


Select the sample results you want to print and press [PRINT]. A message box will pop up to
ask you to confirm the printing, as Figure 7-55 shows. CLICK Yes to print out all the
selected results; CLICK No to abort the printing.

Figure 7-55 Print message box

7-34

Using the QC Programs

8.1 Introduction
Quality Control (QC) consists of strategies and procedures that measure the precision and
stability of the analyzer. The results imply the reliability of the sample results. QC involves
measuring materials with known, stable characteristics at frequent intervals. Analysis of the
results with statistical methods allows the inference that sample results are reliable.
Mindray recommends you run the QC program daily. A new lot of controls should be
analyzed in parallel with the current lot prior to their expiration dates. This may be
accomplished by running the new lot of controls twice a day for five days using any empty QC
files. The QC files calculate the mean, standard deviation and coefficient of variation for each
selected parameter. The instrument-calculated means of these ten runs should be within the
expected ranges published by the manufacturer.
This analyzer provides two QC programs QC with controls and X-B analysis.

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

Use the specified controls. Using controls other than the specified will lead
to misleading results.

Refer to the instructions of use of the controls for how to store and use the
controls.

8-1

Using the QC Programs

8.2 QC With Controls


8.2.1 QC Editing
Entering the Controls screen
Press [MENN] to enter the system menu. SELECT Controls (Figure 8-1), to enter the
Controls screen, as Figure 8-2 shows. At the QC screen you can include a maximum of 12
parameters, WBC, RBC, HGB, PLT, HCT, MCV, MCHC, MCH, Lymph%, Lymph#, Gran% and
Gran# into a QC run.

Figure 8-1 System menu

Figure 8-2 Controls screen

Selecting a QC file
The analyzer provides 9 QC files for you to save QC settings and results. Every QC file can
save the results of a maximum of 31 QC runs. When the saved QC results have reached the
maximum number, the newest result will overwrite the oldest. You can press [F1] to switch the
QC files and the number will be given on the upper left of the screen. After selecting the QC
file, press [F2] to select the Whole Blood or Prediluted mode.
8-2

Using the QC Programs

Editing QC settings
If there are saved QC results and settings, you need to delete them first. You can press [F5]
to enter QC Table screen to delete all the results, see Chapter 8.2.3 for details.

Entering the QC Edit screen

Press [F3] at Controls screen to enter the QC Edit screen (Figure 8-3).

Figure 8-3 QC Edit screen

Entering lot number

ENTER the lot number of the control to be used into the Lot No. box, as Figure 8-4 shows.

Figure 8-4 Entering lot number

Entering expiration date

ENTER the expiration date of the control to be used into the Exp. Date box, as Figure 8-5
8-3

Using the QC Programs


shows.

Figure 8-5 Entering Exp. Date

Entering the expected results (mean) and limits (range)

ENTER the expected results (mean) and limits (range) respectively into the Mean and
Range boxes of the parameters to be included in the QC analysis, as Figure 8-6 shows.

Figure 8-6 Entering Mean of RBC

Refer to the instructions of use of the control for information on the lot
number, expiration date, open-vial stability days, expected results and limits.

The entered expiration date should be either the expiration date printed on
the labeling or the open-vial expiration date. It is earlier.
8-4

Using the QC Programs

The open-vial expiration date is calculated as follows: the date that vial is
opened + the open-vial stability days.

At the QC Edit screen, if you want to correct an erroneous entry, MODIFY


the wrong digit.

Deleting settings

Press [DEL] to delete all the settings.

Printing settings

Press [PRINT to print out all the settings.

Exiting the QC Edit screen

Press [MENU] to exit to the system menu. A message box shown in Figure 8-7 will pop up, if:
1. There is a parameter for which you have entered only the expected result or the limit; or
2. There is a parameter whose expected result is less than or equal to the limit.

Figure 8-7 invalid input


CLICK Yes to close the box and clear the erroneous entries. Re-enter the correct values
before trying to exit the screen again. The settings can be saved only when both the expected
result and limit are valid.
If all the entries are correct, a message box will pop up to remind you to save the changes, as
Figure 8-8 shows. CLICK Yes to save the changes and exit to the Controls screen;
CLICK No to abort the changes and exit to the Controls screen.

8-5

Using the QC Programs

Figure 8-8 Saving changes

8.2.2 Running the Controls

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

Do not re-use such disposable product as collection tubes, test tubes,


capillary tubes, etc.

Keep the sample probe tip away from the tube bottom; otherwise the
aspiration volume may be inaccurate.

When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.

8-6

Using the QC Programs

Whole Blood Mode


1. Be sure the System Status area displays Ready;
2. Press [F2] to select the whole blood mode;
3. Present a vial of control to the sample probe so that the tip is well into the vial, and press
the aspirate key. The System Status area will display Running and the analyzer will
start aspirating sample;
4. When you hear a beep and the sample probe is out of the vial, remove the vial. The
sample probe will retract into the analyzer and the analysis progress will be displayed on
the screen;
5. When the analysis is finished, the result will be displayed on the screen and the
NO./Total in the upper left corner of the screen will automatically increase by 1 and the
sample probe will be repositioned.

If the analyzer detects WBC/RBC clogging or bubbles during the analysis,


the corresponding error messages will be displayed in the lower left corner
of the screen and the results of all the related parameters will be invalidated.
See Chapter 11 Troubleshooting Your Analyzer for solutions.

If the ambient temperature is outside the specified operating range, the


analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting You Analyzer for
solutions.

Deleting the QC Result

To delete the current result, press [DEL] and a message box will pop up, as Figure 8-9 shows.
CLCIK Yes to confirm the deletion.

Figure 8-9 Deleting current result

Printing QC results

Press [PRINT] to print out the current QC result by the printer.

8-7

Using the QC Programs

Exiting the Controls screen

Press [MENU] to exit to the system menu.

Prediluted Mode
1. Be sure the System Status area displays Ready;
2. Press [F2] to select the prediluted mode;
3. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 8-10 shows;

Figure 8-10 A message box showing you how to dispense diluent


4. Present a clean sample tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 8-11 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 0.7ml of diluent (the dispensing volume is controlled by the analyzer) into
the tube;

Figure 8-11 How to dispense diluent


5. When the dispensing is finished, press [ENTER] to close the message box;
6. Add 20L of control to the diluent and shake the tube to mix the sample;
7. Present the mixed control to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display Running and the analyzer
will start aspirating sample;
8. When you hear the beep and the sample probe is out of the tube, remove the sample
8-8

Using the QC Programs


tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;
9. When the analysis is finished, the result will be displayed on the screen and the
NO./Total in the upper left corner of the screen will automatically increase by 1 and the
sample probe will be repositioned.

If the analyzer detects WBC/RBC clogging or bubbles during the analysis,


the corresponding error messages will be displayed in the lower left corner
of the screen and the results of all the related parameters will be invalidated.
See Chapter 11 Troubleshooting You Analyzer for solutions.

If the ambient temperature is outside the specified operating range, the


analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting You Analyzer for
solutions.

Deleting the QC Result

To delete the current result, press [DEL] and a message box will pop up, as Figure 8-12
shows. CLICK Yes to confirm the deletion.

Figure 8-12 Deleting current result

Printing QC results

Press [PRINT] to print out the current QC result by the printer.

Exiting the Controls screen

Press [MENU] to exit to the system menu.

8-9

Using the QC Programs

8.2.3 Reviewing QC Results


You can review the saved results in either of the two modes L-J Graph and QC Table.

L-J Graph
At the Controls screen, press [F4] to enter the L-J Graph screen, as Figure 8-13, Figure
8-14 and Figure 8-15 shows.

Figure 8-13 L-J graph screen (1)

Figure 8-14 L-J graph screen (2)

8-10

Using the QC Programs

Figure 8-15 L-J graph screen (3)


The 12 parameters are divided into 3 groups for display, one group for one screen. You can
press [] or [] to switch among the screens. At every L-J Graph screen, you can press []
or [] to view the results (displayed below the parameter box) of every point presented in the
graph. The current cursor position is displayed to the right of No. field and the time at which
this QC run was done is displayed to the right of Time field.
The L-J graph is interpreted as follows:

The x-coordinate represents how many times the QC program has been run. The
y-coordinate represents the analysis results of the displayed parameters.

For every parameter, its L-J graph presents a maximum of 31 points.

For every parameter, the upper dash line of its L-J graph represents the upper limit of the
expected range of the analysis result. The corresponding value (4.9 in case of the WBC
in Figure 8-13) equals Mean + Range and is displayed to the left of the line.

For every parameter, the lower dash line of its L-J graph represents the lower limit of the
expected range of the analysis result. The corresponding value (4.1 in case of the WBC
in Figure 8-13) equals Mean - Range is displayed to the left of the line.

For every parameter, its expected result (4.5 in case of the WBC in Figure 8-13) is
displayed between the values of the upper dash line and of the lower dash line.

For every parameter, the three numbers displayed to the right of its L-J graph represents:

Mean the mean value of the saved results, as the equation below defines,
n

Mean =

X
i =1

where n represents how many times the QC program has been run and Xi is the result
acquired from every QC analysis.
8-11

Using the QC Programs


Diff standard deviation of the saved analysis results, as the equation below defines,

X i Mean
Diff =
n 1

)2

where n represents how many times the QC program has been run and Xi is the result
acquired from every QC analysis and Mean is the mean value derived from the first
equation.
CV Coefficient of Variation, as the equation below defines

CV =

Diff
100%
Mean

where Mean is the mean value derived from the first equation and Diff is the standard
deviation derived from the second equation.

Every point in the graph is interpreted as follows:

The darkened square that falls between the upper and the lower dash lines is within the
control range. Otherwise, it is not. The blank square represents the QC analysis either ran
into errors or is out of the display range.
If you see any points fallen outside the control range, do the following steps until the problem
is solved. If all the steps have failed, contact Mindray customer service department or your
local distributor for assistance.
1. Check the lower left corner of the screen for error messages. Refer to Chapter 11
Troubleshooting Your Analyzer for solutions to any displayed error messages;
2. Check the L-J settings for inappropriate entries;
3. Do the background check. In case of an abnormal background result, refer to Chapter 11
Troubleshooting Your Analyzer for solutions;
4. Re-run the control;
5. Run another vial of control;
6. Check if the analyzer needs to be calibrated.

Other operations:

To print out the currently displayed L-J graph, press [PRINT]. To acquire help information,
press [HELP]. To return to the Controls screen, press [MENU]

QC Table
At the Controls screen, press [F5] to enter the QC Table screen, as Figure 8-16 shows,
where every screen displays the results of 6 QC analyses. You can press [PgUp] or [PgDn] to
switch to the previous or next screen to view other results.
8-12

Using the QC Programs

Figure 8-16 QC Table screen


If you want to delete all the saved results, press [DEL] and a message box will pop up to
confirm the deletion, as Figure 8-17 shows.

Figure 8-17 Deleting all the result


CLICK Yes to delete current result; CLICK No to abort the deletion.
If you want to transmit the saved QC results to an external computer, follow the steps given
below:
1. Press [F1] at QC Table screen to enter the dialog box shown in Figure 8-18;
2. SELECT Yes to confirm the transmission.

8-13

Using the QC Programs

Figure 8-18 Transmission dialog box

8-14

Using the QC Programs

8.3 X-B Analysis


One weakness of quality control using control materials is that the control material is usually
assayed only once a shift. If a significant change in calibration occurs, it might go undetected
for the remainder of the shift. The X-B represents the moving average of hematology values
calculated using an algorithm developed by Dr. Brian Bull. The X-B analysis uses the Bull
algorithm to monitor the performance of the analyzer by tracking the average red cell indices
MCV, MCH, and MCHC on the patient samples run through the instrument in batches of 20.
The Target Value for X-B is similar to the assay value for a commercial control. It is derived
from the patient population analyzed on the instrument. The Limit is the acceptable limit of
variation around the target value.
The X-B analysis demands random samples and therefore, the samples categorized by
diseases are not suitable for its use.

8.3.1 QC Editing
Entering the X-B Table screen
Press [MENN] to enter the system menu. SELECT X-B analysis (Figure 8-19), to enter the
X-B Table screen, as Figure 8-20 shows.

Figure 8-19 System menu

8-15

Using the QC Programs

Figure 8-20 X-B Table screen


You must empty the X-B table before editing the X-B settings. If there are saved QC results
and settings, you need to delete them first. Press [DEL] and a message box will pop up to
confirm the deletion, as Figure 8-21 shows.

Figure 8-21 Deleting all the result


CLICK Yes to confirm the deletion; CLICK No to abort the deletion.

Entering Editing X-B Settings


At the X-B Table screen, press [F1] to enter the X-B Edit screen as shown in Figure 8-22.

Figure 8-22 X-B Edit screen


8-16

Using the QC Programs

Enabling/disabling X-B analysis


Random samples are required for the X-B analysis. In case of known samples of a particular
type (oncology, neonatal and so forth) that will seriously interfere with the X-B results, disable
the X-B analysis.
SELECT the combo box to the right of X-B analysis, SELECT On or Off from the
pull-down list to enable or disable the X-B analysis, as Figure 8-23 shows.

Figure 8-23 Enabling/disabling X-B Edit

Entering the expected result (mean) and limit (range)


The expected results vary depending on laboratories. It is recommended they are obtained
by calculating the averages of at least 500 random patient samples. The recommended limit
is 5% to 10%.

Calibrate your analyzer before trying to establish the expected results by


calculating the averages of random patient samples.

ENTER the expected mean and range respectively into the Mean box and Range boxes
of the parameters to be included in the QC run.

Deleting settings

Press [DEL] to delete all the settings.

Printing settings

8-17

Using the QC Programs


Press [PRINT] to print out all the settings.

Exiting the X-B Edit screen

Press [MENU] to exit the X-B Edit screen. a message box will pop up to remind you to save
the changes, as shows. CLICK Yes to save the changes; CLICK No to abort the changes.

Figure 8-24 A message box to confirm the changes

8.3.2 Running X-B Analysis


After you have enabled the X-B analysis and assigned valid means and ranges to the three
parameters, the system will automatically run the X-B analysis every 20 patient samples, of
which the MCV, MCH and MCHC results are within the set ranges.

8.3.3 Reviewing X-B Results


This analyzer automatically saves the results of the X-B analyses. You can review the saved
results in two modes - X-B table and X-B graph

X-B Table
Follow the steps introduced in Chapter 8.3.1.

X-B Graph
At the X-B Table screen, press [F2] to enter the X-B Graph screen, as Figure 8-25 shows.

8-18

Using the QC Programs

Figure 8-25 X-B graph screen


The X-B graph can be interpreted as follows:

The x-coordinate represents the number of X-B analyses performed; the y-coordinate

represents the results of the X-B analyses;

For every parameter, its X-B graph can display a maximum of 500 points, 30 points per

screen. The time at which the sample was analyzed is displayed to the right of Time. The
current cursor position and the number of all the saved points are displayed to the right of
Loc./Total.

For every parameter, the upper dash line represents the expected result + limit;

For every parameter, the upper dash line represents the expected result limit;

For every parameter (e.g. MCV), the three numbers to the left of the X-B graph are

defined as follows:
95.0 expected result limit;
90.0 expected result;
85.0 expected result limit.
The points fallen between the upper and lower dash lines are within the expected ranges;
The points fallen outside the upper and lower dash lines are out of the expected ranges
If you see any points fallen outside the control range, do the following steps until the problem
is solved. If all the steps have failed, contact Mindray customer service department or your
local distributor for assistance.
1. Check the lower left corner of the screen for error messages. Refer to Chapter 11
Troubleshooting Your Analyzer for solutions to any displayed error messages;
2. Check the X-B settings for inappropriate entries;
3. Do the background check. In case of an abnormal background result, refer to Chapter 11
8-19

Using the QC Programs


Troubleshooting Your Analyzer for solutions;
4. Run the controls;
5. Check if the analyzer needs to be calibrated.

Browsing X-B analysis results

Press [] or [] to review the preceding or following screen; press [PgUp] or [PgDn] to review
the preceding or following result. The parameter value of the current point (the one the cursor
is located at) is displayed below the parameter. The location of the current point is displayed
in the No. field. The analysis time is displayed in the Time field.

Printing X-B graphs

Press [PRINT] to print out the displayed X-B graphs.

Exiting the X-B Graph screen

Press [MENU] to exit to the system menu,.

8-20

Using the Calibration Programs

9.1 Introduction
The purpose of the calibration is to maintain system accuracy. Quality of the calibration
depends on the calibration materials and reagents used. You should only use the calibrator
and reagents specified by Mindray for the calibration. Store and use the calibrator and
reagents as directed by their instructions for use.
Calibration may be performed with commercial calibrator or fresh whole blood samples. Only
the directly measured parameters WBC, RBC, HGB, MCV, PLT, and MPV may be calibrated.

9-1

Using the Calibration Programs

9.2 When to Calibrate


You should run the calibration program if

It is the first time the analyzer has been used;

Certain major component (s) of the analyzer has been changed;

The quality control results indicate there may be a problem

All of the measured parameters must be calibrated before readings of this


analyzer can be used as valid analysis results.

9-2

Using the Calibration Programs

9.3 How to Calibrate


The analyzer provides 3 calibration programs: manual calibration, calibration using
commercial calibrator and calibration using fresh blood samples. Two sets of calibration
factors are prepared respectively for the whole blood mode and the predilute mode.

9.3.1 Preparing Your Analyzer


Do the following pre-calibration procedures before calibration. If problems are detected
during these checks, do not attempt to calibrate the analyzer. If necessary, call Mindray
customer service department or your local distributor for assistance.
Check and make sure there are enough reagents for the calibration. You need to start over
the calibration if the reagents run out during the process.
Do the background check. If the analyzer alarms for abnormal background results, see
Chapter 11 Troubleshooting Your Analyzer for solutions.
Enter the Count screen and run a vial of normal control 11 consecutive times. Enter the
Review screen to check the reproducibility of the second to eleventh runs and make sure
they meet the following requirements.
Table 9-1 Reproducibility
Parameter

Expected range

CV(%)

WBC

4.0 to 15.0 109 / L

3.0

RBC

3.00 to 6.50 1012 / L

2.0

HGB

100 to 180 g/L

2.0

MCV

70.0 to 100.0 fL

1.0

PLT

200 to 500 109 / L

5.0

At the Count screen, run a vial of high control three consecutive times and then
immediately run the diluent three consecutive times, calculate the carryover per the following
equation.

Carryover(%) =

First low - level sample resultThird low - level sample result


100
Third high - level sample resultThird low - level sample result

The calculated carryovers shall meet the following requirements: WBC, RBC and HGB shall
be no greater than 0.5 % ; PLT shall be no greater than 1%.
It is recommended that you create a log table for your analyzer. This log table should contain
9-3

Using the Calibration Programs


all necessary information that is pertinent to your analyzer. Suggested items that you may
want to include in the log table are:

Calibration date

Supplier of calibrator

Lot number

Expected results and limits

Result of background check.

Enter the administrator password as instructed in Chapter 5.2.1 and then choose one or
several parameters among WBC, RBC, HGB, MCV and PLT for calibration.

9.3.2 Calibration Using Calibrator Program


ENTER the administrator password in the Password screen. Press [MENU] to enter the
system menu.

Figure 9-1 System menu


SELECT Calibration Calibrator (Figure 9-1) to enter the Calibrator screen (Figure
9-2).

Figure 9-2 Calibrator screen

9-4

Using the Calibration Programs

Selecting the count mode


Press [F1] to select desired calibration mode.

Editing calibration settings


Press [F2] to activate the edit boxes, as Figure 9-4 shows.

Figure 9-3 Active Calibrator screen

Entering lot number

ENTER the lot number of the calibrator to be used into the Lot No. box.

Entering Exp. Date

ENTER the expiration date of the calibrator to be used into the Exp. Date box.

Entering the expected results (mean) and limits (range)

ENTER the expected results (mean) into the Mean box of the parameters to be included in
the calibration.

Refer to the instructions of use of the calibrator for information on the lot
number, expiration date, expected results and limits.

Open reagents are stable for 60 days. The entered expiration date should be
the open date + 60 days or the expiration date marked on the packaging of
the reagent, whichever is earlier.

When editing the settings, if you want to correct an erroneous entry,


MODIFY the wrong digit.

9-5

Using the Calibration Programs

Exit editing

When you have finished editing the desired settings, press [F2] to deactivate the edit boxes.

Running the calibrator

Use the Mindray- specified calibrator. Using calibrator other than the
specified will lead to misleading results.

Refer to the instructions of use of the calibrator for how to store and use the
calibrator.

In the prediluted calibration mode, you cannot dispense diluent from the
analyzer. It is recommended that you prepare at least 7 cups of diluent
before starting calibrating the analyzer in the prediluted mode.

Keep the sample probe tip away from the tube bottom, otherwise the
aspiration volume may be inaccurate.

When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

Do not re-use such disposable products.

In the whole blood mode

1. At Calibrator screen, press [F1] to select Whole Blood mode;


2. Present a vial of mixed calibrator to the sample probe so that the tip is well into the tube,
and press the aspirate key and the analyzer will start aspirating sample;
3. When you hear the beep and the sample probe is out of the vial, remove the calibrator.
The sample probe will retract into the analyzer and the analysis progress will be
9-6

Using the Calibration Programs


displayed on the screen;
4. When the analysis is finished, the result will be displayed on the screen and the sample
probe will be repositioned.

In the prediluted mode

1. At Calibrator screen, press [F1] to select Prediluted mode;


2. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 9-4 shows;

Figure 9-4 Add Diluent window


3. Present a clean sample tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 9-5 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 0.7mL of diluent (the dispensing volume is controlled by the analyzer)
into the tube.

Figure 9-5 How to dispense diluent


4. When the dispensing is done, press [ENTER] to close the message box;
5. Make sure the calibrator is at room temperature and not expired;
6. Add 20L of calibrator into one of the prepared sample cups and mix them well;
7. Present the mixed calibrator to the sample probe;
8. Press the aspirate key to start the run. When you hear a beep and the sample probe is
out of the cup, remove the sample;
9. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;

9-7

Using the Calibration Programs


10. When the analysis is finished, the result will be displayed on the screen and the sample
probe will be repositioned.

z
z

Keep dust from the prepared diluent.


Evaluate predilute stability based on your laboratorys sample population
and sample collection techniques or methods.

If the analyzer detects WBC/RBC clogging or bubbles during the analysis,


the corresponding error messages will be displayed and the results of all the
related parameters will be invalidated. See Chapter 11 Troubleshooting Your
Analyzer for solutions.

If the ambient temperature is outside the specified operating range, the


analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting Your Analyzer for
solutions.

Saving the calibration results


If non-numeric parameter values (***) are obtained, a message box will pop up to warn you,
as Figure 9-6 shows. CLICK Yes to close the dialog box and discard the result.

Figure 9-6 A message box to warn you about the invalid results
If the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure 9-7 shows.

9-8

Using the Calibration Programs

Figure 9-7 A message box to confirm the validity


CLICK Yes to save the results; CLICK No to abort the result. The saved results will be
displayed on the screen.
Repeat the above steps to run the calibrator 3 to 5 times (5 is recommended) and the
analyzer will automatically calculate the CVs and calibration factors, as Figure 9-8 shows.

Figure 9-8 Results of the calibration


The calculated calibration factor should be within the 75 to 125. If not, there will be
flagged with a *. Other values will not be displayed. In case of an empty calibration factor, try
to find out the reason and if necessary, contact Mindray customer service department or your
local distributor for assistance.

9-9

Using the Calibration Programs

Verifying new calibration factors


Press [MENU] to exit the Calibrator screen, a message box will pop up to confirm the new
calibration factors, as Figure 9-9 shows.

Figure 9-9 A message box to confirm the new calibration factors


CLICK Yes to save the new calibration factors and enter the Count screen from the
system menu.
At the Count screen, run the calibrator or a normal-level control at least 3 consecutive times
and calculate the mean of the results. Compare the obtained means to the expected means.

Other operations

Printing new calibration factors

Press [PRINT] to print out the current calibration factors.

Exiting the Calibrator screen

Press [MENU] to exit to system menu.

9.3.3 Fresh Blood Calibration


ENTER the administrator password in the Password screen. Press [MENU] to enter the
system menu.

Figure 9-10 System menu

9-10

Using the Calibration Programs


SELECT Calibration Fresh Blood (Figure 9-10) to enter the Fresh Blood screen
(Figure 9-11).

Figure 9-11 Fresh Blood screen


Complete the fresh blood calibration as instructed below:

Determination of the reference values


Reference values may be determined using three or more normal blood samples prepared for
calibration from the reference method or from a reliably calibrated hematology analyzer.

Editing calibration settings

Selecting count mode

At Fresh Blood screen, press [F1] to select the Whole Blood or Prediluted mode.

Selecting sample

When the mode is selected, press [F3] to choose the fresh blood sample whose reference
values you want to set.

Editing the reference value

Press [F2] to enable the edit boxes in the Mean column, as Figure 9-12 shows.

9-11

Using the Calibration Programs

Figure 9-12 Editing reference value


ENTER the reference value into the Mean edit box. To correct any erroneous entry,
MODIFY the digit. After you have finished the editing, press [F2] to exit the editing state.

Running the sample


After you have finished editing the calibration settings of Sample 1, refer to the sample
handling and analysis procedures introduced in Chapter 6 Operating Your Analyzer and
prepare the fresh blood samples in the selected count mode to perform the fresh blood
calibration.

Saving calibration results


If non-numeric parameter values (***) are obtained, a message box will pop up to warn you,
as Figure 9-13 shows.

Figure 9-13 A message box to warn you about the invalid results
9-12

Using the Calibration Programs


If all the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure 9-14 shows. CLICK Yes to save the results to the Fresh
Blood screen; CLICK No to abort the result.

Figure 9-14 A message box to confirm the validity


Repeat the above steps to run the sample 3 to 5 times (5 is recommended) and the analyzer
will automatically calculate the CV and calibration factor, as shows. Note that the CVs should
be within the ranges specified in Table 9-1.

Figure 9-15 Calibration with fresh blood


The calculated calibration factors should be within the 75 to 125. Any calculated value
that falls out of the calibration range will be flagged with a * at the upper right corner. Other
values will not be displayed. In case of an empty calibration factor, try to find out the reason
and if necessary, contact Mindray customer service department or your local distributor.
9-13

Using the Calibration Programs

Follow the calibration steps of sample 1 to run at least another two fresh blood samples.
When you have obtained the calibration factors of at least 3 fresh blood samples, you can
press [F1] to enter the Calculate screen as Figure 9-16 shows.

Figure 9-16 Calculate screen


This screen can maximum display the calibration factors for 5 fresh blood samples. Any factor
out of the calibration range will be flagged by * at the upper right corner. Other values will
not be displayed. In case of an empty calibration factor, try to find out the reason and if
necessary, contact Mindray customer service department or your local distributor. For every
parameter, the analyzer will calculate the average calibration factor, which serves as the new
calibration factor, only when there are at least 3 valid calibration factors, as the WBC in
Figure 9-16 indicates. Otherwise the new factor will be blank, as the RBC in Figure 9-16
indicates.

Verifying new calibration factors


Press [MENU] and a dialog box will pop up to ask you to save the new factors, as Figure 9-17
shows.

9-14

Using the Calibration Programs

Figure 9-17 Saving changes


CLICK Yes to save the new calibration factors; CLICK No to abort the result.
Calibration may be verified by running appropriate commercial controls or by using fresh
whole blood samples that were analyzed on a reliably calibrated hematology analyzer or by
reference methodology. Test the new calibration factors either of the following ways.

Method one:

1. Prepare 3 to 5 normal fresh blood samples and run each one of them on a reference
analyzer at least 3 consecutive times. Calculate the mean (MEAN 1) and SD (SD 1) of
every sample.
2. Run the same samples on your analyzer for the same number of times and calculate the
mean (MEAN 2). The MEAN 2 should be within MEAN 1 2SD. If any of the samples
fails to reach the criterion, call Mindray customers service department or your local
distributor.

Method two:

At the Count screen, run the calibrator at least 5 consecutive times and calculate the
means of the results. The means should be within the expected ranges supplied by the
manufacturer. If not, contact Mindray customer service department or your local distributor.

Other operations

If calibration data (calibration results, CV or new factors) exist

If you press [F2], a dialog box will pop up to warn you, as Figure 9-18 shows. Press [ENTER]
to return to the Fresh Blood screen.

9-15

Using the Calibration Programs

Figure 9-18 The dialog box

If the valid results are less than three (the CV and new factors are not available yet).

If you press [F3], a dialog box will pop up to warn you about the data loss, as Figure 9-19
shows.

Figure 9-19 The dialog box


To switch the modes, CLICK Yes and the saved data will be cleared; Otherwise, CLICK
No to exit.

Printing new calibration factors

Press [PRINT] to print out the new calibration factors.

Exiting the Fresh Blood screen

Press [MENU] to exit to system menu.


9-16

Using the Calibration Programs

9.3.4 Manual Calibration Program


Running the calibrator
At the Count screen, run a calibration material with known expected results 11 consecutive
times as instructed by Chapter 6 Operating Your Analyzer.

Calculating the new calibration factors manually


Press [MENU] to enter the system menu.

Figure 9-20 System menu


SELECT Calibration Manual (Figure 9-20) to enter the Manual screen ( Figure 9-21).

Figure 9-21 Manual screen

The left of the Manual" screen displays the available calibration modes Whole blood
and Prediluted. The right of the Manual screen displays the calibration factors of WBC,
RBC, HGB, MCV, PLT and the time the factors are saved.
Use the following formula to calculate the new calibration factor.

new factor =

old factor exp ected result


recorded mean

Example:
Assuming for a certain calibrator, the expected WBC value (namely the reference value
9-17

Using the Calibration Programs


mentioned in the formula above) is 8.4 and the current whole blood calibration factor is 98.9
, analyze this calibrator in the whole blood mode for ten times n=10and the results are
8.1, 8.0, 8.1, 8.1, 8.3, 8.3, 8.2, 8.0, 8.1, 8.3, CV=1.5%, Mean=8.16
Since the calculated CV meets the requirement of Table 9-1, the mean value, 8.12, is valid
and the new calibration factor can be calculated as follows:

The calculated new calibration factor should be within 75 to 125. If not, try to find out the
reason and if necessary, call Mindray customer service department or your distributor for
assistance.
If the reproducibility of the calibrated parameter does not meet the requirements of Table 9-1,
you must try to find out the reason and re-run the calibrator after you have solved the problem.
If necessary, contact Mindray customer service department or your local distributor for
assistance.

Entering the manually calculated factors


1. ENTER the administrator password as introduced in Chapter 5.2.1;
2. Press [F2] to activate the edit boxes as Figure 9-22 shows

Figure 9-22 Edit boxes activated


3. ENTER the calculated calibration factor into the corresponding boxes. To correct an
erroneous entry, DELETE the wrong digit and enter the correct digit.

Verifying new calibration factors


Press [F2] to exit editing.
If the entered number is out of the calibration range, a dialog box will pop up to remind you
the entered number is invalid, as Figure 9-23 shows.

9-18

Using the Calibration Programs

Figure 9-23 A message box to warn invalid input


Seeing the box, CLICK Yes and re-enter the factors. If the changed factors are all within the
calibration range, a dialog box will pop up to remind you to save the new factors, as Figure
9-24 shows. CLICK Yes to save the new calibration factors

Figure 9-24 A message box to confirm the new calibration factors


At the Count screen, run the calibrator or a normal-level control at least 3 consecutive times
and calculate the mean of the results. Compare the obtained means to the expected means.
If not, contact Mindray customer service department or your local distributor for assistance.

Other operations

Printing new calibration factors

Press [PRINT] to print out the current calibration factors.

Exiting the Manual screen

Press [MENU] to exit to the system menu.

9-19

10 Maintaining Your Analyzer


10.1 Introduction
Preventive and corrective maintenance procedures are required to keep the BC-2800 in a
good operating condition. This analyzer provides multiple maintenance functions for this
purpose. This chapter introduces how to use the provided functions to maintain and
troubleshoot your analyzer.

Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.

In case of problems not specified in this manual, contact Mindray customer


service department or your local distributor for assistance.

Only Mindray-supplied parts can be used for maintenance. For any


questions, contact Mindray customer service department or your local
distributor.

10-1

Maintaining Your Analyzer

10.2 General Guidelines


Maintenance Period
Everyday

Content of Maintenance
If you are to use this analyzer 24 hours a day, perform the Probe
cleanser cleaning procedure everyday.
When the analyzed samples add up to 20, the analyzer will perform
the auto-cleaning procedure.
Run the QC program everyday. See Chapter 8 Using the QC
Programs for details.

Every Month

You should use the supplied probe localizer to calibrate the


position of the probe to that of the probe wipe. The analysis result
is sensitive to their alignment.

As needed

When you think the bath might be contaminated, perform the


Clean the bath procedure.
When the analyzed add up to 600, the analyzer will remind you to
perform the Probe cleanser cleaning procedure.
When the analyzed samples add up to 150, the analyzer will
remind you to perform the Clean Probe Wipe procedure.
When the analyzed samples add up to 100, the analyzer will
remind you to perform the E-Z Cleanser Cleaning procedure.
When this analyzer is not to be used for two weeks, perform the
Prepare to Ship procedure to empty and wash the fluidic lines
and then wipe the analyzer dry and wrap it up for storage.
To obtain reliable analysis results, this analyzer needs to work in a
normal status. Run the Self-test items regularly to check the
status of this analyzer.
When this analyzer gives alarms for clogging, you can perform the
Flush Aperture or Zap Aperture procedure, or press [F2] to
unclog the aperture.
If

you

see

other

error

messages,

see

Troubleshooting Your Analyzer for solutions.

10-2

Chapter

11

Maintaining Your Analyzer

10.3 Using the Maintenance Program


Press [MENU] to enter the system menu. SELECT Service Maintenance (Figure 10-1)
to enter the Maintenance screen (Figure 10-2).

Figure 10-1 System menu

Figure 10-2 Maintenance screen

10-3

Maintaining Your Analyzer

Totally 13 maintenance procedures are available at the Maintenance screen.

Diluent Prime

Rinse Prime

Lyse Prime

Zap Aperture

Flush Aperture

Probe Cleanser Cleaning

E-Z Cleanser Cleaning

Lyse Test

Clean Bath

Drain Bath

Drain Tubing

Clean Probe Wipe

Prepare to Ship

10.3.1 Diluent Prime

The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

After installing new reagents, let the reagents stand for a while before using
them.

After installing a new container of diluent, rinse or lyse, do a background


check to ensure the background results are normal.

You should perform the Diluent prime procedure to prime the diluent tubing when

there are bubbles in the tubing; or


10-4

Maintaining Your Analyzer

the diluent in the tubing is contaminated; or

you have installed a new container of diluent without shutting the analyzer.

At the Maintenance screen, SELECT Diluent prime to prime the tubing and the priming
progress will be displayed at the bottom of the screen, Figure 10-3 shows. When the priming
is done, the screen will return to the initial state.

Figure 10-3 Priming diluent screen

10.3.2 Rinse Prime

The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

After installing new reagents, let the reagents stand for a while before using
them.

After installing a new container of diluent, rinse or lyse, do a background


check to ensure the background results are normal.

10-5

Maintaining Your Analyzer


You should perform the Rinse prime procedure to prime the rinse tubing when

there are bubbles in the tubing; or

the rinse in the tubing is contaminated; or

you have installed a new container of rinse without shutting the analyzer.

At the Maintenance screen, SELECT Rinse prime to prime the tubing and the priming
progress will be displayed at the bottom of the screen, as Figure 10-4 shows. When the
priming is done, the screen will return to the initial state.

Figure 10-4 Priming rinse screen

10.3.3 Lyse Prime

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

After installing new reagents, let the reagents stand for a while before using
them.

After installing a new container of diluent, rinse or lyse, do a background


check to ensure the background results are normal.

10-6

Maintaining Your Analyzer

You should perform the Lyse prime procedure to prime the lyse tubing when

there are bubbles in the tubing; or

the lyse in the tubing is contaminated; or

you have installed a new container of lyse without shutting the analyzer.

At the Maintenance screen, SELECT Lyse prime to prime the tubing and the priming
progress will be displayed at the bottom of the screen, as Figure 10-5 shows. When the
priming is done, the screen will return to the initial state.

Figure 10-5 Priming lyse screen

10.3.4 Zap Aperture


You can perform the Zap aperture procedure to unclog the apertures or prevent clogging.
At the Maintenance screen, SELECT Zap aperture to zap the apertures and the zapping
progress will be displayed at the bottom of the screen, as Figure 10-6 shows. When the
zapping is done, the screen will return to the initial state.

10-7

Maintaining Your Analyzer

Figure 10-6 Zapping aperture

10.3.5 Flush Aperture


You can perform the Flush aperture procedure to flush the apertures to unclog the
apertures or prevent clogging.
At the Maintenance screen, SELECT Flush aperture to flush the aperture and the
flushing progress will be displayed at the bottom of the screen, as Figure 10-7 shows. When
the flushing is done, the screen will return to the initial state.

Figure 10-7 Flushing apertures

10-8

Maintaining Your Analyzer

10.3.6 Probe Cleanser Cleaning

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

The probe cleanser is corrosive. Wear proper personal protective equipment


(e.g. gloves, lab coat, etc.) and follow safe laboratory procedures when
handling them in the laboratory.

You can soak the bath and fluidic lines with the probe cleanser, an alkaline detergent, by
performing the Probe cleanser cleaning procedure. If your analyzer is to run 24 hours a
day, you should perform this procedure.
Follow the steps given below to do so:
1. At the Maintenance screen, move the cursor to Probe cleanser cleaning;
2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser. When you
hear the beep and the sample probe is out of the bottle, remove the cleanser. The
analyzer will start priming process, as Figure 10-8 shows;

Figure 10-8 Priming bath and fluidic lines


3. When the priming is done, the analyzer will start the 5-minute soaking process, as Figure
10-9 shows and you may press [ENTER] to stop it before the time is due. Note that a
10-9

Maintaining Your Analyzer


shortened priming process may not be as effective as a complete one;

Figure 10-9 soaking process


4. When the soaking is done, the analyzer will start the cleaning process, as Figure 10-10
shows, after which screen will return to the initial state;

Figure 10-10 Cleaning process


To make sure this analyzer functions normally, every time the accumulated analyzed samples
reach 600, a message box will pop up to remind you to perform the probe cleanser
cleaning procedure, as Figure 10-11 shows. CLICK Yes to proceed with the cleaning;
CLICK No to cancel the cleaning.

10-10

Maintaining Your Analyzer

Figure 10-11 A message box to confirm the cleaning

10.3.7 E-Z Cleanser Cleaning

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

You can use the E-Z cleanser, an enzyme based, isotonic cleaning solution and wetting agent,
to clean the tubing and bath by performing the E-Z cleanser cleaning procedure.
Follow the steps given below to perform the procedure:
1. At the Maintenance screen, move the item to E-Z cleanser cleaning;
2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser. When you
hear the beep and the sample probe is out of the bottle, remove the cleanser. This
analyzer will automatically prime the bath and fluidic lines with the aspirated cleanser and
the progress is displayed on the screen, as Figure 10-12 shows;

Figure 10-12 Priming the bath and fluidic lines


3. When the priming is done, the analyzer will start the 10-minute soaking process, as
10-11

Maintaining Your Analyzer


Figure 10-13 shows.

Figure 10-13 E-Z cleaning


4. When the soaking is done, the analyzer will start the draining process, as Figure 10-14
shows. When the draining is done, the whole procedure is over and the screen will return
to the initial state.

Figure 10-14 Draining the bath and fluidic lines


If the accumulated analyzed samples reach 100, a message box, as Figure 10-15 shows, will
pop up to remind you to perform the E-Z cleanser cleaning procedure. If you want to do so,
CLICK Yes . Otherwise, CLICK No to cancel the cleaning.

10-12

Maintaining Your Analyzer

Figure 10-15 A message box to confirm the cleaning

10.3.8 Lyse Test

The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

In case of any abnormal WBC counts or histograms, you can perform the Lyse test
procedure to check whether the lyse can be dispensed properly.
Follow the steps given below to do so:
1. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-16) on the right plate;

Figure 10-16 Removing the two screws


2. Follow the arrow shown in Figure 10-17 to push and remove the right plate;
10-13

Maintaining Your Analyzer

Figure 10-17 Removing right plate


3. Remove the screws fixing the shielding box of the bath, as Figure 10-18 shows;

Figure 10-18 Shielding box


4. Remove the shielding box to expose the bath, as Figure 10-19 shows;

10-14

Maintaining Your Analyzer

Figure 10-19 Bath


5. SELECT Lyse test. The analyzer will automatically drain the bath and then dispense
2ml of lyse into the bath;
6. Check the scale to see whether the lyse has reached the expected line (the second from
the bottom). If so, press [ENTER] and the analyzer will automatically flush the bath and
dispense lyse and the test is done;
7. If not, repeat steps 5 and 6 several times. If all the tries have failed, check whether the
lyse has run out or the lyse pickup tube is not properly connected to this analyzer. If the
lyse is still enough and the tube is well connected to the analyzer, contact the Mindray or
your local distributor for assistance.

10.3.9 Clean Bath


Follow the steps given below to perform the Clean bath procedure:
SELECT Clean bath to start the cleaning procedure, as Figure 10-20 shows. When the
cleaning is done, the screen will return to the initial state;

10-15

Maintaining Your Analyzer

Figure 10-20 Clean bath

10.3.10 Drain Bath


When at three or more of the WBC, RBC, PLT and HGB results are abnormal, you may do
the Drain bath procedure to find out the reason.
Follow the steps below to do so:
1. Do steps 1 to 4 of the Drain bath procedure to expose the bath;
2. SELECT Drain bath to drain the bath;

Figure 10-21 Draining the bath


3. When the draining is done, the screen will display the residual time of draining bath;

10-16

Maintaining Your Analyzer

Figure 10-22 The time of draining bath


4. Check the bath and the tubing below them for residual fluid. If there is no fluid, press
[ENTER] to prime the bath with diluent, as Figure 10-23 shows. When the priming is done,
the screen will return to the initial state;

Figure 10-23 Priming the bath with diluent


5. If there is fluid left, turn off the analyzer and call Mindray customer service department or
your local distributor for assistance.

10-17

Maintaining Your Analyzer

10.3.11 Drain Tubing

The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

Do the Drain Tubing procedure before relocating the analyzer.

You can perform the Drain tubing procedure to drain the fluidic system. Follow the steps
given below to do so:
1. Press the appropriate arrow keys ([][] [][]) as needed to move the cursor to Drain
tubing;
2. Remove the diluent, rinse and lyse pickup tubes from the back of the analyzer;
3. Press [ENTER] to start the draining process, as Figure 10-24 shows;

Figure 10-24 Draining the fluidic lines


4. When the draining is done, the screen will display Turn off this analyzer and you
should turn off the power switch.
10-18

Maintaining Your Analyzer

10.3.12 Clean Probe Wipe


After being used for a long time, the bottom of the probe wipe may be contaminated by blood
and the inside of the probe wipe may also be contaminated by the dirt sucked in. So you need
to clean the probe wipe regularly.
Follow the steps given below to do so:
1. Present the probe cleanser to the sample probe;
2. SELECT Clean Probe Wipe to start the aspiration;
3. When you hear the beep and the sample probe is out of the bottle, remove the cleanser;
4. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-25) on the right plate;

Figure 10-25 Removing the two screws


5. Follow the arrow shown in Figure 10-26 to push and remove the right plate;

Figure 10-26 Removing right plate


6. Follow the instructions displayed on the screen to place an empty cup, whose diameter
10-19

Maintaining Your Analyzer


should be no less than 8cm, below the sample probe;
7. Press [ENTER] to soak the probe wipe with the aspirated cleanser. The soaking progress
will be displayed on the screen, as Figure 10-27 shows;

Figure 10-27 Cleaning probe wipe


8. When the soaking is done, wipe the bottom of the probe wipe with a probe
cleanser-dipped cloth that does not leave debris;
9. Press [ENTER] to flush the block and the interior of the probe and the flushing progress is
displayed on the screen, as Figure 10-28 shows;

Figure 10-28 Flush the block and the interior of the probe
10. After the flushing is done, the screen returns to the initial state.
When the accumulated analyzed samples reach 150, a message box will pop up to remind to

10-20

Maintaining Your Analyzer


clean the probe wipe, as Figure 10-29 shows. CLICK Yes to do the procedure; CLICK No
to abort the procedure.

Figure 10-29 message box

10.3.13 Prepare to Ship


Use the Prepare to ship program to prepare your analyzer for a prolonged period of
non-use or for shipping.
Follow the steps given below to do so:
1. Press the appropriate arrow keys ([][][][]) to move the cursor to Prepare to
ship. Remove the diluent, rinse and lyse tubing from the containers following the
instructions displayed on the screen;
2. Press [ENTER] and a message box will pop up to ask you to confirm this operation, as
Figure 10-30 shows;

Figure 10-30 A message box of prepare to ship


3. CLICK No if you want to abort this operation; CLICK Yes to proceed with the
operation. The analyzer starts to drain the fluidic lines and the progress is displayed on
the screen, as Figure 10-31 shows.

10-21

Maintaining Your Analyzer

Figure 10-31 Draining fluidic lines


4. After draining the tubing, follow the instructions displayed on the screen (Figure 10-32) to
put the rinse, diluent and lyse tubing into distilled water and press [ENTER] to flush this
analyzer with the distilled water;

Figure 10-32 Washing the analyzer


5. When the washing is over, follow the instructions displayed on the screen to remove the
rinse, diluent and lyse tubing from the distilled water and press [ENTER] to drain the
tubing again;
6. Turn off the analyzer when the screen displays Turn off the analyzer;
7.

Wipe this analyzer dry and wrap it up for storage.

10-22

Maintaining Your Analyzer

10.4 Using the Status Program


The items displayed in the System Status screen reflect how the analyzer is functioning
and contribute significantly to diagnosing analyzer errors. You may follow the instructions
given below to check those items.
Press [MENU] to enter the system menu and SELECT Service Status, as Figure 10-33
shows, to enter the Status screen, as Figure 10-34 shows.

Figure 10-33 System menu

Figure 10-34 Status screen


At the Status screen you can only view the displayed status information and reference
ranges without changing them.

10-23

Maintaining Your Analyzer

10.5 Using the Self-test Program


The system self-test is a major way to locate system errors. Follow the instructions given
below to view and check the available self-test items.
Press [MENU] to enter the system menu and SELECT Service Self-test, as Figure
10-35 shows, to enter the Self-test screen, as Figure 10-36 shows.

Figure 10-35 System menu

Figure 10-36 Self-test screen

This screen can be interpreted as follows:

Test Groups area (on the left)

This area displays the test groups. The available self-test items are divided into four groups,
Tubing, Machine, Valve and Circuit.
Press [F1] to select the desired group. The selected group is preceded by a .

Test Result area (on the right)

10-24

Maintaining Your Analyzer


This area displays the items included in the test group and the test results.

Help area (on the bottom)

This area displays useful information to help you move to the next step.
At this screen, if you want to acquire help information, press [HELP]; if you want to print out
the test results (except for the results of the tests), press [PRINT].

10.5.1 Testing the Fluidic System


Press [F1] to select the Tubing group. At the self-test screen, press [F1] to select the
Tubing group, as Figure 10-36 shows. To conduct the following tests, just SELECT the
desired test and the results will be displayed later.

Count Time

It measures the duration of a WBC and RBC count, namely how many seconds it takes for
the aspirated fluid flows from the first sensor to the second.

Aperture(v)

It measures the voltage (v) over the aperture.

Vacuum

It checks whether the vacuum system functions normally.

Pressure

It checks whether the system flushes the aperture at a normal pressure.

Filter

It checks whether the filter functions normally.

10.5.2 Testing Motors and Recorder/Printer


To test the motors and recorder/printer, press [F1] to select the Machine group, as Figure
10-37 shows.

10-25

Maintaining Your Analyzer

Figure 10-37 testing mechanic part


To conduct the following tests, SELECT the desired test and the results will be displayed
later.

Syringe motor

The syringe motor controls the aspiration volume. This test checks whether the motor
functions normally.

Rotation motor

The rotation motor rotates the sample probe inside the analyzer. This test checks whether the
motor functions normally.

Elevator motor

The elevator motor controls elevation of the sample probe. This test checks whether the
motor functions normally.

Print

This test checks whether the recorder or printer functions normally. If normal, when you press
[ENTER], the recorder or printer will print out a test page; if abnormal, the screen will display
the corresponding error message and you can see Chapter 11 Troubleshooting Your
Analyzer for solutions.

10.5.3 Testing Valves


To test whether the valves function properly, press [F1] to select the Valve group, as Figure
10-38 shows. Follow the steps below to test the desired valve.

10-26

Maintaining Your Analyzer

Figure 10-38 Testing valves


To test a valve, SELECT the valve. If the valve goes through an Off-On-Off sequence without
making any abnormal sound, it passes the test. Otherwise, something may be wrong with the
valve.

10.5.4 Testing A/D Interrupt


To test the A/D interrupt, press [F1] to select the Circuit group, as Figure 10-39 shows.

Figure 10-39 Testing A/D interrupt


To conduct the test, SELECT A/D interrupt and the test result will be displayed later.

10-27

Maintaining Your Analyzer

10.6 Log
The log records all the major events taking place during the running of this analyzer. It helps
the service engineers diagnose system errors.
Press [MENU] to enter the system menu and SELECT ServiceLog, as Figure 10-40
shows to enter the Log screen, as Figure 10-41 shows.

Figure 10-40 System menu

Figure 10-41 Log screen


The recorded events are divided into three groups, All, Settings and Other(including
setting discriminators, system self-test and updating system software), which are all listed on
the left of the screen. All the recorded events are listed on the right of the screen by default.
You can press [F1] to select the desired group and the right of the screen will display the
events of the selected group only. Every screen displays 10 events. You can press [] or []
to check the events one by one or press [PgUp] or [PgDn] to check the events on the
previous or next screen. If you want to print out the displayed events, press [PRINT]. If you
want to acquire help information, press [HELP].

10-28

Maintaining Your Analyzer


For every recorded event, the NO. column displays the sequences of the recorded events;
the Time column displays the time when this event occurred; the Type column displays
the event type; the Times column displays how many times (1 to 255) this event occurred
and if it occurred more than 255 times, the excessive events will be recorded from 1 to
another log file; the Information column displays extra information regarding the event.
This analyzer can save a maximum of 1000 log files and once the maximum number has
been reached, the newest log will automatically cover the oldest one.

10-29

Maintaining Your Analyzer

10.7 Viewing System Configuration


To view the system configuration, press [MENU] to enter the system menu, and SELECT
ServiceConfig. , as Figure 10-42 shows, to enter the Config. screen, as Figure 10-43
shows.

Figure 10-42 system menu

Figure 10-43 Config. screen


Every screen displays 13 items and you can press [] or [] to select the item you want to
see, or press [PgUp] or [PgDn] to go to the previous or next screen. If you want to print out
the configuration, press [PRINT]. If you want to acquire help, press [HELP].

10-30

Maintaining Your Analyzer

10.8 Printing Management


Press the [MENU] to enter the system menu and SELECT ServicePrint. , as Figure
10-44 shows, to enter the Print screen, as Figure 10-45 shows.

Figure 10-44 System menu

Figure 10-45 Print screen


The printing tasks are queued in this screen, where you can view the all and delete those
waiting to be processed. Once something goes wrong with the printing device, the task being
processed will be deleted and the queued tasks will keep waiting. Once the system finds the
error has been removed, it will resume printing and process the tasks from the first one. Note
that you cannot change the sequence of the queued tasks.
You can perform the following operations at the Print screen:

Press [DEL] to delete the selected task;

Press [HELP] to display the help information;

Press [MENU] to return to the system menu.

10-31

Maintaining Your Analyzer

10.9 Calibrating Sample Probe Position

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

The relative position between the sample probe and probe wipe has influence on the analysis
results. In the accessory box, there is a sample probe localizer, as Figure 10-46 shows. You
need to use the localizer to adjust the position of the sample probe if you have replaced probe
wipe, or observed motor error, or incorrect analysis result. Also, as required by regular
maintenance, you should use the localizer to adjust the position of the sample probe monthly.

Figure 10-46 Probe localizer


1. SELECT Setup Password and enter the administrator password;
2. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-47) on the right plate.

Figure 10-47 Removing the two screws


3. Follow the arrow shown into push and remove the right plate;
10-32

Maintaining Your Analyzer

Figure 10-48 Removing right plate


4. Press [F1] to select the Machine group and SELECT Elevator motor, as Figure
10-49 shows;

Figure 10-49 Self-test screen


5. An Elevator motor window will pop up, as Figure 10-50 shows;

10-33

Maintaining Your Analyzer

Figure 10-50 Elevator motor window


6. Press [] to move the sample probe upward and press [] to move the probe to above
the bath, as Figure 10-51 shows;

Figure 10-51 Sample probe above the bath


7. Loose the retaining screw by a screwdriver, as Figure 10-52 shows.

10-34

Maintaining Your Analyzer

Figure 10-52 Removing screws


8. Remove the probe from the probe wipe and insert the localizer into the probe wipe from
the bottom, as Figure 10-53 shows;

Figure 10-53 Using localizer


9. Insert the probe into the probe wipe until it reaches the localizer, as Figure 10-54 shows;

Figure 10-54 Inserting sample probe into probe wipe


10. Retighten the screw to fix the probe and remove the localizer to wrap up the adjustment.

10-35

Maintaining Your Analyzer

10.10 Replacing the Probe Wipe

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

To replace the probe wipe:


1. Refer to Chapter 10.9 and do the steps 1 to 8;
2. Pull the loosen probe wipe upward to remove the probe wipe and disconnect the tubes
from the probe wipe (pay attention to the correspondence between the tubes and the
connectors), as Figure 10-55 shows;

Figure 10-55 Installing probe wipe


3. Install a new block and connect the tubing end with the black marking to the connector
below the block;
4. Calibration to the sample probe position should be performed after replacing the probe
wipe. Refer to Chapter 10.9.

10-36

Maintaining Your Analyzer

10.11 Replacing the Filter of the Vacuum Chamber


1. Unscrew and remove the retaining screws with hands or screwdrivers (pointed by the
arrows shown in Figure 10-56 ) on the right plate;

Figure 10-56 Removing the two screws


2. Follow the arrow shown in Figure 10-57 to push and remove the right plate;

Figure 10-57 Removing the right plate


3. Find the filter shows in Figure 10-58;

10-37

Maintaining Your Analyzer

Figure 10-58 Vacuum filter


4. Remove the filter and take a new one from the accessory kit and install it.

10-38

Maintaining Your Analyzer

10.12 Maintaining Recorder

Wear proper personal protective equipment (e.g. medical gloves, disposable


wrist strap, etc.) against the static electricity during maintaining recorder.

Make sure the power supply of the analyzer has been cut off before
maintenance.

If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.

Do not add unnecessary force to the recorder head.

Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.

Make sure the alcohol volatilizes completely before using the recorder to
print.

Maintain the recorder strictly as instructed below.

You should maintain the recorder every two months. Do as follows to maintain your recorder:
1. Turn off the analyzer and cut off the power supply;
2. Open the recorder door and take out the recorder paper;
3. Gently wipe the roller from left to right using cotton swabs;
4. Roll the roller and repeat step 3 to clean off all debris and stains on the roller;
5. Gently wipe the heating part of the recorder head from left to right using cotton swabs
dipped with alcohol (no drops) to clean off all debris and stains on the head;
6. Wipe off the alcohol remaining on the heating part of the recorder head using dry cotton
swabs;
7. Wait at least 20 minutes till alcohol on the heating part of the recorder head volatilizes
completely, and then install recorder paper and close the recorder door.
10-39

Maintaining Your Analyzer

Figure 10-59 Heating part of recorder head and roller


See the figure above to find the heating part of the recorder head and the roller when the
recorder door is opened.

10-40

11 Troubleshooting Your Analyzer


11.1 Introduction
The BC-2800 continuously monitors the status of the system and displays pertinent
information in the left corner of the Count screen (the Error Message area). If a problem is
detected, the Error Message area displays the corresponding error message. This chapter
contains information that is helpful in locating and correcting problems that may occur during
operation of your analyzer.

This chapter is not a complete service manual and is limited to problems


that are readily diagnosed and/or corrected by the user of the analyzer. If the
recommended solution fails to solve the problem, contact Mindray or your
local distributor.

Running samples in presence of error messages may lead to misleading


results. If any error message occurs during sample analysis, remove the
error first and then re-run the sample.

Unless otherwise instructed, always turn off the power before trying to fix
the error.

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

11-1

Troubleshooting Your Analyzer

11.2 Errors without available error messages


Error

Possible cause(s)

The analyzer
cannot be
turned on.

Recommend action

1. power cord is broken or not


well connected;

1. check the power cord connection;


2. Check the fuse;

2. The fuse is broken;

3. Check the electrical outlet.

3. The power outlet has no


electricity.
Liquid

drips

from analyzer

Damaged pump hose or blocked

1. Turn off the power and wipe the


analyzer dry;

filter.

2. Call Mindray customer service

inside.

department or your local distributor


for assistance.
Recorder does

1. Recorder paper is jammed;

1. Remove the jammed paper;

not work.

2. Something is wrong with the

2. If the problem remains, turn off the

circuit.

analyzer and turn it on again in 10


seconds.

11-2

Troubleshooting Your Analyzer

11.3 Errors indicated by error messages


The analyzer can provide error messages. See the tables below for the error messages and
their probable causes and recommended actions. If the problem still remains after you have
tried the recommended solutions, contact Mindray customer service department or your local
distributor.
Error Message

Possible Cause(s)

Recommended Action

Ambient temp.

Abnormal ambient

abnormal

temperature or temperature
transducer error.

1. Enter the Service Status screen to


check the ambient temperature;
2. If the actual ambient exceeds 15 to
30, adjust the temperature.
Otherwise, the analysis results may be
unreliable;
3. If the actual temperature is within the
pre-defined range and the problem
remains, contact Mindray customer
service department or your distributor.

Blank
abnormal

1.

Contaminated diluent,
diluent lines or bath;

2.

Expired diluent.

1. Check if the diluent is contaminated or


expired;
2. Enter the Count screen and press
the aspirate key to do the startup
procedure;
3. If the problem remains, enter the
Service Maintenance screen and
do the probe cleanser cleaning
procedure as instructed in Chapter
10.3.6. When the procedure is
finished, return to the Count screen
and do the background check again;
4. If the problem remains, contact
Mindray customer service department
or your local distributor.

HGB error

HGB blank voltage within 0 V


to 3.2 V or 4.9 V to 5 V.

1. Do the Probe cleanser cleaning


procedure as instructed in Chapter
10.3.6.;
2. If the problem remains, adjust the
HGB gain as instructed by Chapter

11-3

Troubleshooting Your Analyzer


5.3.4 to set the voltage within 3.4 to
4.8V, preferably 4.5V;
3. If the problem remains, shut down
your analyzer and contact Mindray
customer service department or you
local distributor.
HGB adjust

HGB blank voltage within 3.2


V to 3.4 V or 4.8 V to 4.9 V.

1. Do the probe cleanser cleaning


procedure as instructed in Chapter
10.3.6.;
2. If the problem remains, adjust the
HGB gain as instructed by Chapter
5.3.4 to set the voltage within 3.4 to
4.8V, preferably 4.5V;
3. If the problem remains, shut down
your analyzer and contact Mindray
customer service department or you
local distributor.

WBC clog

1. Clogged the aperture;


2. Inappropriate WBC count
time setting;

1. Enter the Service Maintenance


screen. Zap and flush the aperture as
instructed by Chapter 10.3.4 and
10.3.5;

3. Solenoid valve error.

2. Enter the Setup Settings


Count screen and record the WBC
count time. Then enter the Service
Self-test screen and test the actual
WBC count time as instructed by
Chapter 10.5.1.;
3. If the difference between the reference
WBC count time and the actual WBC
count time is less than 2 seconds, the
error has been removed;
4. If not, enter the Service
Maintenance screen and do the
probe cleanser cleaning procedure as
instructed by Chapter 10.3.6;
5. Enter the Setup Settings
Count screen and record the WBC
count time. Then enter the Service
Self Test screen and test the actual
WBC count time as instructed by
Chapter 10.5.1;
11-4

Troubleshooting Your Analyzer


6. If the difference between the reference
WBC count time and the actual WBC
count time is less than 2 seconds, the
error has been removed;
7. If the difference is still greater than 2
seconds but consistent, enter the
Setup Settings Count and
reset the WBC count time. Then enter
the Service Self-test screen and
test the actual WBC count time as
instructed by Chapter 10.5.1 to
confirm the difference is less than 2
seconds;
8. If the problem remains, contact
Mindray customer service department
or your local distributor.
WBC bubbles

1. Diluent or rinse running


out;

out. If so, change a new container of

2. Loose tube connections;


3.

1. Check if the diluent or rinse has run


diluent or rinse as instructed in
Chapter 4.4.1;

Inappropriate WBC

2. Check the connection of the diluent

count time setting.

and rinse pickup tube. If necessary,


reconnect and tighten them as
instructed by Chapter 4.4.1;
3. If the problem remains, adjust the
WBC count time as instructed by
Chapter 5.3.5;
4. If the problem remains, contact
Mindray customer service department
or your local distributor.

RBC clog

1. Clogged the aperture;

1. Enter the Service Maintenance


screen. Zap and flush the aperture as

2. Inappropriate RBC

instructed by Chapter 10.3.4. and

count time setting;

10.3.5.;

3. Solenoid valve error.

2. Enter the Setup Settings


Count screen and record the RBC
count time. Then enter the Service
Self-test screen and test the actual
RBC count time as instructed by
Chapter 10.5.1.;
3. If the difference between the reference
11-5

Troubleshooting Your Analyzer


RBC count time and the actual RBC
count time is less than 2 seconds, the
error has been removed;
4. If not, enter the Service
Maintenance screen and do the
probe cleanser cleaning procedure as
instructed by Chapter 10.3.6.;
5. Enter the Setup Settings
Count screen and record the RBC
count time. Then enter the Service
Self-test screen and test the actual
RBC count time as instructed by
Chapter 10.5.1.;
6. If the difference between the reference
RBC count time and the actual RBC
count time is less than 2 seconds, the
error has been removed;
7. If the difference is still greater than 2
seconds but consistent, enter the
Setup Settings Count and
reset the RBC count time. Then enter
the Service Self-test screen and
test the actual RBC count time as
instructed by Chapter 10.5.1 to
confirm the difference is less than 2
seconds;
8. If the problem remains, contact
Mindray customer service department
or your local distributor.
RBC bubbles

1. Diluent or rinse running


out;

1. Check if the diluent or rinse has run


out. If so, change a new container of

2. Loose tube connections;

diluent or rinse as instructed in


Chapter 4.4.1;

3. Inappropriate RBC

2. Check the connection of the diluent

count time setting.

and rinse pickup tube. If necessary,


reconnect and tighten them as
instructed by Chapter 4.4.1;
3. If the problem remains, adjust the RBC
count time as instructed by Chapter
5.3.5;
4. If the problem remains, contact
11-6

Troubleshooting Your Analyzer


Mindray customer service department
or your local distributor.
Trans error

1. Communication cable not


well connected;

1. Check if the communication cable is


well connected;

2. Inappropriate

2. Check the communication settings as

communication settings.

instructed by Chapter 5.3.2 and make


sure they are the same with the host.

Barcode error

1. Poor connection between


the scanner and the

1. Check if the analyzer is well connected


to the analyzer;

analyzer;

2. Check if the bar-code is valid;

2. Invalid bar-code.

3. If the problem remains, contact


Mindray customer service department
or your local distributor.

Barcode

com

Poor connection between the


scanner and the analyzer.

error

1. Check if the analyzer is well connected


to the analyzer;
2. If the problem remains, contact
Mindray customer service department
or your local distributor.

Printer

out

of

Printer paper running out or


not properly installed.

paper

1. Check if there is printer paper;


2. Check if the printer paper is well
installed.

Printer offline
Recorder

com

error

Poor connection between the

Check if the printer is well connected to the

printer and the analyzer.

analyzer.

1. Poor connection between

1. Print again;

the recorder and the

2. If the problem remains, shut down the


analyzer and restart it again, and then

analyzer;

print again;

2. Damaged recorder.

3. If the problem remains, shut down the


analyzer

and

contact

Mindray

customer service department.


Recorder out of
paper

Recorder paper running out


or not properly installed.

1. Check if the recorder paper has run


out. If so, install the paper as
instructed by Chapter 4.4.2;
2. Check if the recorder paper is properly
installed. If not, re-install the paper as
instructed by Chapter 4.4.2;
3. If the problem remains, contact
Mindray customer service department
or your local distributor.

11-7

Troubleshooting Your Analyzer


Recorder too hot

Recorder head too hot.

1. Stop using recorder and cool it for 10


minutes and then print again;
2. If the problem remains, shut down the
analyzer and restart it again, and then
print again;
1. If the problem remains, contact
Mindray customer service department.

Insufficient lyse or wrong lyse

Lyse out

volume setting.

1. Check if there is sufficient lyse left. If


so, access Setup Settings
Reagents and adjust the remaining
lyse volume as instructed by Chapter
5.3.1;
2. If not, change a new container of lyse
as instructed by Chapter 4.4.1.

Diluent expired

Expired diluent or wrong

1. Check if the diluent has expired. If so,

expiration setting

change a new container of diluent as


instructed by Chapter 4.4.1;
2. If not, reset the expiration date as
instructed in Chapter 5.3.1.

Rinse expired

Expired rinse or wrong

1. Check if the rinse has expired. If so,

expiration setting

change a new container of rinse as


instructed by Chapter 4.4.1;
2. If not, reset the expiration date as
instructed in Chapter 5.3.1.

Expired lyse or wrong

Lyse expired

1. Check if the lyse has expired. If so,

expiration setting

change a new container of lyse as


instructed by Chapter 4.4.1;
2. If not, reset the expiration date as
instructed in Chapter 5.3.1.

Vacuum
error

filter

The air inside the vacuum


chamber is not extracted

1. Enter Service Selftest


Tubingto test the filter as instructed

within the given time.

in Chapter 10.5.1;
2. If the test result is normal, the error will
be removed;
3. If the problem remains, replace the
filter as instructed by Chapter 10.11;
4. If the problem still remains after a new
filter has been installed, contact
Mindray customer service department
11-8

Troubleshooting Your Analyzer


or your local distributor.
Real-time clock
error

1. Someone tempered with

1. Enter Setup Settings Date &

the on-board battery off

Time screen and reset the time as

the board;

instructed by Chapter 5.3.3;

2. Something is wrong with

2. Restart the analyzer after the

the on-board battery

adjustment and the time should be

(poor contact, dead

correct;

battery, etc.);

3. If the problem remains, contact

3. Damaged real-clock chip.

Mindray customer service department


or your local distributor.

Syringe

motor

1. Poor contact of the

1. Enter Service Self-test Machine

motor;

error

to test the syringe motor as instructed


by Chapter 10.5.2.;

2. Damaged motor;
3. Poor connection between
the power drive board
and the CPU board;

customer service department or your


local distributor.

photocoupler.
motor

error

1. Jammed sample probe;


2. Poor contact of the signal
line;

the drive board and the


CUP board;

motor as instructed by Chapter


10.5.2.. If the test result is normal, the
error will be removed;
3. If the problem remains, contact

5. Malfunctioning photo

Mindray customer service department

coupler.

error

sample probe is jammed;


Machinescreen to test the rotation

4. Poor connection between

motor

1. Open the front door and check if the


2. Enter Service Self Test

3. Damaged motor;

Elevator

be removed;
3. If the problem remains, contact Mindray

4. Malfunctioning

Rotation

2. If the test result is normal, the error will

or your local distributor.

1. Jammed sample probe;


2. Poor contact of the signal
line;

1. Open the front door and check if the


sample probe is jammed;
2. Enter the Service System Test
screen and check the motor as

3. Damaged motor;
4. Poor connection between
the drive board and the
CUP board;

instructed in Chapter 10.5.2.


3. The error will be removed if the test
result is normal;
4. If the problem remains, contact

5. Malfunctioning photo

Mindray customer service department

coupler.

or your local distributor.

11-9

Troubleshooting Your Analyzer


A/D error

Something is wrong with the


A/D part of the CPU board.

1. Enter the Service Self-test


Circuit screen to test the A/D
interrupt as instructed by Chapter
10.5.4.;
2. If the test result is normal, the error will
be removed;
3. If the problem remains, shut down the
analyzer and contact Mindray
customer service department or your
local distributor.

Vacuum error

The vacuum degree does not


reach the expected value
within the given time.

1. Check whether the external tubing is


pressed;
2. If not, enter Service Self-test
Tubing to check the vacuum as
instructed by Chapter 10.5.1..;
3. If the test result is normal, the error will
be removed;
4. If the problem remains, contact
Mindray customer service department
or your local distributor.

Pressure error

The pressure inside the


pressure chamber does not
reach the expected value
within the given time

1. Check whether the external tubing is


pressed;
2. If not, enter Service Self-test
Tubingscreen to check the pressure
as instructed by Chapter 10.5.1..;
3. If the test result is normal, the error will
be removed.
4. If the problem remains, contact
Mindray customer service department
or your local distributor.

Diluent empty

Insufficient diluent or wrong


diluent volume setting.

1. Check if there is sufficient diluent left. If


so, access Setup Settings
Reagents and adjust the remaining
diluent volume as instructed by
Chapter 5.3.1;
2. If not, change a new container of
diluent as instructed by Chapter 4.4.1.

Rinse empty

Insufficient rinse or wrong


rinse volume setting.

1. Check if there is sufficient rinse left. If


so, access Setup Settings

11-10

Troubleshooting Your Analyzer


Reagents and adjust the remaining
diluent volume as instructed by
Chapter 5.3.1;
2. If not, change a new container of rinse
as instructed by Chapter 4.4.1.
Waste full

The waste container is full.

Empty the waste container and reset


usable volume of the waste container as
instructed by Chapter 5.3.1.

File error

Something is wrong with the

Turn off the power and contact Mindray

analyzers file system.

customer service department or your local


distributor.

Dynamic
memory error

Something is wrong with the

Turn off the power and contact Mindray

analyzers memory.

customer service department or your local


distributor.

+12 V power

Something is wrong with the

Shut down the analyzer and contact

error

power board.

Mindray customer service department or


your local distributor.

-12 V power

Something is wrong with the

Shut down the analyzer and contact

error

power board.

Mindray customer service department or


your local distributor.

56V power error

Something is wrong with the

Shut down the analyzer and contact

power board.

Mindray customer service department or


your local distributor.

11-11

12 Appendices
A

Index

analyzer

Print & comm., 5-7

Intended use, 2-2

reagent, 5-5

name, 2-1

reference range, 5-20

aperture

CV

flush, 10-8

definition, 7-16

zap, 10-7

formula, 7-16

aperture size, B-2

diluent

aspirate key, 2-6

connection, 4-5

aspiration, 3-2

definition, 2-13

bath

prime, 10-4
clean, 10-15

dilution, 3-3

drain, 10-16

dimensions, B-5

baud rate, 5-8

drain tubing, 10-18

bubbles

environment, B-5

RBC, 11-6

error

WBC, 11-5

+12V power error, 11-11

calibration

-12V power error, 11-11

calibrator, 2-14, 9-4

56V power error, 11-11

manual, 9-17

A/D error, 11-10

preparations, 9-3

ambient temp. abnormal, 11-3

procedures, 9-3

barcode com error, 11-7

purpose, 9-1

barcode error, 11-7

clog

blank abnormal, 11-3


RBC, 11-5

diluent empty, 11-10

WBC, 11-4

diluent expired, 11-8

controls, 2-14

dynamic memory error, 11-11

count

elevator motor error, 11-9

principle, 3-1

file error, 11-11

procedure, 6-9

HGB adjust, 11-4

screen, 2-9

HGB error, 11-3

customize

lyse expired, 11-8

date & time, 5-11

lyse out, 11-8

gain, 5-13

pressure error, 11-10

other, 5-25

printer offline, 11-7


A-1

Appendices
printer out of paper, 11-7

RBC, B-3

real-time clock error, 11-9

WBC, B-3

recorder out of paper, 11-7

Lymph#

rinse empty, 11-10

definition, 3-7

rinse expired, 11-8

formula, 3-7

rotation motor error, 11-9

Lymph%

syringe motor error, 11-9

definition, 3-6

Trans error, 11-7

formula, 3-6

vacuum error, 11-10

lyse

vacuum filter error, 11-8

connection, 4-7

waste full, 11-11

definition, 2-13

E-Z cleanser

lyse test, 10-13

definition, 2-14

maintenance

gain

system, 10-3
set HGB gain, 5-15

MCH

set RBC gain, 5-14

definition, 3-10

set WBC gain, 5-13

formula, 3-10

Gran#

MCHC

definition, 3-7

definition, 3-10

formula, 3-7

formula, 3-10

Gran%

MCV

definition, 3-6

definition, 3-9

formula, 3-6

operating range, B-2

handshake, 5-9

Mid#

HCT

definition, 3-7

definition, 3-10

formula, 3-7

formula, 3-10

Mid%

HGB

definition, 3-6

carryover, B-3

formula, 3-6

definition, 3-7

MPV

linearity range, B-3

definition, 3-11

operating range, B-2

NRBC, 3-6

humidity, B-5

optical sensors, 3-4

ID, 6-9

parameter description, 2-2

Impedance Principle, 3-1

password, 5-2

installation

PCT

requirement, 4-2

definition, 3-11

LCD, 2-6

formula, 3-11

leukocyte

PDW

granulocyte, 2-2

definition, 3-11

lymphocyte, 2-2

performance specifications

mid-sized cell, 2-2

operating range, B-2, B-3

linearity range

PLT

PLT, B-3

definition, 3-11
A-2

Appendices
operating range, B-2

install paper, 4-9

power

reference range, 5-20

fuse, 4-2

rinse

voltage, 4-2

definition, 2-14

prediluted mode

prime, 10-5

analyzer, 6-19

sample

sample collection and handling, 6-7

analysis, 6-9

prepare to ship, 10-21

review, 7-1

printer

sample probe

connection, 4-10

adjust, 10-32

format, 5-7

sample probe localizer, 10-32

probe cleanser

shutdown, 6-28

use, 10-9

specification, B-1

probe wipe

system

clean, 10-19

self-test, 10-24

replace, 10-36

status, 10-23

QC

table
edit settings, 8-3

sample, 7-7

L-J graph, 8-10

searched, 7-29

run, 8-6

throughput, B-2

table, 8-12

transmission

RBC

at QC table screen, 8-13

definition, 3-9

at review screen, 7-25

measurement, 3-9

troubleshooting, 11-1

operating range, B-2

unpacking, 4-4

RDW-CV, 3-10

valve

reagent

test, 10-26

connection, 4-5

WBC

required, 2-13

definition, 3-6

recorder

operating range, B-2

format, 5-7

weight, B-6

A-3

Specifications

B.1

Classification

According to the CE classification, the BC-2800 is an In Vitro Diagnostic device.

B.2

Reagents

Diluent

M-18D DILUENT

Rinse

M-18R RINSE

Lyse

M-18CFL LYSE

E-Z CleanserEnzyme cleanser

M-18E E-Z CLEANSER

Probe Cleanser

M-18P PROBE CLEANSER

Calibrator

Specified by Mindray

Controls

Specified by Mindray

B.3

Parameters
Table B-1 Directly measured parameters and histograms

Parameter

Abbreviation

Default
9

White Blood Cell or leukocyte

WBC

10 /L

Red Blood Cell or erythrocyte

RBC

1012/L

Hemoglobin Concentration

HGB

g/L

Platelet

PLT

109/L

WBC histogram

WBC Histogram

RBC histogram

RBC Histogram

PLT histogram

PLT Histogram

Table B-2 Parameters derived from histograms


Parameter

Abbreviation

Default

Lymphocyte percentage

Lymph%

Mid-sized cell percentage

Mid%

Granulocyte percentage

Gran%

Mean Corpuscular Volume

MCV

fL

Variation

RDW-CV

Red Blood Cell Distribution Width Standard Deviation

RDW-SD

fL

Red Blood Cell Distribution Width Coefficient of

B-1

Appendices
Mean Platelet Volume

MPV

fL

Platelet Distribution Width

PDW

Table B-3 Calculated parameters


Parameter

Abbreviation

Default
9

Lymphocyte

Lymph#

10 /L

Mid-sized cell

Mid#

109/L

Granulocyte

Gran#

109/L

Hematocrit

HCT

Mean Cell Hemoglobin

MCH

pg

Mean Cell Hemoglobin Concentration

MCHC

g/L

Mean Platelet Volume

PCT

B.4

Sampling Features

B.4.1 Sample volumes required for each analysis


Whole Blood Mode (vein blood)

13 L

Prediluted Mode (capillary blood)

20 L

B.4.2 Aperture size

Aperture

Diameter

Length

80 m

70 m

B.4.3 Throughput
Less than 120 seconds/analysis

B.5

Performance specifications

B.5.1 Operating range


Parameter

Operating range

0.0 to 499.9

12

RBC (10 /L)

0.00 to 9.99

HGB (g/L)

0.0 to 300.0

MCV (fL)

0.0 to 250.0

WBC (10 /L)

PLT (10 /L)

0 to 2999
B-2

Appendices

B.5.2 Normal background


Parameter

Background result

WBC

0.3 109 / L

RBC

0.03 1012/ L

HGB

1g/L

HCT

0.5 %

PLT

7 109 / L

B.5.3 Linearity range


Parameter

Linearity range

0.0 to 99.9

12

RBC (10 /L)

0.0 to 9.99

HGB (g/L)

0 to 300

WBC (10 /L)

PLT (10 /L)

0 to 999

B.5.4 Carryover
Parameter

Carryover

WBC

0.5 %

RBC

0.5 %

HGB

0.5 %

PLT

1%

B.5.5 Reproducibility (with normal-level control)


Parameter
9

WBC (10 /L)


12

Condition

CV(%)

4.0 to 15.0

3.0

3.00 to 6.50

2.0

HGB (g/L)

100 to 180

2.0

MCV (fL)

70 to 100

1.0

200 to 500

5.0

RBC (10 /L)

PLT(10 /L)

B.6

Input/Output Device

Use the specified devices only.

B-3

Appendices

B.6.1 Keypad
18-key keypad.

B.6.2 Keyboard
PS/2 keyboard.

B.6.3 Bar-code scanner (optional)


B.6.4 Display
Color LCD, 7.8 640480

B.6.5 Recorder
Built-in thermal recorder that supports two printing formats and auto printing.

B.6.6 Recorder paper


Width:

50 +00.7 mm

To ensure the print quality and operating life of the recorder, it is


recommended that you purchase the recorder paper from the analyzer
manufacturer.

B.6.7 Printeroptional
Epson LQ300k+ II
Epson 630K

B.6.8 Interfaces

A keyboard interface.

Two RS-232 interfaces (maximum transmission distance 12 meters);

A parallel port(for printer or floppy disk drive);

A power supply for the floppy disk driveonly to be used with the power cable supplied by
Mindray.

IDE hard disk interface.

B.7

Power supply

Voltage: 100 to 240 VAC;


B-4

Appendices

Frequency: 50/60 Hz;

Input power:180 VA;

Fuse: AC 250 V T4 A

B.8

Use the fuse of the specified type and rating.

EMC Description

The product is subject to the EMC test as required by EN61326:1997+A1:1998+A2:


2001+A3 : 2003;

EMS is compliance with experiment environment;

EMC is compliance with Class A.

B.9

Sound

Maximal sound: 65 dB

B.10 Operating environment

Operating temperature:15 to 30 ;

Relative humidity: 30 % to 85 %;

Atmospheric pressure: 60 kPa to 110 kPa.

B.11 Storage environment

Ambient temperature: 10 to 40

Relative humidity: 10 % to 93 %

Atmospheric pressure: >50 kPa.

B.12 Dimensions
Depth

Width

Height
B-5

Appendices
38.6 cm

32.2 cm

43.7 cm

B.13 Weight
Less than 23 kg

B.14 Contraindications
None.

B-6

Precautions, Limitations and Hazards

C.1

Introduction

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.

C.1.1 Installation Requirements


All the space, power and environmental requirements listed in Chapter 4 and Appendix B
must be met. Establishing and maintaining proper grounding cannot be overemphasized.

C.1.2 Limitations
Whenever the results are outside the normal limits, it is recommended that the laboratory
following whatever written protocol is in place for validating results.
If an error occurs, the analyzer displays the corresponding error message In case of errors
related to the fluidic system (such as clogging or bubbles), it is recommended that you re-run
the sample after removing the error.
If the PLT value is less than 100 109 / L, it is recommended the result be verified by a
microscope.

C.1.3 Maintenance
The maintenance instructions in Chapter 10 describe corrective and preventive procedures
that must be followed to ensure proper operation and performance of your analyzer.

C-1

Appendices

C.2

Warnings

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 to human health.

Operate the analyzer under the condition 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.

Make sure the analyzer is properly grounded.

Before turning on the analyzer, make sure the input voltage meets the above
requirements.

When moving the analyzer, face the front of the analyzer and carry it from
the bottom with hands!

The reagents are irritating to eyes, skin and diaphragm. Wear proper
personal protective equipment (e.g. gloves, lab coat, etc.) and follow safe
laboratory procedures when handling them in the laboratory.

If the reagents accidentally spill on your skin, wash them off with plenty of
water and if necessary, go see a doctor; if the reagents accidentally spill into
your eyes, wash them off with plenty of water and immediately go see a
doctor.

Do not place the analyzer in a flammable or explosive environment.

Dispose of reagents, waste, samples, consumables, etc. according to


government regulations.

Avoid direct contact with blood samples.

The sample probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

To avoid personal injury, keep your clothes, hair and hands away from such
moving parts as the sample probe.

Only install a fuse of the specified type and rating.

Unless otherwise instructed, always turn off the power before trying to fix
the error.

Wear proper personal protective equipment (e.g. medical gloves, disposable


wrist strap, etc.) against the static electricity during maintaining recorder.

Make sure the power supply of the analyzer has been cut off before
maintenance.

C-2

Appendices

C.3

Cautions

Installation by personnel not authorized or trained by Mindray may damage


your analyzer. Do not install your analyzer without the presence of
Mindray-authorized personnel.

Do not place any container on the top of the analyzer.

Do not re-use disposable products.

Do not perform any maintenance procedures that are not described in this
chapter. Performing unauthorized maintenance procedures can damage
your analyzer.

In case of problems not specified in this manual, contact Mindray customer


service department or your local distributor for assistance.

Only Mindray-supplied parts can be used for maintenance. For any


questions, contact Mindray customer service department or your local
distributor.

Use only specified recorder paper. Otherwise, it may cause damage to the
recorder head, or the recorder may be unable to print, or poor print quality
may result.

Never pull the recorder paper with force when a recording is in process.
Otherwise, it may cause damage to the recorder.

Do not leave the recorder door open unless you install paper or remove
trouble.

Improper installation of recorder paper may jam the paper and/or result in
blank printout.

If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.

Do not add unnecessary force to the recorder head.

Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.

Make sure the alcohol volatilizes completely before using the recorder to
print.

C-3

Appendices

C.4

Notes

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

Operate your analyzer strictly as instructed in this manual.

This analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.

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.

Before connecting the power cord, make sure the power switch at the back
of the analyzer is placed in the off (O) position.

If the ambient temperature is outside the specified operating range, the


analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable. See Chapter 11 Troubleshooting Your Analyzer for
solutions.

Retain the shipping carton and all the packing materials, as they can be
used for packaging if analyzer must be reshipped.

Use the specified reagents.

Never use expired reagents.

To prevent contamination, tighten the container caps when the installation is


finished.

Use the printer and scanner of the specified model.

Store and use the reagents as directed by instructions for use of the
reagents.

When you have changed the diluent, rinse or lyse, run a background to see
if the results meet the requirement.

Pay attention to the expiration dates and open-container stability days of all
the reagents. Never use expired reagents.

After installing new reagents, let the reagents stand for a while before using
them.

The recorder paper is treated on one side for printing. To determine which
side is the printing side, gently scratch both sides with a fingernail and the
one with visible nail trace left is the printing side.

For the whole blood samples to be used for WBC differential or PLT count,
you shall store them at the room temperature and run them within 4 hours
C-4

Appendices
after collection.

If you do not need the PLT, MCV and WBC differential results, you can store
the samples in a refrigerator (2 to 8) for 24 hours. You need to warm the
refrigerated samples at room temperature for at least 30 minutes before
running them.

Mix any sample that has been prepared for a while before running it.

Keep dust from the prepared diluent.

After mixing the capillary sample with the diluent, wait 5 minutes before
running the sample.

Run the prediluted samples within 30 minutes after the mixing.

Evaluate predilute stability based on your laboratorys sample population


and sample collection techniques or methods.

If you intend to do the background check instead of a patient sample, enter


0 into the ID box.

Keep the sample probe tip away from the tube bottom; otherwise the
aspiration volume may be inaccurate.

When the aspiration is done, remove the sample tube only when the sample
probe is out of the tube.

If the analyzer detects WBC/RBC clogging or bubbles during the analysis,


the corresponding error messages will be displayed in the error message
area and the results of all the related parameters will be invalidated. See
Chapter 11 Troubleshooting Your Analyzer for solutions.

The result of the background check will not be flagged.

Select proper reference range as instructed in Chapter 5.3.6 before running


the samples. Otherwise, the obtained results may be erroneously flagged.

To ensure stable analyzer performance and accurate analysis results,


perform the Shutdown procedure to shut down the analyzer after it has
been running continuously for 24 hours.

Shut down the analyzer strictly as instructed below.

Fur and skin debris may block the aperture. Keep the sample clean before
using the analyzer to analyze it.

Use the specified controls. Using controls other than the specified will lead
to misleading results.

Refer to the instructions of use of the controls for how to store and use the
controls.

Calibrate your analyzer before trying to establish the expected results by


calculating the averages of random patient samples.

Refer to the instructions of use of the control for information on the lot

C-5

Appendices
number, expiration date, open-vial stability days, expected results and limits.

The entered expiration date should be either the expiration date printed on
the labeling or the open-vial expiration date. It is earlier.

The open-vial expiration date is calculated as follows: the date that vial is
opened + the open-vial stability days.

At the QC Edit screen, if you want to correct an erroneous entry, MODIFY


the wrong digit.

All of the measured parameters must be calibrated before readings of this


analyzer can be used as valid analysis results.

Use the Mindray- specified calibrator. Using calibrator other than the
specified will lead to misleading results.

Refer to the instructions of use of the calibrator for how to store and use the
calibrator.

Keep dust from the prepared diluent.

Do the Drain tubing procedure before relocating the analyzer.

This chapter is not a complete service manual and is limited to problems


that are readily diagnosed and/or corrected by the user of the analyzer. If the
recommended solution fails to solve the problem, contact Mindray or your
local distributor.

When installing the analyzer, our authorized personnel will select a proper
communication protocol that matches the data management software
configured.

To adjust the communication protocol of the analyzer, please contact our


customer service department.

Remove the protective paper between the recorder head and the roller
inside the recorder before installing recorder paper.

Maintain the recorder strictly as instructed below.

To ensure the print quality and operating life of the recorder, it is


recommended that you purchase the recorder paper from the analyzer
manufacturer.

C-6

C.5

Biohazard

Samples, controls, calibrator and waste are potentially infectious. Wear


proper personal protective equipment (e.g. gloves, lab coat, etc.) and follow
safe laboratory procedures when handling them in the laboratory.

C-7

Communication (8ID communication protocol)

D.1

Introduction

The BC-2800 provides two communication protocols. Which protocol to be used depends on
the sample ID digits that can be received by the data management software installed on the
external computer. If the sample ID upper limit to be received is 8 digits, the 8ID
communication protocol should be selected. If the sample ID upper limit to be received is 15
digits, the 15ID communication protocol should be selected.

When installing the analyzer, Mindray authorized personnel will select a


proper communication protocol that matches the data management software
configured.

To adjust the communication protocol of the analyzer, please contact


Mindray customer service department.

The BC-2800 can transmit the sample data and QC data to an external computer (a host)
through its RS-232 serial port. The transmission can be conducted either automatically or
through the command of the operator after the completion of the sample analysis. Based on
the 8ID communication protocol, this section gives detailed discussion about the setup of
transmission parameter, RS-232 serial port and the data transmission format, therefore,
providing detailed information for the software engineers to program and for the user to
conveniently perform transmission.

D-1

Appendices

D.2

Connection

The BC-2800 can be connected with an external computer through a DB9 connector. The
pins of the DB9 connector are shown in Figure D-1.

Figure D-1 DB9 connecter


Pin description:
DCD: Carrier Detect
RXD: Receive Data
TXD: Transmit Data
DTR: Data Terminal Ready
GND: Signal Ground
DSR: Data Set Ready
RTS: Request to Send
CTS: Clear to Send
RI: Ring Indicator
The BC-2800 communicates with a host through serial port 2, using Pin2, Pin 3 and Pin 5.
The maximum transmission distance is 12 meters.

D-2

Appendices

D.3

Transmission Data Format

D.3.1 Description
Symbols
[ENQ]

0x05

[STX]

0x02

[EOT]

0x04

[EOF]

0x1A

[ETX]

0x03

[ACK]

0x06

[NACK]

0x15

"A"

0x41

"B"

0x42

"C"

0x43

"#"

0x30-0x39

"*"

0x2A

If the Lot No., Month, Day, Year are empty in QC Edit menu, the * (2A Hex) will be
transmitted to the host.
For all the data formats, if the data are marked *, then * (2A Hex) will be transmitted to the
host.
L1 Region to L8 Region are LI to L8 of eight histogram discriminators as shown in Figure D-2.

Figure D-2 L1 to L8

D-3

Appendices

Programming
If the Handshake is off, BC-2800 will transmit the body of the text without acknowledging the
presence of an external computer.
If the Handshake is on, BC-2800 will communicate with the external computer in following
procedures:

1. BC-2800 sends an ENQ (05 Hex), then waits up to 4 seconds for the external computer
to respond. If the external computer does not respond, then one more ENQ (05 Hex) is
tried. If it fails again, the analyzer aborts the transmission and reports a transmission
error;
2. The external computer must respond by sending an ACK (06 Hex). If any other response
is received, another ENQ (05 Hex) will be sent by the analyzer (maximum two ENQ [05
Hex] will be sent);
3. The analyzer then sends:
Body of text
EOT (04 Hex)
ETX (03 Hex)
4. Disconnection.
BC-2800 sends an ETX (03 Hex), then waits 4 seconds for the external computer to
respond. If no response is received, one more ETX ( 03 Hex) is sent, BC-2800 waits 4
seconds before giving up and gives alarm of communication error.
If the external compute responds ACK, the transmission is done successfully. If the external
computer responds NACK15 Hex, the analyzer repeat the transmission from step 3. If the
received response from the computer is neither ACK06 Hex nor NACK15 Hex, the
analyzer sends ETX ( 03 Hex) again.

D.3.2 Sample Data Format


If handshake is enabled

[ENQ]

If handshake is disabled

[STX]

Body of the text start


Text Identifier

Version

##

ID length

###

The number of parameters

###

Number of the parameters

##

having format descriptions


D-4

Appendices
Parameter format

###

ID

########

Sample Mode

Month

##

Day

##

Year

####

Hour

##

Minutes

##

Seconds

##

WBC[10 /L]

###.#

###.#

Lymph#[10 /L]
9

Mid#[10 /L]
9

###.#

Gran#[10 /L]

###.#

Lymph%[%]

##.#

Mid%[%]

##.#

Gran%[%]

##.#

12

RBC[10 /L]

##.##

HGB[g/L]

###

MCHC[g/L]

####

MCV[fL]

###.#

MCH [pg]

###.#

RDW-CV[%]

##.#

HCT[%]

##.#

PLT[10 /L]

####

MPV[fL]

##.#

PDW

##.#

PCT[%]

.###

RDW-SD[fL]

###.#

Reserved

###############

Rm

R1

R2

R3

R4

Pm

Ps

Pl

L1 Region

###

L2 Region

###

L3 Region

###

L4 Region

###

L5 Region

###
D-5

Appendices
L6 Region

###

L7 Region

###

L8 Region

###

Reserved

################

WBC Histo (256 channels)

###

RBC Histo (256 channels)

###

PLT Histo (256 channels)

###

Body of the text end


If handshake is enabled

[EOT]

If handshake is disabled

[EOF]

If handshake is enabled

[ETX]

D.3.3 Standard QC Data Format


If handshake is enabled

[ENQ]

If handshake is disabled

[STX]

Body of the text start


Text Identifier

Version

##

The number of parameters

###

Number of the parameters

##

having format descriptions


Parameter format

###

File No.

Lot No.

######

Month

##

Day

##

Year

####
9

WBC[10 /L]

###.#

RBC[1012/L]

##.##

HGB[g/L]

###

PLT[10 /L]

####
9

Lymph#[10 /L]

###.#

Lymph%[%]

##.#

Gran#[10 /L]

###.#

Gran%[%]

##.#

HCT[%]

##.#

MCV[fL]

###.#

MCH[pg]

###.#

MCHC[g/L]

####
9

###.#

12

RBC Limit[10 /L]

##.##

HGB Limit[g/L]

###

WBC Limit[10 /L]

PLT Limit[10 /L]

####
D-6

Appendices
Lymph# Limit[109/L]

###.#

Lymph% Limit[%]

##.#

Gran# Limit[10 /L]

###.#

Gran% Limit[%]

##.#

HCT Limit[%]

##.#

MCV Limit[fL]

###.#

MCH Limit[pg]

###.#

MCHC Limit[g/L]

####

Body of the text end


If handshake is enabled

[EOT]

If handshake is disabled

[EOF]

If handshake is enabled

[ETX]

D.3.4 Running QC Data Format


If handshake is enabled

[ENQ]

If handshake is disabled

[STX]

Body of the text start


Text Identifier

Version

##

The number of parameters

###

Number of the parameters

##

having format descriptions


Parameter format

###

Month

##

Day

##

Year

####

Hour

##

Minutes

##
9

###.#

12

RBC[10 /L]

##.##

HGB[g/L]

###

WBC[10 /L]

PLT[10 /L]

####
9

Lymph#[10 /L]

###.#

Lymph%[%]

##.#

Gran#[10 /L]

###.#

Gran%[%]

##.#

HCT[%]

##.#

MCV[fL]

###.#

MCH[pg]

###.#

MCHC[g/L]

####

Body of the text end


D-7

Appendices
If handshake is enabled

[EOT]

If handshake is disabled

[EOF]

If handshake is enabled

[ETX]

D.4

Transmission

D.4.1 Defining Transmission Settings


The data format is fixed for the transmission so that every byte to be transmitted has 7 data
bits and 1 stop bit. Enter Setup Settings Print & comm. screen and edit the
communication settings as instructed by Chapter 5.3.2.

D.4.2 Transmission at Count Screen


If the auto transmission function is on, once the analysis is done, the analyzer will
automatically transmit the results to the external computer. If the auto transmission function is
off, you can only transmit the results manually at the Review screen.

D.4.3 Transmission at the Review Screen


Select the results you want to transmit and transmit them to the external computer as
instructed by Chapter 7.2.2. and Chapter 7.3.2.

D.4.4 Transmission at the QC Table Screen


Transmit the results as instructed by Chapter 8.2.3..

D-8

Communication (15ID communication protocol)

E.1

Introduction

The BC-2800 provides two communication protocols. Which protocol to be used depends on
the sample ID digits that can be received by the data management software installed on the
external computer. If the sample ID upper limit to be received is 8 digits, the 8ID
communication protocol should be selected. If the sample ID upper limit to be received is 15
digits, the 15ID communication protocol should be selected.

When installing the analyzer, Mindray authorized personnel will select a


proper communication protocol that matches the data management software
configured.

To adjust the communication protocol of the analyzer, please contact


Mindray customer service department.

The BC-2800 can transmit the sample data and QC data to an external computer (a host)
through its RS-232 serial port. The transmission can be conducted either automatically or
through the command of the operator after the completion of the sample analysis. Based on
the 15ID communication protocol, this section gives detailed discussion about the setup of
transmission parameter, RS-232 serial port and the data transmission format, therefore,
providing detailed information for the software engineers to program and for the user to
conveniently perform transmission.

E-1

Appendices

E.2

Connection

The BC-2800 can be connected with an external computer through a DB9 connector. The
pins of the DB9 connector are shown in Figure E-1.

Figure E-1 DB9 connecter


Pin description:
DCD: Carrier Detect
RXD: Receive Data
TXD: Transmit Data
DTR: Data Terminal Ready
GND: Signal Ground
DSR: Data Set Ready
RTS: Request to Send
CTS: Clear to Send
RI: Ring Indicator
The BC-2800 communicates with a host through serial port 2, using Pin2, Pin 3 and Pin 5.
The maximum transmission distance is 12 meters.

E-2

Appendices

E.3

Transmission Data Format

E.3.1 Description
Symbols

Handshake symbol

During the communication, the two parties acknowledge the communication using these
symbols.
Field
name

Coding

ENQ

0x10

ACK

0x06

ETX

0x0F

Description
Communication

command

from

analyzer before data transmission


Response command from terminal
before and after data transmission
Communication

command

from

analyzer after data transmission

Special symbols

The start and end signs of massage and data segment.


Field

Coding

Description

MS

0x05

Message start sign

ME

0x0a

Message end sign

SE

0x04

FE

0x08

name

End sign field of metadata. Each


metadata ends with SE
End sign field of attribute data.
Each attribute data ends with FE

Special delimiter

Delimiter sign between message body, data segment and attribute field.
Field
name

Field
name

Coding

MD

SD

0x03

SD

FD

0x0C

FD

0x16
E-3

Description
Delimiter

between

MD

between

SD

between

FD

and SD
Delimiter
and FD
Delimiter

Appendices
and V

Message description unit

Field

Coding

Description

name
MD

CTR

Data package of normal analysis


results

QCR

Data package of QC running

QCC

Data package of QC standard

Programming
The BC-2800 must communicate with the external computer when the Handshake is on in
following procedures:
1. During the communication connection, the BC-2800 sends an ENQ (10 Hex), then waits
up to 4 seconds for the external computer to respond. If the external computer does not
respond, then one more ENQ (10 Hex) is tried. If it fails again, the analyzer aborts the
transmission and reports a transmission error;
2. The external computer must respond by sending an ACK (06 Hex);
3. After the ACK (06 Hex) is received, the analyzer then sends data block;
4. After the sending, the BC-2800 sends an ETX (0F Hex), then waits 4 seconds for the
external computer to respond. If no response is received, one more ETX (0F Hex) is sent.
The BC-2800 waits 4 seconds before giving up and gives alarm of communication error.

E.3.2 Sample Data format

FD field
FD definition of analysis parameter
FD

Description

Sample information
SampleID

Sample ID

Mode

Analysis Mode (0:whole blood-all parameter; 1: predilute-all parameter;


2: whole blood- WBC/HGB; 3: predilute - WBC/HGB; 4: whole
blood-RBC/PLT; 5: predilute - RBC/PLT)

TestTime

Test time, format: YYYY-MM-DD HH: MM: SS (if the digit is less than
10, add a 0 at the tens place)

Name

Name

E-4

Appendices
Gender

Gender (0: Empty; 1: Undefined; 2:Male; 3: Female)

Group

Group (0: General; 1: Man; 2:Woman; 3:Child; 4: neonate)

AgeVal

Age value

AgeType

Age type (0: Empty; 1: Year; 2:Month; 3:Day; 4: Hour)

Dept

Department

ChartNo

Chart No. (the empty string will be sent if No. is not entered yet/a o is
entered)

BedNo

Bed No. (the empty string will be sent if No. is not entered yet/a o is
entered)

Sender

Sender

Tester

Tester

Checker

Checker

Analysis parameter
Val

Parameter value (transmitted as per the default unit)

Low

Lower limit of parameter

High

Upper limit of parameter

Unit

Parameter unit (default unit is whose index is 0, pure text)

Flag

Suspect sign

Histogram alarm
Rm

Indicates at least two R flags.

R1

Indicates abnormality on the left side of the lymphocyte hump.

R2

Indicates abnormality between the lymphocyte hump and the mid-sized


cell area.

R3

Indicates abnormality between the mid-sized cell area and the


granulocytes.

R4

Indicates abnormality on the right side of the neutrophilic granulocyte


hump.

Pm

Indicates blur demarcation between the platelet and red blood cell
area.

Ps

Indicates excessive small PLTs.

Pl

Indicates excessive large PLTs.

Histogram adjustment
SepWBCLyLeft

WBC LymphLeft line

SepWBCLyMid

WBC LymphMid line

SepWBCGranMid

WBC MidGran line

SepWBCGranRight

WBC GranRight line

SepRBCLeft

RBC left discriminator

SepRBCRight

RBC right discriminator

SepPLTLeft

PLT left discriminator

SepPLTRight

PLT right discriminator

Histogram
DataLen

Binary Data flow length

MetaDataLen

Metadata length of binary data flow. For example, each metadata

E-5

Appendices
length in scattergram data flow is 4; in histogram data flow is 1. If the field is
not included in binary data flow, the metadata length of binary data flow
defaults to 1.
HistoData

Binary data flow of 256*1(MetadataLen=1) Byte

SD field
SD definition of analysis parameter
SD

FD

Sam

FD

pleInfo

Description
FD
2

Sa
mpleID

3
Mo

de

FD
7

Na
me

De

Ge

FD
10

Ag

FD

Be

FD
12

Se

pt

artNo

dNo

nder

FD1

FD2

FD3

FD4

FD5

Val

Low

High

Unit

Flag

Sample information

eVal

11

Ch

FD
6

nder

FD
9

FD
5

Te

FD

Ag

FD
4

stTime

eType

FD

Te
ster

FD
13
Ch
ecker
WBC

Lym

The same with those of WBC

White

blood

cell

count
Lymphocytes

ph#

number
Mid#

The same with those of WBC

Mid-sized cell

Gran

The same with those of WBC

Granulocyte

Lym

The same with those of WBC

Lymphocytes

#
ph%

percentage
Mid

The same with those of WBC

Mid-sized

cell

percentage
Gran

The same with those of WBC

Granulocyte

percentage
HGB

The same with those of WBC

Hemoglobin
Concentration

RBC

The same with those of WBC

Red

Blood

Cell

count
HCT

The same with those of WBC

Hematocrit

MCV

The same with those of WBC

Mean Corpuscular
Volume

MCH

The same with those of WBC

Mean Corpuscular
Hemoglobin

E-6

Appendices
MCH

The same with those of WBC

Mean Corpuscular

Hemoglobin
Concentration
RDW

The same with those of WBC

Red

CV

Blood

Distribution

Cell
Width

Coefficient of Variation
RDW

The same with those of WBC

Red

SD

Blood

Distribution

Cell
Width

Standard Deviation
PLT

The same with those of WBC

Platelet count

MPV

The same with those of WBC

Mean

Platelet

Volume
PDW

The same with those of WBC

Platelet Distribution
Width

PCT

The same with those of WBC

Alar
mFlag

F
D1

F
D2

R
m
SepL
ine

R
1

RBC
Histo
PLT
Histo

D4
R

F
D5

R
3

F
D6

R
4

F
D7
P
s

P
1

FD2

FD3

FD4

SepWB

SepWB

SepWB

SepWB

CLyMid

CGranMid

FD6

FD7

FD8

SepRB

SepRB

SepPLT

SepPLT

Left

Discriminator
information

CGranRight

FD5

CRight

Histogram alarm

D8

P
m

FD1

CLeft
Histo

D3

CLyLeft

WBC

Plateletcrit

Right

FD1

FD2

FD3

DataLen

MeteDataLen

WHistoData

FD1

FD2

FD3

DataLen

MeteDataLen

RHistoData

FD1

FD2

FD3

DataLen

MeteDataLen

PHistoData

WBC Histogram

RBC Histogram

PLT Histogram

E.3.3 Standard QC data format

FD field
FD definition of standard QC parameter
FD

Description

QC information
FileNo

File No

LotNo

Lot No

ExpDate

Expiration date, format: YYYY-MM-DD (if the

E-7

Appendices
digit is less than 10, add a 0 at the tens place)

Sample information
Mean

Expected result (transmitted as per default


unit)

Range

Limit

Unit

Unit

SD field
SD definition of standard QC

SD

FD

StQCInfo

FD1

WBC

RBC

Description
FD2

FD3

Standard QC

FileNo

LotNo

ExpDate

information

FD1

FD2

FD3

White blood cell

Mean

Range

Unit

count
Red Blood Cell

The same with those of WBC

HGB

count
Hemoglobin

The same with those of WBC

PLT

Concentration

The same with those of WBC

Lymph#
Lymph%
Gran#
Gran%
HCT

Platelet count
Lymphocytes

The same with those of WBC

number
Lymphocytes

The same with those of WBC

percentage

The same with those of WBC

Granulocyte
Granulocyte

The same with those of WBC

percentage

The same with those of WBC

MCV
MCH

Hematocrit
Mean Corpuscular

The same with those of WBC

Volume
Mean Corpuscular

The same with those of WBC

Hemoglobin

MCHC

Mean Corpuscular
The same with those of WBC

Hemoglobin
Concentration

E.3.4 Running QC data format

FD field
FD definition of running QC parameter

E-8

Appendices
FD

Description

QC information
FileNo

File No

LotNo

Lot No

TestTime

Test time, format: YYYY-MM-DD HH: MM: SS


(if the digit is less than 10, add a 0 at the tens
place)

Sample information

Val

Analysis result (transmitted as per default unit)

Unit

Unit

SD field
SD definition of running QC

SD
RunQCInfo

WBC

RBC
HGB
PLT
Lymph#
Lymph%
Gran#
Gran%
HCT
MCV
MCH
MCHC

FD

Description
FD1

FD2

FD3

Running QC

FileNo

LotNo

TestTime

information

FD1

FD2

White blood cell

Val

Unit

count
Red Blood Cell

The same with those of WBC

count
Hemoglobin

The same with those of WBC

Concentration

The same with those of WBC

Platelet count
Lymphocytes

The same with those of WBC

number
Lymphocytes

The same with those of WBC

percentage

The same with those of WBC

Granulocyte
Granulocyte

The same with those of WBC

percentage

The same with those of WBC

Hematocrit
Mean Corpuscular

The same with those of WBC

Volume
Mean Corpuscular

The same with those of WBC

Hemoglobin

The same with those of WBC

Mean Corpuscular

E-9

Appendices
Hemoglobin
Concentration

E-10

Appendices

E.4

Transmission

E.4.1 Defining Transmission Settings


The data format is fixed for the transmission so that every byte to be transmitted has 8 data
bits and 1 stop bit. Enter Setup Settings Print & comm. screen and edit the
communication settings as instructed by Chapter 5.3.2.

E.4.2 Transmission at Count Screen


If the auto transmission function is on, once the analysis is done, the analyzer will
automatically transmit the results to the external computer. If the auto transmission function is
off, you can only transmit the results manually at the Review screen.

E.4.3 Transmission at the Review Screen


Select the results you want to transmit and transmit them to the external computer as
instructed by Chapter 7.2.2. and Chapter 7.3.2.

E.4.4 Transmission at the QC Table Screen


Transmit the results as instructed by Chapter 8.2.3..

E-11

P/N: 2800-20-28795 (2.0)