Operators Manual

Auto Hematology Analyzer

Product name: Auto Hematology Analyzer

For this Operators Manual, the issued Date is 2011-05.

Table of Contents
Using This Manual............................................................................................... 1-1

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

Safety Information ................................................................................................. 1-5

1.6

Symbols ................................................................................................................. 1-7

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

2.1

Introduction............................................................................................................ 2-1

2.2

Intended Use ......................................................................................................... 2-2

2.3

Main Structure ....................................................................................................... 2-4

2.4

User Interface ...................................................................................................... 2-12

2.5

Shortcut Button/Menu Item.................................................................................. 2-15

2.6

Software Operation.............................................................................................. 2-16

2.7

Help Information .................................................................................................. 2-28

2.8

Reagents, Controls and Calibrators .................................................................... 2-31

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 ............................................................................................... 3-5

3.5

HGB Measurement................................................................................................ 3-9

3.6

RBC/PLT Measurement....................................................................................... 3-10

3.7

Wash.................................................................................................................... 3-13

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

4.1

Introduction............................................................................................................ 4-1

4.2

Installation Requirements ...................................................................................... 4-2

4.3

Connecting the Analyzer System .......................................................................... 4-4

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

5.1

Introduction............................................................................................................ 5-1

5.2

Common User ....................................................................................................... 5-2

5.3

Administrator ....................................................................................................... 5-13

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

6.1

Introduction............................................................................................................ 6-1
1

Table of Contents
6.2

Initial Checks ......................................................................................................... 6-2

6.3

Startup and Login .................................................................................................. 6-4

6.4

Daily Quality Control.............................................................................................. 6-7

6.5

Sample Collection and Handling ........................................................................... 6-8

6.6

Closed-tube Sampling Analysis........................................................................... 6-12

6.7

Autoloader Sampling Analysis............................................................................. 6-29

6.8

Worklist ................................................................................................................ 6-51

6.9

Shutdown............................................................................................................. 6-57

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

7.1

Introduction............................................................................................................ 7-1

7.2

Graph Review........................................................................................................ 7-2

7.3

Table Review ....................................................................................................... 7-13

7.4

Data Backup ........................................................................................................ 7-31

7.5

Data Export.......................................................................................................... 7-34

7.6

Auto-Backup ........................................................................................................ 7-37

7.7

Auto-Restore ....................................................................................................... 7-38

7.8

Compare .............................................................................................................. 7-39

7.9

Statistics............................................................................................................... 7-45

7.10 History.................................................................................................................. 7-49

8

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

8.1

Introduction............................................................................................................ 8-1

8.2

L-J Quality Control................................................................................................. 8-2

8.3

X mean QC Program ........................................................................................... 8-72

8.4

X mean R QC Program ..................................................................................... 8-122

8.5

X-B QC Program ............................................................................................... 8-163

10

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

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

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

10.2 Maintenance ........................................................................................................ 10-2
10.3 System Status.................................................................................................... 10-43
10.4 Version and Config. Information ........................................................................ 10-50
10.5 Self-test.............................................................................................................. 10-52
10.6 Counter .............................................................................................................. 10-60
10.7 Log..................................................................................................................... 10-63
11

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

11.1 Introduction.......................................................................................................... 11-1
2

Table of Contents
11.2 Errors Indicated by Error Messages.................................................................... 11-2
12

Customizing the Print Template....................................................................... 12-1

12.1 Introduction.......................................................................................................... 12-1
12.2 Entering the Print Template Screen..................................................................... 12-2
12.3 Editing the Template ............................................................................................ 12-4
12.4 Managing the Templates ..................................................................................... 12-7
12.5 Other Functions ................................................................................................. 12-10

13

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

A

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

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

Communication..................................................................................................... C-1

Using This Manual

1.1 Introduction
This chapter explains how to use your operators manual, which is shipped with your AUTO
HEMATOLOGY ANALYZER and contains reference information about the analyzer 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.

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 analyzer hardware and software.

customize system settings.

perform daily operating tasks.

perform system maintenance and troubleshooting.

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Using This Manual

1.3 How to Find Information

This operators manual comprises 12 chapters and 3 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 analyzer

Chapter

Understanding

Your Analyzer
learn about the hardware, interface and software of the

Chapter

analyzer

Your Analyzer

learn about how the analyzer works

Chapter 3 Understanding the

Understanding

System Principles
learn about the installation requirements of the analyzer

Chapter

Installing

Your

Analyzer
learn about how to define/adjust system settings

Chapter 5 Customizing the

Analyzer Software

learn about the process of sample collection and analysis

Chapter 6 Operating Your

Analyzer

learn about how to use the analyzer to perform your daily

Chapter 6 Operating Your

operating tasks

Analyzer

review sample 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 analyzer

Chapter

Using

the

Calibration Programs
learn about how to maintain/service the analyzer

Chapter 10 Maintaining Your

Analyzer

learn about how to solve the problems of the analyzer

Chapter 11 Troubleshooting
Your Analyzer

learn about how to customize the print template of the analyzer

Chapter 12 Customizing the

Print Template

learn about the technical specifications of the analyzer

Appendix B Specifications

learn about the communication protocol of the analyzer

Appendix C 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 on the analyzer or external keyboard,
such as [ENTER].

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 Safety Information

The following symbols are used to indicate danger and alert information in this manual.
When you see

Then
read the statement below the symbol. The statement is
alerting you to a potentially biohazardous condition.
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.

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

If leak happens to the analyzer, the leak liquid is potentially biohazardous.

Please check the firmness of all the doors and covers before running the
analyzer.

Make sure all the safety measurements are adopted. Disable any safety
device or sensor is prohibited.

Please take action to any alarm and problem indication immediately.

Do not touch the moving parts.

Contact the manufacturer or authorized distributors in time if any damaged

part is found.

Be careful when opening/closing and removing/installing the doors, covers

and boards of the analyzer.

Discard the analyzer according to government regulations.

1-5

Using This Manual

Please use the analyzer strictly according to this manual.

Make sure only authorized software is installed on the computer.

Please install the original edition software to prevent the computer from
being infected by virus.

Please adopt proper measurements to prevent the reagents from being

polluted.

It is recommended that the anti-virus software should be installed on the

computer and run regularly.

1-6

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 a potentially biohazardous condition.
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.

You may find the following symbols of the analyzer system:

When you see

It means
CAUTION,

CONSULT

ACCOMPANYING

DOCUMENTS.
BIOLOGICAL RISK

HIGH VOLTAGE

WARNING, LASER BEAM

WARNING, HOT SURFACE

EXERCISE CAUTION WHEN WORKING

AROUND TO AVIOD PRICKING

PROTECTIVE EARTH (GROUND)

1-7

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

WASTE.

1-8

TREATED
BY

AS

ENSURING

HOUSEHOLD
THAT

THIS

Using This Manual

PRODUCT IS DISPOSED OF CORRECTLY,
YOU WILL HELP PREVENT BRINGING
POTENTIAL NEGATIVE CONSEQUENCES
TO THE ENVIRONMENT AND HUMAN
HEALTH.

FOR

INFORMATION
RETURNING
PRODUCT,

MORE
WITH

AND

REGARD

TO

RECYCLING

THIS

CONSULT

THE

PLEASE

DISTRIBUTOR

DETAILED

FROM

WHOM

YOU

PURCHASED THE PRODUCT.

THE DEVICE IS FULLY CONFORMANCE
WITH

THE

CONCERNING

COUNCIL
IN

VITRO

DIRECTIVE
DIAGNOSTIC

MEDICAL DEVICES 98/79/EC.

AUTHORISED REPRESENTATIVE IN THE
EUROPEAN COMMUNITY

1-9

Using This Manual

Figure 1-1 back 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.

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Using This Manual

Figure 1-2 Front of the analyzer (Front Cover Open)

(1)

To avoid injury, do not put your hands around the guide channel of the syringe board.

(2)

The probe is sharp and may contain biohazardous material. Exercise caution when
working around the probe!

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Using This Manual

Figure 1-3 Left side of the analyzer

(1)

To avoid injury, do not put your hands around the guide channel of the syringe board.

1-12

Using This Manual

Figure 1-4 Right side of the analyzer

(1)

Laser radiation when opening, avoid direct eye exposure.

1-13

Understanding Your Analyzer

2.1 Introduction
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

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 a quantitative, automated hematology analyzer and 5-part differential counter
used in clinical laboratories.
It provides the following 23 basic parameters, 4 parameters for research use, 3 histograms
and 1 scattergram of blood samples. It supports 2 measurement modes: CBC and
CBC+DIFF.
Parameter Name

Abbr.

CBC

CBC + DIFF

White Blood Cell count

WBC

Neutrophils percentage

Neu%

Lymphocytes percentage

Lym%

Monocytes percentage

Mon%

Eosinophils percentage

Eos%

Basophils percentage

Bas%

Neutrophils number

Neu#

Lymphocytes number

Lym#

Monocytes number

Mon#

Eosinophils number

Eos#

Basophils number

Bas#

Abnormal Lymphocytes percentage

ALY% (RUO)

Large Immature Cells percentage

LIC% (RUO)

Abnormal Lymphocytes number

ALY# (RUO)

Large Immature Cells number

LIC# (RUO)

RBC

RBC

Hemoglobin Concentration

HGB

Mean Corpuscular Volume

MCV

Mean Corpuscular Hemoglobin

MCH

Mean

MCHC

Width

RDW-CV

Width

RDW-SD

Hematocrit

HCT

Platelet count

PLT

Corpuscular

Hemoglobin

Concentration
Red

Blood

Cell

Distribution

Coefficient of Variation
Red

Blood

Cell

Distribution

Standard Deviation

2-2

Understanding Your Analyzer

Mean Platelet Volume

MPV

Platelet Distribution Width

PDW

Plateletcrit

PCT

White Blood Cell/Basophils Histogram

WBC/BASO

Histogram
White Blood Cell Histogram

WBC Histogram

Red Blood Cell Histogram

RBC Histogram

Platelet Histogram

PLT Histogram

Differential Scattergram

Diff Scattergram

* means the parameter is provided in the mode. / means the parameter is

not provided.

ALY%, LIC%, ALY# and LIC# are parameters for research use only, not for
diagnostic use. For more details about the RUOs, please see 5.3.1 General
Setup Research use only parameter (RUO parameter).

2-3

Understanding Your Analyzer

2.3 Main Structure

The analyzer consists of the main unit (analyzer) and accessories.

Please check the firmness of all the doors, covers and boards before
running the analyzer.

The analyzer is heavy, to move it by one person may cause injury. It is

advisable for two people move it together when transport is needed, and
make sure you follow the instructions and use the proper tools.

Installing other software on the analysis system computer, using mobile

storage devices or using the computer for other purposes (e.g. playing
games, logging on the internet, etc.) may lead to virus infection, system
damage and/or data error. Therefore, please make sure the computer is
used for analysis system only.

2-4

Understanding Your Analyzer

Figure 2-1 Front of the analyzer

1 ---- Power/Status indicator

2 ---- [OPEN] key

3 ---- [RUN] key

4 ---- Sample tube

5 ---- Tube rack

6 ---- Autoloader

2-5

Understanding Your Analyzer

Figure 2-2 back of the analyzer

1 --- Network interface

2 --- M-53D diluent inlet

3 --- M-53 cleanser inlet

4 --- M-53LH Lyse inlet

5 --- M-53LEO (II) Lyse inlet

6 --- M-53LEO (I) Lyse inlet

7 --- AC input

8 --- Waste outlet

2-6

Understanding Your Analyzer

Figure 2-3 Front of the analyzer (Front Cover Open)

1 --- Front Cover

2 --- Sampling module

3 --- Sample tube

4 --- Tube rack

5 --- Syringes

6 --- Fluidic valves

7 --- Pressure release valve module

2-7

Understanding Your Analyzer

Figure 2-4 Angle shot of the analyzer (compartment door open)

1 --- Adapter

2 --- Tube holder

3 --- Sample compartment door

2-8

Understanding Your Analyzer

Figure 2-5 Right side of the analyzer (right door open)

1 --- Optical system

2 --- Sampling module

3 --- Metric unit

4 --- Vacuum chamber

5 --- Vacuum pump/Waste pump

6 --- Fluidic valves

7 --- Bath

2-9

Understanding Your Analyzer

Figure 2-6 Left side of the analyzer (left door open)

1 --- Syringes

2 --- Pressure chamber

3 --- Air pumps

4 --- Liquid level detection unit

5 --- Fluidic valves

6 --- Power switch

7 --- Circuit boards

2.3.1 Main Unit (Analyzer)

The main unit is the principal part of the product. It performs the sample analysis and the data
process.

2.3.2 Power/Status Indicator

The Power/Status indicator is located on the middle of the right of the analyzer (front side). It
tells you about the status of the analyzer including ready, running, error, sleep and on/off, etc.

2.3.3 Power Switch

A power switch is on the left side of the analyzer. It starts up or closes down the analyzer.
2-10

Understanding Your Analyzer

To avoid damage, do not turn on/off the power of the analyzer continually in
a short time.

2.3.4 [RUN] Key

The [RUN] key is located on the middle of the right front side (the right one). You can press
the key to start the selected analysis cycle, dispense diluent or wake up the system from
sleep.

2.3.5 [OPEN] Key

The [OPEN] key is located on middle of the right front side (the left one). You can press the
key to open/close the compartment door.

2.3.6 Network Interface

A network interface is located on the back of the analyzer. It connects the external computer.

2-11

Understanding Your Analyzer

2.4 User Interface

After the starting procedure, you will enter the user interface.

Figure 2-7 User interface

The interface can be divided into several areas as follows according to their functions:
1.

Screen title area

The screen title area on the top left corner displays the title of the current screen. The figure
shown above indicates the current screen is Standby screen.
2.

Analysis status

It indicates the current analysis status and displays in the same way as the Power/Status
indicator on the main unit.
Green icon: it means you can proceed to analyze the sample.
Flickering green icon: it means the analyzer is not ready for analyze yet.
Red icon: it means you can not proceed to analyze the sample but not due to an error
happened. (e.g. the analyzer is in sleep status)
Flickering red icon: it means you can not proceed to analyze the sample and it is due to
an error happened.
Yellow icon: it means you can proceed to analyze the sample under the emergency mode.
2-12

Understanding Your Analyzer

Flickering yellow icon: it means the analyzer is not ready for analyze yet under the
emergency mode.
3.

Information area of the next sample

This area displays the information about the sample ID, sample position, sampling mode
(autoloader/closed-tube), blood mode (whole blood/predilute) and measurement mode
(CBC/CBC+DIFF) of the next sample.
4.

Status area

The area is on the top right of the screen. There are three items from left to right, namely:

LIS/HIS status
Gray icon: disconnected
Color icon: connected
Flickering arrow above the icon: uploading
Flickering arrow below the icon: downloading
The two arrows flickering at the same time: uploading and downloading are processing

at the same time.

Connection status between the analyzer and the computer:

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

Print status:
Gray icon: The printer is not connected to the analyzer yet.
Color icon: The printer is connected to the analyzer.
Flickering icon: The printer is printing.

5.

Minimize button

You can click the button to minimize the interface to the taskbar of the operation system.

Click the interface icon displayed on the taskbar, you can get the display of
the interface back after minimizing it.

6.

Function screen area

It displays the selected screen and the corresponding function buttons.

7.

System time

It displays the time of the operation system. When you move the mouse to this area, the tips
will pop up to display the current system time. See Chapter 5 Customizing the Analyzer

2-13

Understanding Your Analyzer

Software for ways to modify the time format.
8.

Input mode button

It displays the current input mode and you can change the input mode through it. Click the
input mode button to open the input languages menu, and then you can switch to the desired
input language by clicking on the menu.
9.

Error message area

When error(s) is reported, the error message area will pop up a help information message
box and displays error messages one by one. The severity levels are discriminated from high
to low by 4 background colors: red, orange, blue, and green. See Chapter 12
Troubleshooting Your Analyzer for details.
10. Operation/status information area
The area displays the information about the current operation of the analyzer/computer, or
the current status of the analyzer/computer.
11. Information area of the user logged on
This area displays the name and access level of the current user.
12. Menu button
You can click the Menu button on the left bottom corner to open the system menu. Click a
menu option, a relevant screen or message box will appear if the option is not followed by the
symbol ; whereas a submenu will appear if the option is followed by the symbol .Click
the submenu, a relevant screen or message box will appear.
13. Shortcut button area
The left side of the screen is the shortcut button area. When clicking a certain button, you can
enter the relevant screen or a message box will pop up.

2-14

Understanding Your Analyzer

2.5 Shortcut Button/Menu Item

Shortcut button/Menu item

Shortcut key

Function

Menu button

Alt + M

Open the menu

Diluent button

Alt + A

Worklist button

Alt + W

Enter the Worklist screen

Graph button

Alt + G

Enter the Graph screen

Table button

Alt + L

Enter the Table screen

QC button

Alt + Q

Enter the L-J graph screen

Logout" button

Alt + O

Shutdown button

Alt + D

Exit button

Alt + X

Count button

Alt + C

STAT button

Alt + S

Enter the STAT message box

MenuHelpHelp

F1

Open the help message box

Click the Error Message Area

Alt + F1

Open the Diluent message

box

Open the Logout message

box
Open the Shutdown
message box
Open the Exit message box
Enter the Count message
box

Open the Troubleshooting

message box

2-15

Understanding Your Analyzer

2.6 Software Operation

Please make sure you fully understand the meaning of the following operations or interfaces
before you start operating the software of the analyzer.

2.6.1 Move the Pointer

Move the pointer displayed on the interface by operating the mouse.

2.6.2 Click
Move the pointer to the desired content; left click the mouse then release.

Repeat the operation if failed to choose the content; check the connection
of the mouse if necessary. If the problem still exists, please contact our
customer service department or your local distributor immediately.

2.6.3 Double Click

Move the pointer to the desired content, left click the mouse twice rapidly then release.

Repeat the operation if failed to choose the content; check the connection
of the mouse if necessary. If the problem still exists, please contact our
customer service department or your local distributor immediately.

2.6.4 Right Click

Move the pointer to the desired content; right click the mouse then release.

Repeat the operation if failed to choose the content; check the connection
of the mouse if necessary. If the problem still exists, please contact our
customer service department or your local distributor immediately.

2-16

Understanding Your Analyzer

2.6.5 Scroll Bar

In some screens, the information can not be fully displayed in one sight, then a scroll bar
(horizontal/vertical) will appear. You can scroll the scroll bar in the following ways to check the
rest of the information. A scroll bar is shown below:

Click the arrow button on the scroll bar.

Move the pointer to the slide bar, left click the mouse and hold, then scroll the bar at will.

Click the blank area on the scroll bar.

2.6.6 Prompt Information

The software provides the indicating information to the content displayed (e.g. buttons, titles,
etc.)It will display automatically when the pointer moved onto the certain area.

2.6.7 Tab
Tab displays one page of the multi-page information. E.g. you can enter the Settings tab of
the L-J interface to view and set up the information. The Settings tab is shown below.

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Understanding Your Analyzer

2.6.8 Buttons
Common buttons
The system will perform the function after you clicking the certain button. E.g. the system will
print after you clicking the Print button as shown below.

Arrow buttons of the combo box

Click the button to display the pull-down list as shown below. The options will be displayed in
the combo list.

Hide it by clicking the arrow button again.

When a combo list is open, you can choose the desired item in the list by using the []
2-18

Understanding Your Analyzer

and [] keys on the keyboard.

When a combo list is open, you can hide it by pressing the [Enter] key on the keyboard
or clicking a certain option. Then, the original content in the combo box will be replaced
by the current chosen one.

When a combo list is open, you can hide it by pressing the [Esc] key on the keyboard.
Then, no change to the combo box.

The scroll bar will appear if the content of the list can not be displayed in
one sight of a screen. You can scroll or use the [PgUp] and [PgDn] keys on
the keyboard to view the information fully.

Arrow button of the date control

The date control is shown below:

After clicking the arrow button on the date control, a date box will pop up.

Select the year: click the displayed year, arrows will appear on its right side. Then,
choose the desired year by clicking the arrow button.

Select the month:

Method 1: click the arrow button on the both sides of the date box to switch and choose the
desired month.
Method 2: click the displayed month, then click the desired month from the list appeared as
shown below.

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Understanding Your Analyzer

Select the day: click the desired day, then the date box will hide. The chosen date
(including year, month and day) will replace the original date of the date control.

When the data box popping up, you can hide it by pressing the [Esc] on the keyboard.
Then, no change to the date control.

Radio button
Click the single choice button, a mark appears in the circle, indicating the option is chosen.
E.g. the following figure shows that the Autoloader-Whole Blood is chosen whereas the
Closed-tube-Whole blood and Closed-tube-Prediluted Blood is not chosen.

Only one single choice button can be chosen in one setting option.

2.6.9 Check Box

Click the check box, a mark appears in the frame, indicating the option is chosen. E.g. chick
the built-in barcode scan option, it is chosen as shown below:
Click the built-in barcode scan again, the disappeared, it means the option is not
chosen as shown below:

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Understanding Your Analyzer

More than one check box can be chosen at the same time in one setting
option.

2.6.10 Edit Box

Click the edit box; you can start editing when the cursor appears. You can enter the
characters from the location of the cursor and the cursor moves to the right at the time. Enter
the first name into the edit boxes as shown below:

You can also proceed to the following operations in the edit box:

Move the cursor to the left or right by using the [] and [] keys on the keyboard.

Move the cursor to the left of the initial character or the right or the end character by
pressing the [Home] and [End] key on the keyboard.

Delete the character on the right of the cursor by using the [Delete] on the keyboard.

Delete the character on the left of the cursor by using the [Backspace] key on the
keyboard.

Switch to other edit box by using the [Tab] key on the keyboard.

Edit boxes of different use require different entered characters.

You dont have to enter the separators in the date box and the IP box.

The scroll bar (horizontal/vertical) will appear if the content of the edit box
can not be displayed in one sight of a screen. You can scroll or use the
[PgUp] and [PgDn] keys on the keyboard to view the information fully.

2.6.11 Information Box

The content in the information box can only be browsed:

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Understanding Your Analyzer

The scroll bar (horizontal/vertical) will appear if the content of the

information box can not be displayed in one sight of a screen. You can scroll
or use the [PgUp] and [PgDn] keys on the keyboard to view the information
fully.

2.6.12 Combo Box

The combo box consists of an edit box and an arrow button, which is shown below:

See Arrow button of the combo box section for details to complete selecting. See Edit
box section for details to complete editing if the combo box is editable.

2.6.13 Form
The form contains several cells and check box (sometimes).
Click the certain cell, it is chosen as shown below:

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Understanding Your Analyzer

Then, you can proceed to the following operations:

Select the cell by using the [], [], [] and [] keys on the keyboard.

Select the initial or end cell of the current row by using the [Home] and [End] keys on the
keyboard.

Select the next cell of the current line by using the [Enter] key on the keyboard.

Select the next cell of the current row by using the [Tab] key on the keyboard(can not
switch to a new row).

Move the mouse to the boundary line between the rows or lists, then left click the mouse
and hold, drawing the line to change the height/width of the row/list, but the height/width
of the whole form remains.

For an editable cell, a cursor will appear in it if it is double clicked. You can enter the
characters from the location of the cursor and the cursor moves to the right at the time. A
edited form is shown below:

You can proceed to the following operations in the cell:

Move the cursor to the left or right in the cell by using the [] and [] keys on the
keyboard.

Move the cursor to the left of the initial character or the right or the end character by
pressing the [Home] and [End] key on the keyboard.

Delete the character on the right of the cursor by using the [Delete] on the keyboard.
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Understanding Your Analyzer

Delete the character on the left of the cursor by using the [Backspace] key on the
keyboard.

Hide the cursor and quit editing by using the [Enter] key on the keyboard.

If a check box exists in the form, you can operate according to the
instructions of the check box before. The selected check boxes in the forms
will not be cleared when you switching among the screens unless you exit
the software.

If a check box exists in the form, then when you click the check box, it will
be ticked and the record will also be highlighted.

If you wish to choose several continuous records in a form, click the initial
record and a mark appears, the click the end of the desired record while
pressing and holding the [Shift] key on the keyboard, then a set of records
are chosen conveniently.

If you wish to select several consecutive records, click the first record and
then hold and drag the mouse to the last one, and then release the mouse to
select them all.

The scroll bar (horizontal/vertical) will appear if the content of the form can
not be displayed in one sight of a screen. You can scroll or use the [PgUp]
and [PgDn] keys on the keyboard to browse the information of the form fully.

2.6.14 System Menu

Click the Menu button, a system menu with all the first-level options will pop up. If a menu
option is followed by a mark, there is a submenu of the option.

Enter the interface or message box of the relative menu option:

Method 1: click the menu option directly.

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Understanding Your Analyzer

Method 2: move to the desired option by using the [] and [] keys on the keyboard and then
enter it by using the [Enter] key on the keyboard.

Enter the interface or message box of the relative submenu option:

Method 1: click the first-level menu to open the submenu, then click the desired option on it.
Method 2: first, move to the submenu option on the first-level menu by using the [] and []
keys on the keyboard and open it by using the []or [Enter] key, then move to the desired
option by the [] and [] keys, at last open the interface or message box by pressing the
[Enter] key.

Close the menu:

Method 1: click the menu button to close the system menu.

Method 2: close different level of menus one by one by using the [] or [Esc] key on the
keyboard.

2.6.15 Directory Tree

The directory tree can display the content of all the menus of different levels.

A +mark indicates the followed menu option has a submenu. Click the menu option, its
submenu will be fully displayed. At the same time, the + mark changes to -mark(click
the menu option again, its submenu will hide.), and - changes to + again as shown
below:

The menu option without + or - mark has no submenu. Click the menu option, the
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Understanding Your Analyzer

information will display directly.

Use the [] and [] keys on the keyboard to move the highlight bar to the desired menu
option.

Use the [Home] and [End] keys on the keyboard to move the highlight bar to the initial or
ending option.

Use the [Enter] key on the keyboard to display the submenu of a menu option. If the
menu option has no submenu, the relative information will display directly.

If the submenu of a menu option has displayed, you can hide it by using the [Enter] key
on the keyboard.

The scroll bar (horizontal/vertical) will appear if the content of the directory
tree can not be displayed in one sight of a screen. You can scroll or use the
[PgUp] and [PgDn] keys on the keyboard to view the information fully.

2.6.16 Message Box

According to different function buttons, message boxes can be divide into Ok, Ok/Cancel,
Yes/No, Yes/No/Cancel and special indication message boxes.
A message box consists of the title area, information area and function button. Take the
following Ok/Cancel message box for example:

After choosing the data you want to delete, click the Ok button to close the message
box and completing the deletion; click the Cancel button to close the message box
without any operation.

Click the

button on the right side of the title area to close the message box without

any operation.

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Understanding Your Analyzer

2.6.17 Record Switch Column

The current record and the total number of the records are shown in the form current
number/ total numbers in the record switch column. It is shown below:

The 2/79 in the above figure indicates the total number of the records is 79, and the current
record is the second one.

If you wish to switch to the previous or the next record, click

If you wish to switch to the first or the last record, click

or

or

button.

button.

Click the edit box of the record switch column, enter the desired number of the record,
and then switch to the relative interface by using the [Enter] key on the keyboard.

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Understanding Your Analyzer

2.7 Help Information

The software provides the help information for operation.

2.7.1 Browse the Help Information

If you wish to browse the help information, chose MenuHelpHelp option, the
following message box will pop up.

The message box displays the help information of the current screen and the corresponding
menu (highlighted).
If you wish to browse other help information, click the desired menu option then the help
information will display on the right.
Click the

button on the top right corner to close the message box.

2.7.2 Search the Help Information

If you wish to search the help information by key words, click MenuHelpHelp to
display the help information of the current screen and the corresponding menu item(the
highlighted one).

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Understanding Your Analyzer

Then, click the Search tab to enter the key words into the search information box.

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Understanding Your Analyzer

After entering the key words, click the Search button or press the [Enter] key on the
keyboard to start searching.

You can stop searching by clicking the Stop button. Then, the obtained
result displays.

When the search is finished, all the related menu items will be displayed in the left corner and
the corresponding help information will be displayed at the right side screen.
You can click the menu item to check the corresponding help information.

2.7.3 Print
You can click the Print button to print the current displayed help information.

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2.8 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 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.

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

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

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

After installing a new container of reagent, keep it still for a while before use.

2.8.1 Reagents
M-53D Diluent
It provides a stable environment for counting and sizing blood cells.
M-53LEO (I) Lyse
It breaks down red blood cell walls and cooperates with the M-53LEO (II) lyse to
4-differentiate WBCs.
M-53LEO (II) Lyse
It cooperates with the M-53LEO (I) lyse to 4-differentiate WBCs, and dyes Eosinophils.
M-53LH Lyse
It breaks down red blood cell walls and converts hemoglobin to a hemoglobin complex to
determine the HGB. It 2-differentiates WBCs to Basophils and other WBCs, and determines
WBC amount.
M-53 Cleanser
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Understanding Your Analyzer

It is a cleaning solution formulated to prime and clean the fluidic channels and tubing and get
rid of blood albumin and sediment.
M-53P Probe Cleanser
It is used to clean the analyzer regularly.

2.8.2 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.

2-32

Understanding the System

Principles

3.1 Introduction
The measurement methods used in this analyzer are: the Electrical Impedance method for
determining the WBC/BAS, 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.

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Understanding the System Principles

3.2 Aspiration
According to different configurations, the analyzer offers two types of sampling mode:
autoloader mode or closed-tube mode, the closed-tube mode supports two types of blood
samples whole blood samples and prediluted blood samples, and the autoloader mode
supports whole blood samples.
If you are to analyze a whole blood sample under closed-tube mode, the analyzer will
aspirate 16L of the sample.
If you are to analyze a capillary blood sample under closed-tube mode, you should first
manually dilute the sample (20L of capillary sample needs to be diluted by 180L of diluent)
and then present the pre-diluted sample to the analyzer, which will aspirate 80L(CBC+DIFF)
or 40L(CBC) of the sample.
If you are to analyze a whole blood sample under autoloader mode, the analyzer will aspirate
16L of the sample.

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Understanding the System Principles

3.3 Dilution
Then, the sample will be divided into 2 portions and be 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

WBC counting/HGB, RBC/PLT dilution flow chart

6L of Whole blood sample

2.5 mL diluent
52.08L
About 1:416.7 dilution

0.5 mL M-53LH lyse

About

1:500

dilution

for

WBC/HGB analysis

2.672mL diluent

About 1:20000 dilution for

RBC/PLT analysis

WBC differential dilution flow chart

9 L whole blood sample

1.1 mL M-53LEO(I) lyse

0.14mL M-53LEO(II) lyse

About 1:139 dilution for

WBC analysis

3-3

Understanding the System Principles

3.3.2 Predilute Mode

WBC counting/HGB, RBC/PLT dilution flow chart

20 L capillary blood

180 L diluent

About 1:10 dilution

40L
2.46 mL diluent
60L
About 1:625 dilution

0.5 mL M-53LH lyse

About 1:26000 dilution for

About 1:750 dilution for

RBC/PLT analysis

WBC/HGB analysis

2.44 mL diluent

WBC differential dilution flow chart

20 L capillary blood

180 L diluent

About 1:10 dilution

40L
1.1 mL M-53LEO(I) lyse

0.14 mL M-53LEO(II) lyse

About 1:320 dilution for

WBC analysis

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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 , 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.

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Understanding the System Principles

Figure 3-2 DIFF channel scattergram

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

3.4.2 Electrical Impedance Method

BASs/WBCs 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 3-3 Electrical Impedance method

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Understanding the System Principles

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 WBC/BAS
lower threshold, it is counted as a WBC/BAS. The analyzer presents the WBC/BAS
histogram, whose x-coordinate represents the cell volume (fL) and y-coordinate represents
the number of the cells.

3.4.3 Derivation of WBC-Related Parameters

Based on the analysis of the DIFF channel scattergram and the Lym region, Neu region, Mon
region and Eos region, the analyzer calculates the Lym%, Mon%, Eos% and Neu%. Having
achieved the WBC, the analyzer proceeds to calculate Lym#, Neu#, Mon# and Eos# per the
following equations while Bas# is obtained directly by the Electrical Impedance method and
express them in 109/L.

White Blood Cell count

WBC is the number of leukocytes measured directly by counting the leukocytes passing
through the aperture..

Basophils number

Bas# is the number of Basophils measured directly by counting the Basophils

passing

through the aperture.

Basophils percentage

Bas%

Lymphocytes percentage

Lym%

Particles in Lym region of Diff channel

100
Sum of all particles in Diff channel except those in Ghost region

Neutrophils percentage

Neu%

Bas#
100%
WBC

Particles in Neu region of Diff channel

100
Sum of all particles in Diff channel except those in Ghost region

Monocytes percentage

Mon %

Particles in Mon region of Diff channel

100
Sum of all particles in Diff channel except those in Ghost region

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Understanding the System Principles

Eosinophils percentage

Eos%

Particles in Eos region of Diff channel

100
Sum of all particles in Diff channel except those in Ghost region

Lymphocytes number

Lym# WBC Lym%

Neutrophils number

Neu # WBC Neu %

Monocytes number

Mon# WBC Mon%

Eosinophils number

Eos# WBC Eos%

3-8

Understanding the System Principles

3.5 HGB Measurement

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).

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

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Understanding the System Principles

3.6 RBC/PLT Measurement

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.

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Understanding the System Principles

3.6.2 RBC

RBC

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

Mean Corpuscular Volume

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

HCT

RBC MCV
10

MCH

HGB
RBC

MCHC

HGB
100
HCT

Red Blood Cell Distribution Width Coefficient of Variation

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

Red Blood Cell Distribution Width Standard Deviation

RDW-SD (RBC Distribution Width Standard Deviation, fL) is obtained by calculating the
standard deviation of the red blood cell size distribution.

3.6.3 PLT

Platelet count

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

Mean Platelet Volume

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

Platelet Distribution Width

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).
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Understanding the System Principles

PCT

This analyzer calculates the PCT as follows and express it in , where the PLT is expressed
in 109/L and the MPV in fL.

PCT

PLT MPV
10000

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Understanding the System Principles

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

3-13

Installing Your Analyzer

4.1 Introduction

Installation by personnel not authorized or trained by the manufacturer may

cause personal injury or damage your analyzer. Do not install your analyzer
without the presence of our 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 our customer service department or your local distributor immediately

4-1

Installing Your Analyzer

4.2 Installation Requirements

Do not install the software and database in the system disk.

4.2.1 Installation 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 back side for cabling and ventilation.

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

4.2.2 Power Requirements

Connect only to a properly earth grounded outlet.

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

Using pinboard may bring the electrical interference and the analysis results
may be unreliable. Please place the analyzer near the electrical outlet to
avoid using the plug-board.

Please use the original electrical wire shipped with the analyzer. Using other
electrical wire may damage the analyzer or cause unreliable analysis
results.

Analyzer

Voltage

Input power

Frequency

A.C. 100V-240V

300 VA

50/60 Hz

4-2

Installing Your Analyzer

4.2.3 General Environment

Optimal operating temperature: 15 - 30

Optimal operating humidity: 30 % - 85 %

Operating atmospheric pressure: 70 kPa - 106 kPa.

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

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 near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close.

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

The environment should be good ventilation.

Do not place the analyzer on a slope.

4.2.4 Transport and Installation

Transport or installation by personnel not authorized or trained by Mindray

may cause personal injury or damage your analyzer. Do not install your
analyzer without the presence of Mindray-authorized personnel.

To avoid damage during the transportation, the sampling assembly of the

analyzer is fixed with a plastic cable tie and a clamp. Do remove them before
using the analyzer.

The transport and installation shall be conducted by Mindray-authorized personnel. Do not

transport or install the analyzer without contacting our customer service department or your
local distributor.

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Installing Your Analyzer

4.3 Connecting the Analyzer System

Please make sure the length of the diluent pipe and the waste pipe is not
longer than 1500mm; the length of the lyse pipe and the cleanser pipe is not
longer than 850mm.

Connect the electric lines and fluidic lines as follows:

Figure 4-1 connecting the electric lines

4-4

Installing Your Analyzer

Figure 4-2 Connecting the Fluidic Lines

4-5

Customizing the Analyzer Software

5.1 Introduction
The analyzer 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.
The analyzer divides the operators into two levels, common user and administrator. Note that
an administrator can access all the functions open to a common user. This chanter introduces
how to customize your analyzer respectively as a common user level and as an administrator.

5-1

Customizing the Analyzer Software

5.2 Common User

5.2.1 General Setup
When you log in as a common user, click the Menu button, and then select the Setup, and
then select any setting from the displayed menu to enter the General Setup screen.

Date format
Date format can be set at this screen. Note that when the date format setting is changed, all
the displayed and printed date format will be affected, including the draw date, delivery date,
run date, entry date of the work list, reagent expiration date, quality control date, calibration
date, and etc.

Entering the Date format screen

At the General Setup screen, click the Date Format button to enter the Date Format
screen.

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Customizing the Analyzer Software

Selecting date format

Six date formats are available: YYYY-MM-DD, YYYY/MM/DD, MM-DD-YYYY,

MM/DD/YYYY, DD-MM-YYYY and DD/MM/YYYY. To select the desired format, click the
corresponding radio button.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

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Customizing the Analyzer Software

Reagents

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, LH lyse and
cleanser at the Reagent screen.

Entering the Reagent screen

At the General Setup screen, click the Reagent button to enter the Reagent screen.

Selecting whether to set the expiration date

If you wish to set the expiration date for the reagents, you can click the check box Exp. Date
to select it. This option is selected as default.

If the Exp. Date check box is not selected, then the Reagent Expired will
not be alarmed.

Setting the expiration date

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Customizing the Analyzer Software

After selecting the check box of Exp. Date, you can click the arrow button of the edit box to
set the expiration date of each reagent by using the date control.

The range of the expiration date is from the current system date to
2099-12-31.

You can not edit the open-container expiration date for it is calculated
automatically by the software and displayed in the form of text.

If the current system date exceeds the displayed expiration date or the
open-container expiration date whichever is earlier, then the Reagent
Expired will be alarmed.

When the reagent is expired, you can check the expiration date of the sealed
container and the open container here to determine which one led to the
expiration alarm.

When the reagent is expired, you can not run any samples.

If an external barcode scanner is connected, you can click the Use Barcode Scanner
check box to enable it. Scan the barcode with the external barcode scanner. If the scan is
successful, the expiration date of the reagent will be displayed in the corresponding box.

If Use Barcode Scanner is selected, then the date control will be

unavailable for you to enter the expiration date manually.

Selecting whether to set the lot No.

If you wish to set the lot No. for the reagents, you can click the check box Lot No. to select it.
This option is selected as default.

Setting the lot number

Enter the lot number into Lot No. box.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.

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Customizing the Analyzer Software

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Auxiliary

Entering the Auxiliary screen

At the General Setup screen, click the Auxiliary button to enter the Auxiliary screen.

Selecting reminder of the predilute mode

If you have activated the reminder and selected the predilute mode, a message box will pop
up to ask for confirmation every time you try to analyze a sample in the predilute mode.

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Customizing the Analyzer Software

To activate the reminder, click the Ask for confirmation radio button (default). To
deactivate the reminder, click the Do not ask for confirmation radio button.

Setting the sample ID

Select Auto Increase (default) so that the sample ID can increase automatically; select
Manual entry (by keyboard or bar scanner) if you want to enter the sample ID manually.

Even in the Auto increase mode, you can still change the sample ID by
re-entering the desired number through keyboard or the bar-code scanner.

Enter the prefix of the sample ID in the edit box of Prefix.

The new setting of the prefix will only be applied to the later sample IDs. It
will not affect the IDs run previously and those already entered in the
worklist.

If the prefix is entered, and the sample ID entry method is set as Auto
increase, then a revisable prefix will be displayed automatically in the
sample ID box every time when you entering/editing the information.

If the sample ID entry method is set as Manual entry (by keyboard or bar
scanner), then no matter the prefix is set or not, the default sample ID of a
new record in the worklist will be empty.

Other settings

If you want to add a new record automatically after the previous one is entered and saved in
the worklist, you can select Save and jump to next record.
If you wish to jump to the next record once the current one is validated, you can select the
check box Validate and jump to next record. This option is selected as default.
If you wish to switch between different information fields by [Enter] key, you can select the
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Customizing the Analyzer Software

check box Switch between different information fields by [Enter] key. The default
setting of this option is selected and also support switch by [Tab] key. Click the Information
fields button next to the option and the following message box will pop up.

There is a check box in front of each information field; the default setting is all selected. It
means information entries of all demographics are requested. You can click a check box or
some boxes to cancel the selected mark . It means you can jump over the unselected
demographics by pressing [Enter] or [Tab] key, leaving them in blank. However, you can also
re-locate the cursor in the information field by the mouse to re-enter the information.
Click Ok to save the entered information and close the message box, then back to the
Auxiliary screen.
If you wish to delete the completed record from the worklist after each run, you can click the
check box Automatically delete completed records from the worklist, selecting it by a
in the box. The default setting of this option is not selected.
If you wish to apply the current system date to the Draw Time and Delivery Time for new
added sample records, you can select the check box Automatically generate the draw
date and delivery date. The default setting of this option is not selected.

Any change made to the option Automatically generate the draw date and
delivery date will only be applied to later added sample records. Records
entered previously in the worklist will not be affected.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.
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Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

5.2.2 User/Lab management

User and Password
When you log in as a common user, click the Menu button, and then select Setup, then
select User and Password from the pop up menu to enter the information list of all the
administrators and common users.

Change password
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The current login user can change his/her password:
1. Highlight the current login user in the list, and then click the Change password button,
the following message box will pop up.

2. Enter the current login password in the edit box Old password, and then enter the new
password in the New password and Confirm new password box.
3. Finish entering; click Ok, then a message box will pop up.

4. Click Ok to close the message box and back to the previous screen.

The new password could be empty.

Exit

Click the Close button to exit the User and Password screen.

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Lab Information
When you log in as a user of common level, click the Menu button, and then select the
Setup, and then select Lab Info. from the pop-up menu, and then the lab information box
will pop up. You can only browse the information.

Exit

Click the Cancel button to exit the Lab Info. box.

5.2.3 Shortcut Code

When you log in as a user of common level, click the Menu button, and then select the
Shortcut Code, and then the shortcut code message box will pop up.

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You can click the Department, Deliverer, Diagnosis and Gender button to check the
corresponding shortcut code.

Exit

Click the Close button to exit the message box.

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5.3 Administrator
5.3.1 General Setup
When you log in as a user of administrator level, click the Menu button, and then select the
Setup, and then select any setting from the displayed menu to enter the General Setup
screen. Besides the authorities of common level, a user of administrator level is enabled the
following authorities.

Auxiliary

Entering the Auxiliary screen

At the General Setup screen, click the Auxiliary button to enter the Auxiliary screen.

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Authority setup

To allow common users to edit the ID of the sample run already in the review screen, you can
select the check box Edit ID of sample run already. The default setting of this option is not
selected.
If you wish to enable users of common level the authority of editing/restoring the sample
result, you can select the check box Edit sample result. This option is not selected as
default.
If you wish to enable the users of common level the authority of validating the sample result,
you can click the check box Validate sample. This option is not selected as default.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save the changes and close the setup screen.

Cancel
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Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Para. Units
Some references/parameters used by the analyzer could in several different units; you can
select the desired unit.

Entering the Para. Units screen

At the General Setup screen, click the Para. Units button to enter the Para. Units
screen.

Parameters of the same group are displayed together, with the first parameter in black and
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the rest in gray.

Unit standard

Click the check box Select unit system to select the desired unit standard form the
following seven ones: Customized, China, International (default), USA, Canada, Netherlands
and Britain.

When selecting different unit standard, the corresponding unit list and unit
option will be displayed differently.

If Customized is selected, then you can modify the unit of each parameter.

If other option is selected except the Customized, then the unit of each
parameter can only be browsed.

Para. units Setup

When Customized is selected, click the desired parameter, and then click the unit options
provided on the right to select a new unit for the parameter.

For parameters in a same group, if the unit of any parameter changes, the
units of the rest parameters change accordingly.

The unit of MCH changes according to MCHC and HGB, the operator can not
modify it.

If the parameters units change, the format of the data displayed in the list
will change accordingly.

Default

When Customized is selected, click the Default button to have the default units
(International) of all parameters displayed in the corresponding cell.

Print

Click the Print button to print all the parameters units in the current screen.
If you havent saved the settings when clicking the Print button, a message box will pop up.

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Click Yes to save the new settings and print them; click No to print the content of the
original settings without saving.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

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 General Setup screen, click the Ref. Range button to enter the Ref. Range
screen.

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Set ref. group

Click the Set ref. group button, a message box will pop up.

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You can not modify the names and corresponding information of the five
fixed reference groups in the list.

You can modify the names, age range (including age value and unit) and
gender of the five customized reference groups.

Double click the Ref. Group cell of the five customized reference group to modify the name
of the group.

The reference group title can not be empty.

The group title entered can not use General, Man, Woman, Child and
Neonate. The group title can not be the same as existing ones.

Double click the Age cell of the customized reference group to modify the age; double click
the age unit cell to open a combo box with different age units for you to choose from: Year,
Month, Day, and Hour.
Double click the Gender cell of the customized reference group to open a combo box with
different options for you to choose from: Not defined, Male, Female, Empty.
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Click the check box of Automatically match the customized ref. group according to age
and gender to select it. The option is not selected as default.

If Automatically match the customized ref. group according to age and

gender is not selected, then the five fixed ref. groups will be used to match
according to patients age and gender automatically.

If Automatically match the customized ref. group according to age and

gender is selected but the customized ref. groups have not been edited,
then the five fixed ref. groups will be used to match according to patients
age and gender automatically.

If Automatically match the customized ref. group according to age and

gender is selected and the customized ref. groups have been edited, then
the customized ref. groups will be used to match firstly. If matching is failed,
and then the five fixed ref. group will be used to match according to patients
age and gender automatically.

When the customized ref. groups are used to match, the matching will be
performed from top down according to the customized ref. groups displayed
in the screen.

Click one of the reference groups to highlight it, and then click the Set to be default ref.
group button to set the group as the default group when entering the worklist.
Click one of the reference groups to highlight it, and then click the Default button to display
the default information including group title, age limit, age unit and gender in the
corresponding cell.
Click Print to print out the settings in accordance with the age and gender of the reference
group. If the previous settings are not saved when you click the Print button, a message
box will pop up.

Click Yes to save the new settings and print them; click No to print the content of the
original settings without saving.
Click the Ok button to save and refresh the settings and close the Set ref. group message
box.

Setup the Ref. range

1. Click the Ref. Group combo box, and then select the desired group from the options:
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General, Man, Woman, Child, Neonate and Customized 1-5.
2. Drag the scroll bar, and then click the Upper limit or Lower limit of the parameter you
want to customize.
3. Enter the new data.

10 groups of reference range are defined according to 10 reference groups.

When a reference group is selected, the upper and lower limit of the target
will change accordingly.

The default reference ranges of the five customized groups are the same as
that of the General group.

The change of the reference range will not affect the previous flagging
setup, but only affect the following analysis.

Default

Click the Default button to display the default reference range of the current reference
group in the corresponding form.

Print

Click Print to print the reference ranges of all reference groups.

If the previous settings are not saved when you click the Print button, a message box will
pop up.

Click Yes to save the new settings and print them; click No to print the content of the
original settings without saving.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.

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Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Print

Entering the Print screen

At the General Setup screen, click the Print button to enter the Print screen.

Setting the print title

Enter the print title in the Title box. The default title is Hematology Analysis Report.
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Selecting paper type

Click the Paper type box, select the desired paper type from the five types: A5 (default), A4,
continuous paper, B6 and B5.

Setting number of copies

If you want multiple copies of the same patient report to be printed, you can enter the desired
number (1 - 100) into the Copies field. The default number is 1.

Setting print format

Click the Format combo box to display the report format options for you to select from. The
report format in the combo box differs according to the selected paper type. The default
formats for different papery types are shown in the following list:
Paper type

Format

Note

Whole page, all para., with graph

Half page, all para., without graph
A4

Half page, compact

Half page, no diff para., with graph
microscopic exam results report
Common Microscopic Exam. Para.
All para., with graph

A5, continuous

All para., without graph

paper, B5
No diff para., with graph

The same as Half page,

compact of A4
The same as Half page, all
para., without graph of A4
The same as Half page, no
diff para., with graph of A4

Common Microscopic Exam. Para.

All para., with graph
B6

All para., without graph

No diff para., with graph

Print Preview

Click the Print Preview button to preview the print report.

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The same as Half page,

compact of A4
The same as Half page, all
para., without graph of A4
The same as Half page, no
diff para., with graph of A4

Customizing the Analyzer Software

After editing the print setup, you should preview the report before printing
to make sure the setup is correct.

Customizing report format

You can click the Customize button to enter the PrintTemplate screen, and then
customize the print template. See Chapter 12 Customizing the Print Template for details of
how to customize.

Autoprint

The analyzer can auto-print the report in the set format once the analysis result is obtained.
Click On to enable the autoprint function; click Off to disable the autoprint function. The
default setting is Off.

Autoprint after validation

If Autoprint is On, then the Autoprint after validation check box will be activated.
Select the Autoprint after validation to autoprint the report only after the sample is
validated; otherwise, the report will be printed once the running is finished.

Print Flag

If the Flag information is needed in the printed report, you can select the Print Flag check
box .The default setting of this option is not selected.

If the default report template that you selected can display the flag
information, then the Print Flag box here will be available for you to select.

If the default report template that you selected can not display the flag
information, or the selected template is a customized one, then the Print
Flag box here will be unavailable for you to select.

Print suspect flags ?

If the suspect flags ? are needed in the printed report, you should select the Print suspect
flags ? check box. This option is selected as default.

Print ref. range

If the reference range is needed in the printed report, you should select the Print ref. range
check box. This option is selected as default.
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Print ref. range flags

If the ref. range flags (H or L) are needed in the printed report, you should select the Print
ref. range flags check box. This option is selected as default.

If Print ref. range is selected, then the Print ref. range flags option will
also be enabled and unavailable for you to edit. The ref. range and the ref.
range flags (H or L) will be printed in the report together.

If you want to de-select the Print ref. range flags option when Print ref.
range is selected (print the ref. range in the report only), please contact our
customer service department or your local distributor.

If Print ref. range is not selected, then you can select whether to print the
ref. range flags (H or L) in the report at will.

Print result edited flags

If the result edited flags (E or e) are needed in the printed report, you should select the
Print result edited flags check box. This option is selected as default. For details of how to
edit result, please see Edit Result section in 7.2.3 or 7.3.3 Function of the Buttons

Print ambient temp. abnormal flags

If the ambient temp. abnormal flags (T) are needed in the printed report, you should select
the Print ambient temp. abnormal flags check box. This option is selected as default.

Print QC graph time

If the test date of each QC point needs to be printed out when printing QC graphs, you can
select the Print QC graph time check box.

Setting default printer

Click the Default printer check box to display the printers available to the current system,
and then you can select one type from them as the default printer to perform all the print
tasks.

For operating system of Windows Vista, the right of using network printer is
restricted by users' access level. To enable the network printer, you should
log on the system as administrator, and then right click the shortcut icon of
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the terminal software and run it as administrator.

If you change the default printer here, the default printer of the current
system will also change.

If you change the default printer in the operation system, then the printer
name in this check box will also change.

Apply

Click the Apply button to save all the changes without closing the setting screen.

Ok

Click the Ok button to save all the settings and close the setting screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Communication

Entering the Communication screen

At the General Setup screen, click the Communication button to enter the
Communication screen.

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The settings here are applied to the communication between the analyzer
and the external (i.e. LIS), but not between the analyzer and the terminal
software.

Setting IP address

Enter the IP address into the empty (default) IP address box.

Setting Port

Enter the port number into the empty (default) Port box.

Auto-communication

The function is used for automatically transmitting the sample result to the external data
management software or LIS/HIS system.
Click On to enable the auto-communication; click Off to disable the auto-communication.
The default setting is Off.
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Bidirectional LIS/HIS communication

The function is used for automatically obtaining the sample/patient information from the
LIS/HIS system after the sample ID is entered or scanned, and automatically transmitting the
sample result to the LIS/HIS system.
Click On to enable the bidirectional LIS/HIS communication; click Off to disable it. The
default setting is Off.

Histogram transmission method

The function is used to select the histogram transmission method.

Click Not Transmit to disable the transmission of the 3 histograms while transmitting
sample records. Click Bitmap (default), then the 3 histograms will be transmitted in the form
of graphs to the LIS/HIS system. Click Data, then the 3 histograms will be transmitted in the
form of data to the LIS/HIS system.

Scattergram transmission method

The function is used to select the scattergram transmission method.

Click Not transmit to disable the transmission of the scattergram while transmitting sample
records. Click Bitmap (default), then the scattergram will be transmitted in the form of graph
to the LIS/HIS system.

Communication Acknowledgement

Select On: when IPU software is communicating with LIS/HIS, the HL7 protocol must be
strictly followed. After receiving the ACK acknowledgement from LIS/HIS, the communication
can be deemed successful; otherwise the communication fails, a communication failure
notice will pop up.
Select Off: when IPU software is communicating with LIS/HIS, even if no ACK
acknowledgement from LIS/HIS is received, the communication can be deemed successful;
no failure notice will pop up. Communication flag T is recorded in the communication
column in Table Review screen.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

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Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Research Use Only Parameter (RUO parameter)

The RUOs include ALY%, LIC%, ALY# and LIC#.

The RUO parameters are for research use only, not for diagnostic use.

Entering the RUO screen

At the General Setup screen, click the RUO button to enter the RUO screen.

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Setting display

If you wish to display the RUO parameters, select the Display RUO parameters check box.
This option is selected as default.
If Display RUO parameters is selected and you also wish to display the * mark, you can
select the Display * mark check box. This option is selected as default.
If Display RUO parameters and Display * mark are selected and you also wish to
display declaration (* means research use only, not for diagnostic use), you can select the
Display declaration check box. This option is selected as default.

Setting print

If you wish to print the RUO parameters, you can select the Print RUO parameters check
box. This option is selected as default.
If Print RUO parameters is selected and you also wish to print the * mark, you can select
the Print * mark check box. This option is selected as default.
If Print RUO parameters and Print * mark are selected and you also wish to print
declaration (* means research use only, not for diagnostic use), you can select the Print
declaration check box. This option is selected as default.

Any change made to the settings of displaying or printing the RUO

parameters, the * mark and the declaration will be applied to all the RUO
parameters (before and after the change is made).

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the

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new changes will only be saved after you click the Apply or Ok button.

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 General Setup screen, click the Gain button to enter the Gain screen.

You can not modify the gains of FS, SS and SF.

Setting the WBC gain

The WBC gain here is under the Whole Blood Mode.

Click the current value of the WBC and enter the new value.

Setting the RBC gain

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Click the current value of the RBC and enter the new value.

Setting the WBC(P) gain

The WBC gain here is under the Predilute Mode.

Click the current value of the WBC (P) and enter the new value.

Setting the HGB gain

You can adjust the HGB blank voltage by adjusting the HGB gain.
You can enter the value directly in the edit box or click the adjusting button to adjust the HGB
gain.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Auto Maintenance

Entering the Auto Maintenance screen

Click the Auto Maintenance button to enter the Auto Maintenance screen.

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Setting the Auto-sleep

You can set here when to start the auto-maintain procedure after the relevant fluidic operation
stops. Enter the desired time ranging from 15 to 120 minutes into the Wait box.

Setting Time-based maintenance

You can enter the desired time in the Preset time or click the adjusting button to set the
preset time for time-based maintenance ranging from [0:00(default) 23:59].
You can enter the desired time in the Pre-reminding or click the adjusting button to set the
pre-reminding time for time-based maintenance. The setting range is [0 minute, 2 hours], the
default time is 1 hour.
You can enter the desired time in the "Soak for" box to set the duration of the time-based
maintenance. The range for the entry is [2 hours, 72 hours], and the default time is 4 hours.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the settings and close the setup screen.
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Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Autoloader
When the autoloader is adopted, you can set the conditions when to stop the autoloader, the
rules to arrange the sample ID and whether to display statistics.

In order to avoid personal injury and damage to the analyzer, it is

recommended that you set the conditions when to stop the autoloader.

Entering the setup screen

At the General Setup screen, click the Autoloader button to enter the Autoloader
screen.

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When to stop the autoloader:

To stop the autoloader when there are no diluent and lyses, you can select the There are no
diluent and lyses check box. The default setting of this option is not selected.
To stop the autoloader when waste is full, you can select the Waste is full check box. The
default setting of this option is not selected.
To stop the autoloader when there is the sample ID reading error, you can select the Sample
ID reading error check box. The default setting of this option is not selected.
To stop the autoloader when there are n (editable; default is 3; upper limit is 100) continuous
clog errors, you can select the There are n continuous clogging check box. The default
setting of this option is not selected.

If the condition when to stop the autoloader are not set but the certain error
happens (sample ID reading error excluded), the analyzer will only stop
autoloading but the sample analysis will continue.

Rules to arrange the sample ID

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You can click the Increases sequentially according to tube position radio button to have
the sample ID increased sequentially even an empty tube position is detected. You can click
the Increases according to actual tube number radio button to have the sample ID
increased according to actual tube number (i.e. the empty tube position will be excluded).
The default setting of this option is increases sequentially according to tube position.

Statistics

Click On to enable the statistics after the autoloading is finished every time. Click Off to
disable the function (default).

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the changes and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Barcode
You can set the symbology for the analyzer.
Totally 6 code systems are supported by the analyzer, namely, CODE39, CODE93,
CODEBAR, CODE128, UPC/EAN and ITF (chiasmatic 25 code).

Entering the setup screen

At the General Setup screen, click the Barcode Info. button to enter the Barcode Info.
screen.

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Removing restriction on the number of digits

If any of the 4 code systems (CODE39, CODE93, CODEBAR and CODE128) are selected,
you can set to remove the restriction on the number of digits.
Select the Unlimited number of digits check box, and the Digits edit boxes of the
selected code systems turn gray; you are not able to edit the number of digits, and barcodes
of any length of the selected code systems can be scanned.

Using Unlimited number of digits may lead to higher rate of incorrect

scanning.

When Unlimited number of digits is selected, and digit number of the

barcode scanned is more than 20, the barcode will be cut automatically
without any alarm message.

Setting the code system and digits

Select the check box of the desired code system and enter the digits of the code into the
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Digits box. For CODE39, CODE93, CODEBAR and CODE128, the digits range is 1-20. For
ITF, the digits range is the evens between 1 to 20.For UPC/EAN, the digits range is controlled
by the analyzer automatically.

For the code system and digits, the settings should comply with the actual
one.

Apply

Click the Apply button to save all the changes without closing the setup screen.

Ok

Click the Ok button to save all the changes and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

Microscopic Para.
You can set the microscopic parameters for the display of the "Microscopic Exam. And
Others" tab at the "Review" screen and the printout template for reports.

Entering the setup screen

At the General Setup screen, click the Microscopic Para. button to enter the
Microscopic Para. screen.

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The parameters are displayed in the "Para. List".

Creating a microscopic parameter

Do as follows to create a microscopic parameter:

1.

Click the New button, a message box will pop up.

2.

Enter the name of the new microscopic parameter in the edit box.

3.

Click Ok to save the information of the new parameter, refresh the para. list without
closing the message box, and the parameter name entered in the message box will be

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cleared, and then you can continue to add another new microscopic parameter.

New parameter names can be neither empty nor same as existing ones.

Editing the name of a microscopic parameter

Do as follows to edit the name of a microscopic parameter:

1. Click the desired parameter, and then click the Edit button. A message box will pop up.

2. You can enter a new name for the microscopic parameter in the edit box.
3. Click Ok button to save the modified parameter name and close the message box, and
then the edited parameter will be highlighted in the list.

Modified parameter names can be neither empty nor same as existing ones.

Deleting a microscopic parameter

Do as follows to delete a microscopic parameter:

1. Click the desired cell, and then click the Delete button. A message box will pop up.

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Customizing the Analyzer Software

2. Click Ok to delete the microscopic parameter and close the message box, and then the
parameter will be deleted from the list.

Adjust the order of microscopic parameters

1. Click the Adjust Order button and a message box will pop up, displaying the current
order of the microscopic parameters in the para. list.

The buttons ("Top", "Up", "Down" and "Bottom") to the right of the list are
used to adjust the order of the microscopic parameters.

2. Click on a microscopic parameter to highlight it. Adjust the position of this parameter
using the buttons on the right.

Click the "Top" button to move the highlighted microscopic parameter to the top of the
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list.

Click the "Up" button to move the highlighted microscopic parameter upward by one
position.

Click the "Down" button to move the highlighted microscopic parameter downward by
one position.

Click the "Bottom" button to move the highlighted microscopic parameter to the bottom
of the list.

3. Click the Ok button to save the adjusted order, close the message box and go back to
the setup screen. Then the order of parameters will be refreshed.

Ok

Click the Ok button to save all the changes and close the setup screen.

Cancel

Click the Cancel button to close the setup screen without saving the changes.

Exiting the setup screen

Click another setup button to switch to the corresponding screen.

You will not lose the new changes by switching to another screen. But the
new changes will only be saved after you click the Apply or Ok button.

5.3.2 User/Lab management

User and Password
When you log in as a common user, click the Menu button, and then select the Setup,
then select User and Password from the pop up menu to enter the information list of all the
administrators and common users.

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Creating a user

Do as follows to create a user:

1. Click the New button, a message box will pop up.

2. Enter the information in each edit box, and then click the authority combo box to select
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the new user as Common User or Administrator.
3. Click Ok to save the information of the new user, refresh the user list without closing the
message box, and all the information fields in the message box will be cleared, and then
you can continue to add another new user.

New user names can be neither empty nor same as existing ones.

Editing information of users

Do as follows to edit the information of the users:

1.

Click the desired cell, then click the Edit button, then a message box will pop up.

2.

You can change the content of each item in the edit box or change the users authority
level by clicking the authority combo box.

3.

Click Ok button to save the modified users information and close the message box,
then the edited record will be highlighted in the list of users.

Modified user names can be neither empty nor same as existing ones.

If the current login administrator changes the user level into common
user, it takes effect only after logging out and then re-login.

Deleting a user

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Customizing the Analyzer Software

Do as follows to delete a user:
1. Click the desired cell, then click the Delete button, a message box will pop up.

2. Click Ok to delete the user and close the message box, then the user will be deleted
from the list of users.

You can not delete the current login user.

Reset password

You can reset a new password for users who forgot the password to log into the system:
1.

Click the desired cell, and then click the Reset password button, a message box will
pop up.

2.

Enter the new password in the New password and Confirm new password box.

3.

Click Ok button to save the new password and close the message box.

You can not reset the password for the current login user.

Change password

Do as follows to change the password of the current user:

1.

Highlight the current login user in the list, and then click the Change password button,
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Customizing the Analyzer Software

the following message box will pop up.

2.

Enter the current login password in the edit box Old password, and then enter the new
password in the New password and Confirm password box.

3.

Finish entering; click Ok, a message box will pop up.

4.

Click Ok to close the message box and back to the previous screen.

The new password could be empty.

Exiting User and Password screen

Click the Close button to exit the message box of User and Password.

Lab Information
When you login as a user of administrator level, click the Menu button, and then select
Setup, and then select Lab Info. from the pop-up menu, and then the lab information box
will pop up. All the information fields in the box are activated for you to enter/edit.
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Entering hospital name

Enter the hospital name into the Hospital name box.

Entering lab name

Enter the lab name into the Lab name box.

Entering Responsible by

Enter the name into the Responsible by box.

Entering contact information

Enter the contact information (telephone number or E-mail) into the Contact information
box.

Entering postalcode

Enter the postalcode into the Postalcode box.

Entering analyzer model

Enter the analyzer model into the Analyzer model box.

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Entering analyzer name

Enter the analyzer name into the Analyzer name box.

Entering installation date

Enter the installation date into the Installation date box. The installation date must be
entered and it can not be later than the current system date.

Entering contact in service department

Enter the name into the Contact in service department.

Entering contact information of service department

Enter the contact information of service department (telephone number or E-mail) into the
Contact information of service department box.

Entering remark

Enter the remark into the Remark box.

Ok

Click the Ok button to save the entered/edited information and close the lab information
box.

Cancel

Click the Cancel button to close the box without saving the changes.

5.3.3 Shortcut Code

You can set the shortcut code for the following items: Department, Deliverer, Gender
and Diagnosis.
The shortcut code is used to facilitate the entry of the foregoing items. You can enter the
shortcut code and press the [Enter] key instead of entering the whole item.

The shortcut code of different items can be the same.

Department
When you log in as a user of common level, click the Menu button, and then select the
Shortcut Code to enter the shortcut code screen.
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Adding department

Do as follows to add a new department:

1.

Click the New button, and then a message box will pop up.

2.

Enter the information into each field.

3.

Click Ok to save the information of the new department and refresh the department list
without closing the message box. All the information fields in the message box will be
cleared up, and then you can continue to add other new department.

New added department name must be entered and it can not be the same as
existing ones.

The shortcut code of department is not necessary to be entered, but once

you set them, each of the code must be unique.

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Editing department

Do as followings to edit the department information:

1.

Click the desired form cell and click the Edit button, and then the box shown below will
pop up.

2.

Enter the information into each field.

3.

Click Ok to save the information and close the message box, and then the edited
record will be highlighted in the list of department.

New added department name must be entered and it can not be the same as
existing ones.

The shortcut code is not necessary to be entered, but once you set them,
each of the code must be unique.

Deleting department

Do as follows to delete department:

1. Click the desired cell of the department, then click the Delete button, and then a message
box will pop up.

2. Click Ok to delete the department and close the message box, and then it will also be
deleted from the list of department.
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Exiting

Click the Close button to exit the Shortcut Code message box.

Deliverer
At the Shortcut Code message box, click the Deliverer button to enter its shortcut code
settings.

Add, edit and delete the deliverer as instructed in the Department section.

Diagnosis
At the Shortcut Code message box, click the Diagnosis button to enter its shortcut code
settings.

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Add, edit and delete the clinical diagnosis as instructed in the Department section.

Gender
At the Shortcut Code message box, click the Gender button to enter its shortcut code
settings.

Add, edit and delete the Gender as instructed in the Department section.

The existed shortcut code settings for gender can not be modified.

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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.

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Operating Your Analyzer

6.2 Initial Checks

Perform the following checks before turning on the analyzer.

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

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

according to government regulations.

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

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

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

You should only use the specified reagents. Store and use the reagents as
instructed by instructions for use of the reagents.

Check if the reagents are connected correctly before using the analyzer.

After installing a new container of reagent, keep it still for a while before use.

Checking the waste container

Check and make sure the waste container is empty.

Checking tubing and power connections

Check and make sure the reagents and waste tubing are properly connected and not bent.
Check and make sure the power cord of the analyzer is properly plugged into the power
outlet.
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Operating Your Analyzer

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 external computer.

Keyboard, mouse and external computer

Check and make sure the network cable of the external computer is connected to the
analyzer properly.
Check and make sure the keyboard and the mouse are well connected to the external
computer.

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Operating Your Analyzer

6.3 Startup and Login

Start the analyzer:

1. Place the power switch at the left side of the analyzer in the ON position (I). The power
indicator light will be on.
2.

Make sure the indicator light of the analyzer is on.

Start the external computer and run the system software.

1. Start the external computer.

2.

Turn on the display.

3.

After entering the operation system, double click the Auto Hematology Analyzer icon
to run the software.

4.

After starting the software, the message box will pop up.

5.

Enter the correct user name and password in the Login message box.

6.

Click the Ok button to initialize the system.

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Operating Your Analyzer

Before running the software, make sure the network cable of the external
computer is connected to the analyzer properly. The analyzer starts to
initialize only when the connection are detected.

If you failed to run the software continuously, please contact our customer
service department or your local distributor immediately.

After startup, please make sure the data/time of the computer is correct.

The initial user name and password of administrator are ADMIN, which
was set by service engineer.

1 to 12 numeric digits can be entered for the user name and the password.
No Chinese character is allowed. There could be no password.

7.

During the Initialization, the startup information will be displayed in the operation/status
information area at the bottom of the interface.

8.

The whole process lasts 4 to 12 minutes. The time needed for initializing the system
depends on how the analyzer was shut down previously.

9.

After the initialization process, you can enter the Graph screen to check the
background result.

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10. After initialization, if the sample records that are not hidden in the worklist are detected, a
message box will pop up.

Click Yes to set the first record not hidden in the worklist as the next sample ready to be run.
Click No to hide all the records in the worklist.

The background test is to detect the particle interference and electrical

interference.

If the background results exceed the Ref. Range for the first time during
fluidics initialization, then the analyzer will run the background test one
more time.

The sample ID for the background test is 0.

No ref. range or suspect flag is available for background test.

If error happens during initialization (e.g. the background results exceed the
Ref. Range), the analyzer will alarm. See Chapter 11 Troubleshooting Your
Analyzer for solutions.

For the background Ref. Range of each parameter, please see Appendix B
Specifications.

The system opens different functions to the users according to their

authority levels. The users authority level depends on the user name and
the password when the user logs in the system.

You can click Logout button to switch to another user. Enter the new user
name and password in the log-in message box, then click Ok to re-login
as a new user.

Running a test when there is an Abnormal background, you would get an

unreliable testing result.

During the starting procedure, to startup the analyzer first or to run the
software first are both acceptable.

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6.4 Daily Quality Control

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

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6.5 Sample Collection and Handling

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

Do not contact the patients sample blood directly.

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

capillary tubes, etc.

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

glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary
tubes.

Be sure to use the evacuated blood collection tubes as specified in the

appendix.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

If you click the Diluent button under the AL-WB mode, the analyzer will
first switch to the CT-WB mode and then dispense the diluent.

6.5.1 Whole Blood Samples

1. Use clean K2EDTA (1.5 - 2.2mg/mL) anticoagulant collection tubes to collect venous
blood samples.
2.

Mix the sample according to your laboratorys protocol.

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Operating Your Analyzer

Be sure to collect at least 1mL of whole blood sample in the closed-tube

sampling mode and autoloader mode.

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.

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.

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

6.5.2 Prediluted Samples

Be sure to use the 1140 (mm) adapter when collecting and handling the
prediluted samples. For details of how to install the adapter, please see 6.6.4
Replacing the adapter.

1. At the shortcut button area, click the Diluent button, then the compartment door will
open automatically and a message box will pop up.

2.

Present a clean centrifugal tube into the sample compartment with the cap opened.
Press the [RUN] key to dispense 180L of diluent into the tube. During dispensing the

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diluent, a progress bar will display.

If the current mode is autoloader, the analyzer will switch to the close-tube
mode automatically and then dispense the diluent. Then, the mode will be
switched back to autoloader when exiting.

3.

When the dispensing is finished, the compartment door will open automatically and you
can remove the centrifugal tube. Then, the following message box will display.

4.

Add 20L of capillary blood to the diluent, close the tube cap and shake the tube to mix
the sample.

5.

After the prediluted sample is prepared, click the Cancel button to exit dispensing the
diluent.

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6.

After exiting, the above message box will close automatically.

7.

If more portions of diluent are needed, repeat the procedure 2 and 3.

You can also dispense 180L of diluent by pipette into the tube.

Be sure to keep dust from the prepared diluent.

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

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

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

Be sure to evaluate predilute stability based on your laboratorys sample

population and sample collection techniques or methods.

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6.6 Closed-tube Sampling Analysis

The closed-tube sampling mode requests a closed-tube loader.

6.6.1 Entering Work List Information

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

If the analyzer is shut down abnormally, you will lose the worklist
information of the samples that have not been saved yet.

If you want to complete the worklist information after the analysis, see
Chapter 7 Reviewing Sample Results for details.

Click the Worklist button on the shortcut area or click Menu, then select Worklist to
enter the Worklist screen.

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Click the New button, then a new record will be added at the bottom of the worklist and this
blank record is highlighted. All the fields in the information entry area are displayed in defaults
and are activated.

The Run Status of a new record is To Be Run.

You can switch between options in the Sample Info./Patients Info area by the
[Tab] key. You can also use the [Enter] key to switch after setting, see details
in General Setup section of Chapter 5 Customizing the Analyzer Software.

You can skip the options that do not need the entry when switching by [Tab]
or [Enter], see the setup details in General Setup section of Chapter 5
Customizing the Analyzer Software.

Entering the sample ID

Enter the sample ID in the Sample ID box.

The sample ID could be letters, numbers and all the keyboard-supported

characters (including special characters).

The sample ID must be entered and its acceptable length is [1, 20].

The sample ID must be alphanumeric ended with a numeric. Sample ID

being all 0 will be considered invalid.

Selecting analysis mode

Select the loading mode as closed -tube, sample mode (Whole Blood or Predilute)
and the measurement mode (CBC or CBC+DIFF) from the three pull-down lists
respectively.

In the CBC measurement mode, the analyzer only counts the blood cells
without further differentiating the white blood cells. 13 parameters and
histograms of WBC, RBC and PLT are provided in this mode. In the
CBC+DIFF mode, the analyzer counts the blood cells and further
differentiates the white blood cells into 5 sub-populations. 23 basic
parameters,

RUO

parameters,

scattergrams

WBC/BASO, RBC and PLT are provided in this mode.

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and

histograms

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Operating Your Analyzer

Setting ref. group

Select the reference group for the sample from the Ref. Group pull-down list. The analyzer
will judge the test results according to the reference range of the Ref. group. When the results
exceed the reference range, the analyzer will flag.

If you have entered the gender and age of the patient, then the system will
provide a matching Ref. Group automatically.

If the auto-matching Ref. Group is different from the one that you selected
before (excluding the 5 customized Ref. Groups), then the system will adopt
the auto-matching Ref. Group.

Entering the draw time

Select the draw date from the date control; enter the draw time into the time edit box.

Entering the delivery time

Select the delivery date from the date control and then enter the delivery time into the time
edit box.

The delivery date/time can not be earlier than the draw date/time.

The draw and delivery date/time can not be later than the current system
date/time.

Entering the patient ID

Enter the patient ID into the Patient ID box.

In the Uni-directional LIS/HIS mode, after you entering the patient ID and
pressing the [Enter] key, the matched patient information (including Last
Name, First Name, Gender, Age, Birthday, Department and Bed
No.) will be displayed in the screen automatically if there is any. You can
also proceed to edit the information.

In the Bi-directional LIS/HIS mode, the patient information will adopt those
downloaded from the LIS/HIS as default.

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Entering the patient name

Enter the patient name into the Last Name and First Name boxes.

Entering the patient gender

Enter the gender of the patient into the Gender box or select it from the Gender pull-down
list.

Entering the patient age

The 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 older 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.
The Age pull-down list provides four ways for you to enter the patient age in years, in
months, in days and in hours, and you can enter the patient age in the box followed by the
age unit.

Entering the birthday

Select the patient birthday from the date control.

After entering the birthday, the age field will calculate automatically
according to the difference between the current system date and the
Birthday, and then a new result of age and the corresponding unit will be
displayed in the age edit box and the unit combo box respectively. Then, the
age box will be unavailable to edit unless the Birthday is cleared.

If the entered birthday is later than the current system, then it is considered
invalid.

Entering the name of the department

Enter the name of the department, from which the sample came, into the Department box
or select it from the Department pull-down list.

Entering the Bed No.

Enter the bed No. of the patient into the Bed No. box.

Entering the name of the deliverer

Enter the name of the deliverer into the Deliverer box or select it from the Deliverer

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pull-down list (if there are previously saved deliverers names in the list).

Entering the content of clinical diagnosis

Enter the suspect information of diagnosis into the Clinical Diagnosis box.

Entering the remarks

Enter the remarks in the Remark box.

Save

When finish entering the work list information, you can click the Save button or the shortcut
key [F2] to save all the information.

The Sample ID + Mode of the current record can not be the same as the
unhidden records in the following status: To Be Run, Running and
Error.

6.6.2 Running the Samples

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

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

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

capillary tubes, etc.

Repeat piercing the evacuated blood collection tube may break the rubber
tube cap. The fragments produced may lead to incorrect analysis result. It is
recommended that do not pierce each tube for more than three times.

Proper reference range shall be selected at the Setup screen before

analysis. Otherwise, the results may be flagged erroneously.

If the sample mode is switched from the Predilute to Whole Blood, the
analyzer will perform the switching sequence automatically and a progress
bar will be displayed on the screen.

When running as per the worklist, then the next sample ID will always be the
first unhide (or error) sample to be run in the worklist (in closed-tube mode)
till there is no unhide sample left or the worklist is empty; the ID of the latter
sample will increase by 1 automatically. If you set the method of entry for the
sample ID as Auto Increase, the ID of the latter sample will increase by 1
automatically.

If you do not run as per the worklist, then no actions will be taken to the
records in the worklist.

If the Bi-directional LIS/HIS mode is selected, then after the sample ID is

entered/scanned and saved, all the corresponding information will be
obtained from the LIS/HIS, and then the analyzer starts running per the
obtained information. Once the running is finished, the result, graph and
sample/patient information will be uploaded to the LIS/HIS.

CT-WB Sampling Analysis

Run as per the worklist.

1. When it is ready to run samples (i.e. the analysis status icon and analyzer indicator is
green), shake the whole blood sample as shown below to well mix it.

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Operating Your Analyzer

2. Press the [OPEN] key to open the compartment door, and then present the whole blood
sample into the compartment.
3.

Close the compartment door by pushing it.

4.

Click the shortcut button Run, the Run message box will pop up.

5.

Click the CT-WB button, and then select the Run as per the worklist option.

6.

After finishing setting, press [Enter] from keyboard or click the "Run" or Ok from the
dialog box, and then press the [Aspirate] key to start the analysis.

7.

The sample probe will automatically aspirate the sample. Then, the analyzer will
automatically run the sample while the compartment door will open automatically and the
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Operating Your Analyzer

analysis status icon and analyzer indicator is flickering in green.
8.

When the analysis is finished, the analysis status icon and analyzer indicator will return
to lasting green.

9.

Run the rest samples as instructed above.

The sample ID and the measurement mode are determined by the first
unhidden (or error) sample to be run in CT-WB mode in the worklist, and it is
displayed in gray.

If there is no record of CT-WB mode in the worklist, then the Run as per the
worklist button in the Run message box will be displayed in gray.

If you switch to the review screen from other screens, the latest record
information together with its result and graph will be refreshed and then
displayed.

Do not run as per the worklist

1. When it is ready to run samples (i.e. the analysis status icon and analyzer indicator is
green), shake the whole blood sample as shown below to well mix it.

2. Press the [OPEN] key to open the compartment door, and then present the whole blood
sample into the compartment.
3.

Close the compartment door by pushing it.

4.

Click the shortcut button Run, the Run message box will pop up.

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Operating Your Analyzer

5.

Click the CT-WB button but do not select the Run as per the worklist option.

6.

You can enter the starting sample ID of the sample to be run and the analysis mode in
the Run message box.

7.

Click the "Run" button or press the [Aspirate] key after clicking Ok to start the analysis.

8.

The sample probe will automatically aspirate the sample. Then, the analyzer will
automatically run the sample while the compartment door will open automatically and the
analysis status icon and analyzer indicator is flickering in green.

9.

When the analysis is finished, the analysis status icon and analyzer indicator will return
to lasting green.

10. Run the rest samples as instructed above.

If you switch to the review screen from other screens, the latest record
information together with its result and graph will be refreshed and then
displayed.

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CT-PD Sampling Analysis

When running sample under the CT-PD mode, be sure to use the 1140
(mm) adapter. For details of how to install the adapter, please see 6.6.4
Replacing the adapter.

Run as per the worklist

1. When it is ready to run (i.e. the analysis status icon and analyzer indicator is green),
press the [OPEN] key to open the compartment door, then present the prediluted sample
(uncapped) into the compartment.
2.

Close the compartment door by pushing it.

3.

Click the shortcut button Run, the Run message box will pop up.

4.

Click the CT-PD button and select the Run as per the worklist option.

5.

After finishing setting, press [Enter] from keyboard or click the "Run" or Ok from the
dialog box, and then press the [Aspirate] key to start the analysis.

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6.

Click Yes to close the message box and start running.

You can disable the pop-up message box before the predilute run, see
General Setup section in chapter 5 Customizing the Analyzer Software for
details.

7. The sample probe will automatically aspirate the sample. Then, the analyzer will
automatically run the sample while the compartment door will open automatically and the
analysis status icon and analyzer indicator is flickering in green.
8. When the analysis is finished, the analysis status icon and analyzer indicator will return to
lasting green.
9. Run the rest samples as instructed above.

The sample ID and the measurement mode are determined by the first
unhidden (or error) sample to run in CT-PD mode in the worklist, and it is
displayed in gray.

If there is no record of CT-PD mode in the worklist, then the Run as per the
worklist button in the Run screen will be displayed in gray.

If you switch to the review screen from other screens, the latest record
information together with its result and graph will be refreshed and then
displayed.

Do not run as per the worklist

1. When it is ready to run (i.e. the analysis status icon and analyzer indicator is green),
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press the [OPEN] key to open the compartment door, then present the prediluted sample
(uncapped) into the compartment.
2. Close the compartment door by pushing it.
3. Click the shortcut button Run, the Run message box will pop up.

4. Click the CT-PD button but do not select the Run as per the worklist option.
5. You can enter the starting sample ID of the sample to be run and the analysis mode in the
Run message box.
6. Click the "Run" button or press the [Aspirate] key after clicking Ok, then a message box
will pop up.

7. Click Yes to close the message box and start running.

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You can disable the pop-up message box before the predilute run, see
General Setup section in chapter 5 Customizing the Analyzer Software for
details.

8. The sample probe will automatically aspirate the sample. Then, the analyzer will
automatically run the sample while the compartment door will open automatically and the
analysis status icon and analyzer indicator is flickering in green.
9. When the analysis is finished, the analysis status icon and analyzer indicator will return to
lasting green.
10. Run the rest samples as instructed above.

When the analyzer is running, you can perform any operation (including
new, edit and cancel, etc.) to other To Be Run or Error samples in the
work list.

When the analyzer is running, you can switch to Graph/Table Review Screen
to perform operations including data browsing, validating, sample
information editing and printing, etc., and you can also switch to other
screens.

If Automatically delete completed records from the worklist. is selected,

then the completed records will be deleted automatically from the worklist.

When the analyzer is running, all the functions related to the fluidics
sequence are not available.

If you switch to the review screen from other screens, the latest record
information together with its result and graph will be refreshed and then
displayed.

6.6.3 Dealing with the Analysis Results

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 (already backup).The maximum number
of the automatic saving results is 40,000.

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Parameter flags

If parameter follows a 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 the parameter follows a ?, 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.

For the background test, the flags of parameter or flags of abnormal blood
cell differential or morphology are not available.

Flags of abnormal blood cell differential or morphology

The analyzer will flag abnormal or suspect WBC, RBC and PLT according to the scattergrams
and histograms. The flag information is defined in the following table:
Flag Type

Flag information
Abnormal WBC scattergram
Abnormal WBC histogram
WBC abnormal
Leucocytosis
Leucopenia
Neutrophilia

Abnormal

Neutropenia
Lymphocytosis
Lymphopenia

WBC

Monocytosis
Eosinophilia
Basophilia
Left Shift?
Immature Granulocyte (IG)?
Suspect
Abnormal/Atypical Lymphocyte?
RBC Lyse Resist?

RBC/HGB

Abnormal

Erythrocytosis
RBC abnormal distribution
Anisocytosis

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Macrocytosis
Microcytosis
Dimorphologic
Anemia
Hypochromia
Suspect

HGB Abn/Interfere?
PLT Abnormal Distribution

PLT

Abnormal

Thrombocytosis
Thrombopenia

Suspect

PLT Clump?

The analyzer will flag abnormal or suspect WBC, RBC and PLT according to the scattergrams
and histograms. The following table shows how the flags affect parameter results:

Whole Blood
Type

Flag
CBC

WBC

CBC
+5DIFF

Predilute
CBC

CBC
+5DIFF

WBC abnormal?

RBC Lyse Resist?

Abnormal WBC scattergram

Abnormal WBC histogram

Left Shift?

Immature Granulocyte (IG)?

Abnormal/Atypical Lymphocyte?

Leucocytosis

Leucopenia

Neutrophilia

Neutropenia

Lymphocytosis

Lymphopenia

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RBC/HGB

PLT

Monocytosis

Eosinophilia

Basophilia

Dimorphologic

HGB Abn/Interfere?

Anisocytosis

Microcytosis

Macrocytosis

Erythrocytosis

Anemia

Hypochromia

RBC abnormal distribution

PLT Clump?

Thrombocytosis

Thrombopenia

PLT Abnormal Distribution

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

6.6.4 Replacing the Adapter

In closed-tube sampling mode, the model of the tubes and the corresponding adapters are
the followings:

1275(mm)(without the cap) evacuated blood collection tube, used for 1375 (mm)
adapter.

1375(mm)(without the cap) evacuated blood collection tube, used for 1375 (mm)
adapter.

1475(mm)(without the cap) evacuated blood collection tube, used for 1575 (mm)
adapter.

1575(mm)(without the cap) evacuated blood collection tube, used for 1575 (mm)
adapter.
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1140(mm)centrifugal tube, used for 1140 (mm) adapter.

Different adapters should be replaced according to the model of the tubes.

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6.7 Autoloader Sampling Analysis

The autoloader mode requests an autoloader.

6.7.1 Entering Work List Information

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

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

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

Click the Worklist button on the shortcut area or click Menu, then select Worklist to
enter the Worklist screen.

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Click the New button, then a new record will be added at the bottom of the worklist and this
blank record is highlighted. All the fields in the information entry area are displayed in defaults
and are activated.

The Run Status of a new record is To Be Run.

You can switch between options in the Sample Info./Patients Info area by the
[Tab] key. You can also use the [Enter] key to switch after setting, see the
setup details in General Setup section of Chapter 5 Customizing the
Analyzer Software.

You can skip the options that do not need the entry when switching by [Tab]
or [Enter], see the setup details in General Setup section of Chapter 5
Customizing the Analyzer Software.

Entering the sample ID

Enter the sample ID in the Sample ID box.

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The sample ID could be letters, numbers and all the keyboard-supported

characters (including special characters).

The sample ID must be entered and its acceptable length is [1, 20].

The sample ID must be alphanumeric ended with a numeric. Sample ID

being all 0 will be considered invalid.

Selecting analysis mode

Select the sampling mode as AL and the measurement mode as CBC or CBC+DIFF
from the pull-down lists respectively.

If the autoloader mode is selected, then the blood sample mode can only be
whole blood.

In the CBC measurement mode, the analyzer only counts the blood cells
without further differentiating the white blood cells. 13 parameters and
histograms of WBC, RBC and PLT are provided in this mode. In the
CBC+DIFF mode, the analyzer counts the blood cells and further
differentiates the white blood cells into 5 sub-populations. 23 basic
parameters,

RUO

parameters,

scattergrams

and

histograms

of

WBC/BASO, RBC and PLT are provided in this mode.

Setting ref. group

Select the reference group for the sample from the Ref. Group pull-down list. The analyzer
will judge the test results according to the reference range of the Ref. group. When the results
exceed the reference range, the analyzer will flag.

If you have entered the gender and age of the patient, then the system will
provide a matching Ref. Group automatically.

If the auto-matching Ref. Group is different from the one that you selected
before (excluding the 5 customized Ref. Groups), then the auto-matching
Ref. Group will be adopted by the system.

Entering the draw time

Select the draw date from the date control; enter the draw time into the time edit box.
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Entering the delivery time

Select the delivery date from the date control and then enter the delivery time into the time
edit box.

The delivery date/time can not be earlier than the draw date/time.

The draw and delivery date/time can not be later than the current system
date/time.

Entering the Rack No. and Tube No.

Enter the rack No. and tube No. into the Rack No. and Tube No. box respectively.

The entry range of the rack No. is [1, 100]; the entry range of the tube No. is
[1, 10].The rack No. and tube No. can not be empty.

Entering the patient ID

Enter the patient ID into the Patient ID box.

In the Uni-directional LIS/HIS mode, after you entering the patient ID and
pressing the [Enter] key, the matched patient information (including Last
Name, First Name, Gender, Age, Birthday, Department and Bed
No.) will be displayed in the screen automatically if there is any. You can
also proceed to edit the information.

In the Bi-directional LIS/HIS mode, the patient information will adopt those
downloaded from the LIS/HIS as default.

Entering the patient name

Enter the patient name into the Last Name and First Name boxes.

Entering the patient gender

Enter the gender of the patient into the Gender box or select it from the Gender pull-down
list.

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Entering the patient age

The 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 older 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.
The Age pull-down list provides four ways for you to enter the patient age in years, in
months, in days and in hours, and you can enter the patient age in the box followed by the
age unit.

Entering the birthday

Select the patient birthday from the date control.

After entering the birthday, the age field will calculate automatically
according to the difference between the current system date and the
birthday, and then a new result of age and the corresponding unit will be
displayed in the age edit box and the unit combo box respectively.

If the entered birthday is later than the current system, then it is considered
invalid.

Entering the name of the department

Enter the name of the department, from which the sample came, into the Department box
or select it from the Department pull-down list.

Entering the Bed No.

Enter the bed No. of the patient into the Bed No. box.

Entering the name of the deliverer

Enter the name of the deliverer into the Deliverer box or select it from the Deliverer
pull-down list (if there are previously saved deliverers names in the list).

Entering the content of clinical diagnosis

Enter the suspect information of diagnosis into the Clinical Diagnosis box.

Entering the remarks

Enter the remarks into the Remark box.

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Save

When finish entering the work list information, you can click the Save button to save all the
information.

The Sample ID + Mode or Rack No. +Tube No. of the current record can
not be the same as the unhide records in the following status: To Be Run,
Running and Error.

If the Bi-directional LIS/HIS is selected, the terminal software will obtain the
corresponding information from LIS/HIS after you clicking the Save button
and display them in the right field.

6.7.2 Running the Samples

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

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

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

capillary tubes, etc.

Repeat piercing the evacuated blood collection tube may break the rubber
tube cap. The fragments produced may lead to incorrect analysis result. It is
recommended that do not pierce each tube for more than three times.

Be sure that the entered sample ID, rack No., tube No. and the analysis
mode are strictly in accordance with the sample to be run.

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Proper reference range shall be selected at the Setup screen before

analysis. Otherwise, the results may be flagged erroneously.

If the sample mode is switched from the Predilute to Whole Blood, the
analyzer will perform the switching sequence automatically and a progress
bar will be displayed on the screen.

If the Bi-directional LIS/HIS mode is selected, then after the sample ID is

entered/scanned and saved, all the corresponding information will be
obtained from the LIS/HIS, and then the analyzer starts running per the
obtained information. Once the running is finished, the result, graph and
sample/patient information will be uploaded to the LIS/HIS.

Do not scan the sample ID or rack No. and do not run as per the worklist
1. When it is ready to run (i.e. the analysis status icon and analyzer indicator is green), click
the shortcut button Run, the Run message box will pop up.

2.

Select the AL-WB mode in the message box, but do not select the Run as per the
worklist, "Automatically scan sample ID" or "Automatically scan rack No." option.

3.

Select the desired analysis mode, enter the starting sample ID, rack No. and tube No.

4.

Place the tubes into the corresponding tube positions according to the starting rack No.
and tube No. entered.

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5.

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.

6.

After finishing setting, press [Enter] from keyboard or click the "Run" or Ok from the
dialog box, and then press the [Aspirate] key to start the analysis The analyzer will start
the analysis from the starting position as you set. The analysis status icon and analyzer
indicator is flickering in green at the time.

7.

After every analysis cycle, the results will be saved to the Review Screen.

8.

When the analysis is finished, the following statistics message box will pop up.

At the Setup screen, you can set whether to display the statistics after the
autoloading is finished every time.

If there are statistics displayed in the message box, you can click
Details to check the detailed sample ID, run date and sample position
accordingly.

9.

Click Ok to close the box, and then the analysis status icon and analyzer indicator will
return to lasting green.

10. When finish running, all the racks come to the left tray of the autoloader. Remove them
safely.

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If Run as per the worklist, "Automatically scan sample ID" and

"Automatically scan rack No." are not selected, then no running and other
actions will be taken to the records in the worklist.

If more racks are needed when running the samples, you should load the
rack from the right of the autoloader while removing the completed rack
from the left of the autoloader in time.

Do not scan the sample ID or rack No. but run as per the worklist
1. When it is ready to run (i.e. the analysis status icon and analyzer indicator is green), click
the shortcut button Run, the Run message box will pop up.

2.

Select the AL-WB mode in the message box, then select the Run as per the
worklist but do not select the "Automatically scan sample ID" or "Automatically scan
rack No." option.

3.

Mark the prepared tubes according to the record in the list. Place the tubes into the
corresponding tube positions.

4.

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.

5.

After finishing setting, press [Enter] from keyboard or click the "Run" or Ok from the

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dialog box, and then press the [Aspirate] key to start the analysis. The analyzer will start
the analysis according to the tube positions sequentially. The analysis status icon and
analyzer indicator is flickering in green at the time.
6.

After every analysis cycle, the results will be saved to the Review Screen.

7.

When the analysis is finished, the following statistics message box will pop up.

At the Setup screen, you can set whether to display the statistics after the
autoloading is finished every time.

If there are statistics displayed in the message box, you can click
Details to check the detailed sample ID, run date and sample position
accordingly.

8.

Click Ok to close the box, and then the analysis status icon and analyzer indicator will
return to lasting green.

9.

When finish running, all the racks come to the left tray of the autoloader. Remove them
safely.

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For the unhidden (or error) samples to run in the autoloader mode in the
worklist, the analyzer will run the samples according to the sample position.

In the Run message box, the gray-displayed sample ID, rack No., tube No.
and measurement mode are determined by the record in the worklist with
the following features: the earliest, in autoloader mode, unhidden, to be run
(or error).

If there is no record of AL-WB mode in the worklist, then the Run as per the
worklist button in the Run screen will be displayed in gray.

When Run as per the worklist, if the current tube is excluded in the
worklist, the analyzer will still skip it without running.

If Automatically delete completed records from the worklist. is selected,

then the completed records will be deleted automatically from the worklist.

If more racks are needed when running the samples, you should load the
rack from the right of the autoloader while removing the completed rack
from the left of the autoloader in time.

Automatically scan the sample ID and/or rack No. but do not run as per
the worklist
1. When it is ready to run (i.e. the analysis status icon and analyzer indicator is green), click
the shortcut button Run, the Run message box will pop up.

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2.

Select the AL-WB mode in the message box, then select "Automatically scan
sample ID" and/or "Automatically scan rack No." but do not select the Run as per the
worklist option.

3.

Then select the desired analysis mode. If "Automatically scan sample ID" is not
selected, enter the sample ID; if "Automatically scan rack No." is not selected, enter the
starting rack No. and tube No; if both of the two check box are selected, you can not enter
in these edit boxes.

4.

If "Automatically scan sample ID" is selected, place labels on the tubes, and then
place them into the corresponding tube positions.

5. 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.
6. After finishing setting, press [Enter] from keyboard or click the "Run" or Ok from the
dialog box, and then press the [Aspirate] key to start the analysis. The analyzer will scan
the sample ID and/or rack No. from the starting position as you set, then start the analysis.
The analysis status icon and analyzer indicator is flickering in green at the time.
7. After every analysis cycle, the results will be saved to the Review Screen.
8. If "Automatically scan rack No." is selected, when invalid rack No. is scanned during
counting, the following message box will pop up. Click Ok to close it, and the analyzer
will skip the tubes on this rack and continue with other tubes.

9. When the analysis is finished, the following statistics message box will pop up.

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At the Setup screen, you can set whether to display the statistics after the
autoloading is finished every time.

If there are statistics displayed in the message box, you can click
Details to check the detailed sample ID, run date and sample position
accordingly.

10. Click Ok to close the box, and then the analysis status icon and analyzer indicator will
return to lasting green.
11. When finish running, all the racks come to the left tray of the autoloader. Remove them
safely.

If Run as per the worklist is not selected but Built-in barcode scanner is
selected, then no actions will be taken to the records in the worklist during
running in autoloader mode.

If the Sample ID box displays Invalid, it means the scanning is invalid.

You can re-enter the sample ID when reviewing the sample results, see
Chapter 7 Reviewing Sample Results for details.

If more racks are needed when running the samples, you should load the
rack from the right of the autoloader while removing the completed rack
from the left of the autoloader in time.

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Automatically scan the sample ID and/or rack No. and run as per the
worklist
1. When it is ready to run (i.e. the analysis status icon and analyzer indicator is green), click
the shortcut button Run, the Run message box will pop up.

2.

Select the AL-WB mode in the message box, then select "Automatically scan
sample ID" and/or "Automatically scan rack No.", as well as the Run as per the
worklist option.

3.

If "Automatically scan sample ID" is selected, place labels on the tubes, then place
them into the corresponding tube positions.

4.

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.

5.

After finishing setting, press [Enter] from keyboard or click the "Run" or Ok from the
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dialog box, and then press the [Aspirate] key to start the analysis. The analyzer will start
scanning sample IDs and/or rack No., and running samples according to the matched
sample in the worklist sequentially. The analysis status icon and analyzer indicator is
flickering in green at the time.
6.

After every analysis cycle, the results will be saved to the Review Screen.

7.

If "Automatically scan rack No." is selected, when invalid rack No. is scanned during
counting, the following message box will pop up. Click Ok to close it, and the analyzer
will skip the tubes on this rack and continue with other tubes.

8.

When the analysis is finished, the following statistics message box will pop up.

At the Setup screen, you can set whether to display the statistics after the
autoloading is finished every time.

If there are statistics displayed in the message box, you can click
Details to check the detailed sample ID, run date and sample position
accordingly.

9.

Click Ok to close the box, and then the analysis status icon and analyzer indicator will
return to lasting green.

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10. When finish running, all the racks come to the left tray of the autoloader. Remove them
safely.

If there is no record of AL-WB mode in the worklist, then the Run as per the
worklist button in the Run screen will be displayed in gray.

If "Automatically scan rack No." is not selected, the system will search for
the matching record in the worklist according to the scanned sample ID, and
then the rack No. and tube No. will be overwritten. The run status of the
record will be changed from To Be Run to Running.

If no matching record is found in the worklist or a scanning error happens,

the analyzer will skip the sample without running.

If Automatically delete completed records from the worklist. is selected,

then the completed records will be deleted automatically from the worklist.

If more racks are needed when running the samples, you should load the
rack from the right of the autoloader while removing the completed rack
from the left of the autoloader in time.

6.7.3 Special functions

Stop
During running, the Run button at the shortcut buttons area will be replaced by Stop. .
Click the Stop button, after the previously analyzing cycle is finished, the system stops the
analysis and the current sample carrier will be pushed out.

STAT
If there is STAT sample requires running first during the autoloader sampling analysis.

Insert STAT

1. Click the shortcut button STAT, the message box will pop up.

2. Click Yes. After the previously analyzing of the pierced sample is finished, the analysis
stops and the system switch the autoloader mode to the CT-WB sampling mode and

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open the compartment door automatically.
3. Present the whole blood sample into the compartment, push the compartment door to
close it.
4. When the STAT run is ready (i.e. the analysis status icon and analyzer indicator is in
yellow), you can run the STAT sample in ways as the closed tube sampling mode, see
details in Closed Tube Sampling Analysis.

STAT samples can only be run in CT-WB or CT-PD mode.

When the current sample is being run, the massage box Please finish the
current sample then perform STAT operation. Please wait! will pop up. You
can click the Ok button to close it.

When a STAT is inserted, the system will switch to the worklist screen
automatically and add a new STAT record at the first line of the worklist and
it is displayed in yellow background.

When a STAT is inserted, the STAT button will be replaced by Cancel.

You can start the STAT analysis only by pressing the [RUN] key on the
analyzer.

After running a STAT sample, you can switch to the graph or table review
screen to edit the corresponding information.

Cancel

After the running is finished, you can click the Cancel button to cancel the SATA, and then
the analyzer will judge whether to switch to the analysis mode before the inserted STAT
accordingly, and then proceed with autoloading.

If you click the Cancel button when there are unfinished samples left in
the worklist, a message box will pop up and then you can select whether to
delete the unfinished STAT sample.

After exiting the SATA mode, the background of all the SATA samples will
return to normal color.

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6.7.4 Dealing with the Analysis Results

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 (already backup).The maximum number
of automatic saving results is 40,000.

Parameter flags

If the parameter follows a 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 the parameter follows a ?, it means the analysis result obtained is suspect.

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

For the background test, the flags of parameter or flags of abnormal blood
cell differential or morphology are not available.

Flags of abnormal blood cell differential or morphology

The analyzer will flag abnormal or suspect WBC, RBC and PLT according to the scattergrams
and histograms. The flag information is defined in the following table:
Flag Type

Flag information

WBC

Abnormal WBC scattergram

Abnormal WBC histogram
WBC abnormal
Leucocytosis
Leucopenia
Neutrophilia

Abnormal

Neutropenia
Lymphocytosis
Lymphopenia
Monocytosis
Eosinophilia
Basophilia

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Left Shift?
Immature Granulocyte (IG)?
Suspect
Abnormal/Atypical Lymphocyte?
RBC Lyse Resist?
Erythrocytosis
RBC abnormal distribution
Anisocytosis
RBC/HGB

Macrocytosis

Abnormal

Microcytosis
Dimorphologic
Anemia
Hypochromia

Suspect

HGB Abn/Interfere?
PLT Abnormal Distribution

PLT

Abnormal

Thrombocytosis
Thrombopenia

Suspect

PLT Clump?

The analyzer will flag abnormal or suspect WBC, RBC and PLT according to the scattergrams
and histograms. The following table shows how the flags affect parameter results:
Whole Blood
Type

Flag
CBC

WBC

CBC
+5DIFF

Predilute
CBC

CBC
+5DIFF

WBC abnormal?

RBC Lyse Resist?

Abnormal WBC scattergram

Abnormal WBC histogram

Left Shift?

Immature Granulocyte (IG)?

Abnormal/Atypical Lymphocyte?

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RBC/HGB

PLT

Leucocytosis

Leucopenia

Neutrophilia

Neutropenia

Lymphocytosis

Lymphopenia

Monocytosis

Eosinophilia

Basophilia

Dimorphologic

HGB Abn/Interfere?

Anisocytosis

Microcytosis

Macrocytosis

Erythrocytosis

Anemia

Hypochromia

RBC abnormal distribution

PLT Clump?

Thrombocytosis

Thrombopenia

PLT Abnormal Distribution

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

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6.7.5 Barcode Labels

Blood, scratch and powders of the gloves will affect the accurate barcode
scanning. Be sure there are no blood, scratch and powders on the barcode
labels.

The label must be pasted properly to ensure the accurate barcode scanning. You should
paste the label to the area marked with X as shown below.

Be sure the label parallels the tube cap.

6.7.6 Disassembling the Adapter

When using the tubes of 1475(mm)or 1575(mm)model, you should disassembly the
adapter from the rack to load the tubes.

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6.8 Worklist
Click the Worklist button on the shortcut area or click Menu, then select Worklist to
enter the Worklist screen.

The upside of the interface is the worklist; the downside is information entry area including
Sample Info. and Patient Info. The bottom of the screen is the function button area.

The worklist can save a maximum of 2000 records.

All the information fields in the worklist are entered through the information
entry area except the No., Run Status and Entry Time.

If the worklist is empty, all the information fields in the information entry
area are blank and displayed in gray.

If a record in the worklist is highlighted, the corresponding information of

the record will display in the information entry area.

In the Worklist screen, you can perform the following operations to the worklist in the
upside of the screen.

Adjusting the position of each column

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Click and hold the title of the column then drag the column to the desired position to adjust
the display order.

Adjusting the width of each column

Click and hold the boundary line between the two columns, then drag the line to adjust the
width of each column.

Adjusting the position of record

1. Right click the highlighted record; then the following shortcut menu will pop up:

2.

Click Top to set the highlighted record as the first record in the worklist.

3.

Click Up to move the highlighted record upward by one position.

4.

Click Down to move the highlighted record downward by one position.

5.

Click Bottom to set the highlighted record as the last record in the worklist.

If you click a record in the worklist to highlight it, the corresponding information of the record
will display in the information entry area. You can edit each information field in the information
entry area.

For the record whose Run Status is Running, you can not edit its
Sample ID, Mode, Rack No. and Tube No.(autoloader mode).

The information entry area of the records whose Run Status are
Finished will be displayed in gray and unavailable to edit and modify. You
can switch to the Graph review or Table review screen to edit and modify the
corresponding information.

When the mouse is moved just on the function buttons, the name of the button and the
corresponding shortcut key will appear. For example, when moving the mouse on the Save
button, the tips will pop up:

The function buttons at the bottom of the Worklist screen and their shortcut keys are shown
in the table.

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Function button

Shortcut key

Save

[F2]

New

[F3]

Insert

[F4]

Delete

[Alt+Delete]

Search

[F5]

Copy

[F6]

Hide

[F7]

Print

[F8]

New

You can click the New to add a new sample record, see Entering Work List Information
section of this chapter for details.

Insert

1. Click one row of the record to highlight it.

2. Click the Insert button to insert a new record before the highlighted record and then the
new added blank row will be highlighted. All the fields in the information entry area are
displayed in defaults and are activated.
3. You can enter the sample/patient information in the information entry area, see Entering
Work List Information section of this chapter for details.

Save

After performing the Edit, New or Insert operation, you can click the Save button to
save all the information.

Delete

1. Click the Delete button, then the Delete message box will pop up.

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2. Click the radio button Selected Samples, All finished records or All records to
select the records you want to delete. Selected Samples are those selected with
marks in the worklist.
3. Click Ok to perform the deletion and refresh the worklist.

The records whose Run Status are Running can not be deleted.

Search

1. Click the Search button, then the Search message box will pop up.

2.

Click one or more check boxes to define the desired search condition(s).

3.

Enter the search content in the edit box of the desired search condition.

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4.

If you wish to perform the precise search, you can select the Whole Words Only
check box; if you wish to perform the fuzzy search (means to search the related records
which contain the content that you entered), you should leave the check box in blank.

5. Click the Previous/Next button to start searching upwards/downwards from the

highlighted record. The matching record found will be highlighted. Then you can click the
Previous/Next button to continue searching.

If the first/last record is reached, then the searching circle will start again
from the last/first record upwards/downwards.

6. A searching circle will be completed when backing to the initial record. If there is no
matching record found, the prompt message box No record found! will pop up at the
screen; otherwise, the prompt message box Search finished! will pop up.
7. Click Ok button to close the message box.
8. You can repeat procedure 2 to 6 to search for other content; or click the Close button to
finish searching and close the message box.

Copy

1. Click the desired record in the worklist to highlight it.

2. Click the Copy button to add a new record in the worklist and highlight it. The sample ID
of this new added record is empty or will automatically increase by 1 based on the last
sample ID in the worklist, the other information remains the same as the record copied
from. For the autoloader samples, the Rack No.-Tube No. of this new copied record will
increase by 1 based on the greatest Rack No.-Tube No. existed in the worklist.

Hide

1. Select the check box of the desired record in the worklist.

2. Click the Hide button to hide the selected record and display it in gray.

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If the selected records include both hidden and unhidden records, when you
click the Hide button, all of them will be hidden.

The records whose Run Status are Running or Finished can not be
hidden.

You can edit and delete the hidden record.

Cancel

1. Select the check box of the hidden record in the worklist.

2. Click the Cancel button to cancel the hide and gray display status of the record.

If the selected records are all hidden records, the Hide button will
replaced by the Cancel button.

Print

1. Select the check box of the desired record in the worklist.

2. Click the Print button, and then a message box will pop up.

3. Click Ok to start printing.

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6.9 Shutdown

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

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.

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

The shutdown procedure includes closing the analyzer and exiting the software. The
following content will introduce the two procedures respectively.

Shutting down the analyzer

1. Click the shortcut button Shutdown, or select MenuShutdownShutdown

option, the following message box will pop up.

2. Click the Ok button to shutdown the analyzer.

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3. During the shutdown procedure, the shutdown information will be displayed in the
information indicating area at the bottom of the interface.
4. After the shutdown is finished, a message box will pop up.

5. Place the power switch at the left side of the analyzer in the OFF position (O). The
message box will be closed automatically.
6. Empty the waste container and dispose of the waste properly.

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

according to government regulations.

If the analyzer disconnects with the computer, you can not perform the
shutdown procedure.

When the analyzer is running or performing other fluidics sequence, do not

shutdown the analyzer forcibly.

If error happens during shutdown procedure, the analyzer will return to the
status before the shutdown procedure is performed, and then alarm. See
Chapter 11 Troubleshooting Your Analyzer for details to remove the error.

You can click the Restart button to restart the analyzer and perform
startup initialization.

You will not exit the software after the shutdown of the analyzer, and you can
still perform operations that are available without the cooperation of the
analyzer.

Exiting the system software

1. Click the shortcut button Exit, or select MenuExitExit option, the following
message box will pop up.
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2. Click the Ok button to exit the system software.

You must shut down the analyzer before exiting the software.

Turning off the external computer

1. Close the external computer according to the shutdown procedures of the operation
system.
2. Turn off the display.

You should exit the terminal software first and then turn off the external
computer according to standard procedures. Otherwise, the database of the
terminal software might be lost!

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7.1 Introduction
The analyzer automatically saves analysis results. Totally 40,000 results can be saved,
including sample information, parameters, flag prompts, scattergrams and histograms.
You can browse sample results either in the table or graph mode.

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7.2 Graph Review

Click the shortcut button Graph or click the Menu button, and then select the Review,
and then select Graph to enter the Graph review screen:

The Graph screen consists of three parts. The upside displays the Sample/Patient Info. The
downside displays the Results, Scattergrams, Histograms, Flags, DIFF Graphs, Microscopic
Exam Results and Blood Type/ESR results in accordance with the Sample/Patient Info. in the
form of tabs including Data/Graph, DIFF, Microscopic Exam. and Others and
Research. The bottom displays the functional buttons available in the current screen.

7.2.1 Sample/Patient Information

You can use the record switch column in the down right of the screen to browse the sample
records one by one.
You can see the Sample/Patient Info. in the upside of the screen. You can edit all the patient
information except the Operator and the Validater. For details of editing information, see
Editing work list information in Chapter 6 Operating Your Analyzer.

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You can enable users of common level to edit the sample ID by setting in the
Setup screen, see chapter 5 Customizing the Analyzer Software for
details.

You can edit all the information of the sample except the Mode and Run
Time.

7.2.2 Tabs
After selecting a sample record, you can click the tab at the downside of the screen to see the
corresponding information.

Data/Graph
Click the Data/Graph tab to see the data/graph information of the record.

You can select whether to display the four RUOs, the * mark and the
corresponding declarations (* means research use only, not for
diagnostic use) in Setup screen, see Chapter 5 Customizing the Analyzer
Software for details.

When the results of Bas% and Bas# are expressed in *, the second
histogram discriminator will not be displayed.

For details of how to edit and restore the result, please see the following Edit Result and
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Restore Result section of this chapter.
When moving the mouse to any graph of the scattergram/histogram, an icon of magnifier will
appear. Click the icon, a box of enlarged graph will pop up and you can drag the box at will.

When finish browsing, you can click X on the top right of the box to close it.

DIFF
You can click the DIFF tab to check the WBC differential information of the record.

The DIFF tab is unavailable in CBC mode.

You can select whether to display the four RUOs, the * mark and the
corresponding declarations (* means research use only, not for
diagnostic use) in Setup, see Chapter 5 Customizing the Analyzer
Software for details.

When the results of Bas% and Bas# are expressed in *, the second
histogram discriminator will not be displayed.

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For details of how to edit and restore the result, please see the following Edit Result and
Restore Result section of this chapter.
When moving the mouse to any graph of the scattergram/histogram, an icon of magnifier will
appear. Click the icon, a box of enlarged graph will pop up and you can drag the box at will.

When finish browsing, you can click X on the top right of the box to close it.

Microscopic Exam. and Others

Click the Microscopic Exam. and Others tab, you can browse and enter the microscopic
exam and blood type/ESR information of the record.

Entering the Microscopic Exam. Information

1.

Selecting the Sample Type

Click the Sample Type combo box; select the sample type as Venous blood (default) or
Capillary Blood.

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2.

Entering the date and time of the microscopic exam

Click the Microscopic exam. time edit box, enter the date and time of microscopic exam.

3.

The Microscopic exam. time can not exceed the current system time.

Entering the Microscopic Description

You can enter the morphology information for WBC, RBC and PLT respectively into the
multi-line edit box.

4.

Entering the Cell Differential

You can enter the percentage or other form of differential result of each cell differential into
the edit box next to the cell differential name respectively.

You can enter a value within the range [0.0-100.0] and the unit is %.

Entering the Blood Type information

You can select the blood type of the patient in the Blood Type/ESR column. Click the first
combo box next to the blood type, you can select from Blank, A, B, O and AB; click
the second combo box, you can select from Blank, RH+ and RH-.

Entering the Blood ESR information

You can enter the blood ESR value into the edit box follows the ESR. If the value exceeds
the Ref. Range, the flags H or L will appear to indicate the value exceeds the upper limit or
lower limit.
You can modify the reference range of Blood ESR by the following steps:
1.

Click Set Reference Range button, a message box will pop up. Enter the upper limit
and lower limit of the blood ESR in the edit box Upper limit and Lower limit
respectively.

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2.

Click the Ok button to save the settings and refresh the information.

You can enter the value up to 3 numeric characters within the range [0,999].

The upper limit can not be smaller than the lower limit.

The entered reference range of the Blood ESR is only applied to the current
record, and the default range is [0, 20].

Research
Click Research tab on the screen, the specific value of each parameter will be displayed.

The specific values of the parameter results that are out of the display range
or without data collected cannot be provided.
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Edit of the results in the Data/Graph tab will not affect the display of
parameters in the Research tab.

The content of this tab can only be viewed and used for research; it cannot
be edited or printed.

7.2.3 Function of the Buttons

When the mouse is moved just on the function buttons, the name of the button and the
corresponding shortcut key will appear. For example, when moving the mouse on the Save
button, the tips will pop up:

The shortcut keys of the function buttons in the graph review screen are shown in the
following table.
Function button

Shortcut key

Save

F2

Validate

F3

Print

F4

Edit Result

F5

Restore Result

F6

Delete

Alt + Delete

Auto-refresh
At the graph review screen, when browsing the results, you can select to activate or
deactivate the auto-refresh function to display the latest results.
Click the

button at the lower right of the graph review screen to make it raised. Later

on, the graph review screen will refresh automatically to display the latest results and graphs
if any. At the mean time, the graph will be enlarged as shown below.

When the

button is raised, all the information fields and buttons at the graph review

screen will be unavailable (displayed in gray) except the records switching column.

Click the

button at the lower right of the graph review screen to make it sunk. Later

on, the graph review screen will not refresh even the new results are obtained, but still display
the current sample information, results and graphs that you are now browsing. At the mean
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time, the graph will be displayed in normal size as shown below.

When the

button is sunk, all the operations are available to the current displayed

records.

The default status of the

The status of the

button at the graph review screen is sunk.

button keeps still when you return to the graph

review screen after exiting.

When you browsing records at the graph review screen by using the
switching column, the status of the

button automatically changes

into suck.

Save
Click the Save button to save the modified information on all tabs of the current result.

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Print
Click the Print button to print the information, result, histogram and scattergram of the
current sample.

You can set the amount of copies for the printed report in the Setup
screen.

At the Setup screen, you can select whether to print the Flag information
in the report.

Delete
1.

Click the Delete button, a message box will pop up.

2.

Click Ok to delete the current displayed sample record in the Graph screen.

The Delete button and the corresponding deleting operation are not
available to users of common-level.

Validate
Click the Validate button to perform the validating operation.

You can enable the users of common level to validate by setting in the
Setup screen. Otherwise, the user name and the pass word of
administrator level are required.

After validating, you can not edit the Sample/Patient Info. and result.

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You can not validate the background record.

Cancel (validate)
Click the Cancel button to cancel the validating operation.

If the current sample result is validated, the Validate button will be

replaced by the Cancel button.

The users of common level is enabled the authority of Cancel together

with Validate when you setting in the Setup screen. Otherwise, the user
name and the pass word of administrator level are required.

After canceling, you can edit the Sample/Patient Info. and result.

Edit Result
1. Click the Edit Result button, then the result of each parameter and WBC DIFF results
will be displayed in an edit box for you to edit.
2. After editing, click the Save button to save the change and the edit box disappears.

You can enable the users of common level to edit result by setting in the
Setup screen. Otherwise, the user name and the pass word of
administrator level are required.

If the result of one parameter is modified, then the result of other related
parameter(s) will be changed accordingly and the high or low/suspect flags
will also be refreshed.

Only the result of the measurement parameters (WBC, RBC, HGB, HCT and
PLT) and WBC DIFF results can be modified.

After editing and then saving WBC DIFF results, the absolute value of each
DIFF result will be re-calculated and then refreshed.

If the sum of the DIFF results does not equal to 100.00% after being edited,
then the message box The sum of the DIFF results is not 100.00%! will pop
up when you clicking the Save button.

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No matter the sample result is validated or not, as long as it is edited, the

result of the parameter that you modified manually will be flagged with an
E. If any parameter result is then changed due to the one that you
modified manually, it will be flagged with an e. (E or e will be displayed
between the parameter result and its unit.)

You can not edit the results of the background.

Restore Result
1.

Click the Restore Result button, and then the following message box will pop up.

2. Click Ok to restore the result to the original measurement value and remove the result
edited flags (E or e).

The users of common level is enabled the authority of Restore Result

together with Edit Result when you setting in the Setup screen.
Otherwise, the user name and the pass word of administrator level are
required.

Up to 1000 latest measurement results of original value can be saved by the

analyzer.

You can not restore the results of the background.

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7.3 Table Review

Click the shortcut button Table or Click the Menu button, and then select the Review
Table to enter the following table review screen.

The Table screen consists of three parts. The upside of the screen displays the sample
records in tables. The downside of the screen displays the Result, Sample/Patient Info.,
Microscopic Exam Result and Blood Type/ESR Result of the current sample record in the
form of tabs. The top and bottom of the screen displays the functional buttons available in the
current screen.

7.3.1 Sample Records

You can browse each sample record and its Sample/Patient information in the Table screen.

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For the error sample record, the content of each information field is
displayed in red.

For the printed sample, its cell in the Print column displays P. For the
unprinted sample, its cell in the Print column is blank.

For the validated sample, its cell in the Validate column displays V; for
the sample not validated, its cell is blank.

For the transmitted sample, its cell in the Transmission column displays
T; for the sample not transmitted, its cell is blank.

In the sample records table area, you can perform the following operations:

Selecting the sample table

Click the Sample List combo box, then you can select Samples within today (default),
All Samples and Samples found.
The Review List will display different records according to the different options:
Record option

Records displayed

Samples within today

Display only the sample records within today

All Samples

Display all the saved sample records.

Samples found

Display all the sample records met the search requirements.

Adjusting the position of each column

Click and hold the title of the column then drag the column to the desired position to adjust
the display order.

Ranking the records

1.

Right click the Run Date title, and then a shortcut menu will pop up:

2.

Click Ascending to rank the records in ascending order of Run Date + Time (i.e. the
latest testing sample ranks last in the list).

3.

Click Descending to rank the records in descending order of Run Date + Time (i.e.
the latest testing sample ranks the first in the list).

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The records in the graph screen will be ranked the same way as the table
screen, in ascending/descending order of Run Date + Time.

Switching

Double click a record in the list; the screen will switch to the graph review screen of the record
automatically.

7.3.2 Tabs
Result
You can click the Result tab to see all the results of the highlighted record.

You can select whether to display the four RUOs, the * mark and the
corresponding declarations (* means research use only, not for
diagnostic use) in Setup, see Chapter 5 Customizing the Analyzer
Software for details.

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For details of how to edit and restore the result, please see the following Edit Result and
Restore Result section of this chapter.

Sample/Patient Information
You can click the Sample/Patient Info. tab to see the sample information and patient
information of the highlighted record in the list.

For details to edit information, see Editing work list information section in Chapter 6
Operating Your Analyzer.

Microscopic Exam. and Others

Click the Microscopic Exam. and Others tab, you can browse and enter the microscopic
exam and blood type/ESR information of the record.

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Entering the Microscopic Exam. Information

1.

Selecting the Sample Type

Click the Sample Type combo box, and then select the sample type as Venous blood
(default) or Capillary Blood.

2.

Entering the date and time of the microscopic exam.

Click the Microscopic exam. time edit box, enter the date and time of microscopic exam.

3.

The Microscopic exam. time can not exceed the current system time.

Entering the Microscopic Description

You can enter the morphology information for WBC, RBC and PLT respectively into the
multi-line edit box.

4.

Entering the Cell Differential

You can enter the percentage or other form of differential result of each cell differential into
the edit box next to the cell differential name respectively.

You can enter a value within the range [0.0-100.0] and the unit is %.

Entering the Blood Type information

You can select the blood type of the patient in the Blood Type/ESR column. Click the first
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combo box next to the blood type, you can select from Blank, A, B, O and AB; click
the second combo box, you can select from Blank, RH+ and RH-.

Entering the Blood ESR information

Enter the blood ESR value in the edit box follows the ESR. If the value exceeds the Ref.
Range, the mark H or L will appear to indicate the value exceeds the upper limit or the
lower limit.
You can modify the reference range of Blood ESR by the following steps:
1.

Click Set Reference Range button, and then a message box will pop up. Enter the
upper limit and lower limit of the blood ESR into the edit box Lower limit and Upper
limit respectively.

2.

Click the Ok button to save all the settings and refresh the information.

You can enter the value up to 3 numeric characters within the range [0,999].

The upper limit can not be smaller than the lower limit.

The entered reference range of the Blood ESR is only applied to the current
record, and the default range is [0, 20].

Research
Click Research tab on the screen, the specific value of each parameter will be displayed.

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The specific values of the parameter results that are out of the display range
or without data collected cannot be provided.

Edit of the results in the Data/Graph tab will not affect the display of
parameters in the Research tab.

The content of this tab can only be viewed and used for research; it cannot
be edited or printed.

7.3.3 Function of the Buttons

When the mouse is moved just on the function buttons, the name of the button and the
corresponding shortcut key will appear. For example, when moving the mouse on the Save
button, the tips will pop up:

The shortcut keys of the function buttons in the table review screen are shown in the following
table:
Function button

Shortcut key

Save

F2

Validate

F3

Print

F4

Edit Result

F5

Restore Result

F6

Batch Validate

F7

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Search

F8

Communication

F9

Delete

Alt+Delete

Deselect

F10

Trend Graph

F11

CV

F12

Save
Click the Save button to save the modified information on all tabs of the current result.

Search
You can search for the specified sample record from all records in the current list as default.
1.

Click the Search button, and then a Search message box will pop up.

2.

You can define the desired searching conditions.

Entering the sample ID

Select the check box of Sample ID, and then enter the desired sample ID into the Sample
ID edit box.
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Entering the patient name

Select the check boxes of Last Name and First Name, and then enter the desired patient
name into the boxes.

Selecting the run date

Select the check box of Run Date, and then select the limits of the run date.

Selecting the patient gender

Select the check box of Gender, and then click the radio button Male, Female or
Empty to select the patient gender.

Entering the patient ID

Select the check box of Patient No., and then enter the desired patient No. into the Patient
No. edit box.

Entering the department name

Select the check box of Department, and then enter the desired department name in the
Department edit box.

Entering the bed No.

Select the check box of Bed No., and then enter the desired bed No. into the Bed No. edit
box.

Entering the deliverer

Select the check box of Deliverer, and then enter the desired deliverer into the Deliverer
edit box.

Selecting the validate status

Select the check box of the Validate Status, and then click the radio button Validated or
Not Validated to select the validate status.

Selecting the print status

Select the check box of Print Status, and then click the radio button Printed or Not
Printed to select the print status.

Selecting the communicate status

Select the check box of the Communication Status, and then click the radio button

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Transmitted or Not Transmitted to select the communication status.

Selecting the matching type

Select the check box of Whole Words Only, and then the precise search will be performed;
otherwise, the fuzzy search (means to search the related records which contain the content
that you entered) will be preformed.

Selecting the case sensitive

Select the check box of Case Sensitive, and then the capital letters and small letters in the
edit box will be distinguished when searching; otherwise, the search will be insensitive to the
form the letters (i.e. the capita letters and small letters will not be distinguished).
3.

Click Ok to perform the search and switch to the Samples found list of the Table
screen, and the searching results will display..

The desired record is searched from all the sample records as default.

Validate
Click the Validate button to validate the current highlighted record in the list.

You can enable the users of common level to validate by setting in the
Setup screen. Otherwise, the user name and the password of
administrator level are required.

After validating, you can not edit the sample/patient information and the
result

You can not validate the background record.

Batch Validate
1.

Click the Batch Validate button, and then the following message box will pop up.

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2.

Click the radio button Selected Samples or Specified Samples to select the records
you want to validate. Selected Samples are those selected with marks in the
review list.

3.

Click the Specified Samples radio button to specify the starting and finishing time of
the Run Date for the record to be validated.

4.

Click Ok to start validating.

The users of common level is enabled the authority of Batch Validate

together with Validate when setting in the Setup screen. Otherwise, the
user name and the pass word of administrator level are required.

For the validated record, you can not edit the sample/patient information
and the result.

The validated record can also be selected in bath validation.

You can select whether automatically de-select validated records or not.

Cancel (validate)
Click the Cancel button to cancel the validating operation.

If the current highlighted record is validated, the Validate button will be

replaced by the Cancel button.

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The Cancel button is only available to the highlighted record in the list.

The users of common level is enabled the authority of Cancel together

with Validate when setting in the Setup screen. Otherwise, the user
name and the pass word of administrator level are required.

After canceling, you can edit the sample/patient Information and the result.

You can not validate the background record.

Print
1.

Click the Print button, and then a message box will pop up.

2.

Click the radio button Selected Samples or Specified Samples to select the record
you want to export. Selected Samples are those selected with marks in the review
list.

3.

Click the Specified Samples radio button to set the starting and finishing run date of
the records to be printed.

4.

Click the Report or List radio button to select the print format.

5.

When List is selected, you can continue to select one of the four print templates, the
default template selected is the All Para. template.

6.

Click Ok to start printing.

You can set the amount of copies of the printed report in the Setup screen.
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At the Setup screen, you can choose whether to print the Flag prompts in
the report or not.

You can select whether automatically de-select printed records or not.

Communication
You can do as follows to transmit the sample record to the LIS/HIS system.
1.

Click Transmit button, the following message box will pop up.

2.

Click the radio button Selected Samples or Specified Samples to select the record
you want to transmit. Selected Samples are those selected with marks in the
review list.

3.

Click the Specified Samples radio button to specify the starting and finishing time of
the Run Date for the record to be transmitted.

4.

Click Start to start transmitting.

Once the transmission starts, if you click the Com. button again, then the
foregoing message box will also pop up but the Start button will be
replaced by the Stop button. You can click the Stop button to stop
transmitting once the transmission of the current sample record is done.

You can select whether to automatically de-select the transmitted records.

You can select whether to automatically delete the transmitted records.

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CV
You can check the reproducibility of the selected sample record.
1.

Select the sample record used for calculating the reproducibility.

2.

Click the CV button to start calculating the reproducibility, and then the result message
box will pop up:

3.

Click the Calculate Deviation button, and then a message box will pop up. You can
check the absolute deviation of the 5 WBC related parameters of percent-style.

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4.

When finish browsing, you can click the Close button to exit.

At least 3 records should be selected to calculate the reproducibility.

Up to all records in the review list can be selected to calculate the

reproducibility.

There is no restriction to the sample records selected to calculate the

reproducibility as long as they are in the review list.

Trend Graph
You can check the trend graph of all the parameters of the selected sample record. Do as
follows:
1.

Select the desired sample record.

2.

Click the Trend Graph button, and then a message box with the trend graph of all
parameters of the selected record will pop up.

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At least 3 records or at most all records in the review list can be selected.

There is no restriction when selecting the sample records as long as they

are in the review list.

Checking data

Method 1: click the certain data group to move the green line to the place, and then you can
check the data of this group.
Method 2: click the arrow buttons on the Pos./Total control to move the green line and check
the data of each group.
Method 3: when the green line is located, you can press the [] and [] key on the keyboard
to move the green line and check the data of each group.
Method four: when the green line is located, you can press the [Home] or [End] key on the
keyboard to check the first or the last group of data on the graph.

Modifying the range

Method 1: click the arrow buttons next to the range to adjust it. The trend graph will refresh
immediately once the range is changed.
Method 2: click the edit box of the range and enter the value into it. After entering, press the
[Enter] key or switch to other focus to refresh the trend graph.

The modified range will also be saved after closing the trend graph.

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Delete

The Delete button and the corresponding deleting operation are not
available for users of common-level.

1.

Select the sample record you want to delete.

2.

Click the Delete button, and then a message box will pop up.

3.

Click Ok to delete the selected records.

Edit Result
1.

Click the Edit Result button, and then in the Result tab, you can edit the result of
each parameter and WBC DIFF results in the activated edit box.

2.

After editing, click the Save button to save the changes.

You can enable the users of common level to edit result by setting in the
Setup screen. Otherwise, the user name and the pass word of
administrator level are required.

If the result of one parameter is modified, then the result of other related
parameter(s) will be changed accordingly and the high or low/suspect flags
will also be refreshed.

Only the result of the measurement parameters (WBC, RBC, HGB, HCT and
PLT) and WBC DIFF results can be modified.

After editing and then saving WBC DIFF results, the absolute value of each
DIFF result will be re-calculated and then refreshed.

If the sum of the DIFF results does not equal to 100.00% after being edited,
then the message box The sum of the DIFF results is not 100.00%! will pop
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up when you clicking the Save button.

No matter the sample result is validated or not, as long as it is edited, the

result of the parameter that you modified manually will be flagged with an
E. If any parameter result is then changed due to the one that you
modified manually, it will be flagged with an e. (E or e will be displayed
between the parameter result and its unit.)

The scattergram of the sample will not be changed even when the
differential result of the WBC is modified.

You can not edit the results of the background.

Restore Result
1.

Click the Restore Result button, and then the following message box will pop up.

2.

Click Ok to restore the result to the original measurement value and remove the result
edited flags (E or e).

The users of common level are enabled the authority of Restore Result
together with Edit Result when setting in the Setup screen. Otherwise,
the user name and the pass word of administrator level are required.

Up to 1000 latest measurement results of original value can be saved by the

analyzer.

You can not restore the results of the background.

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7.4 Data Backup

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the data backup function, you
should log on the system as administrator, and then right click the shortcut
icon of the terminal software and run it as administrator.

You can back up the data of the sample base in the external computer. Do as follows:
1.

At the table review screen, click the Menu button, then select Review Data
Backup on the pop-up menu, and then a message box will pop up.

2.

Click the radio button Selected Samples or Specified Samples to select the record
you want to backup. Selected Samples are those selected with marks in the review
list.

3.

Click the Specified Samples radio button to specify the starting and finishing time of
the Run Date for the record to be backed up.

4.

Click Ok button, the following dialog box will pop up.

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5.

Select the directory and enter the file name.

6.

Click the Save button, and then a progress bar will pop up.

7.

When the backup is finished, click Ok to exit.

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You can not choose the file format when backing up.

The backup sample record can not be edited and can only be reviewed in
History.

The histograms and scattergram will be backed up in the folder of Bmp at

the selected location.

You can select whether automatically de-select the backed up records or

not.

You can select whether to automatically delete the backed up records.

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7.5 Data Export

You can export the data from the sample base to an external computer and then proceed to
edit or save the data:
1.

At the Table screen, click the Menu button, then select Review Data Export in
the pop-up menu, and then a Export message box will pop up.

2.

Click the radio button Selected Samples or Specified Samples to select the records
you want to export. Selected Samples are those selected with marks in the review
list.

3.

Click the Specified Samples radio button to set the starting and finishing run date of
the record to be printed.

4.

Click the Ok button, and then a message box will pop up.

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5.

Select the directory and format and enter name for the exported file.

6.

Click the Save button, and then a process bar will pop up.

7.

After the export is finished, click Ok to exit.

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The default format of the exported files is .csv and you can also choose
the .txt format.

The exported sample record will keep the same order as displayed in the
table review screen (run time ascending/descending).

You can not review the exported files in History, but you can perform the
operations including editing and deleting, etc. to the exported files on an
external computer.

The histograms and scattergram will be exported in the folder of Bmp at

the selected location.

You can select whether automatically de-select exported records or not.

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7.6 Auto-Backup
When the terminal software connects the analyzer for 4 hours, the backup will be performed
automatically. A progress bar will pop up.

The progress bar will close once the backup is finished.

You can not perform any operation during the process of backup.

The record in the sample base will also be backed up automatically when
you exiting the application software.

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7.7 Auto-Restore
If the data is damaged in the sample base, but the corresponding auto-backed up data is fine,
then a message box will pop up.

Click Yes to close the box and display the auto-backed up data into the sample list.

If you choose not to restore the auto-backed up data and running no new
samples, then the foregoing message box will still pop up when you run the
program again.

A progress bar will be displayed on the screen during auto-restoring.

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7.8 Compare
Click the Menu button, and then select Review Compare from the pop-up menu to
enter the following Compare screen.

The Compare screen consists of three parts. The top of the screen displays the search
conditions: Patient ID, Last Name, First Name and Run Date. The middle of the
screen displays the tab of the patients test results and the trend graphs. The available
function buttons are also displayed in the screen.

7.8.1 Tabs
Comparison Summary
Click the Comparison Summary tab in the screen to check the test results of the patient.

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If Display RUO parameters is not selected in the Setup screen, then the
ALY%, LIC%, ALY# and LIC# will not be displayed in the list.

A blank cell of Result means no measurement result.

The red flags (?, H or L) indicate the result is either out of limit or
suspect.

The yellow background indicates an edited result.

Result Trend
Click the Result Trend tab in the screen to check the trend graphs of the patient.

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You can click the Select Parameter combo box at top-left of the screen to select the desired
the trend graph.

If Display RUO parameters is not selected in the Setup screen, then the
ALY%, LIC%, ALY# and LIC# will not be displayed in the pull-down list of
the combo box.

The x-axis of the Parameter Trend shows the No. of the test and the y-axis shows the result
of each test. Up to 30 data points can be displayed in the trend graph. If the matched data are
more than 30 groups, then only the latest 30 ones will be displayed. The data points in the
trend graph are displayed from left to right in the ascending order of Run Date /Time. Thus,
the latest data point places the last.

The scale on the x-axis of the trend graph changes according to the number
of the result.

The scale on the y-axis of the trend graph changes according to the value of
the result.

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The down side of the tab displays the result of the single parameter in the form of list. The
corresponding No., run date/time and result are displayed in the list.

The data in the list corresponds with the data point in the trend graph one by
one.

The red flags (?, H or L) indicate the result is either out of limit or
suspect.

The yellow background indicates an edited result.

7.8.2 Function of the buttons

Search
You can search for the certain result of the patient by entering the search condition in the top
of the screen.
1.

You can define the desired search conditions.

Entering the patient ID

Enter the patient ID into the Patient ID box.

Entering the patient name

Enter the patient name into the Last Name and First Name boxes.

Selecting the Run Date

Use the date control to specify the range for the run date.

The Patient ID must be entered.

You can leave the Patient Name in blank.

An empty entry of run date indicates the whole database will be searched for
the certain result and there is no restriction to the run date.

2.

Click the Search button to start searching the specified record and the result will be
displayed in the two tabs. You can switch between the two tags to check the result.

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Re-fill
You can click the Re-fill button to clear all the entered search conditions and then re-fill.

Adjust Parameter Order

You can use the Adjust Parameter Order function to adjust the following parameter order.

The display order of the parameter in the Comparison Summary tab and the
parameter order when printing

The display order of the parameter in the combo list of the Result Trend tab

Do as follows to adjust parameter order:

1.

Click the Adjust Parameter Order button, then the following box with the list of the
parameter order will pop up

The right of the parameter list displays the order-adjusting buttons: Top,
Up, Down and Bottom.

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2.

Click one parameter in the list to highlight it.

Click the Top button to move the parameter to the top of the list.

Click the Up button to move the parameter upward by one position.

Click the Down button to move the parameter downward by one position.

Click the Bottom button to move the parameter to the bottom of the list

3.

Click Ok to save the changes and close the box.

Print
When the current tab is Comparison Summary, you can click the Print button to print all
the contents of the summary.
When the current tab is Result Trend, you can click the Print button to print the displayed
result trend and the result list.

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7.9 Statistics
You can select or enter the Statistical Condition to realize the statistics of the workload.

7.9.1 Calculate Workload

Click the Menu button, and then select Statistics Calculate Workload from the
pop-up menu to enter the following Workload Summary screen.

The top of the screen displays the Statistical Item, namely, Department, Deliverer,
Operator and Run Date. Below the Statistical Item, it displays the corresponding
Statistical Condition. The corresponding records are displayed in the workload summary
together with the workload statistics. The available function buttons are also displayed in the
screen.

Workload Summary
All the records that match the statistical conditions will be displayed in the Workload
Summary and be included to calculate the total workload. The records of the same category
(i.e. those with the same field in the first column) will be taken to calculate the subtotal
workload. The default information fields in the workload summary are Department,
Deliverer, Operator, Run Date and Sample Load.

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The cell of the un-selected Statistical Item displays blank.

For several results of the same item, they will be displayed in ascending order by run date. Be
aware that not all the statistics results in the summary are displayed in ascending order by
run date.
In the workload summary, the subtotal workload will be displayed below the records of the
same category, and the total workload will be displayed in the last.

Function of the buttons

Statistics
You can select the desired statistical item and enter the statistical condition to check the
statistics of the workload of the matched record.
1.

You can select the desired statistical item by clicking the check box.

2.

After selecting the statistical item, the corresponding statistical condition will be activated
for you to enter.

Entering the Department

Enter the department into the Department box or select it from the Department pull-down
list.

Entering the Deliverer

Enter the name of the deliverer into the Deliverer box or select it from the Deliverer
pull-down list.

Entering the Operator

Enter the name of the operator into the Operator box or select it from the Operator
pull-down list.

Selecting the Run Date

Use the date control to specify the range for the run date.

The shortcut code entry is supported.

When selecting All, it means all the available options of this field will be
calculated.
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3.

Click the Statistics button to start calculating the workload for the matched records,
and then displays the result in the workload summary.

Re-fill
You can click the Re-fill button to clear all the entered statistical conditions and then re-fill.

Adjust Column Order

You can use the Adjust order function to adjust the column order (including Department,
Deliverer, Operator and Run Date) in the workload summary. Do as follows:
1.

Click the Adjust Order button, then the following box with the list of the column (field)
order will pop up.

The right of the list displays the order-adjusting buttons, namely, Top,
Up, Down and Bottom.

2.

Click one field in the list to highlight it.

Click the Top button to move the field to the top of the list.

Click the Up button to move the field upward by one position.

Click the Down button to move the field downward by one position.

Click the Bottom button to move the field to the bottom of the list

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3.

Click Ok to save the changes, close the box and back to the Calculate Workload
screen. Then, the column order in the workload summary refreshes.

The statistical result will also be refreshed together with the column order.

Print
1.

Click the Print button, and then a message box will pop up.

2.

Click the Print Summary or the Print statistics only radio button to select the
content you want to print.

Print Summary means to print out all the records and statistical results in
the workload summary.

Print statistics only means to print out the statistical results only
(including subtotal and total).

3.

Click Ok to start printing.

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7.10 History
You can review the backed up sample data in History. Do as follows:
1.

At the Table review screen, click the Menu button, and then select Review
History, and then a dialog box will pop up.

2.

Select the desired directory and the file name, and then click Open to go to the
"Sample Data History" screen shown as follows.

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If you select another backed up file, then the history data displayed in the
list will be refreshed.

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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. our 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 analyzer provides 4 QC programs: L-J QC, X mean QC, X mean R QC and X-B QC.

You should only use the ourspecified controls and reagents. Store and use
the controls and reagents as instructed by instructions for use of the
controls and reagents.

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8.2 L-J Quality Control

8.2.1 Editing L-J settings

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

Only users of administrator-level can edit the L-J settings.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow, and the change will
be recorded into the system log.

Before analyzing the new lot of controls, you should set a QC file for each lot of controls and
you can edit the QC settings in the QC file by one of the following ways:

Reading the information provided by the manufacturer

Manual entry

Reading the saved preset values

Reading the information provided by the manufacturer

1.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

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Enter the L-J graph screen.

2.

Click the Settings tab to enter the L-J settings screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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3.

Select a QC File No. with empty QC information.

4.

You can select the file No. within the range [1, 60].

Select the QC mode.

Different QC files can not have the same lot No. and QC mode.

In the "AL-WB" QC mode, you can perform analysis to more than one tube
of control by selecting "Build-in Barcode Scanner".

5.

Set QC ID: if you like to run control in the interval of running blood samples, you can set
a specific ID for the control. If such ID is recognized when the analyzer is running blood
samples, it will identify the sample as control automatically. When the running ends, the
result will be stored in the QC file of the corresponding ID.
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Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.

6.

7.

8.

Click the Read File button, a message box will pop up for you to select the directory.

Click the Browse button to select the directory of the QC information.

Click the Ok button to close the message box shown above, and the following
message box will pop up.
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9.

The QC files for selection are displayed in the form of "Lot No. (Level)".

Click the Ok button to close the message box and go back to the "Read File" box. The
selected directory is displayed in the "Read From:" edit box.

10. In the "Read File" message box, select the "Read Target/Limits" check box, and click
Ok to read the selected QC information to the current QC file.

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If the Read Target/Limits is not selected, you have to enter the target and
limits manually.

11. Click the Save button to save the QC information.

The expiration date can not be earlier than the current system date.

Different QC files can not have the same lot No. and QC mode.

Manual entry
You can enter the graph screen by one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

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1.

Click the Settings tab to enter the L-J setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

Select a QC File No. with empty QC information.

You can select the file No. within the range [1, 60].

3.

You can enter the lot No. of the controls by one of the following ways:

Manual entry

Entering by external barcode scanner

The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters are allowed.

4.

Different QC files can not have the same lot No. and QC mode.

Enter the batch expiration date of the controls.

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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].

5.

Select the QC mode.

6.

Different QC files can not have the same lot No. and QC mode.

Select the control level.

When the QC mode is AL-WB, if you wish to run several controls in a

single running, you should select Built-in barcode scanner.

7.

Set QC ID: if you like to run control in the interval of running blood samples, you can set
a specific ID for the control. If such ID is recognized when the analyzer is running blood
samples, it will identify the sample as control automatically. When the running ends, the
result will be stored in the QC file of the corresponding ID.

Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.

8.

According to the target list of the corresponding lot No., enter the target and limits into
the edit boxes of the parameters to be included in the QC run.

9.

Click the Save button to save all the settings of the QC.

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Reading the Saved Preset Values

If there are the saved preset values (Target and Limits) for the current level,
you can read the preset values into the current QC file. For details of
calculating and saving the preset values, see Section 8.2.3 Reviewing QC
results.

You can enter the graph screen by one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

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1.

Click the Settings tab to enter the L-J setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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Using the QC Programs

2.

Select a QC File No. with empty QC information.

You can select the file No. within the range [1, 60].

3.

You can enter the lot No. of the controls by one of the following ways:

Manual entry

Entering by external barcode scanner

The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.

4.

Different QC files can not have the same lot No. and QC mode.

Enter the batch expiration date of the controls.

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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].

5.

Select the QC mode.

6.

Different QC files can not have the same lot No. and QC mode.

Select the control level.

When the QC mode is AL-WB, if you wish to run several controls in a

single running, you should select Built-in barcode scanner.

7.

Set QC ID: if you like to run control in the interval of running blood samples, you can set
a specific ID for the control. If such ID is recognized when the analyzer is running blood
samples, it will identify the sample as control automatically. When the running ends, the
result will be stored in the QC file of the corresponding ID.

Letters, numbers and all characters that can be entered through the
keyboard (including special characters) are allowed for the QC ID, but the
number must end with a nonzero number. Chinese and other languages
(such as Japanese, Korean, etc) are not supported.

8.

Click the Have Preset Values button to read the saved preset target and limits
(correspond to the current level) into the current QC file.

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If some parameters to be included in the QC run have no preset values, you

should enter the target and limits for them manually; if you dont want some
parameters with preset values to be included in the QC run, you can cancel
the target and limits of them manually after read-in the preset values.

9.

Click the Save button to save all the settings of the QC.

Setting Limits
You can take the following steps to adjust the display format of the limits and the calculation
method of the preset limits.
1.

Click the Set Limits button, and then the following message box will pop up.

2.

Click By SD to display the limits in the form of absolute value; click By CV to display
the limits in the form of percentage.

3.

If By SD is selected, click the 2SD or 3SD to select either double or triple standard
deviation to be the limits; if By CV is selected, click the 2CV or 3CV to select either
double or triple coefficient of variation to be the limits.

4.

Click the Ok button to save all the settings for the limits.

Print
Click the Print button to print the setting information of the current QC file.

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8.2.2 Running controls

You can choose from below two methods to run controls:

Run controls under QC Run screen

Run controls in the interval of running blood samples under sample count screen

Run Controls under QC Run Screen

After editing the QC information, you can start one of the following QC analyses according to
the selected QC mode.

CT-WB

CT-PD

AL-WB (without built-in barcode scanner)

AL-WB (with built-in barcode scanner)

Running Controls (CT-WB)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
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injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

If the sample mode is switched from the Predilute to Whole Blood, the
analyzer will perform the switching sequence automatically and a progress
bar will be displayed on the screen.

You can enter the graph screen by one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

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1.

Click the Run tab to enter the L-J run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

Be sure to use the adapter of 13x75 (mm) model when running the QC in
CT-WB mode. For details to install the adapter, see Chapter 6 Operating Your
Analyzer.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is CT-WB and the analysis status icon and analyzer indicator is
green.
2) Shake the prepared control as shown below to well mix it.

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3) Click the Start button.

4) Press the [OPEN] key to open the compartment door.

5) Present the prepared control into the tube holder and then close the compartment door.
6) Press the [Run] key or click the Run button on the message box to start running.
7) When the running is finished, the compartment door will open automatically and you can
remove the control.

7.

When finish running, the QC results will be displayed in the current screen and be saved
in the QC file automatically.

8.

Up to 300 QC results can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

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Running Controls (CT-PD)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

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Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

You can enter the graph screen by one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

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1.

Click the Run tab to enter the L-J run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

Be sure to use the adapter of 11x40 (mm) model when running the QC in
CT-PD mode. For details to install the adapter, see Chapter 6 Operating Your
Analyzer.

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Using the QC Programs

2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is CT-PD and the analysis status icon and analyzer indicator is
green.
2) Click the shortcut button Diluent, the compartment door will open automatically. A
message box shown below will pop up.

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Using the QC Programs

3)Present a clean centrifugal tube into the sample compartment with the cap opened. Press
the [RUN] key to dispense 180L of diluent into the tube. During dispensing the diluent, a
progress bar will display.

If the current mode is autoloader, the analyzer will switch to the close-tube
mode automatically and then dispense the diluent. Then, the mode will be
switched back to autoloader when exiting.

4)When the dispensing is finished, the compartment door will open automatically and you can
remove the centrifugal tube. Then, the following message box will display.

5) Add 20L of control to the diluent, close the tube cap and shake the tube to mix the
sample.
6) Click the Cancel button to exit the Diluent message box.

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7) After the cleaning is finished, close the message box.

8) Click the Start button.

9) Present the centrifugal tube into the tube holder with the cap opened and then close the
compartment door.
10) Press the [Run] key or click the Run button on the message box to start running.
11) When the running is finished, the compartment door will open automatically and you can
remove the centrifugal tube.
7.

When finish running, the QC results will be displayed in the current screen and be saved
in the QC file automatically.

You can also dispense 180L of diluent by pipette into the tube.

Be sure to keep dust from the prepared diluent.

After mixing the control with the diluent, be sure to wait 3 minutes before
running.

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

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

Be sure to evaluate predilute QC stability based on your laboratorys sample

population and sample collection techniques or methods.

8.

Up to 300 QC results can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

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Running Controls (AL-WB without built-in barcode scanner)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the autoloader or
getting the collection tubes from the autoloader, be sure not to break the
tubes.

The pusher will push the rack inside the autoloader. Be sure you hand is
away from the rack before starting the autoloader.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

You can enter the graph screen by one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

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Using the QC Programs

1.

Click the Run tab to enter the L-J run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is AL-WB and the analysis status icon and analyzer indicator is
green.
2) Click the Start button.

3) Present the prepared control into the rack.

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4) Place racks loading controls on the level of the right tray of the autoloader, with the back of
MINDRAY mark on the carrier facing the analyzer.
5) Press the [Run] key or click the Run button on the message box to start running.
6) When finish running, you can remove the racks from the left of the autoloader.

Without built-in barcode scanner, only one control can be run in single
running.

7.

When finish running, the QC results will be displayed in the current screen and be saved
in the QC file automatically.

8.

Up to 300 QC results can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

Running Controls (AL-WB with built-in barcode scanner)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

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Using the QC Programs

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the autoloader or
getting the collection tubes from the autoloader, be sure not to break the
tubes.

The pusher will push the rack inside the autoloader. Be sure you hand is
away from the rack before starting the autoloader.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

You can enter the graph screen by one of the following ways:
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Using the QC Programs

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

1.

Click the Run tab to enter the L-J run screen.

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For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

2.

Select the QC file No. to be run; the screen displays the corresponding file information.

As long as the QC mode of the select QC file is AL-WB and With Built-in
Barcode Scanner is also selected, even the lot No. of the current QC file
does not match the lot No. of the control, you can still save each QC result
into the corresponding QC file by the scanned barcode.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Paste the barcode to the container of the control.

6.

Prepare the control as instructed by instructions for use of the controls.

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7.

Run the controls:

For details to paste the barcode, see Chapter 6 Operating Your Analyzer.

Be sure that the barcode of the lot No. of the controls is readable by the
built-in barcode scanner, for details to set the symbology, see Chapter 5
Customizing the Analyzer Software; for details to test the built-in barcode
scanner, see Chapter 10 Maintenance.

1) Make sure the QC mode is AL-WB and the analysis status icon and analyzer indicator is
green.
2) Be sure Built-in Barcode Scanner is selected for all the corresponding QC files, and the
barcode labels are pasted to the containers of the controls.
3) Click the Start button.

4) Present the prepared control into the rack.

5) Place racks loading controls on the level of the right tray of the autoloader, with the back of
MINDRAY mark on the carrier facing the analyzer.
6) Press the [Run] key or click the Run button on the message box to start running.
7) When finish running, you can remove the racks from the left of the autoloader.

With built-in barcode scanner, more than one control can be run together in
a single running.

When the barcode of the control is scanned by the built-in barcode scanner,
the screen will switch to the corresponding QC file automatically.

If nothing is scanned or no matching lot No. is found, the analyzer will jump
over the certain control without analyzing, and proceed to the later barcode
scanning and QC analyzing.

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8.

When finish running, the newest QC results will be displayed in the current screen and
be saved in the QC file automatically.

If any control is jumped over without being analyzed, a prompt will pop up
when the analysis cycle is completed. Click the Ok button to close the
prompt.

9.

Up to 300 QC results can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to switch to the pervious or the next QC result.

You can click the

button or

button to switch to the earliest or the latest QC result

saved in the QC file.

The running result of the expired control will begin with an O mark.

The flag prompt H or L will appear in front of the result that out of the
limits.

The enlarging function is available to the scattergrams and histograms of

the screen. See details for operation in Chapter 7 Reviewing Sample
Results.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.

Print
Click the Print button to print the results of the current QC Run screen.

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Run controls in the interval of running blood samples under sample

count screen
After setting special QC ID for controls under the Settings screen, you can run controls in
the intervals of running blood samples under sample count screen.
Before running blood samples, when you are editing worklist or entering information for the
next sample in the Run message box, be sure to enter the special QC ID as sample ID.
(Refer to 6.6.1 or 6.7.1 Entering Work List Information for the way to enter sample IDs)
You can start one of the following QC analyses according to the selected QC mode.

CT-WB

CT-PD

AL-WB (without built-in barcode scanner)

AL-WB (with built-in barcode scanner)

Running Controls (CT-WB)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.
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Using the QC Programs

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

If the sample mode is switched from the Predilute to Whole Blood, the
analyzer will perform the switching sequence automatically and a progress
bar will be displayed on the screen.

1.

Prepare the control as instructed by instructions for use of the controls.

2.

When it is ready to run (i.e. the analysis status icon and analyzer indicator is green),
shake the prepared control as shown below to well mix it.

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Using the QC Programs

3.

Press the [OPEN] key to open the compartment door.

4.

Present the prepared control into the tube holder and then close the compartment door.

5.

Press the [Run] key or click the Run button on the message box to start running.

6.

When the running is finished, the compartment door will open automatically and you can
remove the control.

7.

When finish running, the QC results will be automatically saved in the corresponding QC
file of the QC ID

8.

Up to 300 QC results can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

Running Controls (CT-PD)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

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Using the QC Programs

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

1.

Prepare the control as instructed by instructions for use of the controls.

2.

Make sure the analysis status icon and analyzer indicator is green, and then click the
shortcut button Diluent, the compartment door will open automatically. A message box
shown below will pop up.

3.

Present a clean centrifugal tube into the sample compartment with the cap opened.
Press the [RUN] key to dispense 180L of diluent into the tube. During dispensing the
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Using the QC Programs

diluent, a progress bar will display.

If the current mode is autoloader, the analyzer will switch to the close-tube
mode automatically and then dispense the diluent. Then, the mode will be
switched back to autoloader when exiting.

4.

4)When the dispensing is finished, the compartment door will open automatically and
you can remove the centrifugal tube. Then, the following message box will display.

5.

Add 20L of control to the diluent, close the tube cap and shake the tube to mix the
sample.

6.

Click the Cancel button to exit the Diluent message box.

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Using the QC Programs

7.

After the cleaning is finished, close the message box.

8.

Present the centrifugal tube into the tube holder with the cap opened and then close the
compartment door.

9.

1Press the [Run] key or click the Run button on the message box to start running.

10. 1When the running is finished, the compartment door will open automatically and you
can remove the centrifugal tube.
11. When finish running, the QC results will be automatically saved in the corresponding QC
file of the QC ID.

You can also dispense 180L of diluent by pipette into the tube.

Be sure to keep dust from the prepared diluent.

After mixing the control with the diluent, be sure to wait 3 minutes before
running.

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

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

Be sure to evaluate predilute QC stability based on your laboratorys sample

population and sample collection techniques or methods.

Up to 300 QC results can be saved for each QC file.

12. Do the above procedures to continue running the controls if necessary.

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Using the QC Programs

Running Controls (AL-WB without built-in barcode scanner)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the autoloader or
getting the collection tubes from the autoloader, be sure not to break the
tubes.

The pusher will push the rack inside the autoloader. Be sure you hand is
away from the rack before starting the autoloader.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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Using the QC Programs

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

1.

Prepare the control as instructed by instructions for use of the controls.

2.

Make sure the analysis mode is AL-WB and the analysis status icon and analyzer
indicator is green.

3.

Present the prepared control into the rack.

4.

Place racks loading controls on the level of the right tray of the autoloader, with the back
of MINDRAY mark on the carrier facing the analyzer.

5.

Press the [Run] key or click the Run button on the message box to start running.

6.

When finish running, you can remove the racks from the left of the autoloader.

Without built-in barcode scanner, only one control can be run in single
running.

7.

When finish running, the QC results will be automatically saved in the corresponding QC
file of the QC ID.

8.

Up to 300 QC results can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

Running Controls (AL-WB with built-in barcode scanner)

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Using the QC Programs

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the autoloader or
getting the collection tubes from the autoloader, be sure not to break the
tubes.

The pusher will push the rack inside the autoloader. Be sure you hand is
away from the rack before starting the autoloader.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

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Using the QC Programs

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

1.

Paste the barcode to the container of the control.

2.

Prepare the control as instructed by instructions for use of the controls.

For details to paste the barcode, see Chapter 6 Operating Your Analyzer.

Be sure that the barcode of the lot No. of the controls is readable by the
built-in barcode scanner, for details to set the symbology, see Chapter 5
Customizing the Analyzer Software; for details to test the built-in barcode
scanner, see Chapter 10 Maintenance.

3.

Make sure the analysis mode is AL-WB and the analysis status icon and analyzer
indicator is green.

4.

Be sure Built-in Barcode Scanner is selected for all the corresponding QC files, and the
barcode labels are pasted to the containers of the controls.

5.

Present the prepared control into the rack.

6.

Place racks loading controls on the level of the right tray of the autoloader, with the back
of MINDRAY mark on the carrier facing the analyzer.

7.

Press the [Run] key or click the Run button on the message box to start running.

8.

When finish running, you can remove the racks from the left of the autoloader.

With built-in barcode scanner, more than one control can be run together in
a single running.

When the barcode of the control is scanned by the built-in barcode scanner,
the screen will switch to the corresponding QC file automatically.

If nothing is scanned or no matching lot No. is found, the analyzer will jump
over the certain control without analyzing, and proceed to the later barcode
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Using the QC Programs

scanning and QC analyzing.

9.

When finish running, the QC results will be automatically saved in the corresponding QC
file of the QC ID.

If any control is jumped over without being analyzed, a prompt will pop up
when the analysis cycle is completed. Click the Ok button to close the
prompt.

Up to 300 QC results can be saved for each QC file.

10. Do the above procedures to continue running the controls if necessary.

Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to switch to the pervious or the next QC result.

You can click the

button or

button to switch to the earliest or the latest QC result

saved in the QC file.

The running result of the expired control will begin with an O mark.

The flag prompt H or L will appear in front of the result that out of the
limits.

The enlarging function is available to the scattergrams and histograms of

the screen. See details for operation in Chapter 7 Reviewing Sample
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Using the QC Programs

Results.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.

Print
Click the Print button to print the results of the current QC Run screen.

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8.2.3 Reviewing QC Results

After running controls, you can review the QC results in the following two ways:

Graph

Table

Graph Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

You can enter the graph screen by one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

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1.

Select the QC file No. you want to review, and then the screen will display the
corresponding information and the graph.

2.

You can drag the scroll bar on the right of the graph to browse the desired graph of the
parameter. You can drag the scroll bar down to the graph horizontally to browse all the
QC results.

Introduction to the Graph Screen

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Using the QC Programs

1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line.
3- The operator who run the QC analysis and obtained the QC points located on the green
line.
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- The QC points in each graph are displayed from left to right according to the sequence
from the earliest to the latest. The QC points are connected by a line to illustrate the
distribution trend.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
8- The relative position of the QC point located on the green line and the total QC points
saved currently.

The outliers are excluded from the calculation of Mean, SD and CV%.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.

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Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

next QC point; you can click the

button to move the green line to the pervious or the

button or

button to move the green line to the first

or the last QC point in the graph. When the location of the green line is selected, you can
check the QC results of the QC points located on the green line under each parameter.

New Vial
If the reviewed QC results are obtained by analyzing a new vial of control of the same batch,
you should mark the QC points of the new vial to distinguish the QC results from the old.
1.

Move the green line to the first QC point of the new vial.

2.

Click the New Vial button, and then a blue line appears at the QC point of the new vial.

3.

After another new vial of control (of the same batch) is run and its QC results are saved,
you can continue to mark the current QC points of the new vial according to step 1 and 2.

4.

If the current QC point is marked with the blue line, the New Vial button turns into
Cancel, you can click the button to remove the blue line, then the Cancel button will
turn back to New Vial.

Data Compare
If you wish to compare the graphs of the certain parameter obtained by running controls of
different lot No., do as follows:
1.

Click the Data Compare button to start selecting the desired graph.

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2.

Select the desired QC file No. into the File No. box (3 files can be selected at most).
Then, the graph of the selected QC file will be displayed below together with its lot No.,
QC mode and level.

3.

Select the desired parameter into the Parameter box.

Browse the graph here the same way as instructed in the Graph screen.
Be aware that, for controls of different level, their graphs will be
distinguished by the color of orange, black and blue.

4.

Click the Print button to print the current comparison if necessary.

5.

Click the Close button to exit.

Display Order
Do as follows to adjust the display order of different graphs.
1.

Click the Display Order button to check the current display order of the graphs.

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2.

Click the parameter that you want to adjust.

3.

You can click the

you can click the

button or
button or

button to move parameter upward or downward;

button to move the parameter to the first or the last

position.
4.

Click the Ok button to refresh the display order of the graphs.

Save Preset Values

If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can
take the following steps to calculate and save the preset value for each parameter:
1.

Click the Calculate Preset Values button, and then the screen displays two lines for
you to select the range for calculating the preset values.

2.

Click and drag the two lines respectively to locate them at the beginning and the ending
of the range for calculating the preset values.

3.

The Mean, SD and CV% (on the right of the graph) will change into the new results
which obtained by calculating the selected range.

4.

If you wish to save the new results, you can click the Save Preset Values button to
save the current Mean, SD and CV% as the preset values for the corresponding level
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(high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV%
return to the calculated results of all QC results.

The calculation and display of the preset values are only available to the
parameter (within the calculation range) which has 3 or more than 3 results
within the limit. Otherwise, the display of the preset values will be empty.

According to the high, normal and low level of the controls, three sets of
preset values can be saved respectively.

Entering the Reasons for the Outliers

Do as follows to enter the reasons for the outliers:
1.

After moving the green line to the desired QC point, you can click the Outliers button to
display the QC results, targets and limits of all the parameters located on the green line
(the QC results exceed the limit will be displayed in red) and enter the reasons for the
outliers.

2.

You can select the reason form the given ones or enter the reasons (up to 200
characters) into the edit box manually after selecting Others.

3.

Click the Ok button to save the reasons for the outliers and exit.

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If you enter the reason for the group of QC points whose results are actually
within the limits, then their corresponding QC data both in the QC Graph and
QC Table will be displayed in the color of red. And the data will return in the
color of black if you cancel the reason and then save the changes.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

The operation of deletion will be recorded in the log.

Print
Click the Print button to print all the file information and graphs of the parameters of the
current QC file.

The green line and the corresponding values of the QC points will not be
printed.
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Table Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

You can enter the Table screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCL-J on the pop-up menu.

Enter the L-J graph screen.

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1.

Click the Table tab to enter the L-J table screen.

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2.

Select the QC file No. you want to review, and then the screen will display the
corresponding information and the table.

3.

You can drag the scroll bar on the right of the table vertically to browse the desired table
of the parameter. You can drag the scroll bar down to the table horizontally to browse all
the QC results.

Introduction to the Table Screen

1- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
2- QC Result
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: The flag H or L will be used to prompt the result that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.
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Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to highlight the pervious or the next QC result;

you can click the

button or

button to highlight the first or the last QC result in the

table.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, click the column contains the desired QC result;
if you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

The operation of deletion will be recorded in the log.

Print
You can take the following steps to print the Table:
1.

Click the Print button, and then you can select All Data or Specified Data to be
printed.

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2.

Click the All Data button and then click the Ok button to print all the file information
and tables of the parameters of the current QC file; after clicking the Specified Data
button, you can select the starting and finishing date (the saved date of the QC results)
for printing, then click the Ok button to print the specified data.

Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1.

Click the Communication button, and then you can select All Data or Specified
Data to be transmitted.

2.

Click the All Data button and then click the Start button to transmit the information of
the current QC file and QC data. After clicking the Specified Data button, you can
specify a date range (the date when the QC result was saved), then click the Ok button
to transmit the specified data. The LIS/HIS connected icon on the status bar of the
screen will flicker during transmission.
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3.

While transmitting, the Start button in the pop-up message box will be replaced by
Stop. You can click the Stop button to stop transmitting.

If auto-communication is enabled and a sample is ran during the

transmission of the QC data, then only when the QC data transmission
finished will the auto-communication of the sample result starts.

The QC data saved in the process of transmission will not be transmitted.

Data Backup

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the data backup function, you
should log on the system as administrator, and then right click the shortcut
icon of the terminal software and run it as administrator.

If you wish to backup the information and the result of the current QC file, do as follows:
1.

Click the Data Backup button, a message box will pop up.

2.

Select the backup directory (the default directory is the folder of QC Data under the

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installation location of the terminal software).
3.

Enter the name for the backup data (the default name is [L-J_QC_date saved_time
saved]).

4.

Click the Save button to start backing up.

5.

When the backup is finished, a message box will pop up, and then click Ok to exit.

The backup data can not be modified. You can review the data in History
screen.

You can click the Cancel button to cancel backup when it is in process.

Be sure to backup data regularly.

Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1.

Click the Data Export button, and then a message box will pop up.

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2.

Select the export directory (the default directory is the folder of QC Data under the
installation location of the terminal software).

3.

Enter the name for the export data (the default name is [L-J_QC_date saved_time
saved]).

4.

Select the format for the export file.(default format: . CSV)

5.

Click the Save button to start exporting.

6.

When the export is finished, a message box will pop up, and then click Ok to exit.

You can modify the exported data but can not review the data in the
History screen.

You can click the Cancel button to cancel export when it is in process.

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History

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the history function, you should
log on the system as administrator, and then right click the shortcut icon of
the terminal software and run it as administrator.

If you wish to review the backed up data, do as follows:

1.

Click the History button, and then a message box will pop up.

2.

Locate and then select the desired backup data.

3.

Click the Open button to display the data in History screen.

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4.

The display format and the function button are the same as the QC Table review screen.
Browse, print, transmit and export the data as instructed in the section of QC Table
Review.

5.

After reviewing, click the Close button to exit.

Single Parameter QC Graph

Single parameter QC graph is the QC graph of one parameter under the L-J QC mode.
Click Menu QC L-J QC, and then click the Single Para. QC Graph tab to enter
the following screen.

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Single para. QC graph screen

The single para. QC graph screen consists of the file information area, QC graph area and
the comments area.

File information area

You can select among all valid QC file No. from the File No. pull-down list. The default file
No. is the L-J QC file used by the current operator, and the file No. cannot be null.
The lot No, level, exp. date, QC mode, editor and QC sample ID will be displayed
automatically after you select the QC file No..

QC graph area

You can select the parameter to plot QC graph from the Parameter pull-down list, and
select the plotting mode from the Plotting pull down list: By QC Date, 1/Day, All.
The default values of the Mean and SD boxes are calculated from all the valid QC points
on the graph of the selected parameter in the current QC file by the default plotting mode. You
can edit the values manually.

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If there are less than 3 valid QC points of the current parameter, the mean
and SD will be null.

If you select By QC Date or 1/Day plotting mode, and there are more
than 1 QC point in one day, the points will all be displayed in the graph, but
only the latest one will be the connecting point of the plot.

Drag the scroll bar after setting up all the information, and the QC graph will be plotted
automatically and the analysis results and operator information will be displayed under the
graph.

Comments area

This area displays the conclusion drawn based on the preset rule of outliers, which can be
edited by operators.

Browsing the QC result

Click the arrow buttons under the screen to browse all the QC points.
You can click the

button or

button to highlight the previous or the next QC point;

you can click the

button or

button to highlight the first or the last QC point in the

graph.

New Vial
If the reviewed QC results are obtained by analyzing a new vial of control within the same
batch, you should mark the QC points of the new vial to distinguish the QC results from the
old.
1.

Move the green line to the first QC point of the new vial.

2.

Click the New Vial button, and then a blue line appears at the QC point of the new vial.

3.

After another new vial of control (within the same batch) is run and its QC results are
saved, you can continue to mark the current QC point of the new vial according to step 1
and 2.

4.

If the current QC point is marked with the blue line, the New Vial button will turn into
Cancel; you can click the button to remove the blue line, and then the Cancel button
will turn back to New Vial.

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Calculate Target
Click the Calculate button, the following screen will pop up.

After selecting the date range, the mean, SD and CV will be calculated and displayed in to the
corresponding boxes automatically.
Click Apply to enter the calculated target into the single para. QC graph screen, and then
click OK to save the target and close the dialog box. Click Cancel to exit the Calculate
screen without saving the calculated target.

If there are no data in the selected date range, a prompt will be displayed:
Not enough data! Reselect a date range and make sure there are more than
5 groups of valid data.

Save
Click Save to save the mean and SD (including the manually edited values and the values
obtained by calculating target) and display them on the bottom left of the QC graph.

Print
Click Print to print the QC graph and data on the screen.

Monthly QC Graph
Monthly QC graph is the QC graph of one parameter of the high, normal and low levels within
one month.
Click Menu QC L-J QC, and then click the Monthly QC Graph tab to enter the
following screen.

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Monthly QC graph screen

The monthly QC graph screen consists of the file information area and QC graph area.

File information area

You can select the parameter to plot QC graph from the Parameter pull-down list; select the
level(s) of the control you want to check from the Level pull down list; select the plotting
mode from the Plotting pull down list: 1/Day, All; and select the date range of all QC
data in the QC graph from the Date Range pull-down list.
After you set the above conditions, the matching QC files will be acquired and the Lot No.,
exp. Date, X mean and SD will be displayed in the boxes of the corresponding QC levels. If
no data is acquired, the boxes will be null.
If the X Mean and SD boxes are both null, their values cannot be edited, otherwise you
can edit the values of X mean and SD, then click Save to save the change.

Two QC files of each QC level can be displayed in one month; if there are
more than two QC files, the latest two will be displayed.

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QC graph area

Drag the scroll bar after setting up all the information, the QC graph will be plotted
automatically and the QC point No., analysis results and operator information will be
displayed under the QC graph. If there are QC points in the graph, the Lot No., X mean, SD
and CV% will be displayed above the graph.
Each screen of the QC graph can display 31 groups of QC data. To view more QC data, drag
the horizontal scroll bar.

Browsing the QC result

Click the arrow button under the screen to browse all the QC points.
You can click the

button or

button to highlight the previous or the next QC point;

you can click the

button or

button to highlight the first or the last QC point in the

graph.

Print
Click Print to print the QC graph and data on the screen.

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8.3 X mean QC Program

8.3.1 Editing X mean Settings

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

Only administrators can edit the X mean QC settings.

For the QC files with saved QC results, if changing and then saving the
reference range or limits caused the change of target and limits, then the
changed data will be displayed in yellow background and recorded in the
system log.

Before analyzing a new batch of controls, you should set a QC file for each lot of controls and
edit the QC settings in the QC file by one of the following ways:

Reading the information provided by the manufacturer

Manual entry

Reading the saved preset values.

Reading the information provided by the manufacturer

1.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCX mean on the pop-up menu.

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Enter the "X mean" graph screen.

2.

Click the Settings tab to enter the X mean settings screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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3.

Select a QC File No. with empty QC information.

4.

Select the QC mode.

5.

You can select the file No. within the range [1, 60].

Different QC files can not have the same lot No. and QC mode.

Click the Read File button, a message box will pop up for you to select the directory.

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6.

7.

Click the Browse button to select the directory of the QC information.

Click the Ok button to close the message box shown above, and the following
message box will pop up.

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8.

The QC files for selection are displayed in the form of "Lot No. (Level)".

Click the Ok button to close the message box and go back to the "Read File" box. The
selected directory is displayed in the "Read From:" edit box.

9.

In the "Read File" message box, select the "Read Target/Limits" check box, and click
Ok to read the selected QC information to the current QC file.

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If the Read Target/Limits is not selected, you have to enter the target and
limits manually.

10. Click the Save button to save the QC information.

The expiration date can not be earlier than the current system date.

Different QC files can not have the same lot No. and QC mode.

Manual Entry
You can enter the graph screen by one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QCX mean on the pop-up
menu.

Enter the X mean graph screen.

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1.

Click the Settings tab to enter the X mean setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

Select a QC File No. with empty QC information.

You can select the file No. within the range [1, 60].

3.

You can enter the lot No. of the controls in one of the following ways:

Manual entry

Entering by external barcode scanner

The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.

4.

Different QC files can not have the same lot No. and QC mode.

Enter the batch expiration date of the controls.

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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].

5.

Select the QC mode.

Different QC files can not have the same lot No. and QC mode.

6.

Select the control level.

7.

According to the target list of the corresponding lot No., enter the target and limits into
the edit boxes of the parameters to be included in the QC run.

8.

Click the Save button to save all the settings of the QC.

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Reading the Saved Preset Values

If there are the saved preset values (Target and Limits) for the current level,
you can read-in the preset values into the current QC file. For details of
calculating and saving the preset values, see Section 8.3.3 Reviewing QC
results.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QCX mean on the pop-up
menu.

Enter the X mean graph screen.

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1.

Click the Settings tab to enter the X mean setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

Select a QC File No. with empty QC information.

You can select the file No. within the range [1, 60].

3.

You can enter the lot No. of the controls in one of the following ways:

Manual entry

Entering by external barcode scanner

The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.

4.

Different QC files can not have the same lot No. and QC mode.

Enter the batch expiration date of the controls.

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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].

5.

Select the QC mode.

6.
7.

Different QC files can not have the same lot No. and QC mode.

Select the control level.

Click the Have Preset Values button to read-in the saved preset target and limits
(correspond to the current level) into the current QC file.

If some parameters to be included in the QC run have no preset values, you

should enter the target and limits for them manually; if you dont want some
parameters already with preset values to be included in the QC run, you can
cancel the target and limits of those parameters manually after read-in the
preset values.

8.

Click the Save button to save all the settings of the QC.

Setting Limits
Do as followings to adjust the display format of the limits and the calculation method of the
preset limits.
1.

Click the Set Limits button, and then the following message box will pop up.

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2.

Click By SD to display the limits in the form of absolute value; click By CV to display
the limits in the form of percentage.

3.

If By SD is selected, click the 2SD or 3SD to select either double or triple standard
deviation to be the limits; if By CV is selected, click the 2CV or 3CV to select either
double or triple coefficient of variation to be the limits.

4.

Click the Ok button to save all the settings for the limits.

Print
Click the Print button to print the setting information of the current QC file.

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8.3.2 Running Controls

After editing the QC information, you can start one of the following QC analyses according to
the selected QC mode.

CT-WB

CT-PD

AL-WB

Running Controls (CT-WB)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

If the sample mode is switched from the Predilute to Whole Blood, the
analyzer will perform the switching sequence automatically and a progress
bar will be displayed on the screen.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QCX mean on the pop-up
menu.

Enter the X mean graph screen.

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1.

Click the Run tab to enter the X mean run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

Be sure to use the adapter of 13x75 (mm) model when running the QC in
CT-WB mode. For details to install the adapter, see Chapter 6 Operating Your
Analyzer.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is CT-WB and the analysis status icon and analyzer indicator is
green.
2) Shake the prepared control as shown below to well mix it.

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3) Click the Start button.

4) Press the [OPEN] key to open the compartment door.

5) Present the prepared control into the tube holder and then close the compartment door.
6) Press the [Run] key or click the Run button on the message box to start running.
7) When the running is finished, the compartment door will open automatically and you can
remove the control.
8) After the analyzing is finished, the QC result of the first analysis will be displayed on the
screen.

9) Mix the control well again, and then to run the control for the second time according to the
prompt.

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You can click the Cancel button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.

10) When the running is finished, the compartment door will open automatically and you can
remove the control.
7.

When finish running, the QC results (values of the two QC runs and the X mean) will be
displayed in the current screen and be saved in the QC file automatically.

When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.

8.

Up to 300 QC results (X mean) can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

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Running Controls (CT-PD)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

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Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QCX mean on the pop-up
menu.

Enter the X mean graph screen.

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1.

Click the Run tab to enter the X mean run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

Be sure to use the adapter of 11x40 (mm) model when running the QC in
CT-PD mode. For details to install the adapter, see Chapter 6 Operating Your
Analyzer.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls :

1) Make sure the QC mode is CT-PD and the analysis status icon and analyzer indicator is
green.
2) Click the shortcut button Diluent, the compartment door will open automatically. A
message box shown below will pop up.

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3) Present a clean centrifugal tube into the sample compartment with the cap opened. Press
the [RUN] key to dispense 180L of diluent into the tube. During dispensing the diluent, a
progress bar will display.

If the current mode is autoloader, the analyzer will switch to the close-tube
mode automatically and then dispense the diluent. Then, the mode will be
switched back to autoloader when exiting.

4) When the dispensing is finished, the compartment door will open automatically and you
can remove the centrifugal tube. Then, the following message box will display.

5) Prepare one more diluent according to procedure 3) to 4).

6) Add 20L of control to the diluent, close the tube cap and shake the tube to mix the
sample.
7) Click the Cancel button to exit the Diluent message box.

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8) After the cleaning is finished, close the prompt.
9) Click the Start button.

10) Present the centrifugal tube into the tube holder with the cap opened and then close the
compartment door.
11) Press the [Run] key or click the Run button on the message box to start running.
12) When the running is finished, the compartment door will open automatically and you can
remove the centrifugal tube.
13) After the analyzing is finished, the QC result of the first analysis will be displayed on the
screen.

14) Add 20L of control to the other centrifugal tube with diluent, close the tube cap and
shake the tube to mix the sample, and then present the centrifugal tube into the tube holder
with the cap opened to start the second running.

You can click the Cancel button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.

15) When the running is finished, the compartment door will open automatically and you can
remove the centrifugal tube.
7.

When finish running, the QC results (values of the two QC runs and the X mean) will be
displayed in the current screen and be saved in the QC file automatically.
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You can also dispense 180L of diluent by pipette into the tube.

Be sure to keep dust from the prepared diluent.

After mixing the control with the diluent, be sure to wait 3 minutes before
running.

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

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

Be sure to evaluate the predilute QC stability based on your laboratorys

sample population and sample collection techniques or methods.

Up to 300 QC results can be saved for each QC file.

When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.

8.

Up to 300 QC results (X mean) can be save for each QC file.

Do the above procedures to continue running the controls if necessary.

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Running Controls (AL-WB)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the autoloader or
getting the collection tubes from the autoloader, be sure not to break the
tubes.

The pusher will push the rack inside the autoloader. Be sure your hand is
away from the rack before starting the autoloader.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QCX mean on the pop-up
menu.

Enter the X mean graph screen.

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1.

Click the Run tab to enter the X mean run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is AL-WB and the analysis status icon and analyzer indicator is
green.
2) Click the Start button.

3) Present the prepared control into the rack.

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4) Place racks loading controls on the level of the right tray of the autoloader, with the back of
MINDRAY mark on the carrier facing the analyzer.
5) Press the [Run] key or click the Run button on the message box to start running.
6) When the racks are pushed out, you can remove the racks from the left of the autoloader.
7) After the analyzing is finished, the QC result of the first analysis will be displayed on the
screen.

8) Present the prepared control into the rack according to the prompt, and then place racks
loading controls on the level of the right tray of the autoloader, with the back of MINDRAY
mark on the carrier facing the analyzer, and then start the second running.

You can click the Cancel button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.

9) When the racks are pushed out, you can remove the racks from the left of the autoloader.

7.

Only one control can be run in a single running.

When finish running, the QC results (values of the two QC runs and the X mean) will be
displayed in the current screen and be saved in the QC file automatically.

When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.

8.

Up to 300 QC results (X mean) can be save for each QC file.

Do the above procedures to continue running the controls if necessary.

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Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to switch to the pervious or the next QC result.

You can click the

button or

button to switch to the earliest or the latest QC result

saved in the QC file.

The running result of the expired control will begin with an O mark.

The flag prompt H or L will appear in front of the X mean that out of the
limits.

The enlarging function is available to the scattergrams and histograms of

the screen. See details for operation in Chapter 7 Reviewing Sample
Results.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.

Print
Click the Print button to print the results of the current QC Run screen.

8.3.3 Reviewing QC Results

After running controls, you can review the QC results in the following two ways:

Graph

Table

Graph Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

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You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QC X mean on the pop-up
menu.

Enter the X mean graph screen.

1.

Select the QC file No. you want to review, and then the screen will display the
corresponding information and the graph.
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2.

You can drag the scroll bar on the right of the graph to browse the desired graph of the
parameter. You can drag the scroll bar down to the graph horizontally to browse all the
QC results.

Introduction to the Graph Screen

1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line.
3- The operator who run the QC analysis and obtained the QC points located on the green
line.
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- The QC points in each graph are displayed from left to right according to the sequence
from the earliest to the latest. The QC points are connected by a line to illustrate the
distribution trend.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
8- The relative position of the QC point located on the green line and the total QC points
saved currently.

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The value of the QC point is the X mean of each group of QC results.

The outliers are excluded from the calculation of Mean, SD and CV%.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.

Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

next QC point; you can click the

button to move the green line to the pervious or the

button or

button to move the green line to the first

or the last QC point in the graph. When the location of the green line is selected, you can
check the QC results of the QC points located on the green line under each parameter.

New Vial
If the reviewed QC results are obtained by analyzing a new vial of control of the same batch,
you should mark the QC points of the new vial to distinguish the QC results from the old.
1.

Move the green line to the first QC point of the new vial.

2.

Click the New Vial button, and then a blue line appears at the QC point of the new vial.

3.

After another new vial of control (of the same batch) is run and its QC results are saved,
you can continue to mark the current QC points of the new vial according to step 1 and 2.

4.

If the current QC point is marked with the blue line, the New Vial button turns into
Cancel, you can click the button to remove the blue line, then the Cancel button will
turn back to New Vial.

Data Compare
If you wish to compare the graphs of the certain parameter obtained by running controls of
different lot No., do as follows:
1.

Click the Data Compare button to start selecting the desired graph.

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2.

Select the desired QC file No. into the File No. box (3 files can be selected at most).
Then, the graph of the selected QC file will be displayed below together with its lot No.,
QC mode and level.

3.

Select the desired parameter into the Parameter box.

Browse the graph here the same way as instructed in the Graph screen.
Be aware that, for controls of different level, their graphs will be
distinguished by the color of orange, black and blue.

4.

Click the Print button to print the current comparison if necessary.

5.

Click the Close button to exit.

Display Order
Do as follows to adjust the display order of different graphs.
1.

Click the Display Order button to check the current display order of the graphs.

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2.

Click the parameter that you want to adjust.

3.

You can click the

you can click the

button or
button or

button to move parameter upward or downward;

button to move the parameter to the first or the last

position.
4.

Click the Ok button to refresh the display order of the graphs.

Save Preset Values

If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can
take the following steps to calculate and save the preset value for each parameter:
1.

Click the Calculate Preset Values button, and then the screen displays two lines for
you to select the range for calculating the preset values.

2.

Click and drag the two lines respectively to locate them at the beginning and the ending
of the range for calculating the preset values.

3.

The Mean, SD and CV% (on the right of the graph) will change into the new results
which obtained by calculating the selected range.

4.

If you wish to save the new results, you can click the Save Preset Values button to
save the current Mean, SD and CV% as the preset values for the corresponding level
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(high/normal/low).Then, the two selecting lines disappear and the Mean, SD and CV%
return to the calculated results of all QC results.

The calculation and display of the preset values are only available to the
parameter (within the calculation range) which has 3 or more than 3 results
within the limit. Otherwise, the display of the preset values will be empty.

According to the high, normal and low level of the controls, three sets of
preset values can be saved respectively.

Entering the Reasons for the Outliers

Do as follows to enter the reasons for the outliers:
1.

After moving the green line to the desired QC point, you can click the Outliers button to
display the QC results, targets and limits of all the parameters located on the green
line(the QC results exceed the limit will be displayed in red) and enter the reasons for the
outliers.

2.

You can select the reason form the given ones or enter the reasons (up to 200
characters) into the edit box manually after selecting Others.

3.

Click the Ok button to save the reasons for the outliers and exit.

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If you enter the reason for the group of QC points whose results are actually
within the limits, then their corresponding QC data both in the QC Graph and
QC Table will be displayed in the color of red. And the data will return in the
color of black if you cancel the reason and then save the changes.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

The operation of deletion will be recorded in the log.

Print
Click the Print button to print all the file information and graphs of the parameters of the
current QC file.

The green line and the corresponding values of the QC points will not be
printed.
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Table Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

You can enter the Table screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QC X mean on the pop-up
menu.

Enter the X mean graph screen.

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1.

Click the Table tab to enter the X mean table screen.

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2.

Select the QC file No. you want to review, and then the screen will display the
corresponding information and the table.

3.

You can drag the scroll bar on the right of the table vertically to browse the desired table
of the parameter. You can drag the scroll bar down to the table horizontally to browse all
the QC results.

Introduction to the Table Screen

1- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
2- QC Result
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: The flag H or L will be used to prompt the result (X mean) that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.

The value of the QC result is the X mean of each group of QC results.

For the QC files with saved QC results, if any change is made to the target or
the limits, the changed data will be highlighted in yellow.

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Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to highlight the pervious or the next QC result;

you can click the

button or

button to highlight the first or the last QC result in the

table.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, click the column contains the desired QC result;
if you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

The operation of deletion will be recorded in the log.

Print
You can take the following steps to print the Table:
1.

Click the Print button, and then you can select All Data or Specified Data to be
printed.

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2.

Click the All Data button and then click the Ok button to print all the file information
and tables of the parameters of the current QC file; after clicking the Specified Data
button, you can select the starting and finishing date (the saved date of the QC results)
for printing, then click the Ok button to print the specified data.

Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1.

Click the Communication button, and then you can select All Data or
Specified Data to be transmitted.

2.

Click the All Data button and then click the Start button to transmit the
information of the current QC file and QC data. After clicking the Specified Data
button, you can specify a date range (the date when the QC result was saved), then
click the Ok button to transmit the specified data. The LIS/HIS connected icon on
the status bar of the screen will flicker during transmission.
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3.

While transmitting, the Start button in the pop-up message box will be replaced by
Stop. You can click the Stop button to stop transmitting.

If auto-communication is enabled and a sample is ran during the

transmission of the QC data, then only when the QC data transmission
finished will the auto-communication of the sample result starts.

The QC data saved in the process of transmission will not be transmitted.

Data Backup

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the data backup function, you
should log on the system as administrator, and then right click the shortcut
icon of the terminal software and run it as administrator.

If you wish to backup the information and the result of the current QC file, do as follows:
1.

Click the Data Backup button, a message box will pop up.

2.

Select the backup directory (the default directory is the folder of QC Data under the

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installation location of the terminal software).
3.

Enter the name for the backup data (the default name is [X_QC_date saved_time
saved]).

4.

Click the Save button to start backing up.

5.

When the backup is finished, a message box will pop up, and then click Ok to exit.

The backup data can not be modified. You can review the data in History
screen.

You can click the Cancel button to cancel backup when it is in process.

Be sure to backup data regularly.

Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1.

Click the Data Export button, and then a message box will pop up.

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2.

Select the export directory (the default directory is the folder of QC Data under the
installation location of the terminal software).

3.

Enter the name for the export data (the default name is [X_QC_date saved_time
saved]).

4.

Select the format for the export file.(default format: . CSV)

5.

Click the Save button to start exporting.

6.

When the export is finished, a message box will pop up, and then click Ok to exit.

You can modify the exported data but can not review the data in the
History screen.

You can click the Cancel button to cancel export when it is in process.

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History

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the history function, you should
log on the system as administrator, and then right click the shortcut icon of
the terminal software and run it as administrator.

If you wish to review the backed up data, do as follows:

1.

Click the History button, and then a message box will pop up.

2.

Locate and then select the desired backup data.

3.

Click the Open button to display the data in History screen.

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4.

The display format and the function button are the same as the QC Table review screen.
Browse, print, transmit and export the data as instructed in the section of QC Table
Review.

5.

After reviewing, click the Close button to exit.

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8.4 X mean R QC Program

8.4.1 Editing the X mean R Settings

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

Only administrators can edit the X mean R QC settings.

Before analyzing the new lot of controls, you should set a QC file for each lot of controls and
you can edit the QC settings in the QC file by the following way:

Manual entry

Manual Entry
You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QCX mean R on the pop-up
menu.

Enter the X mean R graph screen.

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1.

Click the Settings tab to enter the X mean R setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

Select a QC File No. with empty QC information.

You can select the file No. within the range [1, 60].

3.

You can enter the lot No. of the controls by one of the following ways:

Manual entry

Entering by external barcode scanner

The lot No. can not be empty and up to 16 digits can be entered. You can
enter characters, numbers, letters and special characters, but no Chinese
characters allowed.

4.

Different QC files can not have the same lot No. and QC mode.

Enter the batch expiration date of the controls.

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You must enter the expiration date, and the entry range is [current system
date, 2099-12-31].

5.

Select the QC mode.

Different QC files can not have the same lot No. and QC mode.

6.

Select the control level.

7.

Click the Save button to save all the settings of the QC.

Print
Click the Print button to print the setting information of the current QC file.

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8.4.2 Running Controls

After editing the QC information, you can start one of the following QC analyses according to
the selected QC mode.

CT-WB

CT-PD

AL-WB

Running Controls (CT-WB)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

If the sample mode is switched from the Predilute to Whole Blood, the
analyzer will perform the switching sequence automatically and a progress
bar will be displayed on the screen.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QCX mean R on the pop-up
menu.

Enter the X mean R graph screen.

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1.

Click the Run tab to enter the X mean R run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

Be sure to use the adapter of 13x75 (mm) model when running the QC in
CT-WB mode. For details to install the adapter, see Chapter 6 Operating Your
Analyzer.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is CT-WB and the analysis status icon and analyzer indicator is
green.
2) Shake the prepared control as shown below to well mix it.

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3) Click the Start button.

4) Press the [OPEN] key to open the compartment door.

5) Present the prepared control into the tube holder and then close the compartment door.
6) Press the [Run] key or click the Run button on the message box to start running.
7) When the running is finished, the compartment door will open automatically and you can
remove the control.
8) After the analyzing is finished, the QC result of the first analysis will be displayed on the
screen.

9) Mix the control well again, and then to run the controls for the second time according to the
prompt.
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You can click the Cancel button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.

10) When the running is finished, the compartment door will open automatically and you can
remove the control.
7.

When finish running, the QC results (values of the two QC runs, X mean and range R)
will be displayed in the current screen and be saved in the QC file automatically.

When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.

8.

Up to 300 QC results (X mean and range R) can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

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Running Controls (CT-PD)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Be sure to place the collection tubes in the right adapter before running,
otherwise, the collection tubes may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

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Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QC X mean R on the
pop-up menu.

Enter the X mean R graph screen.

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1.

Click the Run tab to enter the X mean R run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

Be sure to use the adapter of 11x40 (mm) model when running the QC in
CT-PD mode. For details to install the adapter, see Chapter 6 Operating Your
Analyzer.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is CT-PD and the analysis status icon and analyzer indicator is
green.
2) Click the shortcut button Diluent, the compartment door will open automatically. A
message box shown below will pop up.

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3) Present a clean centrifugal tube into the sample compartment with the cap opened. Press
the [RUN] key to dispense 180L of diluent into the tube. During dispensing the diluent, a
progress bar will display.

If the current mode is autoloader, the analyzer will switch to the close-tube
mode automatically and then dispense the diluent. Then, the mode will be
switched back to autoloader when exiting.

4) When the dispensing is finished, the compartment door will open automatically and you
can remove the centrifugal tube. Then, the following message box will display.

5) Prepare one more diluent according to procedure 3) to 4).

6) Add 20L of control to the diluent, close the tube cap and shake the tube to mix the
sample.
7) Click the Cancel button to exit the Diluent message box.

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8) After the cleaning is finished, close the prompt.
9) Click the Start button.

10) Present the centrifugal tube into the tube holder with the cap opened and then close the
compartment door.
11) Press the [Run] key or click the Run button on the message box to start running.
12) When the running is finished, the compartment door will open automatically and you can
remove the centrifugal tube.
13) After the analyzing is finished, the QC result of the first analysis will be displayed on the
screen.

14) Add 20L of control to the other centrifugal tube with diluent, close the tube cap and
shake the tube to mix the sample, and then present the centrifugal tube into the tube holder
with the cap opened to start the second running.

You can click the Cancel button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.

15) When the running is finished, the compartment door will open automatically and you can
remove the centrifugal tube.
7.

When finish running, the QC results (values of the two QC runs, X mean and range R)
will be displayed in the current screen and be saved in the QC file automatically.
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You can also dispense 180L of diluent by pipette into the tube.

Be sure to keep dust from the prepared diluent.

After mixing the control with the diluent, be sure to wait 3 minutes before
running.

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

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

Be sure to evaluate predilute QC stability based on your laboratorys sample

population and sample collection techniques or methods.

Up to 300 QC results can be saved for each QC file.

When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.

8.

Up to 300 QC results (X mean and range R) can be saved for each QC file.

Do the above procedures to continue running the controls if necessary.

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Running Controls (AL-WB)

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

The sample may spill from the unclosed collection tubes and cause
biohazard. Exercise caution to the unclosed collection tubes.

Be sure to avoid reversing the collection tube when loading, otherwise, the
collection tube may be broken and cause biohazard.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the rack or getting the
collection tubes from the rack, be sure not to break the tubes.

Collection tubes broken may cause personal injury and/or biohazard.

Exercise caution when loading the collection tubes to the autoloader or
getting the collection tubes from the autoloader, be sure not to break the
tubes.

The pusher will push the rack inside the autoloader. Be sure your hand is
away from the rack before starting the autoloader.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

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

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

capillary tubes, etc.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QC X mean R on the
pop-up menu.

Enter the X mean R graph screen.

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1.

Click the Run tab to enter the X mean R run screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

Select the QC file No. to be run; the screen displays the corresponding file information.

3.

Be sure that the level of the control to be run is the same with the current QC file.

4.

Be sure that the control to be run is not expired.

5.

Prepare the control as instructed by instructions for use of the controls.

6.

Run the controls:

1) Make sure the QC mode is AL-WB and the analysis status icon and analyzer indicator is
green.
2) Click the Start button.

3) Present the prepared control into the rack.

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4) Place racks loading controls on the level of the right tray of the autoloader, with the back of
MINDRAY mark on the carrier facing the analyzer.
5) Press the [Run] key or click the Run button on the message box to start running.
6) When the racks are pushed out, you can remove the racks from the left of the autoloader.
7) After the analyzing is finished, the QC result of the first analysis will be displayed on the
screen.

8) Present the prepared control into the rack according to the prompt, and then place racks
loading controls on the level of the right tray of the autoloader, with the back of MINDRAY
mark on the carrier facing the analyzer, and then start the second running.

You can click the Cancel button in the message box to cancel the second
run and the results obtained in the first run will not be saved as well.

9) When the racks are pushed out, you can remove the racks from the left of the autoloader.

7.

Only one control can be run in a single running.

When finish running, the QC results (values of the two QC runs, X mean and range R)
will be displayed in the current screen and be saved in the QC file automatically.

When the QC result of the second QC run is obtained, the screen will refresh
the displayed histograms and scattergrams according to the second QC
run.

Up to 300 QC results (X mean and range R) can be saved for each QC file.

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8.

Do the above procedures to continue running the controls if necessary.

Browse the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to switch to the pervious or the next QC result.

You can click the

button or

button to switch to the earliest or the latest QC result

saved in the QC file.

The running result of the expired control will begin with an O mark.

If 10 batches of QC results (20 times of QC runs) are obtained, the flag

prompt H or L will appear in front of the X mean and R that are out of the
limits.

The enlarging function is available to the scattergrams and histograms of

the screen. See details for operation in Chapter 7 Reviewing Sample
Results.

Print
Click the Print button to print the results of the current QC Run screen.

8.4.3 Reviewing QC Results

After running controls, you can review the QC results in the following two ways:

Graph

Table

Graph Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

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You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QC X mean R on the
pop-up menu.

Enter the X mean R graph screen.

1.

Select the QC file No. you want to review, and then the screen will display the
corresponding information and the graph.
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2.

You can drag the scroll bar on the right of the graph to browse the desired graph of the
parameter. You can drag the scroll bar down to the graph horizontally to browse all the
QC results.

Introduction to the Graph Screen

1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line.
3- The operator who run the QC analysis and obtained the QC points located on the green
line
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- The QC points in each graph are displayed from left to right according to the sequence
from the earliest to the latest. The QC points are connected by a line to illustrate the
distribution trend.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
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8- The relative position of the QC point located on the green line and the total QC points
saved currently.

The graphs for different parameters will be provided only after 10 batches of
QC results (20 times of QC runs) are obtained.

The values of the QC point are the X mean and range R of each batch of QC
results.

The outliers are excluded from the calculation of Mean, SD and CV%.

Browsing the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

next QC point; you can click the

button to move the green line to the pervious or the

button or

button to move the green line to the first

or the last QC point in the graph. When the location of the green line is selected, you can
check the QC results of the QC points located on the green line under each parameter.

New Vial
If the reviewed QC results are obtained by analyzing a new vial of control of the same batch,
you should mark the QC points of the new vial to distinguish the QC results from the old.
1.

Move the green line to the first QC point of the new vial.

2.

Click the New Vial button, and then a blue line appears at the QC point of the new vial.

3.

After another new vial of control (of the same batch) is run and its QC results are saved,
you can continue to mark the current QC points of the new vial according to step 1 and 2.

4.

If the current QC point is marked with the blue line, the New Vial button turns into
Cancel, you can click the button to remove the blue line, then the Cancel button will
turn back to New Vial.

Data Compare
If you wish to compare the graphs of the certain parameter obtained by running controls of
different lot No., do as follows:
1.

Click the Data Compare button to start selecting the desired graph.

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2.

Select the desired QC file No. into the File No. box (3 files can be selected at most).
Then, the graph of the selected QC file will be displayed below together with its lot No.,
QC mode and level.

3.

Select the desired parameter into the Parameter box.

Browse the graph here the same way as instructed in the Graph screen.
Be aware that, for controls of different level, their graphs will be
distinguished by the color of orange, black and blue.

4.

Click the Print button to print the current comparison if necessary.

5.

Click the Close button to exit.

Display Order
Do as follows to adjust the display order of different graphs.
1.

Click the Display Order button to check the current display order of the graphs.

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2.

Click the parameter that you want to adjust.

3.

You can click the

you can click the

button or
button or

button to move parameter upward or downward;

button to move the parameter to the first or the last

position.
4.

Click the Ok button to refresh the display order of the graphs.

Entering the Reasons for the Outliers

Do as follows to enter the reasons for the outliers:
1.

After moving the green line to the desired QC point, you can click the Outliers button to
display the QC results, total mean and average range of all the parameters located on
the green line (the QC results exceed the limit will be displayed in red) and enter the
reasons for the outliers.

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2.

You can select the reason form the given ones or enter the reasons (up to 200
characters) into the edit box manually after selecting Others.

3.

Click the Ok button to save the reasons for the outliers and exit.

If you enter the reason for the group of QC points whose results are actually
within the limits, then their corresponding QC data both in the QC Graph and
QC Table will be displayed in the color of red. And the data will return in the
color of black if you cancel the reason and then save the changes.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

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3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

The operation of deletion will be recorded in the log.

Print
Click the Print button to print all the file information and graphs of the parameters of the
current QC file.

The green line and the corresponding values of the QC points will not be
printed.

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Table Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

You can enter the Table screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen, and then select QC X mean R on the
pop-up menu.

Enter the X mean R graph screen.

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1.

Click the Table tab to enter the X mean R table screen.

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2.

Select the QC file No. you want to review, and then the screen will display the
corresponding information and the table.

3.

You can drag the scroll bar on the right of the table vertically to browse the desired table
of the parameter. You can drag the scroll bar down to the table horizontally to browse all
the QC results.

Introduction to the Table Screen

1- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
2- QC Result
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: If 10 batches of QC results (20 times of QC runs) are obtained, the flag H or L
will be used to prompt the result (X mean) that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.

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The total mean, average range and flag prompt for the parameters will be
provided only after 10 batches of QC results (20 times of QC runs) are
obtained.

The values of the QC result are the X mean and the range R of each batch of
QC results.

Browsing the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to highlight the previous or the next QC result;

you can click the

button or

button to highlight the first or the last QC result in the

table.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, click the column contains the desired QC result;
if you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

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The operation of deletion will be recorded in the log.

Print
You can take the following steps to print the Table:
1.

Click the Print button, and then you can select All Data or Specified Data to be
printed.

2.

Click the All Data button and then click the Ok button to print all the file information
and tables of the parameters of the current QC file; after clicking the Specified Data
button, you can select the starting and finishing date (the saved date of the QC results)
for printing, then click the Ok button to print the specified data.

Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1.

Click the Communication button, and then you can select All Data or
Specified Data to be transmitted.

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2.

Click the All Data button and then click the Start button to transmit the
information of the current QC file and QC data. After clicking the Specified Data
button, you can specify a date range (the date when the QC result was saved), then
click the Ok button to transmit the specified data. The LIS/HIS connected icon on
the status bar of the screen will flicker during transmission.

3.

While transmitting, the Start button in the pop-up message box will be replaced by
Stop. You can click the Stop button to stop transmitting.

If auto-communication is enabled and a sample is ran during the

transmission of the QC data, then only when the QC data transmission
finished will the auto-communication of the sample result starts.

The QC data saved in the process of transmission will not be transmitted.

Data Backup

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the data backup function, you
should log on the system as administrator, and then right click the shortcut
icon of the terminal software and run it as administrator.

If you wish to backup the information and the result of the current QC file, do as follows:
1.

Click the Data Backup button, a message box will pop up.

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2.

Select the backup directory (the default directory is the folder of QC Data under the
installation location of the terminal software).

3.

Enter the name for the backup data (the default name is [X-R_QC_date saved_time
saved]).

4.

Click the Save button to start backing up.

5.

When the backup is finished, a message box will pop up, and then click Ok to exit.

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The backup data can not be modified. You can review the data in History
screen.

You can click the Cancel button to cancel backup when it is in process.

Be sure to backup data regularly.

Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1.

Click the Data Export button, and then a message box will pop up.

2.

Select the export directory (the default directory is the folder of QC Data under the
installation location of the terminal software).

3.

Enter the name for the export data (the default name is [X-R_QC_date saved_time
saved]).

4.

Select the format for the export file.(default format: . CSV)

5.

Click the Save button to start exporting.

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6.

When the export is finished, a message box will pop up, and then click Ok to exit.

You can modify the exported data but can not review the data in the
History screen.

You can click the Cancel button to cancel export when it is in process.

History

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the history function, you should
log on the system as administrator, and then right click the shortcut icon of
the terminal software and run it as administrator.

If you wish to review the backed up data, do as follows:

1.

Click the History button, and then a message box will pop up.

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2.

Locate and then select the desired backup data.

3.

Click the Open button to display the data in History screen.

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4.

The display format and the function button are the same as the QC Table review screen.
Browse, print, transmit and export the data as instructed in the section of QC Table
Review.

5.

After reviewing, click the Close button to exit.

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8.5 X-B QC Program

8.5.1 X-B QC Principles
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.

8.5.2 Editing X-B Settings

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

Only administrators can edit the X-B QC settings.

At the X-B QC setting screen, you can edit the QC information and configure the sample
validity setup.

Editing the QC information

Before the X-B analysis, you should finish editing the QC information by one of the following
ways:

Manual entry

Reading the saved preset values

Manual Entry
You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

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Click the Menu button on the screen; then select QCX-B on the pop-up menu.

Enter the X-B graph screen.

1.

Click the Settings tab to enter the X-B setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

In the Samples/Batch edit box, you can enter the amount of samples [within the range
20(recommended) to 200] to be included in calculating for an X-B QC point.

3.

Click the Open button of X-B to open the X-B QC, and from the time on, all the
samples results will be included to calculate the X-B.

4.

Enter the target and Limits for the QC parameters.

All the targets and limits for the QC parameters shall be entered without
empty.

When first use, the default setting will provide the Initial values for the
targets and limits of the three QC parameters.

If the QC data have existed in the QC file, you are not allowed to edit the
target and limits.

5.

Click the Save button to save all the settings of the QC.

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Reading the Saved Preset Values

If there are the saved preset values (Target and Limits) for the X-B QC, you
can read-in the preset values into the X-B QC file. For details of calculating
and saving the preset values, see Section 8.5.3 Reviewing QC results.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCX-B on the pop-up menu.

Enter the X-B graph screen.

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1.

Click the Settings tab to enter the X-B setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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2.

In the Samples/Batch edit box, you can enter the amount of samples [within the range
20(recommended) to 200] to be included in calculating for an X-B QC point.

3.

Click the Open button of X-B to open the X-B QC, and from the time on, all the
samples results will be included to calculate the X-B.

4.

Click the Have Preset Values button to read-in the saved preset target and limits into
the X-B QC file.

All the targets and limits for the QC parameters shall be entered without
empty.

If some QC parameters have no preset values, you should enter the target
and limits for them manually.

If the QC data have existed in the QC file, you are not allowed to have the
preset values.

5.

Click the Save button to save all the settings of the QC.

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Setting Limits
Do as followings to adjust the display format of the limits and the calculation method of the
preset limits.
1.

Click the Set Limits button, and then the following message box will pop up.

2.

Click By SD to display the limits in the form of absolute value; click By CV to display
the limits in the form of percentage.

3.

If By SD is selected, click the 2SD or 3SD to select either double or triple standard
deviation to be the limits; if By CV is selected, click the 2CV or 3CV to select either
double or triple coefficient of variation to be the limits.

4.

Click the Ok button to save all the settings for the limits.

Restoring Defaults
When editing the QC settings, if you wish to restore the target and limits to the defaults, you
can click the Restore Default button to read-in the defaults to the X-B QC file.

The default target for each parameter:

MCV: 89.5fL
MCH: 30.5pg
MCHC: 340g/L

The default limits for each parameter:

MCV: 2.7 fL
MCH: 0.9 pg
MCHC: 10 g/L

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If the QC data have existed in the QC file, you are not allowed to restore
defaults.

Setting Sample Validity

In X-B QC, sample results conforming to any of the following conditions will be considered as
invalid and can not be used in the QC calculation.
1.

Sample results exceeding the linearity range;

2.

Background results;

3.

Sample results not conforming to the "Sample Validity Setup";

4.

QC data for other QC programs (L-J QC, X mean QC or X mean R QC);

5.

Calibration data;

6.

Results generated while there are errors which could affect the accuracy of the results
(insufficient aspiration volume or clogging for example).

"Sample Validity Setup" is to set up the ranges of valid RBC, MCV, MCH and MCHC results.
Only when the results of all these four parameters are within the specified ranges, the sample
results can be used for X-B QC calculation. Do as follows to set the sample validity:
1.

Enter the graph screen using one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCX-B on the pop-up menu.

Enter the X-B graph screen.

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2.

Click the Settings tab to enter the X-B setup screen.

For details to edit the name of the login user, see chapter 5 Customizing the
Analyzer Software.

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3.

Set the upper and lower limits of the four parameters in the "Sample Validity Setup"
area.

4.

Click "Save" to save the sample validity settings.

5.

If any value you entered is out of range or any upper limit entered is less than the
corresponding lower limit, the following message box will pop up when you click the
"Save" button.

6.

Click "Ok" to go to the QC setting screen and modify the invalid values.

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The default validity ranges for the four parameters are:

1.01012/LRBC8.01012/L
50fLMCV150fL
20pgMCH40pg
240g/LMCHC440g/L

The validity entry range for RBC is its linearity range, and the validity entry
ranges for other three parameters are those of their display ranges.

All the entries should be numbers with only one decimal point, and the
entries should be restricted to the length of the edit boxes.

Once the validity range is changed, the previous results will not be used in
the QC calculation as valid results, for example, if 20 valid samples are
needed for the X-B QC calculation, when you change the validity range after
10 groups of valid sample results have been acquired, these 10 groups of
results will be discarded, and only valid sample results generated
afterwards will be used in the QC calculation.

Print
Click the Print button to print the setting information of the current QC file.

8.5.3 Running Controls

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

After editing the X-B settings, the system will start the X-B run automatically.
After every 20~200 results (determined by the setting) are obtained, the system will perform
the X-B calculation once automatically. You can review the result in X-B graph or X-B table.

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8.5.4 Reviewing QC Results

After the X-B analysis, you can review the QC results in the following two ways:

Graph

Table

Graph Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

You can enter the graph screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCX-B on the pop-up menu.

Enter the X-B graph screen.

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You can drag the scroll bar down to the graph horizontally to browse all the QC results.

Introduction to the Graph Screen

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1- The Mean, SD and CV% of all the QC results of each parameter in the current graph.
2- The saving date and time of the QC points located on the green line
3- The QC points in each graph are displayed from left to right according to the sequence
from the earliest to the latest. The QC points are connected by a line to illustrate the
distribution trend.
4- The QC results of the parameters that correspond to the QC points located on the green
line.
5- When you clicking a QC point in the graph, the QC points of other parameters that saved
together with this one will be marked by a green line.
6- The QC point corresponds to each QC result. Only the selected QC point displays its value
under the parameter. The black QC point indicates the value is within the limit; the red QC
point indicates the value is out of the limit.
7- The relative position of the QC point located on the green line and the total QC points
saved currently.

The value of the outlier is the X-B result of each batch of samples.

The outliers are excluded from the calculation of Mean, SD and CV%.

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Browsing the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

next QC point; you can click the

button to move the green line to the previous or the

button or

button to move the green line to the first

or the last QC point in the graph. When the location of the green line is selected, you can
check the QC results of the QC points located on the green line under each parameter.

Saving Preset Values

If there are 3 or more than 3 QC results within the limits obtained for the parameters, you can
take the following steps to calculate and save the preset value for each parameter:
1.

Click the Calculate Preset Values button, and then the screen displays two lines for
you to select the range for calculating the preset values.

2.

Click and drag the two lines respectively to locate them at the beginning and the ending
of the range for calculating the preset values.

3.

The Mean, SD and CV% (on the right of the graph) will change into the new results
which obtained by calculating the selected range.

4.

If you wish to save the new results, you can click the Save Preset Values button to
save the current Mean, SD and CV% as the preset values for the corresponding level
(high/normal/low). Then, the two selecting lines disappear and the Mean, SD and CV%
return to the calculated results of all QC results.

The calculation and display of the preset values are only available to the
parameter (within the calculation range) which has 3 or more than 3 results
within the limit. Otherwise, the display of the preset values will be empty.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, move the green line to the desired QC result; if
you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

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3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

The operation of deletion will be recorded in the log.

Print
Click the Print button to print all the file information and graphs of the parameters of the
current QC file.

The green line and the corresponding values of the QC points will not be
printed.

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Table Review

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

You can enter the Table screen in one of the following ways:

Click the shortcut button QC.

Click the Menu button on the screen; then select QCX-B on the pop-up menu.

Enter the X-B graph screen.

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1.

Click the Table tab to enter the X-B table screen.

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2.

You can drag the scroll bar down to the table horizontally to browse all the QC results.

Introduction to the Table Screen

1- QC Result
2- The No. of the QC result saved in the QC file (arranged from left to right in the order that
from the earliest to the latest)
3- QC parameters (displayed in the same order as the Graph screen)
4- QC flag: The flag H or L will be used to prompt the result that out of the limits
5- The relative position of the highlighted QC point and the total QC points saved currently.

The value of the QC result is the X-B result of each batch of samples.

Browsing the QC Result

You can click the arrow button in the bottom of the screen to browse the QC result saved in
the current QC file.
You can click the

button or

button to highlight the previous or the next QC result;

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you can click the

button or

button to highlight the first or the last QC result in the

table.

Delete
The administrator can delete the QC results by the following steps:
1.

If you wish to delete a single QC result, click the column contains the desired QC result;
if you wish to delete all the data, perform step 2 directly.

2.

Click the Delete button to select Current Data or All Data.

3.

Click the data you want to delete.

4.

Click the Ok button and then confirm to delete the selected data.

The operation of deletion will be recorded in the log.

Print
You can take the following steps to print the Table:
1.

Click the Print button, and then you can select All Data or Specified Data to be
printed.

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2.

Click the All Data button and then click the Ok button to print all the file information
and tables of the parameters of the current QC file; after clicking the Specified Data
button, you can select the starting and finishing date (the saved date of the QC results)
for printing, then click the Ok button to print the specified data.

Communication
If you wish to transmit the QC data to the external data management software or LIS/HIS, do
as follows:
1.

Click the Communication button, and then you can select All Data or
Specified Data to be transmitted.

2.

Click the All Data button and then click the Start button to transmit the
information of the current QC file and QC data. After clicking the Specified Data
button, you can specify a date range (the date when the QC result was saved), then
click the Ok button to transmit the specified data. The LIS/HIS connected icon on
the status bar of the screen will flicker during transmission.
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3.

While transmitting, the Start button in the pop-up message box will be replaced by
Stop. You can click the Stop button to stop transmitting.

If auto-communication is enabled and a sample is ran during the

transmission of the QC data, then only when the QC data transmission
finished will the auto-communication of the sample result starts.

The QC data saved in the process of transmission will not be transmitted.

Data Backup

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the data backup function, you
should log on the system as administrator, and then right click the shortcut
icon of the terminal software and run it as administrator.

If you wish to backup the information and the result of the current QC file, do as follows:
1.

Click the Data Backup button, a message box will pop up.

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2.

Select the backup directory (the default directory is the folder of QC Data under the
installation location of the terminal software).

3.

Enter the name for the backup data (the default name is [X-B_QC_date saved_time
saved]).

4.

Click the Save button to start backing up.

5.

When the backup is finished, a message box will pop up, and then click Ok to exit.

The backup data can not be modified. You can review the data in History
screen.

You can click the Cancel button to cancel backup when it is in process.

Be sure to backup data regularly.

Data Export
If you wish to export the information and the result of the current QC file, do as follows:
1. Click the Data Export button, and then a message box will pop up.

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2. Select the export directory (the default directory is the folder of QC Data under the
installation location of the terminal software).
3. Enter the name for the export data (the default name is [X-B_QC_date saved_time
saved]).
4. Select the format for the export file. (Default format: . CSV)
5. Click the Save button to start exporting.

6. When the export is finished, a message box will pop up, and then click Ok to exit.

You can modify the exported data but can not review the data in the
History screen.

You can click the Cancel button to cancel export when it is in process.

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History

For operating system of Windows Vista, the right of copying database file is
restricted by users' access level. To enable the history function, you should
log on the system as administrator, and then right click the shortcut icon of
the terminal software and run it as administrator.

If you wish to review the backed up data, do as follows:

1.

Click the History button, and then a message box will pop up.

2.

Locate and then select the desired backup data.

3.

Click the Open button to display the data in History screen.

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4.

The display format and the function button are the same as the QC Table review screen.
Browse, print, transmit and export the data as instructed in the section of QC Table
Review.

5.

After reviewing, click the Close button to exit.

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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: manual calibration, auto
calibration using calibrators and auto calibration using fresh blood samples.
All the parameters or part of the parameters of WBC, RBC, HGB, MCV and PLT can be
calibrated by the calibration procedure.

Calibration

procedures

can

only

be

performed

by

users

of

the

administrator-level.

You should only use the ourspecified calibrations and reagents. Store and
use the calibrations and reagents as instructed by instructions for use of the
calibrations and reagents.

The analyzer identifies a sample as a calibration sample only if the analysis

is started from the Calibration screen.

The calculation of reproducibility is included in the calibration procedure.

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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 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.

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

analyzer can be used as valid analysis results.

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9.3 How to Calibrate

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 our 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 12 Troubleshooting Your Analyzer for solutions.

Run a vial of normal control in the CT-WB-CBC+DIFF mode for 11 consecutive times. Enter
the TABLE screen to check the reproducibility of the second to eleventh runs and make sure
they meet the following requirements.
Whole
Parameter

Condition

Predilute

Reproducibility

Reproducibility

(CV%)

(CV%)

(4.0-15.0)10 /L

2.0%

4.0%

12

WBC

Blood

RBC

(3.50-6.00)10 /L

1.5%

3.0%

HGB

(110-180)g/L

1.5%

3.0%

MCV

(70-120)fL

1.0%

2.0%

4.0%

8.0%

PLT
3.

(150-500)10 /L

Run a vial of high control three consecutive times and then immediately run the diluent
three consecutive times. Calculate the carryover per the following equation.

Carryover(%)

First low - level sample resultThird low - level sample result

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

The calculated carryovers shall meet the requirements in the following table.
Parameter

Carryover

WBC

0.5

RBC

0.5

HGB

0.6

HCT

0.5

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

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number, expected results and limits, and result of background check.

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

The sample probe is sharp and potentially biohazardous, Exercise caution

to avoid contact with the probe when working around it.

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

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.

Keep you clothed, hairs and hands away from the moving parts to avoid
injury.

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

according to government regulations.

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

capillary tubes, etc.

You should only use the ourspecified controls and reagents. Store and use
the controls and reagents as instructed by instructions for use of the
controls and reagents.

Be sure to use the ourspecified disposable products including evacuated

blood collection tube, anticoagulant collection tubes and capillary tubes etc.

Be sure to use the evacuated blood collection tubes as specified in the

appendix.

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9.3.2 Manual Calibration

Do as follows to calibrate the analyzer:
1.

Click Menu, select Calibration to enter the Calibration Factors screen. The
calibration factors of whole blood mode and predilute mode are displayed at the
Calibration Factors screen.

The login users of common-level can not perform the calibration procedures
but only browse the calibration factors at the current screen. To perform the
calibration, please logout and then login as users of administrator-level.

2.

Enter the Calibration Factors screen to check the calibration factors and calculate the
new factors per the following equation.

New calibration factor

Current calibration factor Reference value

Mean

For example: Supposed the WBC reference value of a calibrator is 8.4, 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
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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.
The new calibration factor is obtained:

New calibration factor

98.90% 8.4
101.81%
8.16

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.

The entered calibration factors shall be between 75.0 - 125.0 (calculate

to two decimal places).

3.

Enter the new calibration factors into the factor cell of the parameter that requires
calibration.

4.

After the entry, click the Save button at the bottom of the screen. If the new calibration
factors are valid and different from the originals, a message box shown below will pop
up.

Click Yes to save the news calibration factors and the calibration date of the corresponding
parameter changes to the current system date. Then, close the message box and return to
the Calibration Factors screen without any cell being highlighted.
If the new calibration factors are invalid, the message box will pop up.

Click Ok to close the message box and the cell of the first invalid calibration factors is
highlighted with the data displayed.
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5.

After the calibration factors are modified, a prompt will show if you switch to another
screen without clicking the Save button.

If the entered calibration factors are valid, the message box will pop up when you exiting
the screen.

Click Yes to save the news calibration factors and the calibration date of the corresponding
parameter changes to the current system date and be recorded in the history; then, close the
message box and switch to another screen.

If the entered calibration factors are invalid, the message box will pop up when you
switching to another the screen.

Click Yes to close the message box and switch to another screen without saving; keep the
original calibration factors and date.

Other Operations

Restore

Click the Restore button to restore the calibration factors to the values displayed when you
entering the Calibration Factors screen.

Print

If the calibration factors have not been changed, click the Print button to print the current
calibration factors.
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If the changed calibration factors are invalid, then a message box will pop up when you
clicking the Print button.

Click Ok, then the cell of the first invalid calibration factors will be highlighted and the data in
the cell will not be cleared.
If the changed calibration factors are valid but have not been saved, then a message box will
pop up when you clicking the Print button.

Click Yes to close the message box and save the new calibration factors and date, and then
print the new calibration factors; click No to close the message box without saving the
calibration factors and date, and then print the saved calibration factors before editing.

9.3.3 Auto Calibration Using Calibrators

Do as follows to calibrate the analyzer with calibrators.
1.

Click the Menu button, and then select Calibration to enter the Calibration
Factors screen.

2.

At the Calibration Factors screen, click the Calibrator tab to enter the Calibrator
screen.

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Only in the Whole Blood Mode can the calibration using calibrators be ran.

The default Exp. Date is the current system date.

3.

Enter the lot No. of the calibrator into the Lot No. box.

4.

Enter the expiration date. The default Exp. Date is the current system date. You can
click the Exp. Date box, and then edit the date.

5.

Select the parameter to be calibrated from the check box on the first line of the list.

6.

Enter the target into the edit box Target.

All the samples, controls, calibrators, reagents, wastes and areas contacted
them are potentially biohazardous. Wear proper personal protective
equipment (e.g. gloves, lab coat, etc.) and follow safe laboratory procedures
when handling them and the contacted areas in the laboratory.

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Only ourspecified calibrators shall be used. our will not be responsible for
any error result caused by using other calibrators.

See the instructions for use of the calibrators for the lot No., expiration date
and the target.

The lot No. must be entered.

The expiration date can not be earlier than the current system date.

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.

7.

Prepare the calibrator as instructed by instructions for use of the calibrators.

8.

Click the Start button, and then a message box will pop up.

Press the [RUN] key or click the Run button to start the calibration and the message box will
close automatically, and then a progress bar will pop up.

Once you click the Start button and press the [RUN] key to start the first
run, the Start button will be displayed in gray. Then, you can directly press
the [RUN] key to continue the calibration.

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9.

After every calibration run, the progress bar will close automatically and the analyzer will
have different responses according to different analysis results.

When the current running is done, if there is a parameter whose calibration data is out of
its linear range but still within the display range, then the calibration data will be
displayed in the list and a message box will also pop up.

Click Ok to close the message box and delete the data from the table without saving.

When the running is done, if there is a parameter whose calibration data is out of the
display rage, then the non-numeric parameter values *** will be displayed in the list and
a message box will pop up.

Click Ok to close the message box and delete the data from the table without saving.

The valid results within the linear range will be displayed directly.

When the valid result is obtained, it will be selected to be included in the

calculation for the calibration factors.

10. If the calibration factors have not been calculated but you switch to another screen, then
a message box will pop up.

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Click Yes to switch to another screen while aborting the calibration data and closing the
message box. The original calibration factors remain.
11. When the amount of the valid calibration reaches N (N 6), the analyzer will
automatically calculate the mean, CV% and new calibration factors with all the selected
data ( the first data is excluded).
You can also select the desired data (5 at least) to calculate the calibration factors. Every time
when you select or de-select a data by clicking the check box, the calibration factors will be
refreshed immediately.

The out-of-range CV% does not influence the display of the calibration
factors.

When the amount of the valid calibration data in the list reaches 11, a
message box of Calibrator calibration done! will pop up. Then, if you
press the [RUN] key again, the analyzer will beep and does not response.

12. There may be two cases when you switching to another screen:

If the calculated calibration factor of any parameter is out of the range [75%-125%] or the
CV% of any parameter exceeds the reproducibility standard, then the calculated
calibration factors of all parameters will not be saved and a message box will also pop
up.

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Using the Calibration Programs

Click Yes to close the message box and switch to another screen without changing the
original calibration factors and the calibration date.

If the calculated calibration factors of all parameter are within the range [75%-125%] and
the CV% of all parameter are also within the reproducibility standard, then a message
box will pop up.

Click Yes to save the new calibration factors while closing the message box and switching
to another screen.

Other Operations

Print

If the calibration factors are invalid, then a message box will pop up when you clicking the
Print button.

Click Ok, then the cell of the first invalid calibration factors will be highlighted and the data in
the cell will not be cleared.
If the calibration factors are valid, then a message box will pop up when you clicking the
Print button.
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Click Yes to close the message box and save the calibration results and the calibration date,
and then print the contents of the current calibration screen; click No to close the message
box without saving.

9.3.4 Auto Calibration Using Fresh Blood Samples

Do as follows to calibrate the analyzer with fresh blood samples.
1.

Click Menu; select Calibration to enter the Calibration Factors screen.

2.

At the Calibration Factors screen, click the Fresh Blood tab to enter the Fresh
Blood screen.

3.

Prepare 3 to 5 normal fresh blood samples as instructed by Chapter 6 Operating Your

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Analyzer.
4.

Run each of the prepared samples on the reference instrument (or by the reference
method) three times at least. Average the results for your reference values

5.

Click the radio button CT-WB or CT-PD on the screen to select the desired calibration
mode.

If you run the sample in the Predilute mode, and then the blood mode is
switched from the Predilute to Whole Blood, the analyzer will switch
modes automatically and a progress bar will be displayed on the screen.

Be sure to use the adapter of 11x40 (mm) model when calibrating in CT-PD
mode. For details to install the adapter, see Chapter 6 Operating Your
Analyzer.

6.

Select the sample ID of the current sample from the Current sample ID pull-down list.

7.

Select the parameter to be calibrated from the check box on the first line of the list.

8.

Enter the target into the Target cells.

9.

Prepare the whole blood or predilute fresh blood sample ready for calibration.

10. Click the Start button, a message box will pop up.

Press the [Run] key or click the Run button, and then the message box will close
automatically and a process bar will pop up.

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Be sure to put an uncapped centrifugal tube into the sample compartment

when calibrating in CT-PD mode.

After you click the Start button and press the [RUN] key to start the first
run, the Start button will display in gray. Then, you can press the [RUN]
key to continue the calibration.

11. After the analysis, the progress bar will close and the compartment door will open
automatically. The analyzer will have different responses to different analysis results.

If the results are out of the linear range but still within the display range, the message
box will pop up at the same time the results are displayed in the table.

Click Ok to close the message box and delete the results from the table without saving.

If the results are out of the display rage, the non-numeric parameter values *** are
obtained and the message box will pop up.

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Click Ok to close the message box and delete the results from the table without saving.

The valid results within the linear range will be displayed directly.

When the valid result is obtained, it is selected to be included in the

calculation for the calibration factors.

12. When the amount of the valid calibration reaches N (N 6), the analyzer will calculate the
Mean, CV% and Calibration Factors of the data selected with automatically ( the first
data is excluded.)
You can select several data to calculate the calibration factors, but after 5 groups of the data
are selected at least can you get the calibration factors. Every time when you select or cancel
a data by clicking the check box, the calibration factors will refresh and display immediately.

The exceeded CV% does not influence the display of the calibration factors.

When the amount of calibration data in the table reaches 11, a prompt of
Fresh blood calibration done! will pop up; if you press the [RUN] key
again, the analyzer will beep and does not response.

13. Select other calibration samples from the Current sample ID pull-down list, run the
samples as instructed in steps 8 to 12 to obtain the calibration factors of each sample.

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If some parameters have been selected to be calibrated, the column of the

parameters will still display in gray when you switch to another blood
sample.

14. There may be several cases when switching to another blood sample:

If the calibration factors of the blood sample are invalid or the CV% of any parameter
exceeds the reproducibility standard, a message box will pop up when you switching to
another blood sample.

Click Yes to clear the entered target of the current sample, all the calibration data obtained
and each calculated value including calibration factors, then close the message box and
switch to another blood sample.

If the calibration factors have not been calculated, the message box will pop up.

Click Yes to empty the entered target of the current sample and all the calibration data
obtained, then close the message box and switch to another blood sample.

If the calibration factors of the sample are valid and the CV% of all the parameters do not
exceed the reproducibility standard, you can switch to another blood sample directly.

15. After calibration factors of at least 3 fresh blood samples are obtained, click the
Calculate button to enter the screen of calibration calculation.
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Using the Calibration Programs

Select or cancel the calibration factors of a blood sample to calculate for the Mean calibration
factors by click the relevant check box.
When the selected calibration factors reaches 3 or more than 3, the CV% will be calculated
over again according to the selected calibration factors.

The exceeded CV% does not influence the display of the calibration factors.

When the selected calibration factors reaches 3 or more than 3, the mean calibration factors
will be calculated over again according to the selected calibration factors. If the deviation of
the calibration factor involved in the mean calibration factor calculation from the previous
calibration factor equals to or is greater than 5%, this calibration factor will be considered as
invalid, and the following message box will pop up when you try to exit the fresh blood
calibration screen.

Click "Yes" to close the message box, clear current calibration data, and switch to the
corresponding screen.
Click "No" to go back to the current screen. The invalid calibration factor(s) will be marked
with "?" and highlighted in red.
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Using the Calibration Programs

When the calculated mean calibration factor is invalid, you can perform
manual calibration at the calibration factor screen.

16. If the mean calibration factors have not been calculated, when you switch to the fresh
blood screen or switch to another calibration mode, a message box will pop up.

Click Yes to abort the calibration data and close the message box, switching to the
corresponding screen or other calibration mode. The original calibration factors and date
remain the same.
17. If the calculated mean calibration factors are valid, when you switch to the fresh blood
screen or switch to another calibration mode, a message box will pop up.

Click Yes to save the current mean calibration factors and refresh the calibration factors and
date in the table at the Calibration Factors screen. Then, you can switch to another screen
or calibration mode. Click No to close the message box and switch to another screen or
calibration mode without saving the mean calibration factors and all the calibration data.

Other Operations

Print

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Using the Calibration Programs

If the mean calibration factors are invalid, then a message box will pop up when you clicking
the Print button.

Click OK, then the cell of the first invalid calibration factor will be highlighted and the data in
the cell will not be cleared.
If the mean calibration factors are valid, click the Print button to print the following data in
the form of list, namely, the calibration factors of the sample in the Calculated Result table,
the results included in calculating the calibration factors and the mean calibration factors.

9.3.5 Verifying Calibration Factors

It is recommended that you take the following steps to verify the calibration factors:
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.

3.

Run at least three fresh blood samples with known reference values, each for six times
at least, and check whether the means of the obtained results are within the expected
ranges.

9.3.6 Calibration History

Click the History tab to enter the calibration history screen.

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Using the Calibration Programs

Calibration history list

The history list displays the calibration information for the latest 80 calibrations; you can view
the contents in the list, but you are not allowed to modify or delete any content.

Detailed calibration data

1.

If the calibration mode of the selected record is Adjust Manually, the new calibration
factor and the original calibration factor are displayed in grey edit box.

If the calibration factors of some parameters are not modified, the

corresponding edit boxes are empty.

2.

If the calibration mode of the selected record is Calibrator, the new calibration factor,
the original calibration factor and all medium data are displayed in grey edit box.

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Using the Calibration Programs

The calibration data marked with are used for calculation of calibration
factors.

3.

If the calibration mode of the selected record is Fresh Blood, the calibration factor,
mean calibration factor and original calibration factor of each sample are displayed in
grey edit box.

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Using the Calibration Programs

The calibration factors marked with are used for calculation of mean
calibration factor.

If the calibration factor of a sample is displayed, you can click the Detail button to display
all medium data.

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Using the Calibration Programs

Click Close to close the dialog box and return to the History screen.

The calibration data marked with are used for calculation of sample
calibration factors.

Print

Click the Print button down to the screen to print all calibration history records in table
format.

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10Maintaining Your Analyzer

10.1 Introduction
Preventive and corrective maintenance procedures are required to keep the analyzer 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.

All the analyzer components and surfaces are potentially infectious, take
proper protective measures for operation or maintenance.

Performing unauthorized maintenance procedures can damage your

analyzer. Do not perform any maintenance procedures that are not
described in this chapter.

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

service department or your local distributor for assistance.

Only parts supplied by the manufacturer can be used for maintenance. For
any questions, contact our customer service department or your local
distributor.

Exercise caution to avoid contact with the sharp sample probe when
performing maintenance.

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Maintaining Your Analyzer

10.2 Maintenance
10.2.1 Manual Sleep
You can start the sleep function if stop using the analyzer for a long time.

At the Motor and Valve tabs of the Self-test screen and the Status
screen, the analyzer can not sleep.

If any influential error happens, the analyzer can not sleep.

Click the Menu button on the screen, then select ShutdownSleep on the pop-up
menu.

The following message box will pop up.

Click the Ok button to get ready to sleep.

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Maintaining Your Analyzer

After the preparation is complete, the progress bar closes automatically and the analyzer
enters the sleep status.

When the analyzer is sleeping, the analysis status icon at the screen
displays in red. The indicator on the analyzer displays in red at the same
time.

You can not run any sample when the analyzer is sleeping.

You can perform the operations without the cooperation of the analyzer
when it is sleeping, namely, communication and print etc.

If any error happens during the process of entering the sleep status, the
analyzer will not sleep but alarm for the error. See Chapter 11
Troubleshooting Your Analyzer for solutions.

10.2.2 Exiting Sleep Mode

Different maintenances will be performed by the analyzer automatically

when exiting the sleep mode, and the exiting time depends on how long the
analyzer was in the sleep mode.

The following two ways are available to wakeup the analyzer.

The Cancel button

Click the Menu button on the screen, then select ShutdownCancel on the pop-up
menu.

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Maintaining Your Analyzer

The following prompt box will pop up.

Click the Ok button to exit the sleep mode.

After the exiting is complete, the progress bar closes automatically and the analyzer exits the
sleep mode.

[RUN] key

Press the [RUN] key on the analyzer to wakeup the analyzer from sleeping.

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Maintaining Your Analyzer

After the exiting is complete, the progress bar closes automatically and the analyzer exits the
sleep mode.

If any error happens during the process of exiting the sleep status, see
Chapter 11 Troubleshooting Your Analyzer for details to remove the error.

After waking up from sleeping successfully, the analyzer will return to the
certain status before sleeping. The analysis status icon at the screen
displays in green. The indicator on the analyzer displays in green at the
same time.

10.2.3 Replacing Reagent

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

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

After installing a new container of reagent, keep it still for a while before use.

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

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Maintaining Your Analyzer

You should change the reagents when:

a new container of reagent is installed.

the reagent is contaminated

WBC/RBC bubbles are reported.

Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

Click the Replace Reagent tab to enter the Replace Reagent screen.

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Maintaining Your Analyzer

You can replace any of the following reagents:

Diluent

LEO(I) lyse

LEO(II) lyse

LH lyse

Cleanser

Keep the diluent container from any strong vibration or collision with other
objects. Otherwise unreliable error messages may be reported.

While replacing the diluent container, be sure to follow the following steps: 1)
install the supporting board as shown below; 2) insert the cap assembly
(shown in the figure below) into the diluent container vertically, and then
secure the cap. Otherwise unreliable error messages may be reported.

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Maintaining Your Analyzer

Do as follows to change the reagents:
1.

Double click the icon of the desired reagent, and then enter the lot No. and expiration
date of the new reagent.

The check box Change New Vial should be selected if you wish to change
a container of reagent. Then, the edit box of Lot No. and Exp. Date will
be activated for you to enter the new lot No. and expiration date. When
finishing the replacement, the analyzer will save the new lot No. and
expiration date and then automatically modify the open-container expiration
date. The Change New Vial check box is selected as default.

The check box Change New Vial should not be selected if you only replace
the reagent in the container. Then, the edit box Lot No. and Exp. Date
will be unavailable. When finishing the replacement, the analyzer will not
modify the open-container expiration date.

The expiration date can not be empty.

1 to 16 digits can be entered into the box of Lot No. and an empty entry is
allowed.

After the Use barcode scanner is selected, you can enter the expiration
date of the reagents by the barcode scanner.

2.

Click the Replace button to save the entered expiration date and lot No. and start
replacing.

3.

After the replacing is completed, the following prompt will pop up.

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Maintaining Your Analyzer

4.

Click the Ok button to close the message box.

5.

Do the above procedures to replace other reagents if necessary.

10.2.4 Cleaning
You should clean the corresponding components under the following circumstances:

When the background of WBC and/or HGB relative parameters exceeds the Ref. Range,
you should clean the WBC bath.

When the background of RBC and (or) PLT relative parameters exceeds the Ref. Range,
you should clean the RBC bath.

When the background of the scattergram has abnormal excessive cells, you should
clean the DIFF Bath.

When the background of the scattergram has abnormal excessive cells, or bad
differential of WBC, you should clean the flow cell.

When the sample probe is dirty, you should clean the sample probe.

Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

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Maintaining Your Analyzer

Then, click the Clean tab to enter the Clean screen.

You can clean any of the following components:

WBC bath

RBC bath

DIFF bath

Flow cell

Sample probe

Do as follows to clean:
1.

Double click the icon of the desired part to start cleaning.

2.

After the cleaning is completed, a message box will pop up.

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Maintaining Your Analyzer

3.

Click the Ok button to close the message box.

4.

Do the above procedures to clean other components if necessary.

10.2.5 Unclogging
When clogging happens, you should perform the unclogging procedure.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

Then, click the Maintain tab to enter the Maintain screen.

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Maintaining Your Analyzer

Take the following steps to unclog:

1.

Double click the Unclog icon to start unclogging.

2.

After the unclogging is completed, a message box will display.

3.

Click the Ok button to close the message box.

4.

Do the above procedures to continue unclogging if necessary.

10.2.6 Zapping Apertures

You should perform this procedure to unclog the aperture.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.
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Maintaining Your Analyzer

Then, click the Maintain tab to enter the Maintain screen.

Do as follows to zap apertures:

1.

Double click the Zap Apertures icon to start zapping.

2.

After the zapping is completed, a message box will pop up.

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Maintaining Your Analyzer

3.

Click the Ok button to close the message box.

4.

Do the above procedures to continue zapping apertures if necessary.

10.2.7 Flashing Apertures

You should perform this procedure to flash apertures.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

Then, click the Maintain tab to enter the Maintain screen.

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Maintaining Your Analyzer

Do as follows to flash apertures:

1.

Double click the Flash Apertures icon to start flashing.

2.

After the flashing is complete, a message box will pop up.

3.

Click the Ok button to close the message box.

4.

Do the above procedures to continue flashing apertures if necessary.

10.2.8 Probe Cleanser Soak

You should perform the probe cleanser soak under the following circumstances:

When the problems including the background results exceeds the Ref. Range, bad
differential of scattergram and clogging still exist after other maintenances have been
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Maintaining Your Analyzer

adopted.

If your analyzer is to run few samples, you should perform this procedure every two
weeks.

Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

Then, click the Maintain tab to enter the Maintain screen.

Take the following steps to perform the probe cleanser soak:

1.

Double click the icon of Probe Cleanser Soak, and then a message box will pop up.
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Maintaining Your Analyzer

2.

Click Yes, and then the following progress bar will pop up and the analyzer is preparing
to soak.

3.

After the preparation is done, the message box will pop up.

4.

Perform the aspiration of the cleanser as instructed. Then, the priming process starts
automatically after the aspiration.

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Maintaining Your Analyzer

5.

When the priming is completed, the progress bar closes and a count-down box will pop
up. The soaking process starts.

6.

The soaking process will last about 20 minutes. You may click the Stop Soaking
button in the message box to stop it. If you stop soaking in less than 5 minutes, the
following message box will pop up.

7.

The cleaning process starts after the soaking progress is done.

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Maintaining Your Analyzer

8.

After the cleaning is completed, a message box will pop up.

9.

Click the Ok button to close the message box.

10. Do the above procedures to perform the probe cleanser soak if necessary.

10.2.9 Probe Cleanser Soak for Single Channel

Probe cleanser soaking for DIFF channel, WBC channel and RBC channel, when the
aperture clogs or the abnormal scattergram occurs, can be used to remove the errors.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

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Maintaining Your Analyzer

Then, click the Maintain tab to enter the Maintain screen.

Take the following steps to perform the probe cleanser soak (DIFF bath):
1. Double click the Soak DIFF Bath icon, and then a message box will pop up.

2. Click Yes, and then the progress bar shown below will pop up and the analyzer is
preparing.

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Maintaining Your Analyzer

3. When the preparation is done, a message box will pop up.

4. After aspirating the probe cleanser as instructed, the following progress bar will pop up and
the analyzer starts priming automatically.

5. When the priming is completed, the progress bar closes and a count-down box will pop up.
The soaking process starts.

6. The soaking process will last about 20 minutes. You may click the Stop Soaking button
in the dialog box to stop it. If you stop soaking in less than 5 minutes, the following message
box will pop up.
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Maintaining Your Analyzer

7. The cleaning process starts after the soaking progress is done.

8. After the cleaning is completed, a message box will pop up.

9. Click Ok to close the dialog box.

Do the above procedures to perform the probe cleanser soaking for WBC bath and RBC bath
if necessary.

10.2.10 Cleanser Soak

When the background results exceed the Ref. Range after running plenty of samples, you
should perform this procedure.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

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Maintaining Your Analyzer

Then, click the Maintain tab to enter the Maintain screen.

Take the following steps to perform the cleanser soak:

1. Double click the Cleanser Soak icon, and the following message box will pop up.

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Maintaining Your Analyzer

The duration of the soaking process can be configured at the Auto

Maintenance Setup screen (4 hours by default). See Chapter 5 Customizing
the Analyzer Software for how to configure.

2. Click Ok and then the progress bar shown below will pop up and the analyzer is
preparing.

3. When the preparation is done, the progress bar closes and a count-down box will pop up.
The soaking process starts.

4. You may click the Stop Soaking button in the dialog box to stop the soaking process. If
you stop soaking in less than 4 hours, the following message box will pop up.

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Maintaining Your Analyzer

5. The cleaning process starts automatically after the soaking progress is done

6. After the cleaning is completed, a message box will pop up.

7. Click Ok to close the dialog box.

8. Do the above procedures to perform the cleanser soak if necessary.

You should perform the cleanser soak regularly to ensure the analyzer
works in good condition.

10.2.11 Fluidics Initialization

After maintaining the fluidic system or replacing a main part of the analyzer, you should
perform this procedure to initialize the fluidic system.
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Maintaining Your Analyzer

Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

Then, click the Maintain the whole device tab to enter the screen.

Do as follows to perform the fluidics initialization:

1.

Double click the icon of Fluidics initialization, and then a message box will pop up.

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Maintaining Your Analyzer

2.

Click the Ok button to start initialization and Fluidics initializing will be displayed in
the information area down to the screen.

3.

After the initialization is complete, a message box will display.

4.

Click the Ok button to close the message box.

5.

Do the above procedures to continue performing the cleanser soak if necessary.

10.2.12 Clean Fluidics

When the background of all parameters exceeds the Ref. Range, you should perform the
procedure.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

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Maintaining Your Analyzer

Then, click the Maintain the whole device tab to enter the screen.

Do as follows to clean fluidics:

1.

Double click the icon of Clean Fluidics, and then a message box will pop up.

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Maintaining Your Analyzer

2.

Click the Yes button to start cleaning and Fluidics cleaning will be displayed in the
information area down to the screen.

3.

After the cleaning is complete, a message box will display.

4.

Click the Ok button to close the message box.

5.

Do the above procedures to continue cleaning fluidics if necessary.

10.2.13 Empty Fluidics

Before a short distance transport of the analyzer (transporting time<2h), you should perform
this procedure to empty the fluidic system.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

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Maintaining Your Analyzer

Then, click the Maintain the whole device tab to enter the screen.

Do as follows to empty fluidics:

1.

Double click the icon of Empty Fluidics, and then a message box will pop up.

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Maintaining Your Analyzer

2.

Click the Yes button to start emptying, and a message box shown below will display.

3.

Remove all reagent pickup tube assemblies according to the prompt, and then click OK
to start emptying the fluidic system.

4.

After the emptying is complete, a message box will display. You should turn off the power
switch according to the prompt displayed on the screen.

After the fluidic system is emptied, you can still use the software.

In the message box of Please power off the analyzer!, you can click the
Restart button to restart the analyzer.

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Maintaining Your Analyzer

10.2.14 Prepare to Ship

If the analyzer is not to be used for over one week or needs a long distance transport
(transporting time>2h), you should perform this procedure.
Click the Menu button on the screen, and then select ServiceMaintenance on the
pop-up menu.

Then, click the Maintain the whole device tab to enter the screen.

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Maintaining Your Analyzer

Do as follows to perform the prepare-to-ship procedure:

1.

Double click the icon of Prepare to Ship, and then a message box will pop up.

2.

Click the Yes button to perform the packing up and a message box shown below will
display.

3.

Remove all reagent pickup tube assemblies according to the prompt, and then click the
OK button to start emptying the fluidic system.

4.

After the emptying is complete, a message box will pop up.

5.

Place all reagent pickup tube assemblies into the distilled water, and then click the Ok
button to start priming.

6.

After the cleaning is done, a message box will display.

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Maintaining Your Analyzer

7.

Remove all reagent pickup tube assemblies from the distilled water according to the
prompt, then click Ok to start emptying the fluidic system.

8.

After the emptying is complete, a message box will display. You should turn off the
power switch according to the prompt displayed on the screen.

After the prepared to ship procedure is done, you can still use the software.

In the message box of Please power off the analyzer, you can click the
Restart button to restart the analyzer.

10.2.15 Auto-clean
When the sample count times reach or over 100, the analyzer will perform the cleaning
procedure automatically once, and a prompt will be displayed on the screen.

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Maintaining Your Analyzer

If it is the time to perform the auto-cleaning but the analyzer is running or

error happened; only after the running is completed or the error is removed
will the auto-cleaning starts.

After the auto-cleaning, probe cleanser soaking and cleanser soaking is

completed, or after the analyzer is shut down, the sample count times will
reset to zero automatically.

10.2.16 Auto-prompt for Probe Cleanser Soak

When the sample count times reach or over 1000(default), the analyzer will ask you for
confirmation to perform the probe cleanser soak.

Click Yes, and then the progress bar shown below will pop up and the analyzer is preparing.

When the preparation is done, a message box will pop up.

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Maintaining Your Analyzer

After aspirating the probe cleanser as instructed, the following progress bar will pop up and
the analyzer starts the priming automatically.

When the priming is complete, the progress bar closes and a count-down box will pop up.
The soaking process starts.

The soaking process will last about 20 minutes. You may click the Stop Soaking button in
the dialog box to stop it after five minutes. The cleaning process starts after the soaking
progress is done.

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Maintaining Your Analyzer

After the cleaning is complete, a dialog box will pop up.

Then, click the Ok button to close the box.

At the Self-test or Status screen, the analyzer does not ask for
confirmation to perform the probe cleanser soak.

If it is the time to perform the auto prompt for probe cleanser soak but the
analyzer is running or error happened; only after the running is completed
or the error is removed will the auto prompt starts.

If you cancel the procedure of probe cleanser soaking when it is

auto-prompted, the confirmation prompt will pop up again every time when
you finish running the samples for 50 times.

After the probe cleanser soaking is complete, the sample count times will
reset to zero automatically.

10.2.17 Prompt for Replacing the Sample Probe

When sample count times reach or over 27000(default value), the analyzer will remind you to
have the sample probe replaced.

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Maintaining Your Analyzer

Do as the prompt instructed, and then click the Ok button to close the message box.

If it is the time to perform the auto-prompt for sample probe replacing but
the analyzer is in running status, then only after the running is completed
will the auto-prompt starts.

If you do not replace the sample probe after the prompt is popped up, the
prompt will pop up again every time when you finish running the samples
for 100 times.

10.2.18 Timed Cleanser Soak

When it is the time for cleanser soaking, the analyzer will ask for confirmation to perform the
procedure.

After you confirmed, the following message box will pop up.

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Maintaining Your Analyzer

The duration of the soaking process can be configured at the Auto

Maintenance Setup screen (4 hours by default). See Chapter 5 Customizing
the Analyzer Software for how to configure.

Click Ok and then the progress bar shown below will pop up and the soaking preparation
starts.

After the preparation is finished, the progress bar will be closed automatically and a
count-down box will pop up. The soaking process starts.

You may click the Stop Soaking button in the message box to stop the soaking process. If
you stop soaking in less than 4 hours, the following message box will pop up.
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Maintaining Your Analyzer

The cleaning process starts automatically after the soaking progress is done.

After the cleaning is complete, a message box will pop up. Click the OK button to close the
message box.

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Maintaining Your Analyzer

At the Self-test or Status screen, the analyzer does not ask for
confirmation to perform the preset cleanser soak.

Only when the connecting time of the analyzer and the computer reaches or
over 24hours will the preset cleanser soaking be prompted.

For details to preset the cleanser soaking time and the prompting time, see
chapter 5 Customizing the Analyzer Software.

If it is the time to prompt for cleanser soaking but the analyzer is in running
or error status, then only after the running is completed or the error is
removed will the prompt starts accordingly.

If you cancel the procedure of cleanser soaking when it is prompted, then

the analyzer will perform the cleanser soaking automatically when the
preset time is reached.

When it reaches the preset time to perform the cleanser soaking but the
analyzer is in running or error status, only after the running is completed or
the error is removed will the cleanser soaking starts accordingly.

When it reaches the preset time to perform the cleanser soaking but the
analyzer is sleeping, and then the analyzer will wake up automatically and
then proceed to perform the cleanser soaking.

10.2.19 Auto-sleep
When the fluidics system stop working for 15 minutes (default), then the analyzer will enter
the sleeping status automatically.

When the analyzer is in sleeping status, a prompt will display on the screen.

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You can set the waiting time for auto-sleeping, see chapter 5 Customizing
the Analyzer Software for details.

At the Self-test or Status screen, the analyzer can not sleep.

If it is the time to auto-sleep but the analyzer is error status, then only after
the error is removed will the auto-sleeping starts accordingly.

You can perform the operations without the cooperation of the analyzer
when it is sleeping, namely, communication and print etc.

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10.3 System Status

If the results of the status testing exceed the normal range, they will be
highlighted by the red background.

10.3.1 Temperature and Pressure

Click the Menu button on the screen, and then select ServiceStatus on the pop-up
menu.

Then, click the Temperature&Pressure tab and a message box will pop up.

When the sequence is complete, the message box closes automatically and you will enter the
following screen.

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You can check the information about the temperature and pressure, and also export or print
the information.

Export

1.

Click the Export button at the bottom of the screen and then select the desired
information from the pop-up message box.

2.

Click the Browse button, and then a message box will pop up.

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Maintaining Your Analyzer

3.

Select the directory and format for the exported file and enter the file name.

4.

Click the Ok button to save the selected information to the specified location.

5.

When the exporting succeeded, click the OK button to exit.

If the exporting failed, you should click the Ok button and then try again or
change another exporting directory; if it does not help, please contact our
customer service department or your local distributor.

The default format of the exported information is .txt and you can also
choose the .csv format.

Print

5.

Click the Print button at the bottom of the screen and then select the desired
information from the pop-up message box.

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6.

Click the Ok button to print the selected information.

The user of common level can not see the Analyzer Information option in
the Print message box. If you wish to print the analyzer information,
please log out and then log in as user of administrator level.

10.3.2 Voltage and Current

Click the Menu button on the screen, and then select ServiceStatus on the pop-up
menu.

Then, click the Voltage&Current tab to enter the following screen.

.

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You can check the information about the voltage and current, and also export or print the
information.

Export

1.

Click the Export button at the bottom of the screen and then select the desired
information from the pop-up message box.

2.

Click the Browse button, a message box will pop up.

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3.

Select the directory and format for the exported file and enter the file name.

4.

Click the Ok button to save the selected information to the specified location.

5.

When the exporting succeeded, click the OK button to exit.

If the exporting failed, you should click the Ok button and then try again or
change another exporting directory; if it does not help, please contact our
customer service department or your local distributor.

The default format of the exported information is .txt and you can also
choose the .csv format.

Print

1.

Click the Print button at the bottom of the screen and then select the desired
information from the pop-up message box.

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2.

Click the Ok button to print the selected information.

The user of common level can not see the Analyzer Information option in
the Print message box. If you wish to print the analyzer information,
please log out and then log in as user of administrator level.

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10.4 Version and Config. Information

Click the Menu button, select Service Version and Config. Information on the
menu.

Then you will enter the following screen.

You can check the information about the version and configuration, and export or print them.

Export

1.

Click the Export button, and then the following message box will pop up.

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Maintaining Your Analyzer

2.

Select the directory and format for the exported file and enter the file name.

3.

Click the Ok button to save the selected information to the specified location.

4.

When the exporting succeeded, click the Ok button to exit.

If the exporting failed, you should click the Ok button and then try again or
change another exporting directory; if it does not help, please contact our
customer service department or your local distributor.

The default format of the exported information is .txt and you can also
choose the .cvs format.

Print

Click the Print button at the bottom of the screen to print the information.

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10.5 Self-test
10.5.1 Syringe and Sampling Mechanism
Click the Menu button on the screen, and then select ServiceSelf-test on the pop-up
menu.

Then, click the Syringe and Sampling Mechanism Self-test tab to enter the following
screen.

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You can check the status of all items and print the results.

Self-test

1.

Double click the desired icon to start self-testing.

2.

When the self-testing is finished, a message box will pop up to inform you the normal
testing results. Then, click the Ok button to close the message box.

If the testing result is abnormal, you should click the Ok button and try
again for several times; if it does not help, please contact our customer
service department or your local distributor.

3.

Do the above procedures to test other items if necessary.

Print

Click the Print button at the bottom of the screen to print the latest testing results of all
items.

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10.5.2 Autoloader Assembly

Click the Menu button on the screen, and then select ServiceSelf-test on the pop-up
menu.

Click the Autoloader Assembly Self-test tab to enter the following screen.

You can check the status of all the items and print the results.

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Maintaining Your Analyzer

Self-test

1.

Double click the desired icon to start self-testing.

2.

When the self-testing is finished, a message box will pop up to inform you the normal
testing results. Then, click the Ok button to close the message box.

If the testing result is abnormal, you should click the Ok button and try
again for several times; if it does not help, please contact our customer
service department or your local distributor.

3.

Do the above procedures to test other items if necessary.

Print

Click the Print button at the button of the screen to print the latest testing results of all items.

10.5.3 Valve
Click the Menu button on the screen, and then select ServiceSelf-test on the pop-up
menu.
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Then, click the Valve tab to enter the following screen.

You can check the status of a single valve or all valves.

Single valve

Click the desired Valve No. (e.g. 1), then identify whether it works well by judging its sound
when opening and closing.

All valves

After clicking the All Valves button, all valves will be tested according to their No. one by
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Maintaining Your Analyzer

one. A progress bar will pop up at the same time.

Whether the valve works well or not is identified by judging its sound when
opening and closing

The current status (open/close) of all valves is displayed in the Status box
of the screen. When testing the valves, they open first and then close.

You can click the Cancel button on the progress bar to stop the testing for
all valves.

10.5.4 Others
Click the Menu button on the screen, and then select ServiceSelf-test on the pop-up
menu.

Then, click the Others tab to enter the following screen.

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You can test all above items and print the result.

Self-test

Do as follows to test the WBC volumetric tube filter, RBC volumetric tube filter, WBC aperture
voltage, RBC aperture voltage and count time.
1.

Double click one desired icon to start self-testing.

2.

When the self-testing is finished, a message box will pop up to inform you the result.
Then, you can click the Ok button to close the message box.
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If the testing result is abnormal, you should click the Ok button and try
again for several times; if it does not help, please contact our customer
service department or your local distributor.

3.

Do the above procedures to test other items if necessary.

You can do as follows to test the built-in barcode scanner.

1.

Double-click the Built-in Barcode Scanner button, and a message box will pop up.

2.

The test starts and a progress bar will appear. When the test is completed, a message
will pop up.

3.

Check the sample ID as prompted in the message box. Then, click the Ok button to
close the box.

Print

Click the Print button at the button of the screen to print the latest testing results of the
items.
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10.6 Counter
Click the Menu button on the screen, and then select ServiceCounter on the pop-up
menu.

Then you will enter the following screen.

You can check the statistic information of all the above items and the detail statistic
information of some items.

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Checking the detail information

You can check the detail information for the sample count times, QC times and calibration
times.
You can click the Detail button next to the Sample Count Times to display the detail
statistic information about the sample count times.

You can click the Detail button next to the QC Times to display the detail statistic
information about the QC times.

You can click the Detail button next to the Calibration Times to display the detail
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statistic information about the calibration times.

Print

Click the Print button at the bottom of the screen to print all the statistic information of the
current screen.

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10.7 Log

If you add a new record when the log is full, the newest record will overwrite
the oldest automatically.

Up to records of one year can be saved in the log.

Up to 100 characters can be entered for remarks.

10.7.1 Set Parameters

Click the Menu button on the screen, and then select ServiceLog on the pop-up
menu.

Then, click the Set Paras tab to enter the following screen..

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You can check the log information, enter remark information and also export and print the
information.

Remark
1.

Enter the remark information in the Remark box of the desired log record.

2.

Click the Save button at the bottom of the screen to save the remark.

Print
Click the Print button at the bottom of the screen. You can select Date Range or No.
Range to determine the print range.

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Print by date range

1) Enter the starting date and finishing date of the records you want to print.
2) Click Ok button to print the selected log.

Print by No. range

1) Enter the starting date and finishing date of the log you want to print.
2) Click the Ok button to print the selected log.

Detail
Click the Detail button to check the details of the highlighted record.

10.7.2 Other Logs

Click the Menu button on the screen, and then select ServiceLog on the pop-up
menu.

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Then, click the Other Logs tab to enter the following screen.

You can check the log information, enter remark information and also print the information.

Remark
1.

Enter the remark information in the Remark box of the desired log record.

2.

Click the Save button at the bottom of the screen to save the remark.

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Print
Click the Print button at the bottom of the screen. You can select Date Range or No.
Range to determine the print range.

Print by date range

1) Enter the starting date and finishing date of the records you want to print.
2) Click Ok button to print the selected log.

Print by No. range

1) Enter the starting date and finishing date of the log you want to print.
2) Click the Ok button to print the selected log.

Detail
Click the Detail button to check the details of the highlighted record.

10.7.3 Error Message

The error message is only available to the users of administrators-level (or

higher levels).

Click the Menu button on the screen, and then select ServiceLog on the pop-up
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Maintaining Your Analyzer

menu.

Then, click the Error Info. tab to enter the following screen.

You can check the log information, enter remark information and also print the information.

Remark
1.

Enter the remark information in the Remark box of the desired log record.

2.

Click the Save button at the bottom of the screen to save the remark.

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Print
Click the Print button at the bottom of the screen. You can select Date Range or No.
Range to determine the print range.

Print by date range

1) Enter the starting date and finishing date of the records you want to print.
2) Click Ok button to print the selected log.

Print by No. range

1) Enter the starting date and finishing date of the log you want to print.
2) Click the Ok button to print the selected log.

Detail
Click the Detail button to check the details of the highlighted record.

10.7.4 All Logs

The All Logs tab displays all the available log information for the current
user.

Click the Menu button on the screen, and then select ServiceLog on the pop-up
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Maintaining Your Analyzer

menu.

Then, click the All Logs tab to enter the following screen.

You can check the log information, enter remark information and also print the information.

Remark
1.

Enter the remark information in the Remark box of the desired log record.

2.

Click the Save button at the bottom of the screen to save the remark.

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Print
Click the Print button at the bottom of the screen. You can select Date Range or No.
Range to determine the print range.

Print by date range

1) Enter the starting date and finishing date of the records you want to print.
2) Click Ok button to print the selected log.

Print by No. range

1) Enter the starting date and finishing date of the log you want to print.
2) Click the Ok button to print the selected log.

Detail
Click the Detail button to check the details of the highlighted record.

10-71

11Troubleshooting 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.

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 our customer
service department or your local distributor.

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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 pop-up message box.
In the error message area, the severity levels are discriminated from high to low by
background colors in the order of red, orange, blue, and green.

The red error message means that the analyzer will terminate the current action
immediately and you can not perform any operation.

The orange error message means that the analyzer will terminate the current action
immediately.

The blue error message means that the analyzer can still proceed with the current action,
but other operations related to the error(s) of this kind will be restricted.

The green error message means that the analyzer can still proceed with the current
action and other operations will not be restricted.

The following error message box will pop up.

Figure 12-1 Error messages box

You can see the error name(s) and the corresponding troubleshooting information in the
pop-up message box. The error names are displayed in order.
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Troubleshooting Your Analyzer

You can click the error name in the message box to select (highlight) it and check the
corresponding troubleshooting information in the Troubleshooting list under the message
box. The troubleshooting information of the first error will display (default). Follow the
instructions in the message box to remove the error(s)
The following functions are provided in the current message box.

Remove Error

Press the Remove error button, then the system will remove the error automatically if
possible. If the error(s) still exists, you should follow the instructions of the troubleshooting to
remove the error(s).

Silent

Press the Silent button to disable the beep.

Close the Error message box

Click the Close button to close the Error message box, but the corresponding error
message will display in the error message area. If you click the error message again, the
Error message box will be re-opened.
The possible error(s) and the corresponding troubleshooting information are listed below:
Error Name

Troubleshooting Information
1. Please turn off the analyzer power directly and restart the
analyzer later.

Voltage error

2. If the error still exists, contact our customer service

department.

Laser diode current abnormal

1. Please turn off the analyzer power directly and restart the
analyzer later.
2. If the error still exists, contact our customer service
department.

Drive

board

communication

error

1. Click the Remove error button to remove this error.

2. If the error still exists, contact our customer service
department.
1. Click the Remove error button to remove this error.

Sheath fluid channel clog

2. If the error still exists, contact our customer service

department.
1. Click the Remove error button to remove this error.

Syringe action error

2. If the error still exists, contact our customer service

department.
1. Click the Remove error button to remove this error.

Sample probe action error

2. If the error still exists, contact our customer service

department.
11-3

Troubleshooting Your Analyzer

1. Click the Remove error button to remove this error.
Pressure abnormal

2. If the error still exists, contact our customer service

department.
1. Click the Remove error button to remove this error.

Vacuum abnormal

2. If the error still exists, contact our customer service

department.
1. Click the Remove error button to remove this error.

DIFF reaction bath temp. error

2. If the error still exists, contact our customer service

department.
1. Make sure the ambient temperature is within the normal
range [15, 30].
2. Analysis results may be incorrect if the ambient

Temperature out of working

temperature is out of the normal range.

range

3. If the ambient temperature is within the normal range,

click the Remove error button to remove the error.
4. If the error still exists, contact our customer service
department.
1. The ambient temperature is out of the analysis allowable
range [10, 40].
2. Analysis results may be incorrect if the ambient

Temperature out of operating

temperature is out of the normal range.

range

3. If the ambient temperature is within the normal range, the

error will be removed automatically.
4. If the error still exists, contact our customer service
department.
1. Click the Remove error button to remove this error.

Optical System temp. error

2. If the error still exists, contact our customer service

department.
1. Check if the LEO (I) Lyse is expired. If so, change a new
container of lyse. Then click the Remove error button to
prime the analyzer with the LEO (I) lyse.
2. Click the Remove error button, and then the Reagent
settings screen will pop up. Set the reagent expiration date

LEO(I) Lyse expired

as instructed in chapter 5 Customizing the Analyzer

Software, and then click Ok.
3. Click the Remove error button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department
1. Check if the LEO (II) Lyse is expired. If so, change a new
container of lyse. Then click the Remove error button to

LEO(II) Lyse expired

prime the analyzer with the LEO (II) lyse.

2. Click the Remove error button, and then the Reagent
settings screen will pop up. Set the reagent expiration date
11-4

Troubleshooting Your Analyzer

as instructed in chapter 5 Customizing the Analyzer
Software, and then click Ok.
3. Click the Remove error button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department
1. Check if the cleanser is expired. If so, change a new
container of cleanser. Then click the Remove error button
to prime the analyzer with the cleanser.
2. Click the Remove error button, and then the Reagent
settings screen will pop up. Set the reagent expiration date
Cleanser expired

as instructed in chapter 5 Customizing the Analyzer

Software, and then click Ok.
3. Click the Remove error button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department
1. Check if the diluent is expired. If so, change a new
container of diluent. Then click the Remove error button to
prime the analyzer with the diluent.
2. Click the Remove error button, and then the Reagent
settings screen will pop up. Set the reagent expiration date

Diluent expired

as instructed in chapter 5 Customizing the Analyzer

Software, and then click Ok.
3. Click the Remove error button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department.
1. Check if the LH Lyse is expired. If so, change a new
container of lyse. Then click the Remove error button to
prime the analyzer with the LH lyse.
2. Click the Remove error button, and then the Reagent
settings screen will pop up. Set the reagent expiration date

LH Lyse Expired

as instructed in chapter 5 Customizing the Analyzer

Software, and then click Ok.
3. Click the Remove error button again; the error will be
removed automatically.
4. If the error still exists after a new container of reagent is
installed, contact our customer service department.
1. Check whether the diluent container is empty.
2. If there is no diluent, install a new container of diluent.

No Diluent

Then click the Remove error button to prime the analyzer

with the diluent.
3. Enter Reagent settings to modify the reagent expiration
11-5

Troubleshooting Your Analyzer

date as instructed in chapter 5 Customizing the Analyzer
Software.
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.
1. Check whether the LH lyse container is empty.
2. If there is no LH lyse, change a new container of LH lyse.
Then click the Remove error button to prime the analyzer
with the lyse.
No LH lyse

3. Enter Reagent settings to modify the reagent expiration

date as instructed in chapter 5 Customizing the Analyzer
Software.
4. If there is still plenty of reagent, or if the error still exists
after a new container of reagent is installed, contact our
customer service department.
1. Check whether the LEO (I) lyse container is empty.
2. If there is no LEO (I) lyse, change a new container of
LEO(I)lyse. Then click the Remove error button to prime
the analyzer with the lyse.

No LEO(I) lyse

3. Enter Reagent settings to modify the reagent expiration

date as instructed in chapter 5 Customizing the Analyzer
Software.
4. If there is still plenty of reagent, or if the error still exists
after a new container of reagent is installed, contact our
customer service department.
1. Check whether the LEO (II) lyse container is empty.
2. If there is no LEO(II) lyse, change a new container of
LEO(II) lyse. Then click the Remove error button to prime
the analyzer with the lyse.

No LEO(II) lyse

3. Enter Reagent settings to modify the reagent expiration

date as instructed in chapter 5 Customizing the Analyzer
Software.
4. If there is still plenty of reagent, or if the error still exists
after a new container of reagent is installed, contact our
customer service department.
1. Check whether the cleanser container is empty.
2. If there is no cleanser, change a new container of
cleanser. Then click the Remove error button to prime the
analyzer with the cleanser.

No Cleanser

3. Enter Reagent settings to modify the reagent expiration

date as instructed in chapter 5 Customizing the Analyzer
Software.
4. If there is still plenty of reagent, or if the error still exists
after a new container of reagent is installed, contact our
11-6

Troubleshooting Your Analyzer

customer service department.
1. Empty the waste container or install a new waste
Waste is full

container.
2. If the error still exists, contact our customer service
department.
1. Close the right side door.

Right side door open

2. Click the Remove error button to remove this error.

3. If the error still exists, contact our customer service
department.
1. Close the laser assembly cover.

Optical assembly cover open

2. If the error still exists, contact our customer service

department.
1. Check whether the diluent is contaminated.
2. If it is not contaminated, click the Remove error button to

Background abnormal

remove the error.

3. If the error still exists, contact our customer service
department.
1. Click the Remove error button to remove this error.
2. If the error reports frequently, see Chapter 10

WBC clog

Maintenance to dip the WBC bath with the probe cleanser.

3. If the error still exists, contact our customer service
department.
1. Check whether the pickup tube connection looses.
2. If the connection does not loose, click the Remove error

WBC bubbles

button to remove the error.

3. If the error still exists, contact our customer service
department.
1. Click the Remove error button to remove this error.
2. If the error reports frequently, see Chapter 10

RBC clog

Maintenance to dip the WBC bath with the probe cleanser.

3. If the error still exists, contact our customer service
department.
1. Check whether the pickup tube connection looses.
2. If the connection does not loose, click the Remove error

RBC bubbles

button to remove the error.

3. If the error still exists, contact our customer service
department.
1. Adjust the HGB gain by entering the dialog box to set the
voltage within 4.3 - 4.7V, preferably 4.5V as instructed in

HGB detecting abnormal

chapter 5 Customizing the Analyzer Software.

2. If the error still exists, contact our customer service
department.

Network communication error

1. Check if the communication cable is well connected.

2. If it is well connected, check whether the communication
11-7

Troubleshooting Your Analyzer

cable is damaged.
3. If the cable is not damaged, click the Remove error
button to remove the error.
4. If the error still exists, contact our customer service
department.
Autoloader

board

communication error

1. Click the Remove error button to remove this error.

2. If the error still exists, contact our customer service
department.
1. Click the Remove error button to remove this error.

Mix mechanism action error

2. If the error still exists, contact our customer service

department.
1. Click the Remove error button to remove this error.
2. If the error still exists, please try to remove the tube rack

Autoloader mechanism action

from the autoloader and then click the Remove error button

error

again.
3. If the error still exists, contact our customer service
department.
1. Remove the rack(s) from the unloading tray.

Unloading tray is full

2. If the error still exists, contact our customer service

department.
1. Check whether the barcode is pasted incorrectly,
damaged, or illegible.
2. If there is nothing wrong with the barcode, click the

Scanner error

Remove error button to check the built-in barcode scanner.

3. If the error still exists, contact our customer service
department.
1. Check if the sample compartment door is unexpectedly

Closed-tube
open failed

sampler

door

open.
2. Click the Remove error button to remove this error.
3. If the error still exists, contact our customer service
department.

11-8

12Customizing the Print Template

12.1 Introduction
You can modify the print template based on the default one provided by the software in order
to customize the format of the report.
After customizing and saving a template, you can select the newly customized one in the print
setup. And then, the report will be printed in the customized template.

Users of common level have no authority to customize report.

12-1

Customizing the Print Template

12.2 Entering the Print Template Screen

Log in as an administrator, and then click "Menu" "Setup" "Print" to go to the print setup
screen.

1. Click the Customize button to enter the PrintTemplate screen, and the following
message box will pop up.

2. Enter the correct user name and password in the message box, and go to the print
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Customizing the Print Template

template screen shown as follows.

1 --- Main screen

2 --- Menu bar

3 --- Toolbar

4 --- Working area

5 --- Toolbar

6 --- Status bar

7 --- Property tab

8 --- Report tab

12-3

Customizing the Print Template

12.3 Editing the Template

12.3.1 Opening a Template
You can open a template by one of the following ways:

Click on the "Report" tab in the "ProjectProperty" area to display all existing templates
in the current template library. Click one of the template names and the corresponding
template will be displayed in the working area.

Click "File" "Open" on the menu bar or the

button on the toolbar, and then

specify the directory and select the template file. Click "Open" to open the template.

12.3.2 Editing the Template Property

After you open a template, the properties of this template will be displayed under the
"Property" tab on the left of the screen. Click the cell to the right of the property name box to
edit the property. If the cell is an edit box, modify the property directly; if the cell is a pull-down
list, choose the desired value in the list.

12.3.3 Inserting Controls or Businesses

Inserting a Control
Click "Insert" on the menu bar and choose the control you want to insert; or select a control in
the tool bar on the bottom left, and drag it to the desired place in the working area.

You can click the

button (line control) to draw a straight line or an oblique line in the

working area.

You can click the

You can click the

button (title control) to add a title in the working area.

button (label control) to add the fixed text information in the

working area.

You can click the

button (edit control) to add details associated with the print

template and the changeable information in the working area.

You can click the

button (picture control) to arrange the location and size of the

graph in the working area.

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Customizing the Print Template

You can click the

button (table control) to add a table in the working area.

Inserting a Business
A business is a set of controls which can be inserted in the template to facilitate the editing
process. Do as follows to insert a business:
1. Click "Insert" on the menu bar and choose "Head", "Body" or "Tail". The following
message box will pop up.

2. Select the desired business name in the pull-down list. Click the "Ok" button to close the
message box and insert the selected business.

12.3.4 Editing the Control(s)

You should select the control(s) you want to edit before start editing.
Click on the control to select it.
You can select multiple controls by one of the following ways:

Press and hold the "Ctrl" key on the keyboard, and at the same time, click on the
controls you want to select.

Click on the template in the working area and drag the mouse to enclose the controls
you want to select in the rectangular box displayed.

Moving the Control(s)

You can move the control(s) by one of the following ways:

Select the control(s) you want to move. Left click and hold the mouse, and then move the
control to the destination and release.

Select the control(s) you want to move. Press and hold the "Ctrl" key, and move the
control using the arrow keys on the keyboard.

Aligning the Control(s)

Select the control(s), and select the desired alignment options in the "Format" menu or the
12-5

Customizing the Print Template

corresponding button on the toolbar on the bottom left.

Modifying the Size of a Control

Select the control you want to edit, and then drag the borders to modify the size.

Editing the Property of the Control(s)

Select the control(s) you want to edit, and the properties will be displayed under the
"Property" tab on the left of the screen. Click the cell to the right of the property name box to
edit the property. If the cell is an edit box, modify the property directly; if the cell is a pull-down
list, choose the desired value in the list.

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Customizing the Print Template

12.4 Managing the Templates

12.4.1 Importing a Template
When you enter the main screen, you can see all the imported templates under the "Report"
tab in the "ProjectProperty" area.
Do as follows to import a new template to the current template library:
1. On the menu bar, click "File" "Import", and the following message box will pop up.

2. Choose the import type and click "Ok". Then the following message box will pop up.

3. Select the template file you want to import and click "Open" to import the template into the
current library. The name of the imported template will be displayed under the "Report" tab,
shown as follows.
12-7

Customizing the Print Template

12.4.2 Exporting a Template

1. Click on the "Report" tab in the "ProjectProperty" area to display all the templates in the
current template library.
2. Double click the template you want to export to open it in the working area.
3. On the menu bar, click "File" "Export", and the following message box will pop up.

12-8

Customizing the Print Template

4. Specify the directory you want to save the template and enter the file name. Click "Save" to
save the template.

12.4.3 Previewing a Template

Click "File" "Preview" on the menu bar or the

button on the toolbar to preview

the current template.

12.4.4 Printing a Template

Click "File" "Print" on the menu bar or the

button on the toolbar to print the current

template.

12.4.5 Deleting a Template

Click "File" "Delete" on the menu bar or the
current template.

12-9

button on the toolbar to delete the

Customizing the Print Template

12.5 Other Functions

12.5.1 Creating a New Business
1. Click "Business" "New" on the menu bar to open a blank template.
2. Insert the desired controls and modify their properties.
3. Click "Business" "Save" on the menu bar, and the following message box will pop up.
Enter the information of the business in corresponding boxes and click "Ok" to save the
business.

12.5.2 Loading the Template Library

1. Click "Setting" "LoadTemplateLib" on the menu bar, and the following message box
will pop up.

2. Select the right machine model and click "Ok" to load the template library for this model.
3. When the loading is completed, all the templates in the loaded library will be displayed
under the "Report" tab.
12-10

13Appendices
A Index
CV, 7-26

Adapter, 6-49
analyzer

Date, 5-2

intended, 2-2

Derivation, 3-7

name, 2-1

DIFF, 3-6, 11-4

Aspiration, 3-2

Diluent, 2-31, 11-5

Auto, 9-8, 9-14

Dilution, 3-3

Autoloader, 6-29, 6-35, 6-37, 6-39, 6-41, 11-8

predilute, 3-4
whole, 3-3
Directory, 2-25

Background, 11-7
barcode, 5-5
Barcode, 6-49

Electrical, 3-6

Bas#

Eos#

definition, 3-7

definition, 3-8

formula, 3-7

formula, 3-8

Bas%

Eos%

definition, 3-7

definition, 3-8

formula, 3-7

formula, 3-8
error
drive, 11-3

optical, 11-4
sample, 11-3

calibration
conditions, 9-2

syringe, 11-3

introduction, 9-1

voltage, 11-3

manual, 9-5

Calibrators, 2-32
Cleaning, 10-9
Cleanser, 2-31, 11-5

flags, 6-25

Closed-tube, 6-12, 11-8

Flow, 3-5

Compare, 7-39

Flushing, 10-14

controls, 2-32
CT-PD, 6-21
CT-WB, 6-17

A-1

Appendices
Mon%

definition, 3-7
formula, 3-7

HCT
formula, 3-11

Help, 2-28
HGB, 3-9
Network, 11-8

formula, 3-9

Neu#
definition, 3-8

formula, 3-8
Neu%

Initialization, 6-5

definition, 3-7

Installation, 4-2

formula, 3-7
No, 11-5, 11-6

Laser, 1-13
LEO, 2-31
Optical, 11-4

LEO(I), 11-4
LEO(II), 11-4

LH, 2-31, 11-5

Lym#
parameter

definition, 3-8

ALY#(RUO), 2-2

formula, 3-8

ALY%(RUO), 2-2

Lym%
definition, 3-7

Bas#, 2-2

formula, 3-7

Bas%, 2-2
Eos#, 2-2
Eos%, 2-2

HGB, 2-2
LIC%(RUO), 2-2

Main, 2-4

Lym#, 2-2

Maintenance, 10-2

Lym%, 2-2

Manual, 10-2

MCH, 2-2

MCH

MCHC, 2-2

formula, 3-11

MCV, 2-2

MCHC

Mon#, 2-2

formula, 3-11

Mon%, 2-2

MCV

Neu#, 2-2

definition, 3-11

Neu%, 2-2

message, C-2

RBC, 2-2

Microscopic, 7-5, 7-16

RDW-CV, 2-2

Mix, 11-8

RDW-SD, 2-2

Mon#

WBC, 2-2

definition, 3-8

PCT, 3-12

formula, 3-8

A-2

Appendices
PDW, 3-11

Shortcut, 2-15

PLT, 3-11

Shutdown, 6-56

Power, 4-2

Special, 6-44

Prediluted, 6-9

Startup, 6-4

Print, 5-22

STAT, 6-44

Probe, 2-32

Statistics, 7-45
System, 10-43

Quality, 8-2, 8-68, 8-118, 8-159

Tab, 2-17
Table, 7-13

Temperature, 10-43
Transport, 4-3

RBC, 11-7

troubleshooting, 11-1, 12-1

definition, 3-11
RDV-CV

definition, 3-11
RDW-SD
definition, 3-11

Unclogging, 10-11

Reading, 8-11, 8-77

User, 2-12

Reagents, 2-31

User/Lab, 5-9, 5-42

Record, 2-27
Ref., 5-17

Remove, 11-3
Replacing, 10-5

Vacuum, 11-4

reviewing

Validate

graph, 7-2

graph, 7-10

table, 7-13

table, 7-22

Right, 11-7

Verifying, 9-21

Running, 8-16, 8-82, 8-122, 8-169

Wash, 3-13
Scanner, 11-8

Waste, 11-7

Self-test, 10-52

WBC, 3-5, 11-7

settings

definition, 3-7

auto, 5-32

Worklist, 6-50

communication, 5-26
gain, 5-31

Para., 5-15
print, 5-22

Zapping, 10-12

ref., 5-17
RUO, 5-29
Sheath, 11-3

A-3

B Specifications
B.1

Classification

According to the CE classification, the analyzer belongs to In vitro diagnostic medical devices
other than those covered by Annex II and devices for performance evaluation.

B.2

Reagents

M-53 Diluent

M-53D Diluent

M-53 Lyse

M-53LEO(I) Lyse
M-53LEO(II) Lyse
M-53LH Lyse

Cleanser

M-53 Cleanser
M-53P Probe Cleanser

B.3

Collection Tube Types

The following types of collection tubes can be used in the closed-tube sampling mode.

13X75 (mm) (without the cap) evacuated blood collection tube, used for Whole Blood
Mode

12X75 (mm) (without the cap) evacuated blood collection tube, used for Whole Blood
Mode

14X75 (mm) (without the cap) evacuated blood collection tube, used for Whole Blood
Mode

15X75 (mm) (without the cap) evacuated blood collection tube, used for Whole Blood
Mode

11X40 (mm) (1.5ml centrifugal tube), used for Predilute Mode

Note: the height of the evacuated blood collection tube with cap can not be higher than
83mm.
The tubes of the model that are available in autoloader mode can also be used in CT-WB
mode.

B-1

Appendices

B.4

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

MCHC

g/L

RDW-SD

fL

RDW-CV

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

WBC/BASO Histogram

None

White Blood Cell Histogram

WBC Histogram

None

4 differential Scattergram

Diff Scattergram

None

Corpuscular

Hemoglobin

Concentration
Red Blood Cell Distribution Width
Standard Deviation
Red Blood Cell Distribution Width
Coefficient of Variation

White

Blood

Cell/Basophils

Scattergram

B-2

Appendices

B.5

Sampling Features

B.5.1 Sample Volumes Required for Each Analysis

Whole Blood Mode

20 L

Predilute Mode

20 L

B.5.2 Throughput

B.6

Autoloader mode

60 samples/ 1 hour

Closed-tube Mode

50 samples/ 1 hour

Performance Specifications

B.6.1 Display Range

Parameter

Display range

WBC

0-200.0109/L

RBC

0-18.00.0109/L

HGB

0-300g/L

PLT

0-2000109/L

HCT

0%~80%

B.6.2 Normal Background

Parameter

Background result

WBC

0.3 109 / L

RBC

0.03 1012/ L

HGB

1g/L

HCT

0.5 %

PLT

10 109/ L

B.6.3 Linearity Range

Parameter

Linearity range

Deviation range (Whole

Deviation

blood mode)

(Predilute Mode)

range

WBC

0.00-99.99109/L

0.30109/L or 5

0.60109/L or 6

RBC

0.00-8.001012/L

0.051012/L or 5

0.101012/L or 10

HGB

0-250g/L

2g/L or 2

4g/L or 4

PLT

0-100010 /L(RBC7.0)

1010 /L or 8

20109/L or 16

HCT

0-67%

2%(HCT value) or 3%

4%(HCT value) or 6%

(deviation percent)

(deviation percent)

B-3

Appendices

B.6.4 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)

absolute deviation d)

WBC

(4.0-15.0)10 /L

2.0

4.0

Neu%

50.0%-60.0%

4.0(absolute deviation)

8.0(absolute deviation)

Lym%

25.0%-35.0%

3.0(absolute deviation)

6.0(absolute deviation)

Mon%

5.0%-10.0%

2.0(absolute deviation)

4.0(absolute deviation)

Eos%

2.0%-5.0%

1.5(absolute deviation)

2.5(absolute deviation)

Bas%

0.5%-1.5%

0.8(absolute deviation)

1.2(absolute deviation)

12

RBC

(3.50-6.00)10 /L

1.5%

3.0%

HGB

(110-180) g/L

1.5%

3.0%

MCV

(70-120) fL

1.0%

2.0%

PLT

(150-500)10 /L

4.0%

8.0%

MPV

4.0%

8.0%

: Absolute deviation d = analysis result average of analysis results

B.6.5Carryover

B.7

Parameter

Carryover

WBC

0.5 %

RBC

0.5 %

HGB

0.6 %

HCT

0.5 %

PLT

1.0 %

Input/output Device

Accessory equipment connected to the analogue and digital interfaces must

be complied with the relevant Safety and EMC standards (e.g., IEC 60950
Safety of Information Technology Equipment Standard and CISPR 22 EMC
of Information Technology Equipment Standard (CLASS B)). Any person,
who connects additional equipment to the signal input or output ports and
configures an IVD system, is responsible for ensuring that the system work
normally and complies with the safety and EMC requirements. If you have
any problem, consult the technical services department of your local
representative.

B-4

Appendices

The external computer must meet the requirements specified in B.7.1.

If LIS communication is required, the external computer must have two

network interface cards.

B.7.1 External Computer (Optional)

PC (IBM compatible)

RAM: 256 MB

Hard disk space: 4G

Operation system: Windows 2000 Professional + SP4, XP Home/XP Professional + SP2,

Windows Vista Home Basic*32, Windows Vista Ultimate*32, Windows 7 Home Basic*32,
Windows 7 Ultimate*32

B.7.2 Keyboard (Optional)

101-Key alpha-numeric keyboard

B.7.3 Mouse (Optional)

B.7.4 Bar-code Scanner
External bar-code scanner (optional)
Built-in bar-code scanner

B.7.5 Printer

B.8

Interfaces

One LAN interface

B.9

Power Supply
Voltage

Analyzer

Input power

A.C. 100V-240V

300 VA

Frequency
50/60 Hz

B.10 EMC Description

This equipment complies with the emission and immunity requirements of the EN
61326-1:2006 and EN 61326-2-6:2006.
B-5

Appendices

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.11 Sound
Maximal sound: 67.7 dBA

Be sure to use and store the analyzer in the specified environment.

B.12 Operating Environment

Optimal operating temperature: 15 - 30

Optimal operating humidity: 30 % - 85 %

Atmospheric pressure: 70 kPa - 106 kPa.

B.13 Storage Environment

Ambient temperature: -10 - 40

Relative humidity: 10 % - 90 %

Atmospheric pressure: 50 kPa - 106 kPa.

B.14 Running Environment

Ambient temperature: 10 - 40

Relative humidity: 10 % - 90 %

Atmospheric pressure: 70 kPa - 106 kPa.

B-6

Appendices

B.15 Dimensions and Weight

Height
Depth
Width

Analyzer
Width(mm)

590

Height(mm)

525

Depth(mm)

570

Weight(Kg)

58

B.16 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

1~20

CODE 93

1~20

CODE 128

1~20

CODEBAR

1~20

UPC/EAN

Controlled

by

the

built-in

scanner
ITF

Evens between 1 and 20

Code height: A10mm

Label width: B45mm
Clear area: C5mm

B-7

barcode

Appendices
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.17 Contraindications
None

B-8

C Communication
C.1

Introduction of communication protocol of the auto

hematology analyzers
C.1.1 Messages supported by the HL7 interface protocol
The IPU software of the auto hematology analyzers and the LIS system enable the connection
between the analyzer and the computer of the lab through the Ethernet. The analyzer could
send the analysis results to the lab computer and receive the worklist information from it.
This communication protocol is defined based on the HL7 standard. HL7 is the digital data
switching standard used in the medical field. It is firstly defined by America and now adopted
by many countries. The definition is based on HL7 v2.3.1. For details of the HL7, please see
HL7 Interface Standards Version 2.3.1.

C.1.2 Bottom transmitting layer protocol

The IPU software sends messages through TCP connection and the communication
procedures consist of 3 phases:

Connecting
After starting up, the IPU software connects the LIS server actively according to the settings. If
the connecting is failed, it retries; if the connecting is successful, it keeps the connection to
make sure the data can be sent at any time. If the connection is found disconnected during
operating, it retries to connect.

Data transmitting
Besides batch sending the data at the List Review and QC screen, if auto-communication is
enabled, the IPU software will send the message while the new sample results are obtained.
Sending and receiving the message are synchronous both for batch communication and
auto-communication. i.e. when every message is sent, it will wait for the confirmation. If the
confirmation is received within 10s, then a complete message is sent and the next message
will be sent; if the confirmation is not received within the 10s, then it is regarded that the
sending is failed and it will skip to the sending of the next message.
The communication of QC data records is similar to that of the analysis results: send
messages at the QC screen or QC History screen. Wait for the confirmation after sending each
QC data. If the confirmation is received within 10s, then the message has been sent
successfully; if the confirmation is not received within 10s, then it is regarded that the sending
is failed and it will skip to the sending of the next message.
The bidirectional LIS inquiry communication is different from the processes mentioned above.
The IPU software will send an inquiry (including the sample ID) every time it opens the
C-1

Appendices
bidirectional LIS communication, saves worklists or before counting. The LIS will respond with
a HL7 message based on the message it received, and then IPU will fill in the worklist or
perform counting according to the response. If there is no response within 10s after the inquiry
was sent, it is regarded that the inquiry is failed.

Disconnecting
When exiting the IPU software, the connection will be closed actively. When changing the
communication settings, the connection will also be disconnected and then re-connect
according to the new settings.

C.1.3 HL7 message layer protocol

HL7 top message protocol

The data of sample results etc. are transmitted in the form of UTF-8 coding strings.
The message strings are composed as per the HL7 standard. A message consists of several
segments, each segment consists of several fields, a field consists of several components,
and component consists of several sub components. The segment, field, component and sub
component are divided by separators. The structure of the message is shown in Figure 1.

Figure 1 Structure of the message

A part of the HL7 message is shown below:
MSH|^~\&|Analyzer|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
C-2

Appendices
PID|1||7393670^^^^MR||Joan^JIang||19900804000000|Female
PV1|1||nk^^001
OBR|1||20071207011|00001^Automated
Count^99MRC||20080508140600|20080508150616|||John||||20080508150000||||||||||HM||||||||
Mindray
OBX|1|IS|08001^Take Mode^99MRC||O||||||F
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC||||||F
OBX|4|IS|01002^Ref Group^99MRC||Woman||||||F

HL7 bottom protocol

TCP/IP is a protocol of byte stream. It doesnt provide the message boundary.HL7 of top
protocol is based on messages. The function of terminating the message is not provided. In
order to determine the message boundary, the bottom protocol of MLLP is used (such
descriptions are also included in HL7 Interface Standards Version 2.3.1.).
Communication level
Messages are transmitted in the following format:
<SB> ddddd <EB><CR>
Among them:
<SB> = Start Block character (1 byte)
ASCII <VT>,i.e., <0x0B>.Do not confuse with the SOH or STX character in ASCII.
ddddd = Data (variable number of bytes)
ddddd is the effective data of HL7 message and expressed in the form of string. For the strings
used in the HL7 interface messages of auto hematology analyzers, the UTF-8 code is used.
<EB> = End Block character (1 byte)
ASCII <FS>,i.e. <0x1C>. Do not confuse with the ETX or EOT character in ASCII.
<CR> = Carriage Return (1 byte)
ASCII carriage return character, i.e. <0x0D>.

C.2

Introduction of HL7

C.2.1 HL7 basic grammar

Message constructing principles
C-3

Appendices

Every HL7 message consists of several segments and ends up with the <CR> character.
Each segment consists of the segment name of three characters and field of changeable
characters, and each field consists of the component and subcomponent. For each message,
the separators of the field, component and subcomponent are defined in the MSH segment.
For example:
MSH|^~\&|Analyzer|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
In this message:
The five characters following MSH define the separators to distinguish each field, component
and subcomponent. Although they can be any non-text characters, HL7 standard recommends
the characters in the table below:
Character

Meaning

Field separator

Component separator

&

Subcomponent separator

Repetition separator

ESC

The first field of MSH includes every separator. Some field behind are empty because they are
optional and not used by Mindray HL7 interface. Detailed field definition and selection will be
stated in the following contents.
For message of any type, the segments behind MSH appear in the fixed order. The order will
be described in the following contents and the grammar is used to organize the segments
order.
The segment appeared in [] is optional.
The segment appeared in {} can be repeated once or more.

String transferring principles

For the field data of ST, TX, FT, and CF, etc., separators may be contained in the string data
like remark, clinical diagnosis and customized gender etc. When coding, the separators in the
original strings shall be transferred into transferred character sequence; then, restore them
when decoding. The transferring principles are shown in the table:
Transferred character

Original character

\F\

Field separator

\S\

Component separator

\T\

Subcomponent separator

\R\

Repetition separator

\E\

Transferred separator

\.br\

<CR>,i.e. end character of segment

C-4

Appendices
Note: \ in the transferred character sequence represents the transferred separator. Its value
is defined in MSH segment.

C.2.2 HL7 data types

All the data information can be expressed by different types of HL7 fields. Only part of the HL7
standard is used in the communication protocol, see D4 Appendix for details.

C.3

Duplex communication

C.3.1 HL7 message supported

Process of duplex communication

1. The main unit directly sends the test results (or QC data) to LIS as Figure 2 shows.

Figure 2 Test results (QC data) communication process

2. Worklist information searching
Worklist belongs to the Order message. Thus, the corresponding HL7 messages:
ORM(General Order Message) and ORR(General Order Response Message) can be used.
The communication process is shown in Figure 3.

C-5

Appendices

Figure 3 Worklist searching communication process

Mostly used messages:

ORU^R01 message: it is mostly used for the transmission of the test results and QC data.
ORU Observational Results (Unsolicited)

Description

MSHMessage header, necessary, including the communication information of message No.,

sending time, message separator and coding method, etc
{
PID

Patient basic information, including patient name, gender, patient ID and birthday, etc

[PV1] Patient visit information, including patient type, department, bed No. and charge, etc
{
OBRsample information, including sample No., operator and run time, etc
{[OBX]} test data, including test results and work mode, etc
}
}
ACK^R01 message: it confirms the received ORU^R01 message.
ACK

Acknowledgment

Description

MSHMessage header
MSAMessage affirm, describing whether the communication message is received successfully
ORM^O01 message: Common order message, all the actions related to order basically use
the message of this type. For example, create a new order or cancel an order. Here, the main
unit requests LIS to re-fill the order message.
ORM General Order Message
MSH

Description
Message header

{ORC} Common message of Order, including the No. information of the sample searched
ORR^O02 message: affirming of the ORM^O01 message. Here, returning the completed
information of order (i.e. worklist).
ORR^O02 General Order Response Message
MSH

Description

Message header

MSAMessage affirm
[PIDPatient basic information
C-6

Appendices
[PV1]]Patient visit information
{
ORCCommon message of Order, including the sample No.
[
OBRsample information
{[OBX]}Data of other sample information, including work mode, etc.
]
}

C.3.2 HL7 segment definition involved

Detailed definition of fields contained in each segment will be listed in the table below. The
meaning of each column is explained below.
1. No.: the HL7 message initiates with the segment name of 3 characters. The following each
field will follow a separator, and the No. is the position order of the field.
For example:
PID

|1

Segment name

|7393670^^^^MR||Joan^JIang||19900804000000|Female

filed 1

filed 3

Note: the MSH message is a little different. The separator following the segment name is
regarded as the first field and used to describe the value of the separators used in the
message.
2. Field name: the logical meaning of the field
3. Data type: the HL7 standard type of the data, the structure will be described in Appendix A;
4. Recommended max length: the HL7 standard recommended length. But, during the actual
transmitting, the length may exceed the length, so the separators should be identified to read
the message when decoding the message.
5. Note: the note for the actual value of the fields
6. Samples: the sample of actual field value

MSH
The MSH(Message Header)segment contains basic information of HL7 message including
separators value, message type and coding method etc. It is the first field of every HL7
message.
Message used for example:
MSH|^~\&|Analyzer|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
See Table 1 for definition of each field used in MSH segment.

Table 1 MSH field definitions

C-7

Appendices
No.
1

Field

Data

Recommended

Name

type

max length

Field

ST

Separator

Note

Samples

Includes the separator of the

first field after the segment

name; be used to determine
the separators value of the
rest parts of the message.

Encoding

ST

Characters

Includes

component

separators,

repetition

separators,

transferred

^~\&

separators and subcomponent

separators; the value in the
HL7

message

of

auto

hematology analyzers is ^~\&

3

Sending

EI

180

application

Application

program

of

Analyzer

sending terminal. If the main

unit sends the message; the
value

is

BC-5300

or

Analyzer.
4

Sending

EI

180

Facility

Device of sending terminal. If

the

main

message,

unit

sends

the

the

value

is

Mindray

Mindray.
7

Date/Time

TS

26

Created time of message (in

Of

the

Message

YYYY[MM[DD[HH[MM[SS]]]]]);

format

20080617143943

of

adopts the system time.

9

Message

CM

Type

Message type; in the format of

ORU^R01

message type^event type.

e.g. ORU^R01

10

Message

ST

20

Control ID
11

Processing
ID

Message control ID; be used

to mark a message uniquely.

PT

Message

processing

ID

values:
P-

sample

and

worklist

searching information;
D- QC setup information;
T QC results information;
In

Ack

messages,

it

is

consistent with the previously

C-8

Appendices
received message.
12

Version ID

VID

60

HL7 version information; the

2.3.1

value is 2.3.1.
18

Character

ID

10

UNICODE

Character set.

Set

The value is UNICODE, and

the message is expressed by
Unicode string.

MSA
The MSA(Message Acknowledgement) segment contains message confirming information.
Message used for example:
MSA|AA|1
See Table 2 for definition of the fields used.
Table 2 MSA field definitions
No.

Field Name

Acknowledgment

Data

Recommended

type

max length

ID

Note
Acknowledgement

Code

Samples
code:

AA

AA- receive, AE error,

AR- reject

Message Control

ST

20

Message control ID; its

ID

consistent with the MSH-10

of the received message.

Error Condition

CE

100

Error

condition

(status

code); it also contains error

condition

specification

information; see Table 3 for

the value.
Table 3 Error code of MSA-6 field
Status code

Status text

(MSA-6)

(MSA-3)

Description/Remark

Successful:
0
Error

AA
Message accepted

status

Successful
AE

code:
100
101

Segment sequence

Segment order in the message is wrong, or

error

necessary segment lost

Required

field

Necessary field lost in a segment

missing

C-9

Appendices
102

Data type error

Segment data type error, e.g. numbers are replaced

by characters

103

Table

value

not

Table value is not found; not used temporarily

found
Rejection status

AR

code:
200

Unsupported

Message type is not supported

message type
201

Unsupported event

Event code is not supported

code
202

Unsupported

Processing ID is not supported

processing id
203

Unsupported

Version ID is not supported

version id
204

Unknown

key

identifier
205

Unknown key identifier, e.g. transmitting the patient

information that is not exited

Duplicate

key

Repeated key words existed

identifier
206

Application

207

record

Issues can not be executed at application program

locked

saving level, e.g. database is locked

Application internal

Other interior errors of application program

error

PID
The PID(Patient Identification) segment contains the patient basic information.
Message used for example:
PID|1||7393670^^^^MR||Joan^JIang||19900804000000|Female
See Table 4 for definition of the fields used.
Table 4 PID field definitions
No.
1

Field

Data

Recommended

Name

type

max length

Set ID -

SI

PID

Note

Samples

Sequence NO.; it is used to

mark

the

different

PID

segments of a message.
3

Patient

CX

20

To be used as the patient ID

Identifier

in the message of the sample

List

test results, in the form of

Patient ID^^^^MR.

C-10

7393670^^^^MR

Appendices
To be used as QC lot No. in
the message of QC.
5

Patient

XPN

48

Patient name (dividing into

Name

two

parts

when

Joan^JIang

sending:

FirstName

and

LastName),

e.g.

LastName^FirstName.
7

Date/Time

TS

26

To be used as birthday in the

of Birth

19900804000000

message of sample results

To be used as expiration date
in the message of QC
In

the

form

of

YYYY[MM[DD[HH[MM[SS]]]]]
8

Sex

IS

Gender, string.

Female

PV1
The PV1(Patient Visit) segment contains the patient visit information.
Message used for example:
PV1|1||nk^^001
See Table 5 for definition of the fields used.
Table 5 PV1 field definitions
No.
1

Field Name
Set ID - PV1

Data

Recommended

type

max length

SI

Note

Samples

Sequence NO.; it is used to

mark

the

different

PV1

segments of a message.
3

Assigned

PL

80

Patient location information;

Patient

in the form of Department^

Location

^Bed No.

nk^^001

OBR
The OBR(Observation Request) segment contains the test report information.
Message used for example:
OBR|1||20071207011|00001^Automated
Count^99MRC||20080508140600|20080508150616|||John||||20080508150000||||||||||HM||||||||
Mindray
See Table 6 for definition of the fields used.

C-11

Appendices
Table 6 OBR field definitions
No.
1

Field Name
Set

Data

Recommended

type

max length

SI

10

Note

Samples

Sequence NO.; it is

ID - OBR

used to indicate the

different

OBR

segments

of

used

as

message.
2

Placer

Order

EI

22

To

Number

be

sample ID in the
message of worklist
searching
response,

i.e.

ORC^O02
3

Filler

Order

EI

22

To

Number +

be

used

as

20071207011

sample ID in the
message

of

test

results
To be used as file
No.

in

the

QC

message
4

Universal

CE

200

Service ID

Universal

service

00001^Automated

ID,

identify

Count^99MRC

to

different
test

types

results.

Appendix

of
See

for

detailed values.
6

Requested

TS

26

Requested

Date/time

20080508140600

Date/time
To

express

the

sampling date and

time.
7

Observation

TS

26

Run Time

20080508150616

XCN

60

Sample collector

John

Date/Time #
10

Collector
Identifier *

To

indicate

the

deliverer
13

Relevant

ST

300

Relevant

Clinical Info.

clinical

information.
It can be used as
C-12

Appendices
the

clinical

diagnostic
information in the
patient info.
14

Specimen

TS

26

Sample

Received

time

Date/Time *

To

received

express

20080508150000

the

delivery time.
15

Specimen

CM

300

Sample source

Source *

Its value in HL7

message
auto

on

the

hematology

analyzers:
BLDV-

Venous

blood
BLDC-

Capillary

blood
22

Results

TS

26

Results

Rpt/Status
Chng

report/Status
-

Change

Date/Time +

Date/Time
To

be

used

as

validating time.
24

Diagnostic

ID

10

Diagnostic ID, the

Serv Sect ID

value

is

HM

HM,

means Hematology.
28

Result Copies

XCN

60

Result copies to

To

To

indicate

the

validater.
32

Principal

CM

200

Principal

result

Result

interpreter

Interpreter +

To

be

used

as

tester in the sample

message
To be used as set
by

in

the

QC

used

as

message
To

be

Operator

in

the

QC run message
C-13

Mindray

Appendices

OBX
The OBX(Observation/Result) segment contains the parameter information of each test result.
Message used for example:
OBX|6|NM|6690-2^WBC^LN||9.81|10*9/L|4.00-10.00|N|||F||E
See Table 7 for definition of the fields used.
Table 7 OBX field definitions
No.
1

Field Name
Set

ID

Data

Recommended

type

max length

SI

10

OBX

Note

Samples

Sequence NO.; it is used

to mark the different OBX

segments of a message.

Value Type

ID

Data type of test results;

NM

the values can be ST,

NM, ED and IS, etc.
3

Observation

CE

590

Identifier

Test item mark

6690-2^WBC^LN

Form:
ID^Name^EncodeSys.
The ID is the test item
mark;

Name

the

description information of
the

test

EncodeSys

item;
is

the

coding system of the test

item. For the values of the
code of each test item,
please see configuration
file and Appendix B.
Note:

ID

and

EncodeSys are used to

identify

unique

parameter, but Name is

used for description only.
5

Observation
Value

65535

Test results data. It can

be

numbers,

strings,

enumeration values and

binary

data,

Appendix

C-14

etc.,

see

for

their

9.81

Appendices
values (for the binary
data, they are transferred
by the Base64 coding
method, see Appendix C
for details).
6

Units

CE

90

Units of test items. ISO

10*9/L

standard units are used.

The

units

used

for

communication are listed

in Appendix B.
7

References

ST

90

Range

Reference range; in the

4.00-10.00

form of lower limit-upper

limit, < upper limit or >
lower limit.

Abnormal

ID

Flags

Result flags:

N- Normal
A- Abnormal
H- higher than upper
limit
L- lower than lower limit
Note: The flag for normal
or abnormal and that for
high or low result may be
displayed in this field at
the same time. In this
case, the two flags should
be connected with a ~,
e.g.: H~A

11

Observ

ID

Test result status. The

Result

value

is

Status

Result);it means the final

(Final

result.
13

User

ST

20

Customized contents. It

Defined

stands

Access

expiration

Checks

modification

for

reagent
and
mark,

etc.

The form is mark 1-mark

2.
There are 3 kinds of
marks in all:
C-15

Appendices
O Expired reagent
E Active editing
e Passive editing

ORC
The ORC(Common Order) segment contains the common information of order.
Message used for example:
ORC|RF||SampleID||IP
See Table 8 for definition of the fields used.
Table 8 ORC field definitions
No.
1

Field Name
Order

Data

Recommended

type

max length

ID

Control

Note
Order control word

Samples
RF

In the ORM message the value

is RF which means re-fill the
order request.
In the ORR message the value
is AF which means affirm the
re-filled order.

Placer

EI

22

Placer order number

Order

In the ORM message the value

Number

is empty; in the ORR message

the value is the sample ID.

Filler

EI

22

OrderNum

Filler Order Number

SampleID

In the ORM message the value

is the sample ID; in the ORR
message the value is empty.

Order
Status

ID

Order status

IP

In the ORM message the value

is IP which means order is
being processed, but results are
not obtained; in the ORR
message the value is empty.

C.3.3 Example of a complete message

The following two messages demonstrate the communication process of the sample data.

Sample message

C-16

Appendices

MSH|^~\&|Analyzer|Mindray|||20080617143943||ORU^R01|1|P|2.3.1||||||UNICODE
PID|1||7393670^^^^MR||Joan^JIang||19900804000000|Female
PV1|1||nk^^001
OBR|1||20071207011|00001^Automated
Count^99MRC||20080508140600|20080508150616|||John||||20080508150000||||||||||HM||||||||
Mindray
OBX|1|IS|08001^Take Mode^99MRC||O||||||F
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC||||||F
OBX|4|IS|01002^Ref Group^99MRC||Woman||||||F
OBX|5|NM|30525-0^Age^LN||18|yr|||||F
OBX|6|NM|6690-2^WBC^LN||9.81|10*9/L|4.00-10.00|N|||F||E
OBX|7|NM|704-7^BAS#^LN|||10*9/L|0.00-0.10||||F
OBX|8|NM|706-2^BAS%^LN||||0.000-0.010||||F
OBX|9|NM|751-8^NEU#^LN|||10*9/L|2.00-7.00||||F
OBX|10|NM|770-8^NEU%^LN||||0.500-0.700||||F
OBX|11|NM|711-2^EOS#^LN|||10*9/L|0.02-0.50||||F
OBX|12|NM|713-8^EOS%^LN||||0.005-0.050||||F
OBX|13|NM|731-0^LYM#^LN|||10*9/L|0.80-4.00||||F
OBX|14|NM|736-9^LYM%^LN||||0.200-0.400||||F
OBX|15|NM|742-7^MON#^LN|||10*9/L|0.12-0.80||||F
OBX|16|NM|5905-5^MON%^LN||||0.030-0.080||||F
OBX|17|NM|26477-0^*ALY#^LN|||10*9/L|0.00-0.20||||F
OBX|18|NM|13046-8^*ALY%^LN||||0.000-0.020||||F
OBX|19|NM|10000^*LIC#^99MRC|||10*9/L|0.00-0.20||||F
OBX|20|NM|10001^*LIC%^99MRC||||0.000-0.025||||F
OBX|21|NM|789-8^RBC^LN||4.53|10*12/L|3.50-5.00|N|||F
OBX|22|NM|718-7^HGB^LN||65|g/L|110-150|L|||F
OBX|23|NM|787-2^MCV^LN||89.5|fL|80.0-100.0|N|||F
OBX|24|NM|785-6^MCH^LN||14.4|pg|27.0-31.0|L|||F
OBX|25|NM|786-4^MCHC^LN||160|g/L|320-360|L|||F
OBX|26|NM|788-0^RDW-CV^LN||0.133||0.115-0.145|N|||F
OBX|27|NM|21000-5^RDW-SD^LN||50.9|fL|35.0-56.0|N|||F
OBX|28|NM|4544-3^HCT^LN||0.405||0.370-0.480|N|||F
OBX|29|NM|777-3^PLT^LN||212|10*9/L|100-300|N|||F
OBX|30|NM|32623-1^MPV^LN||6.6|fL|7.0-11.0|L|||F
OBX|31|NM|32207-3^PDW^LN||15.4||15.0-17.0|N|||F
OBX|32|NM|10002^PCT^99MRC||1.40|mL/L|1.08-2.82|N|||F
OBX|33|IS|12014^Anemia^99MRC||T||||||F
C-17

Appendices
OBX|34|IS|15180-3^Hypochromia^LN||T||||||F
OBX|35|NM|15001^WBC Histogram. Left Line^99MRC||7||||||F
OBX|36|NM|15002^WBC Histogram. Right Line^99MRC||65||||||F
OBX|37|NM|15003^WBC Histogram. Middle Line^99MRC||30||||||F
OBX|38|ED|15008^WBC

Histogram.

BMP^99MRC||^Image^BMP^Base64^ WBC

Histogram bmp data||||||F

OBX|39|NM|15051^RBC Histogram. Left Line^99MRC||26||||||F
OBX|40|NM|15052^RBC Histogram. Right Line^99MRC||164||||||F
OBX|41|ED|15056^RBC

Histogram.

BMP^99MRC||^Image^BMP^Base64^ RBC

Histogram bmp data||||||F

OBX|42|NM|15111^PLT Histogram. Left Line^99MRC||3||||||F
OBX|43|NM|15112^PLT Histogram. Right Line^99MRC||43||||||F
OBX|44|ED|15116^PLT Histogram. BMP^99MRC||^Image^BMP^Base64^PLT Histogram
bmp data||||||F
OBX|45|ED|15200^WBC DIFF Scattergram. BMP^99MRC||^Image^BMP^Base64^WBC
Diff Scattergram bmp data||||||F
OBR|2||20071207011|00002^Manual Count^99MRC|||||||||||BLDV
OBX|46|NM|747-6^Myeloblasts%. Manual^LN||0.0|%|||||F
OBX|47|NM|783-1^Promyelocytes%. Manual^LN||0.0|%|||||F
OBX|48|NM|749-2^Myelocytes%. Manual^LN||0.0|%|||||F
OBX|49|NM|740-1^Metamyelocyte%. Manual^LN||0.0|%|||||F
OBX|50|NM|764-1^Neuts Band%. Manual^LN||0.0|%|||||F
OBX|51|NM|769-0^Neuts Seg%. Manual^LN||0.0|%|||||F
OBX|52|NM|714-6^Eosinophils%. Manual^LN||0.0|%|||||F
OBX|53|NM|707-0^Basophils%. Manual^LN||0.0|%|||||F
OBX|54|NM|33831-9^Lymphoblasts%. Manual^LN||0.0|%|||||F
OBX|55|NM|6746-2^Prolymphocytes%. Manual^LN||0.0|%|||||F
OBX|56|NM|737-7^Lymphocytes%. Manual^LN||0.0|%|||||F
OBX|57|NM|29261-5^Abnormal Lymphs%. Manual^LN||0.0|%|||||F
OBX|58|NM|33840-0^Monoblasts%. Manual^LN||0.0|%|||||F
OBX|59|NM|13599-6^Promonocytes%. Manual^LN||0.0|%|||||F
OBX|60|NM|744-3^Monocytes%. Manual^LN||0.0|%|||||F
OBX|61|NM|18309-5^NRBCs%. Manual^LN||0.0|%|||||F
OBX|62|NM|31112-6^Reticulocytes%. Manual^LN||0.0|%|||||F
OBX|63|NM|11000^Undefined Cells%. Manual^99MRC||0.0|%|||||F
OBX|64|NM|11001^Other Abnormal Cells%. Manual^99MRC||0.0|%|||||F

Sample response message

Every time a sample result is received, a sample response message composed of two
C-18

Appendices
message segments (MSH and MSA) will be sent. To send a correct response message, take
into consideration that: the MSH-9 field should be ACK^R01 which indicates that it is a sample
response message; If the value in the MSA-2 field is the same with the MSH-10 value of the
analysis result, it indicates that this response message is corresponding to the sent analysis
result. The MSA-2 value in the following example is 1
MSH|^~\&|LIS||||20080617143944||ACK^R01|1|P|2.3.1||||||UNICODE
MSA|AA|1

QC message
The content of the QC message differs from that of the sample analysis result: the MSH-11
value of the QC message is Q which indicates that it is a QC message; each QC message is
corresponding to one QC point in the IPU software which may contain several analysis results.
For example, there is one analysis result in an L-J QC message, while there are two analysis
results and one mean calculation result in an X-R QC message.
A QC messasge is composed of an MSH message head and several analysis results, each of
which contains the PID and OBR segments as the head of the sample message, as well as
several OBX segments to carry parameters and other information. The OBR-4 field of each
analysis result indicates the type of the result (X-R analysis result, X-R mean or L-J analysis
result). See Appendix: Message coding definition for details.
An example of the X-R QC message is shown as follows:
MSH|^~\&|Analyzer|Mindray|||20081120171602||ORU^R01|1|Q|2.3.1||||||UNICODE
PID|1||6666666||||20080807235959
OBR|1||6|00006^XR QCR^99MRC|||20080807142518|||||||||||||||||HM||||||||R&D Engineer
OBX|1|IS|05001^Qc Level^99MRC||M||||||F
OBX|2|IS|08001^Take Mode^99MRC||C||||||F
OBX|3|IS|08002^Blood Mode^99MRC||W||||||F
OBX|4|NM|6690-2^WBC^LN||0.00|10*9/L|||||F
OBX|5|NM|704-7^BAS#^LN||***.**|10*9/L|||||F
OBX|6|NM|706-2^BAS%^LN||**.*|%|||||F
OBX|7|NM|751-8^NEU#^LN||***.**|10*9/L|||||F
OBX|8|NM|770-8^NEU%^LN||**.*|%|||||F
OBX|9|NM|711-2^EOS#^LN||***.**|10*9/L|||||F
OBX|10|NM|713-8^EOS%^LN||**.*|%|||||F
OBX|11|NM|731-0^LYM#^LN||***.**|10*9/L|||||F
OBX|12|NM|736-9^LYM%^LN||**.*|%|||||F
OBX|13|NM|742-7^MON#^LN||***.**|10*9/L|||||F
OBX|14|NM|5905-5^MON%^LN||**.*|%|||||F
OBX|15|NM|789-8^RBC^LN||0.02|10*12/L|||||F
C-19

Appendices
OBX|16|NM|718-7^HGB^LN||0|g/L|||||F
OBX|17|NM|787-2^MCV^LN||***.*|fL|||||F
OBX|18|NM|785-6^MCH^LN||***.*|pg|||||F
OBX|19|NM|786-4^MCHC^LN||****|g/L|||||F
OBX|20|NM|788-0^RDW-CV^LN||**.*|%|||||F
OBX|21|NM|21000-5^RDW-SD^LN||***.*|fL|||||F
OBX|22|NM|4544-3^HCT^LN||0.0|%|||||F
OBX|23|NM|777-3^PLT^LN||4|10*9/L|||||F
OBX|24|NM|32623-1^MPV^LN||**.*|fL|||||F
OBX|25|NM|32207-3^PDW^LN||**.*||||||F
OBX|26|NM|10002^PCT^99MRC||.***|%|||||F
OBX|27|NM|10003^GRAN-X^99MRC||6||||||F
OBX|28|NM|10004^GRAN-Y^99MRC||32||||||F
OBX|29|NM|10005^GRAN-Y(W)^99MRC||20||||||F
OBX|30|NM|10006^WBC-MCV^99MRC||83||||||F
OBX|31|NM|15001^WBC Histogram. Left Line^99MRC||10||||||F
OBX|32|NM|15002^WBC Histogram. Right Line^99MRC||72||||||F
OBX|33|NM|15003^WBC Histogram. Middle Line^99MRC||37||||||F
OBX|34|ED|15008^WBC

Histogram.

BMP^99MRC||^Image^BMP^Base64^WBC

histogram data||||||F
OBX|35|NM|15051^RBC Histogram. Left Line^99MRC||10||||||F
OBX|36|NM|15052^RBC Histogram. Right Line^99MRC||250||||||F
OBX|37|ED|15056^RBC

Histogram.

BMP^99MRC||^Image^BMP^Base64^RBC

histogram data||||||F
OBX|38|NM|15111^PLT Histogram. Left Line^99MRC||3||||||F
OBX|39|NM|15112^PLT Histogram. Right Line^99MRC||24||||||F
OBX|40|ED|15116^PLT Histogram. BMP^99MRC||^Image^BMP^Base64^PLT histogram
data||||||F
OBX|41|ED|15200^WBC DIFF Scattergram. BMP^99MRC||^Image^BMP^Base64^DIFF
scattergram data||||||F
PID|2||6666666||||20080807235959
OBR|2||6|00006^XR QCR^99MRC|||20080807142640|||||||||||||||||HM||||||||R&D Engineer
OBX|42|IS|05001^Qc Level^99MRC||M||||||F
OBX|43|IS|08001^Take Mode^99MRC||C||||||F
OBX|44|IS|08002^Blood Mode^99MRC||W||||||F
OBX|45|NM|6690-2^WBC^LN||0.00|10*9/L|||||F
OBX|46|NM|704-7^BAS#^LN||***.**|10*9/L|||||F
OBX|47|NM|706-2^BAS%^LN||**.*|%|||||F
OBX|48|NM|751-8^NEU#^LN||***.**|10*9/L|||||F
OBX|49|NM|770-8^NEU%^LN||**.*|%|||||F
C-20

Appendices
OBX|50|NM|711-2^EOS#^LN||***.**|10*9/L|||||F
OBX|51|NM|713-8^EOS%^LN||**.*|%|||||F
OBX|52|NM|731-0^LYM#^LN||***.**|10*9/L|||||F
OBX|53|NM|736-9^LYM%^LN||**.*|%|||||F
OBX|54|NM|742-7^MON#^LN||***.**|10*9/L|||||F
OBX|55|NM|5905-5^MON%^LN||**.*|%|||||F
OBX|56|NM|789-8^RBC^LN||0.02|10*12/L|||||F
OBX|57|NM|718-7^HGB^LN||0|g/L|||||F
OBX|58|NM|787-2^MCV^LN||***.*|fL|||||F
OBX|59|NM|785-6^MCH^LN||***.*|pg|||||F
OBX|60|NM|786-4^MCHC^LN||****|g/L|||||F
OBX|61|NM|788-0^RDW-CV^LN||**.*|%|||||F
OBX|62|NM|21000-5^RDW-SD^LN||***.*|fL|||||F
OBX|63|NM|4544-3^HCT^LN||0.0|%|||||F
OBX|64|NM|777-3^PLT^LN||5|10*9/L|||||F
OBX|65|NM|32623-1^MPV^LN||**.*|fL|||||F
OBX|66|NM|32207-3^PDW^LN||**.*||||||F
OBX|67|NM|10002^PCT^99MRC||.***|%|||||F
OBX|68|NM|10003^GRAN-X^99MRC||28||||||F
OBX|69|NM|10004^GRAN-Y^99MRC||19||||||F
OBX|70|NM|10005^GRAN-Y(W)^99MRC||20||||||F
OBX|71|NM|10006^WBC-MCV^99MRC||60||||||F
OBX|72|NM|15001^WBC Histogram. Left Line^99MRC||10||||||F
OBX|73|NM|15002^WBC Histogram. Right Line^99MRC||72||||||F
OBX|74|NM|15003^WBC Histogram. Middle Line^99MRC||37||||||F
OBX|75|ED|15008^WBC

Histogram.

BMP^99MRC||^Image^BMP^Base64^WBC

histogram data||||||F
OBX|76|NM|15051^RBC Histogram. Left Line^99MRC||10||||||F
OBX|77|NM|15052^RBC Histogram. Right Line^99MRC||250||||||F
OBX|78|ED|15056^RBC

Histogram.

BMP^99MRC||^Image^BMP^Base64^

RBC

histogram data||||||F
OBX|79|NM|15111^PLT Histogram. Left Line^99MRC||3||||||F
OBX|80|NM|15112^PLT Histogram. Right Line^99MRC||24||||||F
OBX|81|ED|15116^PLT Histogram. BMP^99MRC||^Image^BMP^Base64^ PLT histogram
data||||||F
OBX|82|ED|15200^WBC DIFF Scattergram. BMP^99MRC||^Image^BMP^Base64^ DIFF
scattergram data||||||F
PID|3||6666666
OBR|3||6|00008^XR QCR Mean^99MRC||||||||||||||||||||HM
OBX|83|NM|6690-2^WBC^LN||0.00|10*9/L|||||F
C-21

Appendices
OBX|84|NM|704-7^BAS#^LN||***.**|10*9/L|||||F
OBX|85|NM|706-2^BAS%^LN||**.*|%|||||F
OBX|86|NM|751-8^NEU#^LN||***.**|10*9/L|||||F
OBX|87|NM|770-8^NEU%^LN||**.*|%|||||F
OBX|88|NM|711-2^EOS#^LN||***.**|10*9/L|||||F
OBX|89|NM|713-8^EOS%^LN||**.*|%|||||F
OBX|90|NM|731-0^LYM#^LN||***.**|10*9/L|||||F
OBX|91|NM|736-9^LYM%^LN||**.*|%|||||F
OBX|92|NM|742-7^MON#^LN||***.**|10*9/L|||||F
OBX|93|NM|5905-5^MON%^LN||**.*|%|||||F
OBX|94|NM|789-8^RBC^LN||0.02|10*12/L|||||F
OBX|95|NM|718-7^HGB^LN||0|g/L|||||F
OBX|96|NM|787-2^MCV^LN||***.*|fL|||||F
OBX|97|NM|785-6^MCH^LN||***.*|pg|||||F
OBX|98|NM|786-4^MCHC^LN||****|g/L|||||F
OBX|99|NM|788-0^RDW-CV^LN||**.*|%|||||F
OBX|100|NM|21000-5^RDW-SD^LN||***.*|fL|||||F
OBX|101|NM|4544-3^HCT^LN||0.0|%|||||F
OBX|102|NM|777-3^PLT^LN||5|10*9/L|||||F
OBX|103|NM|32623-1^MPV^LN||**.*|fL|||||F
OBX|104|NM|32207-3^PDW^LN||**.*||||||F
OBX|105|NM|10002^PCT^99MRC||.***|%|||||F
OBX|106|NM|10003^GRAN-X^99MRC||17||||||F
OBX|107|NM|10004^GRAN-Y^99MRC||26||||||F
OBX|108|NM|10005^GRAN-Y(W)^99MRC||20||||||F
OBX|109|NM|10006^WBC-MCV^99MRC||72||||||F

QC response message
The only difference between the QC response message and the analysis result response
message is that the MSH-11 value of the QC response message is Q.
An example of the ACK X-R QC message is shown as follows:
MSH|^~\&|LIS||||20081120171602||ACK^R01|1|Q|2.3.1||||||UNICODE
MSA|AA|1

Bidirectional LIS inquiry message

A bidirectional LIS inquiry message contains a sample ID. After the LIS received the inquiry
message, it will search for the corresponding patient and sample information to provide a
response.

C-22

Appendices
The inquiry message is composed of two message segments: MSH and ORC. The MSH
segment is almost the same with that of the analysis result, except that the MSH-9 value is
ORM^O01. The ORC-3 field should be filled with the receiver code (in this case, the sample ID;
where in the following sample, it is SampleID1). Note that in the autoloading analysis, if there
is a barcode scan error while sending an inquiry message, the sample ID will be Invalid.
An example of the inquiry message is shown as follows:
MSH|^~\&|Analyzer|Mindray|||20081120174836||ORM^O01|4|P|2.3.1||||||UNICODE
ORC|RF||SampleID1||IP

Bidirectional LIS inquiry response message

When the LIS received an inquiry message, it needs to send back an inquiry response
message. The first two message segments of the inquiry response message are MSH and
MSA. The MSH-9 field (indicating the type of the segment) is filled with ORR^O02, while the
MSA segment should be filled up as shown in the following example of the inquiry response
message. If the LIS gets searching results for the inquiry, there will be PID, PV1, ORC, OBR
and OBX message segments after the two heading segments to provide the patient and
sample information, in the same way as the sample data message does. The ORC segment is
indispensable for an inquiry response message with searching results, in which the ORC-1
value is AF, and ORC-2 is the filter (the sample ID). Note that the OBR-2 field indicates the
sample ID, which should be the same value as in the ORC-2 field; otherwise, the message will
be regarded as incorrect.
An example of the inquiry response message with searching results is shown as follows:
MSH|^~\&|LIS||||20081120174836||ORR^O02|1|P|2.3.1||||||UNICODE
MSA|AA|4
PID|1||ChartNo^^^^MR||^FName||19810506|NT
PV1|1|nk^^Bn4|||||||||||||||||NewCharge
ORC|AF|SampleID1|||
OBR|1|SampleID1||||20060506||||tester|||Diagnose
content....|20060504||||||||20080821||HM||||Validator||||Operator
OBX|1|IS|08001^Take Mode^99MRC||A||||||F
OBX|2|IS|08002^Blood Mode^99MRC||W||||||F
OBX|3|IS|08003^Test Mode^99MRC||CBC||||||F
OBX|4|IS|01002^Ref Group^99MRC||XXXX||||||F
OBX|5|NM|30525-0^Age^LN||1|hr|||||F
OBX|6|ST|01001^Remark^99MRC||remark content....||||||F
An example of the inquiry response message with no search result is shown as follows, in
which the MSA-2 field indicates the result of the response. In this example, the MSA-2 value is
C-23

Appendices
AR, indicating the inquiry was rejected; if it is AE", then there is an error in the inquiry
process.
MSH|^~\&|LIS||||20081120175238||ORR^O02|1|P|2.3.1||||||UNICODE
MSA|AR|9

C.4

Appendix: Definition of the HL7 data type used

CE - Code Element

<identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^
<alternate text (ST)> ^ <name of alternate coding system (ST)>

CM - Composite

The format is defined by the specific field.

CX - Extended composite ID with check digit

<ID (ST)> ^ <check digit (ST)> ^ <code identifying the check digit scheme employed (ID)> ^ <
assigning authority (HD)> ^ <identifier type code (IS)> ^ < assigning facility (HD)>

ED Encapsulate Data

<source application(HD)> ^ <type of data(ID)> ^ <data sub type(ID)> ^ <encoding(ID)> ^

<data(ST)>

EI - Entity Identifier

<entity identifier (ST)> ^ <namespace ID (IS)> ^ <universal ID (ST)> ^ <universal ID type (ID)>

FC Financial Class

<financial class(IS)> ^ <effective date(TS)>

HD - Hierarchic designator

<namespace ID (IS)> ^ <universal ID (ST)> ^ <universal ID type (ID)>

Used only as part of EI and other data types.

FT - Formatted text

This data type is derived from the string data type by allowing the addition of embedded
formatting instructions. These instructions are limited to those that are intrinsic and
independent of the circumstances under which the field is being used.

IS - Coded value for user-defined tables

The value of such a field follows the formatting rules for an ST field except that it is drawn from
a site-defined (or user-defined) table of legal values. There shall be an HL7 table number
associated with IS data types.

ID - Coded values for HL7 tables

C-24

Appendices
The value of such a field follows the formatting rules for an ST field except that it is drawn from
a table of legal values. There shall be an HL7 table number associated with ID data types.

NM - Numeric

A number represented as a series of ASCII numeric characters consisting of an optional

leading sign (+ or -), the digits and an optional decimal point.

PL - Person location

<point of care (IS )> ^ <room (IS )> ^ <bed (IS)> ^ <facility (HD)> ^ < location status (IS )> ^
<person location type (IS)> ^ <building (IS )> ^ <floor (IS )> ^ <location description (ST)>

PT - Processing type

<processing ID (ID)> ^ <processing mode (ID)>

SI - Sequence ID

A non-negative integer in the form of an NM field. The uses of this data type are defined in the
chapters defining the segments and messages in which it appears.

ST String

TS - Time stamp

YYYY[MM[DD[HHMM[SS[.S[S[S[S]]]]]]]][+/-ZZZZ] ^ <degree of precision>

XCN - Extended composite ID number and name

In Version 2.3, use instead of the CN data type. <ID number (ST)> ^ <family name (ST)> &
<last_name_prefix (ST) ^ <given name (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR
or III) (ST)> ^ <prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (ST)> ^ <source table (IS)> ^
<assigning authority (HD)> ^ <name type code (ID)> ^ <identifier check digit (ST)> ^ <code
identifying the check digit scheme employed (ID)> ^ <identifier type code (IS)> ^ <assigning
facility (HD)> ^ <name representation code (ID)>

XPN - Extended person name

In Version 2.3, replaces the PN data type. <family name (ST)> ^ <given name (ST)> &
<last_name_prefix (ST)> ^ <middle initial or name (ST)> ^ <suffix (e.g., JR or III) (ST)> ^
<prefix (e.g., DR) (ST)> ^ <degree (e.g., MD) (IS)> ^ <name type code (ID) > ^ <name
representation code (ID)>

VID - Version identifier

<version ID (ID)> ^ <internationalization code (CE)> ^ <international version ID (CE)>

C.5

Appendix: Message coding definition

1. In the HL7 message, the OBR-4(Universal Serview ID) field is used for identifying the type
C-25

Appendices
of the test results, for example, to identify the results as sample results, microscope exam
results or QC results in the form of ID^Name^EncodeSys. The coding values of the field are
listed in the table below.
Table 9 OBR-4 Coding
Data

Coding (ID)

Name

EncodeSys

Analysis result

00001

Automated Count

99MRC

Microscope exam result

00002

Manual Count

99MRC

LJ QC result

00003

LJ QCR

99MRC

X QC result

00004

X QCR

99MRC

XB QC result

00005

XB QCR

99MRC

XR QC result

00006

XR QCR

99MRC

X QC result mean

00007

X QCR Mean

99MRC

XR QC result mean

00008

XR QCR Mean

99MRC

2. Each OBX segment contains one test parameter or information of other data and consists of
the following fields: OBX-2, it indicates the HL7 type of the data contained; OBX-3, it is the
mark of the data in the form of ID^Name^EncodeSys; OBX-5, it contains the value of the data;
OBX-6, it contains the unit for the parameter, expressing in the ISO standard.
The HL7 types and coding marks of all the communication data are listed in Table 10. The
units of all the communication data are listed in table 11.
Table 10 HL7 types and coding marks
Data

HL7 Type

Coding

(OBX-2)

(ID)

Name

EncodeSys

OBX-3 field example

Other data
Take Mode

IS

08001

Take Mode

99MRC

Blood Mode

IS

08002

Blood Mode

99MRC

Test mode

IS

08003

Test Mode

99MRC

Age

NM

Age

LN

Remark

ST

01001

Remark

99MRC

Ref Group

IS

01002

Ref Group

99MRC

305250

C-26

08001^Take
Mode^99MRC
08002^Blood
Mode^99MRC
08003^Test
Mode^99MRC
30525-0^Age^LN
01001^Remark^99M
RC
01002^Ref
Group^99MRC

Appendices

QC Level

IS

05001

Qc Level

99MRC

05001^Qc
Level^99MRC

Analysis results data

WBC

NM

6690-2

WBC

LN

6690-2^WBC^LN

BAS

NM

704-7

BAS#

LN

704-7^BAS#^LN

BAS_PER

NM

706-2

BAS%

LN

706-2^BAS%^LN

NEU

NM

751-8

NEU#

LN

751-8^NEU#^LN

NEU_PER

NM

770-8

NEU%

LN

770-8^NEU%^LN

EOS

NM

711-2

EOS#

LN

711-2^EOS#^LN

EOS_PER

NM

713-8

EOS%

LN

713-8^EOS%^LN

LYM

NM

731-0

LYM#

LN

731-0^LYM#^LN

LYM_PER

NM

736-9

LYM%

LN

736-9^LYM%^LN

MON

NM

742-7

MON#

LN

742-7^MON#^LN

MON_PER

NM

5905-5

MON%

LN

5905-5^MON%^LN

ALY

NM

*ALY#

LN

ALY_PER

NM

*ALY%

LN

LIC

NM

10000

*LIC#

99MRC

LIC_PER

NM

10001

*LIC%

99MRC

RBC

NM

789-8

RBC

LN

789-8^RBC^LN

HGB

NM

718-7

HGB

LN

718-7^HGB^LN

MCV

NM

787-2

MCV

LN

787-2^MCV^LN

MCH

NM

785-6

MCH

LN

785-6^MCH^LN

MCHC

NM

786-4

MCHC

LN

786-4^MCHC^LN

RDW_CV

NM

788-0

RDW-CV

LN

788-0^RDW-CV^LN

RDW_SD

NM

RDW-SD

LN

HCT

NM

4544-3

HCT

LN

4544-3^HCT^LN

PLT

NM

777-3

PLT

LN

777-3^PLT^LN

MPV

NM

MPV

LN

PDW

NM

PDW

LN

PCT

NM

10002

PCT

99MRC

GRAN-X

NM

10003

GRAN-X

99MRC

GRAN-Y

NM

10004

GRAN-Y

99MRC

264770
130468

210005

326231
322073

C-27

26477-0^*ALY#^LN
13046-8^*ALY%^LN
10000^*LIC#^99MRC
10001^*LIC%^99MR
C

21000-5^RDW-SD^L
N

32623-1^MPV^LN
32207-3^PDW^LN
10002^PCT^99MRC
10003^GRAN-X^99M
RC
10004^GRAN-Y^99M

Appendices
RC
GRAN-Y(W)

NM

10005

GRAN-Y(W)

99MRC

WBCMCV

NM

10006

WBC-MCV

99MRC

10005^GRAN-Y(W)^
99MRC
10006^WBC-MCV^99
MRC

Microscope exam data

Blood Type
WBC
Morphology
RBC
Morphology

ST
ST
ST

882-1
111567
6742-1
11125-

PLT Morphology

ST

Myeloblast

NM

747-6

Promyelocyte

NM

783-1

Myelocyte

NM

749-2

MetaMyelocyte

NM

740-1

BandFormNeut

NM

764-1

SegmentNeut

NM

769-0

Eosinophils

NM

714-6

Basophils

NM

707-0

Lymphoblast

NM

Prolymphocytes

NM

6746-2

Lymphocytes

NM

737-7

AbnLymph

NM

Blood Type

LN

WBC Morphology

LN

RBC Morphology

LN

PLT Morphology

LN

Myeloblasts%.
Manual
Promyelocytes%.
Manual
Myelocytes%.
Manual
Metamyelocyte%.
Manual
Neuts

Band%.

Manual
Neuts

Seg%.

Manual
Eosinophils%.
Manual
Basophils%.
Manual

33831-

Lymphoblasts%.

Manual

292615

Prolymphocytes
%. Manual
Lymphocytes%.
Manual

LN
LN
LN
LN
LN
LN
LN
LN
LN
LN
LN

Abnormal
Lymphs%.
Manual

C-28

882-1^Blood
Type^LN
11156-7^WBC
Morphology^LN
6742-1^RBC
Morphology^LN
11125-2^PLT
Morphology^LN
747-6^Myeloblasts%.
Manual^LN
783-1^Promyelocytes
%. Manual^LN
749-2^Myelocytes%.
Manual^LN
740-1^Metamyelocyt
e%. Manual^LN
764-1^Neuts Band%.
Manual^LN
769-0^Neuts

Seg%.

Manual^LN
714-6^Eosinophils%.
Manual^LN
707-0^Basophils%.
Manual^LN
33831-9^Lymphoblas
ts%. Manual^LN
6746-2^Prolymphocyt
es%. Manual^LN
737-7^Lymphocytes
%. Manual^LN
29261-5^Abnormal

LN

Lymphs%.
Manual^LN

Appendices

Monoblast

NM

Promonocytes

NM

Monocyte

NM

NRBCS

NM

Reticulocyte

NM

UndefinedCells

OtherAbnormalC
ells
ESR

NM

NM

NM

33840-

Monoblasts%.

Manual

13599-

Promonocytes%.

Manual

744-3

Monocytes%.
Manual

18309-

NRBCs%.

Manual

31112-

Reticulocytes%.

Manual

11000

11001
303412

Undefined
Cells%. Manual
Other

Abnormal

Cells%. Manual
ESR

LN
LN
LN
LN
LN

33840-0^Monoblasts
%. Manual^LN
13599-6^Promonocyt
es%. Manual^LN
744-3^Monocytes%.
Manual^LN
18309-5^NRBCs%.
Manual^LN
31112-6^Reticulocyte
s%. Manual^LN
11000^Undefined

99MRC

Cells%.
Manual^99MRC
11001^Other

99MRC

Abnormal

Cells%.

Manual^99MRC
LN

Analysis results medium data(WBC, RBC, PLT histogram and scattergram data, etc.)
WBC Histogram
Binary Data

ED

15000

WBC Histogram
Left

NM

15001

Discriminator
WBC Histogram
Right

NM

15002

Discriminator
WBC Histogram
Middle

NM

15003

Discriminator
WBC Histogram
Original

Data

NM

15004

Length

WBC Histogram.
Binary
WBC Histogram.
Left Line
WBC Histogram.
Right Line
WBC Histogram.
Middle Line
WBC Histogram.
Meta Length

15000^WBC
99MRC

Binaray^99MRC
15001^WBC
99MRC

Discriminator

Histogram.
15002^WBC

99MRC

Histogram.

Right

Line^99MRC
15003^WBC
99MRC

Histogram.

Middle

Line^99MRC
15004^WBC
99MRC

Histogram.

Meta

Length^99MRC
15005^WBC

IS

15005

IS

15006

WBC Histogram.
Left Line Adjusted

99MRC

Histogram. Left Line

Adjusted^99MRC

Adjusted Mark
WBC Histogram

Left

Line^99MRC

WBC Histogram
Left

Histogram

WBC Histogram.

C-29

99MRC

15006^WBC

Appendices
Right

Right

Discriminator

Adjusted

Line

Histogram. Right Line

Adjusted^99MRC

Adjusted Mark
WBC Histogram
Middle
Discriminator

IS

15007

Bitmap Data
RBC Histogram
Binary Data

ED

ED

15008

15050

RBC Histogram
Left

NM

15051

Discriminator
RBC Histogram
Right

NM

15052

Discriminator
RBC Histogram
Original

Data

Middle

Line

99MRC

Adjusted

Adjusted Mark
WBC Histogram

15007^WBC

WBC Histogram.

15053

Length

WBC Histogram.

Discriminator

Line

BMP

15008^WBC
99MRC

Histogram.
BMP^99MRC

RBC Histogram.
Binary

15050^RBC
99MRC

Histogram.
Binary^99MRC

RBC Histogram.
Left Line

15051^RBC
99MRC

RBC Histogram.
Right Line

Binary

Histogram.

Left

Line^99MRC
15052^RBC
99MRC

Histogram.

Right

Line^99MRC
Meta

15053^RBC
99MRC

Length

Histogram.

Binary

Meta Length^99MRC

RBC Histogram
Left

Middle

Adjusted^99MRC

RBC Histogram.
NM

Histogram.

15054^RBC
IS

15054

RBC Histogram.
Left Line Adjusted

99MRC

Histogram. Left Line

Adjusted^99MRC

Adjusted Mark
RBC Histogram
Right
Discriminator

IS

15055

Bitmap Data
PLT

Histogram

Binary Data
PLT

ED

ED

15056

15100

Histogram

Left

NM

15111

Discriminator
PLT

Histogram

Right

Line

99MRC

Adjusted

Adjusted Mark
RBC Histogram

15055^RBC

RBC Histogram.

NM

15112

RBC Histogram.
BMP
PLT

Histogram.

15056^RBC
99MRC

Histogram.
15100^PLT

99MRC

Histogram.
Binary^99MRC

Histogram.

Left Line
PLT

Adjusted^99MRC

BMP^99MRC

Binary
PLT

Histogram. Right Line

Histogram.
C-30

15111^PLT
99MRC

Histogram.
Line^99MRC

99MRC

15112^PLT

Left

Appendices
Right

Right Line

Histogram.

Discriminator
PLT

Line^99MRC

Histogram

Original

Data

PLT
NM

15113

Length
PLT

Histogram.

Binary

Meta

15113^PLT
99MRC

Length

Discriminator

Histogram.

Binary

Meta Length^99MRC

Histogram

Left

Right

15114^PLT
IS

15114

PLT

Histogram.

Left Line Adjusted

99MRC

Histogram. Left Line

Adjusted^99MRC

Adjusted Mark
PLT

Histogram

Right
Discriminator

PLT
IS

15115

Histogram

Bitmap Data

Right

Line

ED

15116

DIFF

PLT

Histogram.

BMP

ED

15200

Bitmap Data

Histogram. Right Line

Adjusted^99MRC
15116^PLT

99MRC

Histogram.
BMP^99MRC

WBC

Scattergram

99MRC

Adjusted

Adjusted Mark
PLT

15115^PLT

Histogram.

DIFF

Scattergram.

15200^WBC
99MRC

BMP

DIFF

Scattergram.
BMP^99MRC

Abnormal alarm information

WBC

Abn

scattergram
Abnormal WBC
Histogram

IS

IS

12000

12001

WBC

Abnormal

scattergram
WBC

Abnormal

histogram

12000^WBC
99MRC

scattergram^99MRC
12001^WBC
99MRC

Abnormal
histogram^99MRC

Leucocytosis

IS

12002

Leucocytosis

99MRC

Leucopenia

IS

12003

Leucopenia

99MRC

Neutrophilia

IS

12004

Neutrophilia

99MRC

Neutropenia

IS

12005

Neutropenia

99MRC

Lymphocytosis

IS

12006

Lymphocytosis

99MRC

Lymphopenia

IS

12007

Lymphopenia

99MRC

Monocytosis

IS

12008

Monocytosis

99MRC

C-31

Abnormal

12002^Leucocytosis^
99MRC
12003^Leucopenia^9
9MRC
12004^Neutrophilia^9
9MRC
12005^Neutropenia^
99MRC
12006^Lymphocytosi
s^99MRC
12007^Lymphopenia^
99MRC
12008^Monocytosis^

Appendices
99MRC
Eosinophilia

IS

12009

Eosinophilia

99MRC

Basophilia

IS

12010

Basophilia

99MRC

WBC abnormal

IS

12011

WBC Abnormal

99MRC

Left Shift?

IS

WBC Left Shift?

LN

Immature
Granulocyte?
Abnormal/Atypic
al Lymphocyte?
RBC

Lyse

Resist?
Erythrocytosis
RBC

abnormal

distribution

IS
IS
IS
IS

IS

Anisocytosis

IS

Macrocytosis

IS

Microcytosis

IS

Dimorphologic

IS

Anemia

IS

Hypochromia

IS

HGB

177907
34165-

Imm

Granulocytes?

151928
345256
12012

12013
151506
151985
151993
103796
12014
151803

LN

Atypical Lymphs?

LN

rstRBC

LN

Erythrocytosis

99MRC

RBC

Abnormal

distribution

99MRC

Anisocytosis

LN

Macrocytes

LN

Microcytes

LN

RBC Dual Pop

LN

Anemia

99MRC

Hypochromia

LN

HGB Interfere

99MRC

IS

12016

Thrombocytosis

IS

12017

Thrombocytosis

99MRC

Thrombopenia

IS

12018

Thrombopenia

99MRC

Abnormal

Distribution

PLT

Abnormal

Distribution

C-32

12010^Basophilia^99
MRC
12011^WBC
Abnormal^99MRC
17790-7^WBC

Left

Shift?^LN
34165-1^Imm
Granulocytes?^LN
15192-8^Atypical
Lymphs?^LN
34525-6^rstRBC^LN
12012^Erythrocytosis
^99MRC
Abnormal
distribution^99MRC

12015

PLT

9MRC

12013^RBC

IS

Abn/Interfere?

12009^Eosinophilia^9

99MRC

15150-6^Anisocytosis
^LN
15198-5^Macrocytes
^LN
15199-3^Microcytes^
LN
10379-6^RBC

Dual

Pop^LN
12014^Anemia^99M
RC
15180-3^Hypochromi
a^LN
12015^HGB
Interfere^99MRC
12016^PLT Abnormal
Distribution^99MRC
12017^Thrombocytos
is^99MRC
12018^Thrombopenia

Appendices
^99MRC
PLT Clump?

IS

7796-6

Platelet Clump?

LN

7796-6^Platelet
Clump?^LN

Table 11 Units of communication data

Parameters units displayed on the

Units of communication data

screen of the analyzer

(OBX-6)

10^12/L

10*12/L

10^9/L

10*9/L

10^6/uL

10*6/uL

10^4/uL

10*4/uL

10^3/uL

10*3/uL

10^2/uL

10*2/uL

mL/L

mL/L

/nL

/nL

/pL

/pL

g/L

g/L

g/dL

g/dL

L/L

L/L

mmol/L

mmol/L

fL

fL

um^3

um3

pg

pg

fmol

fmol

amol

amol

Year (age unit)

yr

Month (age unit)

mo

Day (age unit)

Hour (age unit)

hr

3. Part of the OBX messages adopt the customized enumeration values listed in the following
table.
Data item
Take Mode

Enumeration values
The values are the following enumerations:
O open vial
A autoloading
C closed vial

C-33

Appendices
Blood Mode

The values are the following enumerations:

W- whole blood
P prediluted

Test Mode

The values are the following enumerations:

CBC
CBC+5DIFF

Age

The values are the numeric data and the units

are the following enumerations:
yr - year
mo month
d

- day

hr - hour
Blood Type ABO

The values are the following enumerations:

A
B
O
AB

Blood Type RH

The values are the following enumerations:

RH+
RH-

Qc Level

The values are the following enumerations:

L- low
M- normal
H- high

Adjusting marks of histogram discriminators

OBX-2 data type is IS; the values are the

and flags

following enumerations:
T- true
F- false

4. Histogram data: according to the software setup, there are several cases for the
communication of the histogram data.
(1)Do not transmit the histogram data.
(2)Transmit histogram data in the form of bitmap. In the OBX segment, the value of the data
type field is ED; the value of data is in the form of ^Image^BMP^Base64^histogram data
in the form of bitmap, the image herein indicates the image data is transmitted; the
BMP is the customized sub-data type, it indicates the BMP bitmap is transmitted; Base64
indicates the coding method of the data.
(3)Transmit binary histogram data. In the OBX segment, the value of the data type field is ED;
the value of data is in the form of ^Application^Octet-stream^Base64^histogram
data; Application^Octer-stream herein is the sub-data of HL7 standard, indicating the
C-34

Appendices
binary data type defined by the application program; Base64 indicates the coding method of
the data.
Note: to transmit the histogram data in the form of bitmap or binary is determined by the ID
field in the OBX segment.
5. Scattergram data: when transmitting bitmap data, in the OBX segment, the value of the data
type field is ED; the value of data is in the form of ^Image^BMP^Base64^scattergram
data in the form of bitmap. The Image^BMP^Base64 indicates the bitmap data is of
BMP type and coded by Base64.
6. Age communication: the age in the patient information will be transferred as an OBX
message segment composed of an integer and the age unit. If the age in the IPU software is
displayed as <1, then the age value in the communication is 0.

C.6

Appendix: Base64 coding procedures

(1) Select the 3 adjacent bytes (i.e. 24 bit) from the data stream to be coded; from left to right,
divide them into 4 groups of 6-bit; then, ASCII string is obtained by mapping as per the Table
12.
Initial data

15H

A3H

4BH

Binary data

00010101

6-bit group obtained after dividing

000101 011010 001101 001011

Corresponding coding value

Corresponding character

10100011

5H

1AH

0DH

0BH

Table 12 Base64 mapping

Value/Code

Value/Code

Value/Code

Value/Code

0A

17 R

34 I

51 z

1B

18 S

35 j

52 0

2C

19 T

36 k

53 1

3D

20 U

37 l

54 2

4E

21 V

38 m

55 3

5F

22 W

39 n

56 4

6G

23 X

40 o

57 5

7H

24 Y

41 p

58 6

8I

25 Z

42 q

59 7

9J

26 a

43 r

60 8

10 K

27 b

44 s

61 9

C-35

01001011

Appendices
11 L

28 c

45 t

62 +

12 M

29 d

46 u

63 /

13 N

30 e

47 v

14 O

31 f

48 w

15 P

32 g

49 x

16 Q

33 h

50 y

(pad) =

(2) Repeat the coding of procedure (1) continuously till finish coding the data stream.
When the data left is less than 3 bytes, 0 is used to complement to the right. If the whole 6-bit
group obtained is composed of 0, then it is mapped to the = character. When one byte is left,
then the obtained coding string consists of two = characters; when two bytes are left, then the
obtained coding string consists of one = character. The two cases are demonstrated below:
Initial data

0AH
00001010

Data obtained after complementing

6-bit groups obtained after dividing

00001010

00000000

000010

100000

Corresponding values

02H

20H

Corresponding characters

Initial data

0AH

0BH

00001010

00001011

Data obtained after complementing

00001010

6-bit groups obtained after dividing

000010

Corresponding values
Corresponding characters

00000000

000000

000000

00H

00H

00001011
100000

101100

00000000
000000

02H

20H

2CH

00H

C-36

P/N: 046-001575-00 (2.0)