Bc-3000plus - Operation - Manual

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BC-3000 Plus

Auto Hematology Analyzer

Operation Manual

Günter Keul GmbH

Postfach 1367
D-48543 Steinfurt/Germany
Tel.: 02551-20-97
Tel.: 02551-20-98
Tel.: 02551-40-90
Tel.: 02551-70-3888 oder 3838
Fax.:02551-80-883
Fax.:02551-12-98
e-mail: [email protected] website: www.keul.de
Lieferanschrift:
Von-Langen-Weg 10
D-48565 Steinfurt/Germany
Copyright

© 2003-2005 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operation Manual, the issued Date is 2005-10 (Version: 1.1).

Intellectual Property Statement


SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual. This
manual may refer to information protected by copyrights or patents and does not convey any
license under the patent rights of Mindray, nor the rights of others. Mindray does not assume
any liability arising out of any infringements of patents or other rights of third parties.

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


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

Release, amendment, reproduction, distribution, rent, adaption and translation of this manual
in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, are the registered trademarks or trademarks owned by Mindray in China


and other countries. All other trademarks that appear in this manual are used only for
editorial purposes without the intention of improperly using them. They are the property of
their respective owners.

Responsibility on the Manufacturer Party


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

All information contained in this manual is believed to be correct. Mindray shall not be liable
for errors contained herein nor for incidental or consequential damages in connection with the
furnishing, performance, or use of this manual.

Mindray is responsible for safety, reliability and performance of this product only in the
condition that:

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

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

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

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

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


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

II
Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,


EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.

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

This warranty shall not extend to:

„ any Mindray product which has been subjected to misuse, negligence or accident;

„ any Mindray product from which Mindray's original serial number tag or product
identification markings have been altered or removed;

„ any product of any other manufacturer.

Return Policy

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

1. Obtain return authorization: Contact the Mindray Service Department and obtain a
Customer Service Authorization (Mindray) number. The Mindray number must appear on the
outside of the shipping container. Returned shipments will not be accepted if the Mindray
number is not clearly visible. Please provide the model number, serial number, and a brief
description of the reason for return;

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

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

III
Company Contact
Manufacture: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen, P.R.China,518057
Phone: +86 755 26582479 26582888

Fax: +86 755 26582500 26582501

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

Address: Eiffestraβe 80, 20537 Hamburg Germany

Phone: 0049-40-2513175

Fax: 0049-40-255726

IV
Table of Contents

1 Using This Manual ................................................................................... 1-1


1.1 Introduction ............................................................................................ 1-1
1.2 Who Should Read This Manual ............................................................. 1-2
1.3 How to Find Information......................................................................... 1-3
1.4 Conventions Used in This Manual ......................................................... 1-4
1.5 Special Terms Used in This Manual....................................................... 1-5
1.6 Symbols ................................................................................................. 1-6

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


2.1 Introduction ............................................................................................ 2-1
2.2 Intended Use.......................................................................................... 2-2
2.3 User Interfaces....................................................................................... 2-3
2.4 Instrument Software ............................................................................. 2-12
2.5 Reagents, 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....................................................................... 3-5
3.5 RBC/PLT Measurement ......................................................................... 3-9
3.6 Wash .................................................................................................... 3-16

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


4.1 Introduction ............................................................................................ 4-1
4.2 Installation Requirements....................................................................... 4-2
4.3 Unpacking .............................................................................................. 4-4
4.4 Installation Procedure ............................................................................ 4-6
4.5 Starting the Analyzer ............................................................................ 4-16

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


5.1 Introduction ............................................................................................ 5-1
5.2 Print........................................................................................................ 5-2
5.3 Count time.............................................................................................. 5-7
5.4 Password ............................................................................................... 5-9
5.5 Transmission........................................................................................ 5-15
5.6 Setting system time (Date & Time) ...................................................... 5-20
5.7 Gain...................................................................................................... 5-23

1
Table of Contents

5.8 Auto Clean Time .................................................................................. 5-29


5.9 Reagent Exp. Date............................................................................... 5-30

5.10 Report Title (external keyboard required)....................................... 5-33

5.11 Parameter Units ................................................................................... 5-35


5.12 Other .................................................................................................... 5-39

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


6.1 Introduction ............................................................................................ 6-1
6.2 Initial Checks.......................................................................................... 6-2
6.3 Power-on................................................................................................ 6-3
6.4 Daily Quality Control .............................................................................. 6-4
6.5 Sample Collection and Handling............................................................ 6-5
6.6 Running Whole Blood Samples ............................................................. 6-8
6.7 Running Prediluted Samples ............................................................... 6-18
6.8 Shutdown ............................................................................................. 6-28

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


7.1 Introduction ............................................................................................ 7-1
7.2 Browsing All Sample Results ................................................................. 7-2
7.3 Searching for Interested Sample Results ............................................ 7-18

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


8.1 Introduction ............................................................................................ 8-1
8.2 “L-J Analysis” Program........................................................................... 8-2
8.3 “ X Analysis ” Program ........................................................................ 8-15
8.4 “ X -R Analysis” program....................................................................... 8-28
8.5 “X-B Analysis” Program........................................................................ 8-40

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


9.1 Introduction ............................................................................................ 9-1
9.2 When to calibrate ................................................................................... 9-2
9.3 How to Calibrate..................................................................................... 9-3

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


10.1 Introduction .......................................................................................... 10-1
10.2 General Guidelines .............................................................................. 10-2
10.3 Using the “Maintenance” Program ....................................................... 10-4
10.4 Using the “System Status” Program................................................... 10-25
10.5 Using the “Valve Test” Program ......................................................... 10-27
10.6 Using the “System Test” Program ...................................................... 10-28
10.7 Using the “Prepare to ship” Program ................................................. 10-29
10.8 Using the “Error Message” Program .................................................. 10-32
10.9 Calibrating Sample Probe Position .................................................... 10-34

2
Table of Contents

10.10 Replacing the Probe Wipe. ................................................................ 10-38


10.11 Replacing the Filter of the Vacuum Chamber .................................... 10-39
10.12 Using the [Flush] key ......................................................................... 10-40
10.13 Using the [Startup] key....................................................................... 10-41

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


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

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

3
1 Using This Manual

1.1 Introduction

This chapter explains how to use your BC-3000 Plus operation manual, which is shipped with
your BC-3000 Plus hematology analyzer and contains reference information about the
BC-3000 Plus and procedures for operating, troubleshooting and maintaining the analyzer.
Read this manual carefully before operating your analyzer and operate your analyzer strictly
as instructed in this manual.

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

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1.2 Who Should Read This Manual

This manual contains information written for clinical laboratory professionals to:

„ learn about the BC-3000 Plus hardware and software;

„ customize system settings;

„ perform daily operating tasks;

„ perform system maintenance and troubleshooting.

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1.3 How to Find Information

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

If you want to … See …

learn about the intended use and parameters of the BC-3000 Chapter 2 Understanding
Plus Your Analyzer
learn about the hardware and software of the BC-3000 Plus Chapter 2 Understanding
Your Analyzer
learn about how the BC-3000 Plus works Chapter 3 Understanding the
System Principles
learn about how to install the BC-3000 Plus Chapter 4 Installing Your
Analyzer
learn about how to define/adjust system settings Chapter 5 Customizing the
Analyzer Software
learn about how to use the BC-3000 Plus to perform your daily Chapter 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-3000 Plus Chapter 9 Using the
Calibration Programs
learn about how to maintain/service the BC-3000 Plus Chapter 10 Maintaining Your
Analyzer
learn about the meanings of the error messages and how to Chapter 11 Troubleshooting
correct the problems Your Analyzer
learn about the technical specifications of the BC-3000 Plus Appendix B Specifications
see the summary of all safety messages included in this Appendix C Precautions,
manual Limitations and Hazards
learn about the communication protocol of the BC-3000 Plus Appendix D Communication

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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.

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

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1.6 Symbols

You will find the following symbols in this manual.

When you see… Then…

read the statement below the symbol. The statement is


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

read the statement below the symbol . The statement is


alerting you to a potentially biohazardous condition.

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

When you see… It means…

EQUIPOTENTIALITY

CAUTION, CONSULT ACCOMPANYING


DOCUMENTS.

BIOLOGICAL RISK

HIGH VOLTAGE

ALTERNATING CURRENT

FOR IN VITRO DIAGNOSTIC USE

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BATCH CODE

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

THE DEVICE IS FULLY CONFORMANCE


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

AUTHORISED REPRESENTATIVE IN THE


EUROPEAN COMMUNITY

IRRITATING SUBSTANCE

THE FOLLOWING DEFINITION OF THE


WEEE LABEL APPLIES TO EU MEMBER
STATES ONLY: THE USE OF THIS SYMBOL
INDICATES THAT THIS PRODUCT SHOULD
NOT BE TREATED AS HOUSEHOLD
WASTE. BY ENSURING THAT THIS
PRODUCT IS DISPOSED OF CORRECTLY,
YOU WILL HELP PREVENT BRINGING
POTENTIAL NEGATIVE CONSEQUENCES

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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.

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5
6
(4)

(1)

(2)
(3)

Figure1-1 Back of the Analyzer

(1)
Equipotentiality.

(2)

„ Connect only to a properly earth grounded outlet;

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

„ Replace fuse only with the type and rating specified.

(3)
Biological risk.

(4)

The following definition of the WEEE label applies to EU member states only: The use of this
symbol indicates that this product should not be treated as household waste. By ensuring
that this product is disposed of correctly, you will help prevent bringing potential negative

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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.

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(5)

Figure1-2 Inside right of the analyzer

(5)

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

1-11
2 Understanding Your Analyzer

2.1 Introduction

The BC-3000 Plus auto hematology analyzer is a quantitative, automated hematology


analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories.

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2.2 Intended Use

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

The analyzer is used for the quantitative determination of the following 19 parameters and 3
histograms of blood samples.

White Blood Cell or leukocyte WBC


Lymphocyte Lymph#
Mid-sized cell Mid#
Granulocyte Gran#
Lymphocyte percentage Lymph%
Mid-sized cell percentage Mid%
Granulocyte percentage Gran%

Red Blood Cell or erythrocyte RBC


Hemoglobin Concentration HGB
Mean Corpuscular (erythrocyte) Volume MCV
Mean Cell (erythrocyte) Hemoglobin MCH
Mean Cell (erythrocyte) Hemoglobin Concentration MCHC

Red Blood Cell (erythrocyte) Distribution Width 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

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2.3 User Interfaces

Figure2-1 Front view

1 ---- LCD 2 ---- Keypad


3 ---- Recorder 4 ---- Power indicator
5 ---- Aspirate key 6 ---- Sample probe

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Figure2-2 Back view

1 --- RS-232 Port1 2 --- Parallel Port


3 --- RS-232 Port2 4 --- Keyboard interface
5 --- Power Interface of Floppy Disk Drive 6 --- Safety labeling
7 --- Diluent inlet 8 --- Diluent sensor connector
9 --- Rinse sensor connector 10 --- Waste outlet
11 --- Rinse inlet 12--- Power switch
13--- Equipotentiality 14--- WEEE labeling

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1
2
3
4
5
6
Figure2-3 Inside front of the analyzer

1 --- Elevator motor 2 --- Sample probe


3 --- Probe wipe 4 --- WBC shielding box
5 --- RBC shielding box 6 --- Aspirate key

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2
0
1

1
8
2

1
7
3

1
6
1
5
4

1
4
5

1
3
6

1
2
7

1
0

1
1
8

Figure2-4 Inside right of the analyzer

1 --- Valve8 2 --- Volumetric metering unit


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

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Figure2-5 Inside left of the analyzer

1 --- Fluid pump 2 --- Gas pump


3 --- Pressure chamber

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2.3.1 LCD
The LCD is located on the front panel of the analyzer. It displays all alphanumeric and graphic
data.

2.3.2 Input Devices


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

„ Aspirate key

The aspirate key is located behind the sample probe, as Figure2-6 shows. You can press the
key to start the selected run cycle or dispense diluent.

Figure2-6 Sample probe and aspirate key

1.Sample Probe 2. Aspirate Key

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„ Built-in keypad

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

Figure2-7 Built-in keypad

„ PS/2 keyboard

The analyzer can also be controlled by an external PS/2 keyboard that should be connected
to the analyzer’s keyboard interface. See the table below for the correspondence between
the keypad keys and the keyboard keys and for their functions.

Keypad PS/2 keyboard Function


[MENU] [Esc] To enter/exit the system menu.
[PRINT] [P]or [p] To print out data by the recorder or printer.
[DEL] [Delete] or [Del] To delete data and characters.
[ENTER] [Enter] To confirm or execute an operation.
[↑][↓][←][→] [↑][↓][←][→] To move the cursor.
[0]...[9] [0]...[9] To enter digits.
[PgUp][PgDn] [PageUp] [PageDown] To scroll screen.
[Flush] / To unclog the apertures.
[FEED] / To advance the recorder paper.
[MAIN] / To go back to the “Count” screen.
[DILUENT] [D]or [d] To enter the dispensing diluent state.
[STARTUP] / To execute the startup procedure (flushing the
fluidic lines and checking background).
[ID] [ I ]or [i] To call out the screen to enter patient information.
/ Alphanumeric keys and To enter alphanumeric data or initiate a function.
other function keys.

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2.3.3 Recorder
The thermal recorder is located on the front panel. You can use it to print out analysis reports
and other interested information.

2.3.4 Keyboard Interface


A PS/2 keyboard can be connected here.

2.3.5 Serial Ports


The analyzer provides two RS-232 ports, one for connecting the scanner and the other for
connecting a computer (host).

2.3.6 Parallel Port


The analyzer provides a parallel port to connect a printer or a floppy disk drive (a floppy disk
drive is needed to upgrade the system software; the drive can only be connected by a
Mindray-supplied cable).

2.3.7 Power Supply for the Floppy Disk Drive


It supplies power to the connected floppy disk drive. Only the drive power cable supplied by
Mindray can be used.

2.3.8 Power Indicator


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

2.3.9 Printer(Optional)
An external printer can be connected to the parallel port at the back of the analyzer. You can
use it to print out a detailed report and other interested information.

2.3.10 Scanner(Optional)
A bar-code scanner can be connected to the RS-232 port 1 of the analyzer. You can use it to
scan the bar-coded sample IDs into the analyzer.

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

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2.4 Instrument Software

2.4.1 Main Screen


After finishing the startup procedure, the analyzer enters the “Count” screen, which is the
screen to be used most frequently, hence the name “Main screen”. The main screen is shown
in Figure2-8.

Error message area


Status area

Title area

Analysis area

Menu area

Help area

Figure2-8 “Count” screen

Error Message Area


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

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

Status Area
„ System Status Area

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

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„ Count Mode Area

The Count Mode area displays in which analysis (count) mode, whole blood or prediluted,
the next sample is to be analyzed.

„ Transmission status

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

„ System Time Area

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

Analysis Result Area


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

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

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

2.4.2 System Menu


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

Figure2-9 System menu

The system menu contains 9 programs. The programs followed by “ ”s have further
sub-menus. See the figure below for the fully expanded menu.

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Count

Sample Mode

Review Sample Review Sample Table Review

Search Review Search Table Review Sample Histogram Review

Search Histogram Review

Quality Control L-J Analysis L-J/X/X-R Edit File 1

L-J/X/X-R Count File 1 File 2


X Analysis
L-J/X/X-R Graph File 1 File 2 File 3
X-R Analysis
L-J/X/X-R Table File 1 File 2 File 3 File 4

X-B Analysis Limit File 2 File 3 File 4 File 5

Samples/Batch File 3 File 4 File 5 File 6

Setup Print Start/Stop File 4 File 5 File 6 File 7

Count Time X-B Graph File 5 File 6 File 7 File 8

Password X-B Table File 6 File 7 File 8 File 9

Ref. range General File 7 File 8 File 9

Transmission Man File 8 File 9

Date & Time Woman File 9

Gain Child
Auto Clean Time Neonate

Reagent Exp. Date

Report Title

Parameter Units

Other Setting

Service Maintenance

System Status

Valve Test

System Test

Prepare to Ship

Error Message

Calibration Manual Calibration

Help Auto Calibration

Shutdown Fresh Blood

Figure 2-10 Fully expanded system menu

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You can select the desired program as instructed below.

If you want to… Select…

analyze samples Count


select an appropriate analysis mode Sample Mode
review sample results Review
run the QC program Quality Control
customize system software Setup
maintain/service the analyzer Service
calibrate the analyzer Calibration
look for help Help
shut down the analyzer Shutdown

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2.5 Reagents, Controls and Calibrators

Because the analyzer, reagents (diluent, rinse, lyse, probe cleanser and E-Z cleanser),
controls, and calibrators are components of a system, performance of the system depends on
the combined integrity of all components. You should only use the Mindray-specified reagents
(see Appendix B Specifications), which are formulated specifically for the fluidic system of
your analyzer in order to provide optimal system performance. Do not use the analyzer with
reagents from multiple suppliers. In such use, the analyzer may not meet the performance
specified in this manual and may provide unreliable results. All references related to reagents
in this manual refer to the reagents specifically formulated for this analyzer.

Each reagent package must be examined before use. Inspect the package for signs of
leakage or moisture. Product integrity may be compromised in packages that have been
damaged. If there is evidence of leakage or improper handling, do not use the reagent.

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

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

z Pay attention to the expiration dates and open-container stability days of all
the reagents. Be sure not to use expired reagents.

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

2.5.1 Diluent
The diluent is formulated to meet the following requirements:

„ To dilute the blood samples;

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

„ To maintain the cell volume of each red blood cell and platelet during the count and
sizing portion of the measurement cycle;

„ To provide a conductive medium for impedance counting of white and red blood cells
and platelets.

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

„ To rapidly break down red blood cell walls, release the hemoglobin from the cell, and
reduce the size of cellular debris to a level that does not interfere with white blood cell
counting.

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


hemoglobin concentration.

2.5.3 Rinse
The rinse is formulated to rinse the baths and metering tubes and to provide proper meniscus
formation in the metering tubes and maintain it during each measurement cycle.

2.5.4 E-Z Cleanser


The E-Z (enzymatic) cleaner is an enzyme-based isotonic, cleaning solution and wetting
agent formulated to clean the fluidic lines and baths.

2.5.5 Probe Cleanser


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

2.5.6 Controls and Calibrators


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

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

Read and follow the instructions for use to use the controls and calibrators. All references
related to controls and calibrators in this manual refer to the controls and calibrators reagents
specifically formulated for this analyzer. You should buy those controls and calibrators from
Mindrayor Mindray-authorized distributors.

2-17
3 Understanding the System
Principles

3.1 Introduction

The two independent measurement methods used in this analyzer are:

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

„ the colorimetric method for determining the HGB.

During each analysis cycle, the sample is aspirated, diluted and mixed before the
determination for each parameter is performed.

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3.2 Aspiration

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

If you are to analyze a whole blood sample, you can simply present the sample to the sample
probe and press the aspirate key to aspirate 13μL of the sample into the analyzer.

If you are to analyze a capillary blood sample, you should first manually dilute the sample (20

μL of capillary sample needs to be diluted by 0.7mL of diluent) and then present the

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

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3.3 Dilution

Usually in blood samples, the cells are too close to each other to be identified or counted. For
this reason, the diluent is used to separate the cells so that they are drawn through the
aperture one at a time as well as to create a conductive environment for cell counting.
Moreover, red blood cells usually outnumber white blood cells by 1,000 times. For this reason,
lyse needs to be added to the sample to eliminate the red cells before the WBC counting.

When analyzing a whole blood sample, this analyzer aspirates 13μL of the sample and
follows the procedure presented in Figure3-1 to dilute it before proceeding to the actual
analysis.

13uL of Whole blood sample

3.5mL of diluent

15.6uL
About 1:269 dilution

0.5mL of lyse About 2.6mL of diluent

About 1:308 dilution for About 1:44872 dilution for


the WBC/HGB analysis the RBC/PLT analysis

Figure3-1 How a whole blood sample is diluted

3-3
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When analyzing a prediluted sample, you should first collect 20μL of capillary sample and

dispense 0.7mL of diluent from this analyzer to predilute it. Then the analyzer aspirates 0.3ml
of the pre-diluted sample for further dilution, as Figure3-2 shows.

20uL of capillary blood sample

0.7mL of diluent

1:36 dilution

0.3mL
2.9 mL of diluent

24.8uL
About 1:384 dilution

0.36 mL of lyse About 2.8mL of diluent

About 1:428 dilution for About 1:43355 dilution


WBC/HGB measurement for RBC/PLT
measurement

Figure3-2 How a capillary sample is diluted

3-4
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3.4 WBC/HGB Measurement

3.4.1 Volumetric Metering


An accurate cell count cannot be obtained unless the precise volume of diluted sample that
passes through the aperture during the count portion of the analysis cycle (the count cycle) is
known. This analyzer uses a volumetric metering unit to control the count cycle and to ensure
that a precise volume of sample is analyzed.

The metering unit controlling the WBC count cycle consists of a metering tube with two
optical sensors mounted on it. This tube ensures that a precise amount of diluted sample is
measured during each count cycle. The exact amount is determined by the distance between
the two optical sensors. The rinse is used to create a meniscus in the metering tube. The
count cycle starts when the meniscus reaches the upper sensor and stops when the
meniscus reaches the lower sensor. The amount of time required for the meniscus to travel
from the upper sensor to the lower sensor is called the WBC Count Time and is measured in
seconds. At the end of the count cycle, the measured count time is compared to the
pre-defined reference count time (see Chapter 5.3 for details). If the former is less than or
greater than the latter by 2 seconds or more, the analyzer will report a WBC bubble or WBC
Clog error. Seeing the error message, you can refer to Chapter 11 Troubleshooting Your
Analyzer for solutions.

Upper sensor Upper sensor

Lower sensor Lower sensor

1 Empty when start 2 Liquid surface fall down through the


volumeritc tube

Upper sensor Upper sensor

Lower sensor Lower sensor

3 Counting start when the 4 Counting end when the liquid


liquid surface pass the upper surface pass the lower sensor
sensor.

Figure3-3 Volumetric metering process

3-5
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3.4.2 Measurement Principles

„ WBC measurement

WBCs are counted and sized by the Coulter method. This method is based on the
measurement of changes in electrical resistance produced by a particle, which in this case is
a blood cell, suspended in a conductive diluent as it passes through an aperture of known
dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an
electrical pathway. As each particle passes through the aperture, a transitory change in the
resistance between the electrodes is produced. This change produces a measurable
electrical pulse. The number of pulses generated signals the number of particles that passed
through the aperture. The amplitude of each pulse is proportional to the volume of each
particle. Each pulse is amplified and compared to the internal reference voltage channels,
which only accepts the pulses of a certain amplitude. If the pulse generated is above the
WBC threshold, it is counted as a WBC.

Figure3-4

„ HGB measurement

HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the
WBC bath where it is bubble mixed with a certain amount of lyse, which converts hemoglobin
to a hemoglobin complex that is measurable at 525 nm. An LED is mounted on one side of
the bath and emits a beam of light, which passes through the sample and a 525nm filter, and
then is measured by a photo-sensor that is mounted on the opposite side. The signal is then
amplified and the voltage is measured and compared to the blank reference reading

3-6
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(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)

3.4.3 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. Note that when you observe NRBCs (nucleated red blood
cells), which do not react with the lyse and can be mistaken by the analyzer for white cells, in
the microscope, be sure to correct the system-generated result by the following formula,

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

where PLT = 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 ).


9

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

3-7
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Lymph# , Mid# and Gran# per the following equations and express them in 10 9 / L .

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 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)

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3.5 RBC/PLT Measurement

3.5.1 Volumetric Metering


An accurate cell count cannot be obtained unless the precise volume of diluted sample that
passes through the aperture during the count cycle is known. This analyzer uses a volumetric
metering unit to control the count cycle and to ensure that a precise volume of sample is
analyzed for the measurement.

The metering unit controlling the RBC/PLT count cycle consists of a metering tube with two
optical sensors mounted on it. This tube ensures that a precise amount of diluted sample is
measured during each count cycle. The exact amount is determined by the distance between
the two optical sensors. The rinse is used to create a meniscus in the metering tube. The
count cycle starts when the meniscus reaches the upper sensor and stops when the
meniscus reaches the lower sensor. The amount of time required for the meniscus to travel
from the upper sensor to the lower sensor is called the RBC Count Time and is measured in
seconds. At the end of the count cycle, the measured count time is compared to the
pre-defined reference count time (see Chapter 5.3 for details). If the former is less than or
greater than the latter by 2 seconds or more, the analyzer will report a RBC bubble or RBC
Clog error. Seeing the error message, refer to Chapter 11 Troubleshooting for solutions.

Upper sensor Upper sensor

Lower sensor Lower sensor

1 Empty when start 2 Liquid surface fall down through the


volumeritc tube

Upper sensor Upper sensor

Lower sensor Lower sensor

3 Counting start when the 4 Counting end when the liquid


liquid surface pass the upper surface pass the lower sensor
sensor.

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Figure3-5 Volumetric metering process

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3.5.2 Measurement Principles


„ RBC/PLT measurement

RBCs/PLTs are counted and sized by the Coulter method. This method is based on the
measurement of changes in electrical resistance produced by a particle, which in this case is
a blood cell, suspended in a conductive diluent as it passes through an aperture of known
dimensions. An electrode is submerged in the liquid on both sides of the aperture to create an
electrical pathway. As each particle passes through the aperture, a transitory change in the
resistance between the electrodes is produced. This change produces a measurable
electrical pulse. The number of pulses generated signals the number of particles that passed
through the aperture. The amplitude of each pulse is proportional to the volume of each
particle. Each pulse is amplified and compared to the internal reference voltage channels,
which only accepts the pulses of a certain amplitude. If the pulse generated is above the
RBC/PLT lower threshold, it is counted as a RBC/PLT.

Figure3-6

3.5.3 Derivation of RBC-Related Parameters

„ RBC

RBC (1012/L) is the number of erythrocytes measured directly by counting the erythrocytes

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passing through the aperture.

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„ 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:
This analyzer calculates the HCT (%), MCH (pg) and MCHC(g/L) as follows:

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%, Figure3-7 shows.

3-13
Fehler! Formatvorlage nicht definiert.

Figure3-7

„ RBC Histogram

Besides the parameters mentioned above, this analyzer also presents a 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 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.

3.5.4 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 = 3-14
10000
Fehler! Formatvorlage nicht definiert.

„ 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 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.

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3.6 Wash

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

„ The sample probe is washed internally and externally with diluent;

„ The WBC bath is washed with diluent and rinse;

„ The RBC/PLT bath is washed with diluent and rinse;

„ The metering tube is washed with rinse.

3-16
4 Installing Your Analyzer

4.1 Introduction

This chapter introduces the installation procedure of the BC-3000 Plus. To ensure all system
components are functioning correctly and to verify system performance, a
Mindray-authorized representative 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
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4.2 Installation Requirements

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

4.2.1 Space Requirements


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

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


procedures;

„ at least 10 cm behind for cabling and ventilation;

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

4.2.2 Power Requirements


Check the availability of a power outlet that is

„ a female receptacle;

„ single phase with ground (confirmed third-wire earth ground);

„ 100 VAC - 240 VAC;

„ 50/60 Hz.

z Make sure the analyzer is properly grounded.

z If a power outlet with confirmed third-wire earth ground is not available, be


sure to connect the equipotentiality pole at the back of the analyzer to the
ground.

z Only install a 250V T4A fuse on the analyzer.

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

4.2.3 General Environment

„ Operating temperature: 15 ℃ - 35 ℃;

4-2
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„ Optimal operating temperature: 15 ℃ - 30 ℃;

z The specified temperature range is necessary to obtain reliable analysis


results.

„ Relative humidity: 30% -85%;

„ Atmospheric pressure: 70 kPa -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.

4-3
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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:

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

2. 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;

3. 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;

4. Remove the top protective foam. Firmly grip the two cardboard handles and lift the
analyzer out of the box and place it on the floor. Carry the analyzer away from the foam
and set it on the countertop.

z Be sure to 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 for a while, do the”Empty Tubing” procedure and shut it
down before moving it;

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z Never move the analyzer without draining the fluidic lines.

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

„ During the moving process, be sure to protect the LCD and the sample probe from
excessive force and from contact with other objects;

„ Be sure to 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.

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4.4 Installation Procedure

4.4.1 Releasing sample probe

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

Before the analyzer is shipped out, the sample probe is fixed by a plastic cable tie to avoid
damage during shipment. After unpacking the analyzers, you need to release the sample
probe as follows:

1. Push the right door latch in the direction indicated in Figure 4-1 to open the right door;

Figure 4-1

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2. Lift up the front panel latch as indicated in Figure 4-2 and open the front panel;

Figure 4-2

3. Cut the plastic cable tie to release the probe, as Figure 4-3 shows;

Figure 4-3

4-7
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4. The released sample probe is shown in Figure 4-4;

Figure 4-4

5. Lift the front panel latch and close the front panel and then release the latch to lock it.
Finally close the right door.

4.4.2 Connecting Reagent Containers

z Consider all materials (samples, reagents, controls, calibrators, or


components that contain or have contacted human blood) as being
potentially infectious. Wear proper laboratory attire (including rubber
gloves, a laboratory coat, and eye protection) and follow safe laboratory
procedures when handling any material 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.

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z Be sure to use the manufacturer-specified reagents.

z Be sure to keep the reagents still for a while before using them.

z Be sure not to use expired reagents.

z To prevent contamination, be sure to tighten the container caps when the


installation is finished.

„ Connecting the lyse container

1. Push the left door latch in the direction indicated in Figure 4-5 to open the left door;

Figure 4-5

2. Locate the black and orange fittings as shown in Figure 4-6;

Figure 4-6

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3. Take out the lyse pickup tube with an orange connector (see Figure4-7) from the
accessory box. Take out the lyse container, in which there should be enough lyse.
Remove the container cap and insert the double-pronged end of the tube into the
container and turn (clockwise) the tube’s cap onto the lyse container until properly
secured;

Figure 4-7

4. Place the lyse container onto the shelf and connect the black connector on the cap to the
black fitting and the orange connector to the orange fitting, as Figure 4-8 shows.

Figure4-8

4-10
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„ Connecting diluent container

1. Take out the diluent pickup tube with a green connector (Figure 4-9) from the accessory
box;

2. Take out the diluent container, in which there should be enough diluent, and place it on or
below the countertop;

3. Remove the container cap and insert the double-pronged end of the tube into the diluent
container and turn the tube’s cap onto the diluent container until properly secured;

Figure4-9

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

5. Locate the transducer fitting, marked DILUENT, in the lower right corner of the back of
the analyzer. Connect the wire by pushing in and turning until properly secured.

„ Connecting rinse container

1. Take out the diluent pickup tube with a blue connector (see Figure 4-10) from the
accessory box;

2. Take out the rinse container, in which there should be enough diluent, and place it on or
below the countertop;

3. Remove the container cap and insert the double-pronged end of the tube into the rinse
container and turn clockwise the tube’s cap onto the diluent container until properly
secured;

4-11
Fehler! Formatvorlage nicht definiert.

Figure 4-10

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

5. Locate the transducer fitting, marked RINSE, in the lower right corner of the back of the
analyzer. Connect the wire by pushing in and turning until properly secured.

„ Connect waste container

1. Take out the waste tube 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. Plug the red connector of the tube into the fitting and turn it clockwise until
properly secured;

3. Prepare a container to receive the waste and place it on or below the countertop;

4. Insert the waste tube into the waste container.

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4.4.3 Installing Recorder Paper


Follow the procedure below to install the recorder paper.

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

1. Locate the projecting part in the upper right corner of the recorder and press it in the
direction shown in Figure 4-11 to open it;

Figure 4-11

2. Flip the paper tension lever on the left side upwards. Keep the printing side face-down.
Insert the pointed end of the paper into the slot below the paper rod and push the paper
until it comes out from above the rod. Pull the paper out. Keep the paper centered and
place the paper into the paper holder. See Figure 4-12;

4-13
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Figure 4-12

z The recorder paper is treated on one side for printing. To determine which
side is the printing side, gently scratch both sides with nails and the one
with visible nail trace left is the printing side.

3. Flip the paper tension level downwards to lock the paper in place, as Figure 4-13 shows.

Figure 4-13

4-14
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4. Close the recorder door, as Figure 4-14 shows;

Figure 4-14

4.4.4 Connecting the Keyboard


Take out the keyboard from the accessory kit and connect it to the keyboard interface marked
“KB” at the back of the analyzer.

4.4.5 Connecting the Printer (Optional)


Follow the printer’s instructions for use to connect the printer to the parallel port at the back of
the analyzer.

4.4.6 Connecting the Bar-Code Scanner (Optional)


Follow the scanner’s instructions for use to connect the scanner to the serial port1 at the back
of the analyzer.

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

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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 3 - 4 minutes. When the initialization is finished, the analyzer will automatically
enter the “Count” screen.

4-16
5 Customizing the Analyzer Software

5.1 Introduction

The BC-3000 Plus is a flexible laboratory instrument that can be tailed to your work
environment. You can use the “Setup”program to customize the software options as
introduced in chapters 5.2 - 5.13.

5-1
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5.2 Print

The “Print” screen is where you set printing options.

5.2.1 Entering the “Print” screen


Press [MENU] to enter the system menu.

Figure 5-1System menu

SELECT “Setup → Print” (Figure 5-1) to enter the “Print” screen(Figure 5-2).

5-2
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Figure 5-2 “Print” screen

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5.2.2 Selecting printing device


You can select either the built-in recorder or an external printer (if available) as the printing
device, as Figure 5-3 shows.

Figure 5-3 Selecting printing device

„ If you prefer the recorder, SELECT “Recorder” from the “Device” pull-down list.

„ If you prefer the printer, SELECT “Printer” from the “Device” pull-down list.

5.2.3 Selecting printing format


If you have selected the printer, you can choose either of the following printing formats.

„ One page with histogram;

„ One page without histogram.

To choose the desired format, SELECT the desired format from the “Print Format”
pull-down list, as Figure 5-4 shows.

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Figure 5-4 Selecting printing format for the printer

If you have selected the recorder, you can choose any of the following 4 printing formats.

„ Format1 - parameter values + histograms;

„ Format2 – parameter values only;

„ Format3 - parameter values + histograms;

„ Format4 - parameter values only.

To choose the desired format, SELECT the desired format from the “Print Format”
pull-down list, as Figure 5-5 shows.

Figure 5-5 Selecting printing format for the recorder

5-5
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5.2.4 Enabling/disabling Auto print


If the “Auto Print ” function is on, the analysis result will be automatically printed out once the
analysis is finished. To enable (or disable) this function, SELECT “ON”(or “OFF”) from the
“Auto Print” pull-down list, as Figure 5-6 shows.

Figure 5-6 Enabling/disabling auto print

5.2.5 Exiting the “Print” screen


Press [MENU] to exit to the system menu or [MAIN] to exit to the “Count” screen, and the
changes will be saved automatically.

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5.3 Count time

The “Count Time” screen is where you view and/or set (if you have the administrator
password) the reference time for the WBC and/or RBC count portion of the measurement
cycle. If the actual WBC or RBC count time (see Chapter 3.4.1 and 3.5.1) deviates from the
reference time by 2 seconds or more, the analyzer will alarm you for clogging or bubbles and
invalidate the results of all related parameters.

5.3.1 Entering the “Count Time” screen and viewing the

settings
Press [MENU] to enter the system menu.

Figure 5-7 System menu

SELECT “Setup → Count Time”(Figure 5-7)to enter the “Count Time” screen (Figure 5-8).

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Figure 5-8 “Count Time” screen

5.3.2 Setting Count Time

1. Enter the administrator password as instructed by Chapter 5.4.1.

2. Enter the “Count Time” screen.

3. ENTER the desired number into the ”WBC Count Time” box or ”RBC Count Time” box
to set the reference WBC or RBC count time.

5.3.3 Exiting “Count Time”screen


Press [MENU] to exit to the system menu or [MAIN] to exit to the “Count” screen, and the
changes will be saved automatically.

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5.4 Password

The BC-3000 Plus classifies users into two categories: common users (default) and
administrators. You need to enter the administrator password to adjust certain options such
as WBC/RBC Count Time, Gain, etc.

5.4.1 Entering the administrator password


Press [MENU] to enter the system menu.

Figure 5-9 System menu

SELECT “Setup → Password” (Figure 5-9) to enter the ”Password” screen (Figure 5-10).

Figure 5-10 “Password” screen

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ENTER “3000” and a message box will pop up to remind you of the current password level,
as Figure 5-11 shows.

Figure 5-11 A message box to confirm the user level

CLICK “Enter” to confirm the password and exit to the system menu.

5.4.2 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 5-12 shows.

Figure 5-12 A message box to confirm the user level

CLICK “Enter” to confirm the password and exit to the system menu.

5.4.3 Ref. Range


The ”Ref. Range” screen is where you view and/or set (if you have the administrator
password) the high and low limits for your patients. The analyzer flags any parameter value
above (H) or below (L) these limits.
This analyzer divides patients into 5 demographic groups, as Table 5-1shows.

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Table 5-1 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

5.4.4 Viewing the limits (e.g. “General”)


Press [MENU] to enter the system menu.

Figure 5-13 System menu

SELECT “Setup→ Ref. Range→ General”(Figure 5-13) to view the limits.

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Figure 5-14 “General” screen

z Manufacturer-recommended ranges of all 19 parameters are available for


the General, Man, Woman and Child groups. As for the Neonate group,
manufacturer-recommended ranges are available for WBC, Lymph#, RBC,
HGB and PLT only and the rest, if deemed necessary, can be set by the users
themselves.

5.4.5 Setting the limits (e.g. the “General” group)

1. Enter the administrator password as introduced in Chapter 5.4.1;

2. Enter the ”General” screen, as Figure 5-15 shows;

3. ENTER the new limits as desired;

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Figure 5-15 “General”screen

5.4.6 Exiting the “Ref.Range” screen (e.g. the “General”

group)
Press [MENU] to exit to the system menu; press [MAIN] to return to the “Count” screen. If
you have made any changes, a message box will pop up to ask you to save the changes, as
Figure 5-16 shows. CLICK “Enter” to save the changes and exit to the system menu or the
main screen; CLICK “Cancel” to abort the changes and exit to the system menu or the
“Count” screen.

Figure 5-16 A message box to confirm the changes

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z At the “General” screen (or the screen of any other group), you can press
[PRINT] to print out the displayed limits.

z At the “General” screen (or the screen of any other group), you can press
[DEL] to resume the manufacturer-recommended settings.

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5.5 Transmission
The “Transmission” screen is where you set communication parameters.

5.5.1 Entering the “Transmission” screen


Press [MENU] to enter the system menu.

Figure 5-17 System menu

SELECT “Setup→Transmission” (Figure 5-17) to enter the “Transmission” screen (Figure

5-18).

Figure 5-18 “Transmission” screen

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5.5.2 Selecting baud rate


Five baud rate options are available: “19200”, “9600”(default), “4800”, “2400” and “1200”. To
select the desired baud rate, SELECT the desired rate from the “Baud Rate”pull-down list,
as Figure 5-19 shows.

Figure 5-19 Selecting baud rate

5.5.3 Selecting parity


Three parity options are available: “Odd”, “Even” and “None” (default). To select the desired
option, SELECT the desired rate from the “Parity”pull-down list, as Figure 5-20 shows.

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Figure 5-20 Selecting parity check

5.5.4 Enabling/disabling handshake


If the “Handshake”function is enabled, the analyzer will send a handshake signal to the host
and wait for the response. If the host does not respond in 8 seconds, the analyzer will abort
the transmission and alarm you for a transmission error. If the “Handshake” function is
disabled, the analyzer will transmit the data without confirming the communication link. To
enable (or disable) the “Handshake” function, SELECT ”Yes” (or ”No”) from the
“Handshake” pull-down list, as Figure 5-21 shows. The “Handshake” function is disabled
by default.

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Figure 5-21 Enabling/disabling handshake

5.5.5 Enabling/disabling auto transmission


When the auto transmission function is enabled, the analyzer will automatically transmit the
analysis result to the host once the analysis is finished. To enable (or disable) the auto
transmission function, SELECT ”ON” (or ”OFF”) from the “Auto Trans.” pull-down list, as
Figure 5-22 shows.

Figure 5-22 Enabling/disabling auto transmission

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5.5.6 Exiting the “Transmission” screen


Press [MENU] to exit to the system menu or [MAIN] to exit to the “Count” screen, and the
changes will be saved automatically.

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5.6 Setting system time (Date & Time)

The “Date & Time” screen is where you set the system date and time.

5.6.1 Entering “Date & Time” screen


Press [MENU] to enter the system menu.

Figure 5-23 System menu

SELECT “Setup→Date & Time” (Figure 5-23) to enter the “Date & Time” screen (Figure

5-24).

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Figure 5-24 “Date & Time” screen

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5.6.2 Selecting date format


Three date formats are available: “YYYY-MM-DD”, “MM-DD-YYYY” and “DD-MM-YYYY”. To
select the desired format, SELECT the desired format from the “Format”pull-down list, as
Figure 5-25 shows.

Figure 5-25 Selecting date format

5.6.3 Setting system time


Respectively ENTER desired numbers into the ” Year”, “Month”, “Day”, “Hour”, “Minute” and
“Second” boxes.

5.6.4 Exiting the “Date & Time” screen


Press [MENU] to exit to the system menu or [MAIN] to exit to the “Count” screen, and the
changes will be saved automatically.

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5.7 Gain

The ”Gain” screen is where you view and/or set (if you have the administrator password)
gains of the “WBC (Whole Blood)”, “WBC (Predilute)”, “RBC” and “HGB” gains.

5.7.1 Entering the “Gain” screen


Press [MENU] to enter the system menu.

Figure 5-26 System menu

SELECT “Setup→Gain”(Figure 5-26) shows to enter the ”Gain” screen (Figure 5-27).

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Figure 5-27 “Gain” screen

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5.7.2 Setting WBC channel gain


You can adjust the shape of the WBC histogram by adjusting the gain of the WBC channel.

„ When WBC histograms of most samples are similar to Figure 5-28, it implies too small a
WBC gain and you need to increase the gain appropriately.

Figure 5-28 WBC gain too small

„ When WBC histograms of most samples are similar to Figure 5-29, it implies too large a
WBC gain and you need to decrease the gain appropriately.

Figure 5-29 WBC gain too large

To increase (or decrease) the gain

1. Enter the administrator password as introduced in Chapter 5.4.1.

2. Enter the ”Gain” screen and ENTER the desired gain into the “WBC (Whole) ”, as Figure
5-30 shows, or “WBC (Predilute)”, as Figure 5-31 shows.

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Figure 5-30 Setting WBC(Whole)gain

Figure 5-31 Setting WBC(Predilute)gain

5.7.3 Setting the RBC gain


If the MCV results of most calibration or QC runs deviate from the expected result by 6%, you
need to follow the rule below to change the RBC gain to adjust the MCV results.

Assume the expected MCV result is 90.0fL and the obtained MCV result is 82.0fL.

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Then

ExpectedMCV 90.0
× 100%= × 100% = 109.8%
ActualMCV 82.0

1. Enter the administrator password as introduced in Chapter 5.4.1.

2. Enter the “Gain” screen and ENTER a number into the ”RBC” box, as Figure 5-32 shows,
so that RBC “Factor” is as close to 109.8% as possible.

Figure 5-32 Setting RBC gain

5.7.4 Setting HGB channel gain


You can adjust the HGB blank voltage by adjusting the HGB gain. Normally the HGB blank
voltage should be within 3.4 - 4.8 V (4.5V is recommended). To set the HGB channel gain,
1. Enter the administrator password as introduced in Chapter 5.4.1.
2. Enter the “Gain” screen and ENTER the desired gain into the ”HGB” box so that the HGB
voltage falls between 3.4 - 4.8 V, as Figure 5-33 shows.

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Figure 5-33 Setting HGB gain

5.7.5 Exiting the “Gain” screen


Press [MENU] or [MAIN] to exit the ”Gain” screen and a message box will pop up to ask you
save the changes, as Figure 5-34 shows.

Figure 5-34 A message box to confirm the changes

CLICK “Enter” to save the changes and exit to the system menu; CLICK “Cancel” to exit to
the system menu or the “Count” screen without saving the changes.

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5.8 Auto Clean Time

The “Auto Clean Time” screen is where you set the interval for auto cleaning of the fluidic
lines. The valid interval is 2 - 24 hours and the default interval is 4 hours. To set the interval,
Press [MENU] to enter the system menu.

Figure 5-35 System menu

SELECT “Setup→Auto Clean Time” (Figure 5-35) to enter the “Auto Clean Time” screen

(Figure 5-36).

Figure 5-36 “Auto Clean Time” screen

ENTER the desired interval. Press [MENU] to exit to the system menu or [MAIN] to exit to the

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“Count” screen, and the changes will be saved automatically.

5.9 Reagent Exp. Date

The ”Reagent Exp. Date” screen is where you set expiration dates for the diluent, rinse and
lyse. The analyzer will alarm you for expired reagents when the system time exceeds any of
the three expiration dates.

5.9.1 Entering the “Reagent Exp. Date” screen


Press [MENU] to enter the system menu.

Figure 5-37 System menu

SELECT ” Setup→ Reagent Exp. Date” (Figure 5-37) to enter the ”Reagent Exp. Date”

screen (Figure 5-38).

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Figure 5-38 “Reagent Exp. Date” screen

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5.9.2 Setting the expiration date


ENTER the desired expiration dates into the ” Diluent”, “Rinse” and ” Lyse” boxes.

z For any reagent, the entered expiration date should be either the expiration
date printed on the labeling or the open-container expiration date, whichever
is earlier.

z The open-container expiration date is calculated as follows: the date that


container is opened + the open-container stability days.

5.9.3 Exiting the “ReagentExp. Date” screen


Press [MENU] or [MAIN] to exit the ” ReagentExp. Date” screen and a message box will pop
up to ask you save the changes, as Figure 5-39 shows.

Figure 5-39 A message box to confirm the changes

„ CLICK “Enter” to save the changes and exit to the system menu or the “Count” screen;

„ CLICK “Cancel” to abort the changes and exit to the system menu or the “Count”
screen.

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5.10 Report Title (external keyboard required)

The “Report Title” screen is where you set the title of the report to be printed. To set the
report title,
Press [MENU] to enter the system menu.

Figure 5-40 System menu

SELECT “Setup→Report Title”(Figure 5-40) to enter the ”Report Title” screen (Figure 5-41).

Figure 5-41 “Report Title” screen

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ENTER the desired title in the ”Report Title (by recorder) ” or ” Report Title (by printer) ”
box, depending on the printing device you choose to print out the report. Press [MENU] or
[MAIN] to save the changes and exit to the system menu or the system menu or the
“Count” screen.

z To correct any erroneous entry, DELETE the wrong character.

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5.11 Parameter Units

The “Parameter Units” screen is where you view and/or set (if you have the administrator
password) the reporting units of the parameters.
See Table 5-2 for the available units for every parameter groups. Note that if you choose g/L
or g/dL for the HGB/MCHC group, the MCH unit will automatically change to pg and its
reporting format will be ***.*; if you choose mmol/L for the HGB/MCHC group, the MCH unit
will automatically change to fmol and its reporting format will be **.**.

Table 5-2 Reporting unit

Parameter group Reporting format Reporting unit Remarks


WBC ***.* 10 /L9
Default
Lymph# ***.* 3
10 /uL
Mid# **** 102/uL
Gran# ***.* /nL

Lymph% **.* Default


Mid% %
Gran%
HGB *** g/L Default
MCHC **.* g/dL
**.* mmol/L
RBC *.** 1012/L Default
*.** 106/uL
*** 104/uL
*.** /pg
HCT **.* % Default
.*** L/L
MCV ***.* fL Default
RDW-SD ***.* um3
RDW-CV **.* % Default
PLT **** 109 /L Default
**** 103 /uL
***.* 104 /uL
**** /nL
MPV **.* fL Default

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**.* um3
PDW **.* None Default
PCT .*** % Default
*.** mL/L

5.11.1 Entering the “Parameter Units” screen and viewing the

settings
Press [MENU] to enter the system menu.

Figure 5-42 System menu

SELECT ”Setup→ Parameter Units” (Figure 5-42), to enter the “Parameter Units” screen

(Figure 5-43 ).

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Figure 5-43 “Parameter Units” screen

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5.11.2 Setting reporting units

1. Enter the administrator password as instructed in Chapter 5.4.1.

2. Enter the “Parameter Units” screen.

3. SELECT the desired unit from the corresponding pull-down list (e.g. RBC in Figure
5-44).

Figure 5-44 Selecting a unit for RBC

5.11.3 Exiting the “Parameter Units” screen


Press [MENU] or [MAIN] to exit to the system menu or the “Count” screen and the changes
will be saved automatically.

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5.12 Other

The “Other” screen is where you define miscellaneous system settings.

5.12.1 Entering the “Other” screen


Press [MENU] to enter the system menu.

Figure 5-45 System menu

SELECT “Setup→Other”(Figure 5-45) to enter the ”Other” screen (Figure 5-46).

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Figure 5-46 “Other” screen

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5.12.2 Muting the Beeper


The analyzer beeps when an error is present. You can mute the beeper by pressing any key
(except for the aspirate key), as long as the ”Any key to mute” function is enabled. To enable
(or disable) the function, SELECT ”ON” (or ” OFF”) from the ”Any key to mute” pull-down
list, as Figure 5-47 shows. Note that if you have disabled the ”Any key to mute” function, the
analyzer will keep beeping for the pre-set alarm time or until the error is removed.

Figure 5-47 Enabling/disabling “Any key to mute” function

5.12.3 Setting LCD contrast


The analyzer divides the LCD contrast into 256 levels (level 0 - level 255) and the higher the
level, the higher the contrast. To select a desired LCD contrast level, ENTER the desired

number into the ”LCD Contrast” box(Figure 5-48)

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Figure 5-48 Selecting LCD contrast

5.12.4 Setting alarm time for error messages


The alarm time of the errors listed in Table 5-3 can be set to 2 - 120 seconds. When the
pre-set alarm times out, both the alarm sound and the corresponding error message will
disappear.

Table 5-3 Errors with adjustable display time

No. Error No. Error No. Error


1 Communication error 2 Scanner error 3 Scanner
communication error

4 Ambient temperature 5 Background abnormal 6 HGB error


abnormal
7 HGB adjust 8 WBC clog 9 WBC bubble
10 RBC Clog 11 RBC bubble 12 Printer connection
error

13 Printer out of paper 14 Recorder too hot 15 Recorder


communication error
16 Press bar up 17 Recorder out of paper

To set the display time, ENTER the desired time into the “Alarm time (s)” box.

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Figure 5-49 Selecting alarm time

5.12.5 Reminder of Predilute mode


If you have enabled the “Reminder of Predilute mode” function and selected the Predilute
mode, the analyzer will ask you to confirm the selection.
To enable (or disable) the “Reminder of Predilute mode” function, SELECT “ON”(or “OFF”)
from the “Reminder of Predilute mode” pull-down list.

Figure 5-50 Enabling/disabling the “Reminder of Predilute mode” function

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Figure 5-51 A message box to confirm the predilute mode

5.12.6 Selecting how to enter sample information


If you have entered the administrator password, you can select in which way to enter the
sample information, “ID only” (to enter the sample ID only) or “All Info.”(to enter all the
sample information), by selecting “ID Only” or “All Info.” from the “Enter Sample Info.”

pull-down list.(Figure 5-52)

Figure 5-52 Selecting how to enter patient information

5.12.7 Exiting the “Other” screen


Press [MENU] or [MAIN] to exit to the system menu or the “Count” screen and all the
changes will be saved automatically.

5-44
6 Operating Your Analyzer

6.1 Introduction

This chapter provides step-by-step procedures for operating your analyzer on a daily basis.
A flow chart indicating the common daily operating process is presented below.

Initial Checks

Power on

Daily Quality Control

Sample Collection and Handling

No
Run Prediluted Samples
Whole Blood Mode?

Yes

Run Whole Blood Samples

Shutdown

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6.2 Initial Checks

Perform the following checks before turning on the analyzer.

1. Checking the waste container;

2. Check and make sure the container is empty.

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 Be sure to dispose of reagents, waste, samples, consumables, etc.


according to government regulations.

3. Checking tubing and power connections ;

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

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

4. Checking the printer (optional) and recorder;

Check and make sure enough printer or recorder paper is installed. Check and make sure the
power cord of the printer is properly plugged into an electrical outlet. Check and make sure
the printer cable is properly connected to the analyzer.

5. Check keyboard connection.

Check and make sure the keyboard is properly connected to the keyboard interface (marked
KB) of the analyzer.

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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 3 to 5 minutes, depending on how the analyzer was previously shut
down.

If any error occurs during the initialization, the analyzer will display the error messages in the
upper left corner of the screen. You should remove all the errors before running any sample.
See Chapter 11 Troubleshooting Your Analyzer for solutions.

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

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6.4 Daily Quality Control

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

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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 Do not re-use disposable products.

z Be sure to use clean K2EDTA anticoagulant collection tubes, fused silica


glass/plastic test tubes 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 - 2.2mg/ml)anticoagulant collection tube;

2. Rapidly and thoroughly mix the blood with the anticoagulant;

z Be sure to use clean K2EDTA anticoagulant collection tubes, fused silica


glass/plastic test tubes and 20μL borosilicate glass capillary tubes.

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 8 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℃ - 8℃) for 24 hours. You need to warm the

refrigerated samples at room temperature for at least 30 minutes before


running them.

z Be sure to mix any sample that has been prepared for a while before running

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it.

6.5.2 Prediluted Samples

1. Collect and handle the prediluted sample as follows;

2. Press [MENU] and SELECT ”Mode” to enter the ”Mode” screen;

3. SELECT “Predilute” from the “Sample Mode” pull-down list;

4. Press [MENU] and SELECT ”Count” to enter the ”Count” screen;

5. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 6-1shows;

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

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

Figure 6-2 How to dispense diluent

7. When the dispensing is finished, press [ENTER] to close the message box;

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

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z Be sure to keep dust from the prepared diluent.

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

z Be sure to run the prediluted samples within 30 minutes after the mixing.

z Be sure to mix any sample that has been prepared for a while before running
it.

z Be sure to evaluate predilute stability based on your laboratory’s sample


population and sample collection techniques or methods.

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6.6 Running Whole Blood Samples

Press [MENU] and SELECT ”Mode” to enter the ”Sample Mode” screen, as Figure 6-4
shows.

Figure 6-3 System menu

SELECT “Whole Blood” from the “Sample Mode” pull-down list.

Figure 6-4 “Sample Mode” Screen

Press [MENU] and SELECT ”Count” to enter the ”Count” screen, as Figure 6-5 shows.

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Figure 6-5 “Count” Screen

z Be sure to select proper reference range as instructed in Chapter 5.5


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

z When switching from the predilute mode to the whole blood mode, the
analyzer will automatically wash the fluidic system.

6.6.1 Entering Sample Information


You can enter the sample information one of the two ways, ID or All Info., depending on the
configuration of your analyzer (see Chapter 5.13 for how to select the entering mode).

All Info. (external keyboard needed)


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

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Figure 6-6 Entering all sample information

„ Entering sample ID

ENTER the ID number in the “ID” box. If you have the bar-code scanner installed, you can
simple scan the sample ID into the analyzer.

„ Selecting patient gender

SELECT the desired item from the “ Gender” pull-down list, as Figure 6-7 shows. Note

that you can select blank in case you are not aware of the patient gender.

Figure 6-7 How to select the patient gender

„ Entering the patient name

ENTER the patient name into the “Name” box.

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„ Entering the 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 adult or pediatric patients no younger than one year;
the second for the infant patients one month to one year; the third for the neonatal patients no
older than 28 days. 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.

„ 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 6-8 shows).

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Figure 6-8 How to select department name from the pull-down list

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„ Entering the names of the sender, tester and reviewer

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, as Figure 6-9 shows) ; 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 “Reviewer” 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.

Figure 6-9 Entering names of the sender, tester and reviewer

z To correct an erroneous entry, DELETE the wrong character and ENTER the
correct one.

z After entering all the desired information, you may press [F4] on the external
keyboard to save the changes and exit to the “Count” screen.

„ “Enter” button

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When you have finished entering the all the interested sample information, CLICK the “Enter”
button to save the changes and return to the “Count” screen.

„ “Cancel” button

If you do not want to save the entered information, CLICK the “Cancel” button to return to
the ”Count” screen without saving the changes.

ID Only
At the ”Count” screen, press [ID] and an ID window will pop up, as Figure 6-10 shows.

Figure 6-10 ID window

ENTER the sample ID into the ID box and press [ENTER] to save the changes and close the
window. If you have the bar-code scanner installed, you can simply scan the sample ID into
the analyzer.

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


ENTER “0” into the “ID” box.

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.

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

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


capillary tubes, etc.

z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be inaccurate.

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

1. At the “Count” screen, be sure the System Status area displays “Ready“ and Count
Mode area displays “Whole“.

2. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display “Running” and the analyzer
will start aspirating sample.

3. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen.

4. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be replaced. And if the auto
print function is enabled, the analysis result will be automatically printed out.

5. 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 upper left corner
of the screen and the results of all the related parameters will be invalidated.
See Chapter 11 Troubleshooting 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 for solutions.

6-15
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6.6.3 Special Functions

Automatic saving of analysis results


This analyzer automatically saves maximum 35,000 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 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

platelets coagulate, large platelet, nucleated red cell, insolvable red cell, protein, lipoid debris
in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mononuclear area and
possible presence of atypical lymphocyte, original cell in the sample and increased eosinophil
or increased basophil.

R3 : indicates abnormality between the mononuclear leukocyte and the neutrophilic

granulocytes and possible presence of immature granulocytes, abnormal sub-population in


the sample, or increased eosinophil.

R4 :indicates abnormality on the right side of the neutrophilic granulocytes hump and

increased absolute number of neutrophilic granulocyte.

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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.

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

6-17
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6.7 Running Prediluted Samples

Press [MENU] and SELECT ”Sample Mode” (Figure 6-11) to enter the ”Sample Mode”
(Figure6-12) screen.

Figure 6-11 System menu

SELECT “Predilute” from the “Sample Mode” pull-down list.

Figure6-12 Selecting Predilute mode

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Press [MENU] and SELECT ”Count” to enter the ”Count” screen,as Figure6-13 shows.

Figure6-13 “Count” screen

z Be sure to select a proper reference range as instructed in Chapter 5.5


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

6.7.1 Entering Sample Information

You can enter the sample information one of the two ways, ID or All Info., depending on the
configuration of your analyzer (see Chapter 5.13 for how to select the entering mode).

All Info. (external keyboard needed)

At the “Count” screen, press [ID] and an edit window will pop up, as Figure6-14 shows.

6-19
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Figure6-14 Entering all 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 Figure6-15 shows.

Note that you can select blank in case you are not aware of the patient gender.

Figure6-15 How to select the patient gender

6-20
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„ 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. The first way is designed for the adult or pediatric patients no younger than one year;
the second for the infant patients one month to one year; the third for the neonatal patients no
older than 28 days s. 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.

„ 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 Figure6-16 shows).

6-21
Fehler! Formatvorlage nicht definiert.

Figure6-16 How to select department name from the pull-down list

„ Entering the names of the sender, tester and reviewer

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, as Figure6-17 shows) ; 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 “Reviewer” 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.

6-22
Fehler! Formatvorlage nicht definiert.

Figure6-17 Entering names of the sender, tester and reviewer

6-23
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„ “Enter” button

When you have finished entering the all the interested sample information, CLICK the “Enter”
button to save the changes and return to the “Count” screen.

„ “Cancel” button

If you do not want to save the entered information, CLICK the “Cancel” button to return to
the ”Count” screen without saving the changes.

ID Only
At the ”Count” screen, press [ID] and an ID window will pop up, as Figure6-18 shows.

Figure6-18 ID window

ENTER the sample ID into the ID box and press [ENTER] to save the changes and close the
window.

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


“0” into the “ID” box.

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.

6-24
Fehler! Formatvorlage nicht definiert.

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

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


capillary tubes, etc.

z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be inaccurate.

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

1. At the “Count” screen, be sure the System Status area displays “Ready“ and Count
Mode area displays “Predilute“.

2. Present the mixed sample to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display “Running” and the analyzer
will start aspirating sample.

3. When you hear the beep and the sample probe is out of the tube, remove the sample
tube. The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen.

4. When the analysis is finished, the result will be displayed on the screen and the sample
ID will automatically increase by 1 and the sample probe will be replaced. And if the auto
print function is enabled, the analysis result will be automatically printed out.

5. 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 upper left corner
of the screen and the results of all the related parameters will be invalidated.
See Chapter 11 Troubleshooting 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 for solutions.

6-25
Fehler! Formatvorlage nicht definiert.

6.7.3 Special Functions

Automatic saving of analysis results


This analyzer automatically saves maximum 35,000 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 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

platelets coagulate, large platelet, nucleated red cell, insolvable red cell, protein, lipoid debris
in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mononuclear area and
possible presence of atypical lymphocyte, original cell in the sample and increased eosinophil
or increased basophil.

R3 : indicates abnormality between the mononuclear leukocyte and the neutrophilic

granulocytes and possible presence of immature granulocytes, abnormal sub-population in


the sample, or increased eosinophil.

R4 :indicates abnormality on the right side of the neutrophilic granulocytes hump and

increased absolute number of neutrophilic granulocyte.

6-26
Fehler! Formatvorlage nicht definiert.

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.

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

6-27
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6.8 Shutdown

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

z To ensure stable analyzer performance and accurate analysis results, be


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

z Be sure to shut down the analyzer strictly as instructed below.

1. Press [MENU] to enter the system menu and SELECT ”Shutdown”, as Figure 6-19
shows;

Figure 6-19 Selecting the Shutdown program

2. A message box will pop up to ask you to confirm the shutdown, as Figure 6-20shows;

Figure 6-20 Shutdown message box

6-28
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3. CLICK “Enter”and a window will pop up to instruct you how to shut down the analyzer, as
Figure6-21shows;

Figure6-21 Shutdown window

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

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 sample probe and press the aspirate key. The analyzer
will aspirate the E-Z cleanser and automatically clean the fluidic lines and the baths. The
cleaning progress will be displayed on the screen, as Figure 6-22 shows;

Figure 6-22 Shutdown progress bar

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

6. Empty the waste container.

6-29
Fehler! Formatvorlage nicht definiert.

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 Be sure to dispose of reagents, waste, samples, consumables, etc.


according to government regulations.

6-30
7 Reviewing Sample Results

7.1 Introduction

The analyzer automatically saves analysis results. Totally 35,000 results can be saved. You
can either browse all the saved sample results in general (see “Browsing All Sample Results”)
or search for the results of a particular sample or samples (see “Searching for Interested
Sample Results”).

7-1
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7.2 Browsing All Sample Results

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

„ The “Sample Table Review” 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 maximum 6 sample results.

„ The “Sample Histogram Review” mode. In this mode, you can review both parameter
values and histograms of the saved sample results. One screen displays one sample result.

7.2.1 Browsing in the “Sample Table Review” mode

Entering the “Sample Table Review” screen


Press [MENU] to enter the system menu. SELECT “Review→ Sample Review→ Sample
Table Review” (Figure7-1 ), to enter the “Sample Table Review” screen (Figure7-2).

Figure7-1 System menu

The sample results are sequentially displayed on the screen, the earliest on the utmost left.
The “Location/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 saved
sample results.

7-2
Fehler! Formatvorlage nicht definiert.

Figure7-2 “Sample Table”screen

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 “Sample Histogram Review” mode


If you are interested in reviewing the histograms of the current sample result, press [6] to
switch to the ”Sample Histogram Review” mode. To switch back to the “Sample Table
Review” mode, press [6] again.

Jumping to a sample result with known location


Press [1] and a “Goto” window will pop up, as Figure7-3 shows.

Figure7-3 “Goto” window

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

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Jumping to a sample result with known sample ID


Press [2] and a “Find” window will pop up, as Figure7-4 shows.

Figure7-4 “Find”window

ENTER the sample ID into the “ID” box and press [↑] to search backward or [↓] to search
forward. If the desired sample result is found, the analyzer will jump to it; if not, a message
box will pop up, as Figure7-5 shows. Press [ENTER] to close the message box.

Figure7-5 A “Result”message box

Selecting/deselecting sample results


You can select certain interested samples for transmission or printing.

„ Selecting/deselecting a sample result

Press [←] or [→] to move the cursor to the interested sample result and press [ENTER] to
select it. The selected sample result will be marked with a “*”, as sample “75” in Figure7-6
shows.

7-4
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Figure7-6 Selecting a sample result

Press [ENTER] again to deselect the sample result. Once the sample is deselected, the “*”
will disappear, as sample “75” in Figure7-7 shows.

Figure7-7 Deselecting a sample result

„ Selecting/deselecting multiple sample results

Example1:To select the sample results of locations 1 – 5 (sample ID:75, 77, 78, 84, 95 in

Figure7-8), follow the procedure below to do so:

1. Press[3] to enter the “Select” window, as Figure7-8 shows;

7-5
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Figure7-8 Entering the “Select” window

2. ENTER the start position (“1”) into the “Start” box;

3. ENTER the start position (“5”) into the “End” box;

4. CLICK “Select” and the lower left corner of the “Select” window will display “Results
selected”, as Figure7-9 shows;

Figure7-9 Selecting sample results of locations 1- 5

5. CLICK “Quit” to return to the “Sample Table Review” screen. The selected sample
results will be marked with “*”, as Figure7-10 shows.

7-6
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Figure7-10 Reviewing the selected results

Example2:To deselect the sample results of locations 1 – 5 (sample ID: 75, 77, 78, 84, 95 in

Figure7-10), follow the procedure below to do so:

1. Enter the start and end positions as instructed in steps 1 – 3 of Example1;

2. CLICK “Deselect” and the lower left corner of the “Select” window will display “Results
deselected”, as Figure7-11 shows;

Figure7-11 Deselecting the sample results of locations 1 – 5

3. CLICK “Quit” to return to the “Sample Table” screen. The “*” above those sample results

7-7
Fehler! Formatvorlage nicht definiert.

will disappear, as Figure7-12 shows.

Figure7-12 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 3 as instructed in steps 1 to 5 of Example1;

2. Select the sample results of locations 5 to 6 as instructed in steps 1 to 5 of Example1;

3. CLICK “Quit” to return to the “Sample Table Review” screen. The selected sample
results will be marked with “*”, as Figure7-13 shows.

Figure7-13 Reviewing the selected results

7-8
Fehler! Formatvorlage nicht definiert.

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 3 as instructed in steps 1 to 3 of Example2;

2. Deselect the sample results of locations 5 to 6 as instructed in steps 1 to 3 of Example2;

3. CLICK “Quit” to return to the “Sample Table Review” screen. The “*” above those
sample results will disappear, as Figure7-14 shows.

Figure7-14 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 [4]
to enter the “Transmission” window, as Figure7-15 shows.

Figure7-15 “Transmission” window

7-9
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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 “Quit”.

Deleting sample results (if configured and administrator passwored


entered)
„ Deleting some sample results

Select the sample results you want to delete and press [DEL]. A message box will pop up to
confirm the deletion, as Figure7-16 shows. CLICK “Enter” to delete the selected results;
CLICK “Cancel” to abort the deletion.

Figure7-16 A message box to confirm the deletion

„ Deleting all sample results

Press [5] and a message box will pop up to ask you to confirm the deletion, as Figure7-17
shows.

Figure7-17 A “Delete All” message box

CLICK ”Enter” to delete all the sample results; CLICK “Cancel” to abort the deletion.

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 Figure7-18 shows. CLICK “Enter” to print out all the
selected results; CLICK “Cancel” to abort the printing.

7-10
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Figure7-18 A Print message box

Calculating reproducibility

This analyzer provides three reproducibility indices Mean,SD(Standard Deviation) and CV%

(Coefficient of Variation).

∑x i
Mean= i=1
n

∑ (X − Mean )
2

SD =
i

n −1

SD
CV% = × 100
Mean

Where n represents how many sample results are selected and Xi is the result of the ith
analysis.

To check the reproducibility of the selected sample results, select at least three sample
results and press [7] to view the reproducibility. If any selected result contains invalid
parameter value (s), the reproducibility indices of that parameter(s) will also be non-numeric
(***).

To print out the displayed indices, press [PRIINT]. To exit the “Reproducibility” screen, press
[MENU] to exit the “Reproducibility”screen.

7.2.2 Browsing in the “Sample Histogram Review” Mode

7-11
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Entering the “Sample Histogram Review” screen


Press [MENU] to enter the system menu.

Figure7-19 System menu

SELECT “Review → Sample Review → Sample Histogram Review” (Figure7-19) to enter


the “Sample Histogram Review” screen (Figure7-20). The sample information will be
displayed at the top of the screen, followed by the parameter values and histograms. The
“Location/Total” displayed in the upper right corner of the screen indicates the location of the
current sample result and the total number of the saved sample results.

Figure7-20 “Sample Histogram Review” screen

Browsing sample results


Press [←] or [→] to browse the preceding or following sample result; press [PgUp] or [PgDn]
to jump 6 locations (e.g. from location 1 to location 7).

7-12
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Switching to the “Sample Table Review” mode


To switch to the “Sample Table Review” mode, press [6]; to switch back to the “Sample
Histogram Review” mode, press [6] again.

Jumping to a sample result with known location


Press [1] and a “Goto” window will pop up, as Figure7-21 shows.

Figure7-21 “Goto” window

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

Editing sample information


Press [F1] to edit the sample information, Figure7-22 shows.

Figure7-22 Editing sample information

„ ID

You cannot edit the sample ID of an analyzed sample.

7-13
Fehler! Formatvorlage nicht definiert.

„ Selecting 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.

„ 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. The first way is designed for the adult or pediatric patients no younger than one year;
the second for the infant patients one month to one year; the third for the neonatal 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.

„ 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.

„ Entering the names of the sender, tester and reviewer

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 ran the sample,

7-14
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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 reviewed the sample results, ENTER the name into the “Reviewer” box, or
SELECT the desired name from the “Reviewer” 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.

„ “Enter” button

When you have finished entering the all the interested sample information, CLICK the “Enter”
button (or press [F4] of the external keyboard) to save the changes and return to the “Sample
Histogram Review” screen.

„ “Cancel” button

If you do not want to save the entered information, CLICK the “Cancel” button to return to
the ”Sample Histogram Review” screen without saving the changes.

Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually, provided
you have 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.

Example 5:To move the third discriminator of the following WBC histogram to 100fL, follow

the procedure below to do so.

1. Press [ENTER] and the discriminator will become adjustable. See Figure7-23;

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Figure7-23 WBC histogram with adjustable discriminators

2. Press [↑] or [↓] to select the WBC histogram;

3. Press [3] to select the third discriminator, as Figure7-24;

Figure7-24 Adjusting discriminator (1)

4. Press [←] to move the third discriminator to 100fL, as Figure7-25 shows;

Figure7-25 Adjusting discriminator (2)

5. Press [ENTER] and a message box will pop up, as Figure7-26 shows.

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Figure7-26 “Note” message box

CLICK “Enter” to save the changes and return to the “Sample Histogram Review” screen;
CLICK ”Cancel” to abort the changes and return to the “Sample Histogram Review” screen.

Printing sample results


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

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7.3 Searching for Interested Sample Results

7.3.1 Starting a search


At the “Sample Table Review” screen, press [F1] of the external keyboard to enter the
“Search”window, as Figure7-27 shows.

Figure7-27 “Search” window

To include a search condition, press [↑] or [↓] to move the cursor to the desired condition and
press [ENTER] to tick the condition, as Figure7-28 shows.

Figure7-28 All 7 search conditions are included

„ Entering the patient name

ENTER the patient name into the “Name”box.

„ Selecting patient gender

SELECT the desired item from the “Gender”pull-down list. Note that you can select blank

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in case you are not aware of the patient gender.

„ 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).

„ Entering sample ID

ENTER the ID number into the “ID” box.

„ Entering 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 “Enter” to start the search. The analyzer will search the saved sample results for
matches and report the conclusion, as Figure7-29 shows. CLICK “Enter” to return to the
“Sample Table Review”screen.

Figure7-29 Reporting conclusion of the search

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7.3.2 Reviewing Search Result in the “Search Table Review”

Mode

z For every search, the analyzer can display maximum 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 “Sample Table Review” screen


Press [MENU] to enter the system menu. SELECT “Review → Search Review → Search
Table Review” (Figure7-30), to enter the “Search Table Review” screen (Figure7-31).

Figure7-30 System menu

The sample results are sequentially displayed on the screen, the earliest on the utmost left.
The “Location/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.

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Figure7-31 “Search Table Review” screen

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 “Search Histogram Review” mode


If you are interested in reviewing the histograms of the current sample result, press [6] to
switch to the ”Sample Histogram Review” mode. To switch back to the “Sample Table
Review” mode, press [6] again.

Jumping to a sample result with known location


Press [1] and a “Goto” window will pop up, as Figure7-32 shows.

Figure7-32 “Goto” window

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

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Selecting/deselecting sample results


You can select certain interested samples for transmission or printing.

„ Selecting/deselecting a sample result

Press [←] or [→] to move the cursor to the interested sample result and press [ENTER] to
select it. The selected sample result will be marked with a “*”, as sample “75” in Figure7-33
shows.

Figure7-33 Selecting a sample result

Press [ENTER] again to deselect the sample result. Once the sample is deselected, the “*”
will disappear, as sample “75” in Figure7-34 shows.

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Figure7-34 Deselecting a patient result

„ Selecting/deselecting multiple sample results

Example 6:To select the sample results of locations 1 – 5 (sample ID: 75, 77, 78, 84, 95, 106

in Figure7-35), follow the procedure below to do so:

1. Press [3] to enter the “Select” window, as Figure7-35 shows;

Figure7-35 Entering the “Select” window

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2. ENTER the start position (“1”) into the “Start” box;

3. ENTER the start position (“5”) into the “End” box;

4. CLICK “Select” and the lower left corner of the “Select” window will display “Results
selected”, as Figure7-36 shows;

Figure7-36 Selecting sample results of locations 1- 5

5. CLICK “Quit” to return to the “Sample Table Review” screen. The selected sample
results will be marked with “*”, as Figure7-37 shows.

Figure7-37 Reviewing the selected results

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Example 7:To deselect the sample results of locations 1 – 5 (sample ID: 75, 77, 78, 84, 95,

106 in Figure7-38), follow the procedure below to do so:

1. Enter the start and end positions as instructed in steps 1 – 3 of Example 6;

2. CLICK “Deselect” and the lower left corner of the “Select” window will display “Results
deselected”, as Figure7-38 shows;

Figure7-38 Deselecting the sample results of locations 1 – 5

3. CLICK “Quit” to return to the “Sample Table” screen. The “*” above those sample results
will disappear, as Figure7-39 shows.

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Figure7-39 Reviewing the deselected results

Example 8: To select the sample results of locations 1 to 3 and 5 to 6, follow the procedure
below to do so:

1. Select the sample results of locations 1 to 3 as instructed in steps 1 to 5 of Example 6;

2. Select the sample results of locations 5 to 6 as instructed in steps 1 to 5 of Example 6;

3. CLICK “Quit” to return to the “Sample Table Review” screen. The selected sample
results will be marked with “*”, as Figure7-40 shows.

Figure7-40 Reviewing the selected results

Example 9:To deselect the sample results of locations 1 to 3 and5 to 6, follow the procedure

below to do so:

1. Deselect the sample results of locations 1 to 3 as instructed in steps 1 to 3 of Example 7;

2. Deselect the sample results of locations 5 to 6 as instructed in steps 1 to 3 of Example 7;

3. CLICK “Quit” to return to the “Sample Table Review” screen. The “*” above those
sample results will disappear, as Figure7-41 shows.

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Figure7-41 Reviewing the deselected 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 Figure7-42 shows. CLICK “Enter” to print out all the
selected results; CLICK “Cancel” to abort the printing.

Figure7-42 Print message box

Calculating reproducibility

This analyzer provides three reproducibility indices Mean, SD(Standard Deviation)and CV%

(Coefficient of Variation).

∑x i
Mean= i=1
n

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∑ (X − Mean )
2

SD =
i

n −1

SD
CV% = × 100
Mean

Where n represents how many sample results are selected and Xi is the result of the ith
analysis.

To check the reproducibility of the selected sample results, select at least three sample
results and press [7] to view the reproducibility. If any selected result contains invalid
parameter value (s), the reproducibility indices of that parameter(s) will also be invalid (***).

To print out the displayed indices, press [PRIINT]. To exit the “Reproducibility” screen, press
[MENU] to exit the “Reproducibility”screen.

7.3.3 Reviewing Search Result in the “Search Histogram

Review” Mode

z For every search, the analyzer can display maximum 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 “Search Histogram Review”screen


Press [MENU] to enter the system menu.

Figure7-43 System menu

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SELECT “Review → Search Review → Search Histogram Review” (Figure7-43) to enter


the “Search Histogram Review” screen (Figure7-44). The sample information will be
displayed at the top of the screen, followed by the parameter values and histograms. The
“Location/Total” displayed in the upper right corner of the screen indicates the location of the
current sample result and the total number of the saved sample results.

Figure7-44 “Sample Histogram Review” screen

Browsing sample results


Press [←] or [→] to browse the preceding or following sample result; press [PgUp] or [PgDn]
to jump 6 locations (e.g. jumping from location 1 to location 7 ).

Switching to the “Search Table Review” mode


To switch to the “Search Table Review” mode, press [6]; to switch back to the “Search
Histogram Review” mode, press [6] again.

Jumping to a sample result with known location


Press [1] and a “Goto” window will pop up, as Figure7-45 shows.

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Figure7-45 “Goto” window

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

Editing sample information


Press [F1] to edit the sample information, Figure7-46 shows.

Figure7-46 Editing sample information

„ ID

You cannot edit the sample ID of an analyzed sample.

„ Selecting 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.

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„ 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. The first way is designed for the adult or pediatric patients no younger than one year;
the second for the infant patients one month to one year; the third for the neonatal patients no
older than 28 days. 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.

„ 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).

„ Entering the names of the sender, tester and reviewer

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 ran 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 reviewed the sample results, ENTER the name into the “Reviewer” box, or
SELECT the desired name from the “Reviewer” pull-down list (if there are previously

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saved names in the list). All the three pull-down lists are capable of saving 30 entered names.

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„ “Enter” button

When you have finished entering all the interested sample information, CLICK the “Enter”
button (or press [F4] of the external keyboard) to save the changes and return to the “Search
Histogram Review” screen.

„ “Cancel” button

If you do not want to save the entered information, CLICK the “Cancel” button to return to
the ”Search Histogram Review” screen without saving the changes.

Adjusting histograms
If you are not satisfied with the obtained histograms, you can adjust them manually, provided
you have 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.

Example10:To move the third discriminator of the following WBC histogram to 100fL, follow

the procedure below to do so.

1. Press [ENTER] and the discriminator will become adjustable. See Figure7-47;

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Figure7-47 WBC histogram with adjustable discriminators

2. Press [↑] or [↓] to select the WBC histogram;

3. Press [3] to select the third discriminator, as Figure7-48 shows;

Figure7-48 Adjusting discriminator (1)

4. Press [←] to move the third discriminator to 100fL, as Figure7-49 shows;

Figure7-49 Adjusting discriminator (2)

5. Press [ENTER] and a message box will pop up, as Figure7-50 shows.

Figure7-50 The message box to ask you to save the changes

CLICK “Enter” to save the changes and return to the “Search Histogram Review” screen;
CLICK ”Cancel” to abort the changes and return to the “Search Histogram Review” screen.

Printing sample results


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

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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 with low, normal and high level controls. 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.

The BC-3000 Plus provides 4 QC programs: L-J Analysis, X Analysis, X -R Analysis and
X-B Analysis.

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8.2 “L-J Analysis” Program

Using the “L-J Analysis” program, you can provide quality control for maximum 12
parameters. The analyzer provides 9 QC files for you to save QC settings and results. Every
QC file can save results of maximum 31 QC runs. When the saved QC results have reached
the maximum number, the newest result will overwrite the oldest. The following introduction
will use “File 1” as the example.

8.2.1 Editing L-J Settings


„ Entering the “L-J Edit” screen

Press [MENU] to enter the system menu.

Figure8-1 System menu

SELECT “Quality Control→ L-J Analysis → L-J Edit → File 1” (Figure8-1)to enter the

“L-J Edit” screen (Figure8-2).

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Figure8-2 “L-J Edit” screen

If there are saved L-J results and settings, you need to delete them first. Press [DEL] and a
message box will pop up to confirm the deletion, as Figure8-3 shows.

Figure8-3 A message box to confirm the deletion

CLICK “Enter”to confirm the deletion; CLICK “Cancel”to abort the deletion.

„ Entering lot number

ENTER the lot number of the control to be used into the “Lot No.” box.

„ Entering Exp. Date

ENTER the expiration date of the control to be used into the “Exp. Date” box.

„ 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 L-J analysis.

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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, whichever 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 “L-J 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 “L-J Edit” screen

Press [MENU] to exit to the system menu; press [MAIN] to exit to the “Count” screen.
A message box shown in Figure8-4 will pop up, if :
There is a parameter for which you have entered only the expected result or the limit;
or
There is a parameter whose expected result is less than or equal to the limit.

CLICK “Enter” 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.

Figure8-4 An “Invalid input”message box

In case of any invalid entries of expiration dates, a message box will pop up to remind you of
the error, as Figure8-5 shows. CLICK “Enter” to close the box and clear the erroneous
entries. Re-enter the correct values before trying to exit the screen again.

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Figure8-5 An“Invalid date”message box

If all the entries are correct, a message box will pop up to remind you to save the changes, as
Figure8-6 shows. CLICK “Enter” to save the changes and exit to the system menu (or the
“Count” screen); CLICK “Cancel” to abort the changes and exit to the system menu (or
the “Count” screen).

Figure8-6 A message box to confirm the changes

8.2.2 Running the Controls


„ Selecting the “Whole Blood” mode

Press [MENU] and SELECT “Mode” to enter the “Sample Mode”screen. SELECT “Whole
Blood” from the “Sample Mode” pull-down list.

„ Entering the “L-J Count” screen

Press [MENU] to enter the system menu. SELECT “Quality Control→L-J Analysis → L-J
Count →File 1” to enter the “L-J Count”screen, as Figure 8-7 shows.

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Figure 8-7 “L-J Count”screen

z Be sure to use the Mindray - specified controls. Using controls other than
the specified will lead to misleading results.

z Refer to the instructions of use of the controls for how to store and use 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 probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

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


capillary tubes, etc.

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z When switching from the Predilute mode to the Whole Blood mode, the
analyzer will automatically flush the fluidic system.

z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be inaccurate.

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

„ Running the controls

1. Be sure the System Status area displays “Ready“ and Count Mode area displays
“Whole“.

2. Present a vial of control to the sample probe so that the tip is well into the vial, and press
the aspirate key. The System Status area will display “Running” and the analyzer will
start aspirating sample.

3. When you hear the beep and the sample probe is out of the vial, remove the vial. The
sample probe will retract into the analyzer and the analysis progress will be displayed on
the screen.

4. When the analysis is finished, the result will be displayed on the screen and the
“NO./Total” in the upper left corner of the screen will automatically increase by 1 and the
sample probe will be replaced.

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


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

„ Browsing results of other L-J analyses

To browse the result of the preceding or following L-J analysis, press [PgUp] or [PgDn].

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„ Deleting L-J results

To delete the current result, press [DEL] and a message box will pop up, as Figure8-8 shows.
CLCIK “Enter” to confirm the deletion; CLICK “Cancel” to abort the deletion.

Figure8-8 A message box to confirm the deletion

„ Printing L-J results

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

„ Exiting the “L-J Count” screen

Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

8.2.3 Reviewing L-J Results


You can review the saved L-J results in either the “L-J Graph” mode or “L-J Table” mode.

“L-J Graph” mode


„ Entering the “L-J Graph” screen

Press [MENU] to enter the system menu.

Figure8-9 System menu

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SELECT “Quality Control→ L-J Analysis→ L-J Graph→ File 1”(Figure8-9) to enter the
“L-J Graph” screen (Figure 8-10).

Figure 8-10 “L-J Graph”screen 1

The 12 parameters are displayed on three screens, 4 parameters on every screen, as Figure
8-10 to Figure 8-12 show. The saved QC results are sequentially displayed in the L-J graph,
the latest on the utmost left (No.1).

The L-J graph can be interpreted as follows:

„ The x-coordinate represents the number of the L-J analyses performed; the y-coordinate
represents the results of the L-J analyses.

„ For every parameter, its L-J graph can display maximum 31 points.

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

„ For every parameter, the lower dash line represents the expected result – limit.

„ For every parameter(e.g. WBC), the three numbers to the left of the graph are:

10.4 – the expected result + limit;

9.9 – the expected result;


9.4 – the expected result – limit.

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Figure 8-11“L-J Graph”screen 2

Figure 8-12“L-J Graph”screen 3

For every parameter,the three numbers to the right of the L-J graph are defined and

calculated as follows:
Mean – the average of the saved QC runs;
SD – Standard Deviation;
CV% – Coefficient of Variation.

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∑x i
Mean= i=1
n

∑ (X − Mean )
2

SD =
i

n −1

SD
CV% = × 100
Mean

Where, n is the number of the saved L-J analyses and Xi is the result of the ith L-J analysis.

If the saved L-J analyses are less than 3, only the “mean” will be displayed. For a parameter,
if any of the saved results is non-numeric (*), the “mean”, “SD” and “CV%” are all empty.

The “■” and “□”points in the graphs can be interpreted as follows:


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
The “□” points represents non-numeric parameter values (*), which can be caused by either
errors during the run or values outside the operating 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, contanct Mindray customer service department or your
local distributor for assistance.

1. Check the upper left corner of the screen for error messages. Refer to Chapter 11
Troubleshooting Your Analyzer for solutions to any displayed error messages;

2. Check the L-J settings for inappropriate entries;

3. Do the background check. In case of an abnormal background result, refer to Chapter 11


Troubleshooting Your Analyzer for solutions;

4. Re-run the control;

5. Run another vial of control;

6. Check if the analyzer needs to be calibrated.

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„ Browsing results of L-J analyses

Press [↑] or [↓] to review the preceding or following screen; press [←] or [→] 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 box. The location of the current point is
displayed in the “No.” field. The analysis time is displayed in the “Time” field.

„ Printing L-J graphs

Press [PRINT] to print out the displayed L-J graphs.

„ Exiting the “L-J Graph” screen

Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

“L-J Table” mode


„ Entering the “L-J Table”screen

Press [MENU] to enter the system menu.

Figure8-13 System menu

SELECT “Quality Control → L-J Analysis →L-J Table → File 1” (Figure8-13) to enter the
“L-J Table” screen (Figure 8-14). Every screen displays 5 results. The parameter values
fallen outside the expected range will be flagged “H” (higher than the upper limit) or “L” (lower
than the lower limit).

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Figure 8-14 “L-J Table”screen

„ Browsing results of L-J analyses

Press [PgUp] or [PgDn] to review the preceding or following screen.

„ Deleting results of L-J analyses

Press [DLE] and a message box will pop up to ask you whether to delete all the QC results
saved in this file, as Figure8-15 shows. CLICK “Enter” to confirm the deletion; CLICK
“Cancel”to abort the deletion.

Figure8-15 A message box to confirm the deletion

„ Transmitting results of L-J analyses to a host

If you want to transmit all the L-J analysis results to an external computer (a host), press [1]
and a message box will pop up to confirm the transmission, as Figure8-16 shows. CLICK

“Enter” to confirm the transmission;CLICK “Cancel” to abort the transmission.

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Figure8-16 A message box to confirm the transmission

„ Printing results of L-J analyses

Press [PRINT] to print out all the L-J analysis results.

„ Exiting the “L-J Table” screen

Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

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8.3 “ X Analysis ” Program

Using the “ X Analysis” program, you can provide quality control for maximum 12
parameters. The analyzer provides 9 QC files for you to save QC settings and results. Every
QC file can save maximum 31 QC run results. When the saved QC results have reached the
maximum number, the newest result will overwrite the oldest. The following introduction will
use “File 1” as the example.

8.3.1 Editing X Analysis Settings


„ Entering the “ X Edit” screen
Press [MENU] to enter the system menu.

Figure8-17 System menu

SELECT “Quality Control → X Analysis → X Edit → File 1”(Figure8-17)to enter the “ X

Edit” screen (Figure 8-18).

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Figure 8-18 “ X Edit” screen

If there are saved X analysis results and settings, you need to delete them first. Press [DEL]
and a message box will pop up to confirm the deletion, as shows Figure8-19 shows.

Figure8-19 A message box to confirm the deletion

CLICK “Enter” to confirm the deletion; CLICK “Cancel”to abort the deletion.

„ Entering lot number

ENTER the lot number of the control to be used into the “Lot No.” box.

„ Entering Exp. Date

ENTER the expiration date of the control to be used into the “Exp. Date” box.

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

ENTER the expected results (mean) and limits (range) respectively into the “Mean” box and
“Range” boxes of the parameters to be included in the X analysis.

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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, whichever 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 “ X 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 “ X Edit” screen


Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

A message box shown in Figure8-20 will pop up, if :


There is a parameter for which you have entered only the expected result or the limit;
or
There is a parameter whose expected result is less than or equal to the limit.

CLICK “Enter” to close the box and clear the erroneous entries. Re-enter the correct values
before trying to exit the screen again.

Figure8-20An “Invalid input”message box

In case of any invalid entries of expiration dates, a message box will pop up to remind you of
the error, as Figure8-21shows. CLICK “Enter” 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

8-17
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saved only when both the expected result and limit are valid.

Figure8-21 An“Invalid date”message box

If all the entries are correct, a message box will pop up to remind you to save the changes, as
Figure 8-22 shows. CLICK “Enter” to save the changes and exit to the system menu (or the
“Count” screen); CLICK “Cancel” to abort the changes and exit to the system menu (or the
“Count” screen).

Figure 8-22 A message box to confirm the changes

8.3.2 Running the Controls


„ Selecting Whole Blood mode

Press [MENU] and SELECT “Mode” to enter the “Mode”screen. SELECT “Whole Blood”
from the“Sample Mode” pull-down list.

„ Entering the “ X Count” screen

Press [MENU] to enter the system menu. SELECT “Quality Control → X Analysis → X
Count → File 1” to enter the “ X Count”screen, as Figure8-23 shows.

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Figure8-23 “ X Count”screen

z Be sure to use the Mindray - specified controls. Using controls other than
the specified will lead to misleading results.

z Refer to the instructions of use of the controls for how to store and use 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 probe tip is sharp and may contain biohazardous materials.
Exercise caution to avoid contact with the probe when working around it.

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


capillary tubes, etc.

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z When switching from the Predilute mode to the Whole Blood mode, the
analyzer will automatically flush the fluidic system.

z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be inaccurate.

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

„ Running the controls

1. Be sure the System Status area displays “Ready“ and Count Mode area displays
“Whole“;

2. Present a vial of control to the sample probe so that the tip is well into the vial, and press
the aspirate key. The System Status area will display “Running” and the analyzer will
start aspirating control;

3. When you hear the beep and the sample probe is out of the vial, remove the control vial.
The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;

4. When the analysis is finished, the sample probe is replaced, the analysis result is
displayed on the screen, and a message box pops up to confirm the validity of the
analysis result, as Figure8-24 shows;

Figure8-24 A message to confirm the validity

5. CLICK “Enter” to save the result and the “NO./Total” in the upper left corner of the
screen will automatically increase by 1; CLICK “Cancel” to abort the result;

6. Follow the above steps to have another QC run. When you have obtained two valid QC
results, the analyzer will calculate the average and take it as an X analysis result. The
average will be flagged “H” or “L” if it falls outside the expected range.

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


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

„ Browsing results of other X analyses

To browse the result of the preceding or following X analyses, press [PgUp] or [PgDn].

„ Deleting results X analyses


To delete the current result, press [DEL] and a message box will pop up, as Figure 8-25
shows. CLICK “Enter” to confirm the deletion; CLICK “Cancel” to abort the deletion.

Figure 8-25 A message box to confirm the deletion

„ Printing X analysis results

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

„ Exiting the “ X Count” screen


Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

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8.3.3 Reviewing X Analysis Results


You can review the X analysis results in either the “ X Graph” mode or “ X Table” mode.

“ X Graph” mode

„ Entering the “ X Graph” screen


Press [MENU] to enter the system menu.

Figure8-26 System menu

SELECT “Quality Control→ X Analysis → X Graph → File 1”(Figure8-26) to enter the “ X


Graph” screen (Figure8-27).

Figure8-27“ X Graph”screen

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The 12 parameters are displayed on three screens, 4 parameters on every screen, as


Figure8-27 to Figure 8-29 show. The saved X analysis results are sequentially displayed in
the X graph, the latest on the utmost left (No.1).

The X graph can be interpreted as follows:

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

„ For every parameter, its X graph can display maximum 31 points;


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

„ For every parameter, the lower dash line represents the expected result – limit;

„ For every parameter(e.g. WBC), the three numbers to the left of the graph are:

10.5 – the expected result + limit;

10.0 – the expected result;


9.5 – the expected result – limit.

Figure 8-28 “ X Graph”screen 2

8-23
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Figure 8-29 “ X Graph”screen 3

For every parameter,the three numbers to the right of the X graph are defined and

calculated as follows:
Mean – the average of the saved X analyses;
SD – Standard Deviation;
CV% – Coefficient of Variation.
n

∑x i
Mean= i=1
n

∑ (X − Mean )
2

SD =
i

n −1

SD
CV % = × 100
Mean

Where, n is the number of the X analyses performed and Xi is the result of the ith X
analysis.

If the saved X analyses are less than 3, only the “mean” will be displayed. For a parameter,
if any of the saved results is non-numeric *, the “mean”, “SD” and “CV%” are all empty.

The “■” and “□”points in the graphs can be interpreted as follows:


The “■”points fallen between the upper and lower dash lines are within the expected ranges;

8-24
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The “■”points fallen outside the upper and lower dash lines are out of the expected ranges ;

The “□” points represents non-numeric parameter values (*).

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 departmentor your
local distributor for assistance.

1. Check the upper 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 settings for inappropriate entries;

3. Do the background check. In case of an abnormal background result, refer to


Chapter 11 Troubleshooting Your Analyzer for solutions;

4. Re-run the control;

5. Run another vial of control;

6. Check if the analyzer needs to be calibrated.

„ Browsing results of X analyses


Press [↑] or [↓]to review the preceding or following screen; press[←] or [→] 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 box. The location of the current point is
displayed in the “No.” field. The analysis time is displayed in the “Time” field.

„ Printing X graphs

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

„ Exiting the “ X Graph” screen


Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

“ X Table” mode

„ Entering the “ X Table”mode


Press [MENU] to enter the system menu.

8-25
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Figure 8-30 System menu

SELECT “Quality Control →Analysis →Table→ File 1” (Figure 8-30) to enter the “ X
Table” screen (Figure8-31). Every screen displays 5 results. The parameter value fallen
outside the expected range will be flagged “H” (higher than the upper limit) or “L” (lower than
the lower limit).

Figure8-31“ X Table”screen

„ Browsing X analysis results


Press [PgUp] or [PgDn] to review the preceding or following screen.

„ Deleting QC results

Press [DLE] and a message box will pop up to ask you whether to delete all the QC results

8-26
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saved in this file, as Figure8-32 shows. CLICK “Enter” to confirm the deletion; CLICK
“Cancel” to abort the deletion.

Figure8-32 A message box to confirm the deletion

„ Printing QC results

Press [PRINT] to print out all the QC results saved in this file.

„ Exiting the “ X Table” screen


Press [MENU] to exit to the system menu; press [MAIN] to exit to the “Count” screen.

8-27
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8.4 “ X -R Analysis” program

Using the “ X -R Analysis” program, you can provide quality control for maximum 12
parameters. The analyzer provides 9 QC files for you to save QC settings and results. Every
QC file can save maximum 31 QC run results. When the saved QC results have reached the
maximum number, the newest result will overwrite the oldest. The following introduction will
use “File 1” as the example.

8.4.1 Editing X -R Analysis Settings


„ Entering the “ X -R Edit” screen
Press [MENU] to enter the system menu.

Figure8-33 System menu

SELECT “Quality Control → X -R Analysis → X -R Edit → File 1” (Figure8-33)to enter

the “ X -R Edit” screen (Figure8-34).

8-28
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Figure8-34 “ X -R Edit” screen

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 Figure8-35 shows.

Figure8-35 A message box to confirm the deletion

CLICK “Enter” to confirm the deletion; CLICK “Cancel” to abort the deletion.

„ Entering lot number

ENTER the lot number of the control to be used into the “Lot No.” box.

„ Entering Exp. Date

ENTER the expiration date of the control to be used into the “Exp. Date” box.

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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, whichever 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 “ X -R Edit” screen, if you want to correct an erroneous entry, MODIFY


the wrong digit.

„ Deleting settings

Press [DEL] to delete all the settings.

„ Exiting the “ X -R Edit” screen


Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.
In case of an invalid entry of expiration date, a message box will pop up to remind you of the
error, as Figure8-36 shows. CLICK “Enter” to close the box and clear the erroneous entries.
Re-enter the correct values before trying to exit the screen again.

Figure8-36 An“Invalid date”message box

If all the entries are correct, a message box will pop up to remind you to save the changes, as
Figure 8-37shows. CLICK “Enter” to save the changes and exit to the system menu (or the
“Count” screen); CLICK “Cancel” to abort the changes and exit to the system menu (or the
“Count” screen).

Figure 8-37 A message box to confirm the changes

8-30
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8.4.2 Running the Controls


„ Selecting Whole Blood mode

Press [MENU] and SELECT “Mode” to enter the “Mode”screen. SELECT “Whole Blood”
from the “Sample Mode” pull-down list.

„ Entering the “ X -R Count” screen

Press [MENU] to enter the system menu. SELECT “Quality Control → X -R Analysis→ X -R
Count → File 1” to enter the “ X -R Count” screen (Figure8-38).

Figure8-38 “ X -R Count”screen

z Be sure to use the Mindray - specified controls. Using controls other than
the specified will lead to misleading results.

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

8-31
Fehler! Formatvorlage nicht definiert.

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

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


capillary tubes, etc.

z When switching from the Predilute mode to the Whole Blood mode, the
analyzer will automatically flush the fluidic system.

z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be inaccurate.

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

„ Running the controls

1. Be sure the System Status area displays “Ready“ and Count Mode area displays
“Whole“;

2. Present a vial of control to the sample probe so that the tip is well into the vial, and press
the aspirate key. The System Status area will display “Running” and the analyzer will
start aspirating sample;

3. When you hear the beep and the sample probe is out of the vial, remove the control vial.
The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;

4. When the analysis is finished, the sample probe is replaced, the analysis result is
displayed on the screen, and a message box pops up to confirm the validity of the
analysis results, as Figure8-39 shows;

8-32
Fehler! Formatvorlage nicht definiert.

5. CLICK “Enter” to save the result and the “NO./Total” in the upper left corner of the
screen will automatically increase by 1; CLICK “Cancel” to abort the result;

Figure8-39 A message to confirm the validity of the QC run

6. Follow the above steps to run the control again. When you have obtained two valid QC

results, the analyzer will calculate the average X and the difference R. The calculated
X and R will be respectively displayed on the screen.

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


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

„ Browsing results of other X -R analyses

Press [PgUp] or [PgDn] to browse the result of the preceding or following X -R analysis.

„ Deleting results of X -R analyses

To delete the current X -R analysis result, press [DEL] and a message box will pop up, as
Figure8-40 shows. CLCIK “Enter” to confirm the deletion; CLICK “Cancel” to abort the
deletion.

8-33
Fehler! Formatvorlage nicht definiert.

Figure8-40 A message box to confirm the deletion

„ Printing results of X -R analyses

Press [PRINT] to print out the current X -R analysis result by the printer.

„ Exiting the “ X -R Count” screen


Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

8.4.3 Reviewing the X -R Analysis Results

You can review the X -R analysis results in either the “ X -R Graph” mode or “ X -R Table”

mode.

“ X -R Graph” mode

„ Entering the “ X -R Graph” screen


Press [MENU] to enter the system menu.

Figure 8-41 System menu

SELECT “Quality Control → X -R Analysis → X -R Graph → File 1” (Figure 8-41) to enter


the “ X -R Graph” screen (Figure8-42).

8-34
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Figure8-42“ X -R Graph”screen

Every screen displays the X and R graphs of one parameter.

The X graph can be interpreted as follows:

„ The x-coordinate represents the number of the X -R analyses performed; the


y-coordinate represents the results of the X -R analyses;

„ For every parameter, its X graph can display maximum 31 points;

„ For every parameter, the center dash line represents the X (average of all the X -R

analyses performed);

„ For every parameter, the upper dash line represents the upper control limit = X +A× R ;

„ For every parameter, the lower dash line represents the upper control limit = X -A× R ;

„ For every parameter(e.g. WBC), the three numbers to the left of the graph are:

10.2 – X +A× R ;

10.1 – X ;

10.0 – X -A× R .

The R graph can be interpreted as follows:

8-35
Fehler! Formatvorlage nicht definiert.

„ The x-coordinate represents the number of the X - R analyses performed; the

y-coordinate represents the difference between the two runs of every X -R analysis;

„ For every parameter,its R graph displays maximum 31 points;

„ For every parameter,the center line of its R-graph represents the average of all the

differences R ;

„ For every parameter,the upper dash line represents the upper control limit B× R ;

„ For every parameter,the lower dash line represents the lower control limit of the

expected range C× R ;
„ For every parameter(e.g. WBC) the three numbers to the left of its R graph are defined
as follows:

0.3 – B× R ;
0.1 – R ;
0.0 – C× R .

Where A, B, C are the control factors.

The “■” and “□”points in the graphs can be interpreted as follows:


The “■”points fallen between the upper and lower dash lines are within the control range;
The “■”points fallen outside the upper and lower dash lines are out of the control range;
The “□” points represents non-numeric parameter values (*).

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 upper 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 -R settings for inappropriate entries;

3. Do the background check. In case of an abnormal background result, refer to Chapter 11


Troubleshooting Your Analyzer for solutions;

4. Re-run the control;

5. Run another vial of control;

6. Check if the analyzer needs to be calibrated.

8-36
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„ Browsing QC results

Press [↑] or [↓] to review the preceding or following screen; press [←] or [→] to review the
preceding or following result. The X or R value of the current point (the one the cursor is
located at) is displayed below the X or R. The location of the current point is displayed in the
“No.” field. The analysis time is displayed in the “Time” field.

„ Printing X and R graphs

Press [PRINT] to print out the displayed X and R graphs.

„ Exiting the “ X -R Graph” screen


Press [MENU] to exit to the system menu, or press [MAIN] to exit to the “Count” screen.

8-37
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“ X -R Table” mode

„ Entering the “ X -R Table” mode


Press [MENU] to enter the system menu.

Figure8-43 System menu

SELECT “Quality Control→ X -R Analysis → X -R Table → File 1” (Figure8-43) shows to


enter the “ X -R Table” screen (Figure 8-44). Every screen displays 3 results.

Figure 8-44“ X -R Table”screen

„ Browsing results of X -R analyses


Press [PgUp] or [PgDn] to review the preceding or following screen.

8-38
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„ Deleting results of X -R analyses


Press [DLE] and a message box will pop up to ask you whether to delete all the QC results
saved in this file, as Figure 8-45 shows. CLICK “Enter” to confirm the deletion; CLICK
“Cancel” to abort the deletion.

Figure 8-45 A message box to confirm the deletion

„ Printing X -R analysis results

Press [PRINT] to print out all the X -R analysis results saved in this file by the printer.

„ Exiting the “ X -R Table” screen


Press [MENU] to exit to the system menu; press [MAIN] to exit to the “Count” screen.

8-39
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8.5 “X-B Analysis” Program

The X-B analysis is a weighted moving average analysis that uses values obtained from
patient samples. It was proposed by Brian Bull, M.D. using the 3 red cell indices, MCV, MCH
and MCHC to indicate the hematology instrument performance. Effective use of X-B requires
randomization of samples and a normal cross section of patients to prevent skewing of
indices.

It is recommended the X-B analysis be enabled when the sample volume of your laboratory is
greater then 100 samples per day.

8.5.1 Editing X-B Settings


„ Entering the “X-B Edit” screen

Press [MENU] to enter the system menu.

Figure 8-46 System menu

SELECT “Quality Control → X-B Analysis → Limit” (Figure 8-46) to enter the “Limit”
screen (Figure8-47).

8-40
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Figure8-47 “Limit” screen

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 Figure8-48 shows.

Figure8-48 A message box to confirm the deletion

CLICK “Enter” to confirm the deletion; CLICK “Cancel”to abort the deletion.

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

The expected results vary depending on laboratories. It is recommended they are obtained
by calculating the averages of at least 500 random patient samples. The recommended limit
is 3% - 5%.

z Be sure to calibrate your analyzer before trying to establish the expected


results by calculating the averages of random patient samples.

8-41
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ENTER the expected results (mean) and limits (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 “Limit” screen

Press [MENU] (or [MAIN] if you want to go directly to the “Count” screen) to exit the “Limit”
screen.

A message box shown in Figure8-49 will pop up, if :


There is a paremter for which you have entered only the expected result or the limit;
or
There is a parameter whose expected result is less than or equal to the limit.

Figure8-49 An “Invalid input” message box

CLICK “Enter” to save the changes and exit to the system menu (or the “Count” screen);
CLICK “Cancel” to abort the changes and exit to the system menu (or the “Count” screen).

Figure8-50 A message box to save the changes

8-42
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8.5.2 Setting frequency of the X-B analysis


The X-B analysis is performed on batches of certain number of patient samples. To determine
how many samples are to be included in every batch, follow the steps below to do so.

„ Entering the “Samples/Batch”screen

Press [MENU] to enter the system menu.

Figure8-51 System menu

SELECT “Quality Control→ X-B Analysis → Samples/Batch” (Figure8-51) to enter the


“Samples/Batch” screen (Figure8-52).

Figure8-52 “Samples/Batch”screen

8-43
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„ Setting Samples/Batch

ENTER the desired number, which should be 20 to 200. 20 is recommended.

„ Exiting the “Sample/Batch” screen

Press [MENU] to exit to the system menu; press [MAIN] to exit to the “Count” screen.

8.5.3 Enabling/Disabling X-B Analysis


„ Entering the “Start/Stop”screen

Press [MENU] to enter the system menu.

Figure8-53 System menu

SELECT “Quality Control→ X-B Analysis→ Start/Stop” (Figure8-53) to enter the


“Start/Stop” screen (Figure8-54).

8-44
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Figure8-54 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.

„ Enabling/disabling X-B analysis

Press [PgUp] or [PgDn] to activate/deactivate X-B analysis.

„ Exiting the ”Limit” screen

Press [MENU] (or [MAIN] if you want to go directly to the “Count” screen) to exit the “Limit”
screen and a message box will pop up to remind you to save the changes, as Figure8-55
shows. CLICK “Enter” to save the changes and exit to the system menu (or the “Count”
screen); CLICK “Cancel” to abort the changes and exit to the system menu (or the “Count”
screen).

Figure8-55 A message box to confirm the changes

8-45
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8.5.4 Performing X-B Analysis


Once enabled, the X-B analysis will be performed on batches of patient samples of the
defined number (20 - 200). The analysis results will be displayed on the X-B graph as well as
the X-B table.

8.5.5 Reviewing X-B Analysis Results


You can review the X-B analysis results in either the “X-B Graph” mode or “X-B Table” mode.

“X-B Graph” mode


„ Entering the “X-B Graph” screen

Press [MENU] to enter the system menu.

Figure8-56 System menu

SELECT “Quality Control → X-B Analysis → X-B Graph” (Figure8-56) to enter the “X-B
Graph” screen (Figure8-57).

8-46
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Figure8-57 “X-B Graph” screen

The saved X-B analysis results are sequentially displayed in the X-B graph, the latest on the
utmost left (No.1).

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 maximum 500 points, 30 points per
screen;

„ 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-BFigure are
defined as follows:

100 – expected result + limit;

90 – expected result;
80 – 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 upper left corner of the screen for error messages. Refer to Chapter 11

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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[←] or [→] 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, or press [MAIN] to exit to the “Count” screen.

“X-B Table” mode


„ Entering the “X-B Table”mode

Press [MENU] to enter the system menu.

Figure8-58 System menu

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SELECT “Quality Control → X-B Analysis → X-B Table → File 1” (Figure8-58) to enter the
“X-B Table” screen (Figure8-59). Every screen displays 5 results. The parameter value fallen
outside the expected range will be flagged “H” (higher than the upper limit) or “L” (lower than
the lower limit).

Figure8-59 “X-B Table”screen

„ Browsing X-B analysis results

Press [PgUp] or [PgDn] to review the preceding or following screen.

„ Deleting X-B analysis results

Press [DLE] and a message box will pop up to ask you whether to delete all the X-B analaysis
results saved in this file, as Figure8-60 shows. CLICK “Enter” to confirm the deletion; CLICK
“Cancel” to abort the deletion.

Figure8-60 A message box to confirm the deletion

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„ Printing X-B analysis results

Press [PRINT] to print out the displayed results by the printer.

„ Exiting the “X-B Table” screen

Press [MENU] to exit to the system menu; press [MAIN] to exit to the “Count” screen.

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9 Using the Calibration Programs

9.1 Introduction

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. Be sure to store and use the calibrators and
reagents as instructed by their instructions for use.

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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.

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9.3 How to Calibrate

The analyzer provides 3 calibration programs: manual calibration, auto calibration using
commercial calibrators and auto 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 enough reagents have been prepared 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 - 15.0 × 109 / L ≤ 2.0
RBC 3.50 - 6.00 × 1012 / L ≤ 1.5
HGB 110 - 180 g/L ≤ 1.5
MCV 80.0 - 110.0 fL ≤ 0.5
PLT 150 - 500 × 109 / L ≤ 4.0

At the “Count” screen, run a vial of high control three consective times and then immediately
run the diluent three consective 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 and HGB
shall be no greater than 0.5 % ; PLT shall be no greater than 1%.

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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 instructed in Chapter 5.4.1 and then choose one or several
parameters among WBC, RBC, HGB, MCV and PLT for calibration.

9.3.2 “Auto Calibration” Program


Press [MENU] to enter the system menu.

Figure9-1 System menu

SELECT “Calibration→ Auto Calibration” (Figure9-1) to enter the “Auto Calibration”


screen (Figure9-2).

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Figure9-2 “Auto Calibration” screen

Selecting the count mode


Press [MENU] and SELECT ”Mode” to enter the ”Mode” screen.
SELECT “Whole Blood” or “Predilute” from the “Sample Mode” pull-down list.
Press [MENU] and SELECT ”Count” to enter the ”Count” screen.

z When switching from the predilute mode to the whole blood mode, the
analyzer will automatically wash the fluidic system.

Editing calibration settings


Press [ENTER] to activate the edit boxes.

„ 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) and limits (range) respectively into the “Mean” and
“Range” boxes of the parameters to be included in the calibration.

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

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


MODIFY the wrong digit.

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

Running the calibrator

z Be sure to use the Mindray- specified calibrator. Using calibrator other than
the specified will lead to misleading results.

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

z Be sure to use fused silica glass/plastic test tubes and 20μL borosilicate
glass capillary tubes.

z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be inaccurate.

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

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

z Do not re-use such disposable products.

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In the whole blood mode:

1. Be sure the System Status area displays “Ready“ and Count Mode area displays
“Whole“;

2. Present a vial of mixed calibrator to the sample probe so that the tip is well into the tube,
and press the aspirate key. The System Status area will display “Running” and the
analyzer will start aspirating sample;

3. When you hear the beep and the sample probe is out of the vial, remove the calibrator.
The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;

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

In the predilute mode:

1. Be sure the System Status area displays “Ready“ and Count Mode area displays
“Predilute“;

2. Press [DILUENT] and a message box will pop up to instruct you how to dispense the
diluent into the sample tube, as Figure 9-3 shows;

Figure 9-3 An “Add diluent” message box

3. Present a clean sample tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 9-4 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 0.7ml of diluent (the dispensing volume is controlled by the analyzer) into
the tube;

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Figure 9-4 How to dispense diluent

4. When the dispensing is finished, press [ENTER] to close the box;

5. Add 20μL of calibrator to the diluent and shake the tube to mix the sample.

z Be sure to keep dust from the prepared diluent.

z After mixing the calibrator with the diluent, be sure to wait 3 minutes before
running it.

z Be sure to run the prediluted calibrators within 30 minutes after the mixing.

z Mix any pre-diluted calibrator that has been prepared for a while before
running it.

z Be sure to evaluate predilute stability based on your laboratory’s sample


population and sample collection techniques or methods.

6. Present the mixed calibrator to the sample probe so that the tip is well into the tube, and
press the aspirate key. The System Status area will display “Running” and the analyzer
will start aspirating sample;

7. When you hear the beep and the sample probe is out of the tube, remove the calibrator.
The sample probe will retract into the analyzer and the analysis progress will be
displayed on the screen;

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

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


the corresponding error messages will be displayed in the upper 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 Your Analyzer for
solutions.

Saving the calibration results


If non-numerci parameter values (“***”) are obtained, a message box will pop up to warn you,
as Figure 9-5 shows.

Figure 9-5 A message box to warn you about the invalid results

CLICK “Enter” to clear the results.

If all the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure 9-6 shows.

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Figure 9-6 A message box to confirm the validity

CLICK “Enter” to save the results; CLICK “Cancel” to abort the result. The saved results will
be displayed on the screen.

Repeat the above steps to run the calibrator 3 – 5 times (5 is recommended) and the analyzer
will automatically calculate the CVs and calibration factors, as Figure 9-7 shows. Be sure the
CVs meet the requirements of Table 9-1.

Figure 9-7 Results of the auto calibration

The calculated calibration factor should be within the 75% - 125%. Any calculated value that

falls between 0%-75% or 125%-9999% 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 [MAIN] to enter the “Count” screen, a message box will pop up to confirm the new
calibration factors, as Figure 9-8 shows.

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Figure 9-8 A message box to confirm the new calibration factors

CLICK ”Enter” to save the new calibration factors to the “Manual Calibration” screen and
enter the “Count” screen.

At the “Count” screen, run the calibrator or a normal control material at least 5 consecutive
times and calculate the mean 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 for assistance.

Printing new calibration factors


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

Exiting the “Auto Calibration” screen


Press [MENU] to exit to the system menu or [MAIN] to exit to the “Count” screen. A message
box will pop up to confirm the new calibration factors, as Figure 9-8 shows. CLICK “Enter” to
save the new factors to the “Manual Calibration” screen and exit to the system menu or the
“Count” screen; CLICK “Cancel” to abort the new factors and exit to the system menu or the
“Count” screen.

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9.3.3 “Fresh Blood” Program


Press [MENU] to enter the system menu.

Figure 9-9 System menu

SELECT “Calibration →“Fresh Blood” (Figure 9-9) to enter the “Fresh Blood” screen
(Figure9-10).

Figure9-10 “Fresh Blood” screen

Complete the fresh blood calibration as instructed below:

Selecting count mode


Press [MENU] and SELECT “Mode” to enter the “Mode” screen. SELECT “Whole Blood” or
“Predilute”from the “Sample Mode” pull-down list.

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z Once switching from the predilute mode to the whole blood mode, the
analyzer will automatically wash the fluidic system.

Editing calibration settings


1. Press [1]...[5] to switch among “Sample 1” to “Sample 5” to select the sample for
calibration. The following introduction takes Sample 1 as the example.
2. Press [ENTER] to enter the editing state of the expected value of sample 1.
3. ENTER the expected result into the “Mean” edit box. To correct any errorneous entry,
MODIFY the digit. After you have finished the editing, press [ENTER] 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.

z You should prepare 3 – 5 normal fresh blood samples for the calibration.

Saving calibration results


If non-numeric parameter values (“***”) are obtained, a message box will pop up to warn you,
as Figure9-11 shows.

Figure9-11 A message box to warn you about the invalid results

CLICK “Enter” to clear the results.

If all the parameter values obtained are numeric, a message box will pop up to confirm the
validity of the results, as Figure9-12 shows.

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Figure9-12 A message box to confirm the validity

CLICK “Enter” to save the results to the “Auto – fresh blood” screen; CLICK “Cancel” to
abort the result.

z If you press [MENU] to enter the system menu before the average is
obtained at the “Calculate” screen, the next time you enter the “Auto-fresh
blood” screen a message box will pop up to ask you whether to clear the
data of the last calibration; If you press [MAIN] to exit to the “Count”screen
before the average is obtained at the “Calculate” screen, the next time you
enter the “Auto-fresh blood” screen a message box will pop up to ask you
whether to clear the data of the last calibration

Repeat the above steps to run the sample 3 – 5 times (5 is recommended) and the analyzer
will automatically calculate the CV and calibration factor, as Figure9-13 shows. Be sure the
CVs meet the requirements of Table 9-1.

Figure9-13 “Fresh Blood” screen

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The calculated calibration factors should be within the 75% - 125%. Any calculated value

that falls between 0%-75% or 125%-9999% 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.

You can enter the “Auto – fresh blood” screen of “Sample 2”... “Sample 5” by pressing [2] ...
[5]. 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 [6] to enter the “Calculate” screen as Figure9-14 shows. At the screen, the digits “1”, “2”,
“3”, “4”and “5”respectively correspond to the calibration factors of samples 1 - 5.

The “Calculate” screen can maximum display 5 sets of calibration factors. The calculated

calibration factors should be within the 75% - 125%. Any calculated factor that falls between

0% - 75% or 125% - 9999% 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 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(e.g. RBC in Figure9-14).

Otherwise, the average calibration factor will be empty (e.g. WBC in Figure9-14).

Figure9-14 “Calculate” screen

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Verifying new calibration factors


Press [MAIN] to enter the “Count” screen, a message box will pop up to confirm the new
calibration factors, as Figure 9-15 shows.

Figure 9-15 A message box to confirm the new calibration factors

CLICK ”Enter” to save the new calibration factors to the “Manual Calibration” screen and
enter the “Count” screen.

Test the new calibration factors either of the following ways.

„ Method one:

Prepare 3-5 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.

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 sample 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.

Printing new calibration factors


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

Exiting the “Fresh Blood” screen


Press [MENU] to exit to the system menu. A message box will pop up to confirm the new
calibration factors, as Figure 9-15 shows. CLICK “Enter” to save the new factors to the
“Manual Calibration” screen and exit to the system menu; CLICK “Cancel” to abort the new
factors and exit to the system menu.

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9.3.4 Manual Calibration Program


If needed, you may run the calibration material at the “Count” screen and calculate the
calibration factors manually.

Press [MENU] to enter the system menu. SELECT “Count” (Figure7-1) to enter the “Count”
screen (Figure9-17).

Complete the manual calibration steps as introduced below.

Selecting count mode


Press [MENU] and SELECT “Mode” to enter the “Mode” screen. SELECT “Whole Blood” or
“Predilute”from the “Sample Mode” pull-down list.

z Once switching from the predilute mode to the whole blood mode, the
analyzer will automatically wash the fluidic system.

Figure9-16 System menu

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Figure9-17 “Count” screen

Running the calibration material


After you have selected the desired sample mode, refer to the sample handling and analysis
procedures introduced in Chapter 6 Operating Your Analyzer and run the calibration
material with known expected results 11 consecutive times.

Checking the reproducibility


When you have finished running the calibration material, enter the “Sample Table Review”
screen to check the Mean, SD and CV% of the 2nd to 11th runs. Press [MENU] to enter the
system menu as Figure9-18 shows.

Figure9-18 System menu

SELECT “Review → Sample Review → Sample Table Review” to enter the “Sample Table
Review” screen, as Figure 9-19 shows.

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Figure9-19 “Sample Table Review”screen

Check the reproducibility as instructed in Chapter 7.11. If the reproducibility meets the
requirements listed in Table 9-1, record the Mean of the 10 runs. If the means of any
parameter falls outside the expected range (see the instructions for use of the calibrator),
calibrate the analyzer as instructed below, otherwise the calibration is not necessary.

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.

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 instructed in Chapter 5.4.1 and then choose one or several
parameters among WBC, RBC, HGB, MCV and PLT for calibration.

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Calculating the new calibration factors manually


Use the following formula to calculate the new calibration factor.

old factor × exp ected result


new factor =
recorded mean

The calculated new calibration factor should be within 75%-125%. If not, try to find out the

reason and if necessary, call Mindray customer service department or your distributor for
assistance.

Entering the manually calculated factors


Press [MENU] to enter the system menu.

Figure 9-20 System menu

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

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Figure 9-21 “Manual Calibration” screen

Press [ENTER] to activate the edit boxes as Figure 9-22 shows.

Figure 9-22 Edit boxes activated

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 [MAIN] to enter the “Count” screen, a message box will pop up to confirm the new
calibration factors, as Figure 9-23 shows.

Figure 9-23 A message box to confirm the new calibration factors

CLICK ”Enter” to save the new calibration factors to the “Manual Calibration” screen and
enter the “Count” screen.

If you have used the calibrator for the manual calibration, verify the new calibration as
instructed in Chapter 9.2.2; If you have used a fresh blood sample for the manual calibration,
verify the new calibration as instructed in Chapter 9.2.3.

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Printing new calibration factors


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

Exiting the “Manual Calibration” screen


Press [MENU] to exit to the system menu. A message box will pop up to confirm the new
calibration factors, as Figure 9-23 shows. CLICK “Enter” to save the new factors to the
“Manual Calibration” screen and exit to the system menu; CLICK “Cancel” to abort the new
factors and exit to the system menu.

9-22
10 Maintaining Your Analyzer
10.1 Introduction

Routine preventive maintenance and cleaning are required to keep the BC-3000 Plus in good
operating condition. Cleanliness is important in keeping your analyzer operating efficiently
and accurately. The analyzer has automatic cleaning functions that are performed during
normal operation. These built-in functions keep the fluidic system clean.

In spite of the automatic cleaning functions, Mindray encourages you to routinely perform the
required maintenance to lengthen the operational life of your analyzer and to minimize
system problems that lead to imprecision and inaccuracy. This chapter describes the
recommended preventive maintenance procedures and provides instructions for preparing
the analyzer for an extended period of inactivity.

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.

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10.2 General Guidelines

Maintenance Period Content of Maintenance

Everyday If you are to use this analyzer 24 hours a day, be sure to perform
the “E-Z cleanser cleaning” procedure everyday.
Run the QC program everyday. See Chapter 7 Using Quality
Control Programs for details.
Every three days If you are to use this analyzer 24 hours a day, be sure to 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.
Every Month You should use the supplied probe localizer to calibrate the
position of the probe to that of the probe wipe. The analysis result
is sensitive to their alignment.

As needed When you think the baths might be contaminated, perform the
“Clean the baths” procedure.
When the analyzed whole blood samples add up to 300 or
prediluted samples add up to 150, the analyzer will remind you to
perform the “Probe cleanser cleaning” procedure.
When the analyzed whole blood samples add up to 2,000 or
prediluted samples add up to 4,000, the analyzer will remind you to
perform the “Clean wipe block” procedure.
When this analyzer is not to be used for two weeks, be sure to
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. Be sure to run the “System Test” items regularly to
check the status of this analyzer.
When this analyzer gives alarms for clogging, you can perform the
“Flush Apertures” or “Zap Apertures” procedure, or press
[FLUSH] to unclog the apertures.

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If you see other error messages, see Chapter 11


Troubleshooting, for solutions.

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10.3 Using the “Maintenance” Program

Press [MENU] to enter the system menu. SELECT “Service → Maintenance” (Figure10-1)
to enter the “Maintenance” screen (Figure10-2).

Figure10-1 System menu

Figure10-2 “Maintenance” screen

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Totally 12 maintenance procedures are available at the “Maintenance” screen.

„ Diluent Prime

„ Rinse Prime

„ Lyse Prime

„ Zap Apertures

„ Flush Apertures

„ Probe Cleanser Cleaning

„ E-Z Cleanser Cleaning

„ Lyse Test

„ Clean Baths

„ Empty Baths

„ Empty Tubing

„ Wipe Block Cleaning

10.3.1 Diluent 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 Be sure to keep the reagents still for a while before using them.

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


check to ensure the background results are normal.

You should perform the “Diluent Prime” procedure to prime the diluent tubing with diluent
when

„ there are bubbles in the tubing; or

„ the diluent in the tubing is contaminated; or

„ the old diluent ran out and a new container of diluent is installed.

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At the “Maintenance” screen, SELECT “Diluent Prime” to prime the tubing with diluent and
the priming progress will be displayed at the bottom of the screen, Figure10-3 shows. When
the priming is done, the screen displays “Diluent Prime End”.

Figure10-3 “Diluent Prime” screen

10.3.2 Rinse 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 Be sure to keep the reagents still for a while before using them.

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


check to ensure the background results are normal.

You should perform the “Rinse Prime” procedure to prime the rinse tubing with rinse when

„ there are bubbles in the tubing; or

„ the rinse in the tubing is contaminated; or

„ the old rinse ran out and a new container of rinse is installed.

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At the “Maintenance” screen, SELECT “Rinse Prime” to prime the tubing with rinse and the
priming progress will be displayed at the bottom of the screen, as Figure10-4 shows. When
the priming is done, the screen displays “Rinse Prime End”.

Figure10-4 Rinse Priming screen

10.3.3 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 Be sure to keep the reagents still for a while before using them.

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


check to ensure the background results are normal.

You should perform the “Lyse Prime” procedure to prime the lyse tubing with lyse when

„ there are bubbles in the tubing; or

„ the lyse in the tubing is contaminated; or

„ the old lyse ran out and a new container of lyse is installed.

10-7
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At the “Maintenance” screen, SELECT “Lyse Prime” to prime the tubing with lyse and the
priming progress will be displayed at the bottom of the screen, as Figure10-5 shows. When
the priming is done, the screen will display “Lyse Prime End”.

Figure10-5 Lyse priming

10.3.4 Zap Apertures


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 Figure10-6 shows. When the
zapping is done, the screen will display “Zap Apertures End”.

10-8
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Figure10-6 Zapping aperture

10.3.5 Flush Aperture


You can perform the “Flush Aperture” procedure to flush the apertures to unclog the
apertures or prevent clogging.

At the “Maintenance” screen, SELECT “Flush Aperture” to flush the aperture and the
flushing progress will be displayed at the bottom of the screen, as Figure10-7 shows. When
the flushing is done, the screen will display “Flush Apertures End”.

Figure10-7 Flushing apertures

10-9
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10.3.6 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 baths 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
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, SELECT “Probe Cleanser Cleaning”.

2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser. When
you hear the beep and the sample probe is out of the bottle, remove the cleanser.

Figure10-8 Priming baths and fluidic lines

10-10
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3. When the screen reminds you for the second aspiration, present the cleanser to the
probe again and press [ENTER]. When you hear the beep and the sample probe is out
of the bottle, remove the cleanser and the priming progress is displayed on the screen,
as Figure10-9 shows.

Figure10-9 Priming baths and fluidic lines again

4. The cleaning process will last about 15 minutes and you may press [ENTER] to stop it
any time. Note that a shortened priming process may not be as effective as a complete
one.

5. When the cleaning is done, press [ENTER] to flush the bath and tubing, after which
screen will display “Probe Cleanser Cleaning End”.

10-11
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Figure10-10 Cleaning process

To make sure this analyzer functions normally, every time the accumulated analyzed whole
blood samples reach 300 or prediluted blood samples reach 150, a message box will pop up
to remind you to perform the “Probe cleanser cleaning” procedure, as Figure10-11 shows.
CLICK “Enter” to proceed with the cleaning; CLICK “Cancel” to cancel the cleaning.

Figure10-11 A message box to confirm the cleaning

10.3.7 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:

10-12
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1. At the “Maintenance” screen, SELECT “E-Z Cleanser Cleaning”;

2. Present the cleanser to the probe and press [ENTER] to aspirate the cleanser.
When you hear the beep and the sample probe is out of the bottle, remove the
cleanser. This analyzer will automatically prime the baths and fluidic lines with the
aspirated cleanser and the progress is displayed on the screen, as Figure10-12
shows;

Figure10-12 Priming the baths and fluidic lines

3. When the priming is done, the cleaning process begins, as Figure10-13 shows. The
default cleansing time is 8 hours and you may press [ENTER] to stop the process
any time;

4. When the cleaning is done, press [ENTER] to drain the baths and fluidic lines, as
Figure10-14 shows. When the draining is done, the screen will display “E-Z
Cleanser Cleaning End”.

10-13
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Figure10-13 E-Z cleaning

Figure10-14 Draining the baths and fluidic lines

10-14
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10.3.8 Lyse Test

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.

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. Push the right door latch in the direction indicated in Figure10-15.

Figure10-15

2. Lift up the front panel latch as indicated in Figure10-16 and open the front panel.

Figure10-16

10-15
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3. Remove the screws fixing the shielding box of the bath and lift the shielding box, as
Figure10-17 shows.

Figure10-17 Shielding box

4. Remove the shielding box to expose the bath, as Figure10-18 shows.

Figure10-18 WBC bath

10-16
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5. At the “Maintenance” screen, SELECT “Lyse Test”. Press [ENTER] and the
analyzer will automatically drain the WBC bath and then dispense 2ml of lyse into
the WBC bath.

6. Check the scale to see whether the lyse has reached the expected line (the first
from bottom).If so, press [ENTER] and the analyzer will automatically flush the bath
and dispense lyse and the test is done.

7. If not, repeat steps 5 and 6 several times. If all the tries have failed, check whether
the lyse has run out or the lyse pickup tube is not properly connected to this
analyzer. If the lyse is still enough and the tube is well connected to the analyzer,
contact the Mindray or your local distributor for repair.

10.3.9 Cleaning Baths


If you suspect the baths are contaminated, follow the steps given below to perform the “Clean
Bath” procedure:

1. At the “Maintenance” screen, SELECT “Clean Baths”.

2. Press [ENTER] to start the procedure.

Figure10-19 Cleaning the baths

3. When the cleaning is done, the screen displays “Clean Baths End”.

10-17
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10.3.10 Empty Baths


When at three or more of the WBC, RBC, PLT and HGB results are abnormal, you may do
the “Empty Baths” procedure to find out the reason.
Follow the steps below to do so:

1. Do steps 1-5 of the “Lyse Test” to expose the baths.

2. At the “Maintenance” screen, SELECT “Drain Baths” to drain the baths.

Figure10-20 Draining the baths

3. When the draining is done, check the baths and the tubing below them for residual fluid. If
there is no fluid, press [ENTER] to prime the baths with diluent, as Figure10-21 shows.
When the priming is done, the screen displays “Empty Baths End”.

10-18
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Figure10-21 Priming the baths with diluent

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

10-19
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10.3.11 Empty Tubing

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 Be sure to do the “Empty Tubing” procedure before relocating the analyzer.

If this analyzer is not to be used for a long time or it is to be maintained, be sure to perform
the “Empty Tubing” procedure to drain the fluidic lines.

Follow the steps given below to do so:

1. At the “Maintenance” screen, press the appropriate arrow keys ([←][→] [↑][↓]) to move
the cursor to “Empty Tubing”.

2. Follow the displayed instructions to remove the diluent, rinse and lyse pickup tubes from
this analyzer and then press [ENTER] to start the draining process, Figure10-22.

Figure10-22 Draining the fluidic lines

3. When the draining is done, the screen will display “Turn off this analyzer” and you

10-20
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should turn off this analyzer as instructed.

10.3.12 Wipe Block Cleaning


After being used for a long time, the bottom of the probe wipe may be contaminated by blood
and the inside of wipe may also be contaminated by the dirt sucked in. So you need to clean
the probe wipe regularly.
Follow the steps given below to do so:

1. At the “Maintenance” screen, SELECT “Clean wipe block”.

2. Present the probe cleanser to the sample probe and press [ENTER] to aspirate the
cleanser. When you hear the beep and the sample probe is out of the bottle, remove the
cleanser.

3. Push the right door latch in the direction indicated in Figure10-23.

Figure10-23

4. Lift up the front panel latch as indicated in Figure10-24 and open the front panel.

10-21
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Figure10-24

10-22
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5. Follow the instructions displayed on the screen to place an empty cup, whose diameter
should be no less than 8cm, below the sample probe.

6. Press [ENTER] to soak the wipe block with the aspirated cleanser. The soaking progress
will be displayed on the screen, as Figure10-25 shows.

Figure10-25 Cleaning wipe block

z Spills are possible during the soaking process. Keep a minimum 30cm
distance from the analyzer.

7. When the soaking is done, wipe the bottom of the wipe block with a probe
cleanser-dipped cloth that does not leave debris.

8. Press [ENTER] to flush the block and the interior of the probe and the flushing progress is
displayed on the screen as Figure10-26 shows .

9. After the flushing is done, the screen returns to the initial state.

When the accumulated analyzed whole blood samples reach 2,000, or prediluted samples
reach 4,000, a message box will pop up to remind to clean the probe wipe, as Figure10-27
shows. CLICK “Enter” to do the procedure; CLICK “Cancel” to abort the procedure.

10-23
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Figure10-26 Washing interior of the probe wipe and sample probe

Figure10-27 A “Wipe Block Clean” message box

10-24
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10.4 Using the “System 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. SELECT “Service” → “System Status”
(Figure10-28) to enter the “System Status” screen (Figure10-29).

Figure10-28 System menu

Figure10-29 “System Status” screen

10-25
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Note that you can only view the displayed status items without changing them. If any of the
displayed item exceeds the given range, see Chapter 11 Troubleshooting for solutions.

Press [MENU] to exit to the system menu and the screen will display “Resetting” and the
system menu will pop up later.

10-26
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10.5 Using the “Valve Test” Program

Malfunctioning valves will lead to fluidic system malfunctions. Therefore, testing the valves is
a major way to remove fluidic errors.

Press [MENU] to enter the system menu. SELECT “Service → Valve Test” (Figure10-30) to
enter the “Valve Test” screen (Figure10-31).

Figure10-30 System menu

Figure10-31 “Valve Test” screen

SELECT the valve you want to check and press [ENTER] to test it. If the valve goes through
the Off-On-Off sequence without making any abnormal sound, it passes the test. Otherwise,
something may be wrong with the valve.

10-27
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10.6 Using the “System Test” Program

Press [MENU] to enter the system menu. SELECT “Service → System Test” ( Figure10-32)
to enter the “System Test” screen (Figure10-33), where 19 test items are available. Note that
you need to enter the administrator password to test the motors.
SELECT the desired item to perform the corresponding test. The test result will be displayed
later. In case of any abnormal test result, see Chapter 11 Troubleshooting Your Analyzer
for solutions and if necessary, contact Mindrayor your local distributor for assistance.

Figure10-32 System test

Figure10-33 System test screen

Press [MENU] to exit to the system menu and the screen will display “Resetting” and the
system menu will pop up later.

10-28
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10.7 Using the “Prepare to ship” Program

Use the “Prepare to ship” program to prepare your analyzer for a prolonged period of
non-use or for shipping.

Press [MENU] to enter the system menu. SELECT “Service→Prepare to ship”(Figure10-34)


to enter the “Prepare to Ship” screen (Figure10-35).

Figure10-34 System menu

Figure10-35 “Prepare to Ship” screen

Follow the steps below to do so:

1. Remove the diluent, rinse and lyse pickup tubes from their containers and press [ENTER].
A message box will pop up to confirm the operation, as Figure10-36 shows.

10-29
Fehler! Formatvorlage nicht definiert.

Figure10-36 A message box to confirm the operation

2. CLICK “Enter” to proceed with the operation.

3. The analyzer starts to drain the fluidic lines and the progress is displayed on the screen,
as Figure10-37 shows.

Figure10-37 Draining fluidic lines

4. When the draining is done, place the diluent, rinse and lyse pickup tubes into a container
filled with distilled water and press [ENTER], as the Figure10-38 shows.

10-30
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Figure10-38 Washing the analyzer

5. When the washing is done, remove the diluent, rinse and lyse pickup tubes from the
distilled water and press [ENTER] to drain the fluidic lines.

6. When the draining is done and the screen displays “You can turn off the analyzer now”,
turn off the analyzer as instructed.

7. Wipe the analyzer dry and wrap it up.

10-31
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10.8 Using the “Error Message” Program

The analyzer can store maximum 1,000 latest error messages. When the maximum number
has reached, the latest overwrites the earliest.

Press [MENU] to enter the system menu. SELECT “Service → Error Message”
(Figure10-39) to enter the “Error Message” screen (Figure10-40).

Figure10-39 System menu

Figure10-40 “Error message” screen

Press [↑] or [↓] to browse the error messages. Press [PRINT] to print out the displayed error
messages.

10-32
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For the displayed error messages, see Chapter 11 Troubleshooting Your Analyzer for
solutions.

Press [MENU] to exit the “Error Message” screen.

10-33
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10.9 Calibrating Sample Probe Position

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

The relative position between the sample probe and probe wipe block has influence on the
analysis results. In the accessory box, there is a sample probe localizer, as Figure10-41
shows. You need to use the localizer to adjust the position of the sample probe if you have
replaced wipe block, or observed motor error, or wrong analysis result. Also, as required by
regular maintenance, you should use the localizer to adjust the position of the sample probe
monthly.

Figure10-41 Sample probe localizer

Follow the steps below to do so:

1. SELECT “Setup → Password” and enter the administrator password (3000);

2. Push the right door latch in the direction indicated in Figure10-42;

10-34
Fehler! Formatvorlage nicht definiert.

Figure10-42

3. Lift up the front panel latch as indicated in Figure10-43 and open the front panel;

Figure10-43

4. SELECT “Service” →“System Test” to enter the “System Test” screen and SELECT
“Elevator motor”;

5. Press [↑] to move the sample probe to its highest position, as Figure10-44 shows;

10-35
Fehler! Formatvorlage nicht definiert.

Figure10-44

6. Loose the retaining screw by a screwdriver, as Figure10-45 shows;

Figure10-45

7. Remove the probe from the wipe block and insert the localizer into the wipe block from
the bottom, as Figure10-46 shows;

Figure10-46

8. Insert the probe into the wipe block until it reaches the localizer, as Figure10-47 shows;

10-36
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Figure10-47

9. Tighten the fixing screws and put away the localizer to finish the work.

10-37
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10.10 Replacing the Probe Wipe.

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

To replace the probe wipe:

1. Refer to Chapter 10.9 and do the steps 1 – 6;

2. Pull the loosen probe wipe upward to remove the wipe block and disconnect the tubes
from the wipe block (pay attention to the correspondence between the tubes and the
connectors), as Figure10-48 shows;

Figure10-48

3. Install a new block and connect the tubing end with the black marking to the connector
below the block;

4. Refer to Chapter 10.9 and do the steps 7 - 9 to fix the sample probe.

10-38
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10.11 Replacing the Filter of the Vacuum Chamber

You need to replace the filter of the vacuum chamber when there is an air filter error. Follow
the steps below to do so:

1. Push the right door latch in the direction indicated in Figure10-49;

Figure10-49

2. Find the filter shows in Figure10-50;

Figure10-50 Vacuum filter

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

10-39
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10.12 Using the [Flush] key

Press the [Flush] key to unclog the apertures when the analyzer alarms you for clogged WBC
or RBC aperture.

10-40
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10.13 Using the [Startup] key

Press the [Startup] key to flush the fluidic lines and check the background.

10-41
11 Troubleshooting Your Analyzer
11.1 Introduction

The BC-3000 Plus continuously monitors the status of the system and displays pertinent
information in the upper 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 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 customer
service department or your local distributor.

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

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
Fehler! Formatvorlage nicht definiert.

11.2 Errors without available error messages

Error Possible Cause(s) Recommended Action


The analyzer cannot
1. The power cord is 1. Check the power cord connection;
be turned on.
broken or not well 2. Check the fuse;
connected;
3. Check the electrical outlet.
2. The fuse is broken;

3. The power outlet has no


electricity.

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

2. Call Mindray customer service


department or your local distributor
for assistance.

Recorder does not 1. Recorder paper is 1. Remove the jammed paper.


work. jammed; 2. If the problem remains, turn off the
2. Something is wrong with analyzer and turn it on again in 10
the circuit. seconds.

11-2
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11.3 Errors indicated by error messages

The analyzer can provide 41 error messages. See the tables below for the error messages
and their probable causes and recommended action. If the problem still remains after you
have tried the recommended solutions, contact Mindray customer service department or your
local distributor.

11.3.1 Pressure errors


Error Message Possible Cause(s) Recommended Action
Pressure 2 Low The pressure inside the 1. Enter the “Service → System Test”
pressure chamber does not screen and test the “Chamber
reach the expected value Pressure” as instructed in Chapter
within the given time 10.6. The error will be removed if
the test result is normal;

2. If the problem remains, contact


Mindray customer service
department or your local distributor.

Vacuum Low The vacuum degree does not 1. Check the tubes connected to the
reach the expected value back of the analyzer and make sure
within the given time. they are not pressed;

2. If the tubes are fine, enter the


“Service → System Test” screen
and test the “Vacuum” as instructed
in Chapter 10.6. The error will be
removed if the test result is normal;

3. If the problem remains, contact


Mindray customer service
department or your local distributor.

11-3
Fehler! Formatvorlage nicht definiert.

Pressure 1 low The pressure inside the 1. Enter the “Service → System Test”
vacuum chamber does not screen and do the “Pressure 1”
reach the expected value procedure as instructed in Chapter
within the given time. 10.6. The error will be removed if the
test result is normal;

2. If the problem remains, contact


Mindray customer service
departmentor your local distributor.

Vacuum Filter The air inside the vacuum


1. Enter the “Service → System Test”
Error chamber is not extracted
screen and test the “Vacuum” as
within the given time.
instructed in Chapter 10.6. The error
will be removed if the test result is
normal;

2. If the problem remains, change a


new filter;

3. If the problem remains, contact


Mindray customer service
department or your local distributor.

11.3.2 Reagent errors


Error Message Possible Cause(s) Recommended Action
Lyse Empty No lyse or a malfunctioning
1. Check if the lyse has run out and if
level transducer.
so;

2. Change a new container of lyse as


instructed in Chapter 4.4.2;

3. If the problem remains, contact


Mindray customer service
department or your local distributor.

Diluent Empty No diluent or a malfunctioning


1. Check if the lyse has run out, and if
level transducer.
so;

2. Change a new container of diluent

11-4
Fehler! Formatvorlage nicht definiert.

as instructed by Chapter 4.4.2;

3. If the problem remains, contact


Mindray customer service
departmentor your local distributor.

Rinse Empty No rinse or a malfunctioning


1. Check if the rinse has run out, and if
level transducer.
so,

2. Change a new container of rinse as


instructed by Chapter 4.4.2;

3. If the problem remains, contact


Mindray customer service
department or your local distributor.

Rinse Expiry Expired rinse or wrong


1. Check if the rinse has expired. If so,
expiration setting
change a new container of rinse as
instructed by Chapter 4.4.2;

2. If not, reset the expiration date as


instructed in Chapter 5.10.1.

Diluent Expiry Expired diluent or wrong


1. Check if the diluent has expired. If
expiration setting
so, change a new container of
diluent as instructed by Chapter
4.4.2;

2. If not, reset the expiration date as


instructed in Chapter 5.10.1.

Lyse Expiry 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 4.4.2;

2. If not, reset the expiration date as


instructed in Chapter 5.10.1.

11-5
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11.3.3 Hardware errors


Error Message Possible Cause(s) Recommended Action
Real-Time Clock
1. Someone tempered with 1. Enter “Setup → Date & Time”
Error
the on-board battery off screen and reset the time as
the board; instructed by Chapter 5.7. Restart

2. Something is wrong with the analyzer after the adjustment

the on-battery (poor and the time should be correct;

contact, dead battery, 2. If the problem remains, contact


etc.); Mindray customer service

3. Damaged real-clock chip. department or your local distributor.

10ml Motor Error


1. Pressed or blocked tubes; 1. Check if the tubes at the back of the

2. Poor contact of the signal analyzer is pressed or blocked;

line; 2. If not, enter the “Service →

3. Damaged motor; System Test” screen and check


the motor as instructed in Chapter
4. Poor connection between
10.6. The error will be removed if
the drive board and the
the test result is normal;
CUP board;
3. If the problem remains, contact
5. Malfunctioning photo
Mindray customer service
coupler.
department or your local distributor.

2.5ml&50ul Motor
1. Poor contact of the signal 1. Enter the “Service → System
Error
line; Test” screen and check the motor

2. Damaged motor; as instructed in Chapter 10.6. The


error will be removed if the test
3. Poor connection between
result is normal.
the drive board and the
CUP board; 2. If the problem remains, contact
Mindray customer service
4. Malfunctioning photo
department or your local
coupler;
distributor.

Elevator Motor
1. Jammed sample probe; 1. Open the front panel and check if
Error

11-6
Fehler! Formatvorlage nicht definiert.

2. Poor contact of the signal the sample probe is jammed;


line; 2. Enter the “Service → System
3. Damaged motor; Test” screen and check the motor

4. Poor connection between as instructed in Chapter 10.6. The

the drive board and the error will be removed if the test

CUP board; result is normal;

5. Malfunctioning photo 3. If the problem remains, contact

coupler. Mindray customer service


department or your local distributor.

Rotation Motor
1. Jammed sample probe; 1. Open the front panel and check if
Error
2. Poor contact of the signal the sample probe is jammed;

line; 2. Enter the “Service → System

3. Damaged motor; Test” screen and check the motor


as instructed in Chapter 10.6. The
4. Poor connection between
error will be removed if the test
the drive board and the
result is normal;
CUP board;
3. If the problem remains, contact
5. Malfunctioning photo
Mindray customer service
coupler.
department or your local distributor.

WBC Interrupt Something is wrong with the


1. Enter the “Service → System
Error A/D part of the CPU board.
Test” screen and check the WBC
AD interrupt as instructed in
Chapter 10.6;

2. The error will be removed if the test


result is normal;

3. If the problem remains, contact


Mindray customer service
department or your local distributor.

RBC Interrupt Something is wrong with the


1. Enter the “Service → System
Error A/D part of the CPU board.
Test” screen and check the RBC
AD interrupt as instructed in

11-7
Fehler! Formatvorlage nicht definiert.

Chapter 10.6;

2. The error will be removed if the test


result is normal;

3. If the problem remains, contact


Mindray customer service
department or your local distributor.

PLT Interrupt Error Something is wrong with the 1. Enter the “Service → System
A/D part of the CPU board. Test” screen and check the PLT
AD interrupt as instructed in
Chapter 10.5;
2. The error will be removed if the test
result is normal;
3. If the problem remains, contact
Mindray customer service
department or your local distributor.

11.3.4 Power supply errors


Error Message Possible Cause(s) Recommended Action
DC/DC Error Something is wrong with the
1. Enter the “Service” → “System
internal DC power supplies.
Status” screen and record the
“DC-DC 12V” and “DC-DC -12V”
values;

2. Shut down the analyzer and


contact Mindray customer service
department or your local distributor.

5V Power Error Something is wrong with the


1. Enter the “Service → System
power board.
Status” screen and record the “5V”
voltage;

2. Shut down the analyzer and


contact Mindray customer service
department or your local distributor.

3.3V Power Error Something is wrong with the


1. Enter the “Service → System
5V power supply.
Status” screen and record the

11-8
Fehler! Formatvorlage nicht definiert.

“3.3V” voltage;

2. Shut down the analyzer and


contact Mindray customer service
department or your local distributor.

56V Power Error Something is wrong with the


1. Enter the “Service → System
power board.
Status” screen and record the
“56V” voltage;

2. Shut down the analyzer and


contact Mindray customer service
department or your local
distributor.

11.3.5 Measurement errors


Error Message Possible Cause(s) Recommended Action
Background
1. Contaminated diluent, 1. Check if the diluent is contaminated
Abnormal
diluent lines or bath (s); or expired;

2. Expired diluent; 2. Check if the tubes connected at the

3. The tubes at the back of back of the analyzer is pressed;

the analyzer are pressed. 3. Enter the “Count” screen and press
[STARTUP] (or [F3] of the external
keyboard) to do the startup
procedure;

4. If the problem remains, enter the


“Service → Maintenance” screen
and do the probe cleanser cleaning
procedure as instructed in Chapter
10.3.6. When the procedure is
finished, return to the “Count”
screen and do the background
check again;

5. If the problem remains, contact


Mindray customer service

11-9
Fehler! Formatvorlage nicht definiert.

department or your local distributor.

HGB Error HGB blank voltage within 0 V


1. Do the “Probe Cleanser Cleaning”
- 3.2 V or 4.9 V - 5 V.
procedure as instructed in Chapter
10.3.6.;

2. If the problem remains, adjust the


HGB gain as instructed by Chapter
5.8.3 to set the voltage within 3.4 -
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 - 3.4 V or 4.8 V – 4.9 V.
procedure as instructed in Chapter
10.3.6;

2. If the problem remains, adjust the


HGB gain as instructed by Chapter
5.8.3 to set the voltage within 3.4 -
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 →

2. Inappropriate WBC count Maintenance” screen. Zap and

time setting; flush the aperture as instructed by


Chapter 10.3.4 and 10.3.5;
3. Solenoid valve error.
2. Enter the “Setup → Count Time”
screen and record the WBC count
time. Then enter the “Service →
System Test” screen and test the
actual WBC count time as

11-10
Fehler! Formatvorlage nicht definiert.

instructed by Chapter 10.6;

3. If the difference between the


reference WBC count time and the
actual WBC count time is less than
2 seconds, the error has been
removed;

4. If not, enter the “Service” →


“Maintenance” screen and do the
probe cleanser cleaning procedure
as instructed by Chapter 10.3.6;

5. Enter the “Setup → Count Time”


screen and record the WBC count
time. Then enter the “Service →
System Test” screen and test the
actual WBC count time as
instructed by Chapter 10.6;

6. If the difference between the


reference WBC count time and the
actual WBC count time is less than
2 seconds, the error has been
removed;

7. If the difference is still greater than


2 seconds but consistent, enter the
“Setup → Count Time” and reset
the WBC count time. Then enter
the “Service → System Test”
screen and test the actual WBC
count time as instructed by
Chapter 10.6 to confirm the
difference is less than 2 seconds.

8. If the problem remains, contact


Mindray customer service
department or your local distributor.

11-11
Fehler! Formatvorlage nicht definiert.

WBC bubbles
1. Diluent or rinse running 1. Check if the diluent or rinse has run
out; out. If so, change a new container

2. Loose tube connections; of diluent or rinse as instructed in


Chapter 4.4.2;
3. Inappropriate WBC count
time setting. 2. Check the connection of the diluent
and rinse pickup tube. If necessary,
reconnect and tighten them as
instructed by Chapter 4.4.2;

3. If the problem remains, adjust the


WBC count time as instructed by
Chapter 5.3;

4. If the problem remains, contact


Mindray customer service
department or your local distributor.

RBC clog
1. Clogged RBC aperture; 1. Enter the “Service →

2. Inappropriate RBC Maintenance” screen. Zap and

count time setting; flush the aperture as instructed by


Chapter 10.2.4 and 10.2.5.;
3. Solenoid valve error.
2. Enter the “Setup → Count Time”
screen and record the RBC count
time. Then enter the “Service →
System Test” screen and test the
actual RBC count time as
instructed by Chapter 10.6;

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 →


Maintenance” screen and do the
probe cleanser cleaning procedure
as instructed by Chapter 10.3.6;

11-12
Fehler! Formatvorlage nicht definiert.

5. Enter the “Setup → Count Time”


screen and record the RBC count
time. Then enter the “Service →
System Test” screen and test the
actual RBC count time as
instructed by Chapter 10.6.;

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 → Count Time” and reset
the RBC count time. Then enter the
“Service → System Test” screen
and test the actual RBC count
time as instructed by Chapter 10.6
to confirm the difference is less
than 2 seconds.

8. If the problem remains, contact


Mindray customer service
department or your local distributor.

RBC bubbles
1. Diluent or rinse running 1. Check if the diluent or rinse has run
out; out. If so, change a new container

2. Loose tube connections; of diluent or rinse as instructed in


Chapter 4.4.2;
3. Inappropriate RBC
count time setting. 2. Check the connection of the diluent
and rinse pickup tube. If necessary,
reconnect and tighten them as
instructed by Chapter 4.4.2;

3. If the problem remains, adjust the


RBC count time as instructed by

11-13
Fehler! Formatvorlage nicht definiert.

Chapter 5.3;

4. If the problem remains, contact


Mindray customer service
department or your local distributor.

11.3.6 External connection errors


Error Message Possible Cause(s) Recommended Action
Com Error
1. Communication cable not 1. Check if the communication cable is
well connected; well connected;

2. Inappropriate 2. Check the communication settings


communication settings. as instructed by Chapter 5.6 and
make sure they are the same with
the host.

Barcode Com Poor connection between the


1. Check if the analyzer is well
Error scanner and the analyzer.
connected to the analyzer;

2. If the problem remains, contact


Mindray customer service
department or your local distributor.

Barcode Error
1. Poor connection between 1. Check if the analyzer is well
the scanner and the connected to the analyzer;
analyzer; 2. Check if the bar-code is valid;
2. Invalid bar-code. 3. If the problem remains, contact
Mindray customer service
department or your local distributor.

Printer Offline Poor connection between the Check if the printer is well connected to
printer and the analyzer. the analyzer.
Recorder Com Shut down the analyzer and contact
1. Poor connection between
Error Mindray customer service department.
the recorder and the
analyzer;

2. Damaged recorder.

11-14
Fehler! Formatvorlage nicht definiert.

Printer out of Printer paper running out or


1. Check if there is printer paper;
paper not properly installed.
2. Check if the printer paper is well
installed.

Recorder out of Recorder paper running out


1. Check if the recorder paper has run
paper or not properly installed.
out. If so, install the paper as
instructed by Chapter 4.4.3;

2. Check if the recorder paper is


properly installed. If not, re-install
the paper as instructed by Chapter
4.4.3;

3. If the problem remains, contact


Mindray customer service
department or your local distributor.

Recorder too Hot Recorder head too hot. Stop using the recorder. If the problem
repeats, contact Mindray customer
service department.
Press Bar Up Tension lever not replaced.
1. Press the tension lever as
instructed in Chapter 4.4.3;

2. If the problem remains, contact


Mindray customer service
department or your local distributor.

11.3.7 Ambient temperature error


Error Message Possible Cause(s) Recommended Action
Ambient Temp. Abnormal ambient 1. Enter the “Service → System
Abnormal
temperature or temperature Status” screen to check the
transducer error. ambient temperature;

2. If the actual ambient exceeds the


pre-defined ambient temperature,
adjust the temperature. Otherwise,
the analysis results may be

11-15
Fehler! Formatvorlage nicht definiert.

unreliable;

3. If the actual temperature is within


the pre-defined range and the
problem remains, contact Mindray
customer service department or
your distributor.

11.3.8 Other errors


Error Message Possible Cause(s) Recommended Action
File Error Something is wrong with the Shut down the analyzer and contact
file system. Mindraycustomer service department or
your local distributor.

Dynamic Memory Something is wrong with the Shut down the analyzer and contact
Error system memory. Mindray customer service department
or your local distributor.

11-16
12 Appendices
A Index

A
calibrator, 2-15
analyzer
clog, 5-36
name, 2-1
RBC, 11-12
intended use, 2-2
WBC, 11-10
aperture
control, 2-15
flush, 10-9
Coulter Principle, 3-6, 3-10
zap, 10-8
count
principle, 3-6, 3-10
B procedure, 6-8, 6-17

Bath CV

clean, 10-17 definition, 3-11

empty, 10-18 formula, 7-11, 7-27

baud rate, 5-15


blank photocurrent, 3-7, 3-8 D
bubbles
dilution, 3-3
RBC, 11-13
dimensions, 12-7
WBC, 11-12
display, 12-5
diluent
C connection, 4-11

calibration definition, 2-15

Auto calibration, 9-4 empty tubing, 10-20

conditions, 9-1 prime, 10-5

Fresh blood, 9-12


Manual, 9-16 E
Count mode, 9-5, 9-12, 9-17
Error
factors, 5-5
10mL Moto Error, 11-6

A-1
Fehler! Formatvorlage nicht definiert.

3.3V Power Error, 11-8 Rotation Motor Error, 11-7


5V Power Error, 11-8 Vacuum Filter Error, 11-4
56V Power Error, 11-9 Vacuum Error, 11-3
WBC Interrupt Error, 11-7
2.5 mL&50μL Motor Error, 11-6
WBC Bubbles, 11-12
Ambient Tem. Abnormal, 11-15
WBC Clog, 11-10
Background Abnormal, 11-9
E-Z cleanser
Barcord Error, 11-14
definition, 2-16
Barcode Com Error, 11-14
use, 6-27, 10-12
Com Error, 11-14
DC/DC Error, 11-8
Diluent Empty, 11-4 G
Diluent Expirity, 11-5 gain
Dynamic Memory Error, 11-16 set HGB gain, 5-24
Elevator Motor Error, 11-6 set RBC gain, 5-23
File Error, 11-17 set WBC gain, 5-22
HGB Adjustment, 11-10 Gran#
HGB Error, 11-10 definition, 3-7
Lyse Expired, 11-5 formula, 3-8
Lyse Empty, 11-4 Gran%
PLT Interrupt Error, 11-8 definition, 3-7
Pressure 1 Low, 11-4 formula, 3-7
Pressure 2 Low, 11-3
Press Bar Up, 11-15
H
Printer Connection Error, 11-14
handshake, 5-16
Printer Offline, 11-14
HCT
Printer Out Of Paper, 11-15
definition, 2-2
RBC Bubbles, 11-13
formula, 3-11
RBC Clog, 11-12
HGB
RBC Inrerrupt Error, 11-7
definition, 2-2
Real-Time Clock Error, 11-6
mesurement, 3-6
Recorder Out Of Paper, 11-15
formula, 3-10
Recorder Com Error, 11-14
linearity range, 12-4
Recorder Too Hot, 11-15
reproducibility, 12-5
Rinse Expired, 11-5
Histogram
Rinse Empty, 11-5

A-2
Fehler! Formatvorlage nicht definiert.

Ajust histograms, 6-16, 6-25 formula, 3-10


humidity, 4-3 MCV
definition, 2-2, 3-11
linearity range, 12-4
I
reproducibility, 12-5
ID, 5-38, 6-13
Mid#
installation, 4-1
definition, 2-2
requirements, 4-2
formula, 3-8
procedure, 4-5
Mid%
definition, 2-2
L formula, 3-7

LCD, 2-8 MPV

leukocyte, 2-2 definition, 2-2, 3-12

granulocyte, 2-2
lymphocyte, 2-2 N
mid-sized cell, 2-2
NRBC, 3-7
linearity range, 12-4
Lymph#
definition, 2-2 P
formula, 3-8 parameter
Lymph% WBC, 2-2
definition, 2-2 RBC, 2-2
formula, 3-7 HGB, 2-2
lyse PLT, 2-2
connection, 4-9 WBC Histogram, 2-2
definition, 2-16 RBC Histogram, 2-2
prime, 10-7 PLT Histogram, 2-2
Lymph%, 2-2
Mid%, 2-2
M
Gran%, 2-2
maintenance, 10-1
MCV, 2-2
MCH
RDW-CV, 2-2
definition, 2-2, 3-10
RDW-SD, 2-2
formula, 3-10
MPV, 2-2
MCHC
PDW, 2-2
definition, 2-2

A-3
Fehler! Formatvorlage nicht definiert.

Lymph#, 2-2 probe cleanser


Mid#, 2-2 definition, 2-16
Gran#, 2-2 use, 10-2, 10-10
HCT, 2-2 probe wipe
MCH, 2-2 calibrate, 10-33
MCHC, 2-2 replace, 10-37
PCT, 2-2 Ps, 6-15
Parity, 5-15
password, 5-8
Q
PCT
Quality control
definition, 2-2
Edit settings, 8-2, 8-15, 8-28, 8-39
formula, 3-12
L-J Analysis, 8-2
PDW
review, 8-8,8-18,8-34, 8-45
definition, 2-2, 3-12
run, 8-5, 8-22, 8-31, 8-45
performance specification, 12-2
X -R Analysis, 8-28
PL, 6-15
X-B Analysis, 8-39
PLT
definition, 2-2, 3-12
linearity range, 12-4 R
reproducibility, 12-5 R1, 6-12
Pm, 6-15 R2, 6-12
power R3, 6-12
fuse, 12-6 R4, 6-12
input power, 12-6 Rm, 6-12
voltage, 12-6 RBC
predilute definition, 2-2, 3-10
mode selection, 6-17 linearity range, 12-4
samples collection and handling, reproducibility, 12-5
6-18 RDW
running samples, 6-22 RDW-CV, 2-2, 3-10
prepare to ship, 10-28 RDW-SD, 2-2, 3-10
printer reagent, 2-15
pringting device, 5-3 connection, 4-8
pringting format, 5-3 Exp. Date, 5-27
printing modle, 5-5 Recorder, 2-10

A-4
Fehler! Formatvorlage nicht definiert.

Install papers, 4-13 transmission


pringting format, 5-3 data format, 12-3
rinse at count screen, 12-8
connection, 4-11 at QC Table Screen, 12-8
definition, 2-16 at review screen, 12-8
prime, 10-6 troubleshooting, 11-1

S U
sample unpacking, 4-4
samples collection and handling, 6-5
run, 6-8, 6-17
V
sample probe
valve
calibrate, 10-33
test, 10-26
sample probe localizer, 10-33
volumetric metering, 3-5
setup
autoclean time, 5-5
count time, 5-6 W
date & time, 5-19 WBC
gain, 5-21 definition, 2-2, 3-7
password, 5-8 formula, 3-7
parameter units, 5-31 linearity range, 12-4
printing & communication, 5-2 reproducibility, 12-5
reagents Exp. Date, 5-27 weight, 12-7
report title, 5-29
other, 5-34
shutdown, 6-26
X
specifications, 12-2 X-B analysis
edit, 8-39
review, 8-45
T run, 8-45
table X Analysis, 8-15
sample table, 7-2 edit, 8-15
search table, 7-19 review, 8-22
Temperature, 4-2, 12-7 run, 8-18
throughput, 12-3 X -R Analysis, 8-28

A-5
Fehler! Formatvorlage nicht definiert.

edit, 8-28 run, 8-31


review, 8-34

Z
zap apertures, 10-8

A-6
B Specifications

B.1 Classification
According to the CE classification, the BC-3000 Plus is an In Vitro Diagnostic device.

B.2 Reagents
Diluent M-30D DILUENT
Rinse M-30R RINSE
Lyse M-30CFL LYSE
M-30E E-Z CLEANSER
E-Z Cleanser(Enzyme cleanser)

Probe Cleanser M-30P PROBE CLEANSER

B.3 Parameters

Table 12-1 Directly measured parameters and histograms

Parameter Abbreviation Default Unit


White Blood Cell or leukocyte WBC 109/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 12-2 Parameters derived from histograms

Parameter Abbreviation Default Unit


Lymphocyte percentage Lymph% %
Mid-sized cell percentage Mid% %
Granulocyte percentage Gran% %
Mean Corpuscular Volume MCV fL
Red Blood Cell Distribution Width Coefficient of RDW-CV %
Red Blood Cell Distribution Width Standard Deviation RDW-SD fL
Mean Platelet Volume MPV fL

B-1
Fehler! Formatvorlage nicht definiert.

Platelet Distribution Width PDW /

Table 12-3 Calculated parameters

Parameter Abbreviation Default Unit


Lymphocyte Lymph# 109/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 Lyse used for every analysis


Whole blood 0.5 mL
Prediluted 0.36mL

B.4.3 Dilution rate


WBC/HGB RBC/PLT
Whole blood 1:308 1:44872
Prediluted 1:428 1:43355

B.4.4 Aperture size


Diameter Length
WBC 100 μm 70 μm
RBC 70 μm 65 μm

B.4.5 Throughput
Less than 1 minute / analysis

B-2
Fehler! Formatvorlage nicht definiert.

B.5 Performance specifications

B.5.1 Operating range


Parameter Operating range
WBC (109/L) 0.0 - 999.9

RBC (1012/L) 0.00 - 9.99


HGB (g/L) 0 - 300
MCV (fL) 0.0 - 250.0
PLT (109/L) 0 - 2999

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
WBC (109/L) 0.3 - 99.9
RBC (1012/L) 0.20 - 8.00
HGB (g/L) 10 - 250
PLT (109/L) 10 - 999

B-3
Fehler! Formatvorlage nicht definiert.

B.5.4 Reproducibility
These reproducibility requirements applies only to the situation in which 11 normal-level
controls have been run and the results of the 2nd to 11th runs are used to calculate the
reproducibilities.

Parameter Condition
Reproducibility(CV%)

WBC 7.0 - 15.0 × 109 / L ≤ 2.5


RBC 3.50 - 6.00 × 1012 / L ≤ 2.0
HGB 110 - 180 g/L ≤ 1.5
MCV 80.0 - 110.0 fL ≤ 0.5

PLT 150 - 500 × 109 / L ≤ 5.0

B.5.5 Carryover
Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 0.5 %
PLT ≤1%

B.6 Input/output device

z Be sure to use the specified devices only.

B.6.1 Display

Color LCD, 10.2″, 800×600.

B.6.2 Keypad
23-key keypad.

B.6.3 Keyboard
PS/2 keyboard.

B-4
Fehler! Formatvorlage nicht definiert.

B.6.4 Bar-code scanner(optioanl)

TYSSO CCD-82 scanner.

B.6.5 Recorder
Built-in thermal recorder that supports two printing formats and auto printing.

B.6.6 Printer(optional)

EPSON LQ-300K+.

B.6.7 Interfaces
„ A keyboard interface.

„ Two RS-232 interfaces (maximum transmission distance 12 meters);

„ A parallele 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 ).

B.7 Power supply


„ Voltage: AC 100 V – 240 V;

„ Frequency: 50/60 Hz;

„ Input power: 180 VA;

„ Fuse: AC 250 V T4 A.

z Be sure to use the fuse of the specified type and rating.

B-5
Fehler! Formatvorlage nicht definiert.

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: 77 dB.

B.10 Operating environment

„ Operating temperature: 15 ℃ - 35 ℃;

„ Optimal operating temperature: 15 ℃ - 30 ℃;

„ Relative humidity: 30 % - 85 %;

„ Atmospheric pressure: 70 kPa - 106 kPa.

B.11 Storage environment

„ Ambient temperature: -10 ℃ - 40 ℃

„ Relative humidity: 10 % - 93 %

„ Atmospheric pressure: 70 kPa - 106 kPa

B.12 Dimensions
Length Width Height
40 cm 39 cm 46 cm

B-6
Fehler! Formatvorlage nicht definiert.

B.13 Weight
21 kg

B.14 Contraindications
None.

B-7
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 prope 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 recommnended 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 decribe corrective and preventive procedures
that must be followed to ensure proper operation and performance of your analyzer.

C-1
Fehler! Formatvorlage nicht definiert.

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 of human health.

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, be sure to 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 Be sure to dispose of reagents, waste, samples, consumables, etc.


according to government regulations.

z Avoid direct contact with patient samples.

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

z To avoid personal injury, be sure to keep your clothes, hair and hand away
from such moving parts as the sample probe.

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

C-2
Fehler! Formatvorlage nicht definiert.

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 Liquid ingression may damage the analyzer. Do not place any bottles on the
analyzer.

z Do not connect or disconnect the printer, bar-code scanner or keyboard


when the anlazyer is on.

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

z Do not re-use disposable products.

z When dispensing or aspirating liquids, remove the bottle or tube away only
after the sample probe is out of it.

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.

C-3
Fehler! Formatvorlage nicht definiert.

C.4 Notes

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

z Be sure to operate the 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 Store and use the reagents as instructed by instructions for use of the
reagents

z When you have changed the diluent, rinse or lyse, run a background to
ensure that the system is primed immediately prior to running any samples.

z Pay attention to and record the expiration date and open-container stability
of all the reagents. Be sure not to use expired reagents

z Keep the reagents still for a while before using them.

z Be sure the analyzer is off before switching on the power.

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

z Be sure to place the analyzer on a countertop.

z Be sure to sue the manufacturer-specified reagents, controls and


calibrators.

z After connecting the reagents, be sure to tighten the cap to prevent


contamination.

z Pay attention to and record the expiration dates and open-container stability
days of all the reagents. Be sure not to use expired reagents

z For any reagent, the entered expiration date should be either the expiration
date printed on the labeling or the open-container expiration date, whichever
is earlier. The open-container expiration date is calculated as follows: the
date that container is opened + the open-container stability days.

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 8 hours
after collection.

z Be sure to use clean K2EDTA anticoagulant collection tubes, fused silica


glass/plastic test tubes and 20μL borosilicate glass capillary tubes.

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z If you do not need the PLT, MCV and WBC differential results, you can store

the samples in a refrigerator (2℃ - 8℃) for 24 hours. You need to warm the

refrigerated samples at room temperature for at least 30 minutes before


running them.

z Be sure to mix any sample that has been prepared for a while before running
it.

z Be sure to keep dust from the prepared diluent.

z After mixing the capillary sample with the diluent, be sure to wait 3 minutes
before running the sample. Be sure to run the prediluted samples within 30
minutes after the mixing.

z Be sure to evaluate predilute stability based on your laboratory’s sample


population and sample collection techniques or methods.

z Be sure to select proper reference range as instructed in Chapter 5.5


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

z When switching from the predilute mode to the whole blood mode, the
analyzer will automatically wash the fluidic system.

z After entering all the desired information, you may press [F4] on the external
keyboard to save the changes and exit to the “Count” screen.

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


ENTER “0” into the “ID” box.

z Be sure to keep the sample probe tip away from the tube bottom, otherwise
the aspiration volume may be inaccurate.

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


the corresponding error messages will be displayed in the upper 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 Your Analyzer for
solutions.

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

z If the PLT value is less than 100 × 109 / L, it is recommended the result be
verified by a microscope.

z To ensure the stability of the analyzer and the acuuracy of the results, be
sure to do the Shutdwon procedure if your analyzer has been working for 24
consecutive hours.

z After entering all the desired information, you may press [F4] on the external
keyboard to save the changes and exit to the “Sample (or Search) Histogram

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Review” screen.

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

z Be sure to use the manufacturer-specified controls. Using controls other


than the specified will lead to misleading results.

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

z Be sure to 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 Refer to the instructions of use of the calibrator 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, whichever is earlier. The
open-vial expiration date is calculated as follows: the date that vial is opened
+ the open-vial stability days.

z Be sure to use the manufacturer-specified calibrator. Using calibrators other


than the specified will lead to misleading results.

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

z After mixing the calibrator with the diluent, be sure to wait 3 minutes before
running it. Be sure to run the prediluted calibrator within 30 minutes after the
mixing.

z Be sure to mix any prediluted calibrator that has been prepared for a while
before running it.

z You should prepare 3 – 5 normal fresh blood samples for the calibration.

z If you press [MENU] to enter the system menu before the average is
obtained at the “Calculate” screen, the next time you enter the “Auto-fresh
blood” screen a message box will pop up to ask you whether to clear the
data of the last calibration; If you press [MAIN] to exit to the “Count”screen
before the average is obtained at the “Calculate” screen, the next time you
enter the “Auto-fresh blood” screen a message box will pop up to ask you
whether to clear the data of the last calibration.

z Probe cleanser is corrosisve. Wear proper personal protective equipment


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

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handling it in the laboratory.

z Spills are possible during the soaking process. Keep a minimum 30cm
distance from the analyzer.

z Before moving the analyzer, be sure to do the “Empty Tubing” procedure.

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

z The troubleshooting 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 customer service department or your local distributor.

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

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

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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.

z All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.

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C.6 Abnormal Results

For your reference only.

C.6.1 Abnormal Sample Analysis Results

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 (***).

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

platelets coagulate, large platelet, nucleated red cell, insolvable red cell, protein, lipoid debris
in sample, or electrical noise.
R2: indicates abnormality between the lymphocyte hump and the mononuclear area and
possible presence of atypical lymphocyte, original cell in the sample and increased eosinophil
or increased basophil.

R3 : indicates abnormality between the mononuclear leukocyte and the neutrophilic

granulocytes and possible presence of immature granulocytes, abnormal sub-population in


the sample, or increased eosinophil.

R4 :indicates abnormality on the right side of the neutrophilic granulocytes hump and

increased absolute number of neutrophilic granulocyte.

Rm:indicates at least two R flags.

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

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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.

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C.7 Abnormal QC Results

In case of any abnormal QC results, do the following steps until the problem is solved. If all
the steps have failed, contanct Mindray customer service department or your local distributor
for assistance.

„ Check the upper left corner of the screen for error messages. Refer to Chaper 11
Troublshooting Your Analyzer for solutions to any displayed error messages;

„ Check the L-J settings for inappropriate entries;

„ Do the background check. In case of an abnormal background result, refer to Chaper 11


Troublshooting Your Analyzer for solutions.

„ Re-run the control;

„ Run another vial of control;

„ Check if the analyzer needs to be calibrated.

C-11
D Communication

D.1 Introduction

The BC-3000 Plus 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. 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.

z When the communication symbol in the upper right corner of the screen
appears animated, it indicates the communication is in process.

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D.2 Connection

The BC-3000 Plus can be connected with an external computer through a DB9 connector.
The pins of the DB9 connector are shown in Figure12-1.

Figure12-1 DB9 connector

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-3000 Plus communicates with a host through serial port 2, using Pin2, Pin 3 and Pin
5. The maximum transmission distance is 12 meters.

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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 - L8 Region are LI - L8 of eight histogram discriminators as shown in Figure-D2.

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Figure12-2 L1- L8 demonstration

Programming
If the Handshake is off, BC-3000 Plus will transmit the body of the text without acknowledging
the presence of an external computer.

If the Handshake is on, BC-3000 Plus will communicate with the external computer in
following procedures:

1. BC-3000 Plus 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-3000 Plus 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-3000 Plus waits 4

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seconds before giving up and gives alarm of communication error.

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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
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] ##.#

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PDW ##.#
PCT[%] .###
RDW-SD[fL] ###.#
Reserved ############
Rm #
R1 #
R2 #
R3 #
R4 #
Pm #
Ps #
Pl #
L1 Region ###
L2 Region ###
L3 Region ###
L4 Region ###
L5 Region ###
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]

D.3.3 Standard L-J QC Data Format

If handshake is enabled [ENQ]


If handshake is disabled [STX]
Body of the text start
Text Identifier “B”
File No. #
Lot No. ######
Month ##
Day ##
Year ####
WBC[109/L] ###.#
12
RBC[10 /L] #.##
HGB[g/L] ###
9
PLT[10 /L] ####

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Lymph#[109/L] ###.#
Lymph%[%] ##.#
9
Gran#[10 /L] ###.#
Gran%[%] ##.#
HCT[%] ##.#
MCV[fL] ###.#
MCH[pg] ###.#
MCHC[g/L] ####
9
WBC Limit[10 /L] ###.#
RBC Limit[1012/L] #.##
HGB Limit[g/L] ###
9
PLT Limit[10 /L] ####
9
Lymph# Limit[10 /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 Run L-J QC Data Format

If handshake is enabled [ENQ]


If handshake is disabled [STX]
Body of the text start
Text Identifier ‘C’
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] ###.#

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Gran%[%] ##.#
HCT[%] ##.#
MCV[fL] ###.#
MCH[pg] ###.#
MCHC[g/L] ####
Body of the text end
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 → Transmission” screen and edit the communication
settings as instructed by Chapter 5.6.

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 Review Screen


Select the results you want to transmit and transmit them to the external computer as
instructed by Chapter 7.2.1. .

D.4.4 Transmission at L-J QC Table Screen


Transmit the results as instructed by Chapter 8.2.3.

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P/N:3003-20-34858

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