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BC-5500

Auto Hematology Analyzer

Operator’s Manual
Copyright

© 2005-2007 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issued Date is 2007-12 (Version: 1.6).

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 intends to maintain the contents of this manual as confidential information. Disclosure
of the information in this manual in any manner whatsoever without the written permission of
Mindray is strictly forbidden.

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

, , , , BeneView, WATO, BeneHeart,


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 the effects on safety, reliability and performance of this product, only
if:

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

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

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

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

z Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.

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:

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

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

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

III
Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan,ShenZhen518057, P. R. China,
Tel: +86 755 26582479 26582888

Fax: +86 755 26582934 26582500

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

Address: Eiffestraβe 80, Hamburg 20537, Germany

Tel: 0049-40-2513175

Fax: 0049-40-255726

IV
Table of Contents

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


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

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


2.1 Introduction ............................................................................................ 2-1
2.2 Intended Use.......................................................................................... 2-2
2.3 Main Structure ........................................................................................ 2-3
2.4 User Interface....................................................................................... 2-16
2.5 Reagents, Controls and Calibrators..................................................... 2-21

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 Measurement................................................................................ 3-7
3.5 HGB Measurement .............................................................................. 3-11
3.6 RBC/PLT Measurement ....................................................................... 3-12
3.7 Wash .................................................................................................... 3-16

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


4.1 Introduction ............................................................................................ 4-1
4.2 Installation Requirements....................................................................... 4-2
4.3 Connecting the Analyzer System ........................................................... 4-4

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


5.1 Introduction ............................................................................................ 5-1
5.2 Common User ........................................................................................ 5-2
5.3 Administrator ........................................................................................ 5-14

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 .............................................................................. 6-5

1
6.5 Entering the “Count” screen................................................................... 6-6
6.6 Sample Collection and Handling.......................................................... 6-10
6.7 Open Vial Sampling Analysis ............................................................... 6-14
6.8 Closed Tube Sampling Analysis........................................................... 6-29
6.9 Autoloading Analysis ............................................................................ 6-43
6.10 Liquid Saver ......................................................................................... 6-65
6.11 Shutdown ............................................................................................. 6-66

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


7.1 Introduction ............................................................................................ 7-1
7.2 Browsing in the “Table Review” mode.................................................... 7-2
7.3 Browsing in the “Graph Review” mode ................................................ 7-22

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


8.1 Introduction ............................................................................................ 8-1
8.2 “L-J QC” Program................................................................................... 8-2
8.3 “X-B QC” Program................................................................................ 8-23

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 Using the “Maintenance” Program ....................................................... 10-2
10.3 Using the “Status” Program................................................................ 10-35
10.4 Using the “Self-test” program............................................................. 10-40
10.5 Using the “Log” Program.................................................................... 10-47
10.6 Using the “Initialization” Program (in the Administrator Level)........... 10-49
10.7 Shortcut button of daily maintenance................................................. 10-51
10.8 Cleaning Manually.............................................................................. 10-52
10.9 Adjustment ......................................................................................... 10-63
10.10 Using the “Replacement” program..................................................... 10-67

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


11.1 Introduction .......................................................................................... 11-1
11.2 Errors indicated by error messages ..................................................... 11-2

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

2
1 Using This Manual

1.1 Introduction

This chapter explains how to use your BC-5500 operation manual, which is shipped with your
BC-5500 AUTO HEMATOLOGY ANALYZER and contains reference information about the
BC-5500 and procedures for operating, troubleshooting and maintaining the analyzer. Read
this manual carefully before operating your analyzer and operate your analyzer strictly as
instructed in this manual.

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

1-1
Using This Manual

1.2 Who Should Read This Manual

This manual contains information written for clinical laboratory professionals to:

„ learn about the BC-5500 hardware and software.

„ customize system settings.

„ perform daily operating tasks.

„ perform system maintenance and troubleshooting.

1-2
Using This Manual

1.3 How to Find Information

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

If you want to … See …

learn about the intended use and parameters of the BC-5500 Chapter 2 Understanding
Your Analyzer
learn about the hardware and software of the BC-5500 Chapter 2 Understanding
Your Analyzer
learn about how the BC-5500 works Chapter 3 Understanding the
System Principles
learn about the installation requirements of the BC-5500 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-5500 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-5500 Chapter 9 Using the
Calibration Programs
learn about how to maintain/service the BC-5500 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-5500 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-5500 Appendix D Communication

1-3
Using This Manual

1.4 Conventions Used in This Manual

This manual uses certain typographical conventions to clarify meaning in the text:

„ all capital letters enclosed in [ ] indicate a key name (either on the pop-up keyboard or the
external keyboard), such as [ENTER].

„ all capital, bold and italic letters indicate a special operation defined in the following
section, such as CLICK.

„ bold letters included in “ “ indicate text you can find on the screen, such as “Clean”.

„ bold letters indicate chapter titles, such as Chapter 1 Using This Manual.

All illustrations in this manual are provided as examples only. They may not necessarily reflect
your analyzer setup or data displayed.

1-4
Using This Manual

1.5 Special Terms Used in This Manual

When you read … It means …

„ to press the desired item lightly with your finger; or


CLICK
„ to left-CLICK it with a mouse.

„ to CLICK the desired edit box and use the external keyboard or
the pop-up keyboard to enter the desired characters or digits;
ENTER
or

„ to scan the number in using the bar-code scanner.

„ to move the cursor to the character or digit to the left of the one
you want to delete and press [DEL]; or
DELETE „ to move the cursor to the character or digit to the right of the
one you want to delete and press [BackSpace] (or the [←] key
at the upper right corner of the pop-up keyboard).

„ to CLICK the appropriate arrow button to move the scroll bar; or

„ to CLICK and hold the mouse down while dragging the scroll
DRAG SCROLL BAR bar until the desired information is displayed; or

„ to CLICK and rest your finger there while dragging the scroll
bar until the desired information is displayed.

„ to CLICK the down arrow button of the desired box to display


the pull-down list (and DRAG SCROLL BAR) to browse and
SELECT from “ **
then CLICK the desired item; or
“ pull-down list
„ to press the keys ([↑][↓][PageUp][PageDown]) to browse the
current list and press [ENTER] to select the desired item.

1-5
Using This Manual

1.6 Symbols

You will find the following symbols in this manual.

When you see… Then…

read the statement below the symbol. The statement is


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

read the statement below the symbol . The statement is


alerting you to a potentially biohazardous condition.

You may find the following symbols on the analyzer, reagents, controls or calibrators.

When you see… It means…


CAUTION, CONSULT ACCOMPANYING
DOCUMENTS.

BIOLOGICAL RISK

HIGH VOLTAGE

WARNING, LASER BEAM

WARNING, HOT SURFACE

PROTECTIVE EARTH (GROUND)

1-6
Using This Manual

EARTH (GROUND)

ALTERNATING CURRENT

FOR IN VITRO DIAGNOSTIC USE

BATCH CODE

USE BY

SERIAL NUMBER

CATALOG NUMBER (FOR CONTROLS)

USE BY (YYYY-MM-DD) (FOR CONTROLS)

DATE OF MANUFACTURE

MANUFACTURER

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

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

1-7
Using This Manual

WASTE. BY ENSURING THAT THIS


PRODUCT IS DISPOSED OF CORRECTLY,
YOU WILL HELP PREVENT BRINGING
POTENTIAL NEGATIVE CONSEQUENCES
TO THE ENVIRONMENT AND HUMAN
HEALTH. FOR MORE DETAILED
INFORMATION WITH REGARD TO
RETURNING AND RECYCLING THIS
PRODUCT, PLEASE CONSULT THE
DISTRIBUTOR FROM WHOM YOU
PURCHASED THE PRODUCT.
THE DEVICE IS FULLY CONFORMANCE
WITH THE COUNCIL DIRECTIVE
CONCERNING IN VITRO DIAGNOSTIC
MEDICAL DEVICES 98/79/EC.
AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY

1-8
Using This Manual

Figure 1-1 Left of the Analyzer

(1)

„ Connect only to a properly earth grounded outlet.

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

„ Replace fuse only with the type and rating specified.

1-9
Using This Manual

Figure 1-2 Stop Bar Position (Front Cover Open)

(1)
To avoid personal injury, after you lift the cover, be sure to fix it with the stop bar exactly as the
above figure shows.

(2)
Mechanical risk may exist if the protective cover is removed.

1-10
Using This Manual

Figure 1-3 Stop Bar Position (Top Cover and Left Door Removed)

(1)
To avoid personal injury, after you lift support plate of the circuit boards, be sure to fix it with the
stop bar exactly as the figure shows.

1-11
Using This Manual

Figure 1-4 Protective cover (Top Cover, Left Door, Right Door and Back Panel Removed)

(1)
Mechanical risk may exist if the protective cover is removed.

1-12
Using This Manual

Figure 1-5 Stop Bar Position (Front Cover Open)

(1)
To avoid personal injury, do not put your hand into the analyzer.

1-13
Using This Manual

Figure 1-6 Back of the Pneumatic Unit

(1)
To avoid damaging the pneumatic unit, do not block the vent at its back.

(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.

„ To avoid the compressor being damaged, wait at least 1 minute before restarting the
pneumatic unit.

(3)
To avoid damaging the pneumatic unit, do not block the vent at its back.

1-14
Using This Manual

Figure 1-7 Inside Left of the Pneumatic Unit (Cover Removed)

(1)
To avoid personal injury, do not put hand into the fan.

(2)
To avoid personal injury, do not put hand into the fan.

1-15
Using This Manual

Figure 1-8 Inside Right of the Pneumatic Unit (Cover Removed)

(1)
Risk of electric shock. Do not touch. Cut off the power before maintenance.

(2)
Risk of electric shock. Do not touch. Cut off the power before maintenance.

(3)
Risk of electric shock. Do not touch. Cut off the power before maintenance.

1-16
2 Understanding Your Analyzer

2.1 Introduction

The BC-5500 AUTO HEMATOLOGY ANALYZER is a quantitative, automated hematology


analyzer and 5-part differential counter for In Vitro Diagnostic Use in clinical laboratories.

2-1
Understanding Your Analyzer

2.2 Intended Use

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

The analyzer is used for the quantitative determination of the following 23 basic parameters, 4
parameters for research use, 2 histograms and 2 scattergrams of blood samples.

White Blood Cell count WBC


Basophils number Bas#
Neutrophils number Neu#
Eosinophils number Eos#
Lymphocytes number Lym#
Monocytes number Mon#
Abnormal Lymphocytes number ALY# (RUO)
Large Immature Cells number LIC# (RUO)
Basophils percentage Bas%
Neutrophils percentage Neu%
Eosinophils percentage Eos%
Lymphocytes percentage Lym%
Monocytes percentage Mon%
Abnormal Lymphocytes percentage ALY% (RUO)
Large Immature Cells percentage LIC% (RUO)
Red Blood Cell count RBC
Hemoglobin Concentration HGB
Mean Corpuscular Volume MCV
Mean Corpuscular Hemoglobin MCH
Mean Corpuscular Hemoglobin Concentration MCHC
Red Blood Cell Distribution Width Coefficient of Variation RDW-CV
Red Blood Cell Distribution Width Standard Deviation RDW-SD
Hematocrit HCT
Platelet count PLT
Mean Platelet Volume MPV
Platelet Distribution Width PDW
Plateletcrit PCT
Red Blood Cell Histogram RBC Histogram
Platelet Histogram PLT Histogram
Basophils Scattergram BAS Scattergram
4 differential Scattergram Diff Scattergram

2-2
Understanding Your Analyzer

2.3 Main Structure

BC-5500 AUTO HEMATOLOGY ANALYZER consists of the main unit (analyzer), pneumatic
unit and accessories.

Figure 2-1 Front of the Analyzer

1 ---- Touch screen 2 ---- Power button


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

2-3
Understanding Your Analyzer

Figure 2-2 Front of the Analyzer (Closed tube Sampler Configured)

1 ---- Touch screen 2 ---- Power button


3 ---- Power indicator 4 ---- Sample probe
5 ---- Aspirate key 6 ---- Sample compartment door
7 ---- Adapter 8 ---- Tube holder

2-4
Understanding Your Analyzer

Figure 2-3 Front of the Analyzer (Autoloader Configured)

1 ---- Touch screen 2 ---- Power button


3 ---- Power indicator 4 ---- Sample probe
5 ---- Aspirate key 6 ---- Sample tube
7 ---- Tube rack 8 ---- Autoloader

2-5
Understanding Your Analyzer

Figure 2-4 Back of the Analyzer

1 --- USB interfaces 2 --- Reserved interface


3 --- Pneumatic unit control interface 4 --- Network interface
5 --- Vacuum interface 6 --- Pressure interface
7 --- M-50 cleanser sensor connector 8 --- Waste sensor connector
9 --- M-50 cleanser inlet 10 --- Waste outlet
11 --- M-50D diluent inlet 12 --- M-50D diluent sensor connector
13 --- M-50LBA Lyse inlet 14 --- M-50LBA Lyse sensor connector
15 --- M-50LEO(Ⅱ)Lyse inlet 16 --- M-50LEO(Ⅱ)Lyse sensor connector
17 --- M-50LEO(Ⅰ)Lyse inlet 18 --- M-50LEO(Ⅰ)Lyse sensor connector
19 --- M-50LH Lyse inlet 20 --- M-50LH Lyse sensor connector

2-6
Understanding Your Analyzer

Figure 2-5 Inside Front of the Analyzer (Front Cover Removed)

1 --- RBC & HGB detecting unit 2 --- WBC detecting unit
3 --- RBC diluent unit 4 --- Open vial sampling & SRV (Sample
Rotator Valve) unit
5 --- Syringes

2-7
Understanding Your Analyzer

Figure 2-6 Inside front of the Analyzer(Front Cover Removed, Autoloader or Closed
tube Sampler Configured)

1 --- RBC&HGB detecting unit 2 --- WBC detecting unit


3 --- RBC diluent unit 4 --- Open vial sampling & SRV unit
5 --- Syringes 6 --- Auto mixing & piercing unit

2-8
Understanding Your Analyzer

Figure 2-7 Inside right of the analyzer (Right Door Removed)

1 --- Optical system 2 --- Fluidic valves


3 --- Reservoir and waste chamber 4 --- Pinch valve
5 --- Metering pump 6 --- Waste pump
7 --- Reagent preheating and temperature control unit

2-9
Understanding Your Analyzer

Figure 2-8 Inside left of the analyzer (Left Door Removed)

1 --- Vacuum regulator(-0.04Mpa) 2 --- Pressure regulator(+0.07Mpa)


3 --- Pressure regulator(+0.16Mpa) 4 --- Air Filter
5 --- AC input 6 --- Power switch
7 --- Air valve 8 --- Volumetric unit

2-10
Understanding Your Analyzer

Figure 2-9 Front of the Pneumatic Unit

1 --- Relief valve 2 --- Operation indicator

Figure 2-10 Back of the Pneumatic Unit

1 --- Pressure interface 2 --- Vacuum interface


3 --- Power switch 4 --- AC input
5 --- Pneumatic unit control interface

2-11
Understanding Your Analyzer

2.3.1 Touch Screen


The touch screen is located on the front panel of the analyzer. It displays all alphanumeric and
graphic data. You can use it to operate your analyzer.

2.3.2 Aspirate Key


The aspirate key is located behind the sample probe. You can press the key to start the
selected analysis cycle or dispense diluent.

2.3.3 Closed tube Sampler (Optional)


The closed-tube sampler is located in the front of the analyzer. You can use it for manual
closed-tube sampling.

2.3.4 Autoloader (Optional)


The autoloader is located in the front of the analyzer. You can use it to load tubes
automatically.

2.3.5 Blood Sensor (Optional)


The blood sensor is located between the sample probe and the SRV. It judges whether
sufficient blood is aspirated.

2.3.6 Sample Compartment


The tube holder inside the sample compartment of the closed-tube sampler can hold collection
tubes of 4 specifications.

2.3.7 USB Interfaces


4 USB interfaces are located on the back of the analyzer. You can use them to connect the
keyboard, printer, etc..

2.3.8 Pneumatic Unit Control Interface


A pneumatic unit control interface is located on the back of the analyzer. It can be used to
startup or shutdown the pneumatic unit.

2-12
Understanding Your Analyzer

2.3.9 Network Interface


A network interface is located on the back of the analyzer.

2-13
Understanding Your Analyzer

2.3.10 Power Indicator


A power indicator is located on the left below the touch screen. It tells you whether the analyzer
is on or off.

2.3.11 Power Switch


A power switch is on the left side of the analyzer. It connects or disconnects the power supply
required by the analyzer.

2.3.12 Power Button


A power button is located on the left below the touch screen. It starts the analyzer when the
power switch is placed in the ON positions (I).

2.3.13 External Equipment


Keyboard (Optional)

An external keyboard can be connected to a USB interface on the back of the analyzer. You
can use it to operate your analyzer.

Mouse (Optional)

A mouse can be connected to a USB interface on the back of the analyzer. You can use it to
operate your analyzer.

Printer (Optional)

An external printer can be connected to a USB interface on the back of the analyzer. You can
use it to print out a detailed report and other interested information displayed on the screen.

Scanner (Optional)

A bar-code scanner can be connected to a USB interface on the back of the analyzer. You can
use it to scan the bar-coded information into the analyzer.

Pneumatic Unit

The pneumatic unit provides pressure and vacuum for the analyzer.

2-14
Understanding Your Analyzer

z Do not adjust the pneumatic relief valve. Contact Mindray customer service
department or your local distributor if necessary.

2-15
Understanding Your Analyzer

2.4 User Interface

2.4.1 Screen
After the starting procedure, you will enter the main screen shown in Figure 2-11. CLICK any
icon to enter the desired function screen.

Figure 2-11 Main screen

2.4.2 Function Icons


You can select the desired icon/button as instructed below.

Table 2-1 Function icons

If you want to… Select…


analyze samples Count

review sample results Review


customize system software Setup
maintain/service the analyzer Service

Switch the user Log-out


run the QC program Quality Control
calibrate the analyzer Calibration

shut down the analyzer Shutdown

2-16
Understanding Your Analyzer

2.4.3 Public information area


At the “Count” or “QC” screen, you can see the public information area on the top. It is divided
into 3 areas: the title area, the error message area and the status area. Take the “Count”
screen for example; we will get more details of the public information area.

CLICK the “Count” icon at the main screen to enter the “Count” screen shown in Figure 2-12.

Figure 2-12 “Count” screen

Title area
The Title area displays the title of the current screen, which, in case of Figure 2-12, is “Count”.
CLICK this area and the help information of the “Count” screen will appear.

Error message area


When error(s) is reported, the Error message area displays error messages one by one,
alternating every two seconds. The severity levels are discriminated from high to low by 5
background colors: red, orange, yellow, green and blue. CLICK it to display the
troubleshooting dialog box, which shows the error name(s) and the corresponding
troubleshooting information. See Chapter 11 Troubleshooting Your Analyzer for details.

2-17
Understanding Your Analyzer

Status area
From left to right, they are:

1. Analysis status

The Analysis status area shows three statuses in different icons: red icon for waiting, green
icon for ready and flickering green icon for running.

z If a STAT sample is to be run, the yellow icon represents ready and the
flickering yellow icon represents running instead.

„ Waiting: it means the analyzer is not ready for the next run yet.

„ Ready: it means this analyzer is ready and you can proceed to analyze the next sample.

„ Running: it means this analyzer is analyzing a sample.

2. Print status

Icons are used to display the current status of the printer.

„ Gray icon: The printer is not connected to the analyzer yet.

„ Color icon: The printer is ready for print.

„ Flickering color icon: The printer is printing.

3. Transmission status

Icons are used to display the current status of the transmission.

„ Gray icon: The communication device is not connected to the analyzer yet.

„ Color icon: The communication device is ready for transmission.

„ Flickering color icon: The communication device is on transmission.

4. X-B QC on/off status

Icons are used to display the on/off status of the X-B analysis, gray icon for off and color icon
for on.

5. Input language status and switch

Icon is used to display the current input language of the pop-up keyboard and you can switch
to other language by clicking it.

2-18
Understanding Your Analyzer

The meanings of the abbreviations of the language are shown below.

EN CN FR DE IT ES RU PT TR

English-US Chinese-CN French German Italian Spanish Russian Portuguese Turkish

z Please select the desired input language properly. Improper input language
may lead to confused screen display.

6. System time

It displays the current system time (in the 24-hour format).

2-19
Understanding Your Analyzer

2.4.4 Pop-up keyboard


CLICK the edit box and the pop-up keyboard shown in Figure 2-13 will appear on the screen.

CLICK to close the pop-up keyboard.

Figure 2-13 Pop-up Keyboard

Here shows an example how to use key combination.

Supposed you are to use key combination; for example, the [Ctrl+Shift], do as follows:
1. CLICK the [Ctrl] key.
2. CLICK the [Shift] key.

To release them, do as follows:


1. CLICK the [Shift] key again.
2. CLICK the [Ctrl] key again.

2-20
Understanding Your Analyzer

2.5 Reagents, Controls and Calibrators

Because the analyzer, reagents (diluent, rinse, lyses, 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, cleansers or lyses, 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 reagent, keep it still for a while before use.

2.5.1 Reagents
M-50D Diluent
It applies to Mindray 5-part differential hematology analyzer.

M-50LEO(I) Lyse
M-50LEO(I) Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks
down red blood cell walls. It 4-differentiates WBCs.

M-50LEO(II) Lyse
M-50LEO(II) Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks
down red blood cell walls. It 4-differentiates WBCs.

2-21
Understanding Your Analyzer

M-50LH Lyse
M-50LH Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks down
red blood cell walls to determine the HGB.

M-50LBA Lyse
M-50LBA Lyse applies to Mindray 5-part differential hematology analyzer. It rapidly breaks
down red blood cell walls to analyze WBCs and basophils.

M-50P Probe Cleanser


M-50P Probe Cleanser applies to Mindray 5-part differential hematology analyzer. It is an
alkaline cleaning solution formulated to clean the sampler.

M-50 Cleanser
M-50 Cleanser cleaner applies to Mindray 5-part differential hematology analyzer. It is an
isotonic, cleaning solution formulated to clean the fluidic lines and maintain the analyzer daily.

2.5.2 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
Mindray or Mindray-authorized distributors.

2-22
3 Understanding the System
Principles

3.1 Introduction

The measurement methods used in this analyzer are:

„ the Electrical Impedance method for determining the RBC and PLT data.

„ the colorimetric method for determining the HGB.

„ flow cytometry by laser for determining the WBC data.

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

3-1
Understanding the System Principles

3.2 Aspiration

The analyzer offers an open vial sampling mode, closed-tube sampling mode and autoloading
mode (if configured). In the open vial sampling mode, the analyzer can process two types of
blood samples – whole blood samples and prediluted blood samples. While in the closed-tube
sampling mode and autoloading mode, the analyzer can process only whole blood samples.

If you are to analyze a whole blood sample in the autoloading mode or closed-tube sampling
mode, the analyzer will aspirate 180µL of the sample.

If you are to analyze a whole blood sample in the open vial sampling mode, the analyzer will
aspirate 120µL of the sample.

If you are to analyze a capillary blood sample in the open vial sampling mode, you should first
manually dilute the sample (40µL of capillary sample needs to be diluted by 120µL of diluent)
and then present the pre-diluted sample to the analyzer, which will aspirate 120µL of the
sample.

3-2
Understanding the System Principles

3.3 Dilution

In the sampling valve, the aspirated sample is quickly and precisely segmented into 4 portions.
The 4 portions are then diluted and processed by different reagents. After this, they are ready
for analysis.

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

3.3.1 Whole Blood Mode


RBC/PLT dilution flow chart

8.3µL of Whole blood sample

2.992mL of diluent

About 1:361 dilution

60µL

About 2.94mL of diluent

About 1:18050 dilution for the


RBC/PLT analysis

HGB dilution flow chart

6µL of Whole blood sample

1.994mL of diluent

About 1.0mL of M-50LH lyse

About 1: 500 dilution for the


HGB analysis

3-3
Understanding the System Principles

WBC differential dilution flow chart

20µL of Whole blood sample

About 1.02mL of M-50LEO(I) lyse

About 0.32mL of M-50LEO(II) lyse

About 1:68 dilution for the WBC


analysis

WBC counting dilution flow chart

20µL of Whole blood sample

About 1.02ml of M-50LBA lyse

About 1: 52 dilution for the


WBC analysis

3.3.2 Predilute Mode


RBC/PLT dilution flow chart

3-4
Understanding the System Principles

40µL of capillary blood sample

120µL of diluent

1:4 dilution

8.3µL

2.992mL of diluent

About 1:1444 dilution

60µL

2.94mL of diluent

About 1:72200 dilution for the


RBC/PLT analysis

HGB dilution flow chart

40µL of capillary blood sample

120µL of diluent

1:4 dilution

6µL

1.994mL of diluent

About 1.0mL of M-50LH lyse

About 1:2000 dilution for the


HGB analysis

3-5
Understanding the System Principles

WBC differential dilution flow chart

40µL of capillary blood sample

120µL of diluent

1:4 dilution

20µL

About 1.02ml of M-50LEO(I) lyse

About 0.32mL of M-50LEO(II) lyse

About 1:272 dilution for the


WBC analysis

WBC counting dilution flow chart

40µL of capillary blood sample

120µL of diluent

1:4 dilution

20µL

About 1.02ml of M-50LBA lyse

About 1:208 dilution for the


WBC analysis

3-6
Understanding the System Principles

3.4 WBC Measurement

3.4.1 Flow Cytometry by Laser

Figure 3-1 WBC measurement

After a predetermined volume of blood is aspirated and diluted by a certain amount of reagent,
it is injected into the flow cell. Surrounded with sheath fluid (diluent), the blood cells pass
through the center of the flow cell in a single column at a faster speed. When the blood cells
suspended in the diluent pass through the flow cell, they are exposed to a laser beam. The
intensity of scatter light reflects the blood cell size and intracellular density. The low-angle
scattered light reflects cell size, and the high-angle scattered light reflects intracellular density
(nucleus size and density). The optical detector receives this scatter light and converts it into
electrical pulses. Pulse data collected can be used to draw a 2-dimensional distribution
(scattergram). As shown in Figure 3-2 and Figure 3-3, X-axis represents the intracellular
density and Y-axis the blood cell size. Various types of analysis data can then be obtained from
the scattergrams.

3-7
Understanding the System Principles

Figure 3-2 DIFF Scattergram

By analyzing the DIFF channel scattergram, the analyzer presents the Lym%, Mon%, Eos%
and Neu%+Bas% .

Figure 3-3 BAS Scattergram

By analyzing the BAS channel scattergram, the analyzer presents the WBC, Bas#, LIC# (RUO)
and Bas%.

3.4.2 Derivation of WBC-Related Parameters


Based on the analysis of the BAS channel scattergram and Bas region, the analyzer calculates
the WBC and Bas#. The Bas% is then calculated. Based on the analysis of the DIFF channel
scattergram and the Lym region, Neu region+Bas region, Mon region and Eos region, the
analyzer calculates the Lym%, Mon%, Eos% and Neu%+Bas%. Having achieved the WBC
and Bas%, the analyzer proceeds to calculate Lym#, Neu#, Mon# and Eos# per the following
equations and express them in 109/L.

3-8
Understanding the System Principles

„ WBC

WBC = Sum of all particles in BAS channel except those in Ghost region

„ Basophilic leucocyte

Bas# = Particles in Bas region of BAS channel

„ Basophilic leucocyte percentage

Bas#
Bas% = × 100%
WBC

„ Lymphocyte percentage

Particles in Lym region of Diff channel


Lym% = × 100%
Sum of all particles in Diff channel except those in Ghost region

„ Neutrophilic leucocyte percentage

Particles in Neu + Bas region of Diff channel


Neu% = × 100% − Bas%
Sum of all particles in Diff channel except those in Ghost region

„ Mononuclear leucocyte percentage

Particles in Mon region of Diff channel


Mon % = × 100%
Sum of all particles in Diff channel except those in Ghost region

„ Eosinophilic leucocyte percentage

Particles in Eos region of Diff channel


Eos% = × 100%
Sum of all particles in Diff channel except those in Ghost region

„ Lymphocyte

Lym# = WBC × Lym%

„ Neutrophilic leucocyte

Neu # = WBC × Neu %

3-9
Understanding the System Principles

„ Mononuclear leucocyte

Mon # = WBC × Mon %

„ Eosinophilic leucocyte

Eos# = WBC × Eos%

3-10
Understanding the System Principles

3.5 HGB Measurement

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

3.5.1 Colorimetric Method


HGB is determined by the colorimetric method. The WBC/HGB dilution is delivered to the HGB
bath where it is bubble mixed with a certain amount of lyse, which converts hemoglobin to a
hemoglobin complex that is measurable at 525 nm. An LED is mounted on one side of the bath
and emits a beam of monochromatic light, whose central wavelength is 525nm. The light
passes through the sample and is then measured by an optical sensor that is mounted on the
opposite side. The signal is then amplified and the voltage is measured and compared to the
blank reference reading (readings taken when there is only diluent in the bath), and the HGB is
measured and calculated in the analyzer automatically. The result will be displayed in the
Analysis result area of the “Count” screen.

3.5.2 HGB
The HGB is calculated per the following equation and expressed in g/L.

⎛ Blank Photocurrent ⎞
HGB(g/L) = Constant × Ln ⎜⎜ ⎟⎟
⎝ Sample Photocurrent ⎠

3-11
Understanding the System Principles

3.6 RBC/PLT Measurement

RBCs/PLTs are measured by the Electrical Impedance method. When blood cells in a certain
amount of sample pass through the aperture, they cause electrical resistance changes
between two electrodes. Electrodes are at sides of the aperture. The analyzer processes the
data of changes and then the RBC, PLT, MCV and MPV are presented.

3.6.1 Electrical Impedance Method


RBCs/PLTs are counted and sized by the Electrical Impedance 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.

Figure 3-4 Electrical Impedance method

Each pulse is amplified and compared to the internal reference voltage channel, 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. The analyzer presents the RBC/PLT histogram, whose
x-coordinate represents the cell volume(fL)and y-coordinate represents the number of the
cells.

3-12
Understanding the System Principles

3.6.2 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 diluent is used to create a meniscus in the metering tube. The
count cycle starts when the meniscus reaches the lower sensor and stops when the meniscus
reaches the upper sensor. The amount of time required for the meniscus to travel from the
lower sensor to the upper sensor is called the RBC Count Time and is measured in seconds.
At the end of the count cycle, the measured count time is compared to the pre-defined
reference count time. 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 Your Analyzer for solutions.

Figure 3-5 Volumetric metering process

3.6.3 Derivation of RBC-Related Parameters


„ RBC

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

3-13
Understanding the System Principles

passing through the aperture.

RBC = n × 1012 / L

„ 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:

RBC × MCV
HCT =
10

HGB
MCH =
RBC

HGB
MCHC = × 100
HCT
where the RBC is expressed in 1012/L, MCV in fL and HGB in g/L.

„ RDW-CV

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

„ RDW-SD

RDW-SD (RBC Distribution Width – Standard Deviation, fL) is set on the 20% frequency level
with the peak taken as 100%, as Figure 3-6 shows.

Figure 3-6

3-14
Understanding the System Principles

3.6.4 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 %,

PLT × MPV
PCT =
10000

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

3-15
Understanding the System Principles

3.7 Wash

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

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

„ The sampling valve is washed with diluent.

„ The baths are washed with diluent.

„ The metering tubes are washed with diluent.

„ The flow cell is washed with diluent.

3-16
4 Installing Your Analyzer

4.1 Introduction

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.

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.

4-1
Installing Your Analyzer

4.2 Installation Requirements

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

4.2.1 Space Requirements


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

„ at least 100 cm on each side, which is the preferred access to perform service
procedures.

„ at least 50 cm behind the analyzer for cabling and ventilation.

„ at least 50 cm behind the pneumatic unit for cabling and ventilation.

„ enough room on and below the countertop to accommodate the diluent, cleansers, lyses,
pneumatic unit and waste containers.

4.2.2 Power Requirements


Voltage Frequency Input power Fuse
Analyzer a.c.100 V~240 V 50/60 Hz ≤300 VA 250 V T5 A
Pneumatic unit a.c.110/115 V 50/60 Hz ≤300 VA/60 Hz 125 V T5 A
≤400 VA/50 Hz
a.c.220/230 V 50/60 Hz ≤300 VA/60 Hz 250 V T2.5 A
≤450 VA/50 Hz

z Make sure the analyzer is properly grounded.

z Only install fuses of specified specification on the analyzer and the


pneumatic unit.

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

4.2.3 General Environment


„ Optimal operating temperature: 15 ℃ - 30 ℃.

„ Running temperature: 10 ℃ - 40 ℃

4-2
Installing Your Analyzer

„ Optimal operating humidity: 30 % - 85 %.

„ Atmospheric pressure: 70 kPa - 110 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.

„ It is advisable to evaluate the electromagnetic environment prior to operation of this


analyzer.

„ Do not use this analyzer in close proximity to sources of strong electromagnetic radiation
(e.g. unshielded intentional RF sources), as these may interfere with the proper
operation.

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

„ The environment should be good ventilation.

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

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 Do not move the analyzer or pneumatic unit. Contact Mindray customer


service department or your local distributor if necessary.

4-3
Installing Your Analyzer

4.3 Connecting the Analyzer System

The connection shall be conducted by Mindray-authorized personnel during the installation.

4.3.1 Pneumatic Unit


Connect the pneumatic unit to the analyzer as shown in Figure 4-1. The operator shall make
sure they are connected properly.

Figure 4-1 Connecting the Pneumatic Unit

4-4
Installing Your Analyzer

4.3.2 Reagents

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


to government regulations.

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

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

z Do not place reagents on or above the analyzer.

Connect the reagent lines as shown in Figure 4-2. Place lyses on the countertop, and the
diluent, cleanser and waste container below the countertop. Be sure to keep all reagent lines
isolated from anything electrical.

Figure 4-2 Connecting the Fluidic Lines

4-5
Installing Your Analyzer

4.3.3 Optional Equipment

z Do not connect or disconnect the printer, bar-code scanner, keyboard or


mouse when the analyzer is on.

z Be sure to use the external device of the specified model only.

Connect the optional equipment to the analyzer as shown in Figure 4-3 and Figure 4-4. The
operator shall make sure they are connected properly.

Figure 4-3 Connecting the Optional Equipment (1)

Figure 4-4 Connecting the Optional Equipment (2)

4-6
5 Customizing the Analyzer Software

5.1 Introduction

The BC-5500 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 this
chapter.

For the safety of the setting and data, the analyzer divides the operators to be the common
user and the administrator. The administrator authority includes all authorities of the common
user. This manual will explain how to customize your analyzer in the common user level and
the administrator level respectively.

5-1
Customizing the Analyzer Software

5.2 Common User

When you log in as a common user, CLICK the “Setup” button to enter the “Setup” screen of
the common user level shown in Figure 5-1.

Figure 5-1 “Setup” screen

5-2
Customizing the Analyzer Software

5.2.1 Settings

Date/Time
You can customize the date, time and the date format of the analyzer. The date and time at the
screen and the printout will change if the settings are changed.

„ Entering the “Date/Time” screen

The “Date/Time” screen is the default screen after you CLICK the “Setup” button. If the
current screen is not the “Date/Time” screen, CLICK the “Date/Time” button to enter the
“Date/Time” screen shown in Figure 5-2.

Figure 5-2 “Date/Time” screen

„ Selecting system date

1. CLICK the “Date” box and a dialog box shown in Figure 5-3 will pop up.

5-3
Customizing the Analyzer Software

Figure 5-3 Date setting dialog box

2. CLICK the arrows of the month and the year respectively to select the desired month and
year.

3. CLICK the desired number to select the desired day.

4. CLICK the “OK” button to close the dialog box and refresh the system date. CLICK the
“Cancel” button to close the dialog box without saving the changes.

If the year selected is out of the range of 2000 – 2036, a dialog box shown in Figure 5-4 will
pop up when you close the date setting dialog box.

Figure 5-4 Dialog box

CLICK the “OK” button to close the dialog box and reselect the year within the range.

„ Setting system time

CLICK the “Time” box and enter the system time.

„ Selecting date format

Three date formats are available: “YYYY-MM-DD”, “MM-DD-YYYY” and “DD-MM-YYYY”. To


select the desired format, CLICK the corresponding radio button.

5-4
Customizing the Analyzer Software

„ Exiting the “Date/Time” screen

To exit the “Date/Time” screen, CLICK any other button at the left of the screen or any button
at the bottom. A dialog box shown in Figure 5-5 will pop up.

Figure 5-5 Dialog box of saving changes

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Assistance
„ Entering the “Assistant” screen

CLICK the “Assistant” button at the “Setup” screen to enter the “Assistant” screen shown in
Figure 5-6.

Figure 5-6 “Assistant” screen

„ Selecting reminder of the predilute mode

5-5
Customizing the Analyzer Software

If you have activated the reminder and selected the predilute mode, a dialog box will pop up
when the sample will be analyzed in the predilute mode. CLICK the “OK” button to proceed
with the analysis or CLICK the “Cancel” button to exit.

Figure 5-7 Dialog box of predilute mode reminder

To activate the reminder, CLICK the “Prompt” radio button. To deactivate the reminder, CLICK
the “No prompt” radio button. The default setting is “Prompt”.

„ Selecting the pop-up keyboard

This setting determines whether to use the pop-up keyboard or not.

To use the pop-up keyboard, CLICK the “Open” radio button so that you can enter information
by the pop-up keyboard. If not, CLICK the “Close” button and you can only enter information
by a USB keyboard. The default setting is “Open”.

„ Entry of next sample ID

Two ID setup methods for new samples are provided for the open-vial/close-tube sampling
mode.
If “Auto increment” is selected, when there is a new sample to be run, the next ID increases by
1 based on the current ID; if “Manual entry” is selected, when there is a new sample to be run,
the default next ID is empty.

„ Enabling/disabling blood sensor(optional)

To enable the blood sensor, CLICK “Open”, and to disable the blood sensor, CLICK “Close”,.
Once enabled, the blood sensor will detect whether sufficient blood is aspirated and warn
operators about insufficient aspiration.

z Disable the blood sensor when running samples with extreme low
concentrations, for example, samples of dialysis patients.

z The blood sensor only works in the closed-tube sampling and autloloading
modes.

5-6
Customizing the Analyzer Software

„ Exiting the “Assistant” screen

To exit the “Assistant” screen, CLICK any other button at the left of the screen or any button at
the bottom. A dialog box shown in Figure 5-8 will pop up.

Figure 5-8 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Reagents

z Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.

You can set the expiration date of the diluent, LEO (I) lyse, LEO (II) lyse, LBA lyse, LH lyse and
cleanser at the “Reagent” screen.

„ Entering the “Reagent” screen

At the “Setup” screen, CLICK the “Reagent” button to enter the screen shown in Figure 5-9.

5-7
Customizing the Analyzer Software

Figure 5-9 “Reagent” screen

„ Setting the expiration date

1. CLICK the box of the desired reagent and a dialog box shown in Figure 5-10 will pop up.
The date displayed at the screen is the current system date.

Figure 5-10 Dialog box of setting the date

5-8
Customizing the Analyzer Software

2. CLICK the arrows of the month and the year respectively to select the desired month and
year. CLICK the desired number to select the desired day.

3. CLICK the “OK” button to close the dialog box and refresh the reagent expiration date.
CLICK the “Cancel” button to close the dialog box without saving the changes.

4. If the year selected is out of the range of 2000 – 2036, a dialog box shown in Figure 5-11
will pop up when you close the date setting dialog box. CLICK the “OK” button to close
the dialog box and reselect the year within the range.

Figure 5-11 Dialog box

If an external barcode scanner is connected, you can CLICK the “Barcode scanner” check
box shown in Figure 5-12 to use it. Scan the barcode with the external barcode scanner. If you
hear a beep, it means the entry is finished. The expiration date of reagents will appear in the
corresponding boxes.

Figure 5-12 Selecting the “Barcode scanner”

5-9
Customizing the Analyzer Software

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.

„ Exiting the “Reagent” screen

To exit the “Reagent” screen, CLICK any other button at the left of the screen or any button at
the bottom. If the setting is valid, a dialog box shown in Figure 5-13 will pop up when you exit
the screen.

Figure 5-13 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen. If the expiration date is set before
the current system date, when you exit the screen, a prompt of reagent expiry will pop up and
you need to change a new container of reagent.

5.2.2 User management


The operator in the common user level can only change his/her own information at the “User
management” screen.

Entering the “User” screen


CLICK the “User” button at the “Setup” screen to enter the “User” screen shown in Figure
5-14.

5-10
Customizing the Analyzer Software

Figure 5-14 “User” screen (common user)

You can view and change only your own information at this screen.

Changing information
CLICK the “Modify” button and the “Modify information” screen shown in Figure 5-15 will
pop up.

5-11
Customizing the Analyzer Software

Figure 5-15 “Modify information” screen

enter the log-in password of the current user in the “Old password” box and CLICK “OK”. If
the password entered does not consist with the password of the current user, a dialog box
shown in Figure 5-16 will pop up, prompting “Invalid password!”. CLICK “OK” to close the
dialog box and reenter the password.

Figure 5-16 Dialog box

If the password entered is correct, the screen will be shown as Figure 5-17.

5-12
Customizing the Analyzer Software

Figure 5-17 “Modify information” screen

enter the new information (the identity or position of the operator or nothing here ), user name
and password of the current operator, CLICK the “OK” button to save the changes and return
to the “User” screen. CLICK the “Cancel” button to abort the changes and return to the “User”
screen.

Exiting the “User” screen


CLICK the “Main” or “Count” button at the bottom of the screen to exit the “User
management” screen.

5-13
Customizing the Analyzer Software

5.3 Administrator

When you log in as an administrator, the “Setup” screen will be shown as Figure 5-18.

Figure 5-18 “Setup” screen

5.3.1 Settings

RBC count time


At the “RBC count time” screen, you can set the RBC count time. If the count time is greater
than the time set, an RBC clogging will be flagged.

„ Entering the “RBC count time” screen

At the “Setup” screen, CLICK the “RBC count time” button to enter the screen shown in
Figure 5-19.

5-14
Customizing the Analyzer Software

Figure 5-19 “RBC count time” screen

„ Setting the RBC count time

The valid count time ranges from 8.0 to 18.0 seconds. The default setting is 10.0 seconds.
Enter the desired numbers in the “RBC count time” box. The analyzer will have one decimal
automatically.

„ Setting the START signal delay of the volume measurement

The valid delay ranges from 4.0 to 7.0 seconds. The default setting is 5.5 seconds.
Enter the desired numbers in the “Start delay” box. The analyzer will have one decimal
automatically.

„ Exiting the “RBC count time” screen

To exit the “RBC count time” screen, CLICK any other button at the left of the screen or any
button at the bottom. If the data entered are out of the valid range, a dialog box shown in
Figure 5-20 will pop up, prompting “Invalid input, exist?”.

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Customizing the Analyzer Software

Figure 5-20 Dialog box

CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” button
to reenter the valid data.

If the data entered is valid, a dialog box shown in Figure 5-21 will pop up when you exit the
screen.

Figure 5-21 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Ref. range
The “Ref. Range” screen is where you view and set 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: General, Man, Woman, Child and
Neonate. You can also customize another 5 groups. The default setting is “General”. The
recommended limits are provided for your reference only. To avoid misleading parameter flags,
be sure to set the patient limits according to the characteristics of your local population.

„ Entering the “Ref. Range” screen

At the “Setup” screen, CLICK the “Ref. Range” button to enter the screen shown in Figure
5-22.

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Customizing the Analyzer Software

Figure 5-22 “Ref. Range” screen

The default expected results of each parameter are displayed on the screen, 12 parameters a
screen. You can DRAG SCROLL BAR to browse. At the right side of the screen, there are
General, Man, Woman, Child, Neonate groups and 5 customized groups.

„ Setting the expected results

1. At the “Ref. Range” screen, CLICK the corresponding radio button of the “General”,
“Man”, “Woman”, “Child”, “Neonate” or the customized group to select the desired group.

2. DRAG SCROLL BAR , CLICK the “H limit” or “L limit” of the parameter you want to
customize.

3. Enter the desired numbers.

4. If you want to resume the factory default after the changing, see Heading 10.6 Using the
“Initialization” Program (in the Administrator Level) for details.

„ Exiting the “Ref. Range” screen

To exit the “Ref. Range” screen, CLICK any other button at the left of the screen or any button
at the bottom. If the data entered is invalid, a dialog box shown in Figure 5-23 will pop up,
prompting “Invalid input, exist?”.

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Customizing the Analyzer Software

Figure 5-23 Dialog box

CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” button
to reenter the valid data.

If the data entered is valid, a dialog box shown in Figure 5-24 will pop up when you exit the
screen.

Figure 5-24 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Ref. units
See Table 5-1 for the available units for every parameter groups. You can choose the desired
unit.

Table 5-1 Ref. unit

Parameter group Ref. format Ref. unit Remarks


WBC,Lymph#, ***.** 109/L Default
Mon#,Bas# ***.** 103/uL /
Eos#,Neu# **** * 102/uL /
ALY#、LIC# ***.** /nL /

RBC **.** 1012/L Default


**.** 106/uL /
**** 104/uL /
**.** /pL /
HGB *** g/L Default
**.* g/dL /

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Customizing the Analyzer Software

**.* mmol/L /

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


***.* um3 /

Lymph% , Mon% , **.* % Default


Bas%,
Eos%,Neu%
ALY%、LIC%
PLT **** 109 /L Default
3
**** 10 /uL /
4
***.* 10 /uL /
**** /nL /

MPV ***.* fL Default


3
***.* um /
PDW **.* None Default
PCT .*** % Default
*.** mL/L /
MCH *.*** pg Default

**.** fmol /
MCHC **** g/L Default
***.* g/dL /
***.* mmol/L /
HCT **.* % Default
.*** L/L /

RDW-CV **.* % Default

„ Entering the “Ref. unit” screen

At the “Setup” screen, CLICK the “Ref. unit” button to enter the screen shown in Figure 5-25.

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Customizing the Analyzer Software

Figure 5-25 “Ref. unit” screen

At the screen, parameters sharing the same unit are in one group, with the first parameter
black and the others gray. Units available for the current group are shown at the right side of
the screen.

Note: Since the unit of MCH varies with the unit of MCHC and HGB, you cannot change the
unit of MCH.

„ Setting ref. unit

1. At the “Ref. unit” screen, CLICK the ref. unit you want to set.

2. CLICK the radio button of the desired unit at the right side of the screen to select a new
unit.

„ Exiting the “Ref. unit” screen

To exit the “Ref. unit” screen, CLICK any other button at the left of the screen or any button at
the bottom. A dialog box shown in Figure 5-26 will pop up.

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Customizing the Analyzer Software

Figure 5-26 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Print
This analyzer supports laser printers (HP), jet printers (color/black and white, HP) and impact
printers (EPSON). You can select the print format and set the print title at the “Print” screen.

z If the impact printer is connected when the analyzer is on, you need to
restart the analyzer to use the printer.

„ Entering the “Print” screen

At the “Setup” screen, CLICK the “Print” button to enter the screen shown in Figure 5-27.

Figure 5-27 “Print” screen

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Customizing the Analyzer Software

„ Selecting the print format for the analysis results

The analyzer provides four print formats in the pull-down list: 23 paras with H&S, 23 paras
without H&S, 23 paras compact and 13 paras with H. The default format is 23 paras with H&S.

„ Setting the print title

Enter the print title in the “Title” box.

z Be sure to check the printout if the print format is changed or a new printing
title is entered.

„ Setting paper size

You can select the desired paper size in the pull-down list.

„ Setting number of copies

If you want multiple copies of the patient report to be printed, yo ucan enter the desired number
(1 - 9) into the “Copies” field. The default number is 1.

z This option applies to patient reports only.

„ Auto-print

If the auto-print function is on, the analyzer can automatically print the analysis results when
the results are shown at the “Count” screen.
CLICK “On” to activate the auto-print function; CLICK “Off” to deactivate it.

„ Print flag

You can select whether to print out the flag in the report.

Click “On” to print report with flag.

Click “Off” to print report without flag.

„ Exiting the “Print” screen

To exit the “Print” screen, CLICK any other button at the left of the screen or any button at the
bottom. A dialog box shown in Figure 5-28 will pop up.

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Customizing the Analyzer Software

Figure 5-28 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Transmission
You can set the IP address and DNS address at the “Com.” screen.

„ Entering the “Com.” screen

At the “Setup” screen, CLICK the “Com.” button to enter the screen shown in Figure 5-29.

Figure 5-29 “Com.” screen

„ Setting the IP address

Enter the legal addresses in the “IP address(I)”, “Subnet mask(U)” and “Default gateway(D)”
boxes respectively.

„ Auto-communication

5-23
Customizing the Analyzer Software

If the auto-communication function is on, the analyzer can automatically communicate the
analysis results when the results are shown at the “Count” screen.
CLICK “On” to activate the auto communication function; CLICK “Off” to deactivate it.

„ MAC address

The MAC address of the analyzer is displayed here.

„ Setting the communication type

Two commucation types are provided for you to select from.


Click the “Uni-directional LIS”, then the measurement mode should be selected by the
operator on the analyzer; Click the “Bi-directional LIS”, then the measurement mode will be
obtained by inquiring the LIS system.

z Be sure that the 10Mbps full duplex mode or auto-detecting function is


supported by the computer used for the LIS communication.

„ Exiting the “Com.” screen

To exit the “Com.” screen, CLICK any other button at the left of the screen or any button at the
bottom. If the setting is invalid, a dialog box as follows will pop up.

Figure 5-30 Dialog box

CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.

If the setting is valid, a dialog box shown in Figure 5-31 will pop up.

5-24
Customizing the Analyzer Software

Figure 5-31 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Gain
You can adjust each digital pot at the “Gain” screen. It is not recommended to adjust gains
frequently.

„ Entering the “Gain” screen

At the “Setup” screen, CLICK the “Gain” button to enter the screen shown in Figure 5-32.

Figure 5-32 “Gain” screen

„ 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.
Then

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

At the “Gain” screen, CLICK the current value of the “RBC” and enter the new value so that

5-25
Customizing the Analyzer Software

RBC “Factor” is as close to 109.8% as possible.

„ Setting the HGB gain

You can adjust the HGB blank voltage by adjusting the HGB gain. Normally the HGB blank
voltage should be within 2.0 – 2.4V (2.28V is recommended). Follow the instruction below to
adjust it.

At the “Gain” screen, CLICK the current value of the “HGB” and enter the new value so that
the HGB blank voltage falls between 2.0 – 2.4V.

„ Exiting the “Gain” screen

To exit the “Gain” screen, CLICK any other button at the left of the screen or any button at the
bottom. If the data entered are out of the valid range, a dialog box shown in Figure 5-33 will
pop up, prompting “Invalid input, exit?”.

Figure 5-33 Dialog box

CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.

If the data entered is valid, a dialog box shown in Figure 5-34 will pop up when you exit the
screen.

Figure 5-34 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

5-26
Customizing the Analyzer Software

Code
To facilitate the operation, you can set some simple codes for frequently used names of
departments or senders. In this case, when editing sample information at the “Count” and
“Review” screen, you can simply enter the corresponding code for the department or sender.

„ Entering the “Code” screen

At the “Setup” screen, CLICK the “Code” button to enter the screen shown in Figure 5-35.

Figure 5-35 “Code” screen

The created code and the name of the department or sender will be displayed at the screen,
10 codes a screen. If out of 10 codes are created, DRAG SCROLL BAR to view the rest
codes.

„ Creating the new code information

CLICK the “Dept.” or “Sender” radio button. If you have selected the “Sender”, CLICK the
“New” button and a dialog box shown in Figure 5-36 will pop up. Enter the desired information
in the “Code” and “Name” box. If you have selected the “Dept”, CLICK the “New” button and a
dialog box shown in Figure 5-37 will pop up. Enter the desired information in the “Code” and
“Dept.” box.

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Customizing the Analyzer Software

Figure 5-36 New dialog box (1)

If you have selected the “Dept.”, CLICK the “New” button and a dialog box shown below will
pop up. Enter the desired information in the “Code” and “Dept.” box.

Figure 5-37 New dialog box (2)

CLICK the “OK” button to save the changes and return to the “Setup” screen. CLICK the
“Cancel” button to abort the changes and switch to the “Setup” screen.

„ Editing the code information

You can change the created code information.

CLICK the “Dept.” or “Sender” radio button. CLICK the code you want to change and CLICK
the “Edit” button. A dialog box shown in Figure 5-38 will pop up.

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Customizing the Analyzer Software

Figure 5-38 Editing dialog box

Enter the new information in the corresponding box. CLICK the “OK” button to save the
change. A dialog box of “Modification succeed!” shown below will pop up. CLICK the
“Cancel” button to abort the change and close the dialog box.

Figure 5-39 Dialog box

„ Deleting the code information

You can delete the created code information.

CLICK the “Dept.” or “Sender” radio button. CLICK the code you want to delete and CLICK
the “DELETE” button. A dialog box shown in Figure 5-40 will pop up.

Figure 5-40 Deleting dialog box

CLICK “OK” to confirm the deletion and close the dialog box. CLICK “Cancel” to abort the
deletion and close the dialog box.

5-29
Customizing the Analyzer Software

z You can delete the only one piece of the code information each time.

Auto-protect
„ Entering the “Auto-protect” screen

At the “Setup” screen, CLICK the “Auto-protect” button to enter the screen shown in Figure
5-41.

Figure 5-41 “Auto-protect” screen

„ Setting the Liquid Saver

You can set here when to start the auto-protect procedure after the relevant fluidic operation
stops. Enter the desired time ranging from 15 to 30 minutes into the “Standby interval” box.

„ Checking the information of the run-based maintenance

You can check here the accumulated runs from the last time the cleanser cleaning procedure
or the SRV cleaning procedure was conducted and the required number of runs to trigger the
auto-maintenance procedure again.

„ Exiting the “Auto-protect” screen

To exit the “Auto-protect” screen, CLICK any other button at the left of the screen or any button

5-30
Customizing the Analyzer Software

at the bottom. If the data entered are out of the valid range, a dialog box shown in Figure 5-42
will pop up.

Figure 5-42 Dialog box

CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-43 will pop up when you exit the
screen.

Figure 5-43 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Input options
„ Entering the “Input options” screen

At the “Setup” screen, CLICK the “Input options” button to enter the screen shown in Figure
5-44.

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Customizing the Analyzer Software

Figure 5-44 “Auto-protect” screen

„ Adding or deleting available input languages

You can set the input language for the pop-up keyboard at the “Input options” screen.
CLICK the desired language from the “All keyboard layouts” box, and then CLICK the “Add”
button to add the selected language to the “Available keyboard layouts”.
CLICK the language from the “Available keyboard layouts” box, and then CLICK the “Delete”
button to delete the selected language from the “Available keyboard layouts”.

„ Exiting the “Input options” screen

To exit the “Input options” screen, CLICK any other button at the left of the screen or any
button at the bottom. A dialog box shown in Figure 5-45 will pop up.

Figure 5-45 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

5-32
Customizing the Analyzer Software

Autoloader (optional)
„ Entering the “Autoloader” screen

At the “Setup” screen, CLICK the “Autoloader” button to enter the screen shown in Figure
5-46.

Figure 5-46 “Autoloader” screen

„ Autoloader stop condition

You can set conditions to stop the autoloader at the “Autoloader” screen.

z To avoid personal injury and analyzer damage, setting the autoloader stop
conditions is recommended.

1. Sample ID reading error


If this condition is activated, the analyzer will stop autoloading and move the current rack out
once the sample label can not read.
CLICK the “Sample ID reading error” check box to activate it. CLICK the check box again to
deactivate it.

2. Measurement mode inquiry failed


If this condition is activated, the analyzer will stop autoloading once the the measurement
mode can not be obtained by inquiring the LIS system.

5-33
Customizing the Analyzer Software

„ ID setup for the empty tube position

In the autoloading mode without using the built-in barcode scanner, you can select the desired
ID setup mode for the empty tube position detected.
If you CLICK “keeps the same”, in case of empty tube position detected, the next sample ID
keeps the same.
If you CLICK “increases automatically”, in case of empty tube position detected, the next
sample ID increases automatically.

„ Match worklist per tube position

When running samples in autoloading mode without the built-in barcode scanner, you can
match the sample results with the worklist with uncontinuous sample IDs by setting here.
Click “Yes” to activate the function that the sample results will be matched with the worklist per
tube position.
Click ”No” to deactivate the function.

„ Exiting the “Autoloader” screen

To exit the “Autoloader” screen, CLICK any other button at the left of the screen or any button
at the bottom. If the data entered are out of the valid range, a dialog box shown in Figure 5-47
will pop up.

Figure 5-47 Dialog box

CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-48 will pop up when you exit the
screen.

Figure 5-48 Dialog box

5-34
Customizing the Analyzer Software

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

Barcode (optional)
You can set the barcode symbologies at the “Barcode” screen.
This analyzer accepts 6 barcode symbologies: CODE 39, CODE 93, CODEBAR, CODE 128,
UPC/EAN and ITF (cross 25 code).

„ Entering the “Barcode” screen

At the “Setup” screen, CLICK the “Barcode” button to enter the screen shown in Figure 5-49.

Figure 5-49 “Barcode” screen

„ Setting the symbologies and the character lengths

CLICK the radio button of the desired symbology and enter the character length in the “digits”
box. The character length of the first 4 symnologies is valid ranging from 1 to 15, while the
character length of the ITF is valid ranging from the even numbers of 2 to 14. You cannot set
the character length of the UPC/EAN symbology, since it has a fixed length of 8 or 13
characters.

z Be sure that the symbology and the character length set match the actual
bar-code.

5-35
Customizing the Analyzer Software

„ Exiting the “Barcode” screen

To exit the “Barcode” screen, CLICK any other button at the left of the screen or any button at
the bottom. If the data entered are out of the valid range, a dialog box shown in Figure 5-50 will
pop up.

Figure 5-50 Dialog box

CLICK “Yes” to abort the changes and switch to the corresponding screen. CLICK “No” to
reenter the valid data.
If the data entered is valid, a dialog box shown in Figure 5-51 will pop up when you exit the
screen.

Figure 5-51 Dialog box

CLICK “Yes” to save the changes and switch to the corresponding screen. CLICK “No” to
abort the changes and switch to the corresponding screen.

5.3.2 User management

Entering the “User” screen


At the “Setup” screen, CLICK the “User” button to enter the “User” screen shown in Figure
5-52.

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Customizing the Analyzer Software

Figure 5-52 “User” screen (administrator)

This screen shows the information of all administrators and common users. The default user is
the current user. At the “User” screen, the operator can not only change his/her own
information, but also can create, delete and change information of other users.

Creating a new user


CLICK the “New” button at the bottom of the “User” screen and a dialog box shown in Figure
5-53 will pop up.

5-37
Customizing the Analyzer Software

Figure 5-53 Dialog box of creating a new user

CLICK the “User” or “Administrator” radio button to add the desired user.

Enter the desired information in each box. CLICK the “OK” button to save the changes and
close the dialog box. The new user information will be displayed at the “User” screen. CLICK
the “Cancel” button to close the dialog box without saving the changes.

z Do not repeat any name when you create users.

Deleting a user
CLICK the user you want to delete, and then CLICK the “DELETE” button at the bottom of the
screen. A dialog box shown in Figure 5-54 will pop up.

Figure 5-54 Dialog box of deleting a user

CLICK “Yes” to confirm the deletion and close the dialog box. CLICK “No” to abort the deletion

5-38
Customizing the Analyzer Software

and close the dialog box.

z You can delete only one piece of user information each time.

Changing information
CLICK the user you want to change, and then CLICK the “Modify” button. The “Modify
information” screen shown in Figure 5-55 will pop up.

Figure 5-55 “Modify information” screen

Enter the log-in password of the current user in the “Old password” box and CLICK “OK”. If
the password entered does not consist with the password of the current user, a dialog box
shown in Figure 5-56 will pop up, prompting “Invalid password!”. CLICK “OK” to close the
dialog box and reenter the password.

Figure 5-56 Dialog box

If the password entered is correct, the screen will be shown as Figure 5-57.

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Customizing the Analyzer Software

Figure 5-57 “Modify information” screen

Enter the new information (you can enter the identity or position of the operator or nothing
here ), user name and password of the current operator, CLICK the “OK “ button to save the
changes and close the dialog box. CLICK the “Cancel” button to abort the changes and close
the dialog box. Note that when changing the information of other users, you can only change
the operators’ name and information, the user names and passwords cannot be changed.

Exiting the “User” screen


CLICK the “Main” or “count” button at the bottom of the screen to exit the “User” screen.

5-40
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

Run Samples

Shutdown

6-1
Operating Your Analyzer

6.2 Initial Checks

Perform the following checks before turning on the analyzer.

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.

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.

1. Checking the waste container

Check and make sure the waste container is empty.

2. Checking tubing and power connections

Check and make sure the reagents, waste and pneumatic unit tubes are properly connected
and not bent.

Check and make sure the power cords of the analyzer and the pneumatic unit are properly
plugged into the power outlet.

3. Checking the printer (optional)

Check and make sure enough printer paper is installed.

Check and make sure the power cord of the printer is properly plugged into power outlet.

Check and make sure the printer is properly connected to the analyzer.

4. Checking the scanner, keyboard or mouse (all optional)

Check and make sure the scanner, keyboard or mouse is properly connected to the analyzer.

6-2
Operating Your Analyzer

6.3 Power-on

Place the power switch at the back of the pneumatic unit in the ON position (I), and then place
the power switch at the left side of the analyzer in the ON position (I). The power indicator light
will be on. Press the power button to turn on the analyzer. The power indicator light will turn
from orange to green. The analyzer will sequentially do the self-test and initialize the systems
and the whole process lasts 4 to 12 minutes. Time needed for initializing the fluidic systems
depends on how the analyzer was previously shut down. After the initialization process, the
system will enter the “Main” screen and the login dialog box, shown in Figure 6-1 will pop up.

Figure 6-1 Login dialog box

Enter the current user name and the password respectively into the “User Name” box and the
“Password” box. CLICK the “OK” button and the user level prompt will pop up. CLICK the
“OK” button to enter the “Main” screen shown in Figure 6-2.

6-3
Operating Your Analyzer

Figure 6-2 “Main” screen

z Since the pneumatic unit is controlled by the analyzer, the power switch of
the pneumatic unit can be kept in the ON position (I).

z The system opens different function for the user according to the user level.
The user level depends on the user name and the password when the user
logs in.

z If user switching is necessary, CLICK the “Logout” icon at the “Main” screen.
Enter the desired user name and the password into the popup dialog box
and CLICK the “OK” button to log in.

6-4
Operating Your Analyzer

6.4 Daily Quality Control

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

6-5
Operating Your Analyzer

6.5 Entering the “Count” screen

At the “Main” screen, CLICK the “Count” icon to enter the “Count” screen shown in Figure
6-3.

Figure 6-3 “Count” screen

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

According to different functions, the “Count” screen can be divided into several areas as
follows.

„ Title area

The Title area displays the title of the current screen, which, in case of Figure 6-3, is “Count”.
CLICK it and the help information of the “Count” screen will appear.

6-6
Operating Your Analyzer

„ Error message area

When error(s) is reported, the Error message area displays error messages one by one,
alternating every two seconds. The severity levels are discriminated from high to low by 5
background colors: red, orange, yellow, green and blue. CLICK it to display the
troubleshooting information.

„ Status area

From left to right, they are:

1. Analysis status

The Analysis status area shows three statuses in different icons: red icon for waiting, green
icon for ready and flickering green icon for running.

z If a STAT sample is to be run, yellow icon represents ready and flickering


yellow icon represents running instead.

Waiting: it means the analyzer is not ready for the next run yet.
Ready: it means this analyzer is ready and you can proceed to analyze the next sample.
Running: it means this analyzer is analyzing a sample.

2. Print status

Icons are used to display the current status of the printer.


Gray icon: The printer is not connected to the analyzer yet.
Color icon: The printer is ready for print.
Flickering color icon: The printer is printing.

3. Transmission status

Icons are used to display the current status of the transmission.


Gray icon: The communication device is not connected to the analyzer yet.
Color icon: The communication device is ready for transmission.
Flickering color icon: The communication device is on transmission.

4. X-B QC on/off status

Icons are used to display the on/off status of the X-B analysis, gray icon for off and color icon
for on.

5. Input language status and switch

6-7
Operating Your Analyzer

Icon is used to display the current input language of the pop-up keyboard and you can switch
to other language by clicking it.

The meanings of the abbreviations of the language are shown below.

EN CN FR DE IT ES RU PT TR

English-US Chinese-CN French German Italian Spanish Russian Portuguese Turkish

z Please select the desired input language properly. Improper input language
may lead to confused screen display.

6. System time

It displays the system time (in the 24-hour format)

„ Analysis result area

It displays the analysis result of the current sample (including histograms and scattergrams,
etc.).

„ Button area

CLICK buttons here and the corresponding screens or dialog boxes will pop up, or the
corresponding functions will be carried out. CLICK the “>>>“ or “<<<“ button to scroll buttons.

„ Sample information area

It displays the sample information of the current sample and the next sample. In the “Next
sample” area, different colors are used to discriminate 3 operating modes: blue for AL-WB(or
CT-WB), green for OV-WB and yellow for OV-PD.

During the startup, the analyzer will automatically do the background check and display the
result in Analysis result area of the “Count” screen. A “Background Abnormal” error will
appear if the result exceeds the normal background. Refer to Appendix B Specifications for
normal background of parameters.

z Background count indicates the measure of the particle and electrical


interference.

6-8
Operating Your Analyzer

z The sample ID for the background check is “0”.

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

If any error occurs during the startup, the analyzer will display the error messages in the Error
message area of the screen. You should remove all the errors before running any sample. See
Chapter 11 Troubleshooting Your Analyzer for solutions.

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Operating Your Analyzer

6.6 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, centrifugal tubes and borosilicate glass capillary
tubes.

6.6.1 Whole blood samples


Collect and handle the whole blood sample as follows:

1. Collect venous blood with a K2EDTA(1.5 - 2.2mg/mL)anticoagulant collection tube.

2. Mix the sample according to your laboratory’s protocol.

z Be sure to collect at least 1mL of whole blood sample when running sample
in the open vial sampling mode; at least 2mL of whole blood sample in the
closed-tube sampling mode and autoloading mode.

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Operating Your Analyzer

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
it.

6.6.2 Prediluted samples


Collect and handle the prediluted sample as follows:

1. At the “Count” screen, CLICK the “Mode” button and the “Work mode” dialog box shown
in Figure 6-4 will pop up.

Figure 6-4 “Work mode” dialog box

2. In the “Work mode” dialog box, CLICK the “OV-PD” radio button.

3. CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.

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

5. CLICK the “OK” button to save the change and return to the “Count” screen.

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Operating Your Analyzer

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z The default ID of the sample to be run in the “OV” mode is determined by the
setup of the Entry of next sample ID. See Heading 5.2.1 Settings for the
setup method.

z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.

z WBC differential results obtained in the predilute mode are for reference
only.

6. CLICK the “Diluent” button at the “Count” screen, and a dialog box will pop up to prompt
that the analyzer is preparing for adding diluent. After the preparation, the dialog box will
close automatically and the other dialog box shown in Figure 6-5 will pop up.

Figure 6-5 Dialog box of dispensing diluent

7. Present a clean centrifugal tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 6-6 shows, to avoid spills and bubbles. Press the aspirate
key to dispense 120µL of diluent (the dispensing volume is controlled by the analyzer) into
the tube. The dispensing progress will be displayed on the screen.

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Operating Your Analyzer

Figure 6-6 Dispensing diluent

8. When you hear the beep, it means the dispensing is finished. Remove the centrifugal tube.

9. Add 40µL of capillary blood to the diluent, close the tube cap and shake the tube to mix the
sample.

10. After the prediluted sample is prepared, CLICK the “OK” button to clean the sample probe.
The cleaning progress will be displayed on the screen. After the cleaning is finished, the
dialog box closes automatically.

z You can also aspirate 120µL of diluent by pipette into the tube.

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.

z Repeat step 7 to 8 and you can prepare more prediluted samples.

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Operating Your Analyzer

6.7 Open Vial Sampling Analysis

6.7.1 Selecting Work Mode


At the “Count” screen, CLICK the “Mode” button and the dialog box shown in Figure 6-7 will
pop up.

Figure 6-7 “Work mode” dialog box

1. CLICK the “OV-WB” or the “OV-PD” radio button in the “Work mode” dialog box to select
the desired work mode.

2. CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.

3. ENTER the sample ID of the next sample into the “ID” box.

4. CLICK the “OK” button to save the changes and return to the “Count” screen.

z For bi-directional LIS mode, the measurement mode will be obtained by


inquring the LIS system, so you don’t need to set the “CBC” or
“CBC+5DIFF” mode.

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z The default ID of the sample to be run in the “OV” mode is determined by the
setup of the Entry of next sample ID. See Heading 5.2.1 Settings for the
setup method.

z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and

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Operating Your Analyzer

PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the count results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.

z Sample ID up to 15 alphanumeric characters may be entered into the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

6.7.2 Entering Work List Information


In the mode of open vial sampling, you can enter the work list information for the next sample
before running it.

z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.

z If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.

At the “Count” screen, CLICK the “Work list” button and the dialog box shown in Figure 6-8
will pop up. Enter the work list information in the box for the next sample.

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Operating Your Analyzer

Figure 6-8 Work List

z For bi-directional LIS mode, only the sampling mode and blood mode will be
displayed in the “Current” field, and you don’t need to set the “CBC” or
“CBC+5DIFF” measurement mode.

z You can edit the “Tester” box at the review screen only after the analysis is
finished.

z Sample ID up to 15 alphanumeric characters may be entered into the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z The previous operating mode and sample ID are default values in the “Work
list”. Modify them as instructed if necessary.

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z The default ID of the sample to be run in the “OV” mode is determined by the
setup of the Entry of next sample ID. See Heading 5.2.1 Settings for the
setup method.

z To correct erroneous entries, DELETE and ENTER the desired information.

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Operating Your Analyzer

„ Selecting work mode

CLICK the “WB” or “PD” radio button. CLICK the “CBC” or “CBC+5DIFF” radio button to
select the work mode.

„ Entering sample ID

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

„ Selecting ref. range

SELECT the ref. range from the “ref. range” pull-down list for the next sample. Different sets
of ref. range are provided. The analyzer will judge and flag the results out of range according to
the corresponding reference range. See Chapter 5 Customizing the Analyzer Software for
how to set the reference range.

„ Entering the patient name

Enter the patient name into the “Name” box.

„ Selecting patient sex

SELECT the desired item from the “Sex” pull-down list.

„ Entering the patient age

This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. 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 one month and the fourth for the neonatal no older than 24 hours. You
can choose only one of the four ways to enter the patient age.

SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. Enter the patient
age after “Age”.

„ Entering the chart number

Enter the number of the patient’s medical record into the “Chart No.” box.

„ Entering the department/area name

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

„ Entering the bed number

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Operating Your Analyzer

Enter the number of the patient’s bed into the “Bed No.” box.

„ Entering the sampling time

Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time).

„ Entering the name of the tester

To enter the name of the person who sent the sample for analysis, 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).

„ Entering the delivery time

Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time).

„ Entering comments

Enter comments in the “Comments” box.

„ Copy

CLICK the “Copy” button to copy the information of the last sample to the current work list,
except the information of “Current”, “Tester” and “ID”. (“Current” remains unchanged,
“Tester” appears to be the current login user and “ID” increases automatically by 1.)

„ “OK” button

When you have finished entering the work list information, CLICK the “OK” button to save the
changes and return to the “Count” screen. “Switching mode to pre-dilute, please wait...”
will pop up when you switch from other modes to the “OV-PD” mode.

„ “Cancel” button

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

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Operating Your Analyzer

6.7.3 Running the samples

z Samples, controls, calibrators and waste are potentially infectious. Wear


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

z The sample 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 disposable products.

z Do not open the front cover after the analysis starts.

z The sample probe should be kept away from the tube bottom, when the
probe is aspirating sample. Otherwise, the aspirated volume may be
imprecisely.

z The probe tip should not contact the sample tube. Otherwise, the blood may
spill.

z Proper reference range shall be selected at the “Setup” screen before


analysis. Otherwise, the results may be flagged erroneously.

z The default ref. range is “General” if you run a sample immediately after the
operating mode setting. After the analysis, the analyzer will flag, if any,
according to the reference range of “General”.

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Operating Your Analyzer

Running whole blood samples

Figure 6-9 “Count” screen 1

At the “Count” screen shown in Figure 6-9, do as follows to run whole blood samples.

1. Be sure the “Mode” of the “Next sample” is “OV-WB” and the analysis status icon is
green.

2. Present the whole blood sample to the sample probe.

3. Press the aspirate key to start the analysis.

4. The sample probe will automatically aspirate 120µL of sample. When you hear the beep,
remove the sample tube. The analyzer will automatically run the sample.

5. When the analysis is finished, the results will be displayed on the screen. The analyzer will
be ready for the next analysis.

6. Run the rest samples as instructed above.

z During the analysis, CLICK the “Work list” button to enter the information for
the next sample.

z If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area

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Operating Your Analyzer

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

z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.

z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See
Heading 5.2.1 Settings for the setup method.

Running prediluted samples

Figure 6-10 “Count” screen 2

At the “Count” screen shown in Figure 6-10, do as follows to run prediluted samples.

1. Be sure the “Mode” of the “Next sample” is “OV-PD” and the analysis status icon is green.

2. Present the prediluted sample (uncapped) to the sample probe.

3. Press the aspirate key to start the analysis.

4. The sample probe will automatically aspirate 120µL of sample. When you hear the beep,
remove the sample tube. The analyzer will automatically run the sample.

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

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Operating Your Analyzer

be ready for the next analysis.

6. Run the rest samples as instructed above.

z During the analysis, CLICK the “Mode” button or the “Work list” button to
select the operating mode for the next sample.

z If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.

z If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.

z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.

z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See
Heading 5.2.1 Settings for the setup method.

6.7.4 Special functions

Print
CLICK the “Print” button at the bottom of the screen to print the analysis results for the current
sample.

Automatic saving of analysis results


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

Parameter flags
„ If parameter is followed by an “H” or “L”, it means the analysis result has exceeded the
upper or lower limit of the reference range, but still within the display range.

„ If parameter is followed by an “?”, it means the analysis result is suspect.

„ If you see *** as opposed to the result, it means the result is either invalid or out of the
display range. If the WBC result of whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 109/L, this analyzer will not perform the differential analysis and all the related

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Operating Your Analyzer

parameter values will be non-numeric (***).

z The result of the background check will not be flagged on parameters,


abnormal blood cell differential or morphology.

Flags of Abnormal Blood Cell Differential or Morphology


The analyzer will flag abnormal or suspect WBC, RBC/HGB and PLT according to the
scattergrams and histograms. See Table 6-1 for flags. Table 6-2 shows how the flags affect
parameter results.

Table 6-1 Flags of Abnormal Blood Cell Differential or Morphology

WBC Flag

Abnormal
Flag Meaning Judgment criterion
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
Leucocytosis High WBC analysis results WBC > 18.0×109/L
Leucopenia Low WBC analysis results WBC < 2.5×109/L
Neutrophilia High neutrophils analysis NEUT# > 11.0×109/L
results
Neutropenia Low neutrophils analysis NEUT# < 1.0×109/L
results
Lymphocytosis High lymphocytes analysis LYMPH# > 4.0×109/L
results
Lymphopenia Low lymphocytes analysis LYMPH# < 0.8×109/L
results
Monocytosis High monocytes analysis MONO# > 1.0×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L
results
Basophilia High basophils analysis BASO# > 0.2×109/L
results

Suspect
Flag Meaning Judgment criterion
Asp. Abn./Abn. Sample? The aspiration may be Results of primary
abnormal, or the sample itself parameters are severely low

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Operating Your Analyzer

may be abnormal simultaneously


WBC Abn. WBC numbers of BASO and WBC numbers of BASO and
DIFF channels are DIFF channels are
inconsistent. The sample inconsistent.
may be abnormal, or the
analyzer may be abnormal.
Left Shift? Left shift may exist. Many scatter-points exist in
the left shift area of the
scattergram.
Immature Cell? Immature cells may exist. The proportion of immature
cells is greater than 2.5%.
Abn./Atypical Lym? Abnormal lymphocytes or The proportion of
atypical lymphocytes may abnormal/atypical
exist. lymphocytes is greater than
2%.
RBC Lyse Resist? RBC hemolysis may be Scatter-points are thick
incomplete. between the lymphocytes
and ghost cells areas of the
scattergram.

RBC/HGB Flag

Abnormal
Flag Meaning Judgment criterion
RBC Abn. Distribution Abnormal RBC scattergram RBC scattergram is
abnormal.
Anisocytosis Sizes of RBCs are dissimilar RDW-SD>64 or RDW-CV>22
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Erythrocytosis Increased RBCs RBC# > 6.50×1012/L
Anemia Anemia HGB < 90g/L
Hypochromia Hypochromia MCHC < 29.0g/dL
Diamorphologic RBC diamorphologic Two or two more peaks in the
distribution RBC histogram.

Suspect
Flag Meaning Judgment criterion
RBC or HGB Abn.? Results of RBC or HGB may Analyzing and comparing
be inaccurate results of HGB and RBC
HGB Abn./Interfere? HGB results may be Calculating and comparing
abnormal, or interference special analysis parameters
may exist

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Operating Your Analyzer

PLT Flag

Abnormal
Flag Meaning Judgment criterion
Thrombocytosis PLTs increase PLT > 600×109/L
Thrombocytopenia PLTs decrease PLT < 60×109/L
PLT Abn Distribution PLT histogram distribution is PLT histogram is abnormal.
abnormal.

Suspect
Flag Meaning Judgment criterion
PLT Clump? PLT clump may exist. Calculating and comparing
special analysis parameters

Table 6-2 How the flags of Abnormal Blood Cell Differential or Morphology

affect parameter results

OV-WB Prediluted
Cell Differential Flag
CBC CBC+5DIFF CBC CBC+5DIFF

WBC Asp. Abn./Abn. Sample? × × × ×

WBC Abn × √ × √

RBC Lyse Resist? × √ × ×

WBC Abn Scattergram × √ × ×

Left Shift? × √ × ×

Immature Cell? × √ × ×

Abn./Atypical Lym? × √ × ×

Leucocytosis √ √ √ √

Leucopenia √ √ √ √

Neutrophilia × √ × ×

Neutropenia × √ × ×

Lymphocytosis × √ × ×

Lymphopenia × √ × ×

Monocytosis × √ × ×

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Operating Your Analyzer

Eosinophilia × √ × ×

Basophilia × √ × ×

Asp. Abn./Abn. Sample? √ √ √ √

RBC or HGB Abn.? √ √ √ √

HGB Abn./Interfere? √ √ × ×

RBC Abn. Distribution √ √ × ×

Anisocytosis √ √ × ×

Microcytosis √ √ √ √
RBC/HGB
Macrocytosis √ √ √ √

Erythrocytosis √ √ √ √

Anemia √ √ √ √

Hypochromia √ √ √ √

Diamorphologic √ √ × ×

Asp. Abn./Abn. Sample? √ √ √ √

PLT Clump? √ √ × ×

Thrombocytosis √ √ √ √
PLT
Thrombocytopenia √ √ √ √

PLT Abn Distribution √ √ × ×

Small PLT √ √ × ×

Remark “√” affected ,“×” not affected

Parameters Affected
Flag Abnormal Sub-populations
Neu Lym Mon Eos Bas
WBC Abn NEU,LYM *.** *.**
Scattergram
NEU,MON *.** *.**
NEU,EOS *.** *.**
NEU,BASO *.** *.**

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Operating Your Analyzer

LYM,MON *.** *.**


LYM,EOS *.** *.**
NEU,MON,EOS *.** *.** *.**
BASO not differentiated *.** *.**
DIFF not differentiated *.** *.** *.** *.**
Remark “*.**” invalid result

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

z In presense of the “WBC Abn Scattergram?” flag, results of certain


sub-populations are still reliable. The sub-population of which the results
are still reliable are displayed in the normal colcor, while the un-reliable
sub-populations are all displayed in blue.

Recount
If you want to recount a sample, do as follows:
1. At the “Count” screen, CLICK the “Work list” button and a dialog box shown in Figure
6-11 will pop up.

Figure 6-11 Work List

2. CLICK the “Copy” button to copy the information of the last sample to the current work list,

6-27
Operating Your Analyzer

except the information of “Current”, “Tester” and “ID”. (“Current” remains unchanged,
“Tester” appears to be the current login user and “ID” increases automatically by 1.)
3. CLICK the “OK” button to rerun the sample as usually as instructed in Heading 6.7.3
Running the samples.

Adjusting histograms
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.

Switching the screen


„ CLICK the “Review” button at the bottom of the screen to enter the “Review” screen to
browse the analysis results. See Chapter 7 Reviewing Sample Results for details.

„ CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.

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Operating Your Analyzer

6.8 Closed Tube Sampling Analysis

z A closed tube sampler is required in the closed-tube sampling analysis.

6.8.1 Selecting Work Mode


At the “Count” screen, CLICK the “Mode” button and the dialog box shown in Figure 6-12 will
pop up.

Figure 6-12 “Work mode” dialog box 1

1. CLICK the “CT-WB” radio button in the “Work mode” dialog box.

2. CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.

3. Enter the sample ID of the next sample into the “ID” box.

4. CLICK the “OK” button to save the changes and return to the “Count” screen.

z For bi-directional LIS mode, the measurement mode will be obtained by


inquring the LIS system, so you don’t need to set the “CBC” or
“CBC+5DIFF” mode.

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z The default ID of the sample to be run in the “CT” mode is determined by


the setup of the Entry of next sample ID. See Heading 5.2.1 Settings for the

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Operating Your Analyzer

setup method.

z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the count results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.

z Sample ID up to 15 alphanumeric characters may be entered into the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

6.8.2 Entering Work List Information


In the mode of closed-tube sampling, you can enter the work list information for the next
sample before running it.

z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.

z If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.

At the “Count” screen, CLICK the “Work list” button and a dialog box shown in Figure 6-13
will pop up. Enter the work list information in the box for the next sample to be run.

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Operating Your Analyzer

Figure 6-13 Work List

z For bi-directional LIS mode, only the sampling mode and blood mode will be
displayed in the “Current” field, and you don’t need to set the “CBC” or
“CBC+5DIFF” measurement mode.

z You can edit the “Tester” box at the review screen only after the analysis is
finished.

z Sample ID up to 15 alphanumeric characters may be entered into the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z The previous operating mode and sample ID are default values in the “Work
list”. Modify them as instructed if necessary.

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z The default ID of the sample to be run in the “CT” mode is determined by


the setup of the Entry of next sample ID. See Heading 5.2.1 Settings for the
setup method.

z To correct erroneous entries, DELETE and ENTER the desired information.

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Operating Your Analyzer

„ Selecting Work Mode

CLICK the “WB” radio button in the current mode. CLICK the “CBC” or “CBC+5DIFF” radio
button to select the work mode.

„ Entering Sample ID

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

„ Selecting ref. range

SELECT the ref. range from the “ref. range” pull-down list for the next sample. Different sets
of ref. range are provided. The analyzer will judge and flag the results out of range according to
the corresponding reference range. See Chapter 5 Customizing the Analyzer Software for
how to set the reference range.

„ Entering the patient name

Enter the patient name into the “Name” box.

„ Selecting patient sex

SELECT the desired item from the “Sex” pull-down list.

„ Entering the patient age

This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. 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 and the fourth for the neonatal no older than 24 hours. You can
choose only one of the four ways to enter the patient age.

SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. Enter the patient
age after “Age”.

„ Entering the chart number

Enter the number of the patient’s medical record into the “Chart No.” box.

„ Entering the department/area name

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

„ Entering the bed number

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Operating Your Analyzer

Enter the number of the patient’s bed into the “Bed No.” box.

„ Entering the sampling time

Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time).

„ Entering the name of the tester

To enter the name of the person who sent the sample for analysis, 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).

„ Entering the delivery time

Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time).

„ Entering comments

Enter comments in the “Comments” box.

„ Copy

CLICK the “Copy” button to copy the information of the last sample to the current work list,
except the information of “Current”, “Tester” and “ID”. (“Current” remains unchanged,
“Tester” appears to be the current login user and “ID” increases automatically by 1.)

„ “OK” button

When you have finished entering the work list information, CLICK the “OK” button to save the
changes and return to the “Count” screen.

„ “Cancel” button

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

6.8.3 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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Operating Your Analyzer

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 disposable products.

z Do not run the same sample over twice.

z Do not open the front cover after the analysis starts.

z Proper reference range shall be selected at the “Setup” screen before


analysis. Otherwise, the results may be flagged erroneously.

z The default ref. range is “General” if you run a sample immediately after the
operating mode setting. After the analysis, the analyzer will flag, if any,
according to the reference range of “General”.

Figure 6-14 “Count” screen

At the “Count” screen shown in Figure 6-14, do as follows to run whole blood samples.

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Operating Your Analyzer

1. Be sure the “Mode” of the “Next sample” is “Closed-Whole blood” and the analysis
status icon is green.

2. CLICK the “Open door” button to open the sample compartment door.

3. Load the mixed sample to the tube holder and close the door.

4. CLICK the “Count” button to start the analysis.

5. When the analysis is finished, the result will be displayed on the screen. The sample
compartment door will automatically open and the sample tube can be removed. The
analyzer will be ready for the next analysis.

6. Run the rest samples as instructed above.

z During the analysis, CLICK the “Mode” button or the “Work list” button to
select the operating mode for the next sample.

z If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.

z If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.

z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.

z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See
Heading 5.2.1 Settings for the setup method.

z If abnormal power failure occurs after the analysis starts, open the front
cover to check for fallen test tube and take it out, if any.

6.8.4 Special functions

Print
CLICK the “Print” button at the bottom of the screen to print the analysis results for the current
sample.

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Operating Your Analyzer

Automatic saving of analysis results


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

Parameter flags
„ If parameter is followed by an “H” or “L”, it means the analysis result has exceeded the
upper or lower limit of the reference range, but still within the display range..

„ If parameter is followed by an “?”, it means the analysis result is suspect.

„ If you see *** as opposed to the result, it means the result is either invalid or out of the
display range. If the WBC result of whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 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 on parameters,


abnormal blood cell differential or morphology.

Flags of Abnormal Blood Cell Differential or Morphology


The analyzer will flag abnormal or suspect WBC, RBC/HGB and PLT according to the
scattergrams and histograms. See Table 6-3 for flags. Table 6-4 shows how the flags affect
parameter results.

Table 6-3 Flags of Abnormal Blood Cell Differential or Morphology

WBC Flag

Abnormal
Flag Meaning Judgment criterion
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
Leucocytosis High WBC analysis results WBC > 18.0×109/L
Leucopenia Low WBC analysis results WBC < 2.5×109/L
Neutrophilia High neutrophils analysis NEUT# > 11.0×109/L
results
Neutropenia Low neutrophils analysis NEUT# < 1.0×109/L
results

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Operating Your Analyzer

Lymphocytosis High lymphocytes analysis LYMPH# > 4.0×109/L


results
Lymphopenia Low lymphocytes analysis LYMPH# < 0.8×109/L
results
Monocytosis High monocytes analysis MONO# > 1.0×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L
results
Basophilia High basophils analysis BASO# > 0.2×109/L
results

Suspect
Flag Meaning Judgment criterion
Asp. Abn./Abn. Sample? The aspiration may be Results of primary
abnormal, or the sample itself parameters are severely low
may be abnormal simultaneously
WBC Abn. WBC numbers of BASO and WBC numbers of BASO and
DIFF channels are DIFF channels are
inconsistent. The sample inconsistent.
may be abnormal, or the
analyzer may be abnormal.
Left Shift? Left shift may exist. Many scatter-points exist in
the left shift area of the
scattergram.
Immature Cell? Immature cells may exist. The proportion of immature
cells is greater than 2.5%.
Abn./Atypical Lym? Abnormal lymphocytes or The proportion of
atypical lymphocytes may abnormal/atypical
exist. lymphocytes is greater than
2%.
RBC Lyse Resist? RBC hemolysis may be Scatter-points are thick
incomplete. between the lymphocytes
and ghost cells areas of the
scattergram.

RBC/HGB Flag

Abnormal
Flag Meaning Judgment criterion
RBC Abn. Distribution Abnormal RBC scattergram RBC scattergram is
abnormal.
Anisocytosis Sizes of RBCs are dissimilar RDW-SD>64 or RDW-CV>22
Microcytosis Small MCV MCV < 70fL

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Operating Your Analyzer

Macrocytosis Large MCV MCV > 110fL


Erythrocytosis Increased RBCs RBC# > 6.50×1012/L
Anemia Anemia HGB < 90g/L
Hypochromia Hypochromia MCHC < 29.0g/dL
Diamorphologic RBC diamorphologic Two or two more peaks in the
distribution RBC histogram.

Suspect
Flag Meaning Judgment criterion
RBC or HGB Abn.? Results of RBC or HGB may Analyzing and comparing
be inaccurate results of HGB and RBC
HGB Abn./Interfere? HGB results may be Calculating and comparing
abnormal, or interference special analysis parameters
may exist

PLT Flag

Abnormal
Flag Meaning Judgment criterion
Thrombocytosis PLTs increase PLT > 600×109/L
Thrombocytopenia PLTs decrease PLT < 60×109/L
PLT Abn Distribution PLT histogram distribution is PLT histogram is abnormal.
abnormal.

Suspect
Flag Meaning Judgment criterion
PLT Clump? PLT clump may exist. Calculating and comparing
special analysis parameters

Table 6-4 How the flags of Abnormal Blood Cell Differential or Morphology

affect parameter results

CT-WB
Cell Differential Flag
CBC CBC+5DIFF

WBC Asp. Abn./Abn. Sample? √ √

WBC Abn × √

RBC Lyse Resist? × √

WBC Abn Scattergram × √

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Operating Your Analyzer

Left Shift? × √

Immature Cell? × √

Abn./Atypical Lym? × √

Leucocytosis √ √

Leucopenia √ √

Neutrophilia × √

Neutropenia × √

Lymphocytosis × √

Lymphopenia × √

Monocytosis × √

Eosinophilia × √

Basophilia × √

Asp. Abn./Abn. Sample? √ √

RBC or HGB Abn.? √ √

HGB Abn./Interfere? √ √

RBC Abn. Distribution √ √

Anisocytosis √ √

Microcytosis √ √
RBC/HGB
Macrocytosis √ √

Erythrocytosis √ √

Anemia √ √

Hypochromia √ √

Diamorphologic √ √

PLT Asp. Abn./Abn. Sample? √ √

PLT Clump? √ √

Thrombocytosis √ √

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Operating Your Analyzer

Thrombocytopenia √ √

PLT Abn Distribution √ √

Small PLT √ √

Remark “√” affected ,“×” not affected

Parameters affected
Flag Abnormal Sub-populations
Neu Lym Mon Eos Bas
NEU,LYM *.** *.**
NEU,MON *.** *.**
NEU,EOS *.** *.**
NEU,BASO *.** *.**
WBC Abn
LYM,MON *.** *.**
Scattergram
LYM,EOS *.** *.**
NEU,MON,EOS *.** *.** *.**
BASO not differentiated *.** *.**
DIFF not differentiated *.** *.** *.** *.**
Remark “*.**” invalid result

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

z In presense of the “WBC Abn Scattergram?” flag, results of certain


sub-populations are still reliable. The sub-population of which the results
are still reliable are displayed in the normal colcor, while the un-reliable
sub-populations are all displayed in blue.

Recount
If you want to recount a sample, do as follows:

1. At the “Count” screen, CLICK the “Work list” button and a dialog box shown in Figure
6-15 will pop up.

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Operating Your Analyzer

Figure 6-15 Work List

2. CLICK the “Copy” button to copy the information of the last sample to the current work list,
except the information of “Current”, “Tester” and “ID”. (“Current” remains unchanged,
“Tester” appears to be the current login user and “ID” increases automatically by 1.)

3. CLICK the “OK” button to rerun the sample as usually as instructed in Heading 6.8.3
Running the samples.

Adjusting histograms
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.

Switching the screen


„ CLICK the “Review” button at the bottom of the screen to enter the “Review” screen to
browse the analysis results. See Chapter 7 Reviewing Sample Results for details.

„ CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.

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Operating Your Analyzer

6.8.5 Disassembling the adapter


Before a collection tube ofφ14×75mm or φ15×75mm is to be placed into the tube holder,
you should disassemble the adapter from the holder first as shown in Figure 6-16.

Figure 6-16 Disassembling the adapter

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Operating Your Analyzer

6.9 Autoloading Analysis

z An autoloader is required in the autoloading analysis.

6.9.1 Selecting Work Mode


At the “Count” screen, CLICK the “Mode” button and the dialog box shown in Figure 6-17 will
pop up.

Figure 6-17 “Work mode” dialog box

1. CLICK the “AL-WB” radio button in the “Work mode” dialog box.

2. CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.

3. You can manually enter the ID for the next sample into the “ID” box; Or just CLICK the “Int.
barcode” button and the ID for the next sample will be entered automatically.

4. Enter the rack No. and tube No. for the first sample. The rack No. ranges from 1 to 20 and
the tube No. from 1 to 10.

5. CLICK the “OK” button to save the change and return to the “Count” screen.

z You can not perform the autoloading analysis if the “Bi-directional LIS”
mode is seleted but without the barcode scanner.

z The barcode scanner is requested for autoloading analysis in “Bi-directional

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Operating Your Analyzer

LIS” mode. Thus, if the “AL-WB” mode is selected in the “work mode” box
in “Bi-directional LIS” mode, the “Int. barcode” button is selected as default.

z For bi-directional LIS mode, the measurement mode will be obtained by


inquring the LIS system, so you don’t need to set the “CBC” or
“CBC+5DIFF” mode.

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the count results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.

z Sample ID up to 15 alphanumeric characters may be entered into the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z The default first rack number is the number of the first detected sample
carrier after the analysis is started.

z To correct erroneous entries, DELETE and ENTER the desired information.

6.9.2 Entering Work List Information


In the mode of autoloading, you can enter the work list information for the next sample before
running it.

z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.

z If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.

At the “Count” screen, CLICK the “Work list” button and a dialog box shown in Figure 6-18
will pop up.

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Operating Your Analyzer

Figure 6-18 Work List

CLICK the “New” button and a dialog box shown in Figure 6-19 will pop up. You can enter the
work list information of the sample to be run into the dialog box.

Figure 6-19 Entering the work list information

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Operating Your Analyzer

z For bi-directional LIS mode, the measurement mode will be obtained by


inquring the LIS system, so you don’t need to set the “CBC” or
“CBC+5DIFF” mode.

z You can edit the “Tester” box at the review screen only after the analysis is
finished.

z Sample ID up to 15 alphanumeric characters may be entered into the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

„ Selecting Work Mode

CLICK the “CBC” or “CBC+5DIFF” radio button to select the work mode.

„ Entering sample ID, rack No. and tube No.

Enter the sample ID, rack No. and tube No. of the sample to be run into the “ID”, “Rack” and
“Tube” boxes respectively. The rack No. ranges from 1 to 20 and the tube No. from 1 to 10.
You can load up to 5 racks at once. Each sample carrier has 10 tube positions. The default
“ID” and “Rack - Tube” will automatically increase by 1 when you CLICK the “New” button.

Example 1: Suppose the current sample “ID” is “1009” and the “Rack - Tube” is “1-9”, save the
entered information and CLICK the “New” button to enter the work list information, you can
see the default “ID” is “1010” and the default “Rack - Tube” is “1-10”.

Example 2: Suppose the current sample “ID” is “1010” and the “Rack - Tube” is “1-10”, save
the entered information and CLICK the “New” button to enter the work list information, you can
see the default “ID” is “1011” and the default “Rack - Tube” is “2-1”.

z The number of empty tube positions of the same sample carrier shall be
within the setting. See Chapter 5 Customizing the Analyzer software for how
to set the setting.

z The system sequences the “Rack - Tube” in ascending order. If the “New” or
“Edit” operation is performed, the system will again sequence the No. in the
work list.

z Do not enter repeated sample ID, rack No., tube No and measuring mode
simultaneously.

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Operating Your Analyzer

„ Selecting ref. range

SELECT the ref. range from the “ref. range” pull-down list for the next sample. Different sets
of ref. range are provided. The analyzer will judge and flag the results out of range according to
the corresponding reference range. See Chapter 5 Customizing the Analyzer Software for
how to set the reference range.

„ Entering the patient name

Enter the patient name into the “Name” box.

„ Selecting patient sex

SELECT the desired item from the “Sex” pull-down list.

„ Entering the patient age

This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. 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 and the fourth for the neonatal no older than 24 hours. You can
choose only one of the four ways to enter the patient age.

SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. enter the patient age
after “Age”.

„ Entering the chart number

Enter the number of the patient’s medical record into the “Chart No.” box.

„ Entering the department/area name

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

„ Entering the bed number

Enter the number of the patient’s bed into the “Bed No.” box.

„ Entering the sampling time

Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time).

„ Entering the name of the tester

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Operating Your Analyzer

To enter the name of the person who sent the sample for analysis, 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).

„ Entering the delivery time

Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time).

„ Entering comments

Enter comments in the “Comments” box.

„ “OK” button

When you have finished entering the work list information, CLICK the “OK” button to save the
changes and return to the “Work list” dialog box.

„ “Cancel” button

If you do not want to save the entered work list information, CLICK the “Cancel” button to
return to the “Work list” dialog box without saving the changes.

You may perform the following functions in the “Work list” screen if necessary.

Edit
You can modify the work list information in the “Ready” or “Error” status in the work list. At the
“Work list” screen, CLICK the desired line, and then CLICK the “Edit” button to enter the
dialog box to modify. See the instruction of entering work list information for how to edit.

z After the sample information is changed, the status of “Error” will become
“Ready”. You can rerun the corresponding sample.

Copy
If there is saved work list information in the work list, you can enter a great lot of work list
information by copy once. At the “Work list” screen, CLICK the desired line, and then CLICK
the “Copy” button and the copy dialog box shown in Figure 6-20 will pop up. As up to 200
samples can be analyzed at the same batch, the dialog box will prompt you the maximum
sample information to be copied currently.

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Operating Your Analyzer

Figure 6-20 Copy dialog box

Enter the number of record you desire copying in the “Copy record piece No.” box, CLICK
the “OK” button to confirm the copy and close the dialog box. The copied work list information
will sequentially appear in the work list.

After the copy, the sample ID will automatically increase by 1 from that of the current selected
sample. The “Rack - Tube” will automatically increase by 1 from that of the last sample in the
work list (the maximum No. of sample carrier is 20 and tube No. 10. When they have reached
the maximum No., the “Rack - Tube” will begin with 1-1.). The measurement mode, ref. range,
age and sex will not change. You can CLICK the “Edit” button to modify the sample
information.

Delete
You can delete the work list information in the “Ready” or “Error” status in the work list. At the
“Work list” screen, CLICK the “DELETE” button and the delete dialog box shown in Figure
6-21 will pop up.

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Operating Your Analyzer

Figure 6-21 Delete dialog box

CLICK the desired radio button and then CLICK the “OK” button to confirm the deletion.

Print
CLICK the “Print” button at the “Work list” screen to print the information for the current work
list.

Return
CLICK the “Return” button at the “Work list” screen to close the “Work list” dialog box and
return to the “Count” screen.

6.9.3 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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Operating Your Analyzer

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 disposable products.

z Do not run the same sample over twice.

z Be sure the sample ID, rack No., tube No, and measuring mode entered are
completely the same with the information of the sample to be analyzed.

z Do not open the front cover after the analysis starts.

z Proper reference range shall be selected at the “Setup” screen before


analysis. Otherwise, the results may be flagged erroneously.

z The default ref. range is “General” if you run a sample immediately after the
operating mode setting. After the analysis, the analyzer will flag, if any,
according to the reference range of “General”.

z The measuring modes of the same batch samples are the same.

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Operating Your Analyzer

Figure 6-22 “Count” screen

„ Without using the built-in barcode scanner

If the built-in barcode scanner is not clicked, run the sample instructed as follows.

1. Be sure the “Mode” of the “Next sample” is “AL-WB”, the built-in barcode scanner is not
clicked and the analysis status icon is green.

2. Mark the prepared tubes according to the sample ID, rack No. and tube No. entered.
Place the tubes into the corresponding tube positions.

3. Place racks loading tubes in ascending order on the level of the right tray of the autoloader,
with the back of “MINDRAY” mark on the carrier facing the analyzer. You can load up to 5
racks at once.

4. CLICK the “Start Count” button at the “Count” screen. The analyzer will start the analysis
automatically.

5. After every analysis cycle, the results will be displayed on the analysis result area and
saved to the sample database. The record of this sample will disappear from the “Work
list” screen.

6. After all samples are analyzed, all the racks come to the left tray of the autoloader.
Remove them safely.

„ Using the built-in barcode scanner

If the built-in barcode scanner is clicked, run the sample instructed as follows.

1. Be sure the “Mode” of the “Next sample” is “AL-WB”, the built-in barcode scanner is
clicked and the analysis status icon is green.

2. Place labels on the tubes as instructed in Heading 6.9.6 Barcode Labels.

3. Place the tubes into the corresponding tube positions as shown in Figure 6-23.

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Operating Your Analyzer

Figure 6-23

4. Load racks sequentially on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the carrier facing the analyzer. You can load up to 5 racks at once.

5. CLICK the “Start Count” button at the “Count” screen. The analyzer will start the analysis
automatically.

6. After every analysis cycle, the results will be displayed on the analysis result area and
saved to the sample database. The record of this sample will disappear from the “Work
list” screen.

7. After all samples are analyzed, all the racks come to the left tray of the autoloader.
Remove them safely.

z The built-in barcode scanner is requested for autoloading analysis in


“Bi-directional LIS” mode.

z If “Invalid” appears on the sample ID box, it means the scan is invalid. You
can enter the sample ID again when reviewing sample results. See Chapter 7
Reviewing Sample Results for details.

z If “Invalid” appears on the Mode box, it means the measurement mode


inquiry is failed.

z You can reedit or delete the information of the sample erroneously analyzed.

z If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.

z If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.

z If the samples to be run of the same batch need more than 5 racks, you need
to timely add the rest racks to the right tray of the autoloader and take away
the racks on the left tray of the autoloader.

z If abnormal power failure occurs after the analysis starts, remove the rack(s)
manually, open the front cover to check for fallen test tube and take it out, if
any.

6.9.4 Special functions

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Operating Your Analyzer

Pause
During the analysis, to make a pause for the current analysis, CLICK the “Pause” button at the
“Count” screen. The system stops the analysis and the “Pause” button turns to the “Continue”
button after the previously analyzing cycle is finished. To continue the analysis, CLICK the
“Continue” button to resume the analysis.
If the analysis pauses for errors, remove the errors first before continuing the analysis. See
Chapter 11 Troubleshooting Your Analyzer for how to remove errors. After the errors are
removed, to continue the analysis, CLICK the “Continue” button and the following dialog box
will pop up.

Figure 6-24

CLICK “OK” to run samples in the autoloading mode from the current tube position and close
the dialog box. CLICK “Cancel” to close the dialog box and stay in the pause status.

Stop
During the analysis or in the status of the pause, to stop the analysis and eject the current
sample rack, CLICK the “Stop Count” button. After the previously analyzing cycle is finished,
the system stops the analysis and the current sample carrier comes to the left tray of the
autoloader.

STAT
If there is STAT sample requires running first during the analysis, CLICK the “STAT” button at
the “Count” screen and CLICK the “OK” button on the prompt dialog box. After the previously
analyzing cycle is finished, the analysis stops and the system switches the autoloading mode
to the open vial sampling mode. When the analysis status icon turns to yellow, you can run the
STAT sample in the open vial sampling mode. See 6.7 Open Vial Sampling Analysis for details.
After the analysis is finished, CLICK the “Exit STAT” button at the “Count” screen to resume
the autoloading mode for the rest samples. The sample ID resumes the next sample ID before
the STAT.

Print
CLICK the “Print” button at the “Count” screen to print out the results of the current sample.
CLICK the “Print” button at the “Work list” screen to print out the information of the current
work list.

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Operating Your Analyzer

Automatic saving of analysis results


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

Parameter flags
„ If parameter is followed by an “H” or “L”, it means the analysis result has exceeded the
upper or lower limit of the reference range, but still within the display range..

„ If parameter is followed by an “?”, it means the analysis result is suspect.

„ If you see *** as opposed to the result, it means the result is either invalid or out of the
display range. If the WBC result of whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 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 on parameters,


abnormal blood cell differential or morphology.

Flags of Abnormal Blood Cell Differential or Morphology


The analyzer will flag abnormal or suspect WBC, RBC/HGB and PLT according to the
scattergrams and histograms. See Table 6-5 for flags.Table 6-6 shows how the flags affect
parameter results.

Table 6-5 Flags of Abnormal Blood Cell Differential or Morphology

WBC Flag

Abnormal
Flag Meaning Judgment criterion
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
Leucocytosis High WBC analysis results WBC > 18.0×109/L
Leucopenia Low WBC analysis results WBC < 2.5×109/L
Neutrophilia High neutrophils analysis NEUT# > 11.0×109/L
results
Neutropenia Low neutrophils analysis NEUT# < 1.0×109/L
results
Lymphocytosis High lymphocytes analysis LYMPH# > 4.0×109/L
results

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Operating Your Analyzer

Lymphopenia Low lymphocytes analysis LYMPH# < 0.8×109/L


results
Monocytosis High monocytes analysis MONO# > 1.0×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L
results
Basophilia High basophils analysis BASO# > 0.2×109/L
results

Suspect
Flag Meaning Judgment criterion
Asp. Abn./Abn. Sample? The aspiration may be Results of primary
abnormal, or the sample itself parameters are severely low
may be abnormal simultaneously
WBC Abn. WBC numbers of BASO and WBC numbers of BASO and
DIFF channels are DIFF channels are
inconsistent. The sample inconsistent.
may be abnormal, or the
analyzer may be abnormal.
Left Shift? Left shift may exist. Many scatter-points exist in
the left shift area of the
scattergram.
Immature Cell? Immature cells may exist. The proportion of immature
cells is greater than 2.5%.
Abn./Atypical Lym? Abnormal lymphocytes or The proportion of
atypical lymphocytes may abnormal/atypical
exist. lymphocytes is greater than
2%.
RBC Lyse Resist? RBC hemolysis may be Scatter-points are thick
incomplete. between the lymphocytes
and ghost cells areas of the
scattergram.

RBC/HGB Flag

Abnormal
Flag Meaning Judgment criterion
RBC Abn. Distribution Abnormal RBC scattergram RBC scattergram is
abnormal.
Anisocytosis Sizes of RBCs are dissimilar RDW-SD>64 or RDW-CV>22
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Erythrocytosis Increased RBCs RBC# > 6.50×1012/L

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Operating Your Analyzer

Anemia Anemia HGB < 90g/L


Hypochromia Hypochromia MCHC < 29.0g/dL
Diamorphologic RBC diamorphologic Two or two more peaks in the
distribution RBC histogram.

Suspect
Flag Meaning Judgment criterion
RBC or HGB Abn.? Results of RBC or HGB may Analyzing and comparing
be inaccurate results of HGB and RBC
HGB Abn./Interfere? HGB results may be Calculating and comparing
abnormal, or interference special analysis parameters
may exist

PLT Flag

Abnormal
Flag Meaning Judgment criterion
Thrombocytosis PLTs increase PLT > 600×109/L
Thrombocytopenia PLTs decrease PLT < 60×109/L
PLT Abn Distribution PLT histogram distribution is PLT histogram is abnormal.
abnormal.

Suspect
Flag Meaning Judgment criterion
PLT Clump? PLT clump may exist. Calculating and comparing
special analysis parameters

Table 6-6 How the flags of Abnormal Blood Cell Differential or Morphology

affect parameter results

AL-WB
Cell Differential Flag
CBC CBC+5DIFF

WBC Asp. Abn./Abn. Sample? √ √

WBC Abn × √

RBC Lyse Resist? × √

WBC Abn Scattergram × √

Left Shift? × √

Immature Cell? × √

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Operating Your Analyzer

Abn./Atypical Lym? × √

Leucocytosis √ √

Leucopenia √ √

Neutrophilia × √

Neutropenia × √

Lymphocytosis × √

Lymphopenia × √

Monocytosis × √

Eosinophilia × √

Basophilia × √

Asp. Abn./Abn. Sample? √ √

RBC or HGB Abn.? √ √

HGB Abn./Interfere? √ √

RBC Abn. Distribution √ √

Anisocytosis √ √

Microcytosis √ √
RBC/HGB
Macrocytosis √ √

Erythrocytosis √ √

Anemia √ √

Hypochromia √ √

Diamorphologic √ √

PLT Asp. Abn./Abn. Sample? √ √

PLT Clump? √ √

Thrombocytosis √ √

Thrombocytopenia √ √

PLT Abn Distribution √ √

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Operating Your Analyzer

Small PLT √ √

Remark “√” affected ,“×” not affected

Parameter affected
Flag Abnormal Sub-populations
Neu Lym Mon Eos Bas
NEU,LYM *.** *.**
NEU,MON *.** *.**
NEU,EOS *.** *.**
NEU,BASO *.** *.**
WBC Abn
LYM,MON *.** *.**
Scattergram
LYM,EOS *.** *.**
NEU,MON,EOS *.** *.** *.**
BASO not differentiated *.** *.**
DIFF not differentiated *.** *.** *.** *.**
Remark “*.**” invalid result

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

z In presense of the “WBC Abn Scattergram?” flag, results of certain


sub-populations are still reliable. The sub-population of which the results
are still reliable are displayed in the normal colcor, while the un-reliable
sub-populations are all displayed in blue.

Adjusting histograms
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.

Switching the screen


„ CLICK the “Review” button at the bottom of the screen to enter the “Review” screen to
browse the analysis results. See Chapter 7 Reviewing Sample Results for details.

„ CLICK the “Main” button at the bottom of the screen to return to the “Main” screen.

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6.9.5 Work List

In the autoloading mode, the system provides a work list shown in .Figure 6-25, to preassign
the information such as patient name and age before sample analysis. The work list also
presents the current analysis status.

Figure 6-25 Work List

At the “Count” screen, CLICK the “Work list” button to enter the “Work list” screen. Up to 200
sample records can be displayed in the list at this screen. You can DRAG SCROLL BAR up
and down/left and right to review the sample records.

The measuring modes consist of CBC and CBC+5DIFF. The analysis status includes “Ready”,
“Analysing” and “Error”. The default ref. range is “General”. You can modify it if necessary.

Sample records in the work list very from whether built-in barcode scanner is used and
whether preassigned entries are available in the work list.

z For bi-directional LIS mode, the measurement mode will be obtained by


inquring the LIS system, so you don’t need to set the “CBC” or
“CBC+5DIFF” mode.

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„ Without using the built-in barcode scanner

If you start the analysis immediately after the operating mode setting, the system will write into
the work list the corresponding record, which “State” changes from “Ready” to “Analysing”.
After the analysis, the sample record and results will be saved to the sample database, and the
sample record will disappear from the work list. The sequent samples are handled in the same
way.

z When the detected tube No. of the first sample is not the same with that
saved in the “Work mode” dialog box, the detected tube No. of the first
sample, and the sample ID, rack No. and measuring mode saved in the
“Work mode” dialog box will be written into the work list as the information
of the sample.

If you start the analysis after you enter the work list information into the work list, the system
will order the sample records ascendingly based on the “Rack - Tube” (eg. “1-1” is before
“1-2”). If sample records have the same “Rack - Tube”, the system will order them ascendingly
based on the “Sample ID”. During the analysis, the “State” in the work list will change into
“Analysing”. After the analysis, the sample record and results will be saved to the sample
database, and the sample record will disappear from the work list. The sequent samples are
handled in the same way.

z When no record in the work list completely meets the detected sample ID,
rack No., tube No. and measuring mode of the sample, the actually detected
information will be written into the work list as the information of the
sample.

„ Clicking the built-in barcode scanner

If you start the analysis immediately after the operating mode setting, the system will write into
the work list the corresponding record, which “State” changes from “Ready” to “Analysing”.
After the analysis, the sample record and results will be saved to the sample database, and the
sample record will disappear from the work list. The sequent samples are handled in the same
way. The sample ID of sequent samples will base on the scanning, the rack No.-tube No. will
automatically increase by 1 based on the last sample respectively, and the measuring mode
keeps the same with that of the last sample.

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z For bi-directional LIS mode, the measurement mode will be obtained by


inquring the LIS system.

z When the detected tube No. or sample ID of the first sample is not the same
with that saved in the “Work mode” dialog box, the detected tube No. and
sample ID of the first sample, and the rack No. and measuring mode saved
in the “Work mode” dialog box will be written into the work list as the
information of the sample.

If you start the analysis after you enter the work list information into the work list, the system
will order the sample records ascendingly based on the “Rack - Tube” (eg. “1-1” is before
“1-2”). If sample records have the same “Rack - Tube”, the system will order them ascendingly
based on the “Sample ID”. During the analysis, the “State” in the work list will change into
“Analysing”. After the analysis, the sample record and results will be saved to the sample
database, and the sample record will disappear from the work list. The sequent samples are
handled in the same way.

z When no record in the work list completely meets the detected sample ID,
rack No., tube No. and measuring mode of the sample, the actually detected
information will be written into the work list as the information of the
sample.

At the “Work list” screen, you can perform the following functions:

„ New: add new information.

„ Edit: modify information.

„ Copy: copy the work list information

„ DELETE: delete information

„ Print: print information in the work list.

„ Return: close the “Work list” screen and return to the “Count” screen.

6.9.6 Barcode Labels

z Blood, scratches and powder from gloves reduces bar-code read rate. Keep
the bar-code label free of blood, scratches and powder from gloves to

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Operating Your Analyzer

maintain a high-read rate.

To ensure the correct barcode can be read, you must place labels right on the region X as
shown in Figure 6-26.

Figure 6-26 Where to place the barcode label

z The bars on the label must be parallel to the stopper. Otherwise, the scanner
may not read it.

6.9.7 Disassembling the adapter


Before a collection tube of φ14×75mm or φ15×75mm is to be placed into the sample
carrier, you should disassemble the adapter from the carrier first as shown in Figure 6-27.

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Operating Your Analyzer

Figure 6-27 Disassembling the adapter

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Operating Your Analyzer

6.10 Liquid Saver


15 minutes after the relevant fluidic operation stops, a dialog box will pop up, prompting
“Preparing Saving, please wait...”. After the preparation, the dialog box closes automatically
and the analyzer is in the liquid saver status. During this condition, you can still perform any
other operations other than relevant fluidic operations.

z To change the time when to start the liquid saver, see Heading 5.3.1 Settings
for details.

z At the screens of “Mechanical”, “Circuit” and “Valve”, the analyzer will not
enter the liquid saver status.

z If it is time for liquid saver, some current operations will pause. When the
analyzer is in the liquid saver status, you can continue the operations.

To cancel the liquid saver, press the aspirate key and a dialog box of “Restoring from Saving,
please wait…” will pop up. After the liquid saver is canceld, the dialog box will close
automatically.

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6.11 Shutdown

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.

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

CLICK the “Shutdown” button at the “Main” screen and the shutdown dialog box shown in
Figure 6-28 will pop up.

Figure 6-28 Shutdown dialog box

CLICK “Yes” to shutdown the analyzer. After the shutdown is finished, the screen will
automatically close.

Place the power switch at the left side of the analyzer to OFF (O) to turn off the analyzer.

Empty the waste container and dispose of the waste properly.

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Operating Your Analyzer

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


according to government regulations.

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7 Reviewing Sample Results

7.1 Introduction

The analyzer automatically saves analysis results. Totally 40,000 results can be saved,
including 23 parameters, 4 RUO (Research Use Only) parameters, scattergrams and
histograms.

You can browse sample results either in the table or graph mode.

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Reviewing Sample Results

7.2 Browsing in the “Table Review” mode

CLICK the “Review” icon button at the “Main” screen to enter the “Table review” screen of the
sample database, as shown in Figure 7-1.

Figure 7-1 Table review screen

To browse sample results, SELECT the “Sample database”, “Search database” or “Selected
database” from the “Current” pull-down list. Sample results that have been found or selected
will be saved respectively to the “Search database” or “Selected database”. See Heading
7.2.2 Selecting/Deselecting sample results and Heading 7.2.3 Search for particular a sample
(s) results for details.

You can review sample results in three databases in the same way. Take “Sample database”
for example, you can review sample results in the table review mode as instructed below.

7.2.1 Browsing sample results


The sample results are sequentially displayed on the screen, the latest on the utmost top of the
table. If the information cannot be displayed in one screen, DRAG SCROLL BAR to browse.
The “Pos./Total” displayed at the top of the screen indicates the position of the current sample
result (with an arrow ahead of the line) and the total number of the saved sample results.

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Reviewing Sample Results

7.2.2 Selecting/Deselecting sample results


You can select desired sample results from the sample database. The selected results will be
saved to the selected database (maximum 500 results).

z You can select up to 500 samples at a time. If the selected results are more
than 500, the first 500 results selected will be taken.

z To correct erroneous entries, DELETE and ENTER the desired information.

„ Selecting/Deselecting a sample result

CLICK at the head of the line of the desired sample result. The selected sample results will be
highlighted as the sample “4” shown in Figure 7-2.

Figure 7-2 Selecting a sample result

Once the sample result is deselected, the highlight will be canceled, as the sample “4” shown
in Figure 7-3.

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Reviewing Sample Results

Figure 7-3 Deselecting a sample result

„ Selecting/Deselecting multiple sample results

Example 1: To select sample results of positions 1 – 8 in the sample database, follow the
procedure below to do so.

1. At the “Table Review” screen of the sample database, CLICK the “Select” button and a
dialog box shown in Figure 7-4 will pop up.

Figure 7-4 “Select” dialog box

2. ENTER “1” in the “From” box and “8” in the “To” box.

3. CLICK the “Select” button to save the selected sample results to the selected database,
and enter the “Table Review” screen of the selected database shown in Figure 7-5 to view

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Reviewing Sample Results

the selected results.

Figure 7-5 “Table Review” screen (selected database)

You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database. The selected sample results will be
highlighted.

Example 2: To select all sample results in the sample database, follow the procedure below to
do so.

1. At the “Table Review” screen of the sample database, CLICK the “Select” button and a
dialog box shown in Figure 7-6 will pop up.

Figure 7-6 “Select” dialog box

2. CLICK the “All” button to save all sample results to the selected database, and enter the

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Reviewing Sample Results

“Table Review” screen of the selected database shown in Figure 7-7 to view the selected
results.

Figure 7-7 “Table Review” screen (selected database)

3. You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database. All selected sample results will be
highlighted.

Example 3: To deselect sample results, follow the procedure below to do so.

1. At the “Table Review” screen of the sample database, CLICK the “Select” button and a
dialog box shown in Figure 7-8 will pop up.

Figure 7-8 “Select” dialog box

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Reviewing Sample Results

2. ENTER “1” in the “From” box and “5” in the “To” box.

3. CLICK the “Deselect” button to deselect the sample results of positions 1 – 5 in the
sample database, and enter the “Table Review” screen of the selected database. The
selected sample results from 1 to 5 will be cleared, as shown in Figure 7-9.

Figure 7-9 “Table review” screen (selected database)

4. You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database. The deselected sample results will not be
highlighted any longer.

z In the “Select” dialog box, without entering any number in the “From” box
and the “To” box, you can CLICK the “Deselect” button directly to deselect all
sample results.

z After exiting the “Table Review” screen, the sample results of the selected
database will be cleared and the sample results of the sample database will
not be highlighted any longer.

7.2.3 Searching for a particular sample result (s)


You can select one or multiple search conditions to search for a particular sample result(s)
from the sample database. The results found each time will be saved to the search database

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Reviewing Sample Results

and overwrite the last results. Maximum 500 results can be saved into the search database.
CLICK the “Search” button and a dialog box shown in Figure 7-10 will pop up.

Figure 7-10 Searching conditions

CLICK the desired search condition button under the “keyword” to select or deselect search
condition. The selected condition will be ticked.

z You can select up to 500 samples at a time. If the results found are more
than 500, the first 500 results found will be taken.

z To correct erroneous entries, DELETE and ENTER the desired information.

„ Entering sample ID

CLICK the “ID” button and enter the sample ID in the “ID” box.

„ Selecting patient sex

CLICK the “Sex” button, then CLICK “Male”, “Female” or “Unknown” radio button to select
the patient sex.

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Reviewing Sample Results

„ Entering the patient name

CLICK the “Name” button and enter the patient name in the “Name” box.

„ Selecting the date

CLICK the “Date” button. You can search sample results in two ways, as shown below.

Example 1: Search for sample results saved during the last 2 days.
CLICK the “Last” button, and SELECT “2” from the “Last” pull-down list.

Example 2: Search sample results saved between Jun. 1st, 2006 and Jul. 1st, 2006.
CLICK the “From” button and CLICK the box behind it. The dialog box shown in Figure 7-11,
will pop up. CLICK the desired date (Jun. 1st, 2006) and CLICK the “OK” button to confirm the
starting date. CLICK the box behind “To” to enter the desired date (Jul. 1st, 2006) in the same
way to set the ending date for search.

Figure 7-11 Setting date dialog box

„ Entering the department/area name

CLICK the “Dept.” button and SELECT the desired department from the “Dept.” pull-down
list.

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Reviewing Sample Results

„ Entering the bed number

CLICK the “Bed No.” button and enter the patient bed number in the “Bed No.” box.

„ Entering the chart number

CLICK the “Chart No.” button and enter the patient chart number in the “Chart No.” box.

„ Selecting the matching type

CLICK the “Exact” or “Contain” button from the “Matching Type” to search the proper sample
results.

After selecting search conditions, CLICK the “Search” button. The screen will automatically
display the search results, as shown in Figure 7-12.

Figure 7-12 Search result prompt

CLICK the “OK” button to enter the “Table Review” screen of the search database shown in
Figure 7-13 to view the found sample results.

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Reviewing Sample Results

Figure 7-13 “Table Review” screen (search database)

You can SELECT “Sample database” from the “Current” pull-down list to return to the
“Table Review” screen of the sample database.

z Once you leave the “Table Review” screen, the sample results saved in the
search database will be cleared.

7.2.4 Jumping to a sample result with known position


You can search sample database for a sample result with known position.
CLICK the “Go to” button and a dialog box shown in Figure 7-14 will pop up..

Figure 7-14 “Go to” dialog box

Enter the sample result position into the “Go to” box and CLICK the “OK” button to go to the
desired sample result. The sample result found will be marked with an arrow at the head of the
line.

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Reviewing Sample Results

z To correct erroneous entries, DELETE and ENTER the desired information.

7.2.5 Editing work list information


You can edit sample information at the “Table Review” screen.

CLICK the desired sample result and it will be marked with an arrow at the head of the line.

CLICK the “Edit” button and a dialog box shown in Figure 7-15 will pop up.

Figure 7-15 Editing sample information dialog box

z Sample ID up to 15 alphanumeric characters may be entered in the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

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Reviewing Sample Results

„ Entering Sample ID

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

„ Entering the patient name

Enter the patient name into the “Name” box.

„ Selecting patient sex

SELECT the desired item from the “Sex” pull-down list.

„ Entering the patient age

This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. 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 one month and the fourth for the neonatal no older than 24 hours. You
can choose only one of the four ways to enter the patient age.

SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. enter the patient age
per the selected unit.

„ Entering the chart number

Enter the number of the patient’s medical record into the “Chart No.” box.

„ Entering the department/area name

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

„ Entering the bed number

Enter the number of the patient’s bed into the “Bed No.“ box.

„ Entering the sampling time

Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time)

„ Entering the name of the tester

To enter the name of the person who sent the sample for analysis, 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).

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Reviewing Sample Results

„ Entering the delivery time

Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time)

„ Entering the name of tester

SELECT the desired name from the “Tester” pull-down list (if there are previously saved
names in the list). If the name of the tester is unavailable in the list, CLICK the “Sign” button to
the right of the “Tester” box. The login dialog box shown in Figure 7-16 will pop up.

Figure 7-16 Sign dialog box

Enter the name and password (administrator level) of the tester respectively into the “User
name” and “Password” boxes. CLICK the “OK” button to return to the Editing work list
information dialog box. The tester’s name will automatically appear in the “Tester” box.

„ Entering comments

Enter comments in the “Comments” box.

„ “OK” button

When you have finished entering the work list information, CLICK the “OK” button to save the
changes and return to the “Table Review” screen.

„ “Cancel” button

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

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Reviewing Sample Results

7.2.6 Calculating reproducibility

The analyzer calculates the reproducibility per the following equations:


n

∑x i
Mean= i=1
n

∑ (X − Mean )
2
i
SD =
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 result, CLICK the “CV” button to enter the
“Calculate CV” screen shown in Figure 7-17.

Figure 7-17 “Reproducibility” screen

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Reviewing Sample Results

z Samples 3 to 30 can be selected to calculate the reproducibility.

z If any selected result contains invalid parameter value (s), the Mean, SD and
CV% of that parameter(s) will also be non-numeric (***).

After browsing, CLICK the “Return” button to close the dialog box and return to the “Table
Review” screen.

7.2.7 Trend graph


You can view trend graphs of six parameters (WBC, RBC, PLT, HGB, MCV and RDW-CV) of
the selected sample result.

After selecting the sample results, CLICK the “Trend” button to enter the “Trend” screen.
Check the trend graph of the selected sample results, as shown in Figure 7-18.

Figure 7-18 Trend graph

z Trend graphs of 3 to 500 sample results can be viewed.

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Reviewing Sample Results

z If any selected result contains invalid parameter value (s), the Mean, SD and
CV% of that parameter(s) will also be non-numeric (***). The system will
automatically adopt the lower limit, mean value and the upper limit of the
“General” reference range as those in the trend graph. See Chapter 5
Customizing the Analyzer Software for how to set the reference range.

The points in the trend graph can be interpreted as follows:


Every “■” in the graph represents a sample result.
Black “■”: the sample result falls within the upper and lower limits.
Red “■”: The sample result falls outside the upper and lower limits, meaning either errors
occurred during the running or the value is outside the display range.

The trend graph can be interpreted as follows:

„ The x-axis represents the number of the sample results selected; the y-axis represents the
analyses results of every parameter.

„ For every parameter, the three numbers to the left of the graph indicate respectively the
three discriminators, upper limit, mean value and lower limit from top to bottom.

Upper limit: the average value + limit (average ×10%).


Mean value: the average value.
Lower limit: the average value – limit (average ×10%).

„ For every parameter,the three numbers to the right of the trend graph are defined and
calculated as follows:

Mean - the average value.


SD - Standard Deviation.
CV% - Coefficient of Variation.
n

∑x i
Mean= i=1
n

∑ (X − Mean )
2
i
SD =
n −1

SD
CV% = × 100
Mean

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

At the “Trend” screen, you can

„ Browse data

The 6 parameters are displayed in 2 screens. You can DRAG SCROLL BAR up and down to

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Reviewing Sample Results

switch screens. At each screen, the saved results are sequentially displayed in the trend graph,
the latest on the utmost left. If information cannot be displayed in one screen, DRAG SCROLL
BAR to scroll the screen.

If you want to view certain parameters of a sample result, CLICK the corresponding “■” in any
trend graph to connect the “■” in 6 trend graphs. The 6 corresponding parameter results will
be displayed below the corresponding parameter. The position of the current sample result and
the total number of sample results at the “Trend” screen are displayed in the “Pos./Total” box.
The analysis time is displayed in the “Time” box.

„ Adjust the limits

1. CLICK the “Edit” button at the “Trend” screen and a dialog box shown in Figure 7-19 will
pop up.

Figure 7-19 Editing dialog box

2. SELECT the desired parameter from the “Parameter” pull-down list.

3. Enter the desired limit in the “Limit” box.

4. CLICK the “OK” button to confirm the change. You can see the adjusted trend graph and
limits of the desired parameter.

„ Exit

CLICK the “Return” button to exit the “Trend” screen and return to the “Table Review” screen.

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Reviewing Sample Results

7.2.8 Deleting sample results (Option)


You can delete sample results at the “Table Review” screen of the sample database as
instructed below.

1. CLICK the “DELETE” button and a dialog box shown in Figure 7-20 will pop up.

Figure 7-20 Deletion dialog box

2. CLICK the “Current Record”, “Selected Record” or “All Records” radio button for
desired sample results.

3. CLICK the “DELETE” button and a dialog box shown in Figure 7-21 will pop up.

Figure 7-21 Prompt dialog box

4. CLICK the “OK” button to close the dialog box and delete the desired sample results.

7.2.9 Printing sample results


You can print the sample results at the “Table Review” screen as instructed below.

1. CLICK the “Print” button and a dialog box shown in Figure 7-22 will pop up.

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Reviewing Sample Results

Figure 7-22 Print dialog box

2. CLICK the “Table Print” or “Graph Print” radio button to select the print mode.

3. CLICK the “Current Record”, “Selected Record” or “All Records” radio button to select
the desired sample results.

4. CLICK the “Print” button and a dialog box shown in Figure 7-23 will pop up.

Figure 7-23 Prompt dialog box

5. CLICK “Yes” to perform the print and close the print dialog box.

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Reviewing Sample Results

7.2.10 Transmission
You can transmit sample results to an external computer (a host) as instructed below.

1. CLICK the “Com.“ button and a dialog box shown in Figure 7-24 will pop up.

Figure 7-24 “Com.” dialog box

2. CLICK the “Selected records” or “All records” button to select the desired sample
results. CLICK the “Start” key and a dialog box will pop up.

3. CLICK “Yes” to perform the transmission.

4. To cancel the transmission, CLICK the “Com.” button again and the “Com.” dialog box will
pop up.

5. CLICK the “Stop” button and the transmission will stop after the current transmission is
completed.

7.2.11 Switching screens


To switch to the “Graph Review” screen, CLICK the “Graph Review” button; to switch back to
the “Table Review” screen, CLICK the “Table Review” button. See 7.3 Browsing in the
“Graph Review” mode for the functions at the “Graph Review” screen.

To switch to the “Main” screen or the “Count” screen, CLICK the “Main” or “Count” button.

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Reviewing Sample Results

7.3 Browsing in the “Graph Review” mode

CLICK the “Review” icon at the “Main” screen and then CLICK the “Graph Review” button to
enter the “Graph Review” screen shown in Figure 7-25.

Figure 7-25 “Graph Review” screen

SELECT “Sample database”, “Search database” or “Selected database” from the “Current”
pull-down list to browse desired sample results. Sample results that have been found or
selected will be saved respectively to the “Search database” or “Selected database”. See
Heading 7.2.2 Selecting/Deselecting sample results and Heading 7.2.3 Search for a particular
sample result(s) for details.

You can review sample results in three databases in the same way. Take reviewing “Sample
database” for example, you can review sample results in the graph mode as instructed below.

7.3.1 Browsing sample results


The “Pos./Total” displayed at the top of the screen indicates the location of the current sample
result (the one highlighted) and the total number of the saved sample results. CLICK the “↑”
or “↓” button to browse sample results.

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Reviewing Sample Results

z CLICK the “RUO” button to browse the analysis results of RUO parameters.

7.3.2 Editing work list information


CLICK the “↑” or “↓” button in the upper right of the screen to select the desired sample
result. CLICK the “Edit” button and a dialog box shown in Figure 7-26 will pop up.

z Sample ID up to 15 alphanumeric characters may be entered in the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

Figure 7-26 Editing work list information dialog box

„ Entering Sample ID

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

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Reviewing Sample Results

„ Entering the patient name

Enter the patient name into the “Name” box.

„ Selecting patient sex

SELECT the desired item from the “Sex” pull-down list.

„ Entering the patient age

This analyzer provides four ways for you to enter the patient age – in years, in months, in days
and in hours. 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 one month and the fourth for the neonatal no older than 24 hours. You
can choose only one of the four ways to enter the patient age.

SELECT “Year”, “Month”, “Day” or “Hour” from the “Age” pull-down list. enter the patient age
per the selected unit.

„ Entering the chart number

Enter the number of the patient’s medical record into the “Chart No.” box.

„ Entering the department/area name

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

„ Entering the bed number

Enter the number of the patient’s bed into the “Bed No.” box.

„ Entering the sampling time

Enter the time when the sample is collected into the “Sampling” box (See Heading 5.2.1
Settings for how to set the sampling time)

„ Entering the name of the tester

To enter the name of the person who sent the sample for analysis, 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).

„ Entering the delivery time

Enter the time when the sample is sent into the “Delivery” box (See Heading 5.2.1 Settings for
how to set the delivery time)

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Reviewing Sample Results

„ Entering the name of the tester

SELECT the desired name from the “Tester” pull-down list (if there are previously saved
names in the list). If the name of the tester is unavailable in the list, CLICK the “Sign” button to
the right of the “Tester” box. The login dialog box shown in Figure 7-27 will pop up.

Figure 7-27 Login dialog box

Enter the name and password (administrator level) of the tester respectively into the “User
name” and “Password” boxes. CLICK the “OK” button to return to the editing work list
information dialog box. The tester’s name will automatically appear in the “Tester” box.

„ Entering comments

Enter comments in the “Comments” box.

„ “OK” button

When you have finished entering the work list information, CLICK the “OK” button to save the
changes and return to the “Graph Review” screen.

„ “Cancel” button

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

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Reviewing Sample Results

7.3.3 Adjusting histograms

z If you have logged in as a common user, you can only view the histograms
without changing them. To adjust the histograms, first log out and then
re-log in as the administrator.

The discriminators of histograms can be adjusted in case you are not satisfied with the result.
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: To move the second discriminator of the following RBC histogram to 100fL, follow
the procedure below to do so.

1. CLICK the “Adjustment” button at the “Graph Review” screen and a dialog box shown in
Figure 7-28 will pop up.

Figure 7-28 Adjusting histogram 1

2. CLICK the “Line 2” radio button.

3. CLICK the “←” button to move the second line of RBC to 100fL, as shown in Figure 7-29.

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Reviewing Sample Results

Figure 7-29 Adjusting histogram 2

4. CLICK the “OK” button to save the changes and close the dialog box.

7.3.4 Printing sample results


To print the analysis results of the current sample, CLICK the “Print” button at the bottom of
the screen.

7.3.5 Switching screens


To switch to the “Table Review” screen, CLICK the “Table Review” button; to switch back to
the “Graph Review” screen, CLICK the “Graph Review” button.

To switch to the “Main” screen or the “Count” screen, CLICK the “Main” or “Count” button.

7-27
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 file. 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-5500 provides 2 QC programs: L-J QC and X-B QC.

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Using the QC Programs

8.2 “L-J QC” Program

Using the “L-J QC” program, you can provide quality control for maximum 23 parameters and
another 5 parameters (GRAN-X, GRAN-Y, GRAN-Y(W), WBC/BA-X and WBC/BA-Y), which
are available in the QC program only. The analyzer provides 12 QC files for you to save QC
settings and results. Every QC file can save 3 lot numbers respectively for high, normal and
low controls. The QC file of every lot 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.

8.2.1 Editing L-J settings

1. At the “Main” screen, CLICK the “QC” button to enter the screen shown in Figure 8-1.

Figure 8-1 “QC count” screen

2. CLICK the “Setting” button in the upper left corner of the screen to enter the screen
shown in Figure 8-2.

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Using the QC Programs

Figure 8-2 “QC setup” screen

3. Editing QC files

„ Selecting the file number

SELECT the desired number from the “File No.” pull-down list, ranging from 1 to 12.

„ Entering the lot number

Every QC file can save results of 3 lot numbers respectively for high, normal and low controls.
Enter the lot number of the control to be used into the “Lot No.” box, or SELECT the desired
number from the “Lot No.” pull-down list (if there are previously saved lot No. in the list).

z Up to 16 digits can be entered into the “Lot No.” box of controls.

„ Selecting the control level

SELECT the desired level from the “Level” pull-down list.

„ Selecting the mode

SELECT the desired mode from the “Mode” pull-down list.

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Using the QC Programs

z If a built-in barcode scanner is equipped and the “AL-WB” mode is selected,


a check box of “Int. barcode” will appear on the screen. CLICK the check box
to select if necessary.

„ Entering the Exp. Date

CLICK the “Exp. date” box and select the desired date from the calendar.

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


Enter the means and ranges for the parameters to be included in the QC run into their
respective “Mean” and “Range” boxes.

z The “Del. Ref. Value” button appears gray when there are saved expected
results and limits at the “Setting” screen. You need to delete all the L-J
analysis results at the current QC file before editing. See Heading 8.2.3
Reviewing L-J analysis results for how to delete the results.

z Refer to the instructions for 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 The expected results entered should be within the display range; the limits
should be less than the expected results and neither of them should be “0”.
Otherwise, the entry is invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

At the “QC setup” screen, you can

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

To clear the expected results (mean) and limits (range) in the current QC file, do the following
steps.
1. CLICK the “Del. Ref. Value” button and a dialog box shown in Figure 8-3 will pop up.

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Using the QC Programs

Figure 8-3 “Del. Ref. Value” dialog box

2. CLICK the “OK” button to clear all the expected results and limits in the current QC file.

„ Choose preset-value

If the analyzer has preset expected results and limits (see Heading 8.2.3 Reviewing L-J
analysis results for how to set the preset-value), you can set them to be preset-values for the
current QC file as instructed below.

1. CLICK the “Have preset” button and a dialog box shown in Figure 8-4 will pop up.

8-5
Using the QC Programs

Figure 8-4 Selecting how to calculate limits

2. Select the “Calculation method” and “Calculation range”.


If you CLICK the “Calculate by #”, the limit will be displayed in the table by absolute value.
CLICK the “2SD” or “3SD” to select either double or triple standard deviation to be the limit.

If you CLICK the “Calculate by %”, the limit will be displayed in the table by percentage (%).
CLICK the “2 CV” or “3 CV” to select either double or triple coefficient of variation to be the
limit.

3. CLICK the “OK” button to save the changes and return to the “QC setup” screen.

„ Print settings

CLICK the “Print” button to print out the settings of the current screen.

„ Switch screens

CLICK the “Main”, “Count” or “X-B QC” button at the bottom of the screen to switch to the
“Main” screen, “Count” screen or “X-B QC” screen.

A dialog box shown in Figure 8-5 will pop up when you want to switch screens.

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Using the QC Programs

Figure 8-5 Saving the changes

CLICK the “OK” button to save the changes and switch to the corresponding screen. CLICK
the “Cancel” button to abort the changes and switch to the corresponding screen.

z The settings can be saved only when both the expected result and limit are
valid.

8.2.2 Running controls


After the editing, CLICK the “Count” button to enter the screen shown in Figure 8-6. You can
select the desired analysis mode according to the sampling mode.

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Using the QC Programs

Figure 8-6 “QC count” screen

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the 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 for use of the controls for how to store and use
them.

z Be sure to keep dust from the prepared diluent.

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

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

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

8-8
Using the QC Programs

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 Be sure to prepare at least 1mL of control when running control in the open
vial sampling mode; at least 2mL of control in the closed-tube sampling
mode and autoloading mode.

z The analysis results may be unreliable if the QC program is run with error(s)
reported. Be sure to troubleshoot your analyzer before moving on.

z Do not re-use disposable products.

Open vial sampling mode

z Do not open the front cover after the analysis starts.

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

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

Run controls as instructed below.


1. SELECT the desired numbers from the “File No.” and “Lot No.” pull-down lists.
2. Refer to the instructions for use of the controls for how to handle the control.
3. Run the control.

„ Running controls in the whole blood mode

a) Be sure the mode is “OV-WB” and the analysis status icon is green.
b) Present the prepared control to the sample probe.
c) Press the aspirate key to start the analysis.
d) The sample probe will automatically aspirate 120µL of sample. When you hear the beep,
remove the control. The analyzer will automatically run the sample.

8-9
Using the QC Programs

„ Running in the prediute mode

a) Be sure the mode is “OV-PD” and the analysis status icon is green.
b) CLICK the “Diluent” button at the lower left corner of the screen, and a dialog box will pop
up to prompt that the analyzer is preparing for adding diluent. After the preparation, the dialog
box will close automatically and the other dialog box shown in Figure 8-7 will pop up.

Figure 8-7 Dispensing diluent dialog box

c) Present a clean centrifugal tube to the sample probe and make sure the tube is tilted
towards the probe, as Figure 8-8 shows, to avoid spills and bubbles.

Figure 8-8 Dispensing diluent

d)Press the aspirate key to dispense 120µL of diluent (the dispensing volume is controlled by
the analyzer) into the tube. When you hear the beep, it means the dispensing is finished.
Remove the centrifugal tube.
e)Add 40µL of control to the diluent, close the tube cap and shake the tube to mix the sample.
f)After the prediluted sample is prepared, CLICK the “OK” button to close the dialog box. The
analyzer will start to clean the sample probe.
g)After the cleaning is finished, present the prepared control to the sample probe.
h)Press the aspirate key to start the L-J analysis. When you hear the beep, remove the
centrifugal tube.
4. When the analysis is finished, the result will be displayed on the screen. The analyzer will
be ready for the next analysis.

8-10
Using the QC Programs

z You can also aspirate 120µL of diluent by pipette into the tube.

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


techniques.

Close-tube sampling mode

z Do not open the front cover after the analysis starts.

z A closed tube sampler is required in the closed-tube sampling analysis.

z If abnormal power failure occurs after the analysis starts, open the front
cover to check for fallen test tube and take it out, if any.

Do as follows to run controls.


1. SELECT the desired numbers from the “File No.” and “Lot No.” pull-down lists.
2. Refer to the instructions for use of the controls for how to handle the control.
3. Be sure the mode is “CT-WB” and the analysis status icon is green.
4. CLICK the “Open door” button to open the sample compartment door.
5. Load the mixed control to the tube holder and close the door.
6. CLICK the “Count” button to start the analysis.
7. When the analysis is finished, the result will be displayed on the screen. The sample
compartment door will automatically open and the sample tube can be removed. The
analyzer will be ready for the next analysis.

Autoloading mode

z Do not open the front cover after the analysis starts.

z An autoloader is required in the autoloading analysis.

z If abnormal power failure occurs after the analysis starts, remove the rack(s)
manually, open the front cover to check for fallen test tube and take it out, if
any.

Do as follows to run controls.


1. SELECT the desired numbers from the “File No.” and “Lot No.” pull-down lists.
2. Refer to the instructions for use of the controls for how to handle the control.
3. Run the control.

8-11
Using the QC Programs

„ Without using the built-in barcode scanner

a) Be sure the mode is “AL-WB” and the analysis status icon is green.
b) Place the prepared control into the first tube position of the sample carrier.
c) Load sample carrier on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the carrier facing the analyzer.
d) CLICK the “Count” button at the “QC count” screen. The analyzer will start the analysis
automatically.

z When the built-in barcode scanner is not used, you can run only one control
each time.

„ Using the built-in barcode scanner

a) Be sure the mode is “AL-WB” and the analysis status icon is green.
b) Place the prepared controls into the tube position.
c) Load racks sequentially on the level of the right tray of the autoloader, with the back of
“MINDRAY” mark on the carrier facing the analyzer.
d) CLICK the “Count” button at the “QC count” screen. The analyzer will start the analysis
automatically. The analyzer will switch the current screen to the corresponding QC file
according to the lot number scanned.

z The QC file No. of the same batch of controls must be the same.

4. After the analysis, racks come to the left tray of the autoloader. Remove them safely. The
analyzer will display the results on the current QC file and be ready for the next analysis.

z If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.

z If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.

8-12
Using the QC Programs

At this screen, you can

„ Browse sample results

CLICK the “↑” or “↓” button below the “Pos./Total” to browse sample results saved in the
current QC file.

If a parameter is followed by an “H” or “L”, it means the analysis result has exceeded the upper
or lower limit of the reference range previously set at the “QC setup” screen.

If you see “***” as opposed to the result, it means the result is either invalid or out of the display
range. If the WBC result of the whole blood control is less than 0.5 × 109/L or the WBC result of
the prediluted control is less than 5 × 109/L, this analyzer will not perform the differential
analysis and all the related parameter values will be non-numeric (***).

„ Print

CLICK the “Print” button to print the analysis results for the current control.

„ Switch screens

CLICK the “Main”, “Count” or “X-B QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “X-B QC” screen.

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Using the QC Programs

8.2.3 Reviewing L-J analysis 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


At the “QC count” screen, CLICK the “Graph” button to enter the screen shown in Figure 8-9.

Figure 8-9 “L-J QC Graph” screen

SELECT desired numbers from the “File No.” and “Lot No.” pull-down lists to switch to the
corresponding “L-J QC Graph” screen.

z If the saved within control results of L-J QC graph are less than 3, the
“Mean”, “SD” and “CV%” of every parameter are all empty.

The L-J graph can be interpreted as follows:

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

„ Points linked by a green line represent results from a same L-J analysis.

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

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

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Using the QC Programs

„ 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:

189.8 - Upper limit: the expected result + limit.


91.4 - the expected result.
0.0 - the expected result – limit.

„ 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 L-J analyses.


SD - Standard Deviation.
CV% - Coefficient of Variation.
n

∑x i
Mean= i=1
n

∑ (X − Mean )
2
i
SD =
n −1

SD
CV% = × 100
Mean

where, n represents how many L-J analyses are run and Xi is the result of the ith L-J analysis.

Every “■” in the graph represents a control result. They are connected by dark lines.
Black “■”: the point falls within the upper and lower limits.
Red “■”: The point falls outside the upper and lower limits, meaning either errors occurred
during the running or the value is outside the display range.

If you see any points fallen outside the control range, do the following steps until the problem is
solved. If all the steps have failed, contact Mindray customer service department or your local
distributor for assistance.

1. Check the screen for error messages and refer to Chapter 11 Troubleshooting Your
Analyzer for solutions.

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.

8-15
Using the QC Programs

At the “L-J QC Graph” screen, you can:

„ Browse sample results

The L-J analysis results are sequentially displayed on the graph, the latest on the utmost right
of the graph. DRAG SCROLL BAR up or down to review the preceding or following screen.

CLICK the “←” or “→” button at the left side of the screen to review the preceding or following
result. The parameter value of each point is displayed below the parameter. The location of the
current point and the total number of the saved sample results are displayed below the
“Pos./Total”. The saving time of result is displayed above the L-J graphs.

„ Set the preset-values

You can select results from the L-J graph to calculate the Mean, SD and CV%, and set the
calculated results to be preset-value when editing the settings. In QC files, you can set a set of
preset-values calculated for 3 lots of controls respectively. Do as instructed below.

z The preset-value can only be calculated by selecting within control results


of at least 3 QC runs.

1. CLICK the “Calculate” button and a dialog box shown in Figure 8-10 will pop up.

Figure 8-10 Calculating the preset-value

8-16
Using the QC Programs

2. Enter the desired data range into the “From” and “To” boxes.
3. CLICK the “OK” button to close the dialog box, return to the “L-J QC Graph” screen and
display on the right of the screen the Mean, SD and CV% calculated from the selected
data (if you return to the “L-J QC Graph” screen after screen switching, the Mean, SD and
CV% calculated from all within control data will be redisplayed on the right of the QC
graph).

z If you want to recalculate the preset-value, repeat step 1 to 3 of setting the


preset-value.

4. CLICK the “Save” button and a dialog box shown in Figure 8-11 will pop up.

Figure 8-11 Saving the preset-value

5. CLICK “Yes” to save the preset-value and return to the “L-J QC Graph” screen.

„ Handling out of control

If out of control data appears, you can give the reasons per the following instructions.
Move the green vertical line in the graph to the out of control point, click the “OOC” (out of
control) button, and a dialog box will pop up as follows.

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Using the QC Programs

Figure 8-12 “OOC” dialog box

The dialog box will list all out of control data of the out of control point on the green line, all L-J
QC parameters, their expected results and limits.
Reasons of out of control points on the green line are provided in the dialog box, you can click
to select the desired ones. You can also enter reasons in the “Others” box manually, up to 100
characters.
After the edit, click the “OK” button to save the out of control reason, close the dialog box and
return to the “L-J QC Graph” screen. Click the “Cancel” button to abort the changes, close the
dialog box and return to the “L-J QC Graph” screen.

„ Print

CLICK the “Print” button to print out the current L-J graph.

„ Switch screens

CLICK the “Main”, “Count” or “X-B QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “X-B QC” screen.

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Using the QC Programs

“L-J Table” mode


At the “QC count” screen, CLICK the “Table” button to enter the screen shown in Figure 8-13.

Figure 8-13 “L-J QC table” screen

SELECT desired numbers from the “File No.” and “Lot No.” pull-down lists to switch to the
corresponding “L-J QC table” screen.

At the “L-J QC table” screen, you can:

„ Browse sample results

The L-J analysis results are sequentially displayed on the table, the latest on the utmost
bottom of the table. DRAG SCROLL BAR up and down to review the preceding or following
screen.

If an “H” or “L” appears to the left of the result, it means the analysis result has exceeded the
upper or lower limit of the reference range previously set at the “QC setup” screen.

If you see “***” as opposed to the result, it means the result is either invalid or out of the display
range. If the result of WBC whole blood control is less than 0.5 × 109/L or the result of WBC
prediluted control is less than 5 × 109/L, this analyzer will not perform the differential analysis
and all the related parameter values will be non-numeric (***).

„ Delete analysis results

You can delete any one or all of the L-J analysis results saved in the current QC file.

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Using the QC Programs

To delete a single result:


CLICK the result you want to delete, then CLICK the “DELETE” button and a dialog box
shown in Figure 8-14 will pop up.

Figure 8-14 “Delete” dialog box 1

To confirm the deletion, CLICK “Yes”. Otherwise, CLICK “No”.

To delete all the results:


CLICK any cell to the right of the “Mean” or “Range”, then CLICK the “DELETE” button and a
dialog box shown in Figure 8-15 will pop up.

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Using the QC Programs

Figure 8-15 “Delete” dialog box 2

To confirm the deletion, CLICK “Yes”. Otherwise, CLICK “No”.

z After every deletion, the following results will sequentially move forward
and their No. will be refreshed.

„ Transmit analysis results

You can transmit all the L-J analysis results to an external computer (a host).

CLICK the “Com.” button and a dialog box shown in Figure 8-16 will pop up.

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Using the QC Programs

Figure 8-16 Communication dialog box

To transmit all the L-J analysis results, CLICK “Yes”. Otherwise, CLICK “No”.

„ Print analysis results

CLICK the “Print” button to printout the L-J table of the current screen.

„ Switch screens

CLICK the “Main”, “Count” or “X-B QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “X-B QC” screen.

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Using the QC Programs

8.3 “X-B QC” Program

The X-B analysis is a weighted moving average analysis that uses values obtained from
patient samples. It uses 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 activated when the sample volume of your laboratory is
greater then 100 samples per day. The analyzer can save maximum 500 X-B QC results.
When the saved QC results have reached the maximum number, the newest result will
overwrite the oldest.

8.3.1 Editing X-B Settings


Before the X-B analysis, you need to edit the X-B settings as follows.
1. At the “Main” screen, CLICK the “QC” icon to enter the “L-J QC Graph” screen. CLICK
the “X-B QC” button to enter the “X-B QC setup” screen shown in Figure 8-17.

Figure 8-17 “X-B QC setup” screen

2. ENTER means and ranges for the parameters to be included in the X-B analysis into their
respective boxes.

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Using the QC Programs

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


results by calculating the averages of random patient samples.

z The expected results vary with areas. It is recommended they are obtained
by calculating the averages of at least 500 random patient samples.

z The recommended limit is 3% - 5%.

z The “Del. Ref. Value” button appears gray when there are saved expected
results and limits at the “Setting” screen. You need to delete all the X-B
analysis results before editing. See Heading 8.3.3 Reviewing X-B analysis
results for how to delete the results.

z The expected results entered should be within the display range; the limits
should be less than the expected results and neither of them should be “0”.
Otherwise, the entry is invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

3. ENTER the desired number, 20 to 200 (20 is recommended), in the “N of S /group” box.
4. CLICK the “Open” radio button of “X-B QC” to activate the X-B analysis.

z 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, deactivate the X-B analysis.

z CLICK the “Close” radio button of “X-B QC” to deactivate the X-B analysis.
The default setting is “OFF”.

At the “X-B QC setup” screen, you can:

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

To clear the expected results (mean) and limits (range) at the current screen, do the following
steps.
1. CLICK the “Del. Ref. Value” button and a dialog box shown in Figure 8-18 will pop up.

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Using the QC Programs

Figure 8-18 “Del. Ref. Value” dialog box

2. CLICK “Yes” to clear all the expected results (mean) and limits (range) at the current
screen.

„ Print settings

CLICK the “Print” button to print out the settings of the current screen.

„ Switch screens

CLICK the “Main”, “Count” or “L-J QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “L-J QC” screen.

A dialog box shown in Figure 8-19 will pop up when you want to switch screens.

Figure 8-19 Saving the changes

CLICK the “OK” button to save the changes and switch to the corresponding screen. CLICK
the “Cancel” button to abort the changes and switch to the corresponding screen.

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z The settings can be saved only when both the expected result and limit are
valid.

8.3.2 Performing X-B analysis


After the editing, CLICK the “Count” button to enter the screen shown in Figure 8-20.

Figure 8-20 “Count” screen

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

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.

8.3.3 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.

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“X-B Graph” mode


At the “Main” screen, CLICK the “QC” button to enter the “L-J QC Graph” screen. CLICK the
“X-B QC” button to enter the “X-B QC setup” screen. Then CLICK the “Graph” button to enter
the screen shown in Figure 8-21.

Figure 8-21 “X-B QC Graph” screen

The X-B graph can be interpreted as follows:

„ The x-axis represents the number of the X-B analyses performed; the y-axis represents
the results of the X-B analyses.

„ Points linked by a green line represent results from a same L-J analysis.

„ For every parameter, its X-B graph can display maximum 500 points, 31 points per
screen.

„ 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. MCV), the three numbers to the left of the X-B Figure are
defined as follows:

6.50 - the expected result + limit.


4.50 - the expected result.
2.50 - the expected result – limit.

„ For every parameter,the three numbers to the right of the X-B graph are defined and
calculated as follows:

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Using the QC Programs

Mean - the average of the saved X-B analyses.


SD - Standard Deviation.
CV% - Coefficient of Variation.
n

∑x i
Mean= i=1
n

∑ (X − Mean )
2
i
SD =
n −1

SD
CV% = × 100
Mean

where, n represents how many sample results are included in an X-B analysis and Xi is the ith
sample result in any X-B analysis.

Every “■” in the graph represents a control result. They are linked by dark lines.
Black “■”: the point falls within the upper and lower limits.
Red “■”: The point falls outside the upper and lower limits.

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 screen for error messages. Refer to Chapter 11 Troubleshooting Your
Analyzer for solutions to any displayed error messages.

2. Check the X-B settings for inappropriate entries.

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


Troubleshooting Your Analyzer for solutions.

4. Run a control.

5. Check if the analyzer needs to be calibrated.

At the “X-B QC Graph” screen, you can:

„ Browse sample results

The X-B analysis results are sequentially displayed on the graph, the latest on the utmost right
of the graph. If the results cannot be view all at once, DRAG SCROLL BAR up or down to
review the preceding or following screen.

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Using the QC Programs

CLICK the “←”or “→” button at the left side of the screen to review the preceding or following
result. The parameter value of each point is displayed below the parameter. The location of the
current point and the total number of the saved sample results are displayed below the
“Pos./Total”. The saving time of result is displayed above the X-B graphs.

„ Print

CLICK the “Print” button to print out the current X-B graph.

„ Switch screens

CLICK the “Main”, “Count” or “L-J QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “L-J QC” screen.

“X-B Table” mode


At the “QC count” screen, CLICK the “Table” button to enter the screen shown in Figure 8-22.

Figure 8-22 “X-B QC table” screen

At the “X-B QC table” screen, you can:

„ Browse sample results

DRAG SCROLL BAR up and down to review the X-B analysis results of the three parameters.
The X-B analysis results are sequentially displayed on the table, the latest on the utmost
bottom of the table.

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Using the QC Programs

If an “H” or “L” appears to the left of the result, it means the analysis result has exceeded the
upper or lower limit of the reference range previously set at the “X-B QC setup” screen.

„ Delete analysis results

You can delete all the X-B analysis results.

CLICK the “DELETE” button and a dialog box shown in Figure 8-23 will pop up.

Figure 8-23 “Delete” dialog box

To confirm the deletion, CLICK “Yes”. Otherwise, CLICK “No”.

„ Print

CLICK the “Print” button to print out the X-B table of the current screen.

„ Switch screens

CLICK the “Main”, “Count” or “L-J QC” radio button at the bottom of the screen to switch to
the “Main” screen, “Count” screen or “L-J QC” screen.

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9 Using the Calibration Programs

9.1 Introduction

Calibration is a procedure to standardize the analyzer by determining its deviation, if any, from
calibration references and to apply any necessary correction factors.

There are three calibration programs available on this analyzer:

„ auto calibration using Mindray-specified calibrators.

„ auto calibration using fresh blood samples.

„ manual calibration.

z Calibration procedures can only be performed by users of the


administrator-level.

z An effective calibration depends on the calibration materials used. Only


Mindray-specified calibration materials shall be used for the calibration.

z The analyzer identifies a sample as a calibration sample only if the analysis


is started from the “Calibration” screen.

z Reproducibility is included in the calibration procedure.

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Using the Calibration Programs

9.2 When to Calibrate


This analyzer is calibrated at the factory just before shipment. It is electronically stable and
does not require frequent recalibration if you operate and maintain it as instructed by this
manual. You only need to recalibrate this analyzer if:

„ it is the first time this analyzer has been used (usually done by a Mindray-authorized
representative when installing the analyzer).

„ an analytical component has been changed.

„ you are going to re-use the analyzer after a long-term storage.

„ 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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Using the Calibration Programs

9.3 How to Calibrate

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.

1. 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.

2. 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 in the OV-WB mode for 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 Condition Whole Blood Predilute


Reproducibility(CV%) Reproducibility (CV%)

WBC (6.0~15.0)×109/L ≤ 2.5% ≤ 9.0%


RBC (4.00~6.00)×1012/L ≤ 1.5% ≤4.5%
HGB (110~180) g/L ≤ 1.5% ≤4.5%
MCV (80~110) fL ≤ 1.5% ≤4.5%
PLT (150~500)×109/L ≤ 4.0% ≤12.0%

3. At the “Count” screen, run a vial of high control three consecutive times and then
immediately run the diluent three consecutive times, calculate the carryover per the
following equation. The calculated carryovers shall meet the requirements in Table 9-2.

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


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

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Using the Calibration Programs

Table 9-2 Carryover

Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 1.0 %
PLT ≤ 1.0 %

4. 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, and result of background check.

You can calibrate one of or more parameters by entering the expected results and limits of
WBC, RBC, HGB, MCV and PLT.

z The probe is sharp and may contain biohazardous material. Exercise


caution when working around the probe!

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


according to government regulations.

z Be sure to use the Mindray-specified controls. Using controls other than the
specified will lead to misleading results. Refer to the instructions for use of
the controls for how to store and use them.

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Using the Calibration Programs

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.

9.3.2 Entering and Exiting the “Calibration” screen


At the “Main”, CLICK the “Calibration” icon to enter the “Calibration” screen.

Figure 9-1 Calibration screen

At the “Calibration” screen, CLICK the “Main” button to return to the “Main”, or CLICK the
“Count” button to enter the “Count” screen.

z If you have logged in as a common user, you can only view the current
calibration factors without changing them. To calibrate the analyzer, first log
out and then re-log in as the administrator.

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Using the Calibration Programs

9.3.3 Auto calibration using commercial calibrators


Do as follows to calibrate the analyzer with commercial calibrators:

1. ENTER the password of administrator-level at the login screen to enter the “Main” screen.

2. CLICK the “Calibration” icon to enter the “Calibration” screen.

3. CLICK the “Calibrator” button to enter the “Calibrator” screen shown in Figure 9-2.

Figure 9-2 “Calibrator” screen

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z The default expiration date is the system time.

4. CLICK the desired analysis mode: OV-WB or OV-PD.

5. ENTER the lot number of the calibrator into the “Lot No.” box.

6. CLICK the “Exp. date” box and select the proper expiration date from the date setting
dialog box shown in Figure 9-3. The default setting is the current system time.

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Using the Calibration Programs

Figure 9-3 Date setting dialog box

7. ENTER the reference values into the “Mean” line for the parameters to be calibrated.

z Do not open the front cover after the analysis starts.

z Only Mindray-specified calibrators shall be used. Mindray are not


responsible for any erroneous analysis results obtained by using calibrators
other than the specified.

z Refer to the instructions for use of the calibrator for information of the lot
number, expiration date and reference values.

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 prepare at least 1mL of calibrator.

z Samples, controls, calibrators and waste are potentially infectious. Wear


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

8. Prepare the calibrator as instructed by its instructions for use.

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Using the Calibration Programs

9. Run the calibrator:

„ For the “OV-WB” mode:

a) Make sure the selected analysis mode is “OV-WB”.

b) Present the mixed calibrator to the sample probe so that the probe is well into the vial.

c) Press the aspirate key and the analyzer will aspirate 120 µL of calibrator.

d) When you hear the beep, remove the vial.

„ For the “OV-PD” mode:

a) Make sure the selected analysis mode is “OV-PD” and the “Calibration” screen is shown as
Figure 9-4.

Figure 9-4 OV-PD screen

b) CLICK the “Diluent” button at the lower right of the screen, and a dialog box will pop up to
prompt that the analyzer is preparing for adding diluent. After the preparation, the dialog box
will close automatically and the other dialog box shown in Figure 9-5 will pop up.

9-8
Using the Calibration Programs

Figure 9-5 Dialog box

c) Present a clean centrifugal tube to the sample probe and make sure the tube is tilted
towards the probe, as the figure below shows, to avoid spills and bubbles.

Figure 9-6 Dispensing diluent

d)Press the aspirate key to dispense 120µL of diluent (the dispensing volume is controlled by
the analyzer) into the tube. When you hear the beep, it means the dispensing is finished.
Remove the centrifugal tube.
e)Add 40µL of calibrator to the diluent, close the tube cap and shake the tube to mix the
sample.
f)After the prediluted sample is prepared, CLICK the “OK” button to close the dialog box. The
analyzer will start to clean the sample probe.
g)After the cleaning is finished, present the prepared calibrator to the sample probe.
h)Press the aspirate key to start the analysis. When you hear the beep, remove the centrifugal
tube.

z Do not re-use disposable products.

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Using the Calibration Programs

z Be sure to keep dust from the prepared diluent.

z You can also aspirate 120µL of diluent by pipette into the tube.

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


population and sample collection techniques or methods.

z If a calibration in the OV-WB mode or OV-PD mode is necessary, call


Mindray customer service department or your local distributor for
assistance. Do not attempt to calibrate the analyzer by yourselves.

z If the ambient temperature is outside the specified range, the analyzer will
alarm you to abnormal ambient temperature and the analysis results may be
unreliable. See Chapter 11 Troubleshooting Your Analyzer for solutions.

10. After the analysis, the analyzer will have different responses to different analysis results.

„ If non-numeric parameter values (“***”) are obtained, a dialog box of “This calibration
data is invalid!” shown in Figure 9-7 will pop up.

Figure 9-7 Dialog box of invalid calibration results

CLICK the “OK” button to close the dialog box and clear the analysis results.

„ If the results obtained are valid, they will be shown on the screen.

11. Repeat steps 8 to 10 to do 3 to 5 valid calibration runs (5 is recommended).

Once you have done 3 valid calibration runs, the analyzer will automatically calculate the CVs
and calibration factors, both of which will be refreshed at every additional calibration run. The
calculated CVs shall be within the ranges specified in Table 9-1. The calculated calibration
factors shall be between 75% - 125%. Any calculated calibration factor that falls outside this
range will be flagged by a question mark. In case of this, CLICK the “DELETE” button to delete
the results and rerun the calibrator. If these cases repeatedly happen, call Mindray customer
service department or your local distributor for assistance.

12. After new valid calibration factors are obtained, exit the calibration screen and verify the

9-10
Using the Calibration Programs

new factors at the count screen.

CLICK the “Main” or “Count” button at the bottom of the screen and a dialog box shown in
Figure 9-8will pop up.

Figure 9-8 Dialog box of saving calibration factors

CLICK “Yes” to save the new calibration factors (factors out of calibration range will not be
saved). CLICK “No” to switch to the corresponding screen without saving new calibration
factors.

Other operations
„ Print

CLICK the “Print” button at the bottom of the screen to printout the calibration analysis results.

9.3.4 Auto calibration using fresh blood samples


Do as follows to calibrate the analyzer with fresh blood samples.

1. ENTER the password of administrator-level at the login screen to enter the “Main” screen.
2. CLICK the “Calibration” icon to enter the “Calibration” screen.
3. CLICK the “Blood” button to enter the “Blood” screen shown in Figure 9-9.

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Using the Calibration Programs

Figure 9-9 Blood calibration screen

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

4. Prepare 3 to 5 normal fresh blood samples as instructed by Chapter 6 Operating Your


Analyzer.
5. Run each of the prepared samples on the reference instrument (or by the reference
method) three times. Average the results for your reference values.
6. CLICK the button to the left of the screen to select the desired analysis mode.
7. SELECT from the “Sample ID” pull-down list for the sample ID of the current sample.
8. Refer to Chapter 6 Operating Your Analyzer to run samples at the “Blood” calibration
screen.
9. After the analysis, the analyzer will have different responses to different analysis results.

„ If non-numeric parameter values (“***”) are obtained, a dialog box of “This calibration
data is invalid!” shown in Figure 9-10 will pop up.

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Using the Calibration Programs

Figure 9-10 Dialog box of invalid calibration results

CLICK the “OK” button to close the dialog box and clear the analysis results.

„ If the results obtained are valid, they will be shown on the screen.

The calculated CVs shall be within the ranges specified in Table 9-1 The calculated calibration
factors shall be between 75% - 125%. Any calculated calibration factor that falls outside this
range will be flagged by a question mark. In case of this, CLICK the “DELETE” button to delete
the results and rerun the calibrator. If these cases repeatedly happen, call Mindray customer
service department or your local distributor for assistance.
10. SELECT other calibration samples from the “Sample ID” pull-down list, run the samples
as instructed in steps 7 to 9 to obtain the calibration factors of each sample.
11. After calibration factors of at least 3 fresh blood samples are obtained, CLICK the
“Calculate” button to enter the screen shown in Figure 9-11. Average the calibration
factors.

Figure 9-11 Calibration calculation screen of fresh blood

12. There may be several cases when saving the new calibration factors (Mean).

9-13
Using the Calibration Programs

„ If the new calibration factors (Mean) are within the valid range, a dialog box of “Save
average calibration factor?” shown in Figure 9-12 will pop up when you CLICK the
“Main” or “Count” button to exit.

Figure 9-12 Dialog box

CLICK “Yes” to save the new factors, close the dialog box and switch to the corresponding
screen. CLICK “No” to abort the new factors.

„ If the new calibration factors (Mean) are out of the valid range, a dialog box of invalid
calibration factors will pop up when you CLICK the “Main” or “Count” button to exit.
CLICK “Yes” and the analyzer will automatically clear all the data from the fresh blood
calibration.

„ If the new calibration factors (Mean) has not been obtained yet, a dialog box of “Discard
meta-data” shown in Figure 9-13 will pop up when you CLICK the “Main” or “Count”
button to exit.

Figure 9-13 Dialog box

CLICK “Yes” to abort the calibration data and switch to the corresponding screen. CLICK “No”
to stay at the fresh blood calibration screen.

Other operations
„ Cleaning

CLICK the “Clean” button and the analyzer will automatically perform the cleaning procedure.

„ Unclogging

CLICK the “Unclog” button and the analyzer will automatically perform the unclogging
procedure.

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Using the Calibration Programs

„ Printing

CLICK the “Print” button and the analyzer will automatically perform the printing procedure.

„ Deleting

If you are not satisfy with calibration results of a certain run, CLICK any cell from the line at the
“Blood” calibration screen, and the selected line will be highlighted. CLICK the “DELETE”
button and a dialog box shown in Figure 9-14will pop up.

Figure 9-14 Dialog box

CLICK “Yes” to clear the selected data and the analyzer will recalculate the calibration factors
and the CVs of the current screen. CLICK “NO” to abort the deletion. If calibration factors of a
certain sample are deleted at the calculation screen, the analyzer will refresh the average
factors of the current screen and the original calibration data of this sample will be deleted too.

z Only one group of data can be deleted each time by clicking the “Delete”
button.

z You can not delete the obtained CVs and calibration factors at the “Blood”
screen.

9.3.5 Manual calibration

Do as follows to calibrate the analyzer:

1. Enter the “Main” as the administrator. CLICK the “Count” button to the screen shown in
Figure 9-15.

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Using the Calibration Programs

Figure 9-15 Count screen

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

2. Refer to relevant instructions in the Chapter 6 Operating Your Analyzer to select the
desired analysis mode at the “Count” screen.

3. Refer to the Heading 6.6 Sample Collection and Handling to run a calibration material with
known reference values 11 consecutive times.

4. Refer to the Chapter 7 Reviewing Sample Results for the CVs of the 2nd to 11th runs.

If any CV does not meet the requirements listed in Table 9-1, try to find out the reason and if
necessary, contact Mindray customer service department for assistance. If the CVs meet the
requirements, record the mean of the last 10 runs and calculate the new calibration factors as
follows:

5. Enter the “Manual” screen to check the calibration factors and calculate the new factors
per the following equation.

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Using the Calibration Programs

old factor × reference value


new factor =
calculated mean
For example: Supposed the WBC reference value of a calibrator is 8.4 (See the instructions for
use of the calibrator for the reference value), and the current calibration factor of the whole
blood mode is 98.9%.

Run the calibrator in the whole blood mode for 11 consecutive times and take the WBC results
of the 2nd to 11th runs (n=10) to calculate: 8.1, 8.0, 8.1, 8.1, 8.3, 8.3, 8.2, 8.0, 8.1, 8.3. The
obtained CV is 1.5% and Mean is 8.16, which meet the requirements in Table 9-1.

The new calibration factor is obtained:

The calculated calibration factors shall be between 75% - 125%. In case of an invalid
calibration factor, try to find out the reason (e.g. calibration material not thoroughly mixed,
misoperation, etc.). Then recalibrate the analyzer and recalculate the calibration factors.

z The entered calibration factors shall be between 75.0% - 125.0% (calculate


to one decimal place).

6. ENTER the new calibration factors into the factor cell of the parameter that requires
calibration.

7. After the entry, CLICK any button at the bottom of the screen to exit the “Manual” screen. If
the new calibration factors are all between 75.0% - 125.0%, a dialog box shown in Figure
9-16 will pop up.

Figure 9-16 Dialog box

CLICK “Yes” to save the new calibration factors and close the dialog box. CLICK “No” to close
the dialog box without saving.

9-17
Using the Calibration Programs

If not all the new calibration factors are within the valid range, a dialog box of “Invalid
calibration factor input,quit?” will pop up.

Figure 9-17 Dialog box

CLICK “Yes” to switch to the corresponding screen without saving the new factors. CLICK
“No” to stay at the current screen and reenter the valid data into the box where the I-beam
stays.

Other operations
„ Printing

If the calibration factors are not modified, CLICK the “Print” button to printout the current
calibration factors directly.

If the calibration factors are modified but the new factors have not been saved yet, a dialog box
shown in Figure 9-18 will pop up when you CLICK the “Print” button.

Figure 9-18 Dialog box

CLICK “Yes” to printout the new calibration factors. CLICK “No” to printout the original
calibration factors.

9.3.6 Verifying calibration factors


It is recommended that you at the “Count” screen,

1. run the calibrator at least three times and check whether the means of the obtained results
are within the expected ranges.

2. run the low, normal and high level controls, each for three times at least, and check
whether the means of the obtained results are within the expected ranges.

9-18
Using the Calibration Programs

3. run at least three fresh blood samples with known reference values, each for three times at
least, and check whether the means of the obtained results are within the expected
ranges.

9.3.7 Checking calibration history

Entering the “History” screen


CLICK the “History” button at the bottom of the screen to review the calibrations at the screen
shown in Figure 9-19.

Figure 9-19 “History” screen

The “History” screen sequences the time, mode, calibration parameters and calibration mode
of the latest 30 calibrations. The latest calibration record is on the top of the list (No.1). The
latest record will overwrite the oldest if the calibration records are out of 30. You can DRAG
SCROLL BAR to view all records in the list but not modify or DELETE the records.

Printing
CLICK the “Print” button at the bottom of the screen to print the list information.

Exiting the “History” screen


CLICK the any button at the bottom of the screen to exit and switch to the corresponding
screen.

9-19
10 Maintaining Your Analyzer
10.1 Introduction

Preventive and corrective maintenance procedures are required to keep the BC-5500 in a
good operating condition. This analyzer provides multiple maintenance functions for this
purpose. This chapter introduces how to use the provided functions to maintain and
troubleshoot your analyzer.

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

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


service department or your local distributor for assistance.

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


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

z All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.

10-1
Maintaining Your Analyzer

10.2 Using the “Maintenance” Program

CLICK the “Service” icon at the “Main” screen to enter the “Service” screen shown in Figure
10-1, which is the default “Maintain” screen.

Figure 10-1 “Maintain” screen

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

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


check to ensure the background results are normal.

10-2
Maintaining Your Analyzer

10.2.1 Replacing/Priming
CLICK the “R / P” button at the “Maintain” screen to enter the “R / P” screen.

At this screen, you can replace any of the following reagents:

„ Diluent

„ LBA lyse

„ LEO (I) lyse

„ LEO (II) lyse

„ LH lyse

„ Cleanser

You can prime any of the following cisterns:

„ Diluent cistern

„ Flow cytometry cistern

„ Cleanser cistern

Replacing the Diluent


You should perform this procedure when:

„ WBC/RBC bubbles are reported; or

„ the diluent is contaminated; or

„ a new container of diluent is installed.

Do as follows:

1. CLICK the “Diluent” button at the “R / P” screen.

2. The replacement will start and the replacement progress will be displayed at the screen.

3. Once the replacement is complete, a dialog box of “Reagent prime finished!” will be
displayed at the “R / P” screen. CLICK “OK” to close it.

Replacing the LBA lyse


You should perform this procedure when:

„ WBC/RBC bubbles are reported; or

„ the LBA lyse is contaminated; or

„ a new container of LBA lyse is installed.

10-3
Maintaining Your Analyzer

Do as follows:

1. CLICK the “LBA lyse” button at the “R / P” screen.

2. The replacement will start and the replacement progress will be displayed at the screen.

3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “R / P” screen. CLICK “OK” to close it.

Replacing the LEO (I) lyse


You should perform this procedure when:

„ WBC/RBC bubbles are reported; or

„ the LEO (I) lyse is contaminated; or

„ a new container of LEO (I) lyse is installed.

Do as follows:

1. CLICK the “LEO(I) lyse:” button at the “R / P” screen.

2. The replacement will start and the replacement progress will be displayed at the screen.

3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “R / P” screen. CLICK “OK” to close it.

Replacing the LEO (II) lyse


You should perform this procedure when:

„ WBC/RBC bubbles are reported; or

„ the LEO (II) lyse is contaminated; or

„ a new container of LEO (II) lyse is installed.

Do as follows:

1. CLICK the “LEO(II)lyse” button at the “R / P” screen.

2. The replacement will start and the replacement progress will be displayed at the screen.

3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “R / P” screen. CLICK “OK” to close it.

Replacing the LH lyse


You should perform this procedure when:

„ WBC/RBC bubbles are reported; or

„ the LH lyse is contaminated; or

„ a new container of LH lyse is installed.

10-4
Maintaining Your Analyzer

Do as follows:

1. CLICK the “LH lyse” button at the “R / P” screen.

2. The replacement will start and the replacement progress will be displayed at the screen.

3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “R / P” screen. CLICK “OK” to close it.

Replacing the cleanser


You should perform this procedure when:

„ WBC/RBC bubbles are reported; or

„ the cleanser is contaminated; or

„ a new container of cleanser is installed.

Do as follows:

1. CLICK the “Cleanser” button at the “R / P” screen.

2. The replacement will start and the replacement progress will be displayed at the screen.

3. Once the replacement is complete, a dialog box “Reagent prime finished!” will be
displayed at the “R / P” screen. CLICK “OK” to close it.

Priming the DIL Cistern


You should perform this procedure to prime the DIL cistern if the reagent in it is not full enough.

Do as follows:

1. CLICK the “DIL cistern” button at the “R / P” screen.

2. The analyzer will start priming and the priming progress will be displayed.

3. Once the priming is complete, a dialog box “Reagent prime finished!” will be displayed at
the “R / P” screen. CLICK “OK” to close it.

Priming the FCM Cistern


You should perform this procedure to prime the FCM cistern if the reagent in it is not full
enough.

Do as follows:

1. CLICK the “FCM cistern” button at the “R / P” screen.

2. The analyzer will start priming and the priming progress will be displayed.

3. Once the priming is complete, a dialog box “Reagent prime finished!” will be displayed at
the “R / P” screen. CLICK “OK” to close it.

10-5
Maintaining Your Analyzer

Priming the cleanser Cistern


You should perform this procedure to prime the cleanser cistern if the reagent in it is not full
enough.

Do as follows:

1. CLICK the “C cistern” button at the “R / P” screen.

2. The analyzer will start priming and the priming progress will be displayed.

3. Once the priming is complete, a dialog box “Reagent prime finished!” will be displayed at
the “R / P” screen. CLICK “OK” to close it.

If the replacement or priming fails, the corresponding dialog box will be displayed at the screen.
CLICK “OK” to close it. Check if the tubing is pinched or disconnected. If so, remove the error
and perform the procedure again. If the procedure fails again, contact Mindray customer
service department or your local distributor for assistance.

10.2.2 Cleaning
CLICK the “Service” icon at the “Main” screen and then CLICK the “Clean” button to enter the
“Clean” screen shown in Figure 10-2.

Figure 10-2 “Clean” screen

10-6
Maintaining Your Analyzer

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.

Cleaning the WBC Bath


When the background of WBC relative parameters is high, do as follows:

1. CLICK the “WBC bath” button at the “Clean” screen to start the cleaning process.

2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.

3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.

Cleaning the RBC Bath


When the background of RBC relative parameters is high, do as follows:

1. CLICK the “RBC bath” button at the “Clean” screen to start the cleaning process.

2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.

3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.

Cleaning the Premix Bath


When the background of RBC relative parameters is high, do as follows:

1. CLICK the “Premix bath” button at the “Clean” screen to start the cleaning process.

2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.

3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.

Cleaning the HGB Bath


When the background of HGB relative parameters, do as follows:

1. CLICK the “HGB bath” button at the “Clean” screen to start the cleaning process.

2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.

3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.

10-7
Maintaining Your Analyzer

Cleaning the Open Vial Unit


You should perform this procedure every month to prevent the sampling unit from being
contaminated.

Do as follows:

1. CLICK the “Open Vial unit” button at the “Clean” screen to start the cleaning process.

2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.

3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.

Cleaning the Autoloader Unit (if configured)


You should perform this procedure every month to prevent the sampling unit from being
contaminated.

Do as follows:

1. CLICK the “Autoloader unit” button at the “Clean” screen to start the cleaning process.

2. The “Cleaning. Please wait...” and the cleaning progress will be displayed at the screen.

3. Once the cleaning is complete, a dialog box of “Clean finished!” will be displayed at the
“Clean” screen. CLICK “OK” to close it.

Cleaning the flow cell to remove bubbles


When abnormal enlarged cell group appears in scatter plots and the background of the WBC
relative parameters is too high, bubbles may exist in the flow cell. Perform this procedure to
remove bubbles.

Do as follows:

1. CLICK the “Remove bubbles” button at the “Clean” screen to start the process.

2. The progress will be displayed at the screen.

3. Once the removal is complete, a dialog box of “Remove bubbles finished!” will be
displayed at the “Clean” screen. CLICK “OK” to close it.

10.2.3 Maintenance
CLICK the “Service” icon at the “Main” screen and then CLICK the “Maintenance” button to
enter the screen shown in Figure 10-3.

10-8
Maintaining Your Analyzer

Figure 10-3 “Maintenance” screen

Emptying
CLICK the corresponding button to empty the desired bath or cistern.

Unclogging the Aperture


„ Zapping

You should perform this procedure to unclog the RBC aperture or prevent clogging. It functions
by putting high-voltage direct current on both sides of the aperture to clear the protein or dust
in the aperture.

Do as follows:

1. CLICK the “Zap” button at the “Maintenance” screen.

2. The analyzer will start zapping and the progress will be displayed at the screen.

3. Once the zapping is complete, a dialog box of “Maintenance finished!” will be displayed
at the “Maintenance” screen. CLICK “OK” to close it.

„ Flushing

After zapping the aperture, perform this procedure to help unclog the RBC aperture or prevent
clogging.

10-9
Maintaining Your Analyzer

Do as follows:

1. CLICK the “Flush” button at the “Maintenance” screen.

2. The analyzer will start flushing and the progress will be displayed at the screen.

3. Once the flushing is complete, a dialog box of “Maintenance finished!” will be displayed
at the “Maintenance” screen. CLICK “OK” to close it.

„ Unclogging

Perform this procedure to zap and flush the aperture to unclog the RBC aperture or prevent
clogging.

Do as follows:

1. CLICK the “Unclog” button at the “Maintenance” screen.

2. The analyzer will start unclogging and the progress will be displayed at the screen.

3. Once the unclogging is complete, a dialog box of “Maintenance finished!” will be


displayed at the “Maintenance” screen. CLICK “OK” to close it.

Probe Cleanser Maintenance


You should perform this procedure every month to clean the assemblies of the RBC bath,
premix bath, HGB bath and SRV.

„ Maintaining the RBC Bath

Do as follows:

1. CLICK the corresponding “RBC bath” button at the “Maintenance” screen. A progress bar
shown in Figure 10-4 will pop up and the maintaining preparation of the RBC bath will start.

Figure 10-4 Progress bar

2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-5 will pop up.

10-10
Maintaining Your Analyzer

Figure 10-5 Dialog box

3. Open the front cover of the analyzer and fix it with the stop bar as shown in Figure 10-6.

block groove

stop bar

Figure 10-6 How to fix the front cover

z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.

4. Once the front cover is open, you will see the premix bath and the external shielding box of
the RBC bath and HGB bath shown in Figure 10-7.

10-11
Maintaining Your Analyzer

external
shielding premix bath
box of the
RBC bath
and HGB
bath

Figure 10-7 Front view (front cover is open)

5. Use your hand to counterclockwise unscrew the fixing screw as shown in Figure 10-8.
Gently remove the top cover of the external shielding box as shown in Figure 10-9.

Figure 10-8 Unscrewing the screw

10-12
Maintaining Your Analyzer

Figure 10-9 Removing the top cover

6. Once the top cover of the external shielding box is removed, you will see a small RBC
shielding box inside. Dispense about 1.5mL of probe cleanser into the RBC bath, as
shown in Figure 10-10.

Figure 10-10 Dispensing the probe cleanser to the RBC bath

z If the probe cleanser accidentally spills on your skin or clothing, wash it off
with plenty of water immediately.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

10-13
Maintaining Your Analyzer

7. After the dispensation, reassemble the top cover as shown in Figure 10-11, relocate and
tighten the screw and then close the front cover.

Figure 10-11 Reassembling the top cover

8. The dialog box will close once the count-down is complete. If the dispensation is complete
before the end of the count-down, CLICK “OK” to close the dialog box. The analyzer will
start to maintain the RBC bath and a count-down dialog box shown in Figure 10-12 will
pop up.

Figure 10-12 Dialog box

9. It takes 5 minutes to maintain the bath. Once the count-down is complete, the dialog box
will close and the analyzer will start to clean the tubing with probe cleanser. Note that you
can choose to end the maintaining process before the time is due by clicking “OK”.
However, a shortened process may not be as effective as a complete one.

10. When “Maintenance finished” appears in the dialog box, CLICK “OK” to close the dialog
box. The RBC bath maintaining with probe cleanser is done.

„ Maintaining the HGB Bath

The HGB bath maintaining has the similar process to the RBC bath maintaining. Do as follows:

1. CLICK the “HGB bath” button at the “Maintenance” screen. A progress bar shown in
Figure 10-13 will pop up and the maintaining preparation of the HGB bath will start.

10-14
Maintaining Your Analyzer

Figure 10-13 Progress bar

2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-14 will pop up.

Figure 10-14 Dialog box

3. Remove the top cover as instructed in the steps 3 to 5 of the Maintaining the RBC Bath.
Dispense about 1.5mL of probe cleanser into the HGB bath as shown in Figure 10-15.

HGB bath

Figure 10-15 Dispensing the probe cleanser to the HGB bath

z If the probe cleanser accidentally spills on your skin or clothing, wash it off

10-15
Maintaining Your Analyzer

with plenty of water immediately.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

4. After the dispensation, reassemble the top cover as instructed in step 7 of the Maintaining
the RBC Bath, and close the front cover.

5. The dialog box will close once the count-down is complete. If the dispensation is complete
before the end of count-down, CLICK “OK” to close the dialog box. The analyzer will start
to maintain the HGB bath and a count-down dialog box shown in Figure 10-16 will pop up.

Figure 10-16 Dialog box

6. It takes 5 minutes to maintain the bath. After the count-down, the dialog box will close and
the analyzer will start to clean the tubing with probe cleanser. Note that you can choose to
end the maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.

7. When “Maintenance finished” appears in the dialog box, CLICK “OK” to close the dialog
box. The HGB bath maintaining with probe cleanser is done.

„ Maintaining the Premix Bath

The premix bath maintaining has the similar process to the RBC bath maintaining. Do as
follows:
1. CLICK the “Premix bath” button at the “Maintenance” screen. The maintaining
preparation of premix bath will start and a progress bar shown in Figure 10-17 will pop up.

10-16
Maintaining Your Analyzer

Figure 10-17 Progress bar

2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-18 will pop up.

Figure 10-18 Dialog box

3. Open the front cover of the analyzer and dispense about 1.5mL of probe cleanser into the
premix bath as shown in Figure 10-19.

premix bath

Figure 10-19 Dispensing the probe cleanser to the premix bath

z If the probe cleanser accidentally spills on your skin or clothing, wash it off

10-17
Maintaining Your Analyzer

with plenty of water immediately.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

4. Once the dispensation is complete, close the front cover.


5. The dialog box will close once the count-down is complete. If the dispensation is complete
before the end of count-down, CLICK “OK” to close the dialog box. The analyzer will start
to maintain the premix bath and a count-down dialog box shown in Figure 10-20 will pop
up.

Figure 10-20 Dialog box

6. It takes 5 minutes to maintain the bath. After the count-down, the dialog box will close and
the analyzer will start to clean the tubing with probe cleanser. Note that you can choose to
end the maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.
7. When “Maintenance finished!” appears in the dialog box, CLICK “OK” to close the dialog
box. The premix bath maintaining with probe cleanser is done.

„ Maintaining the WBC Module

Before maintaining, you should prepare a special syringe used for injecting the probe cleanser
into the DIFF bath and BASO bath manually.

The following materials are needed:


1. One disposable syringe of 2ml model
2. Tygon tubing; ID1/16', OD3/16'; 15mm (materiel code: M6G-020006, you can find it in the
accessory pack)
3. Teflon tubing; ID 0.04', OD1/16'; 80mm (materiel code: 0040-10-32301, you can find it in
the accessory pack)

Do as following to prepare the syringe:


1. Get the tygon tubing (materiel code: M6G-020006) from the accessory pack, then cut
15mm of it; get the Teflon tubing (materiel code: 0040-10-32301) from the accessory pack,
then cut 80mm of it; prepare a disposable syringe of 2ml. The materials needed are

10-18
Maintaining Your Analyzer

shown in Figure 10-21.

Figure 10-21 Materials needed

2. Insert the tip of the syringe into the 15mm Tygon tubing as shown in Figure 10-22.

Figure 10-22 Connect the Tygon tubing

3. Insert the 80mm Teflon tubing from the tip of the 15mmTygon tubing into the syringe, until
it touches the plug of the syringe (be sure the plug is at the “0” scale) as shown in Figure
10-23.

10-19
Maintaining Your Analyzer

Figure 10-23 Connect the Teflon tubing

4. Finally, the special syringe as shown in Figure 10-24 is done.

Figure 10-24 Finished special syringe

After preparing the syringe, you can start maintaining the WBC module. Do as follows:

1. CLICK the “WBC module” button at the “Maintenance” screen. The maintaining
preparation of WBC module will start and a progress bar shown in Figure 10-25 will pop
up.

10-20
Maintaining Your Analyzer

Figure 10-25 Progress bar

2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-26 will pop up.

Figure 10-26 Dialog box

3. Open the front cover of the analyzer and take off the two rubber plugs from the WBC
module as shown in Figure 10-27.

Figure 10-27 Take off the plugs

z If the probe cleanser accidentally spills on your skin or clothing, wash it off
with plenty of water immediately.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

4. Aspirate 1.6ml probe cleanser by the prepared special syringe, then insert the extended
tubing of syringe down to the channels, until it reaches the bottom of the DIFF bath and

10-21
Maintaining Your Analyzer

BASO bath, then Inject about 0.8mL of probe cleanser into the DIFF bath and BASO bath
respectively as shown in Figure 10-28.

Figure 10-28 Inject the probe cleanser into the DIFF bath and BASO bath

5. Once the injection is complete, put the the two rubber plugs back as shown in Figure 10-29
and close the front cover.

Figure 10-29 Put the plugs back

6. The dialog box will close once the count-down is complete. If the injection is complete
before the end of count-down, CLICK “OK” to close the dialog box. The analyzer will start
to prime probe cleanser and a progress bar shown in Figure 10-30 will pop up.

10-22
Maintaining Your Analyzer

Figure 10-30 Dialog box

7. Once the priming is completed, the analyzer will start to maintain the WBC module and a
count-down dialog box shown in Figure 10-31 will pop up.

Figure 10-31 Dialog box

8. It takes 5 minutes to maintain the WBC module and you can not end the maintaining
process. After the count-down, the dialog box will close and the analyzer will start to clean
the tubing, and a progress bar shown in Figure 10-32 will pop up.

Figure 10-32 Dialog box

9. When the cleaning is finished, CLICK “OK”, and then “Maintenance finished!” appears in
the dialog box, and then CLICK “OK” to close the dialog box. The WBC module
maintaining with probe cleanser is done.

„ Maintaining the Five Baths

Before maintaining, you should prepare a special syringe used for injecting the probe cleanser
into the DIFF bath and BASO bath manually. Do as instructed in Maintaining the WBC Module.
After preparing the syringe, you can start maintaining the five baths. Do as follows:

10-23
Maintaining Your Analyzer

1. CLICK the “Five baths” button at the “Maintenance” screen. The maintaining preparation
will start and a progress bar shown in Figure 10-33 will pop up.

Figure 10-33 Progress bar

2. Once the preparation is complete, the progress bar will close. A count-down dialog box
shown in Figure 10-34 will pop up.

Figure 10-34 Dialog box

3. Open the front cover of the analyzer and inject about 0.8mL of probe cleanser into the
DIFF bath and BASO bath respectively as instructed in Maintaining the WBC Module.
Then, inject 1.5ml porbe cleanser into both the HGB bath and the RBC premix bath as
instructed in Maintaing the HGB Bath and Maintaing the Premix Bath. Finally, inject 1.5ml
probe cleanser into the RBC bath as instructed in Maintaing the RBC Bath.

z If the probe cleanser accidentally spills on your skin or clothing, wash it off
with plenty of water immediately.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

4. Once the injection is complete, reassembly the corresponding parts and close the front
cover.
5. The dialog box will close once the count-down is complete. If the injection is complete

10-24
Maintaining Your Analyzer

before the end of count-down, CLICK “OK” to close the dialog box. The analyzer will start
to prime probe cleanser and a progress bar shown in Figure 10-35 will pop up.

Figure 10-35 Dialog box

6. Once the priming is complete, the analyzer will start to maintain the five baths and a
count-down dialog box shown in Figure 10-36 will pop up.

Figure 10-36 Dialog box

7. It takes 5 minutes to maintain the five baths and you can not end the maintaining process.
After the count-down, the dialog box will close and the analyzer will start to clean the
tubing, and a progress bar shown in Figure 10-37 will pop up.

Figure 10-37 Dialog box

8. When the cleaning is finished, CLICK “OK”, and then “Maintenance finished!” appears in
the dialog box, and then CLICK “OK” to close the dialog box. The five baths maintaining
with probe cleanser is done.

10-25
Maintaining Your Analyzer

SRV Maintenance
Do the following steps to maintain the SRV:
1. At the “Maintenance” screen, CLICK the “SRV” button to start the SRV maintenance
preparation process.

Figure 10-38 Progress bar

2. Aspirate probel cleanser into the analyzer as prompted by the message box.

Figure 10-39 Dialog box

3. When the aspiration is done, the analyzer will start to prime probe cleanser and a progress
bar will pop up. Once the priming is done, the maintenance process begins. The probe
cleanser maintenance will repeat for three times together with the following count-down
box of five minutes. Thus, the whole process lasts 15 minutes.

Figure 10-40 Dialog box

4. When the maintenance is done, the cleaning process begins.

10-26
Maintaining Your Analyzer

Figure 10-41 Dialog box

5. When the cleaning process is done, the SRV maintenance ends. You can CLICK the “Ok”
button to exit.

Figure 10-42 Dialog box

Note that every time the analyzed samples add up to 2,000, the analyzer will automatically
start the SRV maintenance process. You wlill see the following message when the analyzed
samples add up to 1,950.

Figure 10-43 Dialog box

If you CLICK the “Ok” button, the maintenance starts right away, and if you CLICK the
“Cancel” button the message will be closed and pop up again after every 10 more samples.
When analyzed samples add up to 2,000, the analyzer automatically starts the maintenance
process.

z After every SRV maintenance, the “Total runs for auto SRV maintenance ”

10-27
Maintaining Your Analyzer

will be reset to zero.

Cleanser Maintenance
After the WBC bath cleaning, if the background of WBC relative parameters is still high, do as
follows:

1. CLICK the “WBC bath” and a progress bar of the maintaining preparation shown in Figure
10-44 will pop up.

Figure 10-44 Progress bar of the cleaning preparation

2. Once the progress bar disappears, a count-down dialog box shown in Figure 10-45 will
pop up.

Figure 10-45 Count – down dialog box

3. It takes 5 minutes to maintain the bath. After the count-down, the dialog box will close and
the analyzer will start to clean the tubing with probe cleanser. Note that you can choose to
end the maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.

4. When “Maintenance finished!” appears in the dialog box, CLICK “OK” to close the dialog
box. The WBC bath maintaining with probe cleanser is done.

10.2.4 Overall Maintenance


CLICK the “Service” icon in the “Main” screen and then CLICK the “Overall” button to enter
the screen shown in Figure 10-46.

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Maintaining Your Analyzer

Figure 10-46 Overall maintenance screen

Fluidic System Initialization


After maintaining the fluidic system or replacing a main part of the analyzer, you should
perform this procedure to initialize the fluidic system.

Do as follows:

1. CLICK the “Init all” button at the “Overall” screen.

2. The fluidic system initialization will start and the “Initializing. Please wait…” and the
progress bar will be displayed at the screen.

3. Once the screen shows “Initialization finished!”, the fluidic system initialization is
complete. If the screen shows “Initialization error!”, contact Mindray customer service
department or your local distributor for assistance.

Priming
If the analyzer has not been used for a long time, you should perform this procedure to prime
the overall fluidic system after startup.

Do as follows:

1. CLICK the “Prime all” button at the “Overall” screen and a dialog box of “This action will
take a long time, continue?” shown in Figure 10-47 will pop up.

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Maintaining Your Analyzer

Figure 10-47 Dialog box

2. CLICK “No” to ignore the priming. CLICK “Yes” to proceed with the priming; the “Priming.
Please wait…” and the progress bar will be displayed at the screen.

3. Once the screen shows “Prime finished!”, the fluidic system priming is complete. If the
screen shows “Prime error!”, contact Mindray customer service department or your local
distributor for assistance.

Emptying
If the analyzer is not to be used in 2 weeks, you should perform this procedure to empty the
fluidic system.

Do as follows:

1. CLICK the “Drain” button at the “Overall” screen and a dialog box of “Start drain?”
shown in Figure 10-48 will pop up.

Figure 10-48 Dialog box

2. CLICK “Yes” to ignore the emptying. CLICK “No” to proceed with the emptying; a dialog
box shown in Figure 10-49 will pop up.

Figure 10-49 Dialog box

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Maintaining Your Analyzer

3. Remove all reagent pickup tube assemblies from their containers per the prompt of the
dialog box. CLICK “OK” to close the dialog box. The fluidic system emptying will start and
the “Draining. Please wait…” and the progress bar will be displayed at the screen.

4. Once the screen shows “Drain finished!”, the fluidic system emptying is complete. If the
screen shows “Drain error!”, contact Mindray customer service department or your local
distributor for assistance.

Cleaning
If the background of all parameters is high, you should perform this procedure to clean the
fluidic system.

Do as follows:

1. CLICK the “Clean all” button at the “Overall” screen and a dialog box of “This action will
take a long time, continue?” shown in Figure 10-50 will pop up.

Figure 10-50 Dialog box

2. CLICK “No” to ignore the cleaning. CLICK “Yes” to proceed with the cleaning. The
“Cleaning. Please wait…” and the progress bar will be displayed.

3. Once the screen shows “Clean finished!”, the fluidic system cleaning is complete. If the
screen shows “Clean error!”, contact Mindray customer service department or your local
distributor for assistance.

Cleanser Soaking
If the background of all parameters is still high after the overall fluidic system cleaning, you
should perform this procedure to soak and clean the fluidic system.

Do as follows:

1. CLICK the “Dip in cleanser” button at the “Overall” screen and a dialog box of “This
action will take a long time, continue?” shown in Figure 10-51 will pop up.

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Figure 10-51 Dialog box

2. CLICK “No” to ignore the soaking. CLICK “Yes” to proceed with the soaking. The
“Prepare for dip.Please wait…” and the progress bar will be displayed.

3. After the preparation, a count-down dialog box shown below will pop up. The soaking will
take 20 minutes. After the count-down, the dialog box will close and the analyzer will start
to empty and then clean the tubing with cleanser. Note that you can choose to end the
maintaining process before the time is due by clicking “OK”. However, a shortened
process may not be as effective as a complete one.

Figure 10-52 Count-down dialog box

4. Once the screen shows “Dip finished!”, the fluidic system soaking is complete. If the
screen shows “Dip error!”, contact Mindray customer service department or your local
distributor for assistance.

If the accumulated sample runs have reached or exceeded 350 but not reached 400 yet, a
dialog box as shown in Figure 10-53 will pop up.

Figure 10-53 Dialog box of Dip in cleanser

If you want to perform the “Dip in cleanser” procedure immediately, CLICK “OK” (the dip
procedure lasts 20 minutes). If not, CLICK “Cancel”.

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If the “Dip in cleanser” procedure is not performed, the dialog box will pop up again to prompt
user for the procedure every 10 runs. The analyzer will start the “Dip in cleanser” procedure
automatically when the accumulated runs reach or exceed 400 (the dip procedure lasts 20
minutes).

Packing up
If the analyzer is not to be used for over 2 weeks, you should perform this procedure and
shutdown the analyzer.

Do as follows:

1. CLICK the “Pack-up” button at the “Overall” screen and a dialog box shown in Figure
10-54 will pop up.

Figure 10-54 Pack – up dialog box

2. CLICK “No” to close the dialog box and return to the “Maintenance” screen. CLICK “Yes”
to proceed with the pack-up and a dialog box shown in Figure 10-55 will pop up.

Figure 10-55 Dialog box

3. Remove all reagent pickup tube assemblies from their containers per the prompt of the
dialog box.

4. CLICK “OK” to start the fluidic system emptying. The progress bar will be displayed at the
screen. Once the progress bar disappears, a dialog box shown in Figure 10-56 will pop up.

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Maintaining Your Analyzer

Figure 10-56 Dialog box

5. Place all reagent pickup tube assemblies into a distilled water container per the prompt of
the dialog box. CLICK “OK” to start to clean the analyzer with distilled water. After the
cleaning, a dialog box shown in Figure 10-57 will pop up.

Figure 10-57 Dialog box

6. Remove all the pickup tube assemblies of diluent, cleanser and lyse from the distilled
water container and place them into the waste container. CLICK “OK” to start to empty the
fluidic system.

7. After the emptying, place the power switch to the OFF (O) to turn off your analyzer.

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Maintaining Your Analyzer

10.3 Using the “Status” Program

The “Status” screen shows the current status of the analyzer. At the “Status” screen, you can
check:

„ the version information

„ the temperature and pressure

„ the voltage and current

„ the position

„ the function configured

At the “Status” screen, you can only check the displayed status information without changing
them. The items displayed contribute significantly to troubleshooting your analyzer.

10.3.1 Version Information


You can check the version information of the current software, FPGA and SCM at the
“Version” screen.

CLICK the “Status” button at the bottom of the “Service” screen and then CLICK the “Version”
button to enter the screen shown in Figure 10-58.

Figure 10-58 Version screen

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To exit the “Version” screen, CLICK any other button at the left of the screen or any button at
the bottom.

10.3.2 Temperature and Pressure


At the “Temp & Pres” screen, you can check:

„ the temperature of the preheating bath

„ the temperature of the reaction bath

„ the ambient temperature

„ the temperature of the laser diode

„ the pressure of each cylinder

CLICK the “Temp & Pres” button at the “Status” screen to enter the screen shown in Figure
10-59.

Figure 10-59 “Temp & Pres” screen

The screen also shows the normal range of each setting, which helps to troubleshoot the
analyzer.

To exit the “Temp & Pres” screen, CLICK any other button at the left of the screen or any
button at the bottom.

10.3.3 Voltage and Current


At the “Vol. & Cur.” screen, you can check the voltage of each power supply and the current of

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Maintaining Your Analyzer

the laser diode.

CLICK the “Vol. & Cur” button at the “Status” screen to enter the screen shown in Figure
10-60.

Figure 10-60 “Vol. & Cur” screen

The “Vol. & Cur” screen shows the voltages of the power supply +24V, +12V, +5V and AVCC
(5V) and the current of the laser diode. It also shows the normal range of each setting, which
helps to troubleshoot the analyzer.

To exit the “Vol. & Cur” screen, CLICK any other button at the left of the screen or any button
at the bottom.

10.3.4 Position
At the “Position” screen, you can check:

„ the syringe unit

„ the reagent bobber unit

„ the sampling unit

„ the sample transport unit

CLICK the “Position” button at the “Status” screen to enter the screen shown in Figure 10-61.

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Figure 10-61 “Position” screen

To exit the “Position” screen, CLICK any other button at the left of the screen or any button at
the bottom.

10.3.5 Function Configured


At the “Func. set” screen, you can check:

„ the sample storage capacity

„ whether the autoloading is configured

„ whether the open vial/closed tube sampling is configured

„ the analyzer serial number

„ whether the external barcode scan is configured

„ whether the internal barcode scan is configured

„ CLICK the “Func. set” button at the “Status” screen to enter the screen shown in Figure
10-62.

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Figure 10-62 “Func. set” screen

To exit the “Func. set” screen, CLICK any other button at the left of the screen or any button at
the bottom.

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Maintaining Your Analyzer

10.4 Using the “Self-test” program

The self-test program is an important method to troubleshoot the analyzer. At the “self-test”
screen, you can do:

„ the mechanical self-test

„ the circuit self-test

„ the valve self-test

„ Dobber self-test

„ the touch screen calibration

At the “Self-test” screen, you can do only one self-test each time. Before proceeding with the
next self-test, make sure the current self-test is complete.

10.4.1 Mechanical Part Self-test


You can perform this procedure to check whether the following parts function normally.

„ whole blood aspiration syringe motor

„ WBC sample injection syringe motor

„ probe wipe clean motor

„ mixing sample motor

„ feeding sample motor (autoloader)

„ loading sample motor (autoloader)

„ unloading sample mechanism (autoloader)

„ DIFF mix motor

„ BASO mix motor

„ the pinch cylinder

„ the elevation cylinder

„ the pierce cylinder

„ the sample compartment door (closed-tube sampling)

CLICK the “Self-test” button at the bottom of the “Service” screen to enter the “Mechanical”
screen shown in Figure 10-63.

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Maintaining Your Analyzer

Figure 10-63 “Mechanical” screen

CLICK the corresponding button to check the desired item. A “Normal” or “Error” will appear
at the “Results” column after each self-test.

To exit the “Mechanical” screen, CLICK any other button at the left of the screen or any button
at the bottom.

10.4.2 Circuit Self–test


CLICK the “Circuit” button at the “Self-test” screen to enter the “Circuit” screen shown in
Figure 10-64.

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Maintaining Your Analyzer

Figure 10-64 “Circuit” self-test screen

CLICK the corresponding button to check the desired item. Mostly, the “Normal” or “Error” will
appear at the “Results” column after the self-test. But for the ASPIRATE key self-test, there is
a little difference. CLICK the “ASPIRATE key” button, a dialog box shown in Figure 10-65 will
pop up and a count-down will begin.

Figure 10-65 Count – down dialog box

Press the ASPIRATE key per the prompt, and a “Normal” will appear at the “Results” column
if the result is normal. An “Error” will appear at the “Results” column if the result is abnormal or
the key is not pressed within the given time.

For the “Laser box switch” self-test, an “On” or “Off” will appear at the “Results” column.
To exit the “Circuit” screen, CLICK any other button at the left of the screen or any button at
the bottom.

10.4.3 Valve Self-test


The analyzer can not function normally if valve errors occur. The valve self-test is an important
method to troubleshoot the fluidic system.

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Maintaining Your Analyzer

CLICK the “Valve” button at the “Self-test” screen to enter the screen shown in Figure 10-66.

Figure 10-66 “Valve” screen

At the “Valve” screen, each number circled represents a valve. To test a valve, CLICK the
corresponding number and the self-test to this valve will begin. If the corresponding number
area appears gray, the analyzer will not do the self-test to the valve.

Before the self-test begins, be sure the pneumatic unit is shut down. Otherwise, a prompt of
“Please turn off air compressor firstly” will appears on the screen. CLICK the “Shut
compressor” button to close the pneumatic unit. The corresponding number area will appear
yellow during the test. It will turn red if the valve is abnormal. If the valve is normal, the
corresponding number area will turn green and the sounds of opening and closing the valve
are normal.

To do the self-test to all valves, CLICK the “Test all” button. During the self-test, the “Test all”
button will turn to the “Cancel” button. To stop the test, CLICK the “Cancel” button and a
dialog box of “Stop all value self-test?” will pop up. CLICK “OK” to confirm the stop.

To exit the “Valve” screen, CLICK any other button at the left of the screen or any button at the
bottom. Then, the analyzer will open the pneumatic unit automatically.

10.4.4 Dobber self-test


You can enter this screen to check whether dobbers function normally.

1. CLICK the “Dobber” button at the “Self-test” screen to enter the screen shown in
Figure 10-67.

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Maintaining Your Analyzer

Figure 10-67 “Dobber” screen

2. CLICK the corresponding button to check the desired item. The “Normal” or “Error”
will appear at the “Results” column after the self-test.

To exit the “Dobber” screen, CLICK any other button at the left of the screen or any button
at the bottom.

10.4.5 Touchscreen Calibration (Administrator)


If the touchscreen cannot respond correctly to the touch, you should perform this procedure to
calibrate the touchscreen.

Do as follows:

1. CLICK the “Touchscreen” button at the “Self-test” screen to enter the screen shown in
Figure 10-68.

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Maintaining Your Analyzer

Figure 10-68 “Touchscreen” screen

2. CLICK the “Calibrate” button in the middle of the screen and the screen will be shown as
Figure 10-69.

Figure 10-69 Starting the calibration

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Maintaining Your Analyzer

z Do not click with the mouse to calibrate the touchscreen.

3. CLICK the blue point at the upper left corner of the screen as prompted to start the
calibration.

4. Then CLICK the blue point at the lower right corner of the screen and the screen will be
shown as Figure 10-70.

Figure 10-70 Touchscreen calibration

5. CLICK the blue rectangular area in the middle of the screen and the screen will display
“Calibration succeeded!”. The calibration screen will close automatically after several
seconds.

6. To exit the “Touchscreen” screen, CLICK any other button at the left of the screen or any
button at the bottom.

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Maintaining Your Analyzer

10.5 Using the “Log” Program

The “Log” screen records all activities of the analyzer. It contributes significantly to searching
for operation history and troubleshooting the analyzer.

The analyzer can save maximum 1000 log records. When the maximum number has been
reached, the newest result will overwrite the oldest. You can only browse or print the logs
without changing them.

CLICK the “Log” button at the bottom of the “Service” screen to enter the screen shown in
Figure 10-71.

Figure 10-71 “Log” screen

At this screen, you can

„ Browse

As a common user, you can only CLICK the “All”, “Set paras” or “Others” button to browse
the interested information.

As an administrator, besides the above information, you can also CLICK the “Error info.”
button to check the lately reported error messages.

„ Print

To print the current log, CLICK the “Print” button.

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Maintaining Your Analyzer

„ Exit

To exit the “Log” screen, CLICK any other button at the left of the screen or any button at the
bottom.

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Maintaining Your Analyzer

10.6 Using the “Initialization” Program (in the


Administrator Level)

You can enter the “Init” screen to resume the factory default, if you need to initialize the
touchscreen or resume the factory expected results.

„ Entering the “Init” screen

CLICK the “Init” button at the “Service” screen to enter the screen shown in Figure 10-72.

Figure 10-72 “Init” screen

„ Setting the initialization

1. CLICK the “Ref. ranges & units” check box to initialize the reference range and units.

2. CLICK the check box to select it. CLICK the check box again to deselect it.

3. After the selection, CLICK the “Init.” button on the screen. If the screen prompts that the
initialization succeeded, the initialization is complete. If the screen prompts that the
initialization failed, you need to contact Mindray customer service department or your local
distributor for assistance.

„ Printing the configurations

CLICK the “Print” button to printout the current configuration information.

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Maintaining Your Analyzer

„ Exiting the screen

To exit the “Init” screen, CLICK any other button at the bottom of the screen.

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Maintaining Your Analyzer

10.7 Shortcut button of daily maintenance

„ “Unclog” button

CLICK the “Unclog” button at the bottom of the “Count” screen directly to prevent or remove
the RBC clogging.

„ “Background” button

CLICK the “Background” button at the bottom of the “Count” screen to do a background
count. The background count will work in the “OV-WB-CBC” mode. The results of background
count shall meet the background range in Appendix B.

„ “Clean” button

When the background values of each parameter are all high, CLICK the “Clean” button at the
bottom of the “Count” screen to clean the overall fluidic system. The cleaning will last about 2
minutes. Place an empty cup under the open vial sampling probe to prevent possible reagents
dripping on the countertop.

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Maintaining Your Analyzer

10.8 Cleaning Manually

10.8.1 Cleaning the SRV tray


You should clean the SRV tray if there is residue or crystal.

Do as follows:

z The SRV tray may contain biohazardous materials. Exercise caution to avoid
direct contact with the tray.

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


according to government regulations.

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.

1. Turn off the power of the analyzer.

2. After a few minutes, open the front cover and pull out the SRV tray shown in Figure 10-73.

z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.

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Maintaining Your Analyzer

SRV tray

Figure 10-73 Pulling out the SRV tray

3. Flush the SRV tray with clean tap water.

4. Reassemble the SRV tray after wipe it dry.

z When removing the SRV tray, do not loosen the thumbscrew fixing the
sample probe; otherwise air may enter the sample probe and unreliable
results may be obtained.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

z Reassemble the SRV tray by facing the side with the groove up.

5. Close the front cover of the analyzer.

10.8.2 Cleaning the SRV


You should clean the SRV manually every two months.

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Maintaining Your Analyzer

z The sample probe and the SRV may contain biohazardous materials.
Exercise caution to avoid direct contact with the probe and the SRV when
working around them.

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 The SRV is so fragile that any knock or drop may damage it. Exercise
caution when disassembling/assembling or cleaning the SRV. Do not loosen
or bend the tiny steel tubes at sides of the SRV.

z Do not loosen or deform the sample probe when disassembling, cleaning


and reassembling the SRV.

z After the analyzer is turned off, wait at least 30 seconds to release the
pressure and vacuum accumulated in the pneumatic lines. Do not perform
any maintenance or replacing procedure immediately after you turn off the
analyzer.

z Be sure to the valve contact surfaces are cleaned thoroughly. Otherwise, it


may lead to the leakage from the SRV and unreliable analysis results.

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 Wear gloves when cleaning the SRV. Wash your hands with disinfector after
the SRV cleaning.

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


according to government regulations.

Do as follows:

1. Turn off the power of the analyzer.

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Maintaining Your Analyzer

2. After a few minutes, open the front cover.

z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.

3. Remove the SRV tray and pull the probe wipe assembly down to the lowest position as
shown in Figure 10-74.

Figure 10-74 Pulling the probe wipe assembly

4. Remove the probe wipe from the sample probe carefully.

z The sample probe should be completely separated from the probe wipe
when the SRV is disassembled. Otherwise, the probe may be deformed or
the probe wipe may be damaged.

5. Disassemble the constant-pressure screw by turning it counterclockwise as shown in


Figure 10-75.

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Maintaining Your Analyzer

Figure 10-75 Disassembling the constant-pressure screw

6. Remove the sampling valve and the rotor valve of the SRV respectively as shown in Figure
10-76.

Figure 10-76 Disassembling the SRV

z When the SRV is disassembled, reagent may leak from the tubes. Place a
dry cloth or tissue under the SRV to absorb any reagent.

z Do not remove the rear fixed valve of the SRV.

z Do not use too much force to pull tubes on sides of the SRV when
disassembling the SRV. Otherwise, the tubes may be disconnected and the
leakage may be caused.

7. Inject some probe cleanser into holes and grooves of the sampling valve, rotor valve and
rear fixed valve respectively. You can also brush holes and grooves gently with probe
cleanser, as shown in Figure 10-77.

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Maintaining Your Analyzer

Figure 10-77 Cleaning the holes and grooves

8. Use clean lint-free damp tissues to wipe the valve contact surfaces clean with probe
cleanser, as Figure 10-78 shows. Then wash the valves with distilled water.

Figure 10-78 Cleaning the contact surfaces

z Make sure no dust should be found in the holes and grooves and on the
surfaces after the cleaning.

9. Reassemble the rotor valve and sampling valve in the reverse order.

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Maintaining Your Analyzer

z The valve contact surfaces must be damp when the SRV is reassembled.

z Position the metal knob between the two stoppers when reassembling the
rotor valve. Otherwise, the SRV may not function.

z Be sure the sampling valve, rotor valve and rear fixed valve of the SRV
attach well after the reassembly.

Figure 10-79 How to reassemble the middle valve

10. Reassemble the constant screw by turning it clockwise and tightening it.

11. With sample probe through the center of the probe wipe, lift the probe wipe assembly back
to the original position when the analyzer is turned off.

12. Reassemble the SRV tray and close the front cover of the analyzer.

z Be sure the sample probe is inserted through the probe wipe, and the probe
wipe is placed back to the original position when the analyzer is turned off.
Otherwise, the probe wipe will be stuck and cannot work after the analyzer is
turned on.

z After the SRV tray is reassembled, check whether the thumbscrew on the top
of the sample probe is loose. If so, tighten it. Otherwise, it can cause air to
come into the probe and lead to unreliable analysis result.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

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Maintaining Your Analyzer

z Once reagents spill on the surface of the analyzer, wipe them off with a damp
cloth or tissue as soon as possible.

13. Do a background check after the startup. Be sure the background values are within the
required range.

10.8.3 Cleaning the probe wipe of the Open – tube Sampling

Unit
You should clean the probe wipe if residual blood or dirt is found in the probe wipe of the open
– tube sampling unit.

z The sample probe and the SRV may contain biohazardous materials.
Exercise caution to avoid direct contact with the probe and the SRV when
working around them.

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 When disassembling, cleaning and reassembling the probe wipe, do not use
too much force. Otherwise, the probe wipe of the open vial sampling unit
will be damaged.

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.

Do as follows:

1. Turn off the power of the analyzer and open the front cover after a few minutes.

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Maintaining Your Analyzer

2. Pull the probe wipe assembly down to the lowest position and remove the probe wipe from
the probe.

3. Separate the probe wipe from the probe wipe assembly as shown in Figure 10-80.
Disconnect the tubes from the probe wipe.

Figure 10-80 Separating the probe wipe of the open vial sampling unit

z Disconnect the tubes by pinching the ends of connects, swaying them while
pulling them outward. Do not use too much force while disconnecting the
tubes. Otherwise, the probe wipe of the open vial sampling unit will be
damaged.

4. Wash the probe wipe with clean tap water, wipe it dry and reassemble it in the reverse
order. Place the probe wipe assembly to the original position when the analyzer is turned
off.

5. Close the front cover of the analyzer.

z Be sure the sample probe is inserted through the probe wipe, and the probe
wipe is placed back to the original position when the analyzer is turned off.
Otherwise, the probe wipe will be stuck and cannot work after the analyzer is
turned on.

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10.8.4 Cleaning the tray under the piercing unit

z To avoid personal injury, after you lift the cover, be sure to fix it with the stop
bar properly.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z To avoid damage to the components of the analyzer, close the front cover
gently.

z After the analyzer is turned off, wait at least 30 seconds to release the
pressure and vacuum accumulated in the pneumatic lines. Do not perform
any maintenance or replacing procedure immediately after you turn off the
analyzer.

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.

If the tray under the piercing unit is accumulated with saline and dirt, you should clean the tray.

Do as follows:

1. Turn off the power of the analyzer.

2. Open the front cover of the analyzer after a few minutes and you will see the tray, as
shown in Figure 10-81.

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Accumulation tray

Figure 10-81 Tray under the piercing unit

3. Remove the tray and flush it with clean tap water. Then wipe it dry.

4. Reassemble the tray after cleaning and close the front cover of the analyzer.

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10.9 Adjustment

10.9.1 Adjusting the vacuum and pressure


Once the pressure error or vacuum error is reported, enter the “Temp & Pres” screen shown in
Figure 10-82 as instructed in 10.3.2 to adjust the pressure or vacuum.

Figure 10-82 “Temp & Pres” screen

Adjusting the 0.25MPa Pressure


0.25MPa pressure drives each cylinder of the analyzer. See Figure 10-83 for the regulator of
0.25MPa pressure.

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0.25MPa pressure

Figure 10-83 0.25MPa pressure regulator

Do as follows:

1. Use a Philips screwdriver to loosen the fixing screw of 0.25MPa pressure regulator, as
shown in Figure 10-84.

fixing screw

Figure 10-84 Loosening the fixing screw

2. Check the pressure value in the “PS1 (250)” column at the “Temp & Pres” screen, then
turn the adjustment knob clockwise to increase the pressure, counterclockwise to
decrease.

Figure 10-85 Turning the adjustment knob

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z If the pressure is adjusted too high, you should adjust it to the lowest level
before readjusting it to the desired level.

3. Check whether the pressure value shown in the “PS1 (250)” column is within the normal
range of (250±10)Kpa. If not, repeat step 2 until it is within the normal range.

4. After the adjustment, tighten the lock screw of the 0.25MPa pressure regulator.

Adjusting the 0.16MPa Pressure


0.16MPa pressure drives the sheath fluid. The 0.16MPa pressure regulator is located at the
inside left of the analyzer.

Do as follows:

1. Use a wrench to loosen the lock nut of the 0.16MPa pressure regulator shown in Figure
10-86.

lock nut

Figure 10-86 0.16MPa pressure regulator

2. Check the pressure value in the “PS2 (160)” column at the “Temp & Pres” screen, then
turn the adjustment knob clockwise to increase the pressure, counterclockwise to
decrease.

3. Check whether the pressure value shown in the “PS2 (160)” column is within the normal
range of (160±1)Kpa. If not, repeat step 2 until it is within the normal range.

4. After the adjustment, tighten the lock nut of 0.16MPa pressure regulator.

Adjusting the 0.07MPa Pressure


0.07MPa pressure is used to empty the waste and dispense reagents. The 0.07MPa pressure
regulator is located at the inside left of the analyzer.

Do as follows:

1. Use a wrench to loosen the lock nut of the0.07MPa pressure regulator shown in Figure
10-87.

10-65
Maintaining Your Analyzer

lock nut

Figure 10-87 0.07MPa pressure regulator

2. Check the pressure value in the “PS3 (70)” column at the “Temp & Pres” screen, then turn
the adjustment knob clockwise to increase the pressure, counterclockwise to decrease.

3. Check whether the pressure value shown in the “PS3 (70)” column is within the normal
range of (70±1)Kpa. If not, repeat step 2 until it is within the normal range.

4. After the adjustment, tighten the lock nut of 0.07MPa pressure regulator.

Adjusting the -0.04MPa Pressure


0.04MPa pressure drives the RBC analysis and the SRV contact surfaces cleaning. The -
0.04MPa pressure regulator is located at the inside left of the analyzer.

Do as follows:

1. Pull up the adjustment knob of the - 0.04MPa pressure regulator as shown in Figure
10-88.

Figure 10-88 -0.04MPa pressure regulator

2. Check the pressure value in the “PS5 (-40)” column at the “Temp & Pres” screen, then
turn the adjustment knob clockwise to increase the pressure, counterclockwise to
decrease.

3. Check whether the pressure value shown in the “PS5 (-40)” column is within the normal
range of (- 40±1)Kpa. If not, repeat step 2 until it is within the normal range.

4. After the adjustment, push the knob of the - 0.04MPa pressure regulator.

10-66
Maintaining Your Analyzer

10.10 Using the “Replacement” program

10.10.1 Replacing the piercer (autoloader)

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

z To ensure the analyzer functions normally, check the piercer periodically


and replace it in time.

You should replace the piercer if it is worn out. Contact Mindray customer service department
or your local distributor for assistance, or follow steps below to replace it.

1. Turn off the power of the analyzer. Open the front cover of the analyzer after a few minutes,
loosen the fixing screws shown in Figure 10-89 to remove the piercer cover.

Figure 10-89 Piercer cover

2. Disconnect tubes from the piercer and probe wipe. Loosen the fixing nut at the end of the
piercer, as Figure 10-90 shows.

10-67
Maintaining Your Analyzer

fixing nut

Probe wipe

Figure 10-90 Loosening the fixing nut

3. Unscrew the two fixing screws secured the fixing block, as Figure 10-91 shows. Remove
the block and then the piercer in the direction shown in Figure 10-92.

piercer

fixing block

Figure 10-91 Piercer and fixing block

Figure 10-92 Removing the piercer and the fixing block

10-68
Maintaining Your Analyzer

4. Take a new piercer from the accessory kit, insert it through the probe wipe, and
reassemble the fixing block to fix the new piercer.

5. Reconnect the tubes to the piercer and probe wipe, reassemble the piercer cover and
close the front cover of the analyzer.

10.10.2 Replacing the pincher (autoloader)


After a long period of running, the pincher of the analyzer will deform and cannot grasp sample
tubes. In this case, you need to replace the pincher.

Do as follows:

1. Turn off the power of the analyzer. Open the front cover of the analyzer after a few minutes
and you will see the pincher, as shown in Figure 10-93.

Pincher

Protective cover

Figure 10-93 Pincher

2. Unscrew the fixing screws shown in Figure 10-94 to remove the protective cover for the
pincher. Unscrew the fixing screw shown in Figure 10-95 to remove the pincher.

10-69
Maintaining Your Analyzer

Figure 10-94 Removing the protective cover for the pincher

Figure 10-95 Unscrewing the fixing screw of the pincher

3. Install a new pincher and prevent it from tilting.

4. Reassemble the protective cover and close the front cover of the analyzer.

10.10.3 Replacing the Filter


After a long period of running, the filter may be blocked by dust, which may cause pressure /
vacuum error or malfunction of the auto drainage. In such case, contact Mindray customer
service department or your local distributor to clean or replace the filter.

10-70
11 Troubleshooting Your Analyzer
11.1 Introduction

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


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

11-1
Troubleshooting Your Analyzer

11.2 Errors indicated by error messages

During the operation, if error(s) is detected, the analyzer will beep and display the
corresponding error message. In the error message area, the severity levels are discriminated
from high to low by background colors in the order of red, orange, yellow, green and blue. You
can CLICK the left mouse button, the external keyboard or anywhere on the touchscreen to
stop the beep.

CLICK the error message area and the corresponding troubleshooting dialog box shown as
Figure 11-1 will pop up.

Figure 11-1 “Troubleshooting” dialog box

You can see the error name(s) and the corresponding troubleshooting information in the
pop-up dialog box. The error names are displayed in order. You can CLICK the error name to
select (highlight) it and check the troubleshooting information in the “Troubleshooting” box.
The troubleshooting information of the first error is displayed. Follow the instructions in the
dialog box to remove error(s). To close the dialog box, CLICK the “Close” button.

Error name Troubleshooting information


Power drive sub-system 1. Press the "Remove error" button to remove this error.
communication error 2. If the error still exists, contact our customer service
department.
PDB: chip error 1. Perform the shutdown procedure to shut down the analyzer
and then restart it.
2. If the error still exists, contact our customer service

11-2
Troubleshooting Your Analyzer

department.
Cistern operation error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Rack(s) loading error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Rack(s) feeding error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Rack(s) unloading error 1. Remove the rack(s) from the autoloader.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
AL: unloading tray is full 1. Remove the rack(s) from the unloading tray.
2. If the error still exists, contact our customer service
department.
Autoloader is working 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Tube ID read error 1. Check whether the barcode is pasted incorrectly, damaged, or
illegible.
2. If there is nothing wrong with the barcode, press the "Remove
error" button to check the built-in barcode scanner.
3. If the error still exists, contact our customer service
department.
Rack(s) moved manually 1. Reposition the rack(s).
2. If the error still exists, contact our customer service
department.
Scanner setup error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Tube barcode is too long 1. Check whether the character length of the barcode is longer
than 15.
2. If the barcode character length is not overlong, and this error
still exists, contact our customer service department.
Sample compartment error 1. Check whether the sample compartment door is unexpectedly
open.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator pinch error 1. Remove the rack(s) from the autoloader or the tube from the

11-3
Troubleshooting Your Analyzer

sample compartment.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator elevation error 1. Remove the rack(s) from the autoloader or the tube from the
sample compartment.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator mix error 1. Remove the rack(s) from the autoloader or the tube from the
sample compartment.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Wipe block action error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Tube fallen off or piercing 1. Remove the tube(s) or rack(s) from the autoloader or the tube
error from the sample compartment.
2. Press the “Remove error” button to remove this error.
3. If the error still exists, contact our customer service
department.
Manipulator is working 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Sheath syringe action error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Pump syringe action error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Heater: preheat bath temp. 1. Perform the shutdown procedure to shut down the analyzer
sensor error and then restart it.
2. If the error still exists, contact our customer service
department.
Heater: reaction bath temp. 1. Perform the shutdown procedure to shut down the analyzer
sensor error and then restart it.
2. If the error still exists, contact our customer service
department.
Laser diode temp. sensor 1. Perform the shutdown procedure to shut down the analyzer
error and then restart it.
2. If the error still exists, contact our customer service
department.
No Diluent 1. Check whether the diluent container is empty.

11-4
Troubleshooting Your Analyzer

2. If there is no diluent, install a new container of diluent. Then


press the "Remove error" button to prime the analyzer with the
diluent.
3. See Heading 5.2.1 Settings to modify the reagent expiration
date.
4. If there is still plenty of diluent, or if the error still exists after a
new container of diluent is installed, contact our customer
service department.
No LH lyse 1. Check whether the LH lyse container is empty.
2. If there is no LH lyse, install a new container of LH lyse. Then
press the "Remove error" button to prime the analyzer with the
LH lyse.
3. See Heading 5.2.1 Settings to modify the reagent expiration
date.
4. If there is still plenty of LH lyse, or if the error still exists after a
new container of LH lyse is installed, contact our customer
service department.
No LEO(I) lyse 1. Check whether the LEO(I) lyse container is empty.
2. If there is no LEO(I) lyse, install a new container of LEO(I)
lyse. Then press the "Remove error" button to prime the
analyzer with the LEO(I) lyse.
3. See Heading 5.2.1 Settings to modify the reagent expiration
date.
4. If there is still plenty of LEO(I) lyse, or if the error still exists
after a new container of LEO(I) lyse is installed, contact our
customer service department.
No LEO(II) lyse 1. Check whether the LEO(II) lyse container is empty.
2. If there is no LEO(II) lyse, install a new container of LEO(II)
lyse. Then press the "Remove error" button to prime the
analyzer with the LEO(II) lyse.
3. See Heading 5.2.1 Settings to modify the reagent expiration
date.
4. If there is still plenty of LEO(II) lyse, or if the error still exists
after a new container of LEO(II) lyse is installed, contact our
customer service department.
No LBA lyse 1. Check whether the LBA lyse container is empty.
2. If there is no LBA lyse, install a new container of LBA lyse.
Then press the "Remove error" button to prime the analyzer with
the LBA lyse.
3. See Heading 5.2.1 Settings to modify the reagent expiration
date.
4. If there is still plenty of LBA lyse, or if the error still exists after
a new container of LBA lyse is installed, contact our customer
service department.

11-5
Troubleshooting Your Analyzer

Waste cistern is full 1. Empty the waste container or install a new waste container.
2. If the error still exists, contact our customer service
department.
No Cleanser 1. Check whether the cleanser container is empty.
2. If there is no cleanser, install a new container of cleanser.
Then press the "Remove error" button to prime the analyzer with
the cleanser.
3. See Heading 5.2.1 Settings to modify the reagent expiration
date.
4. If there is still plenty of cleanser, or if the error still exists after
a new container of cleanser is installed, contact our customer
service department.
Front cover open 1. Close the front cover.
2. If the error still exists, contact our customer service
department.
Laser box open 1. Close the laser box.
2. If the error still exists, contact our customer service
department.
DIFF stirring motor 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
BASO stirring motor 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
Laser diode temp. error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Laser diode current error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Preheat bath temp. error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Reaction bath temp. error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Temperature out of working 1. Make sure the ambient temperature is within the normal
range range [15, 30].
2. Analysis results may be incorrect if the ambient temperature
is out of the normal range.
3. If the ambient temperature is within the normal range, press
the "Remove error" button to remove the error.
Temperature out of 1. The ambient temperature is out of the analysis allowable
operating range range [4, 40].

11-6
Troubleshooting Your Analyzer

2. Make sure the ambient temperature is within the normal


range [15, 30], and then press the "Remove error" button to
remove the error.
3. If the error still exists, contact our customer service
department.
250 KPA pressure 1. Check whether the pneumatic unit indicator is on.
abnormal 2. If the indicator is off, check the power cord connection of the
pneumatic unit, and check that the analyzer is properly
connected to the pneumatic unit.
3. If the indicator is on, see Heading 10.9 Adjustment and tune
the PS1(250) pressure until the pressure becomes normal.
4. When it is normal, press the "Remove error" button to remove
this error.
5. If the error still exists, contact our customer service
department.
160 KPA pressure 1. See Heading 10.9 Adjustment and tune the PS2(160)
abnormal pressure until the pressure becomes normal.
2. When it is normal, press the "Remove error" button to remove
this error.
3. If the error still exists, contact our customer service
department.
70 KPA pressure abnormal 1. See Heading 10.9 Adjustment and tune the PS3(70) pressure
until the pressure becomes normal.
2. When it is normal, press the "Remove error" button to remove
this error.
3. If the error still exists, contact our customer service
department.
-40 KPA pressure 1. See Heading 10.9 Adjustment and tune the PS4(-40)
abnormal pressure until the pressure becomes normal.
2. When it is normal, press the "Remove error" button to remove
this error.
3. If the error still exists, contact our customer service
department.
-85 KPA pressure 1. Press the "Remove error" button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
Data collection sub-system 1. Press the “Remove error” button to remove this error.
com. error 2. If the error still exists, contact our customer service
department.
Main board chip error 1. Perform the shutdown procedure to shut down the analyzer
and then restart it.
2. If the error still exists, contact our customer service
department.
Real-time clock error 1. See Heading 5.2.1 Settings to reset the system time.

11-7
Troubleshooting Your Analyzer

2. If the error still exists, or if it is removed yet appears again at


the next startup, contact our customer service department.
WBC background voltage 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
RBC aperture voltage 1. Press the “Remove error” button to remove this error.
abnormal 2. If the error still exists, contact our customer service
department.
HGB error 1. See Heading 5.3.1 Settings to adjust the HGB background
voltage to 2.0-2.4 V. 2.28 V is recommended.
2. If the error still exists, contact our customer service
department.
HGB adjust 1. See Heading 5.3.1 Settings to adjust the HGB background
voltage to 2.0-2.4 V. 2.28 V is recommended.
2. If the error still exists, contact our customer service
department.
RBC clog 1. Press the “Remove error” button to remove this error.
2. If the error reports frequently, see Heading 10.2.3
Maintenance to dip the RBC bath with the probe cleanser.
3. If the error still exists, contact our customer service
department.
RBC bubbles 1. Check whether the diluent pickup tube connection looses.
2. If the connection does not loose, press the "Remove error"
button to remove the error.
3. If the error still exists, contact our customer service
department.
Background abnormal 1. Check whether the diluent is contaminated.
2. If it is not contaminated, press the "Remove error" button to
remove the error.
3. If the error still exists, contact our customer service
department.
Insufficient sample 1. Check if sufficient sample is prepared.
2. f the sample is sufficient and the error remains, contact our
customer service department.
Blood sensor error If the error remains after several sample runs, contact our
customer service department.
Diluent expired 1. Check whether the diluent is out of the expiration date. If yes,
install a new container of diluent.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the diluent is set correctly.
LEO(I) expired 1. Check whether the LEO(I) lyse is out of the expiration date. If
yes, install a new container of LEO(I) lyse.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the LEO(I) lyse is set correctly.

11-8
Troubleshooting Your Analyzer

LEO(II) expired 1. Check whether the LEO(II) lyse is out of the expiration date. If
yes, install a new container of LEO(II) lyse.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the LEO(II) lyse is set correctly.
LBA expired 1. Check whether the LBA lyse is out of the expiration date. If
yes, install a new container of LBA lyse.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the LBA lyse is set correctly.
LH expired 1. Check whether the LH lyse is out of the expiration date. If yes,
install a new container of LH lyse.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the LH lyse is set correctly.
Cleanser expired 1. Check whether the cleanser is out of the expiration date. If
yes, install a new container of cleanser.
2. If no, see Heading 5.2.1 Settings to check whether the
expiration date of the cleanser is set correctly.
Network connection error 1. Perform the shutdown procedure to shut down the analyzer
and then restart it.
2. If the error still exists, contact our customer service
department.
Network communication 1. Reconnect to the data management software or the LIS
error system.
2. If the connection succeeds, the error will be removed
automatically.
3. If the error still exists, contact our customer service
department.
Auto communication 1. See Heading 5.2.1 Settings and check whether the auto
operation error communication is on
2. If the auto communication is on, check whether the data
management software or the LIS system is connected to the
analyzer successfully.
3. If the error still exists, contact our customer service
department.
IP address collision 1. Check whether there are repeated IDs within the LAN.
2. If no repeated IDs, this error will be removed automatically.
3. If the error still exists, contact our customer service
department.
Printer out of paper 1. Put in print paper.
2. If the error still exists, contact our customer service
department.
ps data generation error 1. Press the “Remove error” button to remove this error.
2. If the error still exists, contact our customer service
department.
Auto-print records full. 1. Print records full. Please wait. This error will be removed

11-9
Troubleshooting Your Analyzer

Cannot add new job now. automatically.


2. If the error still exists, contact our customer service
department.
Printer paper jammed 1. Remove the jammed paper and then continue the print.
2. If the error still exists, contact our customer service
department.
Unknown printer error 1. Check whether the printer status is normal.
2. If the printer status is normal, yet this error still exists, contact
our customer service department.

11-10
12 Appendices
A Index

A C
adapter, 6-41, 6-62 calibration
Adjustment, 10-56 auto calibration, 9-6
AL auto calibration, 9-5
unloading tray is full, 11-3 conditions, 9-2
analyzer manual calibration, 9-15
intended use, 2-2 calibrator, 2-21
name, 2-1 Carryover, B-4
Aspiration, 3-2 Cistern operation error, 11-3
auto calibration Cleaning, 10-6
commercial calibrators, 9-6 Cleaning Manually, 10-45
fresh blood samples, 9-11 Cleanser expired, 11-9
Auto communication operation error, 11-9 Close Tube Sampler, 2-12
Autoloader, 2-12 control, 2-21
Autoloader is working, 11-3 CV
Auto-print records full. Cannot add new job definition, 7-15
now., 11-9 formula, 7-15

B D
Background abnormal, 11-8 Data collection sub-system com. error,
barcode, B-7 11-7
barcode label, 6-61 DIFF stirring motor abnormal, 11-6
Bas# Diluent
definition, 3-9 definition, 2-20
formula, 3-9 Diluent expired, 11-8
Bas% Dilution, 3-3
definition, 3-9
formula, 3-9

BASO stirring motor abnormal, 11-6
blank photocurrent, 3-11 Electrical Impedance method, 3-12
Eos#
definition, 3-10

A-1
Appendices

formula, 3-10 LEO(I) expired, 11-8


Eos% LEO(II) expired, 11-9
definition, 3-9 LH expired, 11-9
formula, 3-9 log program, 10-40
error Lym#
160 KPA pressure abnormal, 11-7 definition, 3-9
250 KPA pressure abnormal, 11-7 formula, 3-9
-40 KPA pressure abnormal, 11-7 Lym%
70 KPA pressure abnormal, 11-7 definition, 3-9
-85 KPA pressure abnormal, 11-7 formula, 3-9

F M
flag, 6-53 M-50 Cleanser
Flow Cytometry by Laser, 3-7 definition, 2-21
Front cover open, 11-6 M-50LBA Lyse
definition, 2-21
M-50LEO(I) Lyse

definition, 2-20
HCT M-50LEO(II) Lyse
formula, 3-14 definition, 2-20
Heater M-50LH Lyse
preheat bath temp. sensor error, 11-4 definition, 2-21
reaction bath temp. sensor error, 11-4 M-50P Probe Cleanser
HGB definition, 2-21
formula, 3-11 Main board chip error, 11-7
measurement, 3-11 Maintenance, 10-8
HGB adjust, 11-8 maintenance program, 10-2
HGB error, 11-8 Manipulator is working, 11-4
Manipulator elevation error, 11-4
Manipulator mix error, 11-4
I Manipulator pinch error, 11-3

initialization program, 10-42 MCH

installation formula, 3-14

requirements, 4-2 MCHC

IP address collision, 11-9 formula, 3-14


MCV
definition, 3-14
L formula, 3-14
Mon#
Laser box open, 11-6
definition, 3-10
Laser diode current error, 11-6
formula, 3-10
Laser diode temp. error, 11-6
Mon%
Laser diode temp. sensor error, 11-4
definition, 3-9
LBA expired, 11-9

A-2
Appendices

formula, 3-9 Mon%, 2-2


MPV MPV, 2-2
definition, 3-15 Neu#, 2-2
Neu%, 2-2
PCT, 2-2

PDW, 2-2
Network communication error, 11-9 PLT, 2-2
Network connection error, 11-9 RBC, 2-2
Neu# RDW-CV, 2-2
definition, 3-9 RDW-SD, 2-2
formula, 3-9 WBC, 2-2
Neu% PCT
definition, 3-9 formula, 3-15
formula, 3-9 PDB
No Cleanser, 11-6 chip error, 11-2
No Diluent, 11-4 PDW
No LBA lyse, 11-5 definition, 3-15
No LEO(I) lyse, 11-5 PLT
No LEO(II) lyse, 11-5 definition, 3-15
No LH lyse, 11-5 Pneumatic Unit Control Interface, 2-12
Pop-up keyboard, 2-19
Power drive sub-system communication
O error, 11-2

Overall Maintenance, 10-21 predilute


samples collection and handling, 6-10
Preheat bath temp. error, 11-6
P Printer out of paper, 11-9
Printer paper jammed, 11-10
parameter
ps data generation error, 11-9
ALY# (RUO), 2-2
Pump syringe action error, 11-4
ALY% (RUO), 2-2
Bas#, 2-2
Bas%, 2-2 Q
Eos#, 2-2
Eos%, 2-2 quality control

HCT, 2-2 L-J analysis, 8-2

HGB, 2-2 X-B analysis, 8-23

LIC# (RUO), 2-2


LIC% (RUO), 2-2 R
Lym#, 2-2
Lym%, 2-2 Rack(s) feeding error, 11-3
MCH, 2-2 Rack(s) loading error, 11-3
MCHC, 2-2 Rack(s) moved manually, 11-3
MCV, 2-2 Rack(s) unloading error, 11-3
Mon#, 2-2 RBC

A-3
Appendices

definition, 3-13 Ref. units, 5-18


RBC aperture voltage abnormal, 11-8 Transmission, 5-23
RBC bubbles, 11-8 Sheath syringe action error, 11-4
RBC clog, 11-8 shortcut button, 10-44
RDW-CV specifications, B-1
definition, 3-14 STAT, 6-53
RDW-SD status program, 10-28
definition, 3-14
Reaction bath temp. error, 11-6

reagent, 2-20
Real-time clock error, 11-7 Temperature out of operating range, 11-6
replacement program, 10-60 Temperature out of working range, 11-6
Replacing/Priming, 10-3 throughput, B-3
reproducibility, B-4 Touch Screen, 2-12
review troubleshooting, 11-1
Graph Review, 7-22 Tube barcode is too long, 11-3
Table review, 7-2 Tube fallen off or piercing error, 11-4
Tube ID read error, 11-3


sample
collection and handling, 6-9 Unknown printer error, 11-10
Sample Compartment, 2-12 User management, 5-35
Sample compartment error, 11-3 Changing information, 5-11
sampling analysis
autoloading, 6-42
close tube, 6-28

open vial, 6-13 volumetric metering, 3-13
Scanner setup error, 11-3
self-test program, 10-33
Settings W
Assistance, 5-5
Waste cistern is full, 11-6
Code, 5-26
WBC
Date/Time, 5-3
definition, 3-9
Gain, 5-24
WBC background voltage abnormal, 11-8
Print, 5-21
Wipe block action error, 11-4
RBC count time, 5-14
work list, 6-58
Reagents, 5-7
Ref. range, 5-16

A-4
B Specifications

B.1 Classification
According to the CE classification, the BC-5500 belongs to In vitro diagnostic medical devices
other than those covered by Annex II and devices for performance evaluation.

B.2 Calibrator
Blood samples with known values.

B.3 Controls
Specified by manufacturer.

B.4 Reagents
M-50 Diluent M-50D DILUENT
M-50LEO (I) LYSE
M-50 Lyse M-50LEO (II) LYSE
M-50LH LYSE
M-50LBA LYSE
M-50 CLEANSER
M-50 Cleanser M-50P PROBE CLEANSER

B.5 Collection tube types


The following 4 types of collection tubes can be used in the closed-tube sampling mode and
the autoloading mode.
Specification Adapter necessary?
φ12×75 (mm) Yes
φ13×75 (mm)
φ14×75 (mm) No
φ15×75 (mm)

B-1
Appendices

B.6 Parameters
Parameter Abbreviation Default Unit
White Blood Cell count WBC 109/L
Neutrophils number Neu# 109/L
Lymphocytes number Lym# 109/L
Monocytes number Mon# 109/L
Eosinophils number Eos# 109/L
Basophils number Bas# 109/L
Abnormal Lymphocytes number ALY# (RUO) 109/L
Large Immature Cells number LIC# (RUO) 109/L
Neutrophils percentage Neu% %
Lymphocytes percentage Lym% %
Monocytes percentage Mon% %
Eosinophils percentage Eos% %
Basophils percentage Bas% %
Abnormal Lymphocytes percentage ALY% (RUO) %
Large Immature Cells percentage LIC% (RUO) %
Red Blood Cell count RBC 1012/L
Hemoglobin Concentration HGB g/L
Hematocrit HCT %
Mean Corpuscular Volume MCV fL
Mean Corpuscular Hemoglobin MCH pg
Mean Corpuscular Hemoglobin MCHC g/L
Concentration
Red Blood Cell Distribution Width RDW-SD fL
Standard Deviation
Red Blood Cell Distribution Width RDW-CV %
Coefficient of Variation
Platelet count PLT 109 / L
Mean Platelet Volume MPV fL
Platelet Distribution Width PDW None
Plateletcrit PCT %
Red Blood Cell Histogram RBC Histogram None
Platelet Histogram PLT Histogram None
Basophils Scattergram BAS Scattergram None
4 differential Scattergram Diff Scattergram None

B-2
Appendices

B.7 Sampling Features

B.7.1 Sample volumes required for each analysis


Autoloading / Closed tube sampling 180 µL
Open vial sampling - Whole blood 120 µL
Open vial sampling - Predilute 40 µL

B.7.2 Dilution rate


HGB RBC/PLT WBC WBC
(differential) (Count)
Whole blood 1:500 1: 18050 1:68 1:52

Prediluted 1:2000 1: 72200 1:272 1:208

B.7.3 Throughput
Autoloading 80 analyses / 1 hour
Open vial sampling (whole blood) 60 seconds / analysis
Open vial sampling (prediluted) 70 seconds / analysis

B.8 Performance specifications

B.8.1 Display range


Parameter Display range
WBC (109/L) 0.00~999.99

RBC (1012/L) 0.00~99.99

HGB (g/L) 0~300

MCV (fL) 0.0~250.0

PLT (109/L) 0~9999

B.8.2 Normal background


Parameter Background result
WBC ≤ 0.3 × 109 / L
RBC ≤ 0.03× 1012/ L
HGB ≤1g/L
PLT ≤ 10 × 109 / L

B-3
Appendices

B.8.3 Linearity range


Parameter Linearity range Deviation range (Whole blood mode)
WBC (1.00~99.99)×109/L ±0.30×109/L 或 ±5%
RBC (0.30~8.20)×1012/L ±0.05×1012/ L 或 ±5%
HGB (1~260) g/L ±2g/L 或 ±2%
PLT (10~1000)×109/L ±10×109/L 或 ±8%

B.8.4 Reproducibility
These reproducibility requirements apply only to the situation in which a qualified sample has
been run for 11 times and the results of the 2nd to 11th runs are used to calculate the
reproducibilities.
Parameter Condition Whole Blood Predilute
Reproducibility(CV% / Reproducibility (CV%)
absolute deviation d※)
WBC (6.0~15.0)×109/L ≤ 2.5% ≤ 9.0%

Neu% 50.0%~60.0% ±5.0% -


Lym% 25.0%~35.0% ±3.0% -
Mon% 5.0%~10.0% ±2.0% -
Eos% 2.0%~5.0% ±1.5% -
Bas% 0.5%~1.5% ±0.8% -
RBC (4.00 ~ 6.00) × ≤ 1.5% ≤ 4.5%
1012/L

HGB (110~180) g/L ≤ 1.5% ≤ 4.5%


MCV (80~110) fL ≤ 1.5% ≤ 4.5%
PLT (150~500)×109/L ≤ 4.0% ≤ 12.0%
※ :Absolute deviation d = analysis result – average of analysis results

B.8.5 Carryover
Parameter Carryover
WBC ≤ 0.5 %
RBC ≤ 0.5 %
HGB ≤ 1.0 %
PLT ≤ 1.0 %

B-4
Appendices

B.9 Input/output device

z Be sure to use the specified devices only.

B.9.1 Touch screen


TFT color touch screen, 10.4″, 800×600.

B.9.2 Keyboard (optional)


101-Key alpha-numeric keyboard, USB

B.9.3 Mouse (optional)


USB mouse

B.9.4 Bar-code scanner (optional)


USB bar-code scanner

B.9.5 Printer(optional)
The analyzer supports such printers:
Black-and-white laser printer: HP LaserJet1320, HP LaserJet2420d, HP LaserJet 1022(B&W),
LaserJet 1010(fast).
Color inkjet printer: HP DeskJet 1280, HP Office Pro K5300.
Dot-matrix printer: Epson LQ-630K.

B.10 Interfaces
„ One LAN interface, built-in 100M network card, TCP/IP compatible

„ One pneumatic unit control interface

„ 4 USB interfaces

B.11 Power supply


Voltage Frequency Input power Fuse
Analyzer a.c.100 V~240 V 50/60 Hz ≤300 VA 250 V T5 A
Pneumatic unit a.c.110/115 V 50/60 Hz ≤300 VA/60 Hz 125 V T5 A
≤400 VA/50 Hz
a.c.220/230 V 50/60 Hz ≤300 VA/60 Hz 250 V T2.5 A
≤450 VA/50 Hz

B-5
Appendices

z Be sure to use the fuse of the specified type and rating.

B.12 EMC Description


„ This equipment complies with the emission and immunity requirements of the EN
61326-1:2006 and EN 61326-2-6:2006.

„ This equipment has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.

B.13 Sound
Maximal sound: 77 dB.

B.14 Operating environment


„ Optimal operating temperature: 15 ℃ - 30 ℃.

„ Running temperature: 10 ℃ - 40 ℃.

„ Optimal operating humidity: 30 % - 85 %.

„ Atmospheric pressure: 70 kPa - 110 kPa.

B.15 Storage environment


„ Ambient temperature: -10 ℃ - 40 ℃

„ Relative humidity: 10 % - 90 %

„ Atmospheric pressure: 50 kPa - 110 kPa

B.16 Dimensions and weight

Height

Depth
Width

B-6
Appendices

Analyzer Pneumatic unit Autoloader (optional)


Width(mm) 664 305 516
Depth(mm) 613/740 (autoloader 475 (knob and 237
configured) connecter included)
Height(mm) 585 425 90/206 (sample carrier
included)
Weight(Kg) ≤68 25 8

B.17 Barcode specifications


See table below for the barcode symbologies and the character length supported by the
built-in barcode scanner. See Chapter 5 Customizing the Analyzer Software for how to set
them.

Code type Code length


CODE 39 1-15
CODE 93 1-15
CODE 128 1-15
CODEBAR 1-15
UPC/EAN Fixed length (8-13)

Code height: A≥10mm


Label width: B≤45mm
Clear area: C≥5mm

Wide-to-narrow ratio: between 2.5: 1 and 3.0: 1


Code precision: above 0.127mm
Code quality: According to ANSI MH10.8M standard, the code quality is greater or equal to C
level.

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 proper grounding cannot be overemphasized.

C.1.2 Limitations
Whenever the results are outside the normal limits, it is recommended that the laboratory
following whatever written protocol is in place for validating results.

If an error occurs, the analyzer displays the corresponding error message In case of errors
related to the fluidic system (such as clogging or bubbles), it is recommended that you re-run
the sample after removing the error.

If the PLT value is less than 100 × 109 / L, it is recommended the result be verified by a
microscope.

C.1.3 Maintenance
The maintenance instructions in Chapter 10 describe corrective and preventive procedures
that must be followed to ensure proper operation and performance of your analyzer.

C-1
Appendices

C.2 Warnings

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


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

z Be sure to operate the analyzer under the situation specified in this manual;
otherwise, the analyzer will not work normally and the analysis results will
be unreliable, which would damage the analyzer components and cause
personal injury.

z Make sure the analyzer is properly grounded.

z Be sure to use the fuse of the specified type and rating.

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

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

z Do not move the analyzer or pneumatic unit. Contact Mindray customer


service department or your local distributor if necessary.

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


according to government regulations.

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

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

z Avoid direct contact with blood 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, after you lift the cover, be sure to fix it with the stop
bar properly.

z To avoid personal injury, when you close the front cover, be sure to hold it
first before releasing the stop bar.

z The SRV tray may contain biohazardous materials. Exercise caution to avoid
direct contact with the tray.

z When removing the SRV tray, do not loosen the thumbscrew fixing the

C-2
Appendices

sample probe; otherwise air may enter the sample probe and unreliable
results may be obtained.

z The sample probe and the SRV may contain biohazardous materials.
Exercise caution to avoid direct contact with the probe and the SRV when
working around them.

C-3
Appendices

C.3 Cautions

z Installation by personnel not authorized or trained by Mindray may damage


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

z Do not place reagents on or above the analyzer.

z Do not connect or disconnect the printer, bar-code scanner, keyboard or


mouse when the analyzer is on.

z Be sure to use the external device of the specified model only.

z The analysis results may be unreliable if the QC program is run with error(s)
reported. Be sure to troubleshoot your analyzer before moving on.

z Do not re-use disposable products.

z Be sure to collect at least 1mL of whole blood sample when running sample
in the open vial sampling mode; at least 2mL of whole blood sample in the
closed-tube sampling mode and autoloading mode.

z Do not run the same sample over twice.

z Be sure to prepare at least 1mL of control when running control in the open
vial sampling mode; at least 2mL of control in the closed-tube sampling
mode and autoloading mode.

z Be sure to prepare at least 1mL of calibrator.

z Be sure the sample ID, rack No., tube No, and measuring mode entered are
completely the same with the information of the sample to be analyzed.

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

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


service department or your local distributor for assistance.

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


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

z To avoid damage to the components of the analyzer, close the front cover
gently.

z The SRV is so fragile that any knock or drop may damage it. Exercise
caution when disassembling/assembling or cleaning the SRV. Do not loosen
or bend the tiny steel tubes at sides of the SRV.

C-4
Appendices

z Do not loosen or deform the sample probe when disassembling, cleaning


and reassembling the SRV.

z After the analyzer is turned off, wait at least 30 seconds to release the
pressure and vacuum accumulated in the pneumatic lines. Do not perform
any maintenance or replacing procedure immediately after you turn off the
analyzer.

z Be sure to the valve contact surfaces are cleaned thoroughly. Otherwise, it


may lead to the leakage from the SRV and unreliable analysis results.

z The sample probe should be completely separated from the probe wipe
when the SRV is disassembled. Otherwise, the probe may be deformed or
the probe wipe may be damaged.

z When the SRV is disassembled, reagent may leak from the tubes. Place a
dry cloth or tissue under the SRV to absorb any reagent.

z Do not use too much force to pull tubes on sides of the SRV when
disassembling the SRV. Otherwise, the tubes may be disconnected and the
leakage may be caused.

z Be sure the sample probe is inserted through the probe wipe, and the probe
wipe is placed back to the original position when the analyzer is turned off.
Otherwise, the probe wipe will be stuck and cannot work after the analyzer
is turned on.

z After the SRV tray is reassembled, check whether the thumbscrew on the
top of the sample probe is loose. If so, tighten it. Otherwise, it can cause air
to come into the probe and lead to unreliable analysis result.

z Once reagents spill on the surface of the analyzer, wipe them off with a
damp cloth or tissue as soon as possible.

z When disassembling, cleaning and reassembling the probe wipe, do not use
too much force. Otherwise, the probe wipe of the open vial sampling unit
will be damaged.

z Disconnect the tubes by pinching the ends of connects, swaying them while
pulling them outward. Do not use too much force while disconnecting the
tubes. Otherwise, the probe wipe of the open vial sampling unit will be
damaged.

z Position the metal knob between the two stoppers when reassembling the
rotor valve. Otherwise, the SRV may not function.

C-5
Appendices

C.4 Notes

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

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

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 Do not adjust the pneumatic relief valve. Contact Mindray customer service
department or your local distributor if necessary.

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

z When you have changed the diluent, cleansers or lyses, 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 reagent, keep it still for a while before use.

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


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

z Be sure to set the reagent expiration date before the first use of the analyzer
or after a new container of reagent is installed.

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 If the impact printer is connected when the analyzer is on, you need to
restart the analyzer to use the printer.

z Be sure to check the printout if the print format is changed or a new printing
title is entered.

z To avoid personal injury and analyzer damage, setting the autoloader stop
conditions is recommended.

z Be sure that the symbology and the character length set match the actual
bar-code.

C-6
Appendices

z You can delete the only one piece of the code information each time.

z Do not repeat any name when you create users.

z You can delete only one piece of user information each time.

z Since the pneumatic unit is controlled by the analyzer, the power switch of
the pneumatic unit can be kept in the ON position (I).

z The system opens different function for the user according to the user level.
The user level depends on the user name and the password when the user
logs in.

z If user switching is necessary, CLICK the “Logout” icon at the “Main” screen.
Enter the desired user name and the password into the popup dialog box
and CLICK the “OK” button to log in.

z If a STAT sample is to be run, yellow icon represents ready and flickering


yellow icon represents running instead.

z Background count indicates the measure of the particle and electrical


interference.

z The sample ID for the background check is “0”.

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

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


glass/plastic test tubes, centrifugal tubes and 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
it.

z In the “CBC” mode, the analyzer only counts blood cells but does not
differentiate WBCs; the count results include 13 parameters and RBC and
PLT histograms. In the “CBC+5DIFF” mode, the analyzer counts blood cells
and 5-part differentiates WBCs; the results include 23 parameters,
scattergrams, histograms and another 4 RUO parameters.

z WBC differential results obtained in the predilute mode are for reference
only.

z You can also aspirate 120µL of diluent by pipette into the tube.

z Be sure to keep dust from the prepared diluent.

C-7
Appendices

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 evaluate predilute stability based on your laboratory’s sample


population and sample collection techniques or methods.

z Repeat steps 7 and 8 and you can prepare more prediluted samples.

z If the analyzer is shut down abnormally, you will lose the work list
information of the samples that have not been analyzed yet.

z Sample ID up to 15 alphanumeric characters may be entered into the ID box.


The sample ID must be alphanumeric ended with a numeric. Sample ID
being all “0” or letter + “0” will be considered invalid.

z If “Invalid” appears on the sample ID box, it means the scan is invalid.

z To correct erroneous entries, DELETE and ENTER the desired information.

z If you want to enter the work list information after the analysis, see Chapter
7 Reviewing Sample Results for details.

z You can edit the “Tester” box at the review screen only after the analysis is
finished.

z The previous operating mode and sample ID are default values in the “Work
list”. Modify them as instructed if necessary.

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

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

z Proper reference range shall be selected at the “Setup” screen before


analysis. Otherwise, the results may be flagged erroneously.

z The default ref. range is “General” if you run a sample immediately after the
operating mode setting. After the analysis, the analyzer will flag, if any,
according to the reference range of “General”.

z During the analysis, CLICK the “Work list” button to enter the information for
the next sample.

z If the analyzer detects RBC clogging or bubbles during the analysis, the
corresponding error messages will be displayed in the error message area
and the results of all the related parameters will be invalidated. See Chapter
11 Troubleshooting Your Analyzer for solutions.

z CLICK the “>>>“ button to scroll to the “Parameters for Research” button.
CLICK it for RUO parameters.

z After the analysis is started, the “ID” of the “Next sample” on the screen will
automatically increase by 1 or be cleared according to the setup. See

C-8
Appendices

Heading 5.2.1 Settings for the setup method.

z The result of the background check will not be flagged on parameters,


abnormal blood cell differential or morphology.

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

z A closed tube sampler is required in the closed-tube sampling analysis.

z An autoloader is required in the autoloading analysis.

z The first default rack number is the number of the first detected sample
carrier after the analysis is started.

z You can reedit or delete the information of the sample erroneously analyzed.

z The system sequences the “Rack - Tube” in ascending order. If the “New” or
“Edit” operation is performed, the system will again sequence the No. in the
work list.

z Do not enter repeated sample ID, rack No. and tube No simultaneously.

z After the sample information is changed, the status of “Error” will become
“Ready”. You can rerun the corresponding sample.

z The measuring modes of the same batch samples are the same.

z If “Invalid” appears on the sample ID box, it means the scan is invalid. You
can enter the sample ID again when reviewing sample results. See Chapter 7
Reviewing Sample Results for details.

z If the samples to be run of the same batch need more than 5 racks, you need
to timely add the rest racks to the right tray of the autoloader and take away
the racks on the left tray of the autoloader.

z When the detected tube No. of the first sample is not the same with that
saved in the “Work mode” dialog box, the detected tube No. of the first
sample, and the sample ID, rack No. and measuring mode saved in the
“Work mode” dialog box will be written into the work list as the information
of the sample.

z When no record in the work list completely meets the detected sample ID,
rack No., tube No. and measuring mode of the sample, the actually detected
information will be written into the work list as the information of the
sample.

z When the detected tube No. or sample ID of the first sample is not the same
with that saved in the “Work mode” dialog box, the detected tube No. and
sample ID of the first sample, and the rack No. and measuring mode saved
in the “Work mode” dialog box will be written into the work list as the
information of the sample.

z Blood, scratches and powder from gloves reduces bar-code read rate. Keep
the bar-code label free of blood, scratches and powder from gloves to

C-9
Appendices

maintain a high-read rate.

z The bars on the label must be parallel to the stopper. Otherwise, the scanner
may not read it.

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.

z You can select up to 500 samples at a time. If the selected results are more
than 500, the first 500 results selected will be taken.

z In the “Selected” dialog box, without entering any number in the “From” box
and the “To” box, you can CLICK the “Deselected” button directly to deselect
all sample results.

z After exiting the “Table Review” screen, the sample results of the selected
database will be cleared and the sample results of the sample database will
not be highlighted any longer.

z You can select up to 500 samples at a time. If the results found are more
than 500, the first 500 results found will be taken.

z Once you leave the “Table Review” screen, the sample results saved in the
search database will be cleared.

z Reproducibility indices of 3 to 30 sample results can be calculated.

z If any selected result contains invalid parameter value (s), the


reproducibility indices of that parameter(s) will also be non-numeric (***).

z Trend graphs of 3 to 500 sample results can be viewed.

z If any selected result contains invalid parameter value (s), the Mean, SD and
CV% of that parameter(s) will also be non-numeric (***). The system will
automatically set the lower limit, mean value and the upper limit in the trend
graph to be within the preset “General” reference range by the operator. See
Chapter 5 Customizing the Analyzer Software for how to set the reference
range.

z CLICK the “RUO” button to browse the analysis results of RUO parameters.

z This function is available for administrator only. If necessary, CLICK the


“Main” button to return to the “Main” screen, CLICK the “Logout” button and
enter the user name and password of the administrator level to log in.

z Up to 16 digits can be entered into the “Lot No.” box of controls.

z If a built-in barcode scanner is equipped and the “AL-WB” mode is selected,


a check box of “Int. barcode” will appear on the screen. CLICK the check box
to select if necessary.

z The “Del. Ref. Value” button appears gray when there are saved expected
results and limits at the “Setting” screen. You need to delete all the L-J

C-10
Appendices

analysis results at the current QC file before editing. See Heading 8.2.3
Reviewing L-J analysis results for how to delete the results.

z Refer to the instructions for 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 The expected results entered should be within the display range; the limits
should be less than the expected results and neither of them should be “0”.
Otherwise, the entry is invalid.

z The settings can be saved only when both the expected result and limit are
valid.

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 for use of the controls for how to store and use
them.

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

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

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

z When the built-in barcode scanner is not used, you can run only one control
each time.

z The QC file No. of the same batch of controls must be the same.

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


techniques.

z If the saved within control results of L-J QC graph are less than 3, the
“Mean”, “SD” and “CV%” of every parameter are all empty.

z The preset-value can only be calculated by selecting within control results


of at least 3 QC runs.

z If you want to recalculate the preset-value, repeat step 1 to 3 of setting the


preset-value.

z After every deletion, the following results will sequentially move forward
and their No. will be refreshed.

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


results by calculating the averages of random patient samples.

z The expected results vary with areas. It is recommended they are obtained

C-11
Appendices

by calculating the averages of at least 500 random patient samples.

z The recommended limit is 3% - 5%.

z The “Del. Ref. Value” button appears gray when there are saved expected
results and limits at the “Setting” screen. You need to delete all the X-B
analysis results before editing. See 8.3.3 Reviewing X-B analysis results for
how to delete the results.

z 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, deactivate the X-B analysis.

z CLICK the “Close” radio button of “X-B QC” to deactivate the X-B analysis.
The default setting is “OFF”.

z Calibration procedures can only be performed by users of the


administrator-level or above.

z The analyzer identifies a sample as a calibration sample only if the analysis


is started from the “Calibration” screen.

z Be sure to use the Mindray- specified calibration materials and reagents.


Using calibration materials and reagents other than the specified will lead to
misleading results.

z Refer to the instructions for use of the calibration materials and reagents for
how to store and use them.

z Reproducibility is included in the calibration procedure.

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


analyzer can be used as valid analysis results.

z Be sure to use the Mindray-specified controls and reagents. Using controls


and reagents other than the specified will lead to misleading results.

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

z If you have logged in as a common user, you can only view the current
calibration factors without changing them. To calibrate the analyzer, first log
out and then re-log in as the administrator.

z The default expiration date is the system time.

z Only Mindray-specified calibrators shall be used. Mindray are not


responsible for any erroneous analysis results obtained by using calibrators
other than the specified.

z Refer to the instructions for use of the calibrator for information on the lot
number, expiration date, open vial stability days and reference values.

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 +

C-12
Appendices

the open vial stability days.

z You can delete only one group of data by clicking the “Delete” button once
on the screen.

z You cannot delete the calculated CVs and calibration factors at the “Blood”
count screen.

z The calibration factors to be entered shall be between 75.0% - 125.0%. One


decimal fraction is allowed.

z Do not click with the mouse to calibrate the touchscreen.

z Reassemble the SRV tray by facing the side with the groove up.

z Do not remove the rear fixed valve of the SRV.

z Make sure no dust should be found in the holes and grooves and on the
surfaces after the cleaning.

z The valve contact surfaces must be damp when the SRV is reassembled.

z Be sure the sampling valve, rotor valve and rear fixed valve of the SRV
attach well after the reassembly.

z If the pressure is adjusted too high, you should adjust it to the lowest level
before readjusting it to the desired level.

z To ensure the analyzer functions normally, check the sample probe


periodically and replace it in time.

z Do not open the front cover after the analysis starts.

z If abnormal power failure occurs after the analysis starts, open the front
cover to check for fallen test tube and take it out, if any.

z If abnormal power failure occurs after the analysis starts, remove the rack(s)
manually, open the front cover to check for fallen test tube and take it out, if
any.

z If the blood mode is switched from the “WB” to “PD” or the sampling mode
is changed, the analyzer will switch modes automatically and give the
prompt on the screen.

z The default ID of the sample to be run in the “OV” mode is determined by


the setup of the Entry of next sample ID. See Heading 5.2.1 Settings for the
setup method.

z The default ID of the sample to be run in the “CT” mode is determined by


the setup of the Entry of next sample ID. See Heading 5.2.1 Settings for the
setup method.

z To change the time when to start the liquid saver, see Heading 5.3.1 Settings
for details.

z At the screens of “Mechanical”, “Circuit” and “Valve”, the analyzer will not
enter the liquid saver status.

C-13
Appendices

z If it is time for liquid saver, some current operations will pause. When the
analyzer is in the liquid saver status, you can continue the operations.

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.

C-14
Appendices

C.6 Abnormal Results


For reference only.

C.6.1 Abnormal Sample Analysis Results

Parameter flags
„ If parameter is followed by an “H” or “L”, it means the analysis result has exceeded the
upper or lower limit of the reference range, but still within the display range.

„ If parameter is followed by an “?”, it means the analysis result is suspect.

„ If you see *** as opposed to the result, it means the result is either invalid or out of the
display range. If the WBC result of whole blood sample is less than 0.5 × 109/L or greater
than 100 × 109/L, or the WBC result of prediluted sample is less than 2 × 109/L or greater
than 100 × 109/L, this analyzer will not perform the differential analysis and all the related
parameter values will be non-numeric (***).

Flags of Abnormal Blood Cell Differential or Morphology


The analyzer will flag abnormal or suspect WBC, RBC/HGB and PLT according to the
scattergrams and histograms. See Table below for flags.

Table C -1 Flags of Abnormal Blood Cell Differential or Morphology

WBC Flag

Abnormal
Flag Meaning Judgment criterion
WBC Abn Scattergram? Abnormal WBC scattergram Abnormal scattergram of the
DIFF channel or BASO
channel
Leucocytosis High WBC analysis results WBC > 18.0×109/L
Leucopenia Low WBC analysis results WBC < 2.5×109/L
Neutrophilia High neutrophils analysis NEUT# > 11.0×109/L
results
Neutropenia Low neutrophils analysis NEUT# < 1.0×109/L
results
Lymphocytosis High lymphocytes analysis LYMPH# > 4.0×109/L
results
Lymphopenia Low lymphocytes analysis LYMPH# < 0.8×109/L
results
Monocytosis High monocytes analysis MONO# > 1.0×109/L
results
Eosinophilia High eosinophils analysis EO# > 0.7×109/L

C-15
Appendices

results
Basophilia High basophils analysis BASO# > 0.2×109/L
results

Suspect
Flag Meaning Judgment criterion
Asp. Abn./Abn. Sample? The aspiration may be Results of primary
abnormal, or the sample itself parameters are severely low
may be abnormal simultaneously
WBC Abn. WBC numbers of BASO and WBC numbers of BASO and
DIFF channels are DIFF channels are
inconsistent. The sample inconsistent.
may be abnormal, or the
analyzer may be abnormal.
Left Shift? Left shift may exist. Many scatter-points exist in
the left shift area of the
scattergram.
Immature Cell? Immature cells may exist. The proportion of immature
cells is greater than 2.5%.
Abn./Atypical Lym? Abnormal lymphocytes or The proportion of
atypical lymphocytes may abnormal/atypical
exist. lymphocytes is greater than
2%.
RBC Lyse Resist? RBC hemolysis may be Scatter-points are thick
incomplete. between the lymphocytes
and ghost cells areas of the
scattergram.

RBC/HGB Flag

Abnormal
Flag Meaning Judgment criterion
RBC Abn. Distribution Abnormal RBC scattergram RBC scattergram is
abnormal.
Anisocytosis Sizes of RBCs are dissimilar RDW-SD>64 or RDW-CV>22
Microcytosis Small MCV MCV < 70fL
Macrocytosis Large MCV MCV > 110fL
Erythrocytosis Increased RBCs RBC# > 6.50×1012/L
Anemia Anemia HGB < 90g/L
Hypochromia Hypochromia MCHC < 29.0g/dL
Diamorphologic RBC diamorphologic Two or two more peaks in the
distribution RBC histogram.

C-16
Appendices

Suspect
Flag Meaning Judgment criterion
RBC or HGB Abn.? Results of RBC or HGB may Analyzing and comparing
be inaccurate results of HGB and RBC
HGB Abn./Interfere? HGB results may be Calculating and comparing
abnormal, or interference special analysis parameters
may exist

PLT Flag

Abnormal
Flag Meaning Judgment criterion
Thrombocytosis PLTs increase PLT > 600×109/L
Thrombocytopenia PLTs decrease PLT < 60×109/L
PLT Abn Distribution PLT histogram distribution is PLT histogram is abnormal.
abnormal.

Suspect
Flag Meaning Judgment criterion
PLT Clump? PLT clump may exist. Calculating and comparing
special analysis parameters

C.6.2 Abnormal QC Results

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.

„ For the L-J analysis program,

1. Check 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.

C-17
Appendices

„ For the X-B analysis program,

1. Check the screen for error messages. Refer to Chapter 11 Troubleshooting Your
Analyzer for solutions to any displayed error messages.

2. Check the X-B settings for inappropriate entries.

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


Troubleshooting Your Analyzer for solutions.

4. Run a control.

5. Check if the analyzer needs to be calibrated.

C-18
D Communication

D.1 Introduction

The BC-5500 can transmit the sample data and QC data to an external computer (a host)
through its network port. This section gives detailed discussion about the setup of transmission
parameter and the data transmission format, etc., therefore, providing detailed information for
the software engineers to program and for the user to conveniently perform transmission.

D-1
Appendices

D.2 Programming

D.2.1 Description
Data transmission communication port: 5500
Measurement mode inquiry communication port: 5501

D.2.2 Data transmission work flow

Client terminal

1. The client terminal (the external computer) requests a network connection to establish a
TCP communication channel with the server terminal (the analyzer).

2. The blocking mode of client terminal receives data and sets the maximum waiting time of
receiving to be 5 seconds.

„ The client terminal starts to receive sample data once it receives the MS (0x05). When
receives the ME (0x0A), the client terminal will parse the data between MS and ME to
obtain a piece of sample data, and then go back to step 2.

„ If the client terminal receives data not begin with MS(0x05), it is invalid data and will be
abandoned directly.

„ If the time is out, it will go to 3.

3. The client terminal disconnects the network.

Server terminal

1. The server terminal establishes the communication thread and monitors the network
connection requested outside.

2. The server terminal receives the network connection, establishes the TCP communication
channel with the client terminal (the external computer) and creates a special data
communication thread for communication.

3. The user sends the sample data package manually. After the sending, it will go back to
step 3.

4. The network connection will be closed data transmission thread will be destroyed.

D-2
Appendices

D.2.3 Measurement mode inquiry work flow

Client terminal (LIS system)

1. The client terminal requests the 5501 port of the analyzer to establish a network
connection.

2. The client terminal waits for receiving measurement mode inquiry request.

„ The client terminal obtains the requested sample ID from the measurement inquiry, and
returns the corresponding measurement mode to the analyzer through measurement
mode inquiry response, and then goes back to step 2.

Server terminal (The analyzer)

1. The 5501 port of the server terminal monitors the TCP communication requested by LIS
system.

2. The server terminal receives the communication request from LIS system, establishes the
TCP measurement mode inquiry communication channel with the client terminal (LIS
system).

3. For bi-directional LIS mode, the server terminal requests the LIS system for measurement
mode inquiry first.

4. If the server terminal receives the measurement mode inquiry response within 2 seconds,
then the inquiry succeeded. Otherwise, the measurement mode inquiry failed, and then go
back to step 3.

D-3
Appendices

D.3 Protocol construction

D.3.1 Data pack construction

Figure D-1 Protocol data construction

Protocol data package is the smallest unit of the transmission. Every transmission shall meet
the requirements of constructing a complete protocol data package, regardless the quantities
of the data.

A complete data package consists of data information of three levels:

„ Message: a complete data package is called the message. There are three description
fields:

MS: Message start field. MS is the first data unit of all messages.
MD: Message description field. It describes the Message type/meaning.
ME: Message end field. ME is the last data unit of all messages.

„ Segment: Data segment. One piece of Message data consists of one or more Segment
data. There are two description fields.

SD: Segment description field. It describes the Segment type/meaning.


SE: Segment end field. SE is the last data unit of all segments.

„ Field: Property field. One Segment data consists of one or more field data. There are three
description fields.

FD: Description field of Field. It describes the Field type/meaning.


V: Value of the Field. It is the final value of the field.
FE: End field of Field. FE is the last data unit of all fields.

For multi-host computer and multi-terminal compatible application and to response the control
flow processing in a fastest way, the following conventions are made.

„ Usually, the transmission of the host ID is not compelled in the Message.

„ Except the MS, ME, SE and FE in the protocol description field and the case that the
transmission type is binary data as described, data is transmitted via ASCII text coding.
The string describing the meaning directly is transmitted in MD, SD and FD.

D-4
Appendices

D.3.2 Data package unit separation

To identify Message from data flow and then identify the combined fields in the Message, we
need to set separation between fields in the protocol. The following shows how to separate
fields.

„ MS and MD do not need to be separated. MS uses binary coding (one byte).

„ MD and SD are separated by “0x03”.

„ SD and FD are separated by “0x0C”.

„ FD and V are separated by “0x16”.

D.3.3 Data package coding

MD, SD, FD and V in the data package are transmitted by ASCII coding to be compatible with
the protocol field changes. The descriptions in V of data attribute can be transmitted via binary
data only when binary data are described in SD.

When data package and fields inside are transmitted via ASCII coding, the host and the
terminal must share the same character set.

D-5
Appendices

D.4 Field descriptions

D.4.1 Message start field


Table D-1 Package start field

Field name Coding Description


MS 0x05 Message start sign

D.4.2 Message end field


Table D-2 Package end field

Field name Coding Description


ME 0x0a Message end sign

D.4.3 Message description unit field


Table D-3 Package description field

Field name Coding Description


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

D.4.4 Data description field

Note:

1. All definitions of SD and FD are transmitted in ASCII coding unless otherwise specified.

2. All attribute data segment FD definitions corresponding to metadata segment SD are


defined in utmost FD. Practically, FD fields of SD may have only several FD fields in SD
definition and can be combined in any order.

3. For graphic data flow, the order and number of FD fields cannot be changed.

SE field

Table D-4 SE field

Field name Coding Description


SE 0x04 End sign field of metadata.
Each metadata ends with SE

D-6
Appendices

FE field

Table D-5 FE field

Field name Coding Description


FE 0x08 End sign field of attribute
data. Each attribute data
ends with FE

FD field

Table D-6 FD field

Field name V format Description


Parameter value indicated
Val
by SD field
Lower limit of analysis
Low
result
Upper limit of analysis
High
result
Unit Unit of parameter
Suspect sign for
Flag
parameters
Expected result of L-J
Mean
analysis
Range limit of L-J analysis

Binary Data flow length


DataLen
(unit: byte)

Metadata length of binary


data flow. For example,
each metadata length in
scattergram data flow is 4;
in histogram data flow is 1.
MetadataLen
If the field is not included in
binary data flow, the default
metadata length of binary
data flow is 1. Note: During
the transmission, using

D-7
Appendices

metadata length as the unit,


binary data is converted to
network byte order and then
transmitted.

Supposed that the particle


type in BASO scattergram
0 1 2 3 4 … N-1
BASOType is N, then the parameter is
binary data flow of
N*2(MetadataLen=2) Byte.
Supposed that the particle
type in DIFF scattergram is
0 1 2 3 4 … N-1
DIFFType N, then the parameter is
binary data flow of
N*2(MetadataLen=2) Byte.
Supposed that there is a
particle N in BASO
scattergram, then the
parameter is binary data
flow of
N*4(MetadataLen=4) Byte.
0 1 2 3 4 5 6 7 …
BASOData Here, x represents the X
x y v x y v …
coordinate in the
scattergram, y for Y
coordinate and v for total
particle number in the
position (x, y) of the
scattergram.
Supposed that there is a
particle N in DIFF
scattergram, then the
parameter is binary data
flow of
N*4(MetadataLen=4) Byte.
0 1 2 3 4 5 6 7 …
DIFFData Here, x represents the X
x y v x y v …
coordinate in the
scattergram, y for Y
coordinate and v for the
total particle number in the
position (x, y) of the
scattergram.

D-8
Appendices

Byte binary data flow


(MetadataLen=1). The
contents are a complete
image of BASO scattergram
bitmap (including bitmap
BASOBmpData
head-of-file, palette and
data information). The data
length is related to the
scattergram bitmap size
setup of the main unit.
Byte binary data flow
(MetadataLen=1). The
contents are a complete
image of DIFF scattergram
bitmap (including bitmap
DIFFBmpData
head-of-file, palette and
data information). The data
length is related to the
scattergram bitmap size
setup of the main unit.
Binary data flow of
0 1 2 3 4 … 255
RHistoData 256*1(MetadataLen=1)
Byte
Binary data flow of
0 1 2 3 4 … 255
PHistoData 256*1(MetadataLen=1)
Byte
BloodMode Sample mode
0: Open vial-predilute; 1:
Open vial-whole blood; 2:
Autoloading-whole blood; 3:
Closed tube-whole blood
AnaMode Analysis mode
0: CBC + 5DIFF mode; 1:
CBC mode
BasoTotal Particle total number of
BASO channel
DiffTotal Particle total number of
DIFF channel
WbcTotal WBC total number
RbcTotal RBC total number
PltTotal PLT total number
SepWbcLyLeft WBC LymphLeft line
SepWbcLyMid WBC LymphMid line
SepWbcGranMid WBC MidGran line

D-9
Appendices

SepWbcGranRight WBC GranRight line


SepRBCLeft RBC left discriminator
SepRBCRight RBC right discriminator
SepPLTLeft PLT left discriminator
SepPLTRight PLT right discriminator
WLeft Left shift?
Note: This field represents
the prompt of abnormal
analysis result. 1: indicates
that suspect of this kind
exists; 0: indicates no
suspect of this kind.
Descriptions from this field
to pMicro field are prompt of
this kind.
WRight Right shift?
WGran Immature cell
WNrbc RBC lyse resist?
WBlast WBC Abn Scattergram?
WAtl Abnormal Lymphocyte
WNeuLow Neutropenia
WNeuHigh Neutrophilia
WLymLow Lymphopenia
WLymHigh Lymphocytosis
WMonHigh Monocytosis
WEosHigh Eosinophilia
WBasHigh Basophilia
WBCHigh Leucocytosis
WBCLow Leucopenia
RDistri RBC Abnormal distribution
RAniso Anisocytosis
RMicro Microcytosis
RMacro Macrocytosis
REryth Erythrocytosis
RAgg RBC Agglutination
RUnnormal HGB Abn/interfere
RAnemia Anemia
RHypo Hypochromia
RTurbi HGB interfere
RDimor diamorphologic
RIron Iron deficiency
PPenia Thrombocytopenia
PSis Thrombocytosis

D-10
Appendices

PDistri PLT Abn distribution


PAgg PLT Clump?
PMicro Small Platelet
SampID sample ID of patient
Name Name
Gender Gender
0 null; 1 undefined; 2 male;
3 female
AgeVal Age value
AgeType Age type
0 null; 1 year; 2 month; 3
day; 4 hour
SampTime YYYY-MM-DD HH:MM:SS Sampling time
SendTime YYYY-MM-DD HH:MM:SS Sending time
TestTime YYYY-MM-DD HH:MM:SS Test time
RepTime YYYY-MM-DD HH:MM:SS Report time
ChargeType Charge type
(meaningless for the
present)
SamSource Sample source
(meaningless for the
present)
ChartNo Chart No.
BedNo Bed No.
InsNo Medical insurance No.
(meaningless for the
present)
Dept Department
Sender Sender
Tester Tester
Checker Checker
Remark Remark
CusRec1 Customized field 1
CusRec2 Customized field 2
CusRec3 Customized field 3
CusRec4 Customized field 4
FileNo L-J analysis QC file No.
LotNo L-J analysis QC lot No.
Level L-J analysis QC level
0 for low, 1 for normal and 2
for high
ExpDate YYYYMMDD L-J analysis QC expiration
date

D-11
Appendices

SampleID Inquiry sample ID


ST OK , DENY Returning status
OK means correct mode is
obtained by inquiring
DENY means inquiry failed
AnaMode 0, 1 Analysis mode 0 means
CBC+5DIFF
1 means CBC

SD Field

Note: All FD fields corresponding to SD fields are from Table 5 FD field definition.

Table D-7 SD Field

SD FD Description
FD1 FD2 FD3 FD4 FD5 FD6 FD7 White Blood
WBC
Val Low High Unit Flag Mean Range Cell count
Neu# Neutrophils
The same with those of WBC
number
Lymphocytes
Lymph# The same with those of WBC
number
Monocytes
Mon# The same with those of WBC
number
Eosinophils
Eos# The same with those of WBC
number
Basophils
Bas# The same with those of WBC
number
Neu% Neutrophils
The same with those of WBC
percentage
Lymphocytes
Lymph% The same with those of WBC
percentage
Monocytes
Mon% The same with those of WBC
percentage
Eosinophils
Eos% The same with those of WBC
percentage
Basophils
Bas% The same with those of WBC
percentage
RBC Red Blood
The same with those of WBC
Cell count
HGB Hemoglobin
The same with those of WBC
Concentration
HCT The same with those of WBC Hematocrit
MCV Mean
The same with those of WBC
Corpuscular

D-12
Appendices

Volume
MCH Mean
The same with those of WBC Corpuscular
Hemoglobin
MCHC Mean
Corpuscular
The same with those of WBC
Hemoglobin
Concentration
RDW-CV Red Blood
Cell
Distribution
The same with those of WBC
Width
Coefficient of
Variation
RDW-SD Red Blood
Cell
Distribution
The same with those of WBC
Width
Standard
Deviation
PLT The same with those of WBC Platelet count
MPV Mean Platelet
The same with those of WBC
Volume
PDW Platelet
The same with those of WBC Distribution
Width
PCT The same with those of WBC Plateletcrit
ALY# Abnormal
The same with those of WBC Lymphocytes
number
ALY% Abnormal
The same with those of WBC Lymphocytes
percentage
LIC# Large
The same with those of WBC Immature
Cells number
LIC% Large
Immature
The same with those of WBC
Cells
percentage
Low angle
WBC(Diff)
LasDiff The same with those of WBC
value of gain
calibration

D-13
Appendices

High angle
WBC(Diff)
MasDiff The same with those of WBC
value of gain
calibration
Low angle
WBC(Baso)
LasBaso The same with those of WBC
value of gain
calibration
High angle
WBC(Diff)
MasBaso The same with those of WBC
value of gain
calibration
QC parameter
GranX The same with those of WBC
GRAN-X
QC parameter
GranY The same with those of WBC
GRAN-Y
QC parameter
GranYW The same with those of WBC
GRAN-Y(W)
QC parameter
WBCBAX The same with those of WBC
WBC/BA-X
QC parameter
WBCBAY The same with those of WBC
WBC/BA-Y
FD1 FD2 FD3 RBC
RBCHisto
DataLen MetaDataLen RHistoData Histogram
FD1 FD2 FD3
PLTHisto PLT Histogram
DataLen MetaDataLen PHistoData
FD1 FD2 FD3
BASOType BASO type
DataLen MetaDataLen BASOTypeData
FD1 FD2 FD3
BASO BASO data
DataLen MetaDataLen BASOData
FD1 FD2 FD3
DIFFType DIFF type
DataLen MetaDataLen DIFFTypeData
FD1 FD2 FD3
DIFF DIFF data
DataLen MetaDataLen DIFFData
FD1 FD2 FD3 BASO bitmap
BASOBMP
DataLen MetaDataLen BASOBmpData data

FD1 FD2 FD3 DIFF bitmap


DIFFBMP
DataLen MetaDataLen DIFFBmpData data

FD1 Protocol
ProtocolVer
Val version No.
FD1 FD2 Mode
Mode
BloodMode AnaMode

D-14
Appendices

Ref. range
0: General; 1:
FD1 Male; 2:
SampGroup
Val Female; 3:
Child; 4:
Neonate;
Particle total
FD1 FD2 FD3 FD4 FD5
Total number of
BasoTotal DiffTotal WbcTotal RbcTotal PltTotal
channels
WBC
differential
sign
FD1
WbcSepFlag 1 for
Val
differential; 0
for
non-differential
FD1 FD2 Discriminators
SepRBCLeft SepRBCRight of histogram
SepLine
FD3 FD4
SepPLTLeft SepPLTRight
Histogram
adjustment
sign
If the
FD1
HistoAdj histogram is
Val
adjusted, the
VAL is 240. If
not, the VAL is
0.
Flag sign
FD1 1 for flag
AlarmFlag
Val exists; 0 for no
flag
FD1 FD2 FD3 FD3 FD4
WLeft WRight WGran WNrbc WBlast
FD5 FD6 FD7 FD8 FD9
WAtl WNeuLow WNeuHigh WLymLow WLymHigh
Prompt of
FD16 FD17 FD18 FD19 FD20
AbnormalFlag abnormal
WMonHigh WEosHigh WBasHigh WBCHigh WBCLow
sample result
FD21 FD22 FD23 FD24 FD25
RDistri RAniso RMicro RMacro REryth
FD26 FD27 FD28 FD29 FD30

D-15
Appendices

FD31 FD32 FD33 FD34 FD35


RDimor RIron PPenia PSis PDistri
FD36 FD37
PAgg PMicro
Time
information of
samples
Including the
FD1 FD2 FD3 FD4
PatTime sample time,
SampTime SendTime TestTime RepTime
sending time,
analysis time
and reporting
time
FD1 FD2 FD3 FD3 FD4
SampleID Name Gender AgeType AgeVal
FD5 FD6 FD7 FD8 FD9 Basic
ChargeType SamSourc ChartNo BedNo InsNo information of
PatInfo
FD10 FD11 FD12 FD13 FD14 patient
Dept Sender Tester Checker Remark samples
FD15 FD16 FD17 FD18
CusRec1 CusRec2 CusRec3 CusRec4
LJInfo FD1 FD2 FD3 FD4 FD5 Information of
FileNo LotNo Level ExpDate TestTime L-J analysis
QC files
QCC includes
FD1, FD2, FD3,
FD4; QCR
includes FD1,
FD2 and FD5.
CTMR FD1 Measurement
mode inquiry
SampleID
DAA FD1 FD2 FD3 Data obtaining
request
ST SampleID AnaMode
response

D-16
Appendices

D.5 Demonstration data

This section demonstrates the communication protocol through the description of sample data
and coding data.

D.5.1 Raw data


Figure below shows the sample data information:

Figure D-2 Raw sample data

D.5.2 Coding data


Special note: To ensure the coding data to be displayed by text, this manual expresses the
delimiters in the communication protocol per the following rules.

Table D-8 Rules for fields and delimiters

Field Protocol coding Demonstration coding


MS 0x05 ‘{‘
ME 0x0A ‘}’
SE 0x04 ‘$’
FE 0x08 ‘;’
Delimiter of MD and SD 0x03 ‘#’
Delimiter of SD and FD 0x0C ‘:’
Delimiter of FD and V 0x16 ‘,’

For example, the MS field (0x05) will be displayed as “{” in the demonstration data in the

D-17
Appendices

manual. The rest fields and delimiters will be displayed according to the table above.
According to character of the sample data, the demonstration data is listed in the following four
parts: analysis parameter, sample information, patient information and graph information.

Analysis parameter

This section includes start bits, data types and analysis parameters of coding data.
{CTR#WBC:Val,9.52;Low,4.00;High,10.00;Flag,0;Unit,10^9/L;$Neu#:Val,6.
20;Low,2.00;High,7.00;Flag,0;Unit,10^9/L;$Lymph#:Val,2.37;Low,0.80;Hi
gh,4.00;Flag,0;Unit,10^9/L;$Mon#:Val,0.71;Low,0.12;High,0.80;Flag,0;U
nit,10^9/L;$Eos#:Val,0.21;Low,0.02;High,0.50;Flag,0;Unit,10^9/L;$Bas#
:Val,0.03;Low,0.00;High,0.10;Flag,0;Unit,10^9/L;$Neu%:Val,65.1;Low,50
.0;High,70.0;Flag,0;Unit,%;$Lymph%:Val,24.9;Low,20.0;High,40.0;Flag,0
;Unit,%;$Mon%:Val,7.5;Low,3.0;High,8.0;Flag,0;Unit,%;$Eos%:Val,2.2;Lo
w,0.5;High,5.0;Flag,0;Unit,%;$Bas%:Val,0.3;Low,0.0;High,1.0;Flag,0;Un
it,%;$RBC:Val,482;Low,350;High,550;Flag,0;Unit,10^4/uL;$HGB:Val,134;L
ow,110;High,160;Flag,0;Unit,g/L;$HCT:Val,0.393;Low,0.370;High,0.500;F
lag,0;Unit,L/L;$MCV:Val,81.6;Low,80.0;High,100.0;Flag,0;Unit,fL;$MCH:
Val,27.8;Low,27.0;High,31.0;Flag,0;Unit,pg;$MCHC:Val,341;Low,320;High
,360;Flag,0;Unit,g/L;$RDW-CV:Val,15.1;Low,11.5;High,14.5;Flag,0;Unit,
%;$RDW-SD:Val,45.5;Low,35.0;High,56.0;Flag,0;Unit,fL;$PLT:Val,320;Low
,100;High,300;Flag,0;Unit,10^9/L;$MPV:Val,6.4;Low,7.0;High,11.0;Flag,
0;Unit,fL;$PDW:Val,15.5;Low,15.0;High,17.0;Flag,0;Unit,;$PCT:Val,0.20
5;Low,0.108;High,0.282;Flag,0;Unit,%;$ALY#:Val,0.08;Low,0.00;High,0.2
0;Flag,0;Unit,10^9/L;$ALY%:Val,0.8;Low,0.0;High,2.0;Flag,0;Unit,%;$LI
C#:Val,0.06;Low,0.00;High,0.20;Flag,0;Unit,10^9/L;$LIC%:Val,0.6;Low,0
.0;High,2.5;Flag,0;Unit,%;$LasDiff:Val,***.*;Low,***.*;High,***.*;Fla
g,0;Unit,fL;$MasDiff:Val,***.*;Low,***.*;High,***.*;Flag,0;Unit,fL;$L
asBaso:Val,***.*;Low,***.*;High,***.*;Flag,0;Unit,fL;$MasBaso:Val,***
.*;Low,***.*;High,***.*;Flag,0;Unit,fL;$GranX:Val,0;Low,*;High,*;Flag
,0;Unit,;$GranY:Val,0;Low,*;High,*;Flag,0;Unit,;$GranYW:Val,0;Low,*;H
igh,*;Flag,0;Unit,;$WBCBAX:Val,0;Low,*;High,*;Flag,0;Unit,;$WBCBAY:Va
l,0;Low,*;High,*;Flag,0;Unit,;$

Sample information

This section includes the following information: histogram discriminator information, particle
total information, mode, protocol version No., reference value group, WBC differential sign,
histogram adjustment sign, prompt of abnormal sample result, etc..

D-18
Appendices

SepLine:SepRBCLeft,30;SepRBCRight,166;SepPLTLeft,5;SepPLTRight,87;$To
tal:BasoTotal,952;DiffTotal,0;RbcTotal,485;PltTotal,329;$Mode:BloodMo
de,1;AnaMode,0;$ProtocolVer:Val,A;$SampGroup:Val,0;$WbcSepFlag:Val,0;
$HistoAdj:Val,0;$AlarmFlag:Val,0;$AbnormalFlag:WLeft,0;WRight,0;WGran
,0;WNrbc,0;WBlast,0;WAtl,0;WNeuLow,0;WNeuHigh,0;WLymLow,0;WLymHigh,0;
WMonHigh,0;WEosHigh,0;WBasHigh,0;WBCHigh,0;WBCLow,0;RDistri,0;RAniso,
0;RMicro,0;RMacro,0;REryth,0;RAgg,0;RUnnormal,0;RAnemia,0;RHypo,0;RTu
rbi,0;RDimor,0;RIron,0;PPenia,0;PSis,0;PDistri,0;PAgg,0;PMicro,0;$

Patient information

This section includes the following information: sample ID., name, gender, age, age type, bed
No., department, sender, tester, sending time, testing time, etc..
PatInfo:SampleID,1221kf9208;Gender,0;AgeType,1;Tester,Yang;$PatTime:T
estTime,2006-12-21 15:25:25;$

Graph information

The graph information is transmitted in binary system data directly. The coding rules for BASO
scattergram, DIFF scattergram, RBC histogram and PLT histogram are exactly the same. Take
the PLT histogram for example,
PLTHisto:DataLen,128;MetaDataLen,1;PHistoData, 
  ".>Pdw 嫛 磁 愚 骒 蝓 鼯   ?       黩 脬 傥 梅   洃 噣
{wrmiffca^\[YXUTROKHD?<977789;;=<::86430.,*((&&&'''('))))*+**('&$"! -
;$
PLTHisto defines that the sequential contents are the PLT histogram information; DataLen,128
defines that the length of binary system data after PHistoData is 128 bytes; DataLen,128 and
MetaDataLen,1 define that the PLT histogram is (128/1=128) 128 channel data; Content after
PHistoData is the binary system data of PLT histogram.

D-19
Appendices

D.6 Complete mode inquiry and inquiry response pack

D.6.1 Mode inquiry pack

MS MD separator SD separator FD separator V FE SE ME

0x05 CMD 0x03 CTMR 0x0C SampleID 0x16 0x08 0x04 0x0A

D.6.2 Inquiry response pack

MS MD separator SD separator FD separator V


0x05 ACK 0x03 DAA 0x0C ST 0x16

FD separator V FE FD separator V FE SE ME
SampleID 0x16 0x08 AnaMode 0x16 0x08 0x04 0x0A

D-20
P/N: 3100-20-49382(1.6)

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