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BC-2300

Hematology Analyzer

Operator’s Manual
© 2005-2009 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.

For this Operator’s Manual, the issued date is 2009-06.

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called


Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyright or patents and does not convey any
license under the patent rights or copyright of Mindray, or of others.

Mindray intends to maintain the contents of this manual as confidential information.


Disclosure of the information in this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rental, adaptation, translation or any other


derivative work of this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.

, are the trademarks, registered or otherwise, of Mindray in China and


other countries. All other trademarks that appear in this manual are used only for
informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein or for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.

Mindray is responsible for the effects on safety, reliability and performance of this product,
only if:

„ all installation operations, expansions, changes, modifications and repairs of this product
are conducted by Mindray authorized personnel;

„ the electrical installation of the relevant room complies with the applicable national and
local requirements; and

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

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

to carry out a reasonable service/maintenance plan. Neglect of this may

result in machine breakdown or personal injury.

z 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.

z 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: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

E-mail Address: service@mindray.com.cn

Tel: +86 755 26582479 26582888

Fax: +86 755 26582934 26582500

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

Address: Eiffestraβe 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

2 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 ............................................................................................. 2-8
2.3.2 Input Devices .............................................................................. 2-8
2.3.3 Recorder.................................................................................... 2-10
2.3.4 Keyboard Interface.................................................................... 2-10
2.3.5 Serial Ports................................................................................ 2-10
2.3.6 Parallel Port............................................................................... 2-10
2.3.7 Power Supply for the Floppy Disk Drive ................................... 2-10
2.3.8 Power Indicator ......................................................................... 2-10
2.3.9 Optional Devices ....................................................................... 2-10
2.4 Instrument Software ............................................................................. 2-11
2.4.1 Main Screen .............................................................................. 2-11
2.4.2 Screen saver ............................................................................. 2-12
2.4.3 System Menu ............................................................................ 2-13
2.5 Reagents, Controls and Calibrators..................................................... 2-15
2.5.1 Diluent ....................................................................................... 2-15
2.5.2 Lyse ........................................................................................... 2-15
2.5.3 E-Z Cleanser ............................................................................. 2-16
2.5.4 Probe Cleanser ......................................................................... 2-16
2.5.5 Controls and Calibrators ........................................................... 2-16

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


3.1 Introduction ............................................................................................ 3-1
3.2 Aspiration ............................................................................................... 3-2
3.3 Dilution ................................................................................................... 3-3
3.4 WBC/HGB Measurement....................................................................... 3-4
3.4.1 Volumetric Metering .................................................................... 3-4
3.4.2 Measurement Principles.............................................................. 3-5
3.4.3 Derivation of WBC-Related Parameters ..................................... 3-6

1
Table of Contents

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

4 Installing Your Analyzer .......................................................................... 4-1


4.1 Introduction ............................................................................................ 4-1
4.2 Installation Requirements....................................................................... 4-2
4.2.1 Space Requirements................................................................... 4-2
4.2.2 Power Requirements................................................................... 4-2
4.2.3 General Environment .................................................................. 4-3
4.3 Unpacking .............................................................................................. 4-4
4.3.1 Unpacking and Inspecting the Analyzer...................................... 4-4
4.3.2 How to move the analyzer........................................................... 4-4
4.4 Installation Procedure ............................................................................ 4-5
4.4.1 Connecting Regents.................................................................... 4-5
4.4.2 Installing Recorder Paper............................................................ 4-8
4.4.3 Connecting the Keyboard............................................................ 4-9
4.4.4 Connecting the Printer (Optional) ............................................... 4-9
4.4.5 Connecting the Bar-Code Scanner (Optional) ............................ 4-9
4.5 Starting the Analyzer ............................................................................ 4-10

5 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......................................... 5-7
5.3.3 Date and Time........................................................................... 5-11
5.3.4 Gain........................................................................................... 5-13
5.3.5 Count......................................................................................... 5-17
5.3.6 Reference Range ...................................................................... 5-21
5.3.7 Other Settings ........................................................................... 5-24

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


6.1 Introduction ............................................................................................ 6-1
6.2 Initial Checks.......................................................................................... 6-2
6.3 Power-on................................................................................................ 6-3
6.4 Daily Quality Control .............................................................................. 6-4

2
Table of Contents

6.5 Sample Collection and Handling............................................................ 6-5


6.5.1 Whole Blood Samples................................................................. 6-5
6.5.2 Prediluted Samples ..................................................................... 6-8
6.6 Running Whole Blood Samples ............................................................. 6-9
6.6.1 Entering Sample Information ...................................................... 6-9
6.6.2 Running the Samples................................................................ 6-14
6.6.3 Special Functions ...................................................................... 6-15
6.7 Running Prediluted Samples ............................................................... 6-18
6.7.1 Entering Sample Information .................................................... 6-18
6.7.2 Running the Samples................................................................ 6-22
6.7.3 Special Functions ...................................................................... 6-23
6.8 Shutdown ............................................................................................. 6-25

7 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 Desired Sample Results ................................................ 7-18
7.3.1 Starting a Search....................................................................... 7-18
7.3.2 Reviewing search result in the “Table” mode ............................ 7-20
7.3.3 Reviewing Search Result in the “Histogram” Mode .................. 7-30

8 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................................................................ 8-19
8.3.3 Reviewing X-B Results.............................................................. 8-19

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


9.1 Introduction ............................................................................................ 9-1
9.2 When to Calibrate .................................................................................. 9-2
9.3 How to Calibrate..................................................................................... 9-3
9.3.1 Preparing Your Analyzer.............................................................. 9-3
9.3.2 Calibration Using Calibrator Program ......................................... 9-4
9.3.3 Fresh Blood Calibration............................................................. 9-11
9.3.4 Manual Calibration Program ..................................................... 9-17

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

3
Table of Contents

10.1 Introduction .......................................................................................... 10-1


10.2 General Guidelines .............................................................................. 10-2
10.3 Using the “Maintenance” Program ....................................................... 10-3
Diluent Prime........................................................................................ 10-4
Prime the Diluent Dispenser ................................................................ 10-5
Lyse Prime ........................................................................................... 10-6
Zap Aperture ........................................................................................ 10-7
Flush Aperture...................................................................................... 10-8
Probe Cleanser Cleaning..................................................................... 10-8
E-Z Cleanser Cleaning....................................................................... 10-10
Lyse Test ............................................................................................ 10-12
Clean Bath ......................................................................................... 10-15
Drain Bath .......................................................................................... 10-15
Drain Tubing....................................................................................... 10-17
Clean the Sample Suction Nozzle ..................................................... 10-18
Prepare to Ship .................................................................................. 10-19
10.4 Using the “Status” Program................................................................ 10-22
10.5 Using the “Self-test” Program ............................................................ 10-23
Testing the Fluidic System ................................................................. 10-24
Testing Motors and Recorder/Printer ................................................. 10-24
Testing Valves .................................................................................... 10-25
Testing A/D Interrupt .......................................................................... 10-26
10.6 Log ..................................................................................................... 10-27
10.7 Viewing System Configuration ........................................................... 10-29
10.8 Printing Management......................................................................... 10-30
10.9 Replacing the Filter of the Vacuum Chamber .................................... 10-31
10.10 Maintaining Recorder ......................................................................... 10-33

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


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

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

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

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

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

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

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

4
1 Using This Manual

1.1 Introduction

This chapter explains how to use your operation manual, which is shipped with your BC-2300
hematology analyzer and contains reference information about the BC-2300 and procedures
for operating, troubleshooting and maintaining the analyzer. Read this manual carefully
before operating your analyzer and operate your analyzer strictly as instructed in this manual.

z Operate your analyzer strictly as instructed in this manual.

z 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-2300 hardware and software;

„ customize system settings;

„ perform daily operating tasks;

„ perform system maintenance and troubleshooting.

1-2
Using This Manual

1.3 How to Find Information

This operation manual comprises 11 chapters and 4 appendices. Refer to the table below to
find the information you need.

If you want to … See …


learn about the intended use and parameters of the BC-2300 Chapter 2 Understanding
Your Analyzer
learn about the hardware and software of the BC-2300 Chapter 2 Understanding
Your Analyzer
learn about how the BC-2300 works Chapter 3 Understanding the
System Principles
learn about how to install the BC-2300 Chapter 4 Installing Your
Analyzer
learn about how to define/adjust system settings Chapter 5 Customizing the
Analyzer Software
learn about how to use the BC-2300 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 8 Using the QC
Programs
learn about how to calibrate the BC-2300 Chapter 9 Using the
Calibration Programs
learn about how to maintain/service the BC-2300 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-2300 Appendix B Specifications
see the summary of all safety messages included in this Appendix C Precautions,
manual Limitations and Hazards
learn about the communication protocol of the BC-2300 Appendix D Communication

1-3
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 sample
IDs and reagent information 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 “ ** ”
cursor to the desired edit box and press [ENTER] to display
pull-down list
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].

z This analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.

1-5
Using This Manual

1.6 Symbols

You will find the following symbols in this manual.

When you see… Then…


read the statement below the symbol. The statement is
alerting you to an operating hazard that can cause
personnel injury.
read the statement below the symbol. The statement is
alerting you to a possibility of analyzer damage or unreliable
analysis results.
read the statement below the symbol. The statement is
alerting you to information that requires your attention.

read the statement below the symbol . The statement is


alerting you to a potentially biohazardous condition.

You may find the following symbols on the analyzer or the reagents.

When you see… It means…


EQUIPOTENTIALITY

CAUTION, CONSULT ACCOMPANYING


DOCUMENTS.

BIOLOGICAL RISK

HIGH VOLTAGE

IN VITRO DIAGNOSTIC

ALTERNATING CURRENT

1-6
Using This Manual

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

THE DEVICE IS FULLY CONFORMANCE


WITH THE COUNCIL DIRECTIVE
CONCERNING IN VITRO DIAGNOSTIC
MEDICAL DEVICES 98/79/EC.
MANUFACTURER

AUTHORISED REPRESENTATIVE IN THE


EUROPEAN COMMUNITY

IRRITATING SUBSTANCE

THE FOLLOWING DEFINITION OF THE


WEEE LABEL APPLIES TO EU MEMBER
STATES ONLY: THE USE OF THIS SYMBOL
INDICATES THAT THIS PRODUCT SHOULD
NOT BE TREATED AS HOUSEHOLD
WASTE. BY ENSURING THAT THIS
PRODUCT IS DISPOSED OF CORRECTLY,
YOU WILL HELP PREVENT BRINGING
POTENTIAL NEGATIVE CONSEQUENCES
TO THE ENVIRONMENT AND HUMAN
HEALTH. FOR MORE DETAILED
INFORMATION WITH REGARD TO

1-7
Using This Manual

RETURNING AND RECYCLING THIS


PRODUCT, PLEASE CONSULT THE
DISTRIBUTOR FROM WHOM YOU
PURCHASED THE PRODUCT.

1-8
Using This Manual

Figure 1-1 Warning labels

(1)

„ 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.

(2)
Biological risk.

(3)
Equipotentiality.

1-9
Using This Manual

(4)

The following definition of the WEEE label applies to EU member states only: The use of this
symbol indicates that this product should not be treated as household waste. By ensuring that
this product is disposed of correctly, you will help prevent bringing potential negative
consequences to the environment and human health. For more detailed information with
regard to returning and recycling this product, please consult the distributor from whom you
purchased the product.

1-10
Using This Manual

Figure 1-2 Warning label

(5)

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

1-11
Using This Manual

Figure 1-3 Warning label

(6)

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

1-12
2 Understanding Your Analyzer

2.1 Introduction

The BC-2300 Hematology Analyzer is a quantitative hematology analyzer and leukocyte


differential counter for In Vitro Diagnostic Use in clinical laboratories.

2-1
Understanding Your Analyzer

2.2 Intended Use

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

The analyzer is used for the quantitative determination of 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 ---- Sample suction nozzle 4 ---- Sample cup stand
5 ---- Recorder 6 ---- Power indicator
7 ---- Diluent dispenser 8 ---- Diluent key

2-3
Understanding Your Analyzer

Figure 2-2 Back view

1 --- Power switch 2 --- Equipotentiality


3 --- Waste outlet(Red) 4 --- Lyse inlet (Orange)
5 --- 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

Figure 2-4 Inside the left view

1 --- Valve 1 2 --- Valve 3


3 --- Valve 2 4 --- Volumetric metering assembly
5 --- Valve 7 6 --- Valve 10
7 --- Valve 4 8 --- Valve 5
9 --- Valve 6 10 --- Vacuum chamber
11 --- Pump assembly 12 --- Valve 9
13 --- Valve bracket

2-6
Understanding Your Analyzer

Figure 2-5 Inside the right view

1 --- Bath shielding box 2 --- 50µL syringe


3 --- 7.5mL syringe 4 --- syringe motor
5 --- Valve 8

2-7
Understanding Your Analyzer

2.3.1 LCD
The LCD is located on the front panel of the analyzer, as Figure 2-6 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.

„ Diluent key

The Diluent key is located behind the diluent dispenser, as Figure 2-6 shows. You can press
the key to aspirate blood in whole blood mode or dispense diluent to the sample cup in
prediluted mode.

Figure 2-6 Diluent dispenser and Diluent key

1.Diluent dispenser 2. Diluent key

2-8
Understanding Your Analyzer

„ Built-in keypad

The 18-key keypad is located below the LCD, as Figure 2-7 shows.

Figure 2-7 Build-in keypad

„ PS/2 keyboard

The analyzer can also be controlled by an external PS/2 keyboard that should be connected
to the analyzer’s keyboard interface. See 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


[COUNT] / Press the key to start the selected run cycle.
[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 analyzer’s 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], [F1], [F2], [F3], Press them to use various functions. See the rest of this
[F3], [F4], [F5] [F4], [F5] manual or the analyzer’s 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).
/ Other keys Use them as needed. See the rest of this manual or the
analyzer’s on-line help for details.

2-9
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 related 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 reagents information into the analyzer.

z Use the printer and scanner of the specified model.

2-10
Understanding Your Analyzer

2.4 Instrument Software


2.4.1 Main Screen
After finishing the startup procedure, the analyzer enters the “Count” screen, which is the
screen to be used most frequently, hence the name is main screen, as Figure 2-8 shows.

Title Area Count Mode Area System Status Area

Error Message Help Area Reagent Status


Area Figure 2-8 “Count” screen Area

„ Title Area

The Title area displays the title of the current screen.

„ Count Mode Area

The Count Mode area displays in which analysis (count) mode, the next sample is to be
analyzed. In case of Figure 2-8, the next sample is to be analyzed in the “Whole Blood”.

„ 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

2-11
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 LCD will turn dark and the power indicator will be flickering.
You can press any key to resume the display.

2-12
Understanding Your Analyzer

2.4.3 System Menu


Press the [MENU] button and the system menu, shown in Figure 2-9 below, will pop up.

Figure 2-9 System menu

The system menu contains 7 programs. The programs followed by “>”s have further
sub-menus. See Figure 2-10 for the expanded menu.

Figure 2-10 Fully expanded system menu

2-13
Understanding Your Analyzer

You can select the desired program as instructed below.

If you want to… Select…

analyze samples 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

2-14
Understanding Your Analyzer

2.5 Reagents, Controls and Calibrators

Because the analyzer, reagents (diluent, lyse, probe cleanser and E-Z cleanser), controls,
and calibrators are components of a system, performance of the system depends on the
combined integrity of all components. You should only use the Mindray-specified reagents
(see Appendix B Specifications), which are formulated specifically for the fluidic system of
your analyzer in order to provide optimal system performance. 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.

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

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

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

z 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:

2-15
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 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.

2.5.4 Probe Cleanser


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

2.5.5 Controls and Calibrators


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

The controls are commercially prepared whole-blood products used to verify that the analyzer
is functioning properly. They are available in low, normal, and high levels. Daily use of all
levels verifies the operation of the analyzer and ensures reliable results are obtained. The
calibrators are commercially prepared whole-blood products used to calibrate the analyzer.

Read and follow the instructions for use to use the controls and calibrators. All references
related to controls and calibrators in this manual refer to the controls and calibrators reagents
specifically formulated for this analyzer. Controls and calibrators can be purchased from
Mindray or Mindray-authorized distributors.

2-16
3 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
diluent dispenser and press the Diluent key to aspirate 20µL of the sample into the dispenser.
A diluted sample (about 1:300) will be dispensed when you press the Diluent key again. Mix
the sample thoroughly and present the well-mixed diluted sample under the sample suction
nozzle and press the [COUNT] key to aspirate sample into the analyzer.

If you are going to analyze a capillary blood sample, you should first manually dilute the
sample (20 µL of capillary sample needs to be diluted by 6 mL of diluent) and then present
the pre-diluted sample to the sample suction nozzle and press the [COUNT] key to aspirate
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.

The diluted sample is aspirated into the analyzer. Part of it will be diluted with diluent again for
the RBC and PLT counting; the rest of it will be mixed with diluent and lyse for the WBC
counting and the hemoglobin concentration measurement.

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 count cycle starts when the meniscus of
diluted sample reaches the lower sensor and stops when the meniscus reaches the upper
sensor. The amount of time required for the meniscus to travel from the lower sensor to the
upper 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.

HGB(g/L) = Constant×Log 10 (Blank Photocurrent/Sample Photocurrent)

3-5
Understanding the System Principles

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 ×10 9 / 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,

100
WBC '=WBC ×
100+NRBC

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.

PL
Lymph% = × 100
PL + PM + PG

PM
Mid% = × 100
PL + PM + PG

PG
Gran% = × 100
PL + PM + PG

9
where PL = particles in the lymphocyte region( 10 / L )

9
PM = particles in the mid size region( 10 / L )

9
PG = particles in the granulocyte region( 10 / L ).

Having achieved the three parameters above, this analyzer proceeds to calculate the
9
Lymph# , Mid# and Gran# per the following equations and express them in 10 / L .

3-6
Understanding the System Principles

Lymph% × WBC
Lymph# =
100
Mid % × WBC
Mid # =
100
Gran % × WBC
Gran # =
100

„ WBC histogram

Besides the parameters mentioned above, this analyzer also presents a WBC histogram,
whose x-coordinate represents the cell volume(fL)and y-coordinate represents the number
of the cells. The histogram is presented in the Analysis 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)=Constant×Log 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 count cycle starts when the meniscus of
diluted sample reaches the lower sensor and stops when the meniscus reaches the upper
sensor. The amount of time required for the meniscus to travel from the lower sensor to the
upper 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 an RBC bubble 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 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
expresses the result in fL.
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows:

3-9
Understanding the System Principles

RBC × MCV
HCT =
10

HGB
MCH =
RBC

HGB
MCHC = × 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 volume(fL)and 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.

PLT × MPV
PCT =
10000

„ PLT Histogram

Besides the parameters mentioned above, this analyzer also presents a PLT histogram,
whose x-coordinate represents the cell volume(fL)and y-coordinate represents the number
of the cells. The histogram is presented in the Analysis 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

Each element of the analyzer is washed.

„ The bath is washed with diluent;

„ The metering tube is washed with diluent;

„ The rest of the fluidic system is washed by diluent.

3-12
4 Installing Your Analyzer

4.1 Introduction

This chapter introduces how to install the BC-2300. To ensure all system components
function correctly and to verify system performance, Mindray-authorized representatives will
handle the installation and initial software setup.

z 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 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: 50/60±1 Hz

„ Power: 180VA

„ Fuse: 250V T4A

z Make sure the analyzer is properly grounded.

z Replace fuse only with the type and rating specified.

z Make sure the electrical outlet meets the requirements.

z 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: 76 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.

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

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

z 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.

z 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, the sample suction nozzle and the diluent
dispenser 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

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


government regulations.

z 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.

z 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 Use the specified reagents.

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

z Never use expired reagents.

z To prevent contamination, tighten the container caps when the installation is


finished.

z Samples, controls, calibrators 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 3 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
(Figure 4-1);

4-5
Installing Your Analyzer

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 lyse container


1. Take out the lyse pickup tube (the one with an orange connector) from the accessory box,
as Figure 4-3 shows;

4-6
Installing Your Analyzer

Figure 4-3 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 4-4 shows;

Figure 4-4 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.

4-7
Installing Your Analyzer

4.4.2 Installing Recorder Paper

z 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 4-5 Installing recorder paper

z 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.

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

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

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

4-8
Installing Your Analyzer

4.4.3 Connecting the Keyboard


Connect the keyboard to the keyboard interface marked “KB”.

4.4.4 Connecting the Printer (Optional)


Follow the printer’s instructions for use to connect the printer to the parallel port.

4.4.5 Connecting the Bar-Code Scanner (Optional)


Follow the scanner’s instructions for use to connect the scanner to the RS-232 port1.

z Use the printer and scanner of the specified model.

4-9
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.

4-10
5 Customizing the Analyzer Software

5.1 Introduction

The BC-2300 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-2300 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)

This area displays useful information to help you move to the next step.

5-4
Customizing the Analyzer Software

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 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” 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 Lyse
Allowed range About 0 to 30.0 L 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 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 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.

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Customizing the Analyzer Software

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
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” pull-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” pull-down list,

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Customizing the Analyzer Software

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.

Figure 5-11 Selecting printing format

„ Auto printing

The auto printing function refers to the analyzer’s 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

5-8
Customizing the Analyzer Software

„ Setting baud rate

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

Figure 5-13 Selecting baud rate

„ Selecting parity

To choose the “Odd”, “Even” or “None” (default) check, SELECT the desired check from the
“Parity” pull-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

5-9
Customizing the Analyzer Software

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.

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

Figure 5-15 Setting handshake

„ Auto Communication

The auto communication function refers to the analyzer’s 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” pull-down list in the “Transmit” field, as
Figure 5-16 shows.

Figure 5-16 Auto communication

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Customizing the Analyzer Software

„ 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
printing device;

2. ENTER the desired report title.

„ Exiting the “Print & comm.” group

When you have finished changing all the 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.

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Customizing the Analyzer Software

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.

„ 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” pull-down list, as
Figure 5-19 shows.

Figure 5-19 Setting date format

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Customizing the Analyzer Software

„ 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 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

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

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Customizing the Analyzer Software

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

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.

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Customizing the Analyzer Software

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.

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

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Customizing the Analyzer Software

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.

5-16
Customizing the Analyzer Software

Figure 5-27 Setting HGB gain

„ Exiting “Gain” group

When you have finished changing all the 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.

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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


9
WBC ***.* 10 /L Default
3
Lymph# ***.* 10 /uL /
2
Mid# **** 10 /uL /
Gran# ***.* /nL /
Lymph% **.* Default
Mid% .*** %
Gran%
HGB, MCHC *** g/L Default
**.* g/dL /
**.* mmol/L /
RBC **.** 1012/L Default

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Customizing the Analyzer Software

**.** 106/uL /
**** 104/uL /

**.** /pL /
HCT **.* % Default
.*** L/L /

MCV, RDW-SD ***.* fL Default


***.* um3 /
RDW-CV **.* % Default

PLT **** 109 /L Default


**** 103 /uL /
***.* 104 /uL /
**** /nL /
MPV ***.* fL Default
***.* um3 /
PDW **.* / Default
PCT .*** % Default
*.** mL/L /
MCH *.*** pg Default
**.** fmol /

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 pull-down list of the desired parameter, as Figure
5-30 shows.

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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 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

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Customizing the Analyzer Software

„ Exiting the “Count” 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 5-32 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 Gender Age


General 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

5-21
Customizing the Analyzer Software

The upper and lower limits of the reference ranges are visible to all users but changeable
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 5-5-34 Selecting patient group

3. SELECT “General”, “Man”, “Woman”, “Child” or “Neonate” from the “Group”


pull-down list.

5-22
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 reenter valid number;

5-23
Customizing the Analyzer Software

Figure 5-37 A message box to note an 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 reference range 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 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” pull-down list ; if you prefer the latter, SELECT “Disabled”
from the “Any key to mute” pull-down list. See Figure 5-38 shows.

Figure 5-38 Selecting how to mute the beeper

5-24
Customizing the Analyzer Software

„ Selecting LCD contrast

Follow the steps given below to adjust the LCD contrast.

1. SELECT “LCD contrast”, as Figure 5-39 shows;

2. ENTER the desired contrast (0 to 255 ).

Figure 5-39 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. Error No. Error No. Error


1 Communication Error 2 Scanner Error 3 Scanner
Communication Error
4 Environmental 5 Background Abnormal 6 HGB Error
Temperature Abnormal
7 HGB Adjustment 8 WBC Clog 9 WBC Bubbles
10 RBC Clog 11 RBC Bubbles

1. SELECT “Alarm time(s)”, as Figure 5-40 shows;

2. ENTER the desired digits.

5-25
Customizing the Analyzer Software

Figure 5-40 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) from the “PMB color” pull-down list, as Figure 5-41 shows.

Figure 5-41 Setting PMB color

„ Exiting the “Other” group

When you have finished changing all the parameter units and count time settings you want to

5-26
Customizing the Analyzer Software

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 5-42 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.

Figure 5-42 Saving changes

5-27
6 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? Run Prediluted Samples

Yes

Run Whole Blood Samples

Shutdown

6-1
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;

z Samples, controls, calibrators 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.

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


government regulations.

3. Checking tubing and power connections ;

„ Check and make sure the diluent 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. When the initialization is over, the system automatically enters the “Count” screen. 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.

Press [MODE] to select “Predilute” mode. Then present a new and clean sample cup to the
diluent dispenser and press the Diluent key. The analyzer will dispense 6mL diluent. Remove
the sample cup which was placed on the cup stand when the analyzer was previously shut
down. Then present that new sample cup under the sample suction nozzle carefully on the
cup stand.

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

z Manufacturer-provided sample cups are recommended to be used.

z This analyzer features an auto-clean function. Always keep a cup of diluent


under the sample suction nozzle when the analyzer is not counting samples.

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 Sample Collection and Handling

z Samples, controls, calibrators 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.

z Avoid direct contact with blood samples.

z The sample suction nozzle and the diluent dispenser may contain
biohazardous materials. Exercise caution to avoid contact with the sample
suction nozzle and the diluent dispenser when working around them.

z Do not re-use disposable products as collection tubes, sample cups,


capillary tubes, etc..

z Use clean K2EDTA anticoagulant collection tubes, plastic sample cups and
20µL borosilicate glass capillary tubes.

6.5.1 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.
Rapidly and thoroughly mix the blood with the anticoagulant.

2. Press [MODE] to select “Whole Blood” mode;

3. Wipe the surface of the diluent dispenser with lint-free tissue;

4. Present the mixed sample under the diluent dispenser so that the tip is well into the tube,
as shown in Figure 6-1.

6-5
Operating Your Analyzer

Figure 6-1 Aspirate blood sample

5. Press the Diluent key and remove the sample when you hear the beep. A message box
will pop up as shown in Figure 6-2.

Figure 6-2 “Dispense Diluent” dialog box

6. Wipe the surface of the diluent dispenser with lint-free tissue from the top to the bottom.
Be careful not to bring out the blood sample in the dispenser, as shown in Figure 6-3.

6-6
Operating Your Analyzer

Figure 6-3 Wipe the surface of the diluent dispenser

7. Present a clean sample cup under the diluent dispenser and make sure the cup is tilted
towards the dispenser, as Figure 6-4 shows, to avoid spills and bubbles. Press the diluent
key to dispense the sample (the dispensing volume is controlled by the analyzer) into the
cup. Keep the dispenser tip away from the sample.

Figure 6-4 Adding diluted sample

8. When the dispensation is finished, shake the cup to mix the sample.

z You should collect at least 2mL venous blood sample.

z To avoid sample coagulation in the diluent dispenser, analyze the sample as


soon as possible.

z 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.

z 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.

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

6-7
Operating Your Analyzer

6.5.2 Prediluted Samples


Collect and handle the prediluted sample as follows:

1. Press [MODE] to select “Prediluted” analysis mode;

2. Present a clean sample cup to the diluent dispenser and make sure the cup is tilted
towards the dispenser, as Figure 6-5 shows, to avoid spills and bubbles. Press the diluent
key to dispense 6mL diluent (the dispensing volume is controlled by the analyzer) into the
cup. Be careful not to dip the tip into the diluent.

Figure 6-5 Adding diluent

3. Add 20µL of capillary blood manually to the diluent and shake the tube to mix the sample.

z Keep dust from the prepared diluent.

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

z Run the prediluted samples within 30 minutes after the mixing.

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

z Evaluate predilute stability based on your laboratory’s sample population


and sample collection techniques or methods.

6-8
Operating Your Analyzer

6.6 Running Whole Blood Samples

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

Figure 6-6 “Count” screen

Press [MODE] to select “Whole Blood” mode;

z Select proper reference range as instructed in Chapter 5.3.6 before running


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

z If the analyzer is restarted, you will lose all the information of the samples
that have not been analyzed yet.

6.6.1 Entering Sample Information


You may enter sample information in either of the two modes, ID only and All info.,
depending on which of the two configurations your analyzer has.

ID only mode
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.

6-9
Operating Your Analyzer

Figure 6-7 “Next sample” window

When you have finished entering the sample ID, you may press [MENU] and a dialog box will
pop up, as Figure 6-8 shows. To ignore the entered number, CLICK “No”; otherwise, CLICK
“Yes”.

Figure 6-8 Dialog box

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


“0” into the “ID” box.

6-10
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 6-9 shows.

Figure 6-9 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” pull-down list, as Figure 6-10 shows. Note
that you can select blank in case you are not aware of the patient gender.

6-11
Operating Your Analyzer

Figure 6-10 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 patient’s medical chart into the “Chart No.” box.

„ Entering the bed number

ENTER the number of the patient’s 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 6-11 shows).

6-12
Operating Your Analyzer

Figure 6-11 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 the 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.

6-13
Operating Your Analyzer

6.6.2 Running the Samples

z Samples, controls, calibrators 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.

z The sample suction nozzle and the diluent dispenser may contain
biohazardous materials. Exercise caution to avoid contact with the sample
suction nozzle and the diluent dispenser when working around them.

z Do not re-use such disposable products as collection tubes, sample cups,


capillary tubes, etc.

1. Press down the cup stand and present the sample cup under the sample suction nozzle
so that the tip is well into the tube, Replace the cup stand lightly to hold the cup.

2. Press the [COUNT] key and the analyzer will start aspirating sample; 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 if the auto print function is enabled, the analysis
result will be automatically printed out;

4. Repeat the above steps on other samples.

z 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.

z 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.

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Operating Your Analyzer

6.6.3 Special Functions

Recount (configured function)


If the system detects clog or bubbles during the analysis, or you don’t 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 6-12 shows.

Figure 6-12 “Re-count” dialog box

If you don’t want to re-count this sample, CLICK “No”; otherwise, CLICK “Yes” to enter the
“Re-count” screen, as Figure 6-13 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.

Figure 6-13 “Re-count” screen

6-15
Operating Your Analyzer

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 (***).

z The result of the background check will not be flagged.

Histogram flag
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.

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.

6-16
Operating Your Analyzer

z 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.

6-17
Operating Your Analyzer

6.7 Running Prediluted Samples

Press [MENU] and SELECT ”Count” to enter the ”Count” screen, as Figure 6-14 shows.

Figure 6-14 “Count” screen in prediluted mode

Press [MODE] to select “Prediluted” mode;

z Select proper reference range as instructed in Chapter 5.3.6 before running


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

6.7.1 Entering Sample Information

You may enter sample information in either of the two modes, ID only and All info.,
depending on which of the two configurations your analyzer has

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.

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Operating Your Analyzer

Figure 6-15 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 6-16 shows. To ignore the entered number, CLICK “No”; otherwise, CLICK
“Yes”.

Figure 6-16 Dialog box

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


“0” into the “ID” box.

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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 6-17 shows.

Figure 6-17 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” pull-down list, as Figure 6-18 shows. Note
that you can select blank in case you are not aware of the patient gender.

Figure 6-18 How to select the patient gender

6-20
Operating Your Analyzer

„ 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’s 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 patient’s medical chart into the “Chart No.” box.

„ Entering the bed number

ENTER the number of the patient’s 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 6-19 shows).

Figure 6-19 Select department name

6-21
Operating Your Analyzer

„ 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.

6.7.2 Running the Samples

z Samples, controls, calibrators 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.

z The sample suction nozzle and the diluent dispenser may contain
biohazardous materials. Exercise caution to avoid contact with the sample
suction nozzle and the diluent dispenser when working around them.

z Do not re-use such disposable products as collection tubes, sample cups,


capillary tubes, etc.

1. Press down the cup stand and present the sample cup under the sample suction nozzle
so that the tip is well into the cup. Replace the cup stand lightly to hold the cup.

2. Press the [COUNT] key and the analyzer will start aspirating sample; 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 if the auto print function is enabled, the analysis

6-22
Operating Your Analyzer

result will be automatically printed out;

4. Repeat the above steps on other samples.

6.7.3 Special Functions

Recount (configured function)


If the system detects clog or bubbles during the analysis, or you don’t 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 6-20 shows.

Figure 6-20 “Re-count” dialog box

If you don’t 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 (***).

6-23
Operating Your Analyzer

z 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.

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.

z 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.

6-24
Operating Your Analyzer

6.8 Shutdown

Perform the “Shutdown” procedure to shut down the analyzer daily.

z 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.

z Shut down the analyzer strictly as instructed below.

1. Press [MENU] to enter the system menu and SELECT ”Shutdown”, as Figure 6-21
shows;

Figure 6-21 Selecting the shutdown program

2. A message box will pop up to ask you to confirm the shutdown, as Figure 6-22 shows;

Figure 6-22 Shutdown message box

6-25
Operating Your Analyzer

3. CLICK “Yes” and a window will pop up to instruct you how to shut down the analyzer, as
Figure 6-23 shows;

Figure 6-23 Shutdown window (1)

z The sample suction nozzle and the diluent dispenser may contain
biohazardous materials. Exercise caution to avoid contact with the sample
suction nozzle and the diluent dispenser when working around them.

z 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 diluent dispenser and press [ENTER] to aspirate the
cleanser. Remove the E-Z cleanser when you hear the beep. Wipe the surface of the
diluent dispenser with lint-free tissue from the top to the bottom as Figure 6-24 shows.

Figure 6-24 Wipe the surface of the diluent dispenser

5. Follow the instructions on the screen (Figure 6-25) and place an empty sample cup under

6-26
Operating Your Analyzer

the diluent dispenser. Press the Diluent key to dispense the diluted cleanser;

Figure 6-25 Shutdown window (2)

6. Place the sample cup filled with E-Z cleanser on the sample cup stand and press
[ENTER] to aspirate the cleanser from the sample suction nozzle, as instructed on the
screen (Figure 6-26 shows). The analyzer will automatically clean fluidic lines and the
bath. The cleaning progress will be displayed on the screen, as Figure 6-27 shows;

Figure 6-26 Shutdown window (3)

6-27
Operating Your Analyzer

Figure 6-27 Shutdown progress bar

7. After the analyzer is off, the cup of E-Z cleanser should be kept on the cup stand, until
being replaced by a new one when the analyzer is power on the next time;;

8. Empty the waste container.

z Samples, controls, calibrators 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.

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


government regulations.

6-28
7 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” pull-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 patient’s medical chart into the “Chart No.” box.

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Reviewing Sample Results

„ Entering the bed number

ENTER the number of the patient’s 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
lower right corner of the screen indicates the location of the current sample result (the one

7-7
Reviewing Sample Results

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 “Start” box;

3. ENTER the end position (“00005”) into the “End” 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.

7-10
Reviewing Sample Results

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 “Deselect” and the lower left corner of the “Select” window will display “Deselect
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.

7-11
Reviewing Sample Results

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.

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;

7-12
Reviewing Sample Results

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.

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”.

7-13
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 7-22 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.

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.

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Reviewing Sample Results

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 (***).

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).

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Reviewing Sample Results

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.

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”.

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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
7-25, 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

∑X
i =1
i
Mean =
n

Diff =
(
∑ X i − Mean )2
n −1

Diff
CV = × 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 parameter’s 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.

7-17
Reviewing Sample Results

7.3 Searching for Desired 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

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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” pull-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 patient’s bed into the ”Bed No.“ box.

„ Entering the chart number

ENTER the number of the patient’s 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.

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Reviewing Sample Results

Figure 7-29 “Search Result” window

7.3.2 Reviewing search result in the “Table” mode

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

z 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.

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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 Deselecting 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 “Start” box;

3. ENTER the end position (“00005”) into the “End” box;

4. CLICK “Select” and the lower left corner of the “Select” window will display “Select
samples”, as Figure 7-35 shows;

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Reviewing Sample Results

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

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 “Deselect” and the lower left corner of the “Select” window will display “Deselect
the result”, as Figure 7-37 shows;

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

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Reviewing Sample Results

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

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:

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Reviewing Sample Results

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 “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”;

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Reviewing Sample Results

„ To return to the 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 7-42shows. 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).

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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”.

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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

∑X
i =1
i
Mean =
n

Diff =
(
∑ X i − Mean )2
n −1

Diff
CV = × 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 parameter’s 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.

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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

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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” pull-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.

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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 patient’s medical chart into the “Chart No.” box.

„ Entering the bed number

ENTER the number of the patient’s 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

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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)

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

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Reviewing Sample Results

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

7-35
8 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.

z Samples, controls, calibrators 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.

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

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

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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 [MODE] 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 [F4]
to enter “QC Table” screen to delete all the results, see Chapter 8.2.3 for details.

„ Entering the “QC Edit” screen

Press [F2] 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

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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

z 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.

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

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Using the QC Programs

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

z 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.

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Using the QC Programs

Figure 8-8 Saving changes

8.2.2 Running the Controls

z Samples, controls, calibrators 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.

z The sample suction nozzle and the diluent dispenser may contain
biohazardous materials. Exercise caution to avoid contact with the sample
suction nozzle and the diluent dispenser when working around them.

z Do not re-use such disposable products as collection tubes, sample cups,


capillary tubes, etc.

Whole Blood Mode

1. Be sure the System Status area displays “Ready“;

2. Press [MODE] to select the whole blood mode;

3. Present a vial of control to the diluent dispenser so that the tip is well into the vial. Press
the Diluent key. When you hear a beep, remove the vial and a message box will pop up
as shown in Figure 8-9;

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Using the QC Programs

Figure 8-9 Message box

4. Wipe the surface of the diluent dispenser with lint-free tissue from the top to the bottom.
Be careful not to bring out the sample from the dispenser, as shown in Figure 8-10.

Figure 8-10 Wipe the surface of the diluent dispenser

5. Present a clean sample cup under the diluent dispenser and make sure the cup is tilted
towards the dispenser, as Figure 8-11 shows, to avoid spills and bubbles. Press the
diluent key to dispense the sample (the dispensing volume is controlled by the analyzer)
into the cup. Keep the dispenser tip away from the sample.

Figure 8-11 Adding the diluted sample

6. When the dispensation is finished, shake the cup to mix the sample;

7. Press down the cup stand and present the sample cup under the sample suction nozzle
so that the tip is well into the cup. Replace the cup stand lightly to hold the cup;

8. Press the [COUNT] key and the analyzer will start aspirating sample and the analysis

8-7
Using the QC Programs

progress will be displayed on the screen;

9. When the analysis is finished, the result will be displayed on the screen and the “Total” in
the left corner of the screen will automatically increase by 1.

z 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.

z 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. CLCIK “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.

Prediluted Mode

1. Be sure the System Status area displays “Ready“;

2. Press [MODE] to select the prediluted mode;

3. Present a clean sample cup to the diluent dispenser and make sure the cup is tilted
towards the dispenser, as Figure 8-13 shows, to avoid spills and bubbles. Press the
Diluent key to dispense 6mL diluent (the dispensing volume is controlled by the analyzer)

8-8
Using the QC Programs

into the cup. Be careful not to dip the tip into the diluent.

Figure 8-13 How to dispense diluent

4. Add 20µL of control to the diluent and shake the cup to mix the sample;

5. Present the mixed control to the sample suction nozzle so that the tip is well into the cup,
Press the [COUNT] key and the analyzer will start aspirating sample;

6. When the analysis is finished, the result will be displayed on the screen and the “Total” in
the left corner of the screen will automatically increase by 1.

z 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.

z 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 8-14
shows. CLICK “Yes” to confirm the deletion.

Figure 8-14 Deleting current result

„ Printing QC results

8-9
Using the QC Programs

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

„ Exiting the “Controls” screen

Press [MENU] to exit to the system menu.

8.2.3 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 [F3] to enter the” L-J Graph” screen, as Figure 8-15, Figure
8-16 and Figure 8-17 shows.

Figure 8-15 L-J graph screen (1)

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Using the QC Programs

Figure 8-16 L-J graph screen (2)

Figure 8-17 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

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Using the QC Programs

expected range of the analysis result. The corresponding value (4.9 in case of the WBC
in Figure 8-15) 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 8-15) 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 8-15) 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

∑X i
Mean = i =1
n
where n represents how many times the QC program has been run and Xi is the result
acquired from every QC analysis.
“Diff” – standard deviation of the saved analysis results, as the equation below defines,

Diff =
(
∑ X i − Mean )2
n −1
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

Diff
CV = × 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;

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Using the QC Programs

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 [F4] to enter the “QC Table” screen, as Figure 8-18 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.

Figure 8-18 “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 8-19 shows.

Figure 8-19 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:

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Using the QC Programs

1. Press [F1] at “QC Table” screen to enter the dialog box shown in Figure 8-20;

2. SELECT “Yes” to confirm the transmission.

Figure 8-20 Transmission dialog box

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Using the QC Programs

8.3 X-B Analysis

One weakness of quality control using control material 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 [MENU] to enter the system menu. SELECT “X-B Analysis” (Figure 8-21), to enter the
“X-B Table” screen, as Figure 8-22 shows.

Figure 8-21 System menu

8-15
Using the QC Programs

Figure 8-22 “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 8-23 shows.

Figure 8-23 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 8-24.

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Using the QC Programs

Figure 8-24 “X-B Edit” screen

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 8-25 shows.

Figure 8-25 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

8-17
Using the QC Programs

by calculating the averages of at least 500 random patient samples. The recommended limit
is 5% to 10%.

z 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

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 Figure 8-26 shows. CLICK “Yes” to save the changes; CLICK “No” to abort
the changes.

Figure 8-26 A message box to confirm the changes

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Using the QC Programs

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 8-27 shows.

Figure 8-27 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

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Using the QC Programs

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


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
9 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 calibrators
and reagents specified by Mindray for the calibration. Store and use the calibrators 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

z 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 calibrators 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 7.0 to 15.0 × 109 / L ≤ 3.0
RBC 3.00 to 6.00 × 1012 / L ≤ 3.0
HGB 100 to 180 g/L ≤ 2.0
MCV 80.0 to 110.0 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.

First low - level sample result-Third low - level sample result


Carryover(%) = × 100%
Third high - level sample result-Third low - level sample result

The calculated carryovers shall meet the following requirements: WBC, RBC, HGB and PLT
shall be no greater than 2 %.

9-3
Using the Calibration Programs

It is recommended that you create a log table for your analyzer. This log table should contain
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

After you have entered 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).

9-4
Using the Calibration Programs

Figure 9-2 “Calibrator” screen

Selecting the count mode


Press [F1] to select desired calibration mode.

Editing calibration settings


Press [F2] to activate the edit boxes, as Figure 9-7 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.

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

z 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.

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

9-5
Using the Calibration Programs

MODIFY the wrong digit.

„ Exit editing

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

Running the calibrator

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

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

z Samples, controls, calibrators 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.

z The sample suction nozzle and the diluent dispenser may contain
biohazardous materials. Exercise caution to avoid contact with them when
working around it.

z Do not re-use such disposable products as collection tubes, sample cups,


capillary tubes, etc..

„ In the whole blood mode

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

2. Present a vial of well-mixed calibrator to the diluent dispenser so that the tip is well into
the vial. Press the Diluent key. When you hear a beep, remove the vial and a message
box will pop up as shown in Figure 9-4;

9-6
Using the Calibration Programs

Figure 9-4 Message box

3. Wipe the surface of the diluent dispenser with lint-free tissue from the top to the bottom.
Be careful not to bring out the sample in the dispenser, as shown in Figure 9-5;

Figure 9-5 Wipe the surface of the diluent dispenser

4. Present a clean sample cup under the diluent dispenser and make sure the cup is tilted
towards the dispenser, as Figure 9-6 shows, to avoid spills and bubbles. Press the
Diluent key to dispense the sample (the dispensing volume is controlled by the analyzer)
into the cup. Keep the dispenser tip away from the sample.

Figure 9-6 Adding the diluted sample

5. When the dispensation is finished, shake the cup to mix the sample;

6. Press down the cup stand and present the sample cup under the sample suction nozzle
so that the tip is well into the tube, Replace the cup stand lightly to hold the cup;

7. Press the [COUNT] key and the analyzer will start aspirating sample and the analysis
progress will be displayed on the screen;

8. When the analysis is finished, the result will be displayed on the screen.

9-7
Using the Calibration Programs

„ In the prediluted mode

1. At “Calibrator” screen, press [F1] to select “Predilute” mode;

2. Present a clean sample cup to the diluent dispenser and make sure the cup is tilted
towards the dispenser, as Figure 9-7 shows, to avoid spills and bubbles. Press the
Diluent key to dispense 6mL diluent (the dispensing volume is controlled by the analyzer)
into the cup. Be careful not to dip the tip into the diluent;

Figure 9-7 How to dispense diluent

3. Add 20µL of calibrator to the diluent and shake the cup to mix the sample.

4. Present the mixed diluted calibrator to the sample suction nozzle so that the tip is well
into the cup. Press the [COUNT] key and the analyzer will start aspirating sample and the
analysis progress will be displayed on the screen;

5. When the analysis is finished, the result will be displayed on the screen.

z Keep dust from the prepared diluent.

z Evaluate predilute stability based on your laboratory’s sample population


and sample collection techniques or methods.

z 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.

z 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 9-8 shows. CLICK “Yes” to close the dialog box and discard the result.

9-8
Using the Calibration Programs

Figure 9-8 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 9-9 shows.

Figure 9-9 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 9-10 shows.

9-9
Using the Calibration Programs

Figure 9-10 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.

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 9-11 shows.

Figure 9-11 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.

9-10
Using the Calibration Programs

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


Press [MENU] to enter the system menu.

Figure 9-12 System menu

SELECT “Calibration → Fresh Blood” (Figure 9-12) to enter the “Fresh Blood Calibration”
screen (Figure 9-13).

Figure 9-13 “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

9-11
Using the Calibration Programs

calibration from the reference method or from a reliably calibrated hematology analyzer.

Editing calibration settings


„ Selecting count mode

At “Fresh Blood Calibration” screen, press [F1] to select the “Whole Blood” or “Predilute”
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 9-14 shows.

Figure 9-14 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 9-15 shows.

9-12
Using the Calibration Programs

Figure 9-15 A message box to warn you about the invalid results

If all the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure 9-16 shows. CLICK “Yes” to save the results to the “Fresh
Blood Calibration” screen; CLICK “No” to abort the result.

Figure 9-16 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 Figure 9-17 shows. Note that the
CVs should be within the ranges specified in Table 9-1.

9-13
Using the Calibration Programs

Figure 9-17 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.

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 9-18 shows.

Figure 9-18 “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

9-14
Using the Calibration Programs

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 9-18 indicates. Otherwise the new factor will be blank, as the RBC in Figure 9-18
indicates.

Verifying new calibration factors


Press [MENU] and a dialog box will pop up to ask you to save the new factors, as Figure 9-19
shows.

Figure 9-19 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.

9-15
Using the Calibration Programs

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 9-20 shows. Press [ENTER]
to return to the “Fresh Blood” screen.

Figure 9-20 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 9-21
shows.

Figure 9-21 The dialog box

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

9-16
Using the Calibration Programs

„ Printing new calibration factors

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

„ Exiting the ”Fresh Blood Calibration” screen

Press [MENU] to exit to system menu.

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 9-22 System menu

SELECT “Calibration → Manual” (Figure 9-22) to enter the “Manual” screen (Figure 9-23).

Figure 9-23 “Manual” screen

The left of the “Manual" screen displays the available calibration modes – “Whole blood”
and “Predilute”. The right of the “Manual” screen displays the calibration factors of WBC,
RBC, HGB, MCV, PLT and the time the factors are saved.

9-17
Using the Calibration Programs

Use the following formula to calculate the new calibration factor.

old factor × exp ected result


new factor =
recorded mean
Example:
Assuming for a certain calibrator, the expected WBC value (namely the reference value
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=10)and 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 9-24 shows;

Figure 9-24 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

9-18
Using the Calibration Programs

the entered number is invalid, as Figure 9-25 shows.

Figure 9-25 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
9-26 shows. CLICK ”Yes” to save the new calibration factors

Figure 9-26 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-2300 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.

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

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


service department or your local distributor for assistance.

z 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 Content of Maintenance

Everyday If you are to use this analyzer 24 hours a day, perform the “E-Z
cleanser cleaning” procedure everyday.
Run the QC program everyday. See Chapter 8 Using the QC
Programs for details.
Every three days If you are to use this analyzer 24 hours a day, perform the “Probe
cleanser cleaning” procedure every three days.
Every Week If you shut down your analyzer every day and follow the specified
shutdown procedure to do that, you need to perform the “Probe
cleanser cleaning” procedure every week.
As needed When you think the bath might be contaminated, perform the
“Clean the bath” procedure.
When the analyzed samples add up to 200, the analyzer will
remind you to perform the “Probe cleanser cleaning” procedure.
When the analyzed samples add up to 30, 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 Chapter 11
Troubleshooting Your Analyzer for solutions.

10-2
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

„ Prime the Diluent Dispenser

„ Zap Aperture

„ Flush Aperture

„ Probe Cleanser Cleaning

„ E-Z Cleanser Cleaning

„ Lyse Test

„ Clean Bath

„ Drain Bath

„ Drain Tubing

„ Clean the Sample Suction Nozzle

„ Prepare to Ship

Diluent Prime

z 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.

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

z After installing a new container of diluent 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

„ the diluent in the tubing is contaminated; or

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

10-4
Maintaining Your 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

Prime the Diluent Dispenser


You should perform the “Prime the diluent dispenser” procedure to replace the old diluent
by the new one or there are bubbles in the tubing.

1. Place a sample cup under the diluent dispenser and SELECT “Prime the diluent
dispenser” at the “Maintenance” screen.

2. The analyzer starts to prime the diluent dispenser with diluent, as Figure 10-4 shows. The
old diluent was dispensed from the dispenser;

10-5
Maintaining Your Analyzer

Figure 10-4 Priming diluent dispenser

3. After the priming is finished, the diluent dispenser will be full of new diluent and the
screen will return to the initial state.

Lyse Prime

z Samples, controls, calibrators 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.

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

z After installing a new container of diluent, or lyse, do a background check to


ensure the background results are normal.

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

10-6
Maintaining Your Analyzer

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

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.

Figure 10-6 Zapping aperture

10-7
Maintaining Your Analyzer

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

Probe Cleanser Cleaning

z Samples, controls, calibrators 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.

z 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 every 3 days. If you follow the shutdown procedure to

10-8
Maintaining Your Analyzer

turn off your analyzer everyday, you should perform this procedure every week.

Follow the steps given below to do so:

1. At the “Maintenance” screen, press the appropriate arrow keys ([↑][↓][←][→]) as


needed to move the cursor to “Probe Cleanser Cleaning”;

2. Present the cleanser to the sample suction nozzle and press [ENTER] to aspirate the
cleanser. When you hear the beep, remove the cleanser and place a sample cup under
the sample suction nozzle. 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
shortened priming process may not be as effective as a complete one;

Figure 10-9 soaking process

10-9
Maintaining Your Analyzer

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 200, 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.

Figure 10-11 A message box to confirm the cleaning

E-Z Cleanser Cleaning

z Samples, controls, calibrators 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, Press the appropriate arrow keys ([↑][↓][←][→]) as

10-10
Maintaining Your Analyzer

needed to move the cursor to “E-Z Cleanser Cleaning”;

2. Present the cleanser to the diluent dispenser and press [ENTER] to aspirate the cleanser.
When you hear the beep, remove the cleanser.

3. Place a sample cup under the diluent dispenser and press the Diluent key to dispense
the E-Z cleanser;

4. Place the cup filled with E-Z cleanser to the sample suction nozzle and press [ENTER] to
aspirate the cleanser. The 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

5. When the priming is done, the analyzer will start the 10-minute soaking process, as
Figure 10-13 shows.

Figure 10-13 E-Z cleaning

6. When the soaking is done, the analyzer will start the draining and cleaning process, as

10-11
Maintaining Your Analyzer

Figure 10-14 shows. When the cleaning 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 your analyzer has been running continuously for 24 hours, a dialog 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.

Figure 10-15 A message box to confirm the cleaning

Lyse Test

z 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.

z 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.

10-12
Maintaining Your Analyzer

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;

Figure 10-17 Removing the left plate

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

10-13
Maintaining Your Analyzer

Figure 10-18 Shielding box

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

Bath

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

10-14
Maintaining Your Analyzer

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.

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;

Figure 10-20 Clean bath

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 and the draining progress will be displayed on
the screen, as Figure 10-21 shows;

10-15
Maintaining Your Analyzer

Figure 10-21 Draining the bath

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

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;

10-16
Maintaining Your Analyzer

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.

Drain Tubing

z 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.

z 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 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 and lyse pickup tubes from the back of the analyzer and present a
sample cup to the sample suction nozzle;

10-17
Maintaining Your 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 this analyzer as instructed.

Clean the Sample Suction Nozzle


You should perform the “Clean the sample suction nozzle” procedure to clean the sample
suction nozzle regularly.

1. Place a sample cup under the diluent dispenser and SELECT the “Clean the sample
suction nozzle” procedure at the “Maintenance” screen.

2. The analyzer starts to clean the sample suction nozzle, as Figure 10-25 shows;

10-18
Maintaining Your Analyzer

Figure 10-25 Cleaning sample suction nozzle

3. After the cleaning is finished, the screen will return to the initial state.

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 and lyse tubing from the containers and present a sample cup
to the sample suction nozzle;

2. Press [ENTER] and a message box will pop up to ask you to confirm this operation, as
Figure 10-26 shows;

Figure 10-26 A message box of prepare to ship

10-19
Maintaining Your Analyzer

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 10-27 shows.

Figure 10-27 Draining fluidic lines

4. After draining the tubing, follow the instructions displayed on the screen (Figure 10-28) to
put the diluent and lyse tubing into distilled water and press [ENTER] to flush this
analyzer with the distilled water;

Figure 10-28 Washing the analyzer

5. When the washing is over, follow the instructions displayed on the screen to remove the
diluent and lyse tubing from the distilled water and press [ENTER] to drain the tubing
again;

6. Turn off the power switch when the screen displays “Turn off the analyzer”;

10-20
Maintaining Your Analyzer

7. Wipe this analyzer dry and wrap it up for storage.

10-21
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 10-29
shows, to enter the “Status” screen, as Figure 10-30 shows.

Figure 10-29 System menu

Figure 10-30 “Status” screen

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

10-22
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
10-31 shows, to enter the “Self-test” screen, as Figure 10-32 shows.

Figure 10-31 System menu

Figure 10-32 “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 ⊙.

10-23
Maintaining Your Analyzer

„ Test Result area (on the right)

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].

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 10-32 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.

„ Air Filter
It checks whether the air filter functions normally.

„ Compressed Filter
It checks whether the compressed filter functions normally

Testing Motors and Recorder/Printer


To test the motors and recorder/printer, press [F1] to select the “Machine” group, as Figure
10-33 shows.

10-24
Maintaining Your Analyzer

Figure 10-33 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.

„ 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.

Testing Valves
To test whether the valves function properly, press [F1] to select the “Valve” group, as Figure
10-34 shows. Follow the steps below to test the desired valve.

10-25
Maintaining Your Analyzer

Figure 10-34 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.

Testing A/D Interrupt


To test the A/D interrupt, press [F1] to select the “Circuit” group, as Figure 10-35 shows.

Figure 10-35 Testing A/D interrupt

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

10-26
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 “Service→Log”, as Figure 10-36
shows to enter the “Log” screen, as Figure 10-37 shows.

Figure 10-36 System menu

Figure 10-37 “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].

10-27
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.

10-28
Maintaining Your Analyzer

10.7 Viewing System Configuration

To view the system configuration, press [MENU] to enter the system menu, and SELECT
“Service→Config.”, as Figure 10-38 shows, to enter the “Config.” screen, as Figure 10-39
shows.

Figure 10-38 system menu

Figure 10-39 “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].

10-29
Maintaining Your Analyzer

10.8 Printing Management

Press the [MENU] to enter the system menu and SELECT “Service→Print.”, as Figure 10-40
shows, to enter the “Print” screen, as Figure 10-41 shows.

Figure 10-40 System menu

Figure 10-41 “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.

10-30
Maintaining Your Analyzer

10.9 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 10-42 ) on the left plate;

Figure 10-42 Removing the two screws

2. Follow the arrow shown in Figure 10-43 to push and remove the left plate;

Figure 10-43 Removing the left panel

3. Find the air filter and compressed air filter shown in Figure 10-44;

10-31
Maintaining Your Analyzer

Air filter

Compressed air
filter

Figure 10-44 Vacuum filter

4. Remove the filter and take a new one from the accessory kit and install it.

10-32
Maintaining Your Analyzer

10.10 Maintaining Recorder

z Wear proper personal protective equipment (e.g. medical gloves, disposable


wrist strap, etc.) against the static electricity during maintaining recorder.

z Make sure the power supply of the analyzer has been cut off before
maintenance.

z If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.

z Do not add unnecessary force to the recorder head.

z Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.

z Make sure the alcohol volatilizes completely before using the recorder to
print.

z 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;

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.

10-33
Maintaining Your Analyzer

Figure 10-45 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.

10-34
11 Troubleshooting Your Analyzer
11.1 Introduction

The BC-2300 continuously monitors the status of the system and displays pertinent
information in the lower 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.

z Unless otherwise instructed, always turn off the power before trying to fix
the error.

z 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.

z 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.

z Samples, controls, calibrators 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) Recommend action


The analyzer 1. power cord is broken or not 1. check the power cord connection;
cannot be well connected; 2. Check the fuse;
turned on.
2. The fuse is broken; 3. Check the electrical outlet.
3. The power outlet has no
electricity.

Liquid drips Damaged pump hose or blocked 1. Turn off the power and wipe the
from analyzer filter. analyzer dry;

inside. 2. Call Mindray customer service


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 1. Enter the “Service →Status” screen to
abnormal temperature or temperature check the ambient temperature;
transducer error.
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, 1. Check if the diluent is contaminated or


diluent lines or bath; expired;

2. Expired diluent. 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. 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 1. Do the “Probe cleanser cleaning”
to 3.2 V or 4.9 V to 5 V. procedure as instructed in Chapter
10.3.;

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 1. Do the probe cleanser cleaning
V to 3.4 V or 4.8 V to 4.9 V. procedure as instructed in Chapter
10.3.;

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 WBC aperture; 1. Enter the “Service → Maintenance”

2. Inappropriate WBC count screen. Zap and flush the aperture as

time setting; instructed by Chapter 10.3;

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.;

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;

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;

6. If the difference between the reference

11-4
Troubleshooting Your Analyzer

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 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 diluent running 1. Check if the diluent has run out. If so,
out; change a new container of diluent as

2. Loose tube connections; instructed in Chapter 4.4.1;

3. Inappropriate WBC 2. Check the connection of the diluent

count time setting. 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 RBC aperture; 1. Enter the “Service → Maintenance”

2. Inappropriate RBC screen. Zap and flush the aperture as

count time setting; instructed by Chapter 10.3.;

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.;

3. 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;

4. If not, enter the “Service →

11-5
Troubleshooting Your Analyzer

Maintenance” screen and do the


probe cleanser cleaning procedure as
instructed by Chapter 10.3.;

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.;

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 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 running out; 1. Check if the diluent has run out. If so,

2. Loose tube connections; change a new container of diluent as


instructed in Chapter 4.4.1;
3. Inappropriate RBC
count time setting. 2. Check the connection of the diluent
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


Mindray customer service department
or your local distributor.

Trans error 1. Communication cable not 1. Check if the communication cable is


well connected; well connected;

2. Inappropriate 2. Check the communication settings as


instructed by Chapter 5.3.2 and make

11-6
Troubleshooting Your Analyzer

communication settings. sure they are the same with the host.

Barcode error 1. Poor connection between 1. Check if the analyzer is well connected
the scanner and the 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 1. Check if the analyzer is well connected
scanner and the analyzer. to the analyzer;
error
2. If the problem remains, contact
Mindray customer service department
or your local distributor.

Printer out of Printer paper running out or 1. Check if there is printer paper;
not properly installed.
paper 2. Check if the printer paper is well
installed.

Printer offline Poor connection between the Check if the printer is well connected to the
printer and the analyzer. analyzer.
Recorder com 1. Poor connection between 1. Print again;

the recorder and the 2. If the problem remains, shut down the
error
analyzer; analyzer and restart it again, and then
print again;
2. Damaged recorder.
3. If the problem remains, shut down the
analyzer and contact Mindray
customer service department.
Recorder out of Recorder paper running out 1. Check if the recorder paper has run
or not properly installed. out. If so, install the paper as
paper
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.

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;
3. If the problem remains, contact

11-7
Troubleshooting Your Analyzer

Mindray customer service department.


Lyse out Insufficient lyse or wrong lyse 1. Check if there is sufficient lyse left. If
volume setting. 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.

Lyse expired Expired lyse or wrong 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.

Air filter error The air inside the vacuum 1. Enter “Service → Self–test →
chamber is not extracted Tubing”to test the filter as instructed
within the given time. in Chapter 10.5;

2. If the test result is normal, the error will


be removed;

3. If the problem remains, replace the


filter as instructed by Chapter 10.9;

4. If the problem still remains after a new


filter has been installed, contact
Mindray customer service department
or your local distributor.

Compressed air The pressure degree for 1. Enter “Service → Self–test →


mixing does not reach the Tubing”to test the filter as instructed
filter error
expected value within the in Chapter 10.5;
given time
2. If the test result is normal, the error will
be removed;

3. If the problem remains, replace the


filter as instructed by Chapter 10.9;

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 1. Someone tempered with 1. Enter “Setup → Settings → Date &
error 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”


error motor; to test the syringe motor as instructed

2. Damaged motor; by Chapter 10.5.;

3. Poor connection between 2. If the test result is normal, the error will

the power drive board be removed;

and the CPU board; 3. If the problem remains, contact Mindray

4. Malfunctioning customer service department or your

photocoupler. local distributor.

A/D error Something is wrong with the 1. Enter the “Service → Self-test →
A/D part of the CPU board. Circuit” screen to test the A/D
interrupt as instructed by Chapter
10.5.;

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 1. Check whether the external tubing is
reach the expected value pressed;
within the given time.
2. If not, enter “Service→ Self-test →
Tubing” to check the vacuum as
instructed by Chapter 10.5..;

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.

11-9
Troubleshooting Your Analyzer

Pressure error The pressure inside the 1. Check whether the external tubing is
pressure chamber does not pressed;
reach the expected value
2. If not, enter “Service→ Self-test →
within the given time
Tubing”screen to check the pressure
as instructed by Chapter 10.5..;

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 1. Check if there is sufficient diluent left. If
diluent volume setting. 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.

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
analyzer’s file system. customer service department or your local
distributor.
Dynamic Something is wrong with the Turn off the power and contact Mindray
analyzer’s memory. customer service department or your local
memory error
distributor.
56V power error Something is wrong with the
1. Enter the “Service → Status” screen
power board.
and record the “56V(V)” voltage;

2. Shut down the analyzer and contact


Mindraycustomer service
department or your local distributor.

11-10
12 Appendices
A Index
RBC, 11-6
A WBC, 11-4
analyzer control, 2-16
Intended use, 2-2 Impedance Principle, 3-1
name, 2-1 count
aperture principle, 3-1
flush, 10-7 procedure, 3-5
zap, 10-6 screen, 2-11
aperture size, 12-4 custermize
asperate key, 2-7 date & time, 5-11
aspiration, 3-2 gain, 5-13
other, 5-21
Print & comm., 5-7
B reagent, 5-5
bath reference range, 5-19
clean, 10-15 CV
drain, 10-16 definition, 3-10
baud rate, 5-8 formula, 8-11
Blank Photocurrent, 3-6
bubbles
RBC, 11-7
D
WBC, 11-5 DB9 connector, 12-16
diluent
connection, 4-5
C definition, 2-15
calibration prime, 10-3
calibrator, 9-4 dilution, 3-3
calibrators, 2-16 dimensions, 3-5
manual, 9-11 drain tubing, 10-18
preparations, 9-3
procedures, 9-3
purpose, 9-1
E
cleanser environment, 4-3
use, 10-11 error
clog A/D error, 11-9

A-1
Appendices

ambient temp. abnormal, 11-3 HCT


barcode com error, 11-7 definition, 3-10
barcode error, 11-7 formula, 3-10
blank abnormal, 11-3 HGB
diluent empty, 11-9 carryover, B-3
diluent expired, 11-8 definition, 3-5
dynamic memory error, 11-10 linearity range, B-3
air filter error, 11-10 operating range, B-3
HGB adjust, 11-4 humidity, B-5
HGB error, 11-3
lyse expired, 11-8
lyse out, 11-8
I
press bar up, 11-7 ID, 6-17
pressure error, 11-10 installation
printer offline, 11-7 requirement, 4-2
printer out of paper, 11-7
real-time clock error, 11-8
recorder com error, 11-7
L
recorder out of paper, 11-7 LCD, 2-7
recorder too hot, 11-7 leukocyte
syringe moter error, 11-8 granulocyte, 2-2
trans error, 11-6 lymphocyte, 2-2
vacuum error, 11-10 Mid-sized cell, 2-2
vacuum filter error, 11-8 Lymph#
waste full, 11-11 definition, 3-7
56V power error, 11-10 formula, 3-7
E-Z cleanser Lymph%
definition, 2-15 definition, 3-6
formula, 3-6
lyse
G connection, 4-7
gain definition, 2-15
set HGB gain, 5-14 Lyse test, 10-13
set RBC gain, 5-13
Gran#
definition, 3-7
M
formula, 3-7 maintenance
Gran% system, 10-3
definition, 3-6 MCH
formula, 3-6 definition, 3-10
handshake, 5-9 formula, 3-10
MCHC
definition, 3-10
H formula, 3-10

A-2
Appendices

MCV prepare to ship, 10-21


definition, 3-9 printer
linearity range, B-3 connection, 4-11
operating range, B-3 format, 5-7
Mid# probe cleanser
definition, 3-7 use, 10-8
formula, 3-7 probe cleaser
Mid% definition, 2-15
definition, 3-6 programming, D-4
formula, 3-6
MPV
definition, 3-10
Q
QC
edit settings, 8-2
N L-J graph, 8-10
NRBC, 3-6 run, 8-6
table, 8-12

O
optical sensors, 3-4
R
RBC
definition, 3-9
P linearity range, 12-5
parameter description, 2-3 measurement, 3-9
password, 5-2 operating range, B-3
PCT RDW-CV, 3-10
definition, 3-11 reagent
formula, 3-11 connection, 4-5
PDW required, 2-14
definition, 3-10 recorder
performance specifications format, 5-8
linearity range, B-3 reference range, 5-19
operating range, B-3 RS-232 serial port, D-2
PLT
definition, 3-10
linearity range, B-3
S
operating range, B-3 sample
power analysis, 6-11
fuse, 4-2 review, 7-1
voltage, 4-2 shutdown, 6-22
predilute mode specification, B-3
sample collection and handling, 6-9 system
prediluted mode self-test, 10-22
analyze, 6-17 status, 10-21

A-3
Appendices

valve
test, 10-24
T
table
sample, 7-6
W
searched, 7-16 WBC
throughput, B-3 definition, 3-6
transmission formula, 3-6
at QC table screen, 8-13 linearity range, B-3
at review screen, 7-21 operating range, B-3
data format, D-4 weight, B-6
troubleshooting, 11-39
unpacking, 4-4
Z
zap aperture, 10-6
V

A-4
B Specifications

B.1 Classification
According to the CE classification, the BC-2300 is an In Vitro Diagnostic device.

B.2 Reagents
Diluent M-23D DILUENT
Lyse M-23CFL LYSE
E-Z Cleanser(Enzyme cleanser) M-23E E-Z CLEANSER
Probe Cleanser M-23P PROBE CLEANSER
Calibrator Specified by Mindray
Control 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
Red Blood Cell Distribution Width Coefficient of
Variation RDW-CV %
Red Blood Cell Distribution Width Standard Deviation RDW-SD fL
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW /

B-1
Appendices

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 µL
Prediluted Mode (capillary blood) 20 µL

B.4.2 Aperture size

Diameter Length
Aperture 80 µm 70 µm

B.4.3 Throughput

Less than 120 seconds/analysis

B.5 Performance specifications

B.5.1 Operating range

Parameter Operating range


9
WBC (10 /L) 0.0 to 499.9
12
RBC (10 /L) 0.00 to 19.99
HGB (g/L) 0.0 to 300.0
MCV (fL) 0.0 to 250.0
9
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 ≤ 10 × 109 / L

B.5.3 Linearity range

Parameter Linearity range


9
WBC (10 /L) 0.3 to 99.9
12
RBC (10 /L) 0.2 to 9.99
HGB (g/L) 0 to 250
9
PLT (10 /L) 10 to 999

B.5.4 Carryover

Parameter Carryover
WBC <2%
RBC <2%
HGB <2%
PLT <2%

B.5.5 Reproducibility (with normal-level control)

Parameter Condition CV(%)


9
WBC (×10 /L) 7.0 to 15.0 ≤ 3.0
12
RBC (×10 /L) 3.00 to 6.00 ≤ 3.0
HGB (g/L) 100 to 180 ≤ 2.0
MCV (fL) 80 to 110 ≤ 1.0
9
PLT(×10 /L) 200 to 500 ≤ 5.0

B.6 Input/Output Device

z 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″ 640×480

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

z 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 Printer(optional)
EPSON LX-300+.

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 drive(only to be used with the power cable supplied by
Mindray).

„ IDE hard disk interface.

B.7 Power supply


„ Voltage: 100 to 240 VAC;

„ Frequency: 50/60 Hz;

B-4
Appendices

„ Input power:180 VA;

„ Fuse: 250 V T4 A

z Use the fuse of the specified type and rating.

B.8 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: 59.4 dB

B.10 Operating environment


„ Operating temperature:15 ℃ to 30 ℃;

„ Relative humidity: 30 % to 85 %;

„ Atmospheric pressure: 76 kPa to 106 kPa.

B.11 Storage environment


„ Ambient temperature: -10 ℃ to 40 ℃

„ Relative humidity: 10 % to 93 %

„ Atmospheric pressure: 50 kPa to 106 kPa.

B.12 Dimensions
Depth Width Height
39.5 cm 32.4 cm 43.7 cm

B-5
Appendices

B.13 Weight
Less than 23 kg

B.14 Contraindications
None.

B-6
C 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

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


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

z 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.

z Make sure the analyzer is properly grounded.

z Before turning on the analyzer, make sure the input voltage meets the above
requirements.

z When moving the analyzer, face the front of the analyzer and carry it from
the bottom with hands!

z 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.

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

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


government regulations.

z Avoid direct contact with blood samples.

z The sample suction nozzle and the diluent dispenser may contain
biohazardous materials. Exercise caution to avoid contact with them when
working around it.

z Only install a fuse of the specified type and rating.

z Unless otherwise instructed, always turn off the power before trying to fix
the error.

z Wear proper personal protective equipment (e.g. medical gloves, disposable


wrist strap, etc.) against the static electricity during maintaining recorder.

z Make sure the power supply of the analyzer has been cut off before
maintenance.

C-2
Appendices

C.3 Cautions

z 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.

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

z Do not re-use disposable products collection tubes, sample cups, capillary


tubes, etc..

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

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


service department or your local distributor for assistance.

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


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

z 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.

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

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

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

z If the recorder finishes a print action, wait at least 20 minutes until the
recorder head is cooled completely and then maintain the recorder.

z Do not add unnecessary force to the recorder head.

z Wipe off the alcohol remaining on the recorder head in time after cleaning
the recorder head.

z Make sure the alcohol volatilizes completely before using the recorder to
print.

C-3
Appendices

C.4 Notes

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

z Operate your analyzer strictly as instructed in this manual.

z This analyzer adopts a fixed decimal point. You can enter the digits without
bothering to look for the [.] on the external keyboard.

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

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

z 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.

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

z Use the specified reagents.

z Never use expired reagents.

z To prevent contamination, tighten the container caps when the installation is


finished.

z Use the printer and scanner of the specified model.

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

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

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

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

z 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.

z 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.

z 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.

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

z Keep dust from the prepared diluent.

z After mixing the capillary sample with the diluent, wait 3 minutes before
running the sample.

z Run the prediluted samples within 30 minutes after the mixing.

z Evaluate predilute stability based on your laboratory’s sample population


and sample collection techniques or methods.

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


“0” into the “ID” box.

z 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.

z The result of the background check will not be flagged.

z Select proper reference range as instructed in Chapter 5.3.6 before running


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

z 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.

z Shut down the analyzer strictly as instructed below.

z Fur and skin debris may block the aperture. Keep the sample clean before
using the analyzer to analyze it.

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

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

z 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.

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

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

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

C-5
Appendices

the wrong digit.

z Calibrate your analyzer before trying to establish the expected results by


calculating the averages of random patient samples.

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


analyzer can be used as valid analysis results.

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

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

z Keep dust from the prepared diluent.

z Do the “Drain tubing” procedure before relocating the analyzer.

z 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.

z When installing the analyzer, Mindray authorized personnel will select a


proper communication protocol that matches the data management software
configured.

z To adjust the communication protocol of the analyzer, please contact


Mindray customer service department.

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

z Maintain the recorder strictly as instructed below.

z 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.5 Biohazard

z Samples, controls, calibrators 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-6
D Communication (8ID communication protocol)

D.1 Introduction

The BC-2300 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.

z When installing the analyzer, Mindray authorized personnel will select a


proper communication protocol that matches the data management software
configured.

z To adjust the communication protocol of the analyzer, please contact


Mindray customer service department.

The BC-2300 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-2300 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-2300 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-2300 will transmit the body of the text without acknowledging the
presence of an external computer.

If the Handshake is on, BC-2300 will communicate with the external computer in following
procedures:

1. BC-2300 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-2300 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-2300 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 NACK(15 Hex), the analyzer repeat the transmission from step 3. If the
received response from the computer is neither ACK(06 Hex) nor NACK(15 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 “A”
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 ##
9
WBC[10 /L] ###.#
9
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[%] ##.#
9
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 “B”
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] ###
9
PLT[10 /L] ####
9
Lymph#[10 /L] ###.#
Lymph%[%] ##.#
9
Gran#[10 /L] ###.#
Gran%[%] ##.#
HCT[%] ##.#
MCV[fL] ###.#
MCH[pg] ###.#
MCHC[g/L] ####
9
WBC Limit[10 /L] ###.#
12
RBC Limit[10 /L] ##.##
HGB Limit[g/L] ###
9
PLT Limit[10 /L] ####

D-6
Appendices

Lymph# Limit[109/L] ###.#


Lymph% Limit[%] ##.#
9
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 ‘C’
Version ##
The number of parameters ###
Number of the parameters ##
having format descriptions
Parameter format ###
Month ##
Day ##
Year ####
Hour ##
Minutes ##
9
WBC[10 /L] ###.#
12
RBC[10 /L] ##.##
HGB[g/L] ###
9
PLT[10 /L] ####
9
Lymph#[10 /L] ###.#
Lymph%[%] ##.#
9
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
E Communication (15ID communication protocol)

E.1 Introduction

The BC-2300 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.

z When installing the analyzer, Mindray authorized personnel will select a


proper communication protocol that matches the data management software
configured.

z To adjust the communication protocol of the analyzer, please contact


Mindray customer service department.

The BC-2300 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-2300 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-2300 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 Description
Coding
name
Communication command from
ENQ 0x10
analyzer before data transmission
Response command from terminal
ACK 0x06
before and after data transmission
Communication command from
ETX 0x0F
analyzer after data transmission

„ Special symbols

The start and end signs of massage and data segment.

Field
Coding Description
name
MS 0x05 Message start sign
ME 0x0a Message end sign
End sign field of metadata. Each
SE 0x04
metadata ends with SE
End sign field of attribute data. Each
FE 0x08
attribute data ends with FE

„ Special delimiter

Delimiter sign between message body, data segment and attribute field.

Field Field Description


Coding
name name
MD SD 0x03 Delimiter between MD and SD
SD FD 0x0C Delimiter between SD and FD
FD V 0x16 Delimiter between FD and V

E-3
Appendices

„ Message description unit

Field Coding Description


name
CTR Data package of normal analysis results
MD QCR Data package of QC running
QCC Data package of QC standard

E-4
Appendices

Programming
The BC-2300 must communicate with the external computer when the Handshake is on in
following procedures:

1. During the communication connection, the BC-2300 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-2300 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-2300 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 ten’s place)
Name Name
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

E-5
Appendices

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 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 Description
SampleIn FD1 FD2 FD3 FD4 FD5 FD6 Sample information
fo Sample Mode TestTim Name Gender AgeVal
ID e
FD7 FD8 FD9 FD10 FD11 FD12
AgeTyp Dept ChartN BedNo Sender Tester
e o

E-6
Appendices

FD13
Checke
r
WBC FD1 FD2 FD3 FD4 FD5 White blood cell count
Val Low High Unit Flag
Lymph# The same with those of WBC Lymphocytes number
Mid# The same with those of WBC Mid-sized cell
Gran# The same with those of WBC Granulocyte
Lymph% The same with those of WBC Lymphocytes
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
MCHC The same with those of WBC Mean Corpuscular
Hemoglobin
Concentration
RDWCV The same with those of WBC Red Blood Cell
Distribution Width
Coefficient of Variation
RDWSD The same with those of WBC Red Blood Cell
Distribution 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 Plateletcrit
AlarmFla FD1 FD2 FD3 FD4 FD5 FD6 FD7 FD8 Histogram alarm
g Rm R1 R2 R3 R4 Pm Ps P1
SepLine FD1 FD2 FD3 FD4 Discriminator
SepWBCLyL SepWBCLyM SepWBCGra SepWBCGra information
eft id nMid nRight
FD5 FD6 FD7 FD8
SepRBCLeft SepRBC SepPLTLeft SepPLTRight

E-7
Appendices

Right
WBCHist FD1 FD2 FD3 WBC Histogram
o DataLen MeteDataLen WHistoData
RBCHisto FD1 FD2 FD3 RBC Histogram
DataLen MeteDataLen RHistoData
PLTHisto FD1 FD2 FD3 PLT Histogram
DataLen MeteDataLen PHistoData

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

digit is less than 10, add a 0 at the ten’s place)

Sample information
Mean Expected result (transmitted as per default

unit)

Range Limit

Unit Unit

„ SD field

SD definition of standard QC
SD FD Description
StQCInfo FD1 FD2 FD3 Standard QC
FileNo LotNo ExpDate information
WBC FD1 FD2 FD3 White blood cell
Mean Range Unit count
RBC Red Blood Cell
The same with those of WBC
count
HGB Hemoglobin
The same with those of WBC
Concentration
PLT The same with those of WBC Platelet count
Lymph# Lymphocytes
The same with those of WBC
number
Lymph% The same with those of WBC Lymphocytes

E-8
Appendices

percentage
Gran# The same with those of WBC Granulocyte
Gran% Granulocyte
The same with those of WBC
percentage
HCT The same with those of WBC Hematocrit
MCV Mean Corpuscular
The same with those of WBC
Volume
MCH 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


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 ten’s

place)

Sample information
Val Analysis result (transmitted as per default unit)

Unit Unit

„ SD field

SD definition of running QC
SD FD Description
RunQCInfo FD1 FD2 FD3 Running QC
FileNo LotNo TestTime information
WBC FD1 FD2 White blood cell
Val Unit count
RBC Red Blood Cell
The same with those of WBC
count
HGB Hemoglobin
The same with those of WBC
Concentration

E-9
Appendices

PLT The same with those of WBC Platelet count


Lymph# Lymphocytes
The same with those of WBC
number
Lymph% Lymphocytes
The same with those of WBC
percentage
Gran# The same with those of WBC Granulocyte
Gran% Granulocyte
The same with those of WBC
percentage
HCT The same with those of WBC Hematocrit
MCV Mean Corpuscular
The same with those of WBC
Volume
MCH Mean Corpuscular
The same with those of WBC
Hemoglobin
MCHC Mean Corpuscular
The same with those of WBC 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: 2002-20-55137(V1.7)

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