Cellagon 5 PRO

Auto Hematology Analyzer

User Manual

130500033BEN

Version: 1.1 Release date: 2022.07.18.

 Disclaimers

All printouts, graphics, displays, screens, etc. are for information and illustration purposes only and shall not be used
for clinical or maintenance evaluations. Data shown in sample printouts and screens do not reflect actual patient
names or test results.

The Information was developed to be used by Diagon Ltd trained personnel, by other persons knowledgeable or
experienced with the operation and service of the product identified, or under the direct supervision and with
cooperation from Diagon Ltd technical sales or service representatives.

In no event shall Diagon Ltd or its affiliates be liable for any damages or losses incurred in connection with or arising
from the use of the Information by persons not fully trained by Diagon Ltd. This limitation shall not apply to those
persons knowledgeable or experienced with the operation and service of the product identified, or under the direct
supervision and with cooperation from Diagon Ltd technical sales or service representatives.

No confidential relationship shall be established in the event that any user of the Information should make any oral,
written or electronic response to Diagon Ltd (such as feedback, questions, comments, suggestions, ideas, etc.). Such
response and any information submitted therewith shall be considered non-confidential, and Diagon Ltd shall be free
to reproduce, publish or otherwise use such information for any purposes whatsoever including, without limitation,
the research, development, manufacture, service, use, or sale of products incorporating such information. The sender
of any information to Diagon Ltd is fully responsible for its content, including its truthfulness and accuracy and its
non-infringement of any other person's proprietary rights.

Diagon Ltd is not engaged in rendering medical advice or services.

Updates to the Information may be provided in either paper or electronic format. Always refer to the latest documents
for the most current information.

Incremental manual updates may cause the master Table of contents or master Index page numbering to change.

No part of this material may be reproduced, stored, retrieved or transmitted in any form or by any means without the
prior written permission of Diagon Ltd.

I
 How to use the user manual

Thank you for your interest in becoming a user of fully automated hematology analyzer.

In order to achieve a best result, you must be familiar with the analyzer and its performance before conducting a
clinical diagnostic test. Untrained or unauthorized personnel must not use and install this analyzer. This user
manual is a guide to the use of the fully automated hematology analyzer including the installation, daily testing,
quality control and routine maintenance of the instrument.

Different versions or configurations of instruments have slightly different functions. The contents of the user
manual are slightly different due to version upgrade without prior notice. If you have any questions, please
contact with your dealer.

Notice: Tips, advice and suggestions.

Warning: Warning instructions must be strictly observed to ensure the proper operation of the analyzer and
the test results are correct and true.

Statement

The illustrations provided in the description are only examples and may not be exactly the same as the actual display
on the product. The actual product shall prevail. Do not use it for other purposes. No individual or organization may
copy, modify, or translate the contents of this manual without the written consent of the manufacturers.

It is responsible for the safety, reliability, and performance of its products when all of the following requirements are
met including:

● Assembly operations, re-commissioning, expansion, improvement, and repairs should all be performed by
authorized personnel by the manufacturers;

● Product operation is performed according to this manual;

● The relevant electrical equipment complies with national standards.

Notice
This analyzer must be used by medical inspection professionals or trained doctors, nurses, or laboratory
technicians.

Warning
The use of a unit that fails to achieve a satisfactory maintenance/maintenance plan may result in an abnormal
analyzer failure and may endanger human health.

Ensure that the analyzer is used under the conditions specified in the instructions. If the analyzer is used outside
of the conditions of use, the analyzer may not operate properly and the measurement results will be unreliable. It
may damage the analyzer components and cause personal injury.

II
 Warnings and safety tips
For in-vitro diagnostic use only. Please read the following warning carefully before use.

Warning: Please read the following precautions carefully before using the instrument.

 The key of the housing is available for service staff only for safety reasons; the on-site user or operator
should not open the instrument.
 If there is any kind of leakage coming from the chassis of the instrument, the instrument must be
turned off, disconnected to power and the service must be informed immediately. Do not re-connect
the instrument before the investigation of service agent.
 If abnormal odor or smoke is generated, immediately cut off the power and unplug the power plug
from the power outlet. At this time, the inspection application should be submitted immediately to the
dealers and agents of the company. Continued use in this condition may result in fire, electric shock
or personal injury.
 The instrument should not spill blood or reagents, nor can it fall into metal items such as staples and
pins. Otherwise it may cause a short circuit or smoke. If abnormality occurs, immediately cut off the
power and unplug the power plug from the power outlet. At this time, the inspection application
should be submitted immediately to the dealers and agents of the company.
 Always wear rubber gloves (EN 388, EN 374 Cat. III.) and use the specified tools and parts for
maintenance and inspection. After the operation is completed, wash your hands with disinfectant.
Otherwise, parts of the skin exposed to blood may be infected.
 Be careful when processing specimens. Be sure to wear rubber gloves (EN 388, EN 374 Cat. III.),
otherwise it may cause infection. If the specimen enters the eyes or the wound, it should immediately
be flushed with plenty of water and be examined by a doctor.

 Please wear medical protective gloves (EN 388, EN 374 Cat. III.) before using this instrument.
 Only certified external devices against electrical hazard are allowed to be connected

III
 Instrument installation and transition
 Do not transport the instrument by squeezing or inverting the instrument.
 When installing for the first time or if you do not know the installation, consult the dealer and its
manufacturer.
 The instrument should be placed on a flat surface that is stable and larger than the area of the
bottom of the machine. There should be at least 100mm space on all sides.
 The power cord, signal-grounding wire, and related reagent bottles and containers should be
connected in strict accordance with the markings on the instrument to ensure that the relevant
connecting tube is not broken.
 As the instrument is around 60 kg special care must be taken, while taking it out from its’ package or
moving it. It is highly recommended to lift the instrument by 2 persons, one from each side, placing
one hand under the instrument and the other around it, making sure that there is a secure grip.
While lifting the instrument bend your knees, do not bend your back, in order to avoid any injuries.

Use of reagents
 It should be immediately rinsed with plenty of water and examined by a doctor if reagents
inadvertently enter the eyes.
 Please seek medical advice immediately and give plenty of water to spit out the reagents if you
mistakenly drink the reagents.
 Please rinse immediately with clean water if the reagent comes into contact with hands or skin.
 Used wastes such as test tubes and other equipment consumables should be disposed of in
accordance with the relevant requirements for medical wastes or infectious wastes. If it is contaminated
by blood, it may be infected by pathogens.
 Please make necessary protection when replacing reagents.

IV
 Power supply voltage, connection and grounding
 The instrument is supplied power cord.
 Do not plug the power plug into a power outlet which is not AC100V ~ 240V. Otherwise, it may cause
fire or electric shock.
 When installing the instrument, use the power cable of random distribution. Ensure that the
grounding cable is properly grounded. Also, connect the chassis signal-grounding cable; otherwise, it
may cause an inaccurate result.
 Do not damage the insulation of the power cord. It is not possible to pull the cord or hang a heavy
object on it. Doing so may cause a short circuit or open circuit, which may cause electric shock or fire.
 When connecting peripheral instruments be sure to turn off the power first or it may result in electric
shock or malfunction.
 Do not open the side cover or panel while the power is on or it may damage some sensitive
instruments.

Contact information
Diagon Ltd.

1047 Budapest, Baross utca 48-52. 1325 Újpest, Pf. 41.

tel.: (+36 1) 369 6500 e-mail: diagon@diagon.com

fax.: (+36 1) 369 6301 www.diagon.com

Hungary, Europe

Ordering stocks, replacement parts and consumables:

If you wish to order stocks, replacement parts and consumables, please, contact our staff at sales@diagon.com

Technical support and maintenance:

In case of technical failure or periodic maintenance of the instrument, please, contact our staff at
customersupport@diagon.com

V
 Name Address Homepage Contact

Manufacturer Diagon Kft. H-1047 Budapest, Phone +36-1-369-6500/144

Baross u. 48- 52. Fax +36-1-369-6301

www.diagon.com
Hungary, e-mail diagon@diagon.com

Europe

Distributor Diagon Kft. H-1047 Budapest, Phone +36-1-369-6500/144

Baross u. 48- 52. Fax +36-1-369-6301

www.diagon.com
Hungary,
e-mail diagon@diagon.com
Europe

Service Diagon Kft. H-1047 Budapest, Phone +36-1-369-6500/122

Baross u. 48- 52. Fax +36-1-369-6301

www.diagon.com
Hungary,
e-mail customersupport@diagon.com
Europe

Information Overview
[Product Name] Cellagon 5 PRO automated five-part differential hematology analyzer with auto loader.

[Product Composition] Automated hematology analyzer consists of aspiration button, sample aspiration
module, WBC and RBC counting chambers, 4 diff laser measurement unit, auto-loader waste valve module,
vacuum and pressure chamber module, sample pump module, inlet valve module, control circuit and supporting
software components.

[Scope of application] Automated Hematology Analyzer is suitable for clinical testing of blood cells (red blood
cells, white blood cells, platelets) count, white blood cell five-part classification, hemoglobin concentration
measurement and blood cell related parameter information calculations on blood samples.

[Contraindication] No.

[Transportation and Storage] The storage and transportation conditions are required as per the section A8a
and A9.

[Production date] see product label

VI
 Table of Contents

Disclaimers ........................................................................................................................................................ I
How to use the user manual ...................................................................................................................... II
Statement................................................................................................................................................... II
Warnings and safety tips .......................................................................................................................... III
Instrument installation and transition ........................................................................................................ IV
Use of reagents......................................................................................................................................... IV
Power supply voltage, connection and grounding ..................................................................................... V
Contact information ......................................................................................................................................... V
Ordering stocks, replacement parts and consumables: ............................................................................ V
Technical support and maintenance: ......................................................................................................... V
Information Overview ................................................................................................................................... VI
Table of Contents ......................................................................................................................................... A
1. Manual Overview .................................................................................................................................. 1
1.1 Introduction .......................................................................................................................................... 1
1.2 Who Should Read This Manual ........................................................................................................... 1
1.3 How to Find Information ....................................................................................................................... 1
1.4 Conventions Used in This Manual ....................................................................................................... 2
1.5 Symbol Conventions ............................................................................................................................ 3
1.6 Safety Information ................................................................................................................................ 6
2 Installation ................................................................................................................................................ 7
2.1 Introduction .......................................................................................................................................... 7
2.2 Installation Personnel........................................................................................................................... 7
2.3 Installation Requirements .................................................................................................................... 7
2.4 Damage Inspection .............................................................................................................................. 9
2.5 Unpacking ............................................................................................................................................ 9
2.6 Connecting the Analyzer System ....................................................................................................... 10
2.6.1 Connecting the electric lines ....................................................................................................... 10
2.6.2 Connecting the reagents ............................................................................................................. 10
2.6.3 Installing the Diluent Float Sensor and Replacing the Diluent ..................................................... 11
2.6.4 Installing the Sensor .................................................................................................................... 11
2.6.5 Replacing Diluent ........................................................................................................................ 12
2.6.6 Installing the Waste Float Sensor ................................................................................................ 12
3 System Overview ..................................................................................................................................... 13
3.1 Introduction ........................................................................................................................................ 13
3.2 Intended Use...................................................................................................................................... 13
3.3 Measurement Parameters ................................................................................................................. 13
3.4 Structure of the Analyzer.................................................................................................................... 15
3.4.1 Main Unit ..................................................................................................................................... 16
3.4.3 Power/Status Indicator ................................................................................................................ 19
3.4.4 Power Switch............................................................................................................................... 19
3.4.5 [RUN] Key ................................................................................................................................... 19
3.4.6 Aspirate Key ................................................................................................................................ 20
3.4.7 Network Interface ........................................................................................................................ 20
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 3.5 User Interface .................................................................................................................................... 20
3.6 Reagents, Controls and Calibrators ................................................................................................... 23
3.6.1 Reagents ..................................................................................................................................... 24
3.6.2 Controls and Calibrators ............................................................................................................. 24
4 Working Principle................................................................................................................................ 25
4.1 Introduction ........................................................................................................................................ 25
4.2 Aspiration ........................................................................................................................................... 25
4.3 Dilution ............................................................................................................................................... 25
4.3.1 Dilution Procedures in Whole-Blood CBC+DIFF Mode .............................................................. 26
4.3.2 Dilution Procedure in Predilute CBC+DIFF Mode ....................................................................... 27
4.4 WBC Measurement ........................................................................................................................... 27
4.4.1 Working Principle of Laser-based Flow Cytometry ..................................................................... 28
4.4.2 Electrical Impedance Method ...................................................................................................... 29
4.5 HGB Measurement ............................................................................................................................ 30
4.5.1 Colorimetric Method .................................................................................................................... 30
4.5.2 HGB ............................................................................................................................................. 31
4.6 RBC/PLT Measurement ..................................................................................................................... 31
4.6.1 Electrical Impedance Method ...................................................................................................... 31
4.6.2 RBC ............................................................................................................................................. 32
4.6.3 PLT .............................................................................................................................................. 32
4.7 Flushing ............................................................................................................................................. 33
5 Setup ....................................................................................................................................................... 34
5.1 Introduction ........................................................................................................................................ 34
5.2 Interface Introduction ......................................................................................................................... 34
5.3 General Settings ................................................................................................................................ 35
5.3.1 Auxiliary Settings ......................................................................................................................... 35
5.3.2 Aspirating- Run as per the worklist ............................................................................................. 36
5.3.3 Predilute ...................................................................................................................................... 36
5.3.4 Sample Numbering Rules ........................................................................................................... 36
5.3.5 Startup sample IP and mode ....................................................................................................... 37
5.3.6 Color Settings .............................................................................................................................. 37
5.3.7 Other ........................................................................................................................................... 38
5.4 Print Settings...................................................................................................................................... 39
5.4.1 Default Printer Settings ............................................................................................................... 39
5.4.2 Format Settings ........................................................................................................................... 40
5.4.3 Report Settings ........................................................................................................................... 41
5.4.4 Printout Setting ............................................................................................................................ 43
5.5 Lab Information .................................................................................................................................. 44
5.6 Date Format ....................................................................................................................................... 45
5.7 Autoloader.......................................................................................................................................... 46
5.8 LIS Communication ........................................................................................................................... 48
5.9 Parameter Settings ............................................................................................................................ 51
5.9.1 Research Use Only (RUO) Parameters ...................................................................................... 51
5.9.2 Parameter Unit ............................................................................................................................ 52
5.9.3 Microscopic Exam. Settings ........................................................................................................ 55
5.9.4 Customized Parameters.............................................................................................................. 59
5.10 User Management ........................................................................................................................... 61
5.10.1 Accessing the Interface ............................................................................................................. 61
B
 5.10.2 Creating a User ......................................................................................................................... 61
5.10.3 Editing a User ............................................................................................................................ 63
5.10.4 Deleting a User ......................................................................................................................... 63
5.10.5 Setting the Default User ............................................................................................................ 63
5.10.6 Changing Password .................................................................................................................. 64
5.10.7 Resetting Password .................................................................................................................. 65
5.11 Data Dictionary ................................................................................................................................. 65
5.11.1 Accessing the Interface ............................................................................................................. 65
5.11.2 Adding a New Item .................................................................................................................... 66
5.11.3 Editing Items/Shortcut Code ..................................................................................................... 68
5.11.4 Deleting a Shortcut Code .......................................................................................................... 69
5.12 Reference Range ............................................................................................................................. 69
5.12.1 Accessing the Interface ............................................................................................................. 69
5.12.2 Setting Reference Group .......................................................................................................... 70
5.12.3 Changing the Ref. Range of the Ref. Group ............................................................................. 72
5.12.4 Restoring Defaults ..................................................................................................................... 73
5.13 Flag .................................................................................................................................................. 73
5.13.1 Accessing the Interface ............................................................................................................. 73
5.13.2 Setting Flag Rules ..................................................................................................................... 74
5.14 Host Settings.................................................................................................................................... 75
5.14.1 Auto Maintenance ...................................................................................................................... 75
5.14.2 Gain Settings ............................................................................................................................. 76
6 Daily Operations ...................................................................................................................................... 79
6.1 Introduction ........................................................................................................................................ 79
6.2 Pre-operation Preparation ................................................................................................................. 80
6.2.1 Equipment Inspection .................................................................................................................. 80
6.2.3 Tube and Barcode Preparation ................................................................................................... 81
6.3 Startup ............................................................................................................................................... 82
6.3.1 Start the analyzer ......................................................................................................................... 82
6.3.2. Log in Terminal Software ............................................................................................................. 83
6.3.3 Log off/Switch User ..................................................................................................................... 84
6.4 Daily Quality Control .......................................................................................................................... 85
6.5 Sample Collection and Handling ........................................................................................................ 85
6.5.1 Venous Whole Blood Samples .................................................................................................... 86
6.5.2 Capillary Whole Blood Samples .................................................................................................. 86
6.5.3 Prediluted Samples ..................................................................................................................... 86
6.6 Sample Analysis ................................................................................................................................ 88
6.6.1 Open-vial Sampling Analysis ...................................................................................................... 88
6.6.2 Autoloader Sampling Analysis..................................................................................................... 93
6.6.3 Dealing with the Analysis Results.............................................................................................. 115
6.7 Report Management ........................................................................................................................ 119
6.8 Shutdown ......................................................................................................................................... 119
6.8.1 Shutting down the analyzer ....................................................................................................... 120
6.8.2 Turning off the external computer ............................................................................................. 122
7 Report ................................................................................................................................................... 123
7.1 Introduction ...................................................................................................................................... 123
7.2 Interface Introduction ....................................................................................................................... 123
7.2.1 Sample List................................................................................................................................ 124
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 7.2.2 Dup. Samples ............................................................................................................................ 126
7.3 Patient Information Area .................................................................................................................. 128
7.4 Graphs and Results Area ................................................................................................................. 132
7.4.1 Parameter Results ..................................................................................................................... 132
7.4.2 Customized Parameters............................................................................................................ 133
7.4.3 Microscopic Exam. Results ....................................................................................................... 134
7.4.4 Research Results ...................................................................................................................... 135
7.5 Functions of the Buttons .................................................................................................................. 137
7.5.1 Validate ..................................................................................................................................... 137
7.5.2 Batch Validate ........................................................................................................................... 137
7.5.3 Cancel Validation ...................................................................................................................... 138
7.5.4 Compare.................................................................................................................................... 139
7.5.5 Edit Result ................................................................................................................................. 140
7.5.6 Restore Result .......................................................................................................................... 142
7.5.7 Print Preview ............................................................................................................................. 142
7.5.8 Print ........................................................................................................................................... 142
7.5.8 Batch Print ................................................................................................................................. 143
7.5.9 Delete ........................................................................................................................................ 144
7.5.10 Comm. ..................................................................................................................................... 145
7.5.11 Save ........................................................................................................................................ 147
8 Worklist ................................................................................................................................................... 148
8.1 Introduction ....................................................................................................................................... 148
8.2 Interface Introduction.......................................................................................................................... 148
8.3 Basic Operations ................................................................................................................................ 149
8.3.1 Adding a Worklist ........................................................................................................................ 149
8.3.2 Editing a Worklist ........................................................................................................................ 149
8.3.3 Saving the Worklist ...................................................................................................................... 150
8.3.4 Deleting a Worklist ...................................................................................................................... 150
8.3.5 Quering a Worklist ....................................................................................................................... 151
8.3.6 Copying a Worklist ...................................................................................................................... 151
8.4 Parameter Description ......................................................................................................................... 151
9 Result Review .......................................................................................................................................... 155
9.1 Introduction ....................................................................................................................................... 155
9.2 Interface Introduction.......................................................................................................................... 155
9.3 List Area ............................................................................................................................................ 156
9.4 Graphs and Results ............................................................................................................................... 157
9.4.1 Parameter Results ......................................................................................................................... 157
9.4.2 Customized Parameters................................................................................................................. 159
9.4.3 Microscopic Exam. Results ........................................................................................................... 160
9.4.4 Research Results .......................................................................................................................... 161
9.4.5 Patient Info. ................................................................................................................................. 162
9.5 Functions ofthe Buttons ........................................................................................................................ 163
9.5.1 Compare ..................................................................................................................................... 164
9.5.2 Print Preview ............................................................................................................................... 165
9.5.3 Print............................................................................................................................................ 165
9.5.4 Batch Print .................................................................................................................................. 166
9.5.5 Run Chart.................................................................................................................................... 166

D
 9.5.6 Query ......................................................................................................................................... 168
9.5.7 Export ......................................................................................................................................... 170
9.5.8 CV ............................................................................................................................................. 173
9.5.9 Comm. ........................................................................................................................................ 175
9.5.10 Delete.................................................................................................................................... 177
10 Quality Control ..................................................................................................................................... 178
10.1 Introduction ................................................................................................................................. 178
10.2 L-J Quality Control ...................................................................................................................... 178
10.2.1 QC Principle ............................................................................................................................ 178
10.2.2 QCSettings .......................................................................................................................... 179
10.2.3 Quality Control Analysis........................................................................................................... 183
10.2.4 QC Result Review ................................................................................................................... 189
10.2.5 QC Table ................................................................................................................................. 197
10.3 X-B Quality Control ........................................................................................................................ 204
10.3.1 QC Principle ............................................................................................................................ 204
10.3.2 QC Settings ............................................................................................................................. 204
10.3.3 Quality Control Analysis........................................................................................................... 208
10.3.4 QC Result Review ................................................................................................................... 209
10.3.5 QC Table ................................................................................................................................ 212
11 Statistics ............................................................................................................................................ 218
11.1 Introduction .................................................................................................................................... 218
11.2 Workload Stats ............................................................................................................................... 218
11.3 Comprehensive Stats ..................................................................................................................... 219
12 Calibration ..................................................................................................................................... 221
12.1 Introduction .................................................................................................................................... 221
12.2 When to Calibrate .......................................................................................................................... 221
12.3 How to Calibrate ........................................................................................................................ 222
12.3.1 Preparation .............................................................................................................................. 222
12.3.2 Manual Calibration .................................................................................................................. 224
12.3.3 Auto Calibration Using Calibrators ........................................................................................... 227
12.3.4 Auto Calibration Using Fresh Blood Samples .......................................................................... 230
12.3.5 Verifying Calibration Coefficients ............................................................................................. 234
12.3.6 Calibration History ................................................................................................................... 234
13 Maintenance ..................................................................................................................................... 236
13.1 Introduction .................................................................................................................................... 236
13.2 Service ........................................................................................................................................... 237
13.2.1 Replacing Reagents............................................................................................................. 237
13.2.2 Cleaning .................................................................................................................................. 238
13.2.3 Maintenance ............................................................................................................................ 239
13.2.4 Comprehensive Device Maintenance ..................................................................................... 245
13.2.5 Reagent Management ............................................................................................................. 251
13.2.6 Auto Clean ............................................................................................................................... 255
13.2.7 Auto Prompt for Cleanser Soak ............................................................................................... 255
13.2.8 Auto Sleep ............................................................................................................................... 255
13.3 System Status ........................................................................................................................... 256
13.3.1 Temperature ............................................................................................................................. 256
13.3.2 Voltage and Current ................................................................................................................. 256
13.3.3 Counter.................................................................................................................................... 257
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 13.3.4 Version Information .................................................................................................................. 259
13.4 Self-test .......................................................................................................................................... 260
13.4.1 Syringe and Sampling Mechanism .......................................................................................... 261
13.4.2 Pressure and Vacuum ............................................................................................................. 261
13.4.3 Valve & Pump.......................................................................................................................... 262
13.4.4 Others...................................................................................................................................... 263
13.5 Log ................................................................................................................................................. 266
13.5.1 Parameter Revision Logs ........................................................................................................ 266
13.5.2 Other Logs .............................................................................................................................. 267
13.5.3 Fault Logs................................................................................................................................ 269
13.5.4 All Logs .................................................................................................................................... 271
14 Troubleshooting ............................................................................................................................. 273
14.1 Introduction .................................................................................................................................... 273
14.2 Dealing with Error Messages ......................................................................................................... 273
14.3 Error Message Reference .............................................................................................................. 274
Appendix A Specifications ........................................................................................................................ a
A.1 Classification ....................................................................................................................................... a
A.2 Reagents ............................................................................................................................................. a
A.3 Parameters .......................................................................................................................................... a
A.4 Sample Volume Required for Each Analysis ........................................................................................c
A.5 Performance Specifications ..................................................................................................................c
A.5.1 Display Range ................................................................................................................................c
A.5.2 Normal Background .......................................................................................................................c
A.5.3 Linearity Range ..............................................................................................................................c
A.5.4 Repeatability ................................................................................................................................. d
A.5.5 Carryover ...................................................................................................................................... d
A.6 Input/output Device ............................................................................................................................. e
A.7 EMC Description.................................................................................................................................. e
A.8 Environment Conditions ....................................................................................................................... f
A.9 Dimensions and Weight........................................................................................................................ f
A.10 Expected Service Life......................................................................................................................... f

F
 1. Manual Overview

1.1 Introduction
This chapter explains how to use this operator’s manual of Cellagon 5 PRO Auto Hematology Analyzer, which is
shipped with the 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 the analyzer and operate your analyzer in strict accordance with
this manual.

1.2 Who Should Read This Manual

This manual contains information written for clinical laboratory professionals to:
 Learn about the hardware and software of the analyzer.
 Customize system settings.
 Perform daily operations.
 Perform system maintenance and troubleshooting.

1.3 How to Find Information

This operator’s manual comprises 14 chapters and 3 appendices. Find the information you need by referring
to the table below.

See… You can find…

1 Manual Overview Instructions for using the auto hematology analyzer.

2 Installation Installation requirements for the auto hematology analyzer.

Applications, measurable parameters, instrument configuration,

3 System Overview software interface and software operations of the auto hematology
analyzer.

Measuring principle and procedures of the auto hematology

4 Working Principle
analyzer.

5 Setup Settings of the system parameters such as the software date format
and parameter units.

6 Daily Operations Daily operations such as sample collection and preparation, the
analysis procedures, startup and shutdown of the instrument.

7 Report How to process the sample results upon the completion of the analysis.

1
 See… You can find…

8 Worklist How to input the sample information and patient information

using the worklist.

9 Result Review Review of the analysis results.

10 Quality Control Basic requirements for quality control and the quality control
methods provided by the auto hematology analyzer.

11 Statistics Introductions of how to generate workload stats and

comprehensive stats.

12 Calibration Basic requirements for calibration and the calibration methods

provided by the auto hematology analyzer.

13 Maintenance Methods for maintaining and testing the auto hematology

analyzer.

14 Troubleshooting Troubleshooting methods for the auto hematology analyzer.

Appendix A Specifications Specification indicators of the auto hematology analyzer.

Appendix B Terms and Terms and abbreviations of the auto hematology analyzer.
Abbreviations

Appendix C Packing List Packing list of the auto hematology analyzer.

1.4 Conventions Used in This Manual

The texts with special meaning in the Manual are highlighted by different fonts and formats.

Format Definition

[XX] All uppercase characters enclosed in [ ] indicate the name of a key on

the analyzer or the (external) keyboard, such as [ENTER].

XX Bold characters indicate text displayed on the screen, such as

Report.

XX XX indicates variables and the specific content depends on the actual

situation.

XX Bold and italic characters Indicate chapter titles, such as 1.1

Introduction.

2
1.5 Symbol Conventions
The following symbols are used to indicate danger and alert messages in this manual.

When you see It means

Follow the instruction below the symbol to avoid potential

biocontamination.

Follow the instruction below the symbol to avoid personnel injury.

Follow the instruction below the symbol to avoid analyzer damage and
failure, or unreliable analysis results.

Follow the instruction below the symbol. The symbol highlights the
important information in operating procedures that calls for special
attention.

Puncture Warning:
The sampling probe is sharp and may contain bio hazardous materials.
Special care should be taken when working with it.

Laser Warning:
This sign serves as a reminder of laser radiation. Avoid staring into the
laser beam or viewing through an optical instrument.

The analyzer or the outer packaging may have the following labels or symbols.

1.3.1 If the labels are damaged or missing, please contact DIAGON LTD. or DIAGON LTD.’s agents for
replacement.
1.3.2 All illustrations in this manual are provided as references only. They may not necessarily reflect actual
analyzer configuration or display.

When you see It means

Caution

Biohazard

Exercise caution to prevent puncture

3
Warning for laser beam

Instruction for Moving

Protective grounding

Alternating current (AC)

For in vitro diagnosis only

Lot No.

Expiry date

Serial No.

The device is in full compliance with the council directive concerning in

vitro diagnostic medical devices 98/79/EC.

Authorized Representative in the European Community

Date of manufacture

Manufacturer

Storage temperature

Humidity level for storage

Atmospheric pressure level for storage

Consult the operator’s manual

Avoid sunlight

Keep dry

No rolling

No Stacking.

4
When you see It means

Let this side face upward.

Fragile, handle with care

Recyclable materials

The analyzer, after being scrapped, should not be disposed with other
household garbage, instead, it should be collected and recycled
following the disposal instructions for scrapped electronic and
electrical equipment.

5
1.6 Safety Information

1.3.3 All the samples, controls, calibrators, reagents, wastes and areas in contact with them are subject to
potential biohazard. Wear proper personal protective equipment (e.g. gloves, lab uniforms, etc.) and
follow laboratory safety procedures when handling relevant items and areas in the laboratory.
1.3.4 If leak happens to the analyzer, the leak liquid is potentially bio hazardous.

1.3.5 Please check the firmness of all the door/ covers/panels before running the analyzer to prevent
unexpected opening or loosening when the analyzer is working.
1.3.6 Make sure all the safety measures are taken. Do not disable any safety device or sensor.
1.3.7 Please respond to any alarm and error message immediately.
1.3.8 Do not touch the moving parts.
1.3.9 Contact Diagon Ltd. or Diagon Ltd.-authorized agents upon the identification of any damaged part.
1.3.10Be careful when opening/closing and removing/installing the doors, covers and panels of the
analyzer.
1.3.11Dispose the analyzer according to government regulations.

1.3.12Please use the analyzer in strict accordance with this manual.

1.3.13Make sure to install only Diagon Ltd.-authorized software on the computer.
1.3.14Please install the original software edition to prevent the computer from being infected by virus.
1.3.15Please take proper measures to prevent the reagents from being polluted.
1.3.16It is recommended that the anti-virus software should be installed on the computer and run
regularly.
1.3.17When running the software for the first time or click the combo boxes for selecting the desired option,
the antivirus software may prompt you to stop running the software. In this case, please choose to allow
the software to run, otherwise, the software may have problems in running.

6
 2 Installation

2.1 Introduction

Installation by personnel not authorized or trained by DIAGON LTD. may cause personal injury or damage to
the analyzer. Do not install the analyzer without the presence of DIAGON LTD.-authorized personnel.

To avoid damage during the transportation, the sampling assembly of the analyzer is fixated with clamps. Do
remove the clamps before using the analyzer.

Your analyzer has passed strict tests before it is shipped from the factory. Internationally-recognized symbols
and instructions show the carrier how to properly handle this electronic instrument in transportation. When
you receive your analyzer, carefully inspect the packaging. If you see any sign of mishandling or damage,
contact DIAGON LTD. customer service department or your local agent immediately.

2.2 Installation Personnel

The analyzer should only be installed by DIAGON LTD. or its authorized agents. You need to provide the
appropriate environment and space. When the analyzer needs to be relocated, please contact DIAGON LTD.
or your local agents.
When you receive the analyzer, please notify DIAGON LTD. or your local agent immediately.

2.3 Installation Requirements

 Connect only to a properly grounded outlet.

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

7
 Do not install the software and database in the system disk. The default installation path for the
software and database is C:\Program Files\Diagon Ltd.\Model. You can change it.
 Using a patch board may introduce electrical interference and generate incorrect analysis results. Please
place the analyzer near the electrical outlet to avoid using the patch board.
 Please use the original electrical wires shipped with the analyzer. Using other electrical wires may
damage the analyzer or generate incorrect analysis results.

Installation requirements for the analyzer are as follows.

Installation
Requirements
Environment

 Level ground and stable workbench with load capacity ≥100kg.

 Free of dust, mechanical vibration, heat and wind sources,
contamination, heavy-noise source or electrical interference.
 Avoid direct sunlight and keep good ventilation.
Site
 It’s recommended to evaluate the electromagnetic environment of the
laboratory before operating the analyzer.
 Keep the analyzer away from sources of strong electromagnetic
interference, otherwise, its proper functioning may be affected.

In addition to the space required for the analyzer itself, set aside:
 At least 100 cm from each side, which is the preferred access to
perform service procedures.
 At least 50 cm from the back for cabling and ventilation.
Space  Enough room on and below the countertop to accommodate for the diluent
and waste containers.
 Place the analyzer near the electrical outlet and avoid being blocked by any
objects, so that you can disconnect the power plug easily as required.

Optimal operating
15°C~30°C
temperature

Optimal operating
30%~85%
humidity

Operating atmospheric
70kPa~110kPa
pressure

Keep air exchange to ensure good air circulation. The wind should not blow
Ventilation
directly at the analyzer.

8
 Installation
Requirements
Environment

Power AC100V~240V, Input Power ≤250VA, 50/60HZ.

 Compliant with related safety requirements

 CPU: >1.4G
 RAM: >2G
 Hard disk space available: >20G
 Graphics Card: OpenGL 2.0 or above
(External) Computer
 Operating system: 32 bit Windows XP, Windows 7 Home Premium,
Windows 7 Professional, Windows 7 Enterprise (not for retail sale), or
Windows 7 Ultimate
 Display aspect ratio: 10: 6
 Resolution: not less than 1280*768

Keep the analyzer away from electric-brush motors, flashing fluorescent and
Electromagnetic Wave
electric-contact equipment which is switched on/off frequently.

Dispose of the waste as per the requirements of the local environment

Waste Disposal
protection authorities.

2.4 Damage Inspection

Before packing and shipping, DIAGON LTD. has applied rigid inspection on all the analyzers. Upon receiving
the analyzer, please check carefully before unpacking to see if there are any of the following damages:
 The outer packaging is placed upside down or distorted.
 The outer packaging shows obvious signs of having been exposed to humid conditions.
 The outer packaging shows obvious signs of having been crashed.
 The outer packaging shows signs of having been opened.
 Once you find the above damages, please notify your local agent immediately.
If the packaging is intact, please open the packaging in the presence of personnel from DIAGON LTD. or its
agents and apply the following inspections:
 Check if all the items listed in the packing list are in the packaging.
 Carefully inspect the appearance of all the items to check if they are damaged or distorted.

2.5 Unpacking
Please unpack the analyzer by taking the following steps:
1. Open the outer packing box; take out the accessory pack; take out the analyzer together with the
protective and cushioning materials.
2. Remove the foam and the protective PE bag.
3. Open the right door (open the linear-shaped cam lock on the right door with a slotted
screwdriver).
4. Remove the binder clips, which are used for fixating two conveyor belts.
To avoid the possible collision resulting from the slippage caused by shaking and slanting during
transportation, the central position of those two belts is fixated with binder clips before they are shipped
from the factory. The binder clips must be removed during unpacking.

9
2.6 Connecting the Analyzer System
2.6.1 Connecting the electric lines
Please refer to Figure 2-1 for the electrical connections of the analyzer.
Figure 2-1 Connecting the electric lines

LAN

Power Connector

2.6.2 Connecting the reagents

 Be sure to dispose reagents, waste, samples, consumables, etc. according to you local
legislations and regulations.
 The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety procedures when handling them in
the laboratory.
 If the reagents accidentally spill on the skin, wash them off with plenty of water and if necessary, go see a
doctor; if the reagents accidentally spill into the eyes, wash them off with plenty of water and
immediately go see a doctor.

 Please make sure the length of the diluent pipe and the waste pipe should be no longer than 1500mm;
the length of the lyse pipe and the cleanser pipe should be no longer than 850mm.
 Tighten the panel connector of the fluidic line so that the overall fluidic line is closed to prevent leakage
and seepage caused by siphonage, etc.

Please refer to Figure 2-2 for the connection of the fluidic lines of the analyzer.

10
 Figure 2-2 Connecting the Fluidic Lines

2.6.3 Installing the Diluent Float Sensor and Replacing the Diluent
Please install the diluent float sensor and replace the diluent as per the approaches stated in this section.

2.6.4 Installing the Sensor

Install the diluent float sensor according to the following steps.
1. Press down and remove the round cardboard with dotted cutting line on the top side of the diluent box so as
to reveal a round hole.
2. Pull out the cover of the container so that the cardboard around the round hole can seize the neck under the vial
cap to prevent invagination.
3. Turn and open the cap (keep the cap) and prevent any foreign objects from getting into the container.
4. Install the diluent float sensor assembly in the accessory pack as shown in Figure 2-3. The float sensor shall be
kept as vertical as possible during installation and the self-contained cap of the sensor shall be tightened.
Figure 2-3 Installing the Diluent Float Sensor

11
2.6.5 Replacing Diluent
Steps for the replacing the diluent are the same as that for installing the sensor. Please keep the empty diluent
container and the cap for future use.

2.6.6 Installing the Waste Float Sensor

The float sensors used in the analyzer are only applicable to DIAGON LTD.-supplied waste containers or the
containers with the same specification and model (such as the vacant diluent container).

1. Take a proper waste container (it can be a vacant diluent container, the opening of which is required to
be pulled out of the hole of the box to expose the opening) and open the vial cap.
2. Install the waste float sensor assembly in the accessory pack as shown in Figure 2-4. The float sensor shall
be kept as vertical as possible during installation and the self-contained cap of the sensor shall be tightened
at the same time to prevent the spilling of the waste.
Figure 2-4 Installing the Waste Float Sensor

The waste container can be replaced according to the steps mentioned above. The replaced waste shall be
properly disposed to avoid contamination.

Be sure to dispose reagents, waste, samples, consumables, etc. according to government regulations.

12
 3 System Overview

3.1 Introduction
Auto Hematology Analyzer is a quantitative, automated hematology analyzer and 5-part differential counter
used in clinical laboratories.
This section describes in details the intended use, measurement parameters, structure, user interface and
compatible reagents of the analyzer.

3.2 Intended Use

It’s intended for blood cell counting, 5-part classification of white blood cell and hemoglobin concentration
measurement in clinical examinations.

The analyzer is intended for screening in the clinical examination. When making clinical judgment based
on the analysis results, the doctors should also take into consideration the clinical examination results or
other test results.

3.3 Measurement Parameters

As shown below, the analyzer provides quantitative analysis results for 25 hematology parameters and four
research parameters, three histograms, one three-dimensional scattergram, three
two-dimensional scattergrams and two measurement modes, namely CBC and CBC+DIFF.

Parameter Name Abbr. CBC CBC+DIFF

White Blood Cell count WBC count * *

Percentage of Neutrophils Neu% / *

Percentage of Lymphocytes Lym% / *

Percentage of Monocytes Mon% / *

Percentage of Eosinophils Eos% / *

Percentage of Basophils Bas% / *

Number of Neutrophils Neu# / *

Number of Lymphocytes Lym# / *

Number of Monocytes Mon# / *

13
 Parameter Name Abbr. CBC CBC+DIFF

Number of Eosinophils Eos# / *

Number of Basophils Bas# / *

Percentage of Abnormal Lymphocytes ALY% (RUO) / *

Percentage of Large Immature Cells LIC% (RUO) / *

Number of Abnormal Lyphocytes ALY# (RUO) / *

Number of Large Immature Cells LIC# (RUO) / *

Red Blood Cell count RBC count * *

Hemoglobin Concentration HGB concentration * *

Mean Corpuscular Volume MCV * *

Mean Corpuscular Hemoglobin MCH * *

Mean Corpuscular Hemoglobin MCHC * *

Concentration

Red Blood Cell Distribution Width - RDW-CV * *

Coefficient of Variation

Red Blood Cell Distribution Width - RDW-SD * *

Standard Deviation

Hematocrit HCT * *

Platelet count PLT count * *

Mean Platelet Volume MPV * *

Platelet Distribution Width PDW * *

Plateletcrit PCT * *

Platelet-Large Cell Ratio P-LCR * *

Platelet-Large Cel Count P-LCC * *

White Blood Cell/ Basophils Histogram WBC/BASO Histogram / *

White Blood Cell Histogram WBC Histogram * /

Red Blood Cell Histogram RBC Histogram * *

Platelet Histogram PLT Histogram * *

3D Differential Scattergram 3D DIFF Scattergram / *

2D Differential Scattergram 2D 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 (RUO), not for diagnostic use.

14
3.4 Structure of the Analyzer

 Please check the firmness of all the doors, covers and boards before running the analyzer.
 The analyzer is heavy, so moving by one person alone may cause injury. It is advisable for two people to
move it together when the transportation is necessary, and make sure you follow the instructions and use
the proper tools.
 Connect only to a properly grounded outlet.
 To avoid electrical shocks, disconnect the power supply before opening the cover.
 To prevent fire, use the fuses with specified model number and working current.

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

The sampling probe is sharp and may contain biohazardous materials. Care must be taken when working with
it.

This sign warns of laser radiation. Do not look directly at the laser beams or see through the optical
instrument.

15
3.4.1 Main Unit
The Auto Hematology Analyzer consists of the main unit (analyzer) and accessories. The main unit is the main
part for analysis and data processing.

To prevent injuries, do not place your hands near the bottom guide tracks of the syringes when the analyzer is
running.

 Front of the analyzer

Figure 3-1 Front of the analyzer

1: [RUN] key 2: Power/Status indicator

3: Sample probe 4: Aspirate key

16
 Back of the analyzer

Figure 3-2 Back of the analyzer

1: Network interface 2: AC input

3: sWaste outlet 4: Cellalyse DIFF 2
5: Cellalyse BASO 6: Cellalyse DIFF 1
7: Cellaton 5D

 Front of the analyzer (cover opened)

Figure 3-3 Front of the analyzer (cover opened)

Autoloader

17
 Right side of the analyzer (right door opened)

Figure 3-4 Right side of the analyzer (right door opened)

1: Optical system 2: Sampling assembly

3: Mix assembly 4: DIFF bath
5: Counting bath 6: Positive pressure pump
7: Positive pressure chamber 8: Negative pressure chamber 9:
Waste pump

 Left side of the analyzer (left door opened)

Figure 3-5 Left side of the analyzer (left door open)

1: Circuit boards 2: Power switch

3: Fluidic valves 4: Liquid level detection unit
5: Syringes
18
3.4.3 Power/Status Indicator
The Power/Status indicator is located in the middle section of the right part of the analyzer (front side). It
shows the status of the analyzer including ready, running, error, sleep and on/off, etc.
The indicators change with the status of the main unit. Details are shown in Table 3-1.
Table 3-1 Main Unit Status Indicators

Instrument Status Indicator Status Remarks

Shutdown Off The main unit has been shut down.

Stopped running with Red light on Stopped running with the occurrence of errors
error conditions

Running with error Red light flickering Running with the occurrence of errors
conditions

Time sequence Yellow light on Initialization or sleep status irrelevant to running

deactivated

Running Green light flickering Execution of the sequence actions is in process

Instrument Status Indicator Status Remarks

Ready Green light on Execution of the sequence actions is allowed.

While the analyzer is running, if the indicator turns dim or off, please contact DIAGON LTD. or DIAGON
LTD.’s agent for maintenance.

3.4.4 Power Switch

To avoid damage, do not power on/off the analyzer repetitively within a short time.

A power switch is on the left side of the analyzer. It turns on or shuts down the analyzer.

3.4.5 [RUN] Key

The [RUN] key is located in the middle of the right front side. You can press the key to start sample analysis
in Auto-Venous Whole Blood (AWB) mode.

19
3.4.6 Aspirate Key
The aspirate key is located in the middle of the front side (behind the sample probe) to start the open-vial
sampling analysis or to add diluent.
3.4.7 Network Interface
A network interface is located on the back of the analyzer. It connects the external computer.

3.5 User Interface

After the startup procedure, you will enter the user interface, as shown in Figure 3-6.
Figure 3-6 User Interface

The interface can be divided into several areas as follows according to their functions:
 1 - Menu navigation area
On the top of the screen is the menu navigation area. Click on a menu tab to access the corresponding
interface or dialog box.
 2 - Status display area
On the top right of the screen is the status display area where the current counting status, connection
status between the main unit and the computer, connection status between the computer and the LIS
system and printer status are displayed from left to right. The icons correspond to different statuses as
shown in Table 3-2.

20
 Table 3-2 Status Icon Description

Status Icon Remarks

Current Counting Status The main unit allows the execution of the
Green icon
sequential actions.
(displayed in the same
way as the power/status Flickering green icon The main unit is executing the sequential
indicator on the main actions.
unit)
The main unit has a problem and is not
Red icon running.

Flickering red icon The main unit has a problem and is running.

The main unit is in a condition with no errors but

Yellow icon not allowing the execution of the counting (such
as: sleep status)

Connection status The computer is not connected to the

between the analyzer Gray icon analyzer yet.
and the computer
The computer is connected to the analyzer.
Color icon

Status Icon Remarks

LIS/HIS status The computer is not connected to the

Gray icon LIS/HIS.

The computer is connected to the LIS/HIS.

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

The printer is connected to the analyzer.

Color icon

 3 - Function screen area

It displays the selected screen and the corresponding function buttons.
 4 - 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. For example, in the startup process, Fluidics cleaning… appears in this
area.
 5 - Information area of the next sample
This area displays the information about the sample ID, sample position, blood mode (whole
blood/predilute) and measurement mode (CBC/CBC+DIFF) of the next sample.
 6, 7 - Function Button Area
The Function Button Area is divided into two parts: the upper area and the lower area

 The upper area contains the Minimize button, the Logoff button and the Shutdown button. :
You can click the button to minimize the interface to the taskbar of the operation system.
21
 Click the interface icon displayed on the taskbar, you can restore the display of the interface after
minimizing it.

: Clicking this button will log off the current account. Entering another account’s username
and password in the pop-up dialog box will switch to another user’s interface.
: Clicking this button will activate the shutdown operation.
 The lower area is where you can set the measurement modes, add diluent, start the counting and
perform other operations.
: Click this button to set the blood sample mode, measurement mode and
sample ID.

: Click this button to add diluent.

: Click this button to start the counting.

: Click this button to run STAT sample first during the autoloader sampling

analysis.

22
  8 - Error message area

Upon the occurrence of a system failure, the corresponding error message will appear in this area (See
Figure 3-7). When there is more than one failure, the error message for the latest failure will appear in
this area.
Figure 3-7 Error Message Area

Double-click in this area, you can deal with the failures in the popup dialog box of troubleshooting help.
For more information, see 14 Troubleshooting.

3.6 Reagents, Controls and Calibrators

Because the analyzer, reagents, controls, and calibrators are components of the system, system performance
depends on the combined integrity of all the components. You should only use the DIAGON LTD.-specified
reagents (see A.2 Reagents), which are formulated specifically for the fluidic system of your analyzer in order
to achieve optimal system performance. Do not operate the analyzer using reagents from multiple suppliers.
Under such circumstances, the analyzer may not achieve the performance specified in this manual and may
generate unreliable results. All references to “reagents” in this manual refer to the reagents specifically
formulated for this analyzer.
Each reagent package should 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 by following the instructions for use of the reagents.
 When you have changed the diluents or lyses, run a background check 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 at least one day before use.

23
3.6.1 Reagents
The following reagents are intended to be used with the analyzer for 5-part diff counting, daily cleaning and
other operations.
 Cellaton 5D diluent
This product is intended for sample dilution and preparation of cell suspension before running the
samples.
 Cellalyse DIFF 2
This product is intended for lysing the red blood cells and it works with Cellalyse DIFF 1 Lyse for white
blood cell classification.
 Cellalyse DIFF 1
This product is intended for lysing the red blood cells and it works with Cellalyse DIFF 2 Lyse for the
white blood cell classification and eosinophils coloration.
 Cellalyse BASO
This product is intended for lysing the red blood cells, determining the hemoglobin, white blood cell
classification and counting the total number of white blood cells.
 Cellaclean
This product is intended for cleaning the fluidic system of the analyzer and regular instrument cleaning.

3.6.2 Controls and Calibrators

The controls and calibrators are used for quality control and analyzer calibration.
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 normal
operation of the analyzer and ensures the acquisition of reliable results. The calibrators are commercially
prepared whole-blood products used to calibrate the analyzer.
Read and follow the instructions to use the controls and calibrators.

The "calibrators" and "controls" mentioned in this manual refer to DIAGON LTD.-specified calibrators and
controls and need to be purchased from DIAGON LTD. or its specified agent.

24
 4 Working Principle

4.1 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; laser-based flow
cytometry for determining the WBC data. During each analysis cycle, the sample is aspirated, diluted and
mixed before the determination for each parameter is performed.

4.2 Aspiration
The analyzer provides two types of sampling mode: open-vial sampling and autoloader sampling. Among
which, the open-vial sampling mode supports whole blood samples and prediluted samples, the autoloader
sampling mode supports whole blood samples.
 In whole blood mode, the analyzer will aspirate quantitative whole blood sample.
 In predilute mode, the analyzer will aspirate the prediluted sample (with the dilution ratio of 1:10) which is
a mixture of 20μL of whole blood/capillary blood sample and 180μL of diluent the diluted sample thus
prepared is then delivered to the analyzer for sampling and aspiration.

4.3 Dilution
After being aspirated into the analyzer, the sample is divided into two parts. After the reaction with reagents
in parallel dilution procedures, each part forms the sample for red blood cell/platelet, white blood cell
count/hemoglobin measurement and white blood cell differential measurement.
To meet different needs, the analyzer offers two working modes –Whole Blood and Predilute, and two
measurement modes- CBC and CBC+DIFF.
Taking CBC+DIFF mode as an example, this section introduces the dilution procedures of the test sample in
Whole Blood mode and Predilute mode separately. (The dilution procedure in CBC mode is not introduced
here since it’s the same as that in CBC+DIFF mode.)

CBC mode, namely complete blood cell count, is intended for counting only, not for white blood cell
classification. CBC+DIFF mode is intended for both counting and white blood cell classification.

25
 4.3.1 Dilution Procedures in Whole-Blood CBC+DIFF Mode
In CBC+DIFF mode, the dilution procedure for the whole-blood sample is shown in Figure 4-1.

Figure 4-1 Dilution Procedures in Whole-Blood CBC+DIFF Mode

Whole blood sample for

CBC+DIFF mode

Discard
thebottom section
of the sample
Sampling

Cellalyse
II Cellaton 5D

Prepare WBC diff Dilute the sample

samples with certain
dilution ratios
Take the sample that
has been diluted once
Cellalyse BASO from the WBC bath

Cellaton 5D

Prepare WBC samples Prepare RBC samples

and HGB samples with and PLT samples with
certain dilution ratios certain dilution ratios

Where,

is the dilution procedure for white blood cell diff, namely DIFF;

is the dilution procedure for red blood cell and platelet,

is the dilution procedure for white blood cell count/hemoglobin; namely CBC.

26
4.3.2 Dilution Procedure in Predilute CBC+DIFF Mode
In CBC+DIFF mode, the dilution procedure for the prediluted sample is shown in Figure 4-2.

Figure 4-2 Dilution Procedure in Predilute CBC+DIFF Mode

20μL of blood sample

180μL of diluent

Diluted sample with the

dilution ratio of 1:10

Sampling Sampling
Cellalyse DIFF
1 Cellalyse
DIFF 2 Cellaton 5D

samples with certain

dilution ratios Dilute the sample

Take the sample that

has been diluted once
Cellalyse
from the WBC bath
BASO

Cellaton 5D

Prepare WBC samples Prepare RBC samples

and HGB samples with
certain dilution ratios and PLT samples with
certain dilution ratios

Where,

is the dilution procedure for white blood cell diff, namely DIFF;

is the dilution procedure for red blood cell and platelet;

is the dilution procedure for white blood cell count/hemoglobin; namely CBC.

4.4 WBC Measurement

The analyzer obtains the white blood cell differential count using a semiconductor-laser-based flow
cytometry, obtains the white blood cell count/basophils count using the principle of impedance method (also
known as Coulter principle) and eventually calculates the parameters relevant to white blood cells.

27
4.4.1 Working Principle of Laser-based Flow Cytometry
The analyzer obtains the white blood cell differential count using semiconductor-laser-based flow Cytometry.
The principle of laser-based flow cytometry is illustrated by Figure 4-3.

Figure 4-3 WBC Measurement

After a predetermined volume of blood is aspirated and diluted by a certain amount of reagent, it is injected
into the flow chamber. Surrounded with sheath fluid (diluent), the blood cells pass through the center of the
flow chamber in a single column at a faster speed. When the blood cells suspended in the diluent pass through
the flow chamber, they are exposed to a laser beam. The intensity of scattered light reflects the blood cell size
and intracellular density. The low-angle scattered light reflects cell size, while the high-angle scattered light
reflects intracellular density (nucleus size and density). The optical detector receives this scattered light and
converts it into electrical pulses. Pulse data thus collected can be used to draw a 2-dimensional distribution
(scattergram) as shown in Figure 4-4.

28
 Figure 4-4 DIFF channel scattergram

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

4.4.2 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 thus
generated is equal to the number of particles that have passed through the aperture. The amplitude of each
pulse is proportional to the volume of each particle.

29
 Figure 4-5 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 WBC/BAS lower threshold value, it is counted as a
WBC/BAS. The analyzer presents the WBC/BAS histogram, where the
x-coordinate represents the cell volume (fL) and the y-coordinate represents the number of the cells.

4.5 HGB Measurement

HGB is determined by the colorimetric method.

4.5.1 Colorimetric Method

The WBC/HGB diluent is delivered to the HGB bath where it is 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 with a central wavelength
of 525nm. The light passes through the sample and is then measured by an optical sensor mounted on the
opposite side. The signal is then amplified and the voltage is measured and compared with the blank reference
reading (readings taken when there is only diluent in the bath).

30
4.5.2 HGB
The HGB is calculated using the following equation and expressed in g/L.

4.6 RBC/PLT Measurement

The analyzer detects the red blood cell count and platelet count and their volume distribution by impedance
method and eventually obtains the results of related parameters.

4.6.1 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 thus generated is equal to the number of
particles that passed through the aperture. The amplitude of each pulse is proportional to the volume of each
particle.

Figure 4-6 Counting Principle

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 value, it is counted as a
RBC/PLT. The analyzer presents the RBC/PLT histogram, where the x-coordinate represents the cell volume
(fL) and the y-coordinate represents the number of the cells.

31
4.6.2 RBC
 Red Blood Cell count
12
RBC (10 /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 corpuscular volume (MCV) and
expresses the result in fL.
 Hematocrit (HCT), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin
Concentration (MCHC)
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/L) as follows, where the RBC is
12
expressed in 10 /L, MCV in fL and HGB in g/L.
RBC MCV
HCT
10

HGB
MCH
RBC

HGB
MCHC 100
HCT
 Red Blood Cell Distribution Width Coefficient of Variation (RDW-CV)
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)
RDW-SD (RBC Distribution Width – Standard Deviation, fL) is obtained by calculating the standard
deviation of the red blood cell size distribution.

4.6.3 PLT
9
 Platelet count (PLT count, 10 /L)
PLT is measured directly by counting the platelets passing through the aperture.
 Mean Platelet Volume (MPV, fL)
Based on the PLT histogram, this analyzer calculates the MPV.
 Platelet Distribution Width (PDW)
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).
 Plateletcrit (PCT)
9
This analyzer calculates the PCT as follows and expresses it in %, where the PLT is expressed in 10 /L
and the MPV in fL.
PLT MPV
PCT
10000

9
 Platelet-Large Cell Count (P-LCC, 10 /L)
P-LCC is measured directly by counting the large platelets passing through the aperture.
 Platelet-Large Cell Ratio (P-LCR)
32
4.7 Flushing
After each analysis cycle, each component of the analyzer is flushed.

33
 5 Setup

5.1 Introduction
The analyzer has been initialized before delivery. The interfaces upon the initial startup of the analyzer are
system settings by default. Some parameters of the analyzer can be reset to meet various demands in practical
applications.
The analyzer divides the operators into two access levels, common user and administrator. Note that an
administrator can access all the functions accessible to a common user. This chapter introduces how to
customize your analyzer as an administrator.

5.2 Interface Introduction

After logging in the software system (see 6.3 Startup), click Setup to access the Setup interface. See
Figure 5-1.

Figure 5-1 Setup

34
 The administrator is allowed to set the following functions in the Setup interface:
 General Settings
 Parameter
 User Management
 Data Dictionary
 Ref. Range
 Flag
 Host Settings

5.3 General Settings

5.3.1 Auxiliary Settings
Clicking Setup > General Settings to access the Auxiliary Settings interface by default. See Figure 5-2.

Figure 5-2 Auxiliary Settings

The administrator is allowed to set the following functions in the Auxiliary Settings interface:

 Aspirating
 Predilute
 Sample numbering rules
 Startup sample IP and mode
 Color Settings
 Number of samples displayed per page in the Review interface
 Other

35
5.3.2 Aspirating- Run as per the worklist
Set if you want the system to the run the samples as per the worklist upon aspiration. It’s unchecked by
default.
If checked, the sample analysis will be conducted according the worklist. The process is as follows:
 In Open-vial-Venous Whole Blood (VWB), Open-vial-Capillary Whole Blood (CWB) or Open-vial-
Predilute (PD) mode, the analyzer will obtain the sample information automatically in the worklist
according to the entered sample ID.
 In Auto-Venous Whole Blood (AWB) mode, if the Automatically scan Sample ID is checked, the
analyzer will obtain the sample information automatically in the worklist according to the scanned
sample ID; If it's unchecked, the analyzer will obtain the sample information in the worklist according to
the Rack No.-Tube No..
For details about the setting of the Automatically scan Sample ID, see 5.3.5 Autoloader.

5.3.3 Predilute
Set if you wish to see a popup dialog box when you perform the Predilute counting.
 Ask for confirmation (default setting): In the Predilute mode, when you press the aspirate key to start the
analysis, a dialog box will pop up to remind you that the ongoing analysis is for Predilute counting.
 Do not ask for confirmation: the dialog box for confirming the Predilute counting will not pop up.

5.3.4 Sample Numbering Rules

Set the sample ID entry rules.
 Sample ID Entry Method
Click the dropdown list of the Sample ID Entry Method and select the entry method of the sample ID
from the following options.
 Auto increment (default setting)
 Manual entry
 Prefix Length
When Auto Increment is selected as the Sample ID Entry Method, you can add a prefix to a certain
batch of samples for identification.

Enter the prefix length ranging from 0 to 24 (e.g. 2) of the sample ID in the Prefix Length textbox. The
prefix length will applied to all sample IDs after the setting is saved.

36
5.3.5 Startup sample IP and mode
Set the sample ID and measurement mode for the next sample after startup.
 Next Sample ID and mode after startup
The sample ID and mode set by the user will be used by the system after the next startup when the
specified sample ID is entered into the textbox and the measurement mode (CBC or CBC+DIFF) is
selected from the dropdown list.

If the Effective tomorrow is checked, the modification of the next sample ID and mode after startup will
become effective on the next day.

 Continue using the sample ID and mode before the last shutdown
If checked, the system will by default add 1 to the last sample ID analyzed before shutdown as the next
sample ID after startup.

5.3.6 Color Settings

Set the text color and background color of the high/low flag as well as the background color of the
Printed, Validated and Transmitted items displayed on the screen.

 High/Low Flag Color

Click the corresponding Text Color button of the High Flag Color (or Low Flag Color) to select the
text color of the flag items.

Click the corresponding Background button of the High Flag Color (or Low Flag Color) to select the
background color of the flag items.

After setting, you can view the effect in the Display Example box.

 Printed Sample Color

Click the corresponding Background button of the Printed Sample Color to select the background color
of the printed items.

After setting, you can view the effect in the Display Example box.

 Validated Sample Color

Click the corresponding Background button of the Validated Sample Color to select the background
color of the validated items.

After setting, you can view the effect in the Display Example box.

 Transmitted Sample Color

Click the corresponding Background button of the Transmitted Color to select the background color of
the transmitted items.

After setting, you can view the effect in the Display Example box.
37
 Number of samples displayed per page in the Review interface

Set the number (100 by default) of sample results displayed per page in the result list in the Review
interface. An Integer between 100 and 2000 can be entered.

5.3.7 Other
 Automatically generate the sampling/delivery date
It is checked by default, which means you don't need to input the Sampling Time/Delivery Time when you
add a new worklist or modify patient information after running a sample. The operating date will be
displayed in the date textbox. See the Worklist and Report interface.
If unchecked, the Sampling Time/Delivery Time shall be inputted when a new record is added in the
Worklist interface or patient information is modified after sample analysis.

 Automatically delete completed records from the worklist

It’s unchecked by default. If it is checked, the corresponding sample record in the worklist will be
automatically deleted by the software system upon the completion of sample analysis.
 Show Result Edited Flags

It’s unchecked by default, which means the edited results are marked with an M at the end, while the
corresponding results with manual modifications are marked with an m at the end. M or m is displayed
between the result data and the parameter unit by default.
If unchecked, the edited result will not be marked with an M or m.

 Show Flags
It's checked by default, which means the flag information of WBC Message, RBC Message and PLT
message in the Report and Review interfaces will be displayed.
If this is unchecked, the flag information will not be displayed.
 Auto refresh count result(report)
It's checked by default, which means the sample result will be displayed in the Report interface in real
time after each sample analysis.
If this is unchecked, the Report interface shows the selected result with no real-time update.
 Suspicious Flag
A single character (an English letter only) can be re-entered in the textbox as a suspicious flag. The
default value is ?.
 Ref. Range Flags
You can select the Ref. Range Flags from the dropdown list. The default high flag is ↑ and the default
low flag is ↓.

38
5.4 Print Settings
Click Print Settings in the Setup > General Settings interface for relevant print settings, including the
default printer, template, report, copies and margins, etc.

5.4.1 Default Printer Settings

The analyzer uses the system default printer (see Figure 5-3).
Figure 5-3 Default Printer Settings

To set your desired default printer, select a printer from the dropdown list of the Default printer, then click
OK to save the modification. Thereafter, all the printing tasks issued by the analyzer will be assigned to this
printer by default.
If the dropdown list is blank, it indicates that no printer has been installed for the operating system. In this
case, install a printer, and then perform the relevant settings and printing operations.

39
 5.4.2 Format Settings
The Type, Customize, Format Preview and Set to be Default, etc. can be set in the Format Settings combo
box. See Figure 5-4.

Figure 5-4 Format Settings

 Selecting Report Type

Select the format type to be set from the dropdown list of the Report Type. The default setting is Report.

 Customization
The administrator can customize the format as per the actual demand (common user does not have such
access). Click the Customize button to access the Template Designer interface.
 Refresh

Click Refresh to refresh the format list after the customization by the administrator.
 Format Preview

Click the Format Preview button to check the printing effect of the current report.

After the print setting is completed, the operator should preview the printing effect of the current report, then
print the report after the confirmation of its correctness

40
  Setting the Default Template
Select the report template according to the actual demand and click Set to be Default to set the current
template as the default template.
The checked template with bright green background is the default setting. See the figure below.

5.4.3 Report Settings

You can set relevant parameters of the report in the Report combo box. See Figure 5-5.
Figure 5-5 Report Print Setting

 Title
Enter the title of the report in the Title textbox. The default setting is Hematology Analysis Report.

 Autoprint
The default setting is OFF. If it is set to be On, the system will automatically print the report of the sample
as per the current report template once the counting results are obtained.

If Print after validation is checked, the autoprint function becomes invalid.

41
 Two reports in one page (half of A4)
It’s unchecked by default. If this is checked, the default template size in Format Settings is half an A4
page (e.g., A4_Half-Portrait-Parameters), so two reports can be printed in one piece of A4 paper.

 Print Flag
It's checked by default, which means the flag information will be printed in the report. If it’s not checked,
it will not be printed.
 Print Ref. Range
It’s checked by default, which means the reference range of the parameter will be shown in the printed
report; If it’s unchecked, the reference range, will not be shown in the printed report.
 Print result edited flags
It’s checked by default, which means the mark (M or m) for the edited results will be shown in the printed
report if the parameters have been modified.
If it’s unchecked, the mark for the edited results will not be shown in the printed report.
 Print Microcropic Exam. Para.
It's checked by default , which means the result of Microscopic Exam. Parameters will be printed in the
report. If it’s not checked, it will not be printed.
 Autoprint after validation
It’s unchecked by default, which means the system can print the report automatically without validation.
If it’s checked, the report will be printed automatically after it’s been validated instead of being printed
right after the results are obtained each time.

The parameter is valid only when the Autoprint is set to be On.

 Print Suspicious Flag “?”

It’s unchecked by default, which means the printed report will not show the suspicious flag “?”; If it’s
checked, such flag will be shown.
 Print Ref. Range Flags
It’s checked by default, which means the printed report can show the ref. range flag (↑ or ↓); If it’s
unchecked, such a flag will not be shown.
 Print after validation
It’s unchecked by default, which means the report can be printed without validation.
If it’s checked, the report can be printed only after validation and autoprint is unexecutable.
 Update blank test time before be printed
It’s unchecked by default, which means the blank test time will not be processed by the system.
If it’s checked, the Delivery Time will be automatically updated as the Run Time by the system at the
time of printing.
 Auto validate when printing
It’s unchecked by default, which means the report will not be automatically validated by the system at the
time of printing.
If it’s checked, the report will be automatically validated and printed by the system at the time of
printing.
 Print as black and white

42
 It’s unchecked by default, which means the report will be printed according to the default settings of the
printer. If it’s checked, the report will be printed as black and white.

5.4.4 Printout Setting

You can set the number of copies and page margins for each report in the Print Setting combo box.
 Copies
You can enter the number of copies to be printed for a report in the Copies textbox according to the
actual demand. Range of the copies is between 1 and 100 and the default value is 1.
Figure 5-6 Copies

 Page Margins
You can adjust the page margins according to the actual needs.
The upper, lower, left and right textboxes are designed for adjusting the margins on the top, bottom, left
and right. The default value is 0.00 and the default unit is cm. See Figure 5-7.
Figure 5-7 Adjusting Page Margins

43
5.5 Lab Information
Click Lab Information in the Setup > General Settings interface, then you can set the lab
information. See Figure 5-8.

Figure 5-8 Setting Lab Information

Only the administrator has the access for setting the lab information. Common users are only allowed to
browse such information.

Refer to the table below for the detailed instructions of parameter setting.
Table 5-1 Setting Lab Information

Parameter Setting instructions

Hospital Name Enter the name of the hospital where the lab is located.

Lab Name Enter the lab name.

Responsible Person Enter the responsible person of the lab.

Contact Information Enter the contact information (telephone number or E-Mail) of the
lab.

44
 Postal code Enter the postal code of the hospital.

Contact in Service Department Enter the name of the contact person in Service Department.

Contact Information of Service Enter the contact information of the contact person in the
Department Service Department.

Analyzer SN Display the serial number of the analyzer. It cannot be edited.

Installation Date Display the installation date of the analyzer. It cannot be

edited.

Remarks Enter the remarks regarding the lab.

Logo Click Browse, select the logo of the hospital in the popup
dialog box, and click Open. The logo format is .png.

5.6 Date Format

Click Date Format in the Setup > General Settings interface to enter the date format setting interface. You
can set the date format of the system.

Select the format setting from the dropdown list of the Date Format and click OK as shown in Figure 5-9.
Figure 5-9 Setting the Date Format

You’ll be prompted that the date format is set successfully and you’ll see the updated date format. See Figure
5-10. The date in the lower right corner of the user interface will be displayed in form of new settings.
Figure 5-10 Successful Setting of the Date Format

45
5.7 Autoloader
Before running samples in AWB mode, you can perform the settings about autoloader parameters.
Click Autoloader in the Setup > General Settings interface to enter the autoloader setting interface. See
Figure 5-11.

Figure 5-11 Setting Autoloader

Refer to Table 5-2 for the description of relevant parameters.

46
 Table 5-2 Description of Autoloader parameters

Parameter Meaning Operation

If checked, you don't need to input the sample IDs

when running samples in AWB mode. The analyzer Please set it
will scan the sample ID from the starting position as according to the
Automatically scan you set. actual situation. It’s
Sample ID
If unchecked, the starting sample ID should be unchecked by
inputted. The next sample ID will increase default.
automatically.

If checked, you don't need to input the Rack No.

when running samples in AWB mode. The analyzer Please set it
will scan the rack No. from the starting position as according to the
Automatically scan you set. actual situation. It’s
rack No.
If unchecked, the starting rack No. should be unchecked by
inputted. The next rack No. will increase default.
sequentially automatically.

If checked, the sample ID will increase

sequentially even an empty tube position is
detected. If unchecked, the sample ID will
increase sequentially according to actual tube
number (i.e. the empty tube position will be
excluded).
Sample ID increases For example, there are two tubes in the tube positions Please set it
sequentially according of No.1 and No.7 respectively (other positions are according to the
to tube position empty), and the sample ID for tube No.1 is 1. Then, if actual situation. It’s
it's checked, the sample ID for tube No.7 will be 7; or if checked by default.
unchecked, the sample ID will be 2.
NOTE
The parameter is valid only when the
Automatically scan Sample ID is unchecked.

If checked, when no matching record is found in the

worklist during AWB sample analysis, the analyzer
will skip this sample and continue with other Please set it
Skip the sample samples. according to the
when it failed to
If unchecked, when no matching record is found in the actual situation. It’s
match the worklist
worklist, the analyzer will automatically assign sample checked by default.
ID for this sample and perform analysis in CBC+DIFF
mode.

If checked, when invalid rack No. is scanned during

AWB sample analysis, the analyzer will skip the tubes Please set it
Skip the sample on this rack and continue with other tubes. according to the
when Rack No.
If unchecked, the analyzer will run the samples on this actual situation. It’s
scanning failed
rack even when the rack No. scanning failed. checked by default.

47
 Parameter Meaning Operation

If checked, when invalid sample ID is scanned during

AWB sample analysis, the analyzer will skip this Please set it
Skip the sample
sample and continue with other samples. according to the
when Sample ID
actual situation. It’s
scanning failed If unchecked, the analyzer will run this sample checked by default.
even if the sample ID scanning failed.

Please set it
Automatically display If checked, the statistics will be displayed after
according to the
statistical result every autoloading analysis is finished every time.
actual situation. It’s
time after autoloading If unchecked, the statistics will not be displayed. checked by default.

If checked, when there are 3 continuous clog and/or

Stop autoloading bubble errors during AWB sample analysis, the Please set it
when clog and/or analysis will be stopped. according to the
bubble error count actual situation. It’s
reached 3 If unchecked, the analysis will not be stopped even checked by default.
when there are clog and/or bubble errors happen.

5.8 LIS Communication

Click LIS Communication in the Setup > General Settings interface to enter the laboratory information
system (LIS) communication setting interface. You can set the communication between the system and the
LIS. See Figure 5-12.
Figure 5-12 Setting LIS Communication

Refer to Table 5-3 for the description of relevant parameters.

48
 Table 5-3 Description of LIS Communication Setting Parameters

Parameter Meaning Operation

Communication Type Type of the communication between N

the system and the LIS. /A
The current version of software support
communication with the LIS via
network.
Network IP Address The IP Address of the LIS. Please set it according
Settings to the actual situation.

Port The port of the LIS. The default value is Please set it according
5600. to the actual situation.

Protocol Protocol Type Type of the protocol used for the N/A
Settings communication between the system
and the LIS. The default value is HL7.

Communication If checked, the communication Please choose

Acknowledgement between the system and the LIS is according to the actual
successful when the ACK response situation.
from the LIS is received within the
duration of ACK timeout; no response
received indicates communication
failure.
If unchecked, the communication
between the system and the LIS shall
be considered successful no matter the
ACK response from the LIS is received
or not.
NOTE
The system will send the next
message continuously no matter the
communication is successful or not.

ACK timeout Timeout duration of the ACK response. Click ↑ or ↓ or directly

The default value is10 seconds, that is, enter in the textbox.
the communicationwill be considered Input range: an integer
failed if the system receives no ACK between 0 and 100.
response within 10 seconds. Unit: second.
NOTE
The parameter is
valid only when the
Communication
Acknowledgement
is checked.

Transmission Auto-communication If checked, the system will Please choose

Mode automatically upload the result to the according to the actual
LIS upon the completion of the situation.
analysis.
If unchecked, the result of analysis will
not be automatically uploaded.

49
Parameter Meaning Operation

Histogram The methods for transmitting the Please choose according

Transmission histogram to the LIS when the result is to the actual situation.
Method transmitted by the system, including:
 Not transmit
Do not transmit the histogram to
the LIS.
 Bitmap
Transmit the histogram to the LIS in the
format of screen display.
 Transmitting bitmap for printing
The histogram is transmitted by the
system to the LIS in the format of a
printed report.
Scattergram The methods for transmitting the Please choose according
Transmission scattergram to the LIS when the result is to the actual situation.
Method transmitted by the system, including:
 Not transmit
Do not transmit the scattergram to the
LIS.
 Bitmap
Transmit the scattergram to the LIS in
the format of screen display.
 Transmitting bitmap for printing
The scattergram is transmitted by the
system to the LIS in the format of a
printed report.

Selecting You can set the system to transmit one or Please choose according to
Scattergram several specified scattergrams to the LIS, the actual situation.
including LS-MS, LS-HS and
HS-MS. NOTE
The parameter is
invalid when Not
transmit is set as the
Scattergram
Transmission
Method.

50
5.9 Parameter Settings

5.9.1 Research Use Only (RUO) Parameters

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

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

Click RUO Parameters in the Setup > Parameter interface to enter the RUO Parameters setting interface.
See Figure 5-13.

Figure 5-13 Setting RUO Parameters

 Display RUO Parameters

 It’s checked by default, which means the information regarding the RUO parameters will be
displayed in the counting results. If it’s unchecked, the RUO parameters, the “*” mark and the
declaration will not be displayed in the counting results.
 Display "*" mark: It’s checked by default, which means the “*” mark will be displayed in the
counting results; If it’s unchecked, the “*” mark and the declaration will not be displayed.
 Display declaration: It’s checked by default, which means the declaration will be displayed in the
counting results; if it’s unchecked, the declaration will not be displayed.
 Print RUO parameters

51
  It’s checked by default, which means the RUO parameters will be printed in the report. If it’s
unchecked, the RUO parameters, the “*” mark and the declaration will not be printed in the report.

 Print “*” mark: It’s checked by default, which means the “*” mark will be printed in the report. If
it’s unchecked, the “*” mark and the declaration will not be printed in the report.
 Print declaration: It’s checked by default, which means the declaration will be printed in the report.
If it’s unchecked, the declaration will not be printed in the report.
 Editing Declaration
The default declaration is: "*" means "research use only, not for diagnostic use". You can modify the
declaration in the textbox as per the actual demand.

Any change made to the display settings or printing of the RUO parameters, the “*” mark and the declaration
will be applied to all the RUO parameters (before and after the change).

5.9.2 Parameter Unit

Some of the parameters of the analyzer can use different units which can be chosen as per user demand.

52
Accessing the interface
Click Parameter Unit in the Setup > Parameter interface to access the Parameter Unit setting interface. See
Figure 5-14.

Figure 5-14 Setting Parameter Unit

Selecting Unit System

Click the Select unit system dropdown list and select a unit system for the parameters among the 7 unit
systems (Custom, China, International, Britain, Canada, USA and Netherlands). The default unit system is
USA.

 When selecting different unit standards, the corresponding unit list and unit option will be
displayed differently.
 If another option is selected except the Custom, then the unit of each parameter can only be browsed.

53
Customizing Parameter Unit
1. Select Custom from the dropdown list of Select unit system.

2. Click the parameter, of which the unit is to be set, from the parameter list (such as WBC).
3. Select a new parameter unit from the Unit Options list.

4. Click OK to save the configuration.

 For parameters in the same group, if the unit of any parameter changes, the units of the other
parameters change accordingly. (In the list, parameters will be sorted by group; the first parameter will
be displayed in black and the other parameters in the same group will be displayed in grey.)
 The unit of MCH changes according to MCHC and HGB, the operator can not modify it.
 If the parameters units change, the display format of the list data will change accordingly.

Retrieving Defaults
When setting the Custom unit system, if you click Default, the unit of the parameters can be restored to the
initial default values.

54
5.9.3 Microscopic Exam. Settings
You can perform the microscopic exam. settings, including adding, editing, deleting and adjusting the list
order as per the actual demand.

The operations of adding, editing, deleting and adjusting the list order do not affect the sample record in
which the microscopic examination results have been entered and saved. Such operations are only valid for
the record in which the microscopic examination results have not been saved, and the samples analyzed after
the setting operations.

Accessing the interface

Click Microscopic Exam. Settings in the Setup > Parameter interface to access the Microscopic Exam.
Settings interface. See Figure 5-15.

Figure 5-15 Microscopic Exam. Settings

55
Adding a New Microscopic Exam. Parameter
Click New and enter the name of the new parameter in the popup dialog box, then click OK.
Figure 5-16 Adding a New Microscopic Exam. Parameter

The name of the new parameter will be displayed in the microscopic exam. parameter list. The
number of microscopic exam. parameters can be increased to 40 at maximum.

56
Editing a Microscopic Exam. Parameter
Select a parameter name from the list and click Edit to modify it. See Figure 5-17.
Figure 5-17 Editing a Microscopic Exam. Parameter

Deleting a Microscopic Exam. Parameter

Select a parameter name from the list, click the Delete button and then click Yes in the popup dialog box to
delete this parameter.

57
 Figure 5-18 Deleting a Microscopic Exam. Parameter

Adjusting Order

Click Adjust Order to move the selected parameter to the top ( ) or bottom ( ) or move it upwards (
) and downwards ( ) on the popup screen.
Figure 5-19 Adjusting the Order of the Microscopic Exam. Parameters

58
5.9.4 Customized Parameters
Except for this analyzer's analysis parameters, parameters collected from other testing instruments or via
manual testing by the user are customized parameters. You can set customized parameters so they can be
printed together with this analyzer's analysis parameter details on the Blood Examination Report.
This analyzer's default customized parameters include: Blood Type, RH Blood Group, ESR,
C-reactive Protein and Reticulocyte. You can set the unit and reference range of default customized
parameters as well as add and set customized parameters.

Accessing the interface

Click Custom Para. in the Setup > Parameter interface to enter the custom parameter setting interface. See
Figure 5-20.

Figure 5-20 Customized Parameter Settings

59
Adding a Customized Parameter
Click New, enter the name of the new parameter in the popup dialog box, then click OK. See Figure 5-21.
Figure 5-21 Adding a Customized Parameter

The name of the added parameters will be displayed in the customized parameter list.

Editing a Customized Parameter

You can set the unit and reference range of customized parameters. Detailed steps are as follows:
1. Select the customized parameter to be edited.
2. Double click corresponding cells of the unit and (or) reference group (including the Upper Limit
and Lower Limit), and input values.

You can also customize the reference group according to the actual situation. For details, see 5.7 Reference
Range.
3. Click Save.

Deleting a Customized Parameter

Select a customized parameter, and click on Delete. Then, the parameter and its corresponding reference
group can be deleted.

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5.10 User Management
After logging in the system, the administrator has the access to set the account information of common users
and other administrators; common users can only browse the user list and change their own passwords.

5.10.1 Accessing the Interface

Click Setup > User to access the User management interface. See Figure 5-22.

Figure 5-22 User management

5.10.2 Creating a User

Click New to set the account information of a new user in the popup interface, including username, first and
last name, password, user group and remarks, etc. See Figure 5-23.

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 Figure 5-23 Creating a user

User Group includes Common User and Administrator. Users are assigned different access levels
according to the user group they belong to.

Click OK after the setting is complete. The information of the new user will be shown in the user list.

62
5.10.3 Editing a User
Select the user to be edited and click Edit to modify the name and user group
Figure 5-24 Editing a User

5.10.4 Deleting a User

Select the user to be deleted and click Delete to delete the selected user.

The administrator cannot delete his/her own information.

5.10.5 Setting the Default User

Select a user and click Set as default user to set this user as the default user.

After it is set successfully, the default user name will be displayed in the login box next time and you only
needs to enter the corresponding password. See Figure 5-25.

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 Figure 5-25 Login after Setting the Default User

5.10.6 Changing Password

Click Change Password, enter the old password and new password of the user and confirm the new password
in the popup dialog box, then click OK.
Figure 5-26 Changing Password

You can only change his/her own password and cannot change the password of other users.

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5.10.7 Resetting Password
If the user forgets the password or the password is required to be reset due to other reasons, please click Reset
Password to reset the password of the selected user to the initial password. The reset password is the same as
the user name.
Figure 5-27 shows that the password is successfully reset.
Figure 5-27 Resetting Password

The administrator is allowed to reset the password of all administrators and common users; common users do
not have the access to reset the password.

5.11 Data Dictionary

Users can set shortcut codes for the relevant items of the patient information.

If a shortcut code is set, the shortcut code corresponding to the above mentioned item can be entered directly
when the information is input or numbered, then the complete information can be displayed by pressing the
[Enter] key without entering (or selecting) complete information. It is a shortcut operation.
Different items can share one shortcut code.

5.11.1 Accessing the Interface

Click Setup > Data to access the data dictionary setting interface. You can set the shortcut code for the
relevant items of the patient information in this interface.
You can set the shortcut code for the following items: Department, Submitter, Patient Type, Charge Type,
Diagnosis, Gender, Area, Bed No., Sample Type and Remarks. See Figure 5-28.

65
 Figure 5-28 Shortcut Code

5.11.2 Adding a New Item

This section takes the adding of a new department as an example to introduce the method for adding a new item
and its shortcut code. The method for adding other new items is similar and is not introduced in details herein.
Steps for adding a new department are shown as follows:
1. Click New in the Department interface.
A dialog box will pop up as shown in Figure 5-29.

66
 Figure 5-29 Adding a New Item

2. Enter a new department name, shortcut code and remarks. See Figure 5-30.
Figure 5-30 Entering the Department Name and Shortcut Code

 Newly 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 set, every code must be unique.

3. Click OK to save the information about the new department.

Information about the newly added department will be displayed in the department interface. See Figure 5-
31.

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 Figure 5-31 Information of the Newly Added Department

5.11.3 Editing Items/Shortcut Code

This section takes the editing of a department as an example to introduce the method for editing items and its
shortcut code. The method for editing other new items is similar and is not introduced in details herein.
Steps for editing a department are shown as follows:
4. Select the department to be modified in the Department interface, then click Edit. A
dialog box will pop up as shown in Figure 5-32.
Figure 5-32 Editing Item/Shortcut Code

5. Modify the Name, Shortcut Code and Remarks in each textbox according to the actual
demand.

 Newly 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 set, every code must be unique.

6. Click OK to save the information.

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5.11.4 Deleting a Shortcut Code
This section takes the deleting of a department as an example to introduce the method for deleting items and
this shortcut code. The method for deleting other new items is similar and is not introduced in details herein.
Steps for deleting a department are shown as follows:
7. Select the department to be deleted in the Department interface, and then click Delete. A dialog
box will pop up as shown below.

Figure 5-33 Deleting a Department

8. Click Yes to delete the department.

5.12 Reference Range

The reference range based on various normal groups can be set for the analyzer in the actual practice. If
the analysis result of a sample is beyond the reference range, it will be regarded as clinically abnormal.
The Ref. Range interface is where you view and set the high and low limits for your patients. The analyzer
flags any parameter value above (↑) or below (↓) these limits.
This analyzer divides the patients into 5 demographic groups: General, Man, Woman, Child and Neonate. You
can also customize another 10 groups. The recommended limits are for reference only. To avoid misleading
parameter flags, be sure to set the patient limits according to the characteristics of local population.

5.12.1 Accessing the Interface

Click Setup > Ref. Range to access the Ref. Range setting interface. See Figure 5-34.

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 Figure 5-34 Ref. Range

5.12.2 Setting Reference Group

You can set the name, age range and gender of the customized reference group in the Set Ref. Group
interface. In addition, you can also set the selected reference group as the default reference group.

5.12.2.1 Setting Customized Reference Group

If the fixed reference group does not meet the actual requirements, you can customize a proper reference
group by taking the following steps:
1. Click Set Ref. Group.
A screen will pop up as shown in Figure 5-35.

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 Figure 5-35 Customized Ref. Group

2. Double click the cell of the customized group (e.g. Customized 1) and directly enter the name of the new
reference group.
3. Double click the cell to set the Upper Limit of Age and Lower Limit of Age of the reference group
and select the age Unit and Gender of the reference group from the dropdown list.

 The reference group name entered is not allowed to be empty nor the same as the existing ones.
 You cannot modify the names and corresponding information of the five fixed reference groups in the
list.

4. Click OK to complete the setting of the customized reference group.

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Automatically match the customized reference group according to age and gender

If Automatically match the customized reference group according to age and gender is checked, the
customized reference group will be automatically assigned patients by the system according to their age and
gender when the patient information is entered. If it fails to find a matching customized reference group for a
patient, the patient will be assigned to the fixed reference group.

When the system automatically matches the reference group according to age and gender, the rules listed in
Table 5-4 shall be followed.

Table 5-4 Rules for Matching the Reference Group

Automatically match the Information of the default Match the reference group
customized reference group customized reference group
according to age and gender

Unchecked (default setting) N/A Built-in reference group

Checked No change Built-in reference group

Checked With change Preferentially match the

customized reference group

5.12.2.2 Setting Default Ref. Group

The default setting is General.

Select a reference group and click Set to be default ref. group to set the selected reference group as the
default group.

5.12.2.3 Restoring Defaults

Select a customized reference group and click the Default button under the reference group list to restore the
setting of the selected reference group to the default value.

5.12.3 Changing the Ref. Range of the Ref. Group

You can modify the reference range of the specified parameter in the Ref. Range setting interface.
1. Select the reference group, of which the range is intended to be modified, from the Ref. Group
dropdown list (e.g. General).

2. Double click the Upper Limit (or Lower Limit) cell in the row, where the parameter to be
modified is located, and enter the Upper Limit (or Lower Limit) of the parameter value.
See Figure 5-36.

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 Figure 5-36 Setting the Ref. Range of the Ref. Group

3. Click OK to save the modification.

5.12.4 Restoring Defaults

Click Default to restore the upper/lower limit of the selected reference group to the default value.

5.13 Flag
When the test result meets the requirement of the Flag rules, the corresponding Flag will be displayed on the
screen. The operator can edit the Flag rules as per the actual demand and relevant lab procedures.

5.13.1 Accessing the Interface

Click Setup > Flag to access the Flag rules setting interface. See Figure 5-37.

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 Figure 5-37 Flag

5.13.2 Setting Flag Rules

You can select the name of the Flag in the Flag interface, then click Edit to modify the rules in the popup
dialog box.
For example, if the Flag rules of the leucopenia are required to be modified, you can refer to Figure 5-38 for
operations.

74
 Figure 5-38 Setting Flag Rules

You can also click Restore to restore all the parameters to the default value.

5.14 Host Settings

5.14.1 Auto Maintenance

The system auto sleep waiting time and cleanser maintenance time can be set in the auto maintenance interface.
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 5.14.1.1 Accessing the Interface
Click Auto Maintenance in the Setup > Host Settings interface to access the Auto Maintenance

setting interface. See Figure 5-39

Figure 5-39 Auto Maintenance

5.14.1.2 Auto Sleep

In the Wait textbox, the administrator is allowed to set the waiting time for entering the sleep state after the
main unit is halted. The range is between 15 and 120 minutes and the default value is 60 minutes.

5.14.1.3 Auto Cleanser Soak

The administrator is allowed to set the start time of the cleanser soak in the Start Time textbox and the default
value is 17:00. The acceptable value ranges from 0:00 to 23:59.

5.14.2 Gain Settings

You can adjust each digital pot at the Gain interface. It is not recommended to adjust gains frequently.
At the Setup > Host Settings interface, click the Gain Settings button to enter the Gain Settings

interface. See Figure 5-40.

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 Figure 5-40 Gain Settings

New value of the gain adjustment = Current Value ×Adjustment Rate.

 Setting the WBC gain

The WBC gain here is under the Whole Blood Mode.
Setting method I: Click the current value of the WBC and enter the new value.
Setting method II: Click the Adjustment Rate cell of the WBC and enter the adjustment rate of the new
value relative to the current value.
 Setting the RBC gain
Setting method I: Click the current value of the RBC and enter the new value.
Setting method II: Click the Adjustment Rate cell of the RBC and enter the adjustment rate of the new
value relative to the current value.
 Setting the HGB gain
Current digital circuit gain. The purpose for adjusting the HGB channel gain is to change the HGB
background voltage.
You can enter the value directly in the HGB Current Value textbox or click the adjusting button to adjust
the HGB gain.
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 Setting the HGB Blank Voltage
The background voltage derived from HGB gain cannot be modified.
HGB Background Voltage can be adjusted within the specified range (4.2~4.8V) by modifying HGB Current
Value.

 Setting the LS/HS/MS gain

Optical channel gain.
Setting method I: Click the current value of the LS (HS, or MS) and enter the new value.
Setting method II: Click the Adjustment Rate cell of the LS (HS, or MS) and enter the
adjustment rate of the new value relative to the current value.

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 6 Daily Operations

6.1 Introduction
This chapter introduces the daily operations from the startup to the shutdown of the analyzer with a focus on
the detailed operation procedures for running samples in different working modes.
A flow chart indicating the common daily operation process is presented below.
Figure 6-1 Daily Operations Procedure

Preparation before
the operation

Startup of the
Startup instrument and the
terminal software

Daily Quality
Control

Sample Collection
and Handling

Sample Analysis

Report
Management

Shutdown of the terminal

Shutdown software and the
instrument

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6.2 Pre-operation Preparation

6.2.1 Equipment Inspection

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

 Be sure to dispose reagents, waste, samples, consumables, etc. according to your local
legislations and regulations.
 The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety procedures when handling them in
the laboratory.
 If the reagents accidentally spill on the skin, wash them off with plenty of water and if necessary, go see a
doctor; if the reagents accidentally spill into the eyes, wash them off with plenty of water and immediately
go see a doctor.
 Keep clothing, hairs and hands away from the moving parts to avoid injury.
 The sample probe tip is sharp and may contain biohazardous materials. Exercise caution to avoid
contact with the probe when working around it.

 You should only use the DIAGON LTD.-specified reagents. Store and use the reagents as specified in
instructions for use of the reagents.
 Check if the reagents are connected correctly before using the analyzer.
 After long-distance transportation, the reagent should settle for more than one day before use.
 Be sure to use clean K2EDTA vacutainer blood collection tubes with anticoagulant, fused silica
glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary tubes.
 Be sure to use the DIAGON LTD.-specified disposable products including vacutainer blood collection
tube, vacutainer blood collection tubes with anticoagulant and capillary tubes etc.

80
 Perform the following checks before turning on the analyzer.
 Waste container
Check and make sure the waste container is empty.
 Fluidic 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.
 Printer (optional)
Check and make sure enough printer paper is installed, the power cord of the printer is properly plugged
into power outlet, and 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 properly connected to the analyzer.
Check and make sure the keyboard and the mouse are well connected to the external computer.

6.2.3 Tube and Barcode Preparation

Before running samples in AWB mode, you should prepare the DIAGON LTD.-specified tube racks and tubes,
and make sure the barcode labels meet the requirements.

6.2.3.1 Tube Specifications

The following types of vacutainer collection tubes should be used to collect whole blood samples.
 Ф13X75 (mm) (without the cap) vacutainer blood collection tube
 Ф12X75 (mm) (without the cap) vacutainer blood collection tube

 The height of the vacutainer blood collection tube with cap can not be higher than 83mm.
 The referred vacutainer collection tubes are not only available in AWB mode, but also available in VWB
and CWB mode.

6.2.3.2 Barcode Symbologies

The following barcode symbologies are intended to be used to make the tube barcode.
 CODE39
Code length: 1~20
 CODE93
Code length: 1~20
 CODE128
Code length: 1~20
 CODEBAR
Code length: 1~20
 CODE128
Code length: 1~20

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 6.2.3.3 Barcode Specifications

The requirements for the barcode specification are as follows.

 Code height: d ≥ 10mm
 Label width: a ≤ 45mm
 Clear area: b ≥ 5mm, C ≥ 5mm
 Wide-to-narrow ratio: between 2.5:1 and 3.0:1
 Code quality: according to ANSI MH10.8M standard, the code quality is greater or equal to C level.

Grades of A, B, C, D, and F are assigned to evaluate the quality of barcode. The grade (G) of each level is
defined in specified range: A(3.5≤G≤4.0), B(2.5≤G<3.5), C(1.5≤G<2.5), D(0.5≤G<1.5), F(G<0.5).

6.3 Startup
This section introduces the operations related to the startup of the analyzer, including turning on the
instrument and launching the terminal software.

6.3.1 Start the analyzer

Before turning on the analyzer, make sure the autoloading area is cleared without racks or any other objects.

82
 1. Place the power switch at the left side of the analyzer in the [I] position. The
power indicator light will be on.
2. Check the indicator light on the analyzer.
If the indicator light is on, it indicates the analyzer has been started up.

6.3.2. Log in Terminal Software

6.3.2.1 Before running the software, make sure the network cable of the external computer is properly connected
to the analyzer. The analyzer starts to initialize only when the connection are detected.
6.3.2.2 If you failed to run the software continuously, please contact DIAGON LTD. customer service
department or your local agent immediately.
6.3.2.3 After startup, please make sure the data/time of the computer is correct.
6.3.2.4 You can either start up the main unit first or run the software first.

1. Start the external computer.

2. Turn on the display.

3. After entering the operation system, double click the icon to run the software. After
starting the software, the message box as shown in Figure 6-2 will pop up.
Figure 6-2 Login

4. Enter the correct user name and password in the Login message box.
The initial user name and password of administrator are admin, which was set by service engineer.
1 to 12 digits of numeric characters can be entered for the user name and the password. No Chinese
character is allowed.
5. Click Login.
The system starts to execute the initialization operations.
The whole process lasts for 4 to 12 minutes. The time needed for initializing the system depends on how the
analyzer was shut down previously.
For the background Ref. Range of each parameter, please see A.5.2 Normal Background.
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 6.3.2.5 The background test is designed for detecting particle interference and electrical interference.
6.3.2.6 The sample ID for the background test is background.
6.3.2.7 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.
6.3.2.8 Running a test when there is a Background abnormal, you would obtain an unreliable testing result.
6.3.2.9 If any error is detected during initialization (e.g. the background results exceed the Ref. Range), the
analyzer will activate the alarm.

6.3.3 Log off/Switch User

You can refer to the following steps to log off or switch users.

1. Click on the top right corner of the screen. The

following dialog box will pop up.

2. Click OK and enter the username and password in the dialog box.

3. Click Login to log in the interface as a different user.

84
6.4 Daily Quality Control
To ensure reliable analysis results, conduct daily QC analysis on the analyzer before running samples. See 10
Quality Control.

6.5 Sample Collection and Handling

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

Do not touch the patients' blood sample directly.

 Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
 Prepare the samples as per the procedures recommended by the reagent manufacturer.

 Be sure to use clean K2EDTA vacutainer blood collection tubes with anticoagulant, fused silica
glass/plastic test tubes, centrifugal tubes and borosilicate glass capillary tubes.
 Be sure to use the DIAGON LTD.-specified disposable products including vacutainer blood collection
tube, vacutainer blood collection tubes with anticoagulant and capillary tubes etc.
 For the whole blood samples to be used for WBC classification or PLT count, store them at 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°C - 8°C) for 24 hours. You need to warm the keep samples at room temperature for at least
30 minutes before running them.
 Be sure to shake any sample that has been prepared for a while before running it.

85
6.5.1 Venous Whole Blood Samples
The procedure for preparing whole blood samples is as follows:
1. Use clean K2EDTA (1.5~2.2mg/mL) vacutainer blood collection tubes with anticoagulant to collect
venous blood samples.
2. Shake the sample well according to your laboratory’s protocol.

For vacutainer blood collection tube (Ф12X75, cap excluded), please make sure the volume of the whole
blood sample is not less than 0.5mL.

6.5.2 Capillary Whole Blood Samples

The procedure for preparing capillary whole blood sample is as follows:
1. Users clean centrifugal tube with anticoagulant to collect capillary whole blood samples.
2. Mix the sample according to your laboratory’s protocol.

To ensure the accuracy of the analysis, make sure the volume of the capillary whole blood sample is not less
than 100μL.

Run the capillary whole blood sample within 3 minutes to 2 hours after its collection.

6.5.3 Prediluted Samples

The procedure for preparing prediluted sample is as follows:
1. Click the Add Diluent button in the function button area.
The system will prompt you with a message to add the diluent.

86
 2. Take a clean centrifugal tube, uncap and set it under the sample probe as shown in the following picture so
that the probe tip is vertically in contact with the bottom of the tube so as to avoid bubbles, liquid attached
to the inner wall or spatter.

3. Press the aspirate key and add the diluent (180μL at a time).
After the diluent is added and you hear a beep, you can remove the centrifugal tube.
4. After the prediluted sample is prepared, click Cancel to exit dispensing the diluent.
5. If more portions of diluent are needed, repeat steps 3~4.

6.3.2.10 You can also dispense 180μL of diluent by pipette into the tube.
6.3.2.11 Be sure to keep dust from the prepared diluent.
6.3.2.12 Be sure to run the prediluted samples within 30 minutes after the mixing.
6.3.2.13 Be sure to mix any sample that has been prepared for a while before running it.
6.3.2.14 Be sure to evaluate predilute stability based on your laboratory’s sample population and sample
collection techniques or methods.

87
6.6 Sample Analysis
The analyzer provides the following four blood sample modes and two measurement modes for sample
analysis.
Blood sample modes include:
 Open-vial Venous Whole Blood (VWB)
 Open-vial Capillary Whole Blood (CWB)
 Open-vial Predilute (PD)
 Auto Venous Whole Blood (AWB)
Measurement modes include:
 CBC
 CBC+DIFF
Where, the VWB, CWB and PD modes belong to open-vial sampling analysis, the AWB mode belongs to
autoloader sampling analysis. The sample analysis procedures for open-vial sampling and autoloader
sampling will be presented on the following pages.

6.6.1 Open-vial Sampling Analysis

All the samples, controls, calibrators, reagents, wastes and areas in contact with them are potentially
biohazardous. Wear proper personal protective equipment (e.g. gloves, lab uniforms, etc.) and follow laboratory
safety procedures when handling them and the relevant 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.
 Make sure that the entered sample ID and mode exactly match those of the samples to be run.

88
  During aspiration, the tip of the probe should be kept at a certain distance from the bottom of the sample
container, otherwise the accuracy of aspiration volume will be affected.
 Keep the tip of the probe from contacting with the wall of the test tube to avoid blood splashing.
 Proper reference range shall be selected on the Setup interface before analysis. Otherwise, the results
may be flagged erroneously.
 Open-vial sampling analysis includes VWB sample analysis, CWB sample analysis and PD sample
analysis. Since the analysis procedures are similar, they will be presented together.

The system does not run samples as per the worklist by default. If the Run as per the worklist is checked
(See 5.3.1 Auxiliary Settings), the sample analysis will be conducted according to the worklist upon start-
up.

The sample analysis procedures in the conditions mentioned above will be presented on the following pages.

6.6.1.1 Do not run as per the worklist

If you are not running samples as per the worklist, do as follows:
1. When the green indicator light is steady-on, click Mode & ID in the function button area to enter the
Mode & ID interface.

2. Choose the blood sample mode Open-vial-Venous Whole Blood (VWB), Open-vial-Capillary Whole
Blood (CWB) or Open-vial-Predilute (PD) in the Mode selection area according to the actual situation.

Figure 6-3 Open-vial sampling analysis (do not run as per the worklist)

3. Choose the measurement mode CBC or CBC+DIFF, and enter the Sample ID.

89
 Refer to Table 6-1 for the description of relevant parameters.

Table 6-1 Description of open-vial sampling analysis parameters

Parameter Meaning Operation

Open-vial- Running the venous whole blood

Venous Whole samples in open-vial sampling Select from the radio box.
Blood (VWB) mode.

Open-vial-Capill Running the capillary whole blood

ary Whole Blood samples in open-vial sampling mode. Select from the radio box.
(CWB)

Open-vial-Predil Running the prediluted samples in

Select from the radio box.
ute (PD) open-vial sampling mode.

Complete Blood Count with no

differential count for white blood cells.
CBC The counting results comprise 15 Select from the radio box.
parameters and the histograms for
WBC, RBC and PLT.

Complete Blood Count plus differential

count for white blood cells. In addition
to a total of 25 parameters, differential
CBC+DIFF scattergrams and the histograms for Select from the radio box.
WBC/BASO, RBC and PLT, the
counting results also include 4 research
parameters.

Input in the textbox directly.

NOTE
 Letters, numbers and all characters
that can be entered through the
keyboard (including special
characters) are allowed for the
Sample ID. Chinese and other
Identification number for the languages (such as Japanese,
Sample ID Korean, etc) are not supported.
samples to be run.
 The length of the entries ranges
from 1 to 25 and the entries shall
not be empty.
 The last character of a sample ID
must be numeric, but a string of "0"
only is not an acceptable sample ID.

4. Click OK.
5. Shake the capped tube of sample for a homogeneous specimen.
For details about the preparation of blood samples, see 6.5 Sample Collection and Handling.

6. Remove the tube cap carefully and place the sample under the probe so that the probe can aspirate
the well-mixed sample.
7. Click Start or press the aspirate key on the analyzer to start running the sample. The
sample will be automatically aspirated by the sample probe.
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 When the predilute counting begins, the system will prompt a dialog box. To disable such reminders,
please refer to 5.3.1 Auxiliary Settings.

8. When you hear a beep, remove the sample tube.

The analyzer will automatically run the sample and the analysis status icon and analyzer indicator is
flickering in green; the information area of the Next Sample will be refreshed.
When the analysis is complete, the analysis status icon and analyzer indicator return to
constantly-on green.
9. Repeat steps 5~8 to run the remaining samples.

 When the analyzer is running the samples, you can switch to Report interface to perform operations
including data browsing, validating, sample information editing, printing, etc. (see 7 Report), and you
can also switch to other interfaces.
 When the analyzer is running the samples, all the functions related to the fluidics sequence are not
available.

6.6.1.2 Run as per the worklist

If the samples are set to be run as per the worklist, the analyzer will obtain the sample information in the
worklist according to the entered sample ID, then perform the counting. In this case, you don't need to set the
blood sample mode and measurement mode of the sample.

For details about the setting of the Run as per the worklist, see 5.3.1 Auxiliary Settings.
The procedure for running samples as per the worklist is as follows:

1. Input the sample information in the Worklist interface.

For details, see 8 Worklist.

2. When the green indicator light is steady-on, click Mode & ID in the function button area to enter the
Mode & ID interface.

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 Figure 6-4 Open-vial sampling analysis (run as per the worklist)

3. Enter the sample ID, which should be the same as the sample to be run in the worklist. The analyzer
will match the sample information in the worklist according to the sample ID.
 If a matched sample ID is found, the sample will be run according to the blood sample mode and
measurement mode in the worklist.
 If no matching sample ID is found, and it's the first running sample, then the sample will be run in
the mode as you set.
 If no matching sample ID is found, and it's not the first running sample, then the sample will be run
in the mode of the last run.
4. Click OK.
5. Shake the capped tube of sample for a homogeneous specimen.
For details about the preparation of blood samples, see 6.5 Sample Collection and Handling.

6. Remove the tube cap carefully and place the sample under the probe so that the probe can aspirate
the well-mixed sample.
7. Click Start or press the aspirate key on the analyzer to start running the sample. The
sample will be automatically aspirated by the sample probe.
8. When you hear a beep, remove the sample tube.
The analyzer will automatically run the sample and the analysis status icon and analyzer indicator is
flickering in green; the information area of the Next Sample will be refreshed.
When the analysis is complete, the analysis status icon and analyzer indicator return to
constantly-on green.
9. Repeat steps 5~8 to run the remaining samples.

92
 11.

 When the analyzer is running the samples, you can switch to Report interface to perform operations
including data browsing, validating, sample information editing, printing, etc. (see 7 Report), and you
can also switch to other interfaces.
 When the analyzer is running the samples, all the functions related to the fluidics sequence are not
available.

6.6.2 Autoloader Sampling Analysis

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

 Be sure to avoid reversing the collection tube when loading, otherwise, the collection tube may be
broken and/or cause biohazard.
 Collection tubes broken may cause personal injury and/or biohazard. Be sure to place the collection
tubes in the right adapter before running, otherwise, the collection tubes may be broken and cause
biohazard.
 Before starting autoloader sample analysis, keep your hands away from the racks to avoid injury.

 Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
 Repeat piercing the vacutainer 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.
 Sample clump may lead to incorrect analysis results. Check if clump exists before running the samples;
if it does, handle it as per the related laboratory procedures.
 Make sure that the entered sample ID, rack No., tube No. and mode could match those of the sample to
be run exactly.

93
  During aspiration, the tip of the probe should be kept at a certain distance from the bottom of the sample
container, otherwise the accuracy of aspiration volume will be affected.
 Keep the tip of the probe from contacting with the wall of the test tube to avoid blood splashing.
 Proper reference range shall be selected on the Setup interface before analysis. Otherwise, the results may
be flagged erroneously.

6.6.2.1 Preparation
1. Prepare tubes and racks as instructed by 6.2.2 Tube and Barcode Preparation.
2. Prepare whole blood samples as instructed by 6.5.1 Venous Whole Blood Samples, and place
them in the racks.
If tube barcode scanning is required, make sure the barcode labels on the tubes, which are placed in the
racks, are facing the analyzer.
3. Place racks from the outer side of loading tray.
Placing rack from the center of loading tray may easily lead to the rack out of level.
4. Check if there is a rack in the feeding area; if so, remove it manually.
5. Remove all rack(s) on the unloading tray.

6.6.2.2 Starting Sample Analysis

 During sample analysis, please do not move the rack or tubes in the feeding area.
 If more than 6 racks samples are needed to be analyzed, you should load the rack from the right of the
autoloader while removing the completed rack from the left of the autoloader in time. Load the rack from
the outer side of loading tray, and do not push forward it.
 Make sure that the entered sample ID, rack No., tube No. and mode could match those of the sample to
be run exactly.

 If any error happens during the analysis process, which leads to remaining racks in feeding area, click
Remove Error. The analyzer will remove the error automatically and unload the rack to the left tray of the
autoloader.
 In case of power failure during sample analysis, remove the rack manually. Then open the front housing
to check if there is a fallen tube; if so, take it out.

94
 According to different settings, the autoloader sampling analysis can be divided into:
 Do not scan the sample ID or rack No. and do not run as per the worklist
 Do not scan the sample ID or rack No. but run as per the worklist
 Automatically scan the sample ID and/or rack No. but do not run as per the worklist
 Automatically scan the sample ID and/or rack No. and run as per the worklist

6.6.2.3 Do not scan the sample ID or rack No. and do not run as per the worklist
When running autoloader sampling analysis, the analyzer does not scan the sample ID or rack No. and does
not run as per the worklist by default. Take the following steps to perform autoloader sampling analysis.

 For details about the settings of the sample ID and rack No. scanning, see the description of
Automatically scan Sample ID and Automatically scan Rack No. in 5.3.5 Autoloader.

 For details about the setting of the Run as per the worklist, see 5.3.1.1 Aspirating- Run as per the
worklist.

6. When the green indicator light is steady-on, click Mode & ID in the function button area to enter the
Mode & ID interface.
7. Choose Auto-Venous Whole Blood (AWB) in the Mode selection.
See Figure 6-5.

Figure 6-5 Running the AWB Samples

95
8. Select the measurement mode CBC or CBC+DIFF according to the actual situation, and enter the
values of Sample ID, Rack No. and Tube No..
Refer to Table 6-2 for the description of relevant parameters.
Table 6-2 Description of AWB Sample analysis parameters

Parameter Meaning Operation

Auto-Venous
Running the venous whole blood samples
Whole Blood Select from the radio box.
in autoloader sampling mode.
(AWB)

Complete Blood Count with no differential

count for white blood cells. The counting
CBC results comprise 15 parameters and the Select from the radio box.
histograms for WBC, RBC and PLT.

Complete Blood Count plus differential

count for white blood cells. In addition to a
total of 25 parameters, differential
CBC+DIFF scattergrams and the histograms for Select from the radio box.
WBC/BASO, RBC and PLT, the counting
results also include 4 research parameters.

Input in the textbox directly.

NOTE
 Letters, numbers and all characters
Starting identification number of the that can be entered through the
keyboard (including special
sample to be run. The next sample ID characters) are allowed for the
will increase sequentially. Sample ID. Chinese and other
languages (such as Japanese,
Sample ID NOTE
Korean, etc) are not supported.
You don't need to input the sample ID if  The length of the entries ranges
the Automatically scan Sample ID is from 1 to 25 and the entries shall
checked. See section 5.3.5 Autoloader. not be empty.
 The last character of a sample ID
must be numeric, but a string of "0"
only is not an acceptable sample ID.

Starting rack number of the sample to be run.

NOTE
You don't need to input the rack No. if Input in the textbox directly. The
Rack No.
the Automatically scan Rack No. is input range is 1 to 100.
checked. See section 5.3.5 Autoloader.

Starting tube number of the sample to be run.

For example, if you enter 5 in the textbox, Input in the textbox directly.
Tube No. the sample analysis will be started from the The input range is 1 to 10.
fifth tube position of the first rack.

96
9. Click OK to save the settings.
10. Place racks loading tubes in ascending order on the level of the right tray of the autoloader, with the rack
numbers on the racks facing the analyzer.
11. Click the Start button or press the [RUN] key on the analyzer to start the sample analysis from the
starting position as you set.

After starting the AWB sample analysis, the Start button will be replaced by Stop. When you click Stop, the
analysis will be stopped after the previously analyzing of the pierced sample is finished. Then the statistical
result will be displayed.

When the sample analysis is complete, a statistics dialog box will pop up as shown in Figure 6-6.

Figure 6-6 AWB sample analysis statistic

Refer to Table 6-3 Description of AWB sample analysis statistics parameters for the description of
relevant parameters.
Table 6-3 Description of AWB sample analysis statistics parameters
97
Parameter Description

Rack No. and Tube No. of the sample.

Sample Position For example, 1-2 means the rack No. of the sample is 1, and the tube
No. is 2.

Identification number of the sample.

If the sample ID is displayed like INVALID1 (INVALID2,
INVALID3, …), it means the sample ID entered or scanned is invalid. The
reason may be:
Sample ID  Invalid Rack No.
 Invalid tube barcode (sample ID)
 Worklist query failed
 LIS query failed

Parameter Description

Indicates that the analyzer skipped the

Skip (Not at starting sample without running because the
position) sample was placed before the starting
position.

Indicates that the analyzer skipped the sample

Skip (Invalid Rack No.) without running because Rack No. scanning
failed.

Indicates that the analyzer skipped the

Skip (Invalid tube
sample without running because Sample ID
barcode)
scanning failed.

Indicates that the analyzer skipped the

Skip (Worklist query sample without running because no matching
failed) record was found when running as per the
worklist.

Indicates that the analyzer skipped the

Remarks Skip (LIS query failed) sample without running because LIS
communication failed.

Indicates that the sample analysis is

Run
complete.

Indicates that the sample analysis is

Run (Invalid Rack No.)
complete with Rack No. scanning failure.

Run (Invalid tube Indicates that the sample analysis is complete

barcode) with Sample ID scanning failure.

Indicates that the sample analysis is complete,

Run (Worklist query
but no matching record is found in the
failed)
worklist.

Indicates that the sample analysis is complete

Run (LIS query failed)
with LIS communication failure.

Indicates that there is no tube in the

Vacancy
sample position.

98
 Finished samples Number of analyzed samples.

Skipped samples Number of skipped samples without analyzing.

Rack vacancies Number of vacancies on the rack.

You can set whether or not to display the autoloading sampling analysis statistics, and whether or not to
run samples when scanning failed or any error happened. See section 5.3.5 Autoloader.

12. Click OK to close the message box.

The analysis status icon and analyzer indicator return to constantly-on green.
When finish running, all the racks come to the left tray of the autoloader. Remove them safely.

 When the analyzer is running the samples, you can switch to Report interface to perform operations
including data browsing, validating, sample information editing, printing, etc. (see 7 Report), and you
can also switch to other interfaces.
 When the analyzer is running the samples, all the functions related to the fluidics sequence are not
available.
 After every analysis cycle, the results will be saved to the Review interface.

6.6.2.4 Do not scan the sample ID or rack No. but run as per the worklist
If the analyzer does not scan the sample ID or rack No. but runs as per the worklist, you can take the following
steps to perform autoloader sampling analysis.

 For details about the settings of sample ID and rack No. scanning, see the description of
Automatically scan Sample ID and Automatically scan Rack No. parameters in 5.3.5
Autoloader.
 For details about the setting of the Run as per the worklist, see 5.3.1.1 Aspirating- Run as per the
worklist.

1. When the green indicator light is steady-on, click Mode & ID in the function button area to enter the
Mode & ID interface.
2. Choose Auto-Venous Whole Blood (AWB) in the Mode selection. See
Figure 6-7.

Figure 6-7 Running the AWB Samples

99
3. Enter the rack No. and tube No., which should be the same as the sample to be run in the worklist.
The analyzer will match the sample information in the worklist according to the sample position (Rack
No. and Tube No.), then perform the analysis.
 If a matched record is found, the analyzer will run the sample according to the mode as you set in the
worklist.
 If no matching record is found, and the Skip the sample when it failed to match the worklist is
checked, then the analyzer will skip the sample and continue with other samples.
 If no matching record is found, and the Skip the sample when it failed to match the worklist
is unchecked, then the analyzer will run the sample in CBC+DIFF mode.
Refer to Table 6-4 for the description of relevant parameters.
Table 6-4 Description of AWB Sample analysis parameters

Parameter Meaning Operation

Auto-Venous
Running the venous whole blood samples in
Whole Blood Select from the radio box.
autoloader sampling mode.
(AWB)

Complete Blood Count with no differential

count for white blood cells. The counting
CBC Select from the radio box.
results comprise 15 parameters and the
histograms for WBC, RBC and PLT.

Complete Blood Count plus differential count for

white blood cells. In addition to a total of 25
parameters, differential scattergrams and the
CBC+DIFF Select from the radio box.
histograms for WBC/BASO, RBC and PLT, the
counting results also include 4 research
parameters.

Starting rack number of the sample to be run.

NOTE Input in the textbox directly.
Rack No.
You don't need to input the rack No. if the The input range is 1 to 100.
Automatically scan Rack No. is checked. See
section 5.3.5 Autoloader.

100
 Starting tube number of the sample to be run.
For example, if you enter 5 in the textbox, the Input in the textbox directly.
Tube No.
sample analysis will be started from the fifth tube The input range is 1 to 10.
position of the first rack.

4. Click OK.
5. Place racks loading tubes in ascending order on the level of the right tray of the autoloader, with the rack
numbers on the racks facing the analyzer.
6. Click the Start button or press the [RUN] key on the analyzer to start the sample analysis from the
starting position as you set.

After starting the AWB sample analysis, the Start button will be replaced by Stop. When you click Stop, the
analysis will be stopped after the previously analyzing of the pierced sample is finished. Then the statistical
result will be displayed.

When the sample analysis is complete, a statistics dialog box will pop up as shown in Figure 6-8.

101
 Figure 6-8 AWB sample analysis statistics

Refer to Table 6-5 for the description of relevant parameters.

Table 6-5 Description of AWB sample analysis statistics parameters

Parameter Description

Rack No. and Tube No. of the sample.

Sample Position For example, 1-2 means the rack No. of the sample is 1, and the tube No. is 2.

Identification number of the sample.

If the sample ID is displayed like INVALID1 (INVALID2, INVALID3, …), it
means the sample ID entered or scanned is invalid. The reason may be:
Sample ID  Invalid Rack No.
 Invalid tube barcode (sample ID)
 Worklist query failed
 LIS query failed

Indicates that the analyzer skipped the sample

Skip (Not at starting
Remarks without running because the sample was placed
position)
before the starting position.

102
 Parameter Description

Indicates that the analyzer skipped the Skip

(Invalid Rack No.) sample without running because Rack No.
scanning failed.

Indicates that the analyzer skipped the

Skip (Invalid tube barcode)
sample without running because Sample ID
scanning failed.

Indicates that the analyzer skipped the

Skip (Workl ist query sample without running because no matching
failed) record was found when running as per the
worklist.

Indicates that the analyzer skipped the

Skip (LIS query failed) sample without running because LIS
communication failed.

Indicates that the sample analysis is

Run
complete.

Indicates that the sample analysis is complete

Run (Invalid Rack No.) with Rack No. scanning failure.
Run (Invalid tube Indicates that the sample analysis is complete
barcode) with Sample ID scanning failure.

Run (Workli st query Indicates that the sample analysis is

complete, but no matching record is found in
failed)
the worklist.

Indicates that the sample analysis is complete

Run (LIS query failed) with LIS communication failure.
Indicates that there is no tube in the sample
Vacancy
position.

Finished samples Number of a nalyzed samples.

Skipped samples Number of s kipped samples without analyzing.

Rack vacancies Number of va cancies on the rack.

You can set whether or not to display the autoloading sampling analysis statistics, and whether or not to run
samples when scanning failed or any error happened. See section 5.3.5 Autoloader.

7. Click OK to close the message box.

The analysis status icon and analyzer indicator return to constantly-on green.
When finish running, all the racks come to the left tray of the autoloader. Remove them safely.

103
  When the analyzer is running the samples, you can switch to Report interface to perform operations
including data browsing, validating, sample information editing, printing, etc. (see 7 Report), and you
can also switch to other interfaces.
 When the analyzer is running the samples, all the functions related to the fluidics sequence are not
available.
 After every analysis cycle, the results will be saved to the Review interface.

6.6.2.5 Automatically scan the sample ID and/or rack No. but do not run as per the
worklist
If the analyzer is set to automatically scan the sample ID and/or rack No. but not run as per the worklist, you
can take the following steps to perform autoloader sampling analysis.

 For details about the settings of the Sample ID and rack No. scanning, see the description of
Automatically scan Sample ID and Automatically scan Rack No. in 5.3.5 Autoloader.

 For details about the setting of the Run as per the worklist, see 5.3.1.1 Aspirating- Run as per the
worklist.
 When placing tubes in the rack, make sure the barcode labels on the tubes are facing the analyzer.

1. When the green indicator light is steady-on, click Mode & ID in the function button area to enter the
Mode & ID interface.
2. Choose Auto-Venous Whole Blood (AWB) in the Mode selection. See
Figure 6-9.
Figure 6-9 Running the AWB Samples

104
3. Choose the measurement mode CBC or CBC+DIFF.
4. Enter the values of Sample ID, Rack No. and Tube No. according to the actual situation.
 If the Automatically scan Rack No. and Automatically scan Sample ID are displayed, the starting
tube No. should be entered.
 If the Automatically scan Rack No. is displayed, the starting sample ID and starting tube No. should be
entered.
 If the Automatically scan Sample ID is displayed, the starting rack No. and starting tube No. should
be entered.

 If the barcode scan is successful, the sample analysis will be performed in the set mode.
 The analyzer will skip the sample and continue with other samples when: the sample ID scanning
failed and the parameter Skip the sample when Sample ID scanning failed is checked, or the
rack No. scanning failed and the parameter Skip the sample when Rack No. scanning failed is
checked.
 The analyzer will run the sample in CBC+DIFF mode when: the sample ID scanning failed and
the parameter Skip the sample when Sample ID scanning failed is unchecked, or the rack No.
scanning failed and the parameter Skip the sample when Rack No. scanning failed is
unchecked.
 For details about the settings of Skip the sample when Sample ID scanning failed and
Skip the sample when Rack No. scanning failed parameters, see 5.3.5 Autoloader.

Refer to Table 6-6 for the description of relevant parameters.

Table 6-6 Description of AWB Sample analysis parameters

Parameter Meaning Operation

Auto-Venous Running the venous whole blood

Whole Blood samples in autoloader sampling Select from the radio box.
(AWB) mode.

Complete Blood Count with no

differential count for white blood cells.
CBC The counting results comprise 15 Select from the radio box.
parameters and the histograms for
WBC, RBC and PLT.

Complete Blood Count plus differential

count for white blood cells. In addition
to a total of 25 parameters, differential
CBC+DIFF scattergrams and the histograms for Select from the radio box.
WBC/BASO, RBC and PLT, the
counting results also include 4 research
parameters.

105
 Input in the textbox directly.
NOTE
Starting identification number of the
 Letters, numbers and all characters that can
sample to be run. The next sample ID
be entered through the keyboard (including
will increase sequentially. special characters) are allowed for the
NOTE Sample ID. Chinese and other languages
Sample ID (such as Japanese, Korean, etc) are not
You don't need to input the sample ID supported.
if the Automatically scan Sample ID  The length of the entries ranges from 1 to
is checked. See section 25 and the entries shall not be empty.
5.3.5 Autoloader.
 The last character of a sample ID must be
numeric, but a string of "0" only is not an
acceptable sample ID.

Starting rack number of the sample to

be run.
NOTE Input in the textbox directly. The input
Rack No.
You don't need to input the rack No. if range is 1 to 100.
the Automatically scan Rack No. is
checked. See section 5.3.5 Autoloader.

Starting tube number of the sample to

be run.
For example, if you enter 5 in the Input in the textbox directly.
Tube No.
textbox, the sample analysis will be The input range is 1 to 10.
started from the fifth tube position of
the first rack.

5. Click OK to save the settings.

6. Place racks loading tubes in ascending order on the level of the right tray of the autoloader, with the rack
numbers on the racks facing the analyzer.
7. Click the Start button or press the [RUN] key on the analyzer to start the sample analysis from the
starting position as you set.

After starting the AWB sample analysis, the Start button will be replaced by Stop. When you click Stop, the
analysis will be stopped after the previously analyzing of the pierced sample is finished. Then the statistical
result will be displayed.

106
When the sample analysis is complete, a statistics message box will pop up. See Figure 6-10.

Figure 6-10 AWB sample analysis statistics

Refer to Table 6-7 for the description of relevant parameters.

Table 6-7 Description of AWB sample analysis statistics parameters

107
Parameter Description

Rack No. and Tube No. of the sample.

Sample Position For example, 1-2 means the rack No. of the sample is 1, and the tube
No. is 2.

Identification number of the sample.

If the sample ID is displayed like INVALID1 (INVALID2,
INVALID3, …), it means the sample ID entered or scanned is invalid. The
reason may be:
Sample ID  Invalid Rack No.
 Invalid tube barcode (sample ID)
 Worklist query failed
 LIS query failed

Indicates that the analyzer skipped the

Skip (Not at starting sample without running because the
Remarks
position) sample was placed before the starting
position.

Parameter Description

Indicates that the analyzer skipped the Skip

(Invalid Rack No.) sample without running because Rack No.
scanning failed.

Indicates that the analyzer skipped the

Skip (Invalid tube
sample without running because Sample
barcode)
ID scanning failed.
Indicates that the analyzer skipped the ist
Skip (Workl query sample without running because no
failed) matching record was found when running as
per the worklist.

Indicates that the analyzer skipped the

Skip (LIS query failed) sample without running because LIS
communication failed.

Indicates that the sample analysis is

Run
complete.

Indicates that the sample analysis is

Run (Invalid Rack No.) complete with Rack No. scanning failure.
Run (Invalid tube Indicates that the sample analysis is barcode)
complete with Sample ID scanning failure.

Run (Workli st query Indicates that the sample analysis is complete,

failed) but no matching record is found
in the worklist.

Indicates that the sample analysis is

Run (LIS query failed) complete with LIS communication failure.

Indicates that there is no tube in the

Vacancy
sample position.

108
 Finished samples Number of analyzed samples.

Skipped samples Number of skipped samples without analyzing.

Rack vacancies Number of vacancies on the rack.

You can set whether or not to display the autoloading sampling analysis statistics, and whether or not to run
samples when scanning failed or any error happened. See section 5.3.5 Autoloader.

8. Click OK to close the message box.

The analysis status icon and analyzer indicator return to constantly-on green.
When finish running, all the racks come to the left tray of the autoloader. Remove them safely.

 When the analyzer is running the samples, you can switch to Report interface to perform operations
including data browsing, validating, sample information editing, printing, etc. (see 7 Report), and you
can also switch to other interfaces.
 When the analyzer is running the samples, all the functions related to the fluidics sequence are not
available.
 After every analysis cycle, the results will be saved to the Review interface.

6.6.2.6 Automatically scan the sample ID and/or rack No. and run as per the worklist
If the analyzer is set to automatically scan the sample ID and/or rack No. and run as per the worklist, you can
take the following steps to perform autoloader sampling analysis.

 For details about the settings of the sample ID and rack No. scanning, see the description of
Automatically scan Sample ID and Automatically scan Rack No. in 5.3.5 Autoloader.

 For details about the setting of the Run as per the worklist, see 5.3.1.1 Aspirating- Run as per the
worklist.
 When placing tubes in the rack, make sure the barcode labels on the tubes are facing the analyzer.

1. When the green indicator light is steady-on, click Mode & ID in the function button area to enter the
Mode & ID interface.
2. Choose Auto-Venous Whole Blood (AWB) in the Mode selection. See
Figure 6-11.

109
 Figure 6-11 Running the AWB Samples

3. Enter the starting tube No. of the sample to be run.

 If the Run as per the worklist and Automatically scan Sample ID are displayed (no matter whether
the Automatically scan Rack No. is displayed or not), the analyzer will obtain the sample
information in the worklist according to the scanned sample ID.
 If the Run as per the worklist and Automatically scan Rack No. are displayed, the analyzer
will obtain the sample information in the worklist according to the sample position.

 If the barcode scanning and worklist matching are successful, the analyzer will run the sample
in the mode as you set in the worklist, and update the sample position.
 The analyzer will skip the sample and continue with other samples when: no matching record is
found and the Skip the sample when it failed to match the worklist is checked; the sample ID
scanning failed and the parameter Skip the sample when Sample ID scanning failed is checked;
or the rack No. scanning failed and the parameter Skip the sample when Rack No. scanning failed
is checked.
 The analyzer will run the sample in CBC+DIFF mode when: no matching record is found, and the
Skip the sample when it failed to match the worklist is unchecked; the sample ID scanning
failed and the parameter Skip the sample when Sample ID scanning failed is unchecked; or the
rack No. scanning failed and the parameter Skip the sample when Rack No. scanning failed is
unchecked.
 For details about the settings of Skip the sample when it failed to match the worklist, Skip the
sample when Sample ID scanning failed and Skip the sample when Rack No. scanning failed,
see 5.3.5 Autoloader.

110
 Refer to Table 6-8 for the description of relevant parameters.
Table 6-8 Description of AWB Sample analysis parameters

Parameter Meaning Operation

Auto-Venous
Running the venous whole blood samples in
Whole Blood Select from the radio box.
autoloader sampling mode.
(AWB)

Complete Blood Count with no differential

count for white blood cells. The counting
CBC Select from the radio box.
results comprise 15 parameters and the
histograms for WBC, RBC and PLT.

Complete Blood Count plus differential count for

white blood cells. In addition to a total of 25
parameters, differential scattergrams and the
CBC+DIFF Select from the radio box.
histograms for WBC/BASO, RBC and PLT, the
counting results also include 4 research
parameters.

Starting rack number of the sample to be run.

NOTE Input in the textbox directly.
Rack No.
You don't need to input the rack No. if the The input range is 1 to 100.
Automatically scan Rack No. is checked. See
section 5.3.5 Autoloader.

Starting tube number of the sample to be run.

For example, if you enter 5 in the textbox, the Input in the textbox directly.
Tube No.
sample analysis will be started from the fifth tube The input range is 1 to 10.
position of the first rack.

4. Click OK to save the settings.

5. Place racks loading tubes in ascending order on the level of the right tray of the autoloader, with the rack
numbers on the racks facing the analyzer
6. Click the Start button or press the [RUN] key on the analyzer to start the sample analysis from the
starting position as you set.

After starting the AWB sample analysis, the Start button will be replaced by Stop. When you click Stop, the
analysis will be stopped after the previously analyzing of the pierced sample is finished. Then the statistical
result will be displayed.

111
When the sample analysis is complete, a statistics dialog box will pop up as shown in Figure 6-12.
Figure 6-12 AWB sample analysis statistics

Refer to Table 6-9 for the description of relevant parameters.

112
 Table 6-9 Description of AWB sample analysis statistics parameters

Parameter Description

Rack No. and Tube No. of the sample.

Sample Position For example, 1-2 means the rack No. of the sample is 1, and the tube
No. is 2.

Parameter Description

Identification number of the sample.

If the sample ID is displayed like INVALID1 (INVALID2,
INVALID3, …), it means the sample ID entered or scanned is invalid. The
reason may be:
Sample ID  Invalid Rack No.
 Invalid tube barcode (sample ID)
 Worklist query failed
 LIS query failed

Indicates that the analyzer skipped the

Skip (Not at starting sample without running because the
position) sample was placed before the starting
position.

Indicates that the analyzer skipped the sample

Skip (Invalid Rack No.) without running because Rack No. scanning
failed.

Indicates that the analyzer skipped the

Skip (Invalid tube
sample without running because Sample ID
barcode)
scanning failed.

Indicates that the analyzer skipped the

Skip (Worklist query sample without running because no matching
failed) record was found when running as per the
worklist.

Indicates that the analyzer skipped the

Remarks Skip (LIS query failed) sample without running because LIS
communication failed.

Indicates that the sample analysis is

Run
complete.

Indicates that the sample analysis is

Run (Invalid Rack No.)
complete with Rack No. scanning failure.

Run (Invalid tube Indicates that the sample analysis is complete

barcode) with Sample ID scanning failure.

Indicates that the sample analysis is complete,

Run (Worklist query
but no matching record is found in the
failed)
worklist.

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 Indicates that the sample analysis is complete
Run (LIS query failed)
with LIS communication failure.

Indicates that there is no tube in the

Vacancy
sample position.

Finished samples Number of analyzed samples.

Skipped samples Number of skipped samples without analyzing.

Rack vacancies Number of vacancies on the rack.

You can set whether or not to display the autoloading sampling analysis statistics, and whether or not to run
samples when scanning failed or any error happened. See section 5.3.5 Autoloader.

7. Click OK to close the message box.

The analysis status icon and analyzer indicator return to constantly-on green.
When finish running, all the racks come to the left tray of the autoloader. Remove them safely.

 When the analyzer is running the samples, you can switch to Report interface to perform operations
including data browsing, validating, sample information editing, printing, etc. (see 7 Report), and you
can also switch to other interfaces.
 When the analyzer is running the samples, all the functions related to the fluidics sequence are not
available.
 After every analysis cycle, the results will be saved to the Review interface.

6.6.2.7 Stopping Sample Analysis

When the analyzer is running AWB samples, the Start button will be replaced by Stop. When you click Stop,
the analysis will be stopped after the previously analyzing of the pierced sample is finished.

6.6.2.8 Inserting STAT

If there is STAT sample requires running first during AWB sample analysis, you can click the STAT
button in the function button area to start the STAT sample analysis.
The autoloader will be stopped after the previously analyzing of the pierced sample is finished. Then, the
Mode & ID, Add Diluent, Start and Exit STAT buttons in the function button area will be activated. See
Figure 6-13

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 Figure 6-13 Inserting STAT

You can run the STAT sample in ways as the open-vial sampling mode, see details in 6.6.1 Open-
vial Sampling Analysis.

During STAT sample analysis, you don’t need to move the racks on the autoloader which was stopped. After
exiting STAT, the autoloading sampling analysis will continue.

6.6.2.9 Exiting STAT

After the STAT sample analysis is finished, click the Exit STAT button to cancel the STAT operation. The
analysis mode will be switched to before the inserted STAT. Then the analyzer will automatically run the
unfinished samples.

6.6.3 Dealing with the Analysis Results

6.6.3.1 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 backed up). The maximum number of the automatically saved results
is 300,000.

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6.6.3.2Parameter Flags
 If parameter is followed by a “↑” or “↓”, 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 is followed by a “?”, it means the analysis result is suspicious.
 If you see *** instead of a result, it means the result is either invalid or beyond the display range.

For the background test, the flags for parameters or abnormal blood cell differential and morphology are not
available.

6.6.3.3 Flags of Abnormal Blood Cell Differential or Morphology

The analyzer will flag abnormal or suspicious WBC, RBC and PLT according to the scattergrams and
histograms. The flag information is defined in the table below.
Table 6-10 Flags of abnormal blood cell differential or morphology

Flag Type Flag information

Leucocytosis

Leucopenia

Neutrophilia
WBC Abnormal
Neutropenia

Lymphocytosis

Lymphopenia

Flag Type Flag information

Monocytosis
Eosinophilia

Basophilia

WBC abnormal

Abn.WBC scattergram

Abn. WBC histogram

Left Shift?
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 Immature Cell?
Suspicious
RBC Lyse Resistant?

Abnor./Atypical Lym?

Abnormal WBC Channel

Abnormal DIFF Channel

Erythrocytosis

Anisocytosis

Macrocytosis
Abnormal
Microcytosis

Anemia

Hypochromia
RBC/HGB
Abnor. RBC Distr.

Dimorphologic

Iron Deficiency?

Suspicious HGB Abn./Interfere?

RBC Clump?

Abnormal RBC Channel

Abnormal HGB Channel

Thrombocytosis
Abnormal
Thrombopenia
PLT
Abnor. PLT Distr.
Suspicious
PLT Clump?

The system shows flags for abnormal or suspicious items in different samples and measurement modes in
accordance with the impact of the abnormal or suspicious WBC, RBC or PLT items on the results of the
parameters. The correlation is shown in the following table.

117
Table 6-11 Flags for abnormal or suspicious items in different samples and measurement modes

Whole Blood Predilute

Type Flag
CBC CBC+DIFF CBC CBC+DIFF

WBC abnormal √ √ √ √
RBC Lyse Resistant? × √ × √

Abnormal WBC scattergram × √ × √

Abnormal WBC histogram √ √ √ √

Left Shift? × √ × √

Immature Granulocyte (IG)? × √ × √

Abnormal/Atypical Lymphocyte? × √ × √

Leucocytosis √ √ √ √

Leucopenia √ √ √ √
WBC
Neutrophilia × √ × √

Neutropenia × √ × √

Lymphocytosis × √ × √

Lymphopenia × √ × √

Monocytosis × √ × √

Eosinophilia × √ × √

Basophilia × √ × √

Abnormal WBC Channel √ √ √ √

Abnormal DIFF Channel × √ × √

Dimorphologic √ √ √ √

HGB Abn/Interfere? √ √ √ √

Anisocytosis √ √ √ √

Microcytosis √ √ √ √

RBC/HGB Macrocytosis √ √ √ √

Erythrocytosis √ √ √ √

Anemia √ √ √ √

Hypochromia √ √ √ √

Abn. RBC distr. √ √ √ √

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 Whole Blood Predilute
Type Flag
CBC CBC+DIFF CBC CBC+DIFF

Iron Deficiency? √ √ √ √
RBC Clump? √ √ √ √

Abnormal RBC Channel √ √ √ √

Abnormal HGB Channel √ √ √ √

PLT Clump? √ √ √ √

Thrombocytosis √ √ √ √
PLT
Thrombopenia √ √ √ √

Abnor. PLT distr. √ √ √ √

 "√" indicates that flags will be displayed in the mode. "×" indicates that flags will not be displayed in the
mode.
9
 When the PLT value is less than 100 10 /L, a manual count by the microscope is
recommended.

6.7 Report Management

Upon the completion of sample analysis, you can process the results in the Report interface and print the
report.
For more details on the report, please refer to 7 Report.

6.8 Shutdown

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

119
 The sample probe is sharp and potentially biohazardous, Exercise caution to avoid contact with the probe
when working around
it.

Do not turn on the analyzer immediately after its shutdown. Wait at least 10 seconds before power-
on to avoid damage to the machine.

 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.
 If the analyzer is shut down abnormally, you will lose the unsaved worklist information of the
samples.
 Be sure to shut down the analyzer in strict accordance with the instruction below.

Shutdown here refers to the shutdown of the analyzer and the external computer. The following sections will
introduce both procedures.

6.8.1 Shutting down the analyzer

Procedures for shutting down the analyzer are as follows:

1. Click on the top right corner of the screen. The

following message box will pop up.

2. Click Yes.
The system starts to execute the shutdown sequence and a message box pops up showing the procedures
for cleanser maintenance as below.

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3. Follow the instructions and set the cleanser under the sample probe, and press the aspirate key on the
analyzer or click Aspirate to run the first cleanser sample aspiration.
Upon the completion of the first sample aspiration, a message box will pop up as below.

4. Follow the instructions and set the cleanser under the sample probe again, press the aspirate key on the
analyzer or click Aspirate to run the second cleanser sample aspiration.
Upon the completion of cleanser maintenance, a dialog box will pop up as below.

5. Turn to [O] the [O/I] switch located on the left side of the analyzer. Once the
analyzer is powered off, the following dialog box will pop up.

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 6. Click Yes and the software program will automatically shut down.
If you click No, the software program will not exit and you are still able to perform any operation
independent from the analyzer.
7. After the shut-down, vacate the waste containers and handle the waste properly.

Be sure to dispose reagents, waste, samples, consumables, etc. according to local legislations and regulations.

 When the analyzer is not connected to the computer, shutdowns will not be executed.
 When the analyzer is running or performing other fluidics sequence, do not force shutdown the
analyzer.
 If any error is detected during shutdown procedure, the analyzer will return to the status before the
shutdown procedure is performed, and then activate the alarm. See
14 Troubleshooting for details of removing the error.

6.8.2 Turning off the external computer

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!

8. Turn off the external computer according to the shutdown procedures of the operation system.
9. Turn off the display.

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 7 Report

7.1 Introduction
The report interface is the main interface of the analyzer. It is used for assisting the user to perform various
operations after the sample analysis is completed and before the report is printed.
Before the report is printed, you can carry out operations, such as validation, comparison and editing of the test
results in Report interface.

7.2 Interface Introduction

Click Report to enter Report interface. See Figure 7-1.

Figure 7-1 Report

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 The report interface can be divided into the following four areas:
 Sample list area
It displays the result list with specified date and conditions. It displays all the samples of the current day
by default. You can browse various sample records and the main sample/patient information in this area.
 Patient information area
You can input the relevant information of the patient corresponding to the selected sample.
 Graphs and results area
You can check/edit various parameter results, enter the microscopic exam. parameters and browse the
research results in this area.
 Function buttons
You can perform operations such as validation, batch validation, result comparison, editing and
restoration, export and printing, etc. for the sample selected from the result list by clicking the function
buttons.

7.2 Sample List Area

7.2.1 Sample List

The result list displays all the sample results of the current day by default. You can
carry out the following operations in sample list area:
 Browse the sample list with specified conditions.
 Modify the sample ID
In addition to the aforementioned operations, you can also carry out other operations such as editing/restoring
result, validation/cancelling validation, printing/batch printing and deletion, etc. by clicking the function
buttons. For details, see 7.6 Functions of the Buttons.

7.2.1.1 Browsing the Sample List with Specified Conditions

1. Click the Run Date control and select the run date of the sample.
2. Click the Conditions dropdown box and select the sample with specified conditions.
The system will display the qualified sample results, including sample information, name, run date and
sample status (whether it is validated, printed or transmitted). See Figure 7-2.

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 Figure 7-2 Report Result List

With different options selected, the records displayed in the list will vary. Refer to the table below for the
correlation.

Options Records displayed in the list

All (default Display all the sample records of specified dates.

Options Records displayed in the list

setting)

Not Validated Display the unverified sample records of specified dates.

Not Printed Display the unprinted sample records of specified dates.

Display the sample records, which are not transmitted to the LIS, of
Not Transmitted
specified dates.

7.2.1.2 Modifying Sample ID

3. Select and right click a row of record from the list and select Modify Sample ID in the popup shortcut
menu. See Figure 7-3.
Figure 7-3 Modifying Sample ID (1)

125
 4. Enter a new sample ID and click Save to finish the modification as shown in Figure 7-4.
Figure 7-4 Modifying Sample ID (2)

 The operator only has the access to modify the ID of the samples which are not validated.
 The ID of new samples cannot be the same ID of samples that have been approved.
 If the ID of sample B is changed to the ID of sample A in the list, the details of sample A (mode, run time,
and parameter results) will be updated to be the details of sample B, while other details will remain the
same.

7.2.2 Dup. Samples

The Dup. Samples interface displays the sample results with the same sample ID received by the system
within the same day.

Select a sample from the top of dup. samples list and browse the corresponding parameter result of this sample
at the lower part of the screen. See Figure 7-5.

126
 Figure 7-5 Dup. Results

 Matching Result
Tick off one of the samples to match the patient information with this sample to generate a report for this
sample.

The matching operation is not allowed to be executed over validated samples.

 Modifying Sample ID

127
 The ID of matched sample can not be modified.

a. Select and right click a row of record from the Dup. Samples list and select Modify Sample ID in
the popup shortcut menu.

b. Enter new sample ID in the popup dialog box.

The Sample ID can not be the same as validated ones.

c. Click Save to finish the modification.

7.3 Patient Information Area

You can enter the patient information corresponding to the sample after the test result is obtained. Click the
Save button after information input to save the entered information.
Please refer to Table 7-1 Parameter Description for the description and entry methods of each parameter.

128
 Table 7-1 Parameter Description

Parameter Meaning Operation

Counting mode of the You do not need to enter it and it will be displayed by the
selected sample. The system automatically.
format is blood sample
Mode
mode-measurement
mode. For example,
AWB-CBC+DIFF.

ID of the sample under You do not need to enter it and it will be displayed by the
Sample ID
analysis system automatically.

Parameter Meaning Operation

Rack No. and Tube No. of

the sample in AWB mode.
In other modes, the
parameter will be displayed
as 0-0.
Sample You do not need to enter it and it will be displayed
NOTE
Position automatically.
The Rack No. and Tube
No. are required to be
filled only when the blood
sample mode is Auto-
Venous Whole Blood
(AWB).

Patient type, including:

 Inpatient
Patient Type  Physical Examination Select from the dropdown list.
 STAT
 Outpatient

Med Rec. No. Med Rec. No. of a patient. Directly enter in the textbox.

First Name First name of a patient Directly enter in the textbox.

Last Name Last name of a patient Directly enter in the textbox.

Patient gender, including:

 Not defined
Gender Select from the dropdown list.
 Male
 Female

Select the age unit from the dropdown list (Year,

Age Age of a patient Month, Day or Hour) and enter a number into the box
next to the age unit.

Birthday Birthday of a patient Select from the date control.

129
 Select from the dropdown list.
Reference group of the
NOTE
sample under analysis.
 If the Automatically match the customized reference
The result is judged group according to age and gender is set, gender and
Ref. Group according to the reference age of a patient will automatically match the reference
range of the reference group group according to the corresponding relationship (No
and the result beyond the matter the reference group is selected or not).
normal range will be  Refer to 5.7 Reference Range for the setting of the
flagged. reference group and range.

Charge type of an item,

including:
 Public expense
Charge Type Select from the dropdown list.
 Military expense
 Medicare
 Self-pay

Parameter Meaning Operation

Department, to which a
Department Select from the dropdown list or directly enter.
patient is admitted.

The ward area where a

Area Select from the dropdown list or directly enter.
patient is admitted.

Directly enter in the textbox.

The bed number of a
Bed No. NOTE
patient
The bed No. is required to be filled only for inpatients.

Type of the sample under Select from the dropdown list.

analysis:
 Venous blood
Sample Type
 Capillary blood
 Cord blood
 Blood

Select the sampling date from the date control and enter
the time in the time textbox.
NOTE
 The system automatically displays the time of sample
Sampling
Sampling date and time. analysis as sampling time. To deactivate the auto display,
Time uncheck Automatically generate the sampling date in
Auxiliary Settings interface. For details, see 5.3.1
Auxiliary Settings.
 The sampling time can be no later than the current
system time.

130
 Select the delivery date from the date control and
enter the time in the time textbox.
NOTE
 The system automatically displays the time of sample
Delivery Time Delivery date and time. analysis as sample delivery time. To deactivate the auto
display, uncheck Automatically generate the Delivery
date in Auxiliary Settings interface. For details, see 5.3.1
Auxiliary Settings.
 The delivery time can be no later than the current
system time.

Personnel submitting the

Submitter Select from the dropdown list or directly enter.
sample.

The default operator is the user name who is carrying out

Personnel testing the
Operator the current analysis. It can be modified according to the
sample.
actual situation.

The person who validates This parameter will be automatically displayed after the
Validator
the sample. sample is validated.

The date and time when the

This parameter will be automatically displayed after the
Report Time report is printed for the first
report is printed.
time.

Parameter Meaning Operation

Select from the dropdown list or enter in the textbox.

NOTE
Suspected diagnosis The administrator can set the shortcut code for the options of
Diagnosis information. this parameter list in the Setup > Data interface and the
corresponding name will be displayed in the dropdown list.
Please refer to 5.6 Data Dictionary for the setting methods.

Select from the dropdown list or enter in the textbox.

NOTE

Clarifications or notes. The administrator can set the shortcut code for the options of
Remarks
this parameter list in the Setup > Data interface and the
corresponding name will be displayed in the dropdown list.
Please refer to 5.6 Data Dictionary for the setting methods.

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7.4 Graphs and Results Area

7.4.1 Parameter Results

After selecting a sample from the sample list area, you can browse the parameter results, scattergram
(DIFF), histogram and alarm information, etc. of this sample under the Parameter Results tab and can
edit the results. See Figure 7-6 .

Figure 7-6 Parameter Results

132
 Double click the DIFF diagram or the histogram to check the enlarged image. Furthermore, the DIFF diagram
can be dragged around to browse the 3D histogram of the WBC diff.

 You can set whether or not to display the four RUO parameters, “*” mark and declaration ("*" means
"Research user only, not for diagnostic use".) in the setting interface. For details, see Chapter 5 Setup.
 Please refer to 7.6.5 Edit Result and 7.6.6 Restore Result for the detailed operations
concerning the editing and restoring of the result data.

7.4.2 Customized Parameters

After selecting one sample from the sample list, you can input a customized parameter value for the sample in
the Custom Para. Tab. See Figure 7-7.

Figure 7-7 Customized Parameters Results

If the unit and reference range of parameters have been set in the Setup > Parameter > Custom Para.
interface settings, the corresponding unit and range (lower limit~upper limit) will be displayed in this tab.
When both the value and range of parameters are numbers, and the number is out of the reference range, the
relevant mark ↑ or ↓ will be displayed in the Flag column.
Please refer to 5.4.4 Customized Parameter for customized parameters settings.

133
7.4.3 Microscopic Exam. Results
After selecting a sample from the sample list area, you can enter the microscopic exam. results of this sample
under the Microscopic Exam. Results tab, including the Microscopic Exam. Time, Microscopic
Description and Cell Classification, etc. See Figure 7-8.

Figure 7-8 Microscopic Exam. Results

Please refer to Table 7-2 for the description and operating methods of the parameters relevant to the
microscopic exam. results.

134
 Table 7-2 Microscopic Exam. Parameter

Parameter Meanings Operation

Type of the microscopic Click the Sample Type dropdown list box and select the
exam. sample type of the microscopic exam. sample.
 Venous blood
Sample Type
 Capillary blood
 Cord blood
 Blood

Click the Microscopic exam. Time combo box and

select the date and time of the microscopic exam.
Microscopic Time of the microscopic
exam. Time exam. NOTE
The Microscopic exam. time can be no later than the
current system time.

Description of WBC, Enter the morphology information for WBC, RBC and
Microscopic
RBC and PLT PLT respectively into the multi-line textbox.
Description
morphology.

Parameter Meanings Operation

Enter the percentage or other form of differential result of

Percentage of each cell each cell classification into the textbox next to the cell class
Cell name respectively.
classification in total cell
Classification
count You can enter a value within the range [0.0-100.0] and the
unit is %.

7.4.4 Research Results

After selecting a sample from the sample list area, you can check the detailed results of each parameter under
the Research Results tab. See Figure 7-9.

135
 Figure 7-9 Research Results

 The specific values of the parameter results that are beyond the display range or without data collected
cannot be provided.
 The editing of the parameter results will not affect the display of parameters in the Research Results
tab.
 The content of this tab can only be viewed and used for research; it cannot be edited or printed.

136
7.5 Functions of the Buttons

7.5.1 Validate
You can select one or several samples from the result list for validation.
1. Select one or several (point at and click on the target while pressing the [Ctrl] key on the
keyboard) samples.
2. Click Validate or right click and select Validate from the shortcut menu popped up. The
system will perform validation operations for the selected sample(s).
If the selected records contain samples with no test results, after validating the samples with test results,
the system will prompt you that the samples with no test results cannot pass the validation.

 After validating, you can not edit the sample/patient information and the result.
 For the validated samples, “√” will be displayed in the cell corresponding to its Validate column and the
button icon will turn into Cancel Validation; for the samples which are not validated, the cell
corresponding to its Validate column will not be checked.

7.5.2 Batch Validate

If the number of samples required to be validated is large, the function of batch validate can be used for the
samples within the specified ID range. Steps for such an operation are shown as below:
3. Click Batch Validate.
The Batch Validate dialog box will pop up on the screen as shown in Figure 7-10.
Figure 7-10 Batch Validate

4. Select the run date of the sample according to the actual situation, e.g. 08/21/2014.
137
 5. Enter the ID range of the sample to be validated.
If the sample IDs 000001 and 000100 are entered, it means that the system will validate the samples
between 000001 and 000100 in batches.
6. Click Validate.
Upon the successful validation, a dialog box will pop up as shown in Figure 7-11.
Figure 7-11 Batch Validate Succeeded

 After validating, you can not edit the sample/patient information and the result.
 For the validated samples, “√” will be displayed in the cell corresponding to its Validate column and the
button icon will turn into Cancel Validation; for the samples which are not validated, the cell
corresponding to its Validate column will not be checked.

7.5.3 Cancel Validation

You can cancel the validation of one or several validated samples from the result list.
7. Select one or several (point at and click on the target while pressing the [Ctrl] key on the
keyboard) validated samples.
8. Click Cancel Validation or right click and select Cancel Validation from the popup shortcut menu.
The system will cancel the validation of the selected sample(s).
After canceling the validation, you can edit the sample/patient information and the result.

For the sample of which the validation is cancelled, the cell corresponding to its Validate column will be
unchecked and the button icon will turn into Validate.

138
7.5.4 Compare
You can compare the sample results of one patient obtained from several runs.
 Parameter Comparison
 Click Compare, enter the First Name, Last Name, Med Rec. No. and Run Date of the patient
and click Query.
 Select the record to be compared from the sample list (including the name and Med Rec. No. ),
click Compare, then click Query.
The Compare interface will pop up as shown in Figure 7-12.
Figure 7-12 Results Comparison (1)

 Run Chart
Click Run Chart in the Compare interface to view the Run Chart of the results of a qualified patient
obtained from several runs. See Figure 7-13.

139
 Figure 7-13 Run Chart

7.5.5 Edit Result

You can edit the parameter result of the selected sample as per the following steps.
9. Select a row of record from the result list and click the Edit Result button.
The Edit Result dialog box will pop up on the screen as shown in Figure 7-14.

140
 Figure 7-14 Editing Parameter Result

10. Edit the result of each parameter and WBC DIFF results in the popup textbox.
11. Click OK to save the changes and exit.
If the sum of the percentage of the diff parameters is not equal to 100.00% or the WBC value is invalid
after modification, the system will prompt in a message box that the entered value is invalid. Please re-
enter after confirmation.
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/suspicious flags will also be updated.

 You can not edit the results of validated samples.

 You can not edit the results of the background.
 In the CBC mode, only the results of the test parameters are available, the results concerning the
percentage of the WBC diff parameters are not available.
 The result of the parameter that you modified manually will be flagged with an M. If any parameter
result is then changed due to the one that you modified manually, it will be flagged with an m. M or m
will be displayed in the Flag column by default. To cancel the display, please refer to 5.3.1.7 Other for
modifying the settings in the Setup interface.

141
7.5.6 Restore Result
You can restore the modified results to the initial measurement results as per the following steps.
12. Select the modified result record from the result list.
In the Parameter Results interface in the Graphs and Results area, the edited parameter is flagged with an
M, while the corresponding results with manual modifications are marked with an
m. As shown in Figure 7-15.

Figure 7-15 Edited Results

13. Click Restore Result.

A message box indicating the successful restoration will pop up on the screen as shown in Figure 7-16.
Figure 7-16 Restoring Result

After the restoration is successful, the flag (M or m) generated after the Restore Result
operation will be removed.

7.5.7 Print Preview

Before printing the result of comparison, you can first click Print Preview to browse the result to be

printed. Click to print the result after the confirmation of its correctness.
7.5.8 Print
You can click Print in the result list to print the report of one or several selected samples.
14. Select the samples to be printed.
 Select one sample: click to select the sample.
 Select several discontinuous samples: click to select each sample while pressing the [Ctrl] key on
the keyboard.
 Select several continuous samples: click the first sample, and then drag to the last sample.

142
 Figure 7-17 Printing the Report

In case of printing several continuous samples, you can also use the Batch Print function to print the
samples within the specified ID range. Please refer to 7.6.9 Batch Print for detailed operations.
15. Click Print.

For the printed sample, “√” will be displayed in the cell corresponding to its Print column; for the sample
which is not printed, the cell corresponding to its Print column will be unchecked.

7.5.8 Batch Print

If you want to print a large number of samples within a specified ID range, you can choose Batch Print and
the system will print the report in sequence.
16. Click Batch Print.
A dialog box will pop up on the screen as shown below.

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 Figure 7-18 Batch Print

17. Select the run date, e.g. 2014/05/22.

18. Enter the ID range of the samples to be printed.
If you enter 1137 in the first textbox and 1140 in the second textbox, the system will print the report
between ID 1137 and 1140 in sequence.
19. Click Print.
The system will print the selected records in a batch.

For the printed sample, “√” will be displayed in the cell corresponding to its Print column; for the sample
which is not printed, the cell corresponding to its Print column will be unchecked.

7.5.9 Delete

 Validated samples are not allowed to be deleted.

 Common users do have the access to delete the sample record.

20. Select one or several sample records to be deleted.

21. Click Delete.
A prompt box will pop up on the screen as shown below.

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 Figure 7-19 Deleting Record

22. Click OK to delete the record selected from the list.

7.5.10 Comm.
You can transmit the selected sample data or the sample data within the specified date range (excluding the
blank sample) to the LIS/HIS system.
 Transmitting the selected data
a. Select one or several samples from the result list for data transmission.
b. Click Comm..
A prompt box will pop up on the screen as shown below.

Figure 7-20 Transmitting the Selected Data

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 c. Select Selected Data.
d. Click Begin to start transmitting.
A prompt box will pop up on the screen as shown below after the data is transmitted to the
LIS/HIS.

 Transmitting the data within specified date range

a. Click Comm..
b. Select Specified Data and set the starting and ending dates for the data to be
communicated.
See Figure 7-21.

Figure 7-21 Communication for the data within the specified date range

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 c. Click Begin to start transmitting.
A prompt box will pop up on the screen as shown below after the data is transmitted to the
LIS/HIS.

After the communication starts, the interface will show the comm. progress and the Stop button. If you click
the Stop button, the transmission will be stopped after the current sample record is transmitted.

7.5.11 Save
The operator can click Save after modifying the patient information to save the entered information

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 8 Worklist

8.1 Introduction
If a large number of samples are to be entered in batches or in advance, the worklist function provided in this
system can be used. Once the counting of the samples in the worklist is completed, the corresponding patient
information can be viewed in the Review interface, and it can also be modified in the Report interface.
The worklist can save a maximum of 5000 records.

8.2 Interface Introduction

Click Worklist to access the Worklist Interface. See Figure 8-1.
Figure 8-1 Worklist

In the interface, the upper part consists of the function buttons and the worklist list and the lower part contains
the worklist contents, including the sample information and the patient information. The operation results of the
function buttons and the worklist content will be displayed in the worklist list; and when a record in the list is
selected, the worklist content will be shown below the record.

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8.3 Basic Operations

8.3.1 Adding a Worklist

The operation procedures for adding a worklist and executing the counting are as shown below:
1. Click the New button to add one record at the bottom of the worklist list.
2. Enter the sample/patient information in the worklist content area. See
Figure 8-2.
Figure 8-2 Adding a Worklist

For relevant parameter description, please refer to 8.4 Parameter Description.

3. Click Save to save all the worklist information.

The added record will be displayed in the worklist list. The analysis status of the record is To Be Run.
Click the Start button or press the aspirate key on the analyzer to start the sample analysis.

8.3.2 Editing a Worklist

When a worklist in the worklist list area is selected, its content can be edited in the worklist content area.
 For the worklist with the analysis status of To Be Run or Error, all information is editable.
 For the worklist with the analysis status of Running, the Sample ID and Mode are non-editable and the
other parameters are editable.

149
  For the worklist with the analysis status of Finished, all information is non-editable.
For the meaning and entering method of parameters in the worklist, please refer to 8.4 Parameter
Description.

8.3.3 Saving the Worklist

After performing the Edit, or New operation, you can click the Save button to save all the information.

8.3.4 Deleting a Worklist

The operation procedures for deleting a worklist are as shown below:
1. Check the worklist you want to delete and then click Delete, or directly click Delete. The
pop-up dialog box appears as shown in Figure 8-3.
Figure 8-3 Deleting a Worklist

2. Select the records you want to delete.

 Delete checked records: Delete the checked records in the worklist list.
 Delete all completed records: Delete all the records whose Run Status are Finished in the worklist
list.
 Delete all records: Delete all the records in the worklist except those whose Run Status are
Running..

The records whose Run Status are Running can not be deleted.

3. Click OK.
The system will delete all the selected records and refresh the worklist list.

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8.3.5 Quering a Worklist
1. Click Query.
The pop-up dialog box appears as shown in Figure 8-4.

Figure 8-4 Searching for a Worklist

2. Enter the Sample ID, Med Rec. No. or First Name of the patient record to be search for.
3. Click Previous or Next.
system will start searching upward or downward from the currently highlighted record, and the eligible
records will be highlighted.
4. Click Cancel to close the Search dialog box.

8.3.6 Copying a Worklist

Select one worklist from the worklist list and click the Copy button to add one record at the bottom of the list.
The Sample ID of this record is 1 plus the Sample ID of the last record entered into the worklist, and the other
information is the same as the copied worklist.

8.4 Parameter Description

Table 8-1 introduces the meaning and operation methods on sample information and patient
information in the worklist.

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 Table 8-1 Parameter Description

Parameter Meaning Operation

Input in the textbox directly.

NOTE
 Letters, numbers and all characters that can
be entered through the keyboard (including
special characters) are allowed for the
Sample ID. Chinese and other languages
(such as Japanese, Korean, etc) are not
Identification number of the sample to be
Sample ID supported.
analyzed
 The length of the entries ranges from 1 to 25
and the entries shall not be empty.
 The last character of a sample ID must be
numeric, but a string of "0" only is not an
acceptable sample ID.
 Different samples to be run can not have the
same sample ID.

Sampling mode, Blood sample mode and

measurement mode of the sample to be
run. For example,
Open-vial-VWB-CBC.
Sampling modes include Open-vial and
Auto.
 For Open-vial sampling mode, the
blood sample modes Venous Whole
Blood (VWB), Capillary Whole
Blood (CWB) and Predilute (PD) are
available.
 For Auto (Autoloader) sampling
mode, the blood sample mode Venous
Whole Blood is available. Successively select the sampling mode,
Mode Measurement modes can be set freely, blood sample mode and measurement mode
include: from three dropdown lists.

 CBC
Complete Blood Count without DIFF.
The counting results include 15
parameters, WBC histogram, RBC
histogram and PLT histogram.
 CBC+DIFF
Complete Blood Count plus DIFF.
The counting results include 25
parameters, DIFF scattergram,
WBC/BASO histogram, RBC
histogram, PLT histogram and 4
RUO parameters.

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Parameter Meaning Operation

Rack No. and Tube No. of the sample to be

run. Successively enter the rack No. and tube No.
Sample in the two textboxes.
NOTE
Position The entry range of the rack No. is 1~100; the
The Rack No. and Tube No. are
required to be filled only when the entry range of the tube No. is 1~10.
sampling mode is Auto.

Select from the dropdown list or enter

directly.
NOTE
Reference group of the samples to be  If you have set Automatically match the
analyzed. customized reference group according to
age and gender, when you enter the gender
The system evaluates the counting results and age of a patient, the system will
Ref. Group
based on the reference range of the automatically match the patient with the
reference group and flags the results corresponding reference group (no matter
beyond the normal range. whether user has selected a reference group or
not.)
 Refer to 5.7 Reference Range for the
settings of the reference group and
reference range.

Select the sampling date from the date

control and enter the time in the time
textbox.
NOTE
 The system automatically displays the time of
Sampling Date and time when the sample is
sample analysis as sampling time. To
Time collected.
deactivate the auto display, uncheck
Automatically generate the sampling date
in Auxiliary Settings interface. For details,
see 5.3.1 Auxiliary Settings.
 The sampling time can be no later than the
current system time.

Select the delivery date from the date

control and enter the time in the time
textbox.
NOTE
 The system automatically displays the time
Delivery Date and time when the sample is of sample analysis as sample delivery time.
Time delivered. To deactivate the auto display, uncheck
Automatically generate the Delivery date
in Auxiliary Settings interface. For details,
see 5.3.1 Auxiliary Settings.
 The delivery time can be no later than the
current system time.

Med Rec.
Med Rec. No. of a patient. Input in the textbox directly.
No.

First Name First name of a patient Input in the textbox directly.

Last Name Last name of a patient. Input in the textbox directly.

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Parameter Meaning Operation

Gender of a patient. You can choose

from the following:
Gender  Not defined Select from the dropdown list.
 Male
 Female

Select the unit of age from the dropdown list

(Year, Month, Day or Hour) and enter the
Age Age of a patient.
age of the patient in the textbox before the
age unit.

Select in the data control or enter

Birthday Birthday of a patient.
directly..

You can choose from the following:

 Inpatient
Patient Select from the dropdown list or enter
 Physical Examination
Type directly.
 STAT
 Outpatient

Type of the charge. You can choose

among the following:

Charge  Public expense Select from the dropdown list or enter

Type  Military expense directly.
 Medicare
 Self-pay

The ward area in which the patient is Select from the dropdown list or enter
Area
admitted directly.

The department in which the patient is Select from the dropdown list or enter
Department
admitted directly.

Input in the textbox directly.

The bed number of the patient in the NOTE
Bed No.
hospital.
The Bed No. is required to be filled only
when the Patient Type is Inpatient.

Select from the dropdown list or enter

Submitter Personnel submitting the sample.
directly.

Diagnosis Suspicious diagnosis. Input in the textbox directly.

Remarks Clarification, notes or explanation. Input in the textbox directly.

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 9 Result Review

9.1 Introduction
Upon the completion of each sample analysis, the analyzer will automatically save the sample information,
result data, flag messages, histograms and scattergrams to the Review Database. The Sample Pool of the
analyzer can save up to 300,000 sample records.
In the Review Interface, you can browse the saved sample information, result data, flag messages, histograms
and scattergrams, and can search, compare or export the saved sample information.

9.2 Interface Introduction

You can browse, search, compare, print, and export the existing results in the Review interface. Click
Review to access the Review Interface. See Figure 9-1.
Figure 9-1 Review

The Review interface can be divided into three areas, namely the List Area, the Graph Area and the Function
Buttons Area.
 List area: Sample records and their main sample/patient information can be browsed here.

155
  Graphs and results area: Test Parameter Results (Main Window), Microscopic Examination Results,
RUO Results, Patient Information, etc. can be viewed here.
 Function buttons: You can perform the operations such as comparing or searching the sample results,
deleting and viewing the Run Charts, exporting and printing reports.

9.3 List Area

The List Area is in the left of Review interface and displays the list of analyzed samples, including the basic
information of samples, such as the Sample ID, Mode, Run Time, etc. See Figure 9-2.
Figure 9-2 List Review

Click a sample in the List Area to view the detailed parameter information of this sample in the Graph Area.

The List Area displays all the analyzed records by default.

In the Sample Results List Area, you can switch between the tabs above the list to view the following types of
sample lists:
 All Samples
Display all the sample records saved in the Sample Pool.
 Not Validated
Display non-validated sample records in the Sample Pool.
 Not Printed
Display non-printed sample records in the Sample Pool.
 Query Results
Display all the sample records that satisfy the query conditions.

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9.4 Graphs and Results
You can switch between the tabs on top of the Graphs and Results area to view the parameter results,
customized parameters, microscopic examination results, RUO results and patient informationn

Figure 9-3 Graphs Review

Double-clicking the scattergram or histogram will launch an enlarged view. Click to exit.

9.4.1 Parameter Results

The main window displays by default all the report parameter results, RUO parameter results, flags, one 3D
scattergram (DIFF), three histograms (including WBC/BASO, RBC and PLT) and three 2D scattergrams
(DIFF).

157
 Figure 9-4 Parameter Results

You can set whether or not to display the four RUO parameters, “*” mark and declaration ("*" means
"Research use only, not for diagnostic use".) in the Setting interface. For details, see Chapter 5 Setup.

 Parameter Results
This list displays the analysis results of all the parameters of the samples.
You can compare the values in the Result column with the corresponding Ref. Range.

If the values are within the reference range, it means that they are normal. If not, it indicates that the
sample may be abnormal and the corresponding symbols will be displayed in the Flag column.
 WBC Message
Displays the alert message regarding the WBC.
 RBC Message

158
 Displays the alert message regarding the RBC.
 PLT Message

Displays the alert message regarding the platelet.

 DIFF
WBC 3D scattergram (DIFF) in the CBB+DIF mode.
 WBC/BASO
WBC distribution histogram in CBC mode. BASO distribution histogram in CBC+DIFF mode.
 RBC
RBC distribution histogram
 PLT
Platelet distribution histogram.
 HS/MS/LS
Three 2D scattergrams for WBC (DIFF) in CBB+DIFF mode, namely HS/MS, MS/LS and HS/LS.

9.4.2 Customized Parameters

After selecting one sample from the sample list, you can input customized parameter value for the sample in
the Custom Para. Tab. See Figure 9-5.
Figure 9-5 Customized Parameters Results

159
 If the unit and reference range of parameters have been set in the Setup > Parameter > Custom Para.
interface settings, the corresponding unit and range (lower limit~upper limit) will be displayed in this tab.
When both the value and range of parameters are numbers, and the number is out of the

reference range, the relevant mark ↑ or ↓ will be displayed in the Flag column.
Please refer to 5.4.4 Customized Parameter for customized parameters settings.

9.4.3 Microscopic Exam. Results

After selecting a sample in the sample list area, you can enter the microscopic exam. results
including the microscopic exam. date and time, description and cell classification under the
Microscopic Exam. tab. See Figure 9-6.

Figure 9-6 Microscopic Exam.

160
 Refer to Table 9-1 for parameter description and operation methods regarding the microscopic examination.
Table 9-1 Microscopic Exam. Parameters

Parameter Meaning Operation

Type of sample for Click the Sample Type dropdown list box and
microscopic examination. select the type of sample for microscopic
 Venous blood examination.
Sample
Type  Capillary blood
 Cord blood
 Blood

Parameter Meaning Operation

Click the Microscopic exam. Time combo box and

select the time and date for the microscopic examination.
Microscopic Time of microscopic NOTE
exam. Time examination
The Microscopic exam. time can be no later than the
current system time.

Enter the morphology information for WBC, RBC

Microscopic Description of WBC, RBC and PLT respectively into the multi-line textbox.
Description and PLT morphology.

Enter the percentage or other form of differential result

Percentage of each cell of each cell classification into the textbox next to the cell
Cell classification in total cell classification name respectively.
Differential count You can enter a value within the range [0.0-100.0] and
the unit is %.

9.4.4 Research Results

After selecting a sample from the sample list area, you can browse the detailed results of each parameter under
the Research Results tab.
Clicking the Research Results tab in the Review interface to access the Research Results

interface as shown in Figure 9-7.

161
 Figure 9-7 Research

 The specific values of the parameter results that are beyond the display range or without data collected
cannot be provided.
 The editing of the parameter results will not affect the display of parameters in the Research tab.
 The content under this tab can only be viewed and used for research; it cannot be edited or printed.

9.4.5 Patient Info.

Click the Patient Info. tab in the Review interface and view the sample information and patient information
corresponding to the currently selected records in the sample list. See Figure 9-8.

162
 Figure 9-8 Patient Info.

The content under this tab can only be viewed and used for research; it cannot be edited or printed. You can

refer to 8.4 Parameter Description for parameter description of the patient information.

9.5 Functions of the Buttons

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9.5.1 Compare
You can compare the test results of several samples taken from the same patient.
 Parameter Comparison

Click Compare, enter the First Name, Last Name, Med Rec. No., Run Date and other
information of the patient, and click Query.

The system will launch the Parameter Result Comparison interface as shown in Figure 9-9.

Figure 9-9 Parameter Result Comparison

 Run Chart
Click Run Chart in the Compare interface to view the Run Chart for several test results of an eligible
patient. See Figure 9-10.

164
 Figure 9-10 Run Chart

9.5.2 Print Preview

Before printing the comparison result, the operator can preview the printing effect by clicking Print Preview,

and then clicking for printing after confirmation.

9.5.3 Print
In the sample list, you can click the Print button to print the test report of selected samples.
1. Check the samples to be printed in the list.
If several samples are to be printed in a row, you can use the Batch Print function to print samples
within the specified ID range. See 9.5.4 Batch Print for the detailed operations.
2. Click Print.

You can view the non-printed samples in the Not Printed tab.

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9.5.4 Batch Print
If you want to print a large number of samples within the specified ID range, select the Batch Print and the
system will print the test report in sequence.
1. Click Batch Print.
The interface pops up a dialog box as shown below.
Figure 9-11 Batch Print

2. Select the Sample Date, e.g. 2015/02/12.

3. Enter the Sample ID range to be printed.
If 1137 is entered in the first textbox and 1140 is entered in the second textbox, the system will print the
test report of samples numbered from 1137 to 1140 in sequence.
4. Click Print.
The system will perform the Batch Print for all selected records.

You can view the non-printed samples in the Not Printed tab.

9.5.5 Run Chart

The operator can view the Parameter Result Run Chart of all samples in the Review Database. The operation
procedures are shown below:
1. Check no fewer than three sample records.
2. Click Run Chart.
The system pops up a dialog box as shown below to display the parameter result Run Chart of selected
samples.

3. Click Close to exit.

166
 Figure 9-12 Run Chart

 The upper limit of number of selected records is the number of all the records in the review list.
 There is no restriction when selecting the sample records as long as they are in the review list.

167
9.5.6 Query
You can view the test results of a patient within a certain test date range by entering the query conditions. The
operation procedures are as shown below:
1. Click the Query button to enter the multi-conditional query dialog box as shown below.

Figure 9-13 Query Conditions

2. Determine the query conditions as needed.

For the specific parameter description, see Table 9-2.
Table 9-2 Parameter Description of Query Conditions

Parameter Meaning Operation Description

Sample ID Sample ID to be queried. Enter into the textbox directly.

Med Rec. No. Med Rec. No. of patient. Enter into the textbox directly.

First Name First name of patient. Enter into the textbox directly.

Select the starting and ending dates of the

Run Date Test date range of sample. sample test in the two data controls
successively.

Gender of patient. Including:

 Not defined Select from the dropdown list or enter
Gender
 Male directly.
 Female

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 Type of patient. Including:
 Inpatient
Select from the dropdown list or enter
Patient Type  Physical Examination
directly.
 STAT
 Outpatient

Charge type of an item. Select from the dropdown list or enter

Including: directly.
 Public expense
Charge Type
 Military expense
 Medicare
 Self-pay

Parameter Meaning Operation Description

Type of analyzed sample. Select from the dropdown list or enter

 Venous blood directly.

Sample Type  Capillary

 Cord blood
 Blood

Select from the dropdown list or enter

Area Ward area of patient.
directly.

Department receiving the Select from the dropdown list or enter

Department
patient. directly.

Enter into the textbox directly.

Bed No. Bed No. of inpatient. NOTE

The Bed No. is required to be filled only
when the Patient Type is Inpatient.

Personnel submitting the Select from the dropdown list or enter

Submitter
sample. directly.

Personnel testing the Select from the dropdown list or enter

Operator
sample. directly.

Personnel validating the Select from the dropdown list or enter

Approver
sample. directly.

Validation status of sample. Select from the dropdown list.

Validation Including:
Status  Validated
 Not Validated

Print status of sample. Select from the dropdown list.

Print Status  Printed
 Not Printed

169
 Communication status of Select from the dropdown list.
Communication sample.
Status  Transmitted
 Not Transmitted

3. Click Query.
The system performs the query operation as per the query conditions, automatically switches to the Query
Results list, and displays all query records. See Figure 9-14.
Figure 9-14 Query Results

9.5.7 Export
The operator can export the sample data to the external computer for backup. There are two ways of exporting
the sample data: exporting selected records and exporting records of specified dates.
 Export selected records in the list
a. Check records to be backed up in the Review List Area, and click Export.
As shown in the following figure, the export range of the system is Selected Records by default.
Figure 9-15 Export Selected Records

170
 b. Select the Export Content according to the actual demand.
Content available for export includes: Patient Info., Sample Info., RUO Parameters, Graphs and
Flags.
c. Click Browse.
d. Select the data Export Path in the popup dialog box, enter the backup file name, and click
Save.

Files are exported to the system installation path and are named as SampleExport.csv by default.
e. Click Export.
The system pops up a dialog box as shown below to indicate that the data export is successful.

 Export record of the specified test dates

a. Click Export.
The system pops up a dialog box as shown below.
Figure 9-16 Export Records of the Specified Dates

171
 b. Select Records of the Specified Dates in the Export Range and set the test date range of sample in
the two date textboxes.

For example, .
c. Select the export content according to the actual demand.
Content available for export includes: Patient Info., Sample Info., RUO Parameters, Graphs and
Flags.
d. Click Browse.
e. Select the data export path in the popup dialog box, enter the backup file name, and click
Save.

Files are exported to the system installation path and are named as SampleExport.csv by default.
f. Click Export.

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9.5.8 CV
The system pops up a dialog box as shown below to indicate that the data export is successful.

You can check the repeatability of the selected sample record. Specific steps are shown below:
1. Select the sample records used for calculating the repeatability.

 At least 3 records should be selected to calculate the repeatability.

 There is no restriction to the sample records selected to calculate the repeatability as long as they are in
the review list.
 If the selected sample records contain records in CBC Mode, only the repeatability of CBC parameters
will be calculated and the repeatability of WBC DIFF parameters and the DIFF absolute deviation
will not be calculated.

2. Click CV to start calculating the repeatability.

The result message box as shown in Figure 9-17 will pop up.

173
 Figure 9-17 Calculation Results

3. Click DIFF Deviation.

You can check the absolute deviation of the 5 WBC-related parameters of percent-style.

4. After browsing, click to return to the CV Calculation Results dialog box.

5. Click Print to print the CV Calculation Results, or Click Close to exit.

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9.5.9 Comm.
You can transmit the selected or specified sample data (except the background sample) to the LIS/HIS system.
9.5.9.1 Communication for selected data
a. Select one or several sample data to be communicated in the result list.
b. Click Comm..
The interface pops up a dialog box as shown in Figure 9-18.
Figure 9-18 Communication for Selected Data

c. Select Selected Data.

d. Click Begin to start transmitting.
After the data are transmitted to LIS/HIS, the interface will pop up a dialog box as shown below.

9.5.9.2 Communication for the data within specified date range

a. Click Comm..
b. Select Specified Data, and set the starting and ending dates of data to be communicated. See Figure
9-19.
175
 Figure 9-19 Communication for data on specified dates

c. Click Begin to start transmitting.

After the data are transmitted to LIS/HIS, the interface will pop up a dialog box as shown below.

After the communication starts, the interface will show the comm. progress and the Stop button. If you click
the Stop button, the transmission will be stopped after the current sample record is transmitted.

176
9.5.10 Delete

9.5.10.1 Validated samples are not allowed to be deleted.

9.5.10.2 The common user has no access to delete the sample records.

1. Check one or several sample records to be deleted.

2. Click Delete.
The interface pops up a dialog box as shown below.

Figure 9-20 Delete Sample Records

3. Click OK to delete the selected records in the list

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 10 Quality Control

10.1 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. DIAGON
LTD. recommends running the QC program on a daily basis with low, normal and high level controls. A new
lot of controls should be analyzed in parallel with the current lot prior to their Exp. 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 results should be within the expected ranges published by the manufacturer.

 You should only use the DIAGON LTD.-specified controls and reagents. Store and use the controls and
reagents as instructed by the instructions for use of the controls and reagents.
 Controls beyond their Exp. date shall not be used. Controls (similar to standard blood samples) must be
well mixed before use.
 Common users only have the access for browsing and executing the QC analysis other than editing.

10.2 L-J Quality Control

10.2.1 QC Principle
In the L-J quality control, quality control can be applied to 25 parameters. Considering operators’ different
needs, the system allows operators to apply quality control to a few parameters. The analyzer provides 60 QC
files for storing the QC parameters and results. Each QC file can be assigned1 batch number for high, normal
and low level controls. Each QC file can store up to 500 QC results. When there are more than 500 QC
results, the new QC results will overwrite the oldest results in sequence.

178
10.2.2 QC Settings

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

Only users with administrator-level access can edit the L-J settings.

Before running a new batch of controls, you need to assign a QC file to each batch of controls. You can
complete the QC settings by any of the following means in the QC files.
 Manual entry
 Reading the saved preset values

10.2.2.1 QC entry
1. Click QC > QC Settings to enter the QC Settings interface. See
Figure 10-1.

179
 Figure 10-1 L-J Quality Control

2. Select a QC File No. with empty QC information (the selection range is 1~60), refer to Table 10-1 for
setting the parameters in the QC files, including lot number, level, Exp. date of the controls, QC mode and
sample ID.

Table 10-1 Parameter Description of QC File

Parameter Parameter Description Operation description

File No. QC file No.. The system provides 60 Read only.

QC files in total for users to set the
parameters.

Lot No. Lot number of controls. Manual entry.

NOTE
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.

Level Level of the controls, including 3 Select from the dropdown list.
levels, i.e. High, Normal and Low

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 Exp. Date Exp. date of the controls. The default Exp. Date is the current system date
and needs to be changed to the actual Exp. date
of the controls.

QC Mode QC mode of the controls, including Select from the dropdown list.
Whole Blood and Predilute.

QC Sample Number of the QC sample It can be empty. But you are not allowed to enter
ID any sample ID other than the finished ones.
NOTE
 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.
 The length of the entries ranges from 1 to 25
and the entries shall not be empty.
 The last character of a sample ID must be
numeric, but a string of "0" only is not an
acceptable sample ID.

Editor The one who is setting the QC Read only.

files, namely the user who is
currently logged in the system.

Existing/Total The existing data and total QC results Read only.

in the current QC file. Up to 500 QC
results can be saved for each QC file.

Parameter Parameter Description Operation description

In-use Set if you want to specify the QC It is not checked by default. Select
sample ID in the selected file so that according to the actual situation.
you can run the QC sample in the
interface other than the QC Analysis
interface.
 If it’s checked, you can run the
sample with the corresponding
sample ID in any interface and
the system will run the QC
analysis for this sample.
 If it’s not checked, you can only
run the QC sample in the QC
Analysis interface.

3. According to the target list of the corresponding lot No., enter the target and limits into the
textboxes of the parameters to be included in the QC run.
For details about the unit of the parameters, see A.3 Parameters.

4. Click the Save button to save all the settings of the QC.

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10.2.2.2 Reading the Saved Preset Values
If the current level of preset values (Target and Limits) is saved in the system, they can be read into the
current QC file.

Refer to 10.2.4 QC Result Review for calculation and saving methods for the preset values.

1. Click QC > QC Settings to enter the QC Settings interface.

2. Select a QC File No. with empty QC information (the selection range is 1~60), refer to Table 10-1 for
setting the parameters in the QC files, including lot number, level, Exp. date of the controls, QC mode and
sample ID.
3. Click the Get Preset Values button read the saved preset target and limits (corresponding to the current
level) into the current QC file.

If some of the expected QC parameters are not provided with preset values, you need to manually enter their
reference values and deviation limits. If you do not wish to carry out quality control on some parameters with
preset values, you can manually delete their reference values and deviation limits.

4. Click the Save button to save all the settings of the QC.

10.2.2.3 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 QC > QC Settings to enter the QC Settings interface.

2. Click the Set Limits button, and then the following message box will pop up.

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 Figure 10-2 Setting Limits

3. Select By SD or By CV according to the actual needs.

 If By SD is selected, the limits will be displayed in form of absolute value.
Click 2SD or 3SD to select either double or triple standard deviation to be the limits.
 If By SD is selected, the limits will be displayed in form of percentage.
Click the 2CV or 3CV to select either double or triple coefficient of variation to be the limits.
4. Click OK to save all the settings for the limits.

10.2.2.4 10.2.2.4 Print

After completing the QC settings, you can click the Print button to print the data.

10.2.3 Quality Control Analysis

After completing the QC settings, you can choose one of the following two modes according to the selected
QC mode to run the quality control samples:
 Whole Blood
 Predilute

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10.2.3.1 Quality Control Analysis (Whole Blood)

All the samples, controls, calibrators, reagents, wastes and areas in contact with them are potentially
biohazardous. Wear proper personal protective equipment (e.g. gloves, lab uniforms, etc.) and follow laboratory
safety procedures when handling them and the relevant 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/or 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.
 Keep your clothes, hairs and hands away from the moving parts to avoid injury.
 The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety 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.

 Running quality controls in presence of errors may lead to incorrect analysis results. If you see the error
alarms when running the quality controls, please stop and resume the analysis until the errors are
removed.
 Do not re-use such disposable products as collection tubes, test tubes, capillary tubes, etc.
 Sample clump may lead to incorrect analysis results. Check if clump exists before running the controls;
if it does, handle it as per the related laboratory procedures.

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 You should only use the DIAGON LTD.-specified controls and reagents. Store and use the controls and
reagents as instructed by instructions for use of the controls and reagents. Using other controls may lead to
incorrect QC results.
 Before being used for analysis shake well the controls that have been settled for a while.
 Be sure to use the DIAGON LTD.-specified disposable products including vacutainer blood collection
tube, vacutainer blood collection tubes with anticoagulant and capillary tubes etc.

Procedure for quality control analysis in Whole Blood mode is as follows:

1. Click QC > QC Settings to access the QC Settings interface.
2. Click QC Analysis.
3. Select the QC file No. to be run.
The screen displays the corresponding file information, as shown in Figure 10-3.

Figure 10-3 QC File Information

4. Be sure that the Lot NO. and level of the control to be run are the same with the current QC file, and the
control to be run is not expired.
5. Prepare the control as instructed by the instructions for use of the controls.
6. Make sure the QC mode is Whole Blood and the analysis status icon and analyzer indicator are both green.
7. Shake the prepared control as shown below to mix it well.
Figure 10-4 Mixing the Controls

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 8. Place the controls under the sample probe where the probe can aspirate the well mixed sample.
9. Press the aspirate key and start running the controls.
Upon the completion of the aspiration, you’ll hear a beep and you can remove the controls.
When the running of QC analysis is complete, the QC results will be displayed in the current screen (as
shown in Figure 10-5) and saved in the QC file automatically.

Figure 10-5 QC Analysis Results

10. Perform the above procedures to continue running the controls if necessary.

10.2.3.2 Quality Control Analysis (Predilute)

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

186
 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/or 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.
 Keep your clothes, hairs and hands away from the moving parts to avoid injury.
 The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety 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.

 Running quality controls in presence of errors may lead to incorrect analysis results. If you see the error
alarms when running the quality controls, please stop and resume the analysis until the errors are removed.
 Do not re-use such disposable product as collection tubes, test tubes, capillary tubes, etc.
 Sample clumps may lead to incorrect analysis results. Check if clumps exist before running the controls;
if it does, handle it as per the related laboratory procedures.

 You should only use the DIAGON LTD.-specified controls and reagents. Store and use the controls and
reagents as instructed by instructions for use of the controls and reagents. Using other controls may lead to
incorrect QC results.
 Be sure to use the DIAGON LTD.-specified disposable products including vacutainer blood collection
tube, vacutainer blood collection tubes with anticoagulant and capillary tubes etc.
 You can also dispense 180μL of diluent by pipette into the tube.
 Be sure to keep dust from the prepared diluent.
 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 laboratory’s sample population and sample collection
techniques or methods.

187
1. Click QC > QC Settings to access the QC Settings interface.
2. Click QC Analysis.
3. Select the QC file No. to be run.
The screen displays the corresponding file information, as shown in Figure 10-6.

Figure 10-6 QC File Information (Predilute Mode)

4. Be sure that the Lot NO. and level of the control to be run are the same with the current QC file, and the
control to be run is not expired.
5. Prepare the control as instructed by instructions for use of the controls.
6. Make sure the QC mode is Predilute and the analysis status icon and analyzer indicator are green.
7. Shake the prepared control as shown below to mix it well.

8. Click the Add Diluent button in the shortcut button area.

You’ll be prompted with a message shown in the Operation/Status information area.

188
 9. Take a clean centrifugal tube, uncap it and present it to the sample probe in a manner as shown in the
following picture in which the probe tip is vertically in contact with the bottom of the tube so as to avoid
bubbles, liquid attached to the inner wall or spatter.

10. Press the aspirate key and start adding diluent. Upon the completion, you’ll hear a beep and you can
remove the centrifugal tube.
11. Add 20μL of control to the diluent, seal the tube with the cap and shake the tube to mix the sample.
12. Click Cancel to exit dispensing the diluent.
13. Place the centrifugal tube under the aspiration key and press the aspirate key. Upon the
completion, you can remove the centrifugal tube.
When the running of the controls is complete, the QC results will be displayed in the current screen and
be saved in the QC file automatically.
14. Perform the above procedures to continue running the controls if necessary.

 If the QC file is outdated, its valid period will be displayed in red.

 “↑” or “↓” alarm symbol will be displayed next to the results with deviations exceeding the set limits.

10.2.4 QC Result Review

After running controls, you can review the QC results in the following two forms:
 Graph
 Table

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10.2.4.1 Graph

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

Access the L-J QC Graph interface by taking the following steps:

1. Click QC > QC Settings to access the QC Settings interface.
2. Click QC Graph.
3. Select the QC file No. you want to review.

The screen will display the corresponding information and the graph. See Figure 10-7.
Figure 10-7 QC Graph

4. You can drag the scroll bar on the right of the graph to browse the desired graph of the parameter. You can
also drag the scroll bar down to the graph horizontally to browse all the QC results.

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10.2.4.2 Introduction to the Graph Interface
Figure 10-8 L-J QC Graph Interface

Interface Description:
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 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%.

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10.2.4.3 New Vial
If the reviewed QC results are obtained by analyzing a new vial of control from the same batch, you should
mark the QC points of the new vial to distinguish the QC results from the old one.
The procedure for marking new vial QC points is as follows:
1. Move the green line to the last QC point of the old vial.
2. Click New Vial.
Blue vertical lines will appear between the selected QC point and QC points of new vial. See Figure 10-9.
All the QC results after this mark are the analysis results for the new vial controls.

Figure 10-9 QC Point of the New Vial

3. Reopen the same lot of controls and save its QC analysis results, click the Cancel “New Vial” button.
After the original mark is cancelled, follow steps 1~2 and mark the current QC point of the new vial.

10.2.4.4 Calculate Preset Values/Save Preset Values

If the existing QC parameter has 3 or more QC results within the limits, take the followings steps to calculate
and save the preset values of the QC parameters.
1. Click Calc Preset Values.
The screen will display two black lines for you to select the range for calculating the preset values.

192
 2. Click and drag the two lines respectively to place them at the beginning and the ending of the range for
calculating the preset values.
The Mean, SD and CV% (on the right of the graph) will change into the new results obtained by
calculating the selected range.
3. Click Save Preset Values to save the current Mean, SD and CV% as the preset values for the
corresponding level (high/normal/low).
Then, the two selecting lines will disappear and the Mean, SD and CV% will return to the calculated
results of all QC results.

 If the QC results are less than 3, the preset value cannot be obtained.
 When calculating the preset values, the results of all parameters should be within their limits.

10.2.4.5 Ordering
Do as follows to adjust the display order of different graphs.
1. Click Ordering.
A window as shown in Figure 10-10 will pop up.

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 Figure 10-10 QC Graph Parameter Sorting

2. Select the parameter that you want to adjust the order (such as WBC), and sort the parameters by clicking

(top), (moving upwards), (moving downwards) or (bottom).

3. Click OK.

10.2.4.6 Entering the Reasons for the Outliers

Do as follows to enter the reasons for the outliers:
1. Move the green line to the desired QC point, and then click Outliers.
The pop-up window displays the QC results, reference values and deviation limits of all
parameters corresponding to the green line as shown in Figure 10-11.
The QC results exceeding the limit will be displayed in red.

194
 Figure 10-11 Enter Cause of Outliers

2. You can select the reason from the given ones or input the reasons (up to 200 characters) into the
textbox after selecting Others.
3. Click OK 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 red. And the data will return
in black if you cancel the reason and then save the changes.

10.2.4.7 Data Comparison

As per the following steps, you can compare the QC graph of the same parameters for controls from different
lots.
1. Click Compare.
The system pops up the Data Comparison window as shown in Figure 10-12.

195
 Figure 10-12 QC Data Comparison

2. Select from the dropdown list the parameters you wish to compare, such as WBC.
3. Select the desired QC file No. from the File No. box (3 files can be selected at most).
The graph of the selected QC file will be displayed below together with its lot No., QC mode and level.

10.2.4.8 Delete
The administrator can delete the QC results by the following steps:
 Delete a single QC result
a. Move the green line to the desired QC result, and click Delete.
b. Select Current Data in the pop-up dialog box as shown in Figure 10-13.

196
 Figure 10-13 Deleting Current QC Data (QC Graph)

c. Click OK.

10.2.4.9 Print Preview

Before printing the QC graph, you can preview the printing effect by clicking Print Preview, and then click

for printing after confirmation.

10.2.5 QC Table

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

1. Click QC > QC Settings to access the QC Setting interface.

2. Click QC Table.
3. Select the QC file No. you want to review, such as 2.
The corresponding file information and QC table are displayed on the screen as shown in Figure 10-15.

197
 Figure 10-15 QC Table

4. You can drag the scroll bar on the right of the table vertically to browse the desired table of the parameter.
You can also drag the scroll bar down to the table horizontally to browse all the QC results.

10.2.5.1 Delete
The administrator can delete the QC results by the following steps:
 Delete a single QC result
a. Click the column containing the desired QC result, and then click Delete.
b. Select Current Data in the popup dialog box as shown in Figure 10-16.

198
 Figure 10-16 Deleting current QC data (QC Table)

c. Click OK.
 Deleting all the QC results in the current QC file
Click Delete, select All Data in the popup dialog box, then click OK. See Figure 10-17.

Figure 10-17 Deleting all QC Data (QC Table)

10.2.5.2 Editing
Double click the cells in the QC table, then you can edit the selected QC data. The edited
data will be marked with an “E”. See Figure 10-18.
Figure 10-18 Editing QC Results

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10.2.5.3 Restoring
Click Restore to cancel the editing of the QC results. After the data is restored, the E mark will disappear.

10.2.5.4 Saving
Click Save to save the editing operations for the QC results.

10.2.4.6 Communication
All the QC data or the data within the specified date range can be transmitted to LIS/HIS.

 Communication for all data

a. Click Comm..
A message box as shown below will pop up.
Figure 10-19 Communication for all data

b. Select All Data.

c. Click Begin to start the communication.
After the data is transmitted to LIS/HIS, a message box as shown below will pop up.

200
 Transmitting the data within specified date range
a. Click Comm..
b. Select Specified Data, and set the starting and ending dates for the data to be
communicated.
See Figure 10-20.

Figure 10-20 Communication for the Data within the Specified Date Range

c. Click Begin to start the communication.

After the data is transmitted to LIS/HIS, A message box as shown below will pop up.

After the communication is started, the communication progress and the Stop button will appear on the
screen. If you click Stop, the system will stop the communication after the current QC data is completely
transmitted.

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10.2.4.7 Export
If you wish to export the information and the result of the current QC file, do as follows:
1. Click Export.
2. Select the export directory.
3. Enter the name for the export data.
The default file name is [QC_L-J_Data_saving date_saving time]. The file format is .csv. See Figure 10-

Figure 10-21 Export QC Data

4. Click Save to start exporting.

When the export is finished, a message box as shown below will pop up.
Figure 10-22 Export successfully

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10.2.4.8 Print
5. Click OK to exit.Click Print, and choose all the data, or the data of a specified date range from the popup
dialog box, and the corresponding quality control list will be printed.

10.2.4.9 Print Preview

Before printing the quality control list, you can first browse a print result preview. Detailed steps are as
follows:
1. Click Print Preview.
A dialog box will pop up as shown below.

2. Select all the data, or data within a specified date range according to actual demands.

3. Click OK, browse the print result preview for the selected data, and click after
confirmation to print.

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10.3 X-B Quality Control

10.3.1 QC Principle
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. This is
QC with no controls, which is a method of performance control like QC with controls. Both methods reflect
the analysis performance of the analyzer from different perspective. Thus, one method should not be replaced
with the other.
It is recommended the X-B analysis be activated when the sample volume of your laboratory is greater than
100 samples per day. Effective use of X-B requires randomization of samples and a normal cross section of
patients to prevent skewing of indices. A reference range is established by the given reference values as well
as lower and upper limits for the purpose of observing the variation of QC results within the reference range.
The analyzer performs X-B QC for three parameters, MCV, MCH, and MCHC. Twenty to two hundred
samples can be grouped together for X-B numerical analysis. The samples are derived from the results of
normal analyzer counting, with no distinction of whole-blood or predilute mode. 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.

10.3.2 QC Settings

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

 Only users with administrator-level access can edit the L-J settings.
 If the system has stored preset values and QC data, the user needs to delete all the QC data in QC Graph
screen before performs the operations such as retrieving preset values, setting limits and restoring default
settings.

Perform the QC Settings before running the controls. You can complete the QC settings by any of the
following means.
 Manual entry.
 Reading the saved preset values.

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10.3.2.1 QC entry
You can manually set the QC information according to the following steps:
1. Click QC to enter the QC interface.
2. Select X-B from the dropdown list.
3. Click QC Settings.
You'll enter the QC Settings interface as shown in Figure 10-23.

Figure 10-23 X-B QC Setting

4. In the Samples/Batch textbox, enter the number of the samples to be included in the calculation of an X-
B QC point.
The range to select from is 20~200, and the recommended value is 20.

205
 Once the Samples/Batch is changed, the number of valid sample results will be recalculated. For
example, if 20 valid samples are needed for the X-B QC calculation, when you change the value of
Samples/Batch after 10 group of valid sample results have been acquired, these 10 group of results will
be discarded, and only valid sample results generated afterwards will be used in the QC calculation.

5. Click the Open button of X-B to open the X-B QC.

The samples results will be included to calculate the X-B.
6. Enter the targets and limits for the QC parameters.

 All the targets and limits for the QC parameters must be entered.
 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.

7. Set the valid upper and lower limits for the QC parameter in Sample Validity Setting field.

Setting sample validity is to set the valid range of four QC parameters, RBC, MCV, MCH and MCHC. To
be incorporated into X-B QC calculation, the sample results should satisfy the validity ranges of all these
four parameters.

Once the validity range is changed, the number of valid sample results will be recalculated. For example,
if 20 valid samples are needed for the X-B QC calculation, when you change the validity range after 10
group of valid sample results have been acquired, these 10 group of results will be discarded, and only
valid sample results generated afterwards will be used in the QC calculation.

8. Click the Save button to save all the settings of the QC.
If the entered value exceeds the acceptable range or the upper limit is lower than the lower limit, a
reminder message will pop up and you will be prompted to re-enter the correct data and save the entry
again.

10.3.2.2.Reading the Saved Preset Values

If the current level of preset values (Target and Limits) is saved in the system, they can be read into the current
QC file.

206
 Refer to 10.3.4.1 QC Graph for calculation and saving methods for the preset values.

1. Click QC to enter the QC interface.

2. Select X-B from the dropdown list.
3. Click QC Settings to enter the QC Setting interface.
4. Click the Get Preset Values button to read-in the saved preset target and limits into the X-B QC file.
 If some QC parameters have no preset values, you should enter the target and limits for them
manually.
 If you do not intend to perform QC operations for the parameters with preset values, the
reference values and limits can be manually removed after the preset value is set.
5. Click the Save button to save all the settings of the QC.

10.3.2.3 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.

Figure 10-24 Setting Limits

2. Select By SD or By CV according to the actual needs.

 If By SD is selected, the limits will be displayed in form of absolute value.
Click 2SD or 3SD to select either double or triple standard deviation to be the limits.
207
  If By CV is selected, the limits will be displayed in form of percentage.
Click the 2CV or 3CV to select either double or triple coefficient of variation to be the limits.
3. Click OK to save all the settings for the limits.

10.3.2.4 Restoring Defaults

In QC setting, click Restores Defaults button to restore the parameter reference values, limits and sample
validity to the default settings.
Table 10-2 shows the default values of Targets, Limits and Sample Validity for the QC parameters.
Table 10-2 Default Values of the QC Parameters

Sample Validity
Parameter Unit Target Limits(#)
Lower Limit Upper Limit

MCV fL 89.5 2.7 50.0 150.0

MCH pg 30.5 0.9 20.0 40.0

MCHC g/L 340 10 240 440

12
RBC 10 /L N/A N/A 1.00 8.00

10.3.2.4.1 If the QC data have existed in the QC file, you are not allowed to restore the parameters.
10.3.2.4.2 Clicking Restores Defaults can only store the default settings of Target, Limits and Sample
Validity Setting, while Samples/Group, X-B QC switch and limit settings cannot be restored.

10.3.2.5Print
After completing the QC settings, you can click the Print button to print the data.

10.3.3 Quality Control Analysis

All the samples, controls, calibrators, reagents, wastes and areas in contact with them are potentially
biohazardous. Wear proper personal protective equipment (e.g. gloves, lab uniforms, etc.) and follow laboratory
safety procedures when handling relevant items and areas in the laboratory.

208
 After the QC settings, the analyzer will automatically start the X-B QC analysis.
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.
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.
 Sample results exceeding the linearity range
 Background results
 Sample results not conforming to the Sample Validity Setting
 QC data for other QC programs (such as L-J QC)
 Calibration data
 Results generated while there are errors which could affect the accuracy of the results
(insufficient aspiration volume or clogging for example).

10.3.4 QC Result Review

After running controls, you can review the QC results in the following two forms:
 Graph
 Table

10.3.4.1 Graph

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

Access the X-B QC Graph interface by taking the following steps:

1. Click QC to access the QC interface.
2. Select X-B from the dropdown list.
3. Click QC Graph.
The X-B QC Graph interface will be displayed. See Figure 10-25.

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 Figure 10-25 QC Graph Interface

4. You can also drag the scroll bar down to the graph horizontally to browse all the QC results.

10.3.4.2 Introduction to the Graph Interface

Figure 10-26 X-B QC Graph

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 1 - The amount of samples included in calculating for each QC point.
2 - The saving date and time of the QC points located on the green line
3 - The Mean, SD and CV% of all the QC results of each parameter in the current graph.
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 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.

10.3.4.3 Calculate Preset Values/Save Preset Values

If the existing QC parameter has 3 or more QC results within the limits, take the followings steps to calculate
and save the preset values of the QC parameters.

 If the QC results are less than 3, the preset value cannot be obtained.
 When calculating the preset values, the results of all parameters should be within their limits.
 After the preset values are set, you can no longer perform the operations relevant to QC settings, such as
retrieving preset values, setting limits and restoring default settings.

1. Click Calc Preset Values.

The screen will display two lines for you to select the range for calculating the preset values.
2. Click and drag the two lines respectively to place them at the beginning and the ending of the range for
calculating the preset values.
The Mean, SD and CV% (on the right of the graph) will change into the new results obtained by
calculating the selected range.
3. Click Save Preset Values to save the current Mean, SD and CV% as the preset values for the X-B
control.
Then, the two selecting lines will disappear and the Mean, SD and CV% will return to the calculated
results of all QC results.

10.3.4.4 Delete
The administrator can delete the QC results by the following steps:
 Delete a single QC result
a. Move the green line to the desired QC result, and click Delete.
b. Select Current Data in the pop-up dialog box as shown in Figure 10-27.

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 Figure 10-27 Deleting Current QC Data (QC Graph)

c. Click OK.
10.3.4.5 Print

Click the Print button to print the QC graph.

10.3.5 QC Table

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

Access the X-B QC Graph interface by taking the following steps:

1. Click QC to access the QC interface.
2. Select X-B from the dropdown list of the QC Type.
3. Click QC Table.
The X-B QC table interface will be displayed. See Figure 10-29.

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 Figure 10-29 QC Table

10.3.5.1 Introduction to the QC Table Interface

1 - QC parameters (displayed in the same order as the Graph screen)

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 Result. The value of the QC result is the X-B result of each batch of samples. 4 - QC
flag: The flag ↑ or ↓ will be used to prompt the result that out of the limits

10.3.5.2 Delete
The administrator can delete the QC results by the following steps:
 Delete a single QC result
a. Click the column containing the desired QC result, and then click Delete.
b. Select Current Data in the pop-up dialog box as shown in Figure 10-30.

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 Figure 10-30 Deleting current QC data (QC Table)

d. Click OK.
 Deleting all the QC results in the current QC file
Figure 10-31 Deleting all QC Data (QC Table)

10.3.5.3 Comm.
All the QC data or the data within the specified date range can be transmitted to LIS/HIS.
 Communication for all data
a. Click Comm..
A prompt box will pop up on the screen as shown below.

214
 Figure 10-32 Communication for all data

b. Select All Data.

c. Click Begin to start the communication.
After the data is transmitted to LIS/HIS, a message box as shown below will pop up.

 Transmitting the data within specified date range

a. Click Comm..
b. Select Specified Data, and set the starting and ending dates for the data to be
communicated.
See Figure 10-33.

215
 Figure 10-33 Transmitting the data within specified date range

c. Click Begin to start the communication.

After the data is transmitted to LIS/HIS, a message box as shown below will pop up.

After the communication is started, the communication progress and the Stop button will appear on the
screen. If you click Stop, the system will stop the communication after the current QC data is completely
transmitted.

10.3.5.4 Export
If you wish to export the information and the result of the current QC file, do as follows:
1. Click Export.
2. Select the export directory.
3. Enter the name for the export data. See Figure 10-34.
The default file name is QC_XB_Data_saving date_saving time. The file format is .csv.

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 Figure 10-34 Export QC Data

4. Click Save to start exporting.

When the export is finished, a message box as shown below will pop up.

Figure 10-35 Export successfully

10.3.5.5 Print
5. Click OK to close the message box.
Click the Print button to print the QC table.

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 11 Statistics

11.1 Introduction
You can statistically collect the workload and comprehensive information by selecting and entering stat
conditions.

11.2 Workload Stats

You can calculate the workload under different circumstances (item count and patient count). The statistical
method is applied as follows:
1. Click Stats to enter the interface.
The Workload Stats interface will be displayed by default. As shown in Figure 11-1, the upper part of
workload screen lists stat conditions, while the lower part lists the stat results.
Figure 11-1 Workload Stats

2. You can select the project and conditions based on actual needs; if no selection is made, the system
will take into account all the workload entries.
The stat conditions of workload include: Department, Submitter, Operator, Validator, Sample type,
Area, Patient type, Charge Type and Run Date.

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 3. Click the Stats button in the function button area.
The screen will display all the workload stats that satisfy the requirements, including the item count and
patient count in different measurement modes, as shown in Figure 11-2.
Figure 11-2 Workload Stats result

Click Reset to clear all the current stat conditions and results. You can perform the stat operation again.

4. (Optional operation) Click Print Preview for a print preview of the current stat results or directly click
Print to print out the workload stat results by following the screen instructions.

11.3 Comprehensive Stats

You can generate different stats under different circumstances. The statistical method is applied as follows:
5. Click Stats > Comprehensive Stats to enter the Comprehensive Stats interface.
As shown in Figure 11-3, the upper part of workload screen lists stat conditions and stat items, while the
lower part lists the stat results.
Figure 11-3 Comprehensive Stats

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6. You can enter or select the stat items and conditions based on actual needs.
For example, to obtain the stat results of the item count and patient count for Physical Examination for
different modes and charge types, you can select Physical Examination from Patient Type drop-down
list, before selecting Mode from Item 1 drop-down list and Charge Type from Item 2 drop-down list.

7. Click the Stats button in the function button area.

The screen will display all the workload stats that satisfy the requirements, as shown in Figure 11-4.
Figure 11-4 Comprehensive Stats

 The first column shows the information extracted from Item 1, e.g. Mode.
 The second column shows the information extracted from Item 2, e.g. Charge Type. Subtotal row
shows the item count and patient count within the same stat item; Total row shows the total item
count and patient count that satisfy the stat conditions and stat items.
 Item column shows the number of items that satisfy the preset conditions.
 Patient column shows the number of patients that satisfy the preset conditions.

Click Reset to clear all the current stat conditions and results. You can perform the stat operation again.

8. (Optional operation) Click Print Preview for a print preview of the current stat results or directly click
Print to print out the comprehensive stat results by following the instructions.

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 12 Calibration

12.1 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.
To get accurate blood analysis results, perform regular calibration of the analyzer following the procedures
given in this chapter.

 Calibration procedures can only be performed by users with the administrator-level access.
 You should only use the DIAGON LTD.-specified calibrators and reagents. Store and use the calibrator
and reagents following the 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
Cal interface.

 The calculation of repeatability is included in the calibration procedure.

12.2 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 DIAGON LTD.-authorized
representative when installing the analyzer).
 An analytical component has been changed.
 You are going to re-use the analyzer after long-term storage.
 The quality control results indicate that 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.
 For laboratories conducting routine tests, the calibration should be applied at least once every six
months.

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12.3 How to Calibrate
There are three calibration programs available on this analyzer: manual calibration, auto calibration using
calibrators and auto calibration using fresh blood samples.
All or part of the parameters of WBC, RBC, HGB, MCV and PLT can be calibrated by the calibration
procedure.

12.3.1 Preparation

All the samples, controls, calibrators, reagents, wastes and areas in contact with them are potentially
biohazardous. Wear proper personal protective equipment (e.g. gloves, lab uniforms, etc.) and follow laboratory
safety procedures when handling them and the relevant 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.
 The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety 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 your clothes, hairs and hands away from the moving parts to avoid injury.
 Be sure to dispose of reagents, waste, samples, consumables, etc. according to local
legislations and regulations.

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Do not re-use such disposable products as collection tubes, test tubes, capillary tubes, etc.

 You should only use the DIAGON LTD.-specified controls and reagents. Store and use the controls and
reagents by following the instructions for use of the controls and reagents.
 Be sure to use the DIAGON LTD.-specified disposable products including vacutainer blood collection
tube, vacutainer blood collection tubes with anticoagulant and capillary tubes etc.

Carry out the calibration only when the background range, repeatability and carryover are within the
specified limits given in the manual, otherwise, the problems must be identified and solved before you
determine if calibration is needed. If you cannot solve the problems, please contact DIAGON LTD. Service
Department.
Before the launch of a calibration, do as follows to make sure that the analyzer is ready for use.
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 are activated for abnormal background results, see
14 Troubleshooting for solutions. (Refer to A.5.2 Normal Background for background range.)

3. Run the median controls in Whole Blood CBC+DIFF mode consecutively for 11 times, take and view
nd th
repeatability of the counting results from the 2 run through the 11 run in the Review interface and
make sure they are within the range specified in the table below.

Parameter Condition Whole Blood Repeatability (CV)

9
WBC (4.0~15.0)×10 /L ≤2.0%
12
RBC (3.50~6.00)×10 /L ≤1.5%

HGB (110~180)g/L ≤1.5%

MCV (70~120)fL ≤1.0%

9
PLT (150~500)×10 /L ≤4.0%

4. Run the corresponding diluent for 3 times immediately after running the high-level controls for 3 times
and calculate the carryover by the following formulae:

First low - level s ample res ult Third low - level s ample res ult
Carryover(%) 100%
Third high - level sample result Third low - level sample result
The calculated carryovers shall meet the requirements in the following table.

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 Parameter Carryover

WBC ≤0.5%

RBC ≤0.5%

HGB ≤0.5%

HCT ≤0.5%

PLT ≤1.0%

5. It is recommended that you create a log table for your analyzer. This log table should contain all the
necessary information pertinent to your analyzer. The suggested items that you may want to include in the
log table are: calibration date, supplier of calibrator, lot number, expected results and limits, and result of
background check.

12.3.2 Manual Calibration

Complete the manual calibration as per the following procedure:
1. Click Cal to access the Manual interface.
See Figure 12-1. The calibration coefficients of whole blood mode and predilute mode are displayed on
the Manual interface.

Figure 12-1 Manual Calibration

The login users with the access level of common users can not perform the calibration procedures but only
browse the calibration coefficients on the current screen. To perform the calibration, please log out and then
log in as users with administrator-level access.

2. Check the calibration coefficient and calculate the new coefficient using the following equation.

Current cal ibrati on factor Reference val ue

New cal ibrati on factor＝
Mean

For example, the WBC reference value of a calibrator is 8.3, and the current calibration
coefficient of the whole blood mode is 99.00%.

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 nd
Run the calibrator in whole blood mode for 11 consecutive times and calculate the WBC results of the 2
th
to 11 runs (n=10): 8.4, 8.2, 8.2, 8.3, 8.3, 8.1, 8.2, 8.1, 8.2, 8.2. The obtained CV is 1.1% and the Mean is

8.22, which meet the requirements.

The new calibration coefficient is obtained:
99.00% 8.3
New calibration factor＝ ＝99.96%

8.22

The calculated calibration coefficients shall be between 75%~125%. In case of an invalid calibration
coefficient, try to find out the reason (e.g. calibration material not thoroughly mixed, incorrect operation,
etc.). Then recalibrate the analyzer and recalculate the calibration coefficients.
3. Enter the new calibration coefficients into the factor cell of the parameter that requires
calibration.

The entered calibration coefficients shall be between 75.0%~125.0% (calculation results rounded to two
decimal places).

4. Click Save.
 If the new calibration coefficient is valid and different from the original value, the following
dialog box will pop up.
Figure 12-2 Calibration set successfully

On the screen, the calibration coefficient is refreshed to be the new one and the calibration date is
refreshed to be the current system date.
 If the new calibration coefficients are invalid, the message box will pop up.
Figure 12-3 Invalid Coefficients

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 Click OK to close the message box and enter a valid factor.
5. (Optional) Click Print to print the calibration results.

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12.3.3 Auto Calibration Using Calibrators

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

 Only DIAGON LTD.-specified calibrators shall be used. DIAGON LTD. will not be responsible for any
erroneous result caused by using other calibrators.
 See the instructions for use of the calibrators for the lot No., Exp. date and the target.
 Calibration with calibrators can only be carried out in Whole Blood CBC+DIFF mode.

Complete the calibration with calibrators as per the following procedure:

1. Click Cal > Calibrator.
Access the Calibration Using Calibrators interface as shown in Figure 12-4.

Figure 12-4 Auto Calibration Using Calibrators

2. Enter the lot No. of the calibrator into the Lot No. box.
3. Click the Exp. Date box, and then edit the Exp. date.

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 The Exp. date can be no earlier than the current system date.
 The entered Exp. date should be either the Exp. date printed on the labeling or the
open-container Exp. date, whichever is earlier. The open-container Exp. date is calculated as follows: the
date on which the container is opened + the open-container stability days.

4. Enter the target values of the parameters in the corresponding Target textboxes.
5. Prepare the calibrators following their instructions for use and place the calibrators under the sampling
probe.
6. To start the calibration counting sequence, click the Start button or press the aspiration key on the
analyzer.
After every calibration run, the progress bar will close automatically and the analyzer will have different
responses according to different analysis results.
 The valid results within the linearity range will be displayed directly.
 When the current running is complete, if there is a parameter whose calibration data is beyond its
linearity range but still within the display range, then the calibration data will be displayed in the
list and a message box as below will also pops up.

Click OK to close the message box and delete the data from the table without saving.

 When the running is complete, if there is a parameter whose calibration data is beyond the display
rage, then the non-numeric parameter values “***” will be displayed in the list and a message box as
below will pop up.

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 Click OK to close the message box and delete the data from the table without saving

 If any of the parameter’s value in the calibration counting differs from the Target value by more
than 50%, the system will prompt you with a message box asking if the calibration counting results
should be kept.
To keep the results, click Yes. To remove the results, click No.

 After the valid calibration result is obtained, the parameters with corresponding checkboxes ticked
off will be involved in the calculation of the calibration coefficients by default.
 If you switch to other interfaces before the new calibration coefficients are obtained, the system will
discard the current calibration data and keep the original calibration coefficients.

7. To get 10 valid counting results, repeat steps 5~6 ten times.

The analyzer will, by default, calculate the Mean, CV% and the new calibration coefficients based on all the
ticked-off calibration data according to the formulae.
8. You can select a few groups of data for the calculation of the calibration coefficients which can be obtained
unless at least 5 groups of ticked-off data are included. Each time when you tick off or uncheck the
checkboxes, the calibration coefficients will be refreshed and displayed in time.
When the amount of the valid calibration data in the list reaches 10, a message box of Calibrator
calibration done! will pop up. Click OK to close the message box.

The out-of-range CV% does not influence the display of the calibration coefficients.

9. Click Save.
 If the calculated calibration coefficients of all parameter are within the range of 75%~125% and the
CV% of all parameter are also within the repeatability, then a message box will pop up.

Figure 12-5 Save New Calibration Coefficients

Click OK to close the message box.

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  If the obtained calibration coefficient of any parameter is not within the range of 75%~125% or the
CV% of any calibrated parameter does not meet the repeatability, the calibration coefficient will not
be saved and a dialog box will pop up.

Figure 12-6 Invalid New Calibration Coefficients

 Clicking Yes will clear the data of the current calibration operation; clicking No will return to the
original screen.

12.3.4 Auto Calibration Using Fresh Blood Samples

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

Complete the calibration using fresh blood samples as per the following procedure:
1. Click Cal > Fresh Blood.
Enter the Calibration Using Fresh Blood Samples interface as shown in Figure 12-7.

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 Figure 12-7 Auto Calibration Using Fresh Blood Samples

2. Click the Mode button in the function button area and select Whole Blood or Predilute as the
calibration mode for fresh blood samples in the pop-up dialog box.

3. Prepare 3 to 5 normal fresh blood samples as instructed by 6.5 Sample Collection and
Handling.
4. Run each of the prepared samples on the reference instrument three times at least. Average the results for
your reference values.

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The reference instrument must be a properly running standard analyzer so as to ensure the accuracy of the
reference values.

5. Enter the reference values for the parameters to be calibrated in the corresponding Target textbox.
6. Place the blood sample under the sampling probe, click the Start button or press the aspirate key on the
analyzer to run the samples.
7. Repeat step 6 for 10 times and calculate the counting results for sample No. 1 in the 10 runs.
The system will calculate the Mean, CV and Calibration coefficient for each parameter of the sample.
See Figure 12-8.
Figure 12-8 Calibration Results for Fresh Blood Samples

If the obtained calibration coefficient for any sample is not within the valid range or CV% or any
calibrated parameters does not meet the repeatability, a dialog box as shown below will pop up when you
are selecting other blood samples.

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 Click Yes to clear the calibration data of the sample. Redo the calibration or redo after running another
sample meeting all criteria.
8. Refer to steps 6~7 and perform the counting operations for the remaining four blood samples.
The system will calculate the Mean, CV and Calibration Coefficient for each parameter of the remaining
4 blood samples.
9. Click Calculate.
As shown below, the system will calculate the average of the calibration coefficients, namely, the mean
calibration coefficient (%), as the new calibration coefficient based on the five blood samples.

Figure 12-9 Calculating Mean Calibration Coefficient (%)

You can also check at least three accurate calibration coefficients and the system will re-
calculate the mean calibration coefficient (%).

The mean calibration coefficient is invalid if its absolute value of deviation from the original calibration
coefficient is greater than or equal to 5%.

10. Click Save.

 If the mean calibration coefficient is within the valid range, namely, the absolute value of deviation
from the original calibration coefficient is less than 5%), a dialog box will pop up.
Figure 12-10 Saving New Calibration Coefficient

233
 Click OK to close the message box.
 If the mean calibration coefficient is not within the valid range, namely, the absolute value of
deviation from the original calibration coefficient is greater than or equal to 5%, you’ll be prompted
that the mean calibration coefficient is invalid.

 If the blood-sample mode is Predilute, then a reminder of predilute counting will pop up if the user
presses the aspirate key to perform the counting. To close the prompt, see 5.3.1 Auxiliary Settings.
 CV% out of standard will not affect the display of calibration coefficient.

11. (Optional) Click Print to print the calibration results.

12.3.5 Verifying Calibration Coefficients

It is recommended that you take the following steps to verify the calibration coefficients:
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.

12.3.6 Calibration History

Click Cal > History to enter the calibration history screen. You can view the calibration history list and the
detailed calibration data.
Figure 12-11 Calibration History

 Calibration History List

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 The list shows the latest 100 calibration history records, including the following items:
 Date: The operating system date when the calibration coefficient is saved.

 Cal. Operator: The one who performs the calibration operations, such as the Admin.
 Calibration Method: Including Manual, Calibrator and Fresh Blood.
 Calibration Mode: The mode adopted for the calibration, including Whole Blood and Predilute.
 Description: Supplementary description of the calibration information about the
corresponding entries.
 Detailed Calibration Data
Selecting any row of record in the Calibration History List will enable you to view the detailed
calibration data of that record.
If the calibration method of the selected record is Fresh Blood, you can click Details… next to each
intermediate calibration record and view the detailed calibration data of each intermediate calibration
record.

 Print
You can click the Print button to print the calibration record.

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 13 Maintenance

13.1 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.

 The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety 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.

 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 DIAGON LTD. customer service department or
your local agent for assistance.
 Only DIAGON LTD.-supplied parts can be used for maintenance. For any question, contact
DIAGON LTD. customer service department or your local agent.
 Exercise caution to avoid contact with the sharp sample probe when performing maintenance.
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13.2 Service
The analyzer provides multiple service functions helping users to perform daily maintenance.

13.2.1Replacing Reagents

 The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety 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 long-distance transportation, the reagent must be allowed to settle for more than one day.
 When you have changed the diluent, cleansers or lyses, run a background check to see if the results
meet the requirement.

You should replace the reagents when:

 The system indicates that the reagent is used up
 The suspicious flag indicates that the reagent in the pipeline is contaminated
 The reagent is contaminated or expired
 WBC or RBC bubbles are identified.
You can replace any of the following reagents:
 Cellaton 5D
 Cellalyse DIFF 2
 Cellalyse DIFF1
 Cellalyse BASO
Do as follows to replace the reagents:
1. Refer to Figure 2-2 in 2.6.2 Connecting the reagents for reagent connections.
2. Click Service > Replace Reagent to access the interface.
3. Double click the name of the reagent that needs to be replaced, such as Cellaton 5D Diluent.
After the replacement is completed, the following message box will pop up.
4. Click OK to close the message box.
237
 5. Perform the above procedures to replace other reagents if necessary.

13.2.2 Cleaning
Clean corresponding parts according to the actual situation:
 DIFF bath
When the background of the scattergram has abnormal excessive cells, you should clean the DIFF
Bath.
 WBC bath
When the background of WBC- and/or HGB-specific parameters exceeds the Ref. Range, you should
clean the WBC bath.
 RBC bath
When the background of RBC- and (or) PLT-specific parameters exceeds the Ref. Range, you should
clean the RBC bath.
 Flow chamber
When the background of the scattergram has abnormal excessive cells, or bad differential of WBC, you
should clean the flow chamber.
 Sample probe
When the sample probe is dirty, you should clean the sample probe.
The cleaning procedures are as follows:
1. Click Service > Clean to access the interface as shown in Figure 13-1.
Figure 13-1 Cleaning

2. Double click the icon of the part that needs to be cleaned, such as Sample Probe.
When the system cleaning is complete, the message box will pop up to show that the cleaning is done.

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 Figure 13-2 Cleaning Done

3. Click OK to close the message box.

4. Perform the above procedures to clean other components if necessary.

13.2.3 Maintenance
Instrument maintenance includes: unclogging, cleanser soak, cleanser soak for DIFF channels, cleanser soak
for WBC channel, and cleanser soak for RBC channel.

13.2.3.1 Unclogging
If clogging is found, or it is suspected that the counting results are not accurate due to aperture clogging, you
can perform the unclogging operations.
The unclogging procedures are shown as follows:
1. Select Service > Maintain tab to access the interface as shown in Figure 13-3.
Figure 13-3 Maintenance

2. Double click the Unclog icon to start unclogging.

After the unclogging is completed, a message box will pop up.

239
 3. Click OK to close the message box.
4. Perform the above procedures to continue unclogging if necessary.

13.2.3.2 Cleanser Soak

The cleanser soak should be performed under the following circumstances:
 When the problems including the background results exceed the Ref. Range, bad differential of
scattergram and clogging still exist after other maintenance procedures have been adopted.
 Analyzer has been running for more than 24 hours. The
cleanser soak procedures are shown as follows.
1. Select Service > Maintain tab to access the Maintain interface.

2. Double click the icon of Cleanser Soak. A

dialog box as shown below will pop up.

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 Figure 13-4 Cleanser Soak

3. Click Yes.
A dialog box as shown below will pop up.
Figure 13-5 Cleanser Soak Prompt

4. Present the cleanser to the sample probe as per the prompt, and press the aspirate key or click the
Aspirate button.
30 seconds after the first aspiration of the cleanser soak, the following dialog box will pop up.

Figure 13-6 Cleanser Soak Prompt Again

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 5. Present the cleanser to the sample probe again, then press the aspirate key or click the Aspirate
button.
A prompt Soaking Cleanser… will appear and the soaking time will appear as shown below.

Figure 13-7 Cleanser Soaking Process Prompt

After one minute of soaking, you can stop it manually.

6. Click the Stop soaking button, or wait for 19 minutes until the automatic soaking is completed.
After the soaking is completed, a prompt “Cleanser Maintenance done!” will appear. See Figure 13-8.

Figure 13-8 Cleanser Maintenance Done

7. Click Close.

8. Perform the above procedures to perform the cleanser soak again if necessary.

13.2.3.3 Cleanser Soak for DIFF Channel

In case the DIFF channel scattergram is abnormal or the clogging is believed to exist in the flow chamber, the
Cleanser Soak for DIFF Channel feature can be used as a means for troubleshooting.
Procedures of cleanser soak for DIFF channel are shown as below:
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1. Select Service > Maintain to access the Maintain interface.

2. Double click the icon of DIFF Channel Cleanser Soak. A

dialog box will pop up.

3. Click Yes.
A dialog box will pop up.
Figure 13-9 DIFF Channel Cleanser Aspiration Prompt

4. Present the cleanser to the sample probe as per the prompt, and press the aspirate key or click the
Aspirate button.
“Cleanser soaking…” and the soaking time will appear as shown below.

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 Figure 13-10 DIFF Channel Soaking Process

After one minute of soaking, you can stop it manually.

5. Click the Stop soaking button, or wait for 19 minutes until the automatic soaking is completed. After the
soaking is completed, a prompt “Cleanser Maintenance done!” will appear.
Figure 13-11 Cleanser Maintenance Done

6. Click Close.
7. Perform the above procedures to perform the DIFF channel cleanser soak again if necessary.

13.2.3.4 Cleanser Soak for WBC Channel

Probe cleanser soaking for WBC channel can be used to remove the errors for aperture clogging or abnormal
scattergram.
Please refer to 13.2.3.3 Cleanser Soak for DIFF Channel for performing the operations for cleanser soaking
for WBC channel.

13.2.3.5 Cleanser Soak for RBC Channel

In case the RBC distribution histogram is abnormal or the clogging is believed to exist in the flow chamber,
Cleanser Soak for PBC Channel feature can be used as a means for troubleshooting.
Please refer to 13.2.3.3 Cleanser Soak for DIFF Channel for procedures of Cleanser Soaking for RBC
Channel.

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13.2.4 Comprehensive Device Maintenance
The Comprehensive Device Maintenance feature includes fluidics initialization, comprehensive device
cleaning, emptying fluidics and preparing to ship.

13.2.4.1 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.
Do as follows to perform the fluidics initialization:
1. Select Service > Comprehensive Device tab to access the Comprehensive Device
maintenance interface.

2. Double click the icon of Fluidics Initialization.

A prompt saying “Performing Fluidics Initialization…” will appear. After
the initialization is complete, a message box will pop up.

3. Click OK.

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13.2.4.2 Clean Fluidics
If the background results of parameters are out of the background range, the comprehensive device cleaning
should be cleansed.
Procedures for comprehensive device cleaning are shown as below:
1. Select Service > Comprehensive Device tab to access the Comprehensive Device
maintenance interface.

2. Double click the icon of Clean Fluidics.

A prompt saying “Performing Clean Fluidics…” will appear.

After the cleaning is completed, the following message box will pop up.

3. Click OK.

13.2.4.3 Empty Fluidics

This function enables the device to empty fluidics to prevent crystallization and maintain device performance
when the device has not been used for more than one week.
Procedures for emptying fluidics are shown as below:
1. Select Service > Comprehensive Device tab to access the Comprehensive Device
maintenance interface.
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2. Double click the icon of Empty Fluidics. A
message box shown below will pop up.

3. Click Yes to start the emptying, and a message box shown below will pop up.

4. Remove all reagent pickup tube assemblies according to the prompt, and then click OK to start emptying
the fluidic system.
After the emptying is complete, a message box will pop up.

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5. Place the [O/I] switch at the left side of the main unit in the [O] position. Once
the main unit is powered off, the following dialog box will pop up.

6. Click Yes, the software system will close automatically.

If clicking No, you can still use the software for any operation not related to the main unit.
7. After shutdown, empty the waste in the waste container, and dispose of it.

Be sure to dispose of reagents, waste, samples, consumables, etc. according to local legislations and
regulations.

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13.2.4.4 Prepare to Ship
If the analyzer is not to be used for over two week or needs be transported over a long distance (transporting
time>2h), you should perform this procedure.
Do as follows to perform the prepare-to-ship procedure:
1. Select Service > Comprehensive Device tab to access the Comprehensive Device
maintenance interface.

2. Double click the icon of Prepare to Ship. A

message box shown below will pop up.

3. Click Yes button to perform the packing up and a message box shown below will pop up.

4. Remove all reagent pickup tube assemblies according to the prompt, and then click OK to start emptying
the fluidic system.
After the emptying is complete, a message box will pop up.

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5. Place all reagent pickup tube assemblies into the distilled water, and then click OK to start priming.

 Be sure to use distilled water in order to ensure the normal use of the device in the future. In addition,
the beaker holding the distilled water needs to be cleaned thoroughly.
 The diluent pipe and lyse pipes should be stored separately in two beakers.
 About 200ml of distilled water is needed for perfusion.

System performs the filling operation. After the filling is completed, the following dialog box will pop up.

6. Take out the diluent and lyse pipes from the distilled water as per the prompt, then click OK.
After the prepare-to-ship procedure is completed, a dialog box will pop up to prompt you to power off the
analyzer.

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 7. Place the [O/I] switch at the left side of the main unit in the [O] position. Once
the main unit is powered off, the following dialog box will pop up.

8. Click Yes, the software system will shut down automatically.

If clicking No, you can still use the software for any operation not related to the main unit.
9. After shutdown, empty the waste in the waste container, and dispose of it.

Be sure to dispose of reagents, waste, samples, consumables, etc. according to local legislations and
regulations.

13.2.5 Reagent Management

Once the new reagent is connected to the analyzer, you need to set the reagent configurations, including
validity period, residue volume and reagent barcode on the Reagent Management interface. Upon the
completion of reagent configuration, you can perform the procedures for reagent replacement.

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  The reagents are irritating to eyes, skin and mucosa. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety 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 long-distance transportation, the reagent must be allowed to settle for more than one day before
use.
 When you have changed the diluent, cleansers or lyses, run a background check to see if the results
meet the requirement.

13.2.5.1 Accessing the interface

Click Service > Reagent Management to access the Reagent Management setting interface. Refer to
Table 13-1 for related parameter descriptions.

Table 13-1 Parameter Description for Reagent Management

Parameter Description

Current model of the analyzer.

 Closed system
Current Model Reagent setting procedures for different analyzer models vary, please
refer to 13.2.5.2 Reagent Information Settings.

Agent (code) Agent Code of the reagent.

Please tick off the corresponding box in the Replace column for the
reagent before reagent replacement.
Replace
You can select multiple reagents and click Replace button to
replace multiple reagents.

Reagent Name Name of the reagent.

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 Exp. date of the unopened reagent will be shown upon the
completion of the reagent settings.
Exp. Date
Any reagent, regardless of its container being opened or not,
should not be used beyond this date.

The date on which the reagent container is opened. The default open-
Open-container Date container date is the date on which the reagent settings are completed.

Period after opening The validity period (days) after the reagent container is opened. It will
(PAO) be shown upon the completion of the reagent settings.

Open-container Exp. Exp. date of the opened reagent, and it will be shown upon the
Date completion of the reagent settings.

Parameter Description

The current residue volume of the reagent, and it will be shown in ml

Residue Volume
upon the completion of the reagent settings.

13.2.5.2 Reagent Information Settings

This section will show you how to set the Exp. date, residue volume and other information for the connected
reagent.
Reagent setting procedures for different analyzer models vary. The reagent setting procedures for both open
and closed models will be presented on the following pages.

13.2.5.3 Reagent setting procedure

Reagent setting procedures are as follows:
1. Select the reagent to be set, and then click Setup.
This launches the Reagent Information setting page.

2. To enter the reagent information, use any of the following methods.

 Manual Entry
Detailed parameter description is shown in Table 13-2.
Table 13-2 Parameter Description of Reagent Information

Parameter Meaning Operation

Exp. date of the unopened Click the date control for the settings
reagent (see the outer
packaging of the reagent). NOTE
Exp. Date The reagent, regardless of the The validity date of the reagent should be no
container being opened or later than the current system date or the
not, should not be used validity date indicated on the packaging.
beyond this date.

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 The validity period (days) of
Period after
the open-container reagent Enter the information directly into the
opening
(see the product packaging). textbox.
(PAO)

Residue The current residue volume of Enter the information directly into the
Volume the reagent (ml). textbox.

 Input the reagent barcode, and click Load.

A correctly entered barcode will prompt a message shown below the barcode box, indicating a
successful loading, and the validity date and residue volume will be shown in the corresponding
textboxes.
If the barcode fails to be loaded, check if the reagent has been used or expired and the reagent name is
correct. If all the information is correct, but the failure persists, please contact DIAGON LTD. After-
sales Service Department.
 Input the barcode via a external barcode scanner
A correctly entered barcode will prompt a message shown below the barcode box, indicating a
successful loading, and the validity date and residue volume will be shown in the corresponding
textboxes.
If the barcode fails to be loaded, check if the reagent has been used or has expired and the reagent
name is correct. If all the information is correct, but the failure persists, please contact DIAGON LTD.
After-sales Service Department.
3. Click Apply.
The system message will pop up, indicating the successful reagent settings.
4. Click OK.
5. Click Close to exit.

 Once the reagent settings are successfully completed, the system prompt at the bottom right corner of the
screen will show that the reagent has not been replaced. To complete the reagent replacement, please refer
to 13.2.5.3 Reagent Replacement.
 When you have changed the diluents, cleansers or lyses, run a background check to see if the results
meet the requirement.

13.2.5.4 Reagent Replacement

1. Tick off one or multiple reagents in the Service > Reagent Management interface.
2. Click Replace.
A message box will pop up indicating reagent replacement is in progress.
Upon the completion of reagent replacement, the message box will be closed automatically.

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13.2.6 Auto Clean
There will be a certain amount of contamination accumulated after running a certain amount of samples
without shutting down the analyzer. When the sample count amounts to over 100, the analyzer will perform
the cleaning procedure automatically once, and a prompt will be displayed on the screen.
In addition, the analyzer will perform the auto clean procedures if there has been no fluidics sequential
operation for more than one hour.

Once the auto clean is performed or the analyzer is shut down, the statistical data of auto clean will be cleared
automatically.

13.2.7 Auto Prompt for Cleanser Soak

If the analyzer has been running for more than 24 hours but hasn’t performed cleanser maintenance when the
auto maintenance time is reached, the system will prompt to perform cleanser soak immediately, so as to
prevent the accumulation of contamination.
 Click Yes, then you can perform the cleanser maintenance as per the prompt and the description in 13.2.3.2
Cleanser Soak.
 Click No, then the system will remind you every 10 minutes until you perform the maintenance.

 Administrators can set auto maintenance time for cleanser. See 5.9.1 Auto Maintenance.
 At the Self-test or Status interface, the analyzer does not ask for confirmation to perform the cleanser
soak.
 If the analyzer is running or has problems when the conditions of auto prompt for cleanser soak is
satisfied, the analyzer will prompt again after the current operation is completed or the problems are
resolved.
 After cleanser soak is completed, the accumulative count values will be cleared automatically.
 Cleanser soak is an important step in comprehensive device maintenance. It is recommended not to stop
soaking halfway.

13.2.8 Auto Sleep

When the fluidics system stops working for 60 minutes (default setting), then the analyzer will enter the
sleeping status automatically.
When the main unit is in the Sleep state, operation/status message area will show that the device is in the

255
 Sleep mode. Click Exit to exit the Sleep mode.

 You can set the waiting time for auto sleeping, see 5.9.1 Auto Maintenance.
 At the Self-test or Status interface, 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 auto
sleep start accordingly.
 You can perform the operations without the cooperation of the analyzer when it is sleeping, namely,
communication and print etc.
 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.

13.3 System Status

User can view the current status information of the analyzer in the Status interface, including temperature,
voltage and current, counting statistics and version information.

13.3.1 Temperature
Click Status > Temperature to access the Temperature interface. See Figure 13-12.

Figure 13-12 View Temperature Status

User can view the current temperature information of the analyzer, including the temperature of DIFF reaction
bath, ambient temperature and the temperature of the optical system. If the results of the temperature testing
exceed the normal range, they will be highlighted by the red background.

13.3.2 Voltage and Current

Click Status > Voltage to access the Voltage interface.

256
 Figure 13-13 Voltage and Current

User can view the voltage and current information of the analyzer. The voltage or current value that exceeds
the normal range will be displayed in a red background.

13.3.3 Counter
Click Status > Counter to access the Counter interface.

Figure 13-14 Counter

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User can view the device related statistics, such as Sample times, QC times, Laser diode lifetime (hr), and
clogging count. Besides, user can view the detailed statistics of Sample Count and QC Count.
 View details of Sample Count.
Click the Details button next to Sample Times, the detailed statistics of Sample Times will be displayed.
 View details of QC Times.
Click the Details button next to QC Times, the detailed statistics of QC times will be displayed. See
Figure 13-15.
Figure 13-15 Details of QC Count

 View details of Calibration Times.

Click the Details button next to Calibration Times, the detailed statistics of Calibration Times

will be displayed. See Figure 13-16.

Figure 13-16 Details of Calibration Count

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13.3.4 Version Information
User can view the current version information of all parts of the analyzer, and export the version information
to a local disk. Procedures are shown as follows:
1. Click Status > Version to access the version Information interface. See Figure 13-17.
Figure 13-17 Version Information

2. Click Export, and select the export path in the dialog box, and then enter the file name. As
shown below.

259
 3. Click Save to start exporting.
After Export is completed, the message box as shown below will pop up.

4. Click OK to exit.

13.4 Self-test
This feature is to test if some important components of the device can function properly or not, including
syringe self-test, pressure and vacuum self-test, valve self-test and other self-tests.

If the testing result is abnormal, you should try again for several times; if the abnormalities persist, please
contact DIAGON LTD. customer service department or your local agent.

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13.4.1 Syringe and Sampling Mechanism
You can test the performance of all syringes and sampling mechanisms. The self-
test procedures are shown as below:
1. Click Self-test > Syringe to access the Syringe self-test interface. See Figure 13-18.
Figure 13-18 Syringe

2. Double click the part that needs to be tested, e.g. Diluent syringe, and wait for the self-test results.
After the self-test is completed, a dialog box will pop up to show the self-test results.
Figure 13-19 Syringe Self-test Results

3. Click OK to close the message box.

13.4.2 Pressure and Vacuum

This feature is to test the pressure and vacuum inside the device. Procedures for
261
 pressure (or vacuum) self-test are shown as below:
4. Click Self-test > Pressure to access the Pressure and Vacuum interface.

Figure 13-20 Pressure and Vacuum Self-test

5. Double click Pressure (or Vacuum).

The system will perform the corresponding self-test operations. After the self-test is completed, a dialog
box will pop up to show the self-test results.

6. Click OK to close the message box.

13.4.3 Valve & Pump

When controlling the switches of different valves (pumps), you can judge if the valves (pumps) are operating
properly by the sound of opening, closing or manually touching the corresponding valves (pumps).
The procedures for valve self-test are shown as follows:
7. Select Self-test > Valve & Pump tab.
The Valve & Pump self-test interface appears as shown in Figure 13-21.

262
 Figure 13-21 Valve Self-test

8. Click the desired Valve No. (e.g. 1), then confirm whether it works properly by the sound of its
opening and closing.
13.4.4 Others
You can also perform the following self-tests:
 WBC aperture voltage
 RBC aperture voltage
 Mix Mechanism
 Autoloader
 Filter
 Barcode scanner
 RF card reader

13.4.4.1 WBC Aperture Voltage, RBC Aperture Voltage, Mix Mechanism and Filter
The self-test procedures of WBC aperture voltage, RBC aperture voltage, ,mix mechanism and filter are
shown as below:
9. Click Self-test > Other Self-test to access the interface as shown in Figure 13-22.
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 Figure 13-22 Other Self-tests

10. Double click the icon of the desired item, e.g. WBC Aperture Voltage, to start self-test.

The system will perform corresponding self-test operations. After the self-test is completed, a dialog box
will pop up to show the self-test results.
Figure 13-23 Other Self-test Results

13.4.4.2 Barcode Scanner

The self-test procedure of barcode scanner is shown as below:
1. Double click the icon of Barcode Scanner in the Self-test > Other Self-test interface. A dialog
box will pop up as shown below.

264
2. Follow the instructions and place a rack loading 10 tubes on the loading tray, with the barcode labels on
the tubes facing the analyzer.
3. Click OK.
The system will perform corresponding self-test operations. After the self-test is completed, a dialog box
will pop up to show the self-test results.

4. Click OK to close the message box.

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13.5 Log
In the Log interface, you can view the records of Set Paras, Other Logs, Fault Logs and All Logs.

 If a new record is added when the log is full, the newest record will overwrite the oldest one
automatically.
 The administrator can view both his/her own operation logs and the common users’ operation logs,
while the common users can only review their own operation logs.
 The log can keep Records of up to 5 years.

13.5.1 Parameter Revision Logs

Click Log > Set Paras to access the Parameter Revision Logs interface.

Figure 13-24 Parameter Revision Logs

 View the parameter revision logs on specified dates

Select the dates in the two date textboxes, and then you can view the parameter revision logs within the
date range, including the revision date and time, revision summary and the operator.
 Exporting Logs
Click Export, and select the export range and export path in the dialog box, then you can save the

266
 parameter logs of the specified dates to the external computer, as shown below.
Figure 13-25 Exporting Logs

 Refresh

Click Refresh to refresh the record.

13.5.2 Other Logs

Click Log > Other Logs to access the Other Logs interface (except for Parameter Revision Logs and Fault
Logs).

Figure 13-26 Other Logs

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 View the logs of the specified date
Select the dates in the two date textboxes to view the logs within the date range, including operation date
and time, operation records and the operator.
 Exporting Logs
Click Export, and select the export range and export path in the dialog box, then you can save the other
logs of the specified dates to the external computer, as shown below.

268
 Figure 13-27 Exporting Logs

 Refresh
Click Refresh to refresh the record.

13.5.3 Fault Logs

Click Log > Fault Logs to access the Fault Logs interface.

Figure 13-28 Fault Logs

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 View the fault logs of the specified dates
Select the dates in the two date textboxes, and then you can view the fault logs within the date range,
including date and time when the faults occur, fault description and the operator.
 Exporting Logs
Click Export, and select the export range and export path in the dialog box, then you can save the fault
logs of the specified dates to the external computer, as shown below.

Figure 13-29 Exporting Logs

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  Refresh
Click Refresh to refresh the record.

13.5.4 All Logs

Click Log > All Logs to access the All Logs interface. User can view All Logs (visible to the users of the
current access level).

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 Figure 13-30 All Logs

 View all the fault logs of the specified date

Select the dates in the two date textboxes, and then you can view the all logs within the date range,
including operation date and time, operation details and the operator.
 Exporting Logs
Click Export, and select the export range and export path in the dialog box, then you can save all logs of
the specified dates to the external computer, as shown below.
Figure 13-31 Exporting Logs

 Refresh
Click Refresh to refresh the record.

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 14 Troubleshooting

14.1 Introduction
This chapter contains information that is helpful in locating and resolving problems that may occur during the
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
DIAGON LTD. customer service department or your local agent.

14.2 Dealing with Error Messages

In the use of the analyzer, when the software detects abnormalities, an error message will be displayed on the
bottom right of the screen as shown in Figure 14-1 and the main unit will sound an alarm.
Figure 14-1 Error Messages

You can refer to the following steps to deal with the error messages.
1. Double click the error message area.
As shown in Figure 14-2, the popup dialog box displays the error description and its help information.
The error descriptions are displayed in the order of error occurrence.

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 Figure 14-2 Error Message Dialog Box

2. Press Mute the Alarm to disable the beep.

3. Click Remove Error.
Normally, the system will automatically remove the errors.
For errors which cannot be removed automatically, you can take appropriate actions by following the error
help information or 14.3 Error Message Reference.

14.3 Error Message Reference

Possible errors and the corresponding help information are shown in Table 14-1.

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 Table 14-1 Error Message Reference

Error description Troubleshooting Information

1. Please power off the analyzer directly and restart later.

Abnormal -12V power.
2. If the error still exists, contact our customer service department.

Error description Troubleshooting Information

Abnormal 12V driving 1. Please power off the analyzer directly and restart later.
power supply. 2. If the error still exists, contact our customer service department.

Abnormal 24V driving 1. Please power off the analyzer directly and restart later.
power supply. 2. If the error still exists, contact our customer service department.

Abnormal voltage of 1. Please power off the analyzer directly and restart later.
constant-current voltage
2. If the error still exists, contact our customer service department.
abnormal.

1. Please power off the analyzer directly and restart later.

Abnormal laser current.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Startup failure.
2. If the error still exists, contact our customer service department.

Startup initialization is not 1. Click the Remove Error button to remove this error.
executed. 2. If the error still exists, contact our customer service department.

1. Close the right side door.

Right side door is 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 right side door.

Left side door is open. 2. Click the Remove Error button to remove this error.
3. If the error still exists, contact our customer service department.

1. Please turn off the analyzer power directly and restart later.
Abnormal +12V power.
2. If the error still exists, contact our customer service department.

The temperature setting of 1. Click the Remove Error button to remove this error.
DIFF bath exceeds the limit.
2. 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 [4.2,
Abnormal HGB 4.8] V, preferably 4.5V as instructed in 5.9.2 Gain Settings.
background voltage
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Data transmission failure
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 is reported frequently, see 13.2.3.5 Cleanser Soak for RBC
RBC clogging
Channel to dip the RBC bath in the cleanser.
3. If the error still exists, contact our customer service department.

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Clogging of volumetric 1. Click the Remove Error button to remove this error.
tube filter. 2. If the error still exists, contact our customer service department.

Abnormal RBC aperture 1. Click the Remove Error button to remove this error.
voltage. 2. If the error still exists, contact our customer service department.

Error description Troubleshooting Information

1. Click the Remove Error button to remove this error.

2. If the error reports frequently, see 13.2.3.4 Cleanser Soak for WBC
WBC clogging.
Channel to dip the WBC bath in the cleanser.
3. If the error still exists, contact our customer service department.

Abnormal WBC aperture 1. Click the Remove Error button to remove this error.
voltage 2. If the error still exists, contact our customer service department.

1. Check whether the diluent is contaminated.

Abnormal background 2. If not, click the Remove Error 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.

Sample syringe timeout
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Sample syringe is busy.
2. If the error still exists, contact our customer service department.

Sampling assembly is 1. Click the Remove Error button to remove this error.
busy. 2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Vertical motor is busy.
2. If the error still exists, contact our customer service department.

Failed to read DIFF bath 1. Make sure the temperature sensor is correctly installed.
temperature. 2. If the error still exists, contact our customer service department.

Failed to read optical 1. Make sure the temperature sensor is correctly installed.
system temperature. 2. If the error still exists, contact our customer service department.

Failed to read ambient 1. Make sure the temperature sensor is correctly installed.
temperature. 2. If the error still exists, contact our customer service department.

1. Empty the waste container or install a new waste container.

Waste container is full. 2. Click the Remove Error button to remove this error.
3. If the error still exists, contact our customer service department.

The setting value of optical

system temperature 1. Click the Remove Error button to remove this error.
exceeds the limit. 2. If the error still exists, contact our customer service department.

Optical system 1. Click the Remove Error button to remove this error.
temperature out of
working range. 2. If the error still exists, contact our customer service department.

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 1. Click the Remove Error button to remove this error.
Flow chamber clogging.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Horizontal motor is busy.
2. If the error still exists, contact our customer service department.

Error description Troubleshooting Information

1. Check whether the Cellaton 5D expires. If so, replace it with a new

container of Cellaton 5D.
2. Click the Remove Error button. The reagent management interface will
Cellaton 5D expiration. pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.

1. Check whether the Cellaton 5D container is empty. If so, replace it with a

new container of Cellaton 5D.
2. Click the Remove Error button. The reagent management interface will
Insufficient Cellaton 5D. pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Cellaton 5D not replaced.
2. If the error still exists, contact our customer service department.

1. Check whether the Cellaton 5D container is empty.

If so, perform step 2; or if there is still plenty of Cellaton 5D, contact our
customer service department.
2. Install a new container of Cellaton 5D. Then click the Remove Error
No Cellaton 5D. button to prime the analyzer with the Cellaton 5D.
3. Enter Reagent Management to modify the reagent Exp. date as
instructed in 13.2.5 Reagent Management.
4. If the error still exists after a new container of Cellaton 5D is installed,
contact our customer service department.

1. Check if the Cellalyse BASO lyse expires. If so, replace it with a new
container of Cellalyse BASO.
2. Click the Remove Error button. The reagent management interface will
Cellalyse BASO expiration. pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.

1. Check whether the Cellalyse BASO container is empty. If so, replace it with a
new container of Cellalyse BASO.
2. Click the Remove Error button. The reagent management interface will
Insufficient Cellalyse BASO pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.

277
 1. Click the Remove Error button to remove this error.
Cellalyse BASO not replaced.
2. If the error still exists, contact our customer service department.

Error description Troubleshooting Information

1. Check whether the Cellalyse BASO container is empty.

If so, perform step 2; or if there is still plenty of Cellalyse BASO, contact
our customer service department.
2. Install a new container of Cellalyse BASO. Then click the Remove Error
No Cellalyse BASO button to prime the analyzer with the Cellalyse BASO.
3. Enter Reagent Management to modify the reagent Exp. date as
instructed in 13.2.5 Reagent Management.
4. If the error still exists after a new container of Cellalyse BASO is installed,
contact our customer service department.

1. Check if the Cellalyse DIFF 1 lyse expires. If so, replace it with a new
container of Cellalyse DIFF 1.
2. Click the Remove Error button. The reagent management interface will
Cellalyse DIFF 1 expiration. pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.

1. Check whether the Cellalyse DIFF 1 container is empty. If so, replace it with
a new container of Cellalyse DIFF 1.
2. Click the Remove Error button. The reagent management interface will
Insufficient Cellalyse DIFF 1 pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Cellalyse DIFF 1 not replaced.
2. If the error still exists, contact our customer service department.

1. Check whether the Cellalyse DIFF 1 container is empty.

If so, perform step 2; or if there is still plenty of Cellalyse DIFF 1, contact
our customer service department.
2. Install a new container of Cellalyse DIFF 1. Then click the Remove Error
No Cellalyse DIFF 1 button to prime the analyzer with the Cellalyse DIFF 1.
3. Enter Reagent Management to modify the reagent Exp. date as
instructed in 13.2.5 Reagent Management.
4. If the error still exists after a new container of Cellalyse DIFF 1 is installed,
contact our customer service department.

1. Check if the Cellalyse DIFF 2 lyse expires. If so, replace it with a new
container of Cellalyse DIFF 2.
2. Click the Remove Error button. The reagent management interface will
Cellalyse DIFF 2 expiration. pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.
278
Error description Troubleshooting Information

1. Check whether the Cellalyse DIFF 2 container is empty. If so, replace it with
a new container of Cellalyse DIFF 2.
2. Click the Remove Error button. The reagent management interface will
Insufficient Cellalyse DIFF 2 pop up.
3. Set the reagent information as instructed in 13.2.5 Reagent
Management.
4. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Cellalyse DIFF 2 not replaced.
2. If the error still exists, contact our customer service department.

1. Check whether the Cellalyse DIFF 2 container is empty.

If so, perform step 2; or if there is still plenty of Cellalyse DIFF 2, contact
our customer service department.
2. Install a new container of Cellalyse DIFF 2. Then click the Remove Error
No Cellalyse DIFF 2 button to prime the analyzer with the Cellalyse DIFF 2.
3. Enter Reagent Management to modify the reagent Exp. date as
instructed in 13.2.5 Reagent Management13.2.5 .
4. If the error still exists after a new container of Cellalyse DIFF 2 is installed,
contact our customer service department.

1. Click the Remove Error button to remove this error.

Diluent syringe timeout
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Diluent syringe busy.
2. If the error still exists, contact our customer service department.

The pressure of the

positive-pressure chamber 1. Click the Remove Error button to remove this error.
exceeds the normal 2. If the error still exists, contact our customer service department.
operation range.

Positive pressure is 1. Click the Remove Error button to remove this error.
abnormal (low). 2. If the error still exists, contact our customer service department.

Positive pressure is 1. Click the Remove Error button to remove this error.
abnormal (high). 2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

DIFF probe clogging
2. If the error still exists, contact our customer service department.

Vacuum pressure out of 1. Click the Remove Error button to remove this error.
working range. 2. If the error still exists, contact our customer service department.

Vacuum pressure is 1. Click the Remove Error button to remove this error.
abnormal (low). 2. If the error still exists, contact our customer service department.

Vacuum pressure is 1. Click the Remove Error button to remove this error.
abnormal (high). 2. If the error still exists, contact our customer service department.

SOCKET initialization 1. Click the Remove Error button to remove this error.
failed. 2. If the error still exists, contact our customer service department.

279
Error description Troubleshooting Information

Abnormal network 1. Click the Remove Error button to remove this error.
disconnection 2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Loading motor busy.
2. If the error still exists, contact our customer service department.

Loading motor action 1. Click the Remove Error button to remove this error.
overtime. 2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Failed to start mixing.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Mixing failed.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Mix assembly busy.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Feeding assembly busy.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Failed to start feeding.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Feeding failed.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Feeding action overtime.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Autoloader busy.
2. If the error still exists, contact our customer service department.

1. Remove the tube rack from the unloading tray.

Unloading tray is full. 2. Click the Remove Error button to remove this error.
3. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Counter falsely triggered.
2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Counter trigger abnormal.
2. If the error still exists, contact our customer service department.

Driver board 1. Click the Remove Error button to remove this error.
communication failed. 2. If the error still exists, contact our customer service department.

Autoloader panel 1. Click the Remove Error button to remove this error.
communication failed. 2. If the error still exists, contact our customer service department.

RF card reader 1. Click the Remove Error button to remove this error.
communication failed. 2. If the error still exists, contact our customer service department.

280
Error description Troubleshooting Information

FPGA communication 1. Click the Remove Error button to remove this error.
failed. 2. If the error still exists, contact our customer service department.

RF card reader reset 1. Click the Remove Error button to remove this error.
failed. 2. If the error still exists, contact our customer service department.

1. Click the Remove Error button to remove this error.

Rf card read-white failed.
2. If the error still exists, contact our customer service department.

281
 Appendix A Specifications

Appendix A Specifications

A.1 Classification
According to the CE classification, the Auto Hematology Analyzer belongs to in vitro diagnostic medical
devices, rather than those covered by Annex II and devices for performance evaluation.

A.2 Reagents

Reagent Type Reagent Name

Diluent Cellaton 5D Diluent

Cellalyse DIFF 2 Lyse

Lyse Cellalyse DIFF 1 Lyse

Cellalyse BASO Lyse

Medical cleanser CLEANSER

A.3 Parameters

Parameter Abbreviation Default Unit

9
White Blood Cell count WBC count 10 /L
9
Number of Neutrophils Neu# 10 /L
9
Number of Lymphocytes Lym# 10 /L
9
Number of Monocytes Mon# 10 /L
9
Number of Eosinophils Eos# 10 /L
9
Number of Basophils Bas# 10 /L
9
Number of Abnormal Lymphocytes ALY# (RUO) 10 /L
9
Number of Large Immature Cells LIC# (RUO) 10 /L

Percentage of Neutrophils Neu% %

Percentage of Lymphocytes Lym% %

Percentage of Monocytes Mon% %

Percentage of Eosinophils Eos% %

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 Appendix A Specification

Parameter Abbreviation Default Unit

Percentage of Basophils Bas% %

Percentage of Abnormal Lymphocytes ALY% (RUO) %

Percentage of Large Immature Cells LIC% (RUO) %

12
Red Blood Cell count RBC count 10 /L

Hemoglobin Concentration HGB concentration g/L

Hematocrit HCT %

Mean Corpuscular Volume MCV fL

Mean Corpuscular Hemoglobin MCH pg

Mean Corpuscular Hemoglobin Concentration MCHC g/L

Red Blood Cell Distribution Width Standard

RDW-SD fL
Deviation

Red Blood Cell Distribution Width Coefficient of

RDW-CV %
Variation
9
Platelet count PLT count 10 /L

Mean Platelet Volume MPV fL

Platelet Distribution Width PDW NA

Plateletcrit PCT %

Platelet-large cell ratio P-LCR %

9
Platelet-large cell count P-LCC 10 /L

Red Blood Cell Histogram RBC Histogram NA

Platelet Histogram PLT Histogram NA

White Blood Cell/Basophils Scattergram WBC/BASO Histogram NA

White Blood Cell Histogram WBC Histogram NA

5 Differential Scattergram DIFF Scattergram NA

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 Appendix A Specification

A.4 Sample Volume Required for Each Analysis

No more than 20 μL.

A.5 Performance Specifications

A.5.1 Display Range

Parameter Linearity Range Display Range

9 9
WBC (0.00~300) ×10 /L (0.00~999.99) ×10 /L
12 12
RBC (0.00~8.50) ×10 /L (0.00~18.00) ×10 /L

HGB 0~250g/L 0~300g/L

9 9
PLT 0~3000×10 /L 0~5000×10 /L

HCT 0~67% 0%~80%

A.5.2 Normal Background

Parameter Background Result

9
WBC ≤0.2×10 /L
12
RBC ≤0.02×10 /L

HGB ≤1g/L
9
PLT ≤10×10 /L

HCT ≤0.5%

A.5.3 Linearity Range

Parameter Linearity range Deviation range (Whole blood mode)

9 9
(0.00~100.00) ×10 /L ±0.50×10 /L or ±5%
WBC
9
(100.01~300.00) ×10 /L ±10%
12 12
RBC (0.00~8.50) ×10 /L ±0.05×10 /L or ±5%

HGB (0~250) g/L ±2g/L or ±2%

9 9
(0~1000) ×10 /L (RBC≤7.0) ±10×10 /L or ±8%
PLT
9
(1001~3000) ×10 /L (RBC≤7.0) ±12%

HCT 0~67% ±2% (HCT value) or ±3% (deviation

percent)

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 Appendix A Specification

A.5.4 Repeatability
These repeatability requirements apply only to the situation in which a qualified sample has been run for 11
nd th
times and the results of the 2 to 11 runs are used to calculate the repeatabilities.

Parameter Condition Whole Blood Repeatability

(CV%/absolute deviation
d*)
9
WBC (4.0~15.0)×10 /L ≤2.0%

Neu% 50.0%~60.0% ±4.0 (absolute deviation)

Lym% 25.0%~35.0% ±3.0 (absolute deviation)

Mon% 5.0%~10.0% ±2.0 (absolute deviation)

Eos% 2.0%~5.0% ±1.5 (absolute deviation)

Bas% 0.5%~1.5% ±0.8 (absolute deviation)

12
RBC (3.50~6.00)×10 /L ≤1.5%

HGB (110~180) g/L ≤1.5%

9
PLT (150~500)×10 /L ≤4.0%

MCV (70~120) fL ≤1.0%

*: Absolute deviation d = analysis result – average of analysis results

A.5.5 Carryover

Parameter Carryover

WBC ≤0.5%

RBC ≤0.5%

HGB ≤0.5%

PLT ≤1.0%

HCT ≤0.5%

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 Appendix A Specification

A.6 Input/output Device

Accessory equipment connected to the analogue and digital interfaces must comply 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)). Anyone who connects additional
equipment to the signal input or output ports and configures an IVD system is responsible for ensuring that
the system works properly and complies with the safety and EMC requirements. If you have any problem,
consult the technical services department of your local agent.

If LIS communication is required, the external computer must have two network interface cards.

 External Computer (Optional)

The external computer for the analyzer must meet the following requirements:
 RAM: ≥2G
 Hard disk space: ≥20G
 Operation system: 32 bit Windows XP, Windows 7 Home Premium, Windows 7 Professional,
Windows 7 Enterprise (not for retail sale), or Windows 7 Ultimate
CPU: ≥1.4G
 Graphics Card: OpenGL 2.0 or above
 Display aspect ratio: 10: 6
 Resolution: not less than 1280*768
 Keyboard (Optional)
101-Key alpha-numeric keyboard
 Mouse (Optional)
 External barcode scanner (optional)
 RF card reader (for closed systems only)
 Printer (Optional)
 One LAN interface
 Power Supply
 Voltage: A.C 100V~240V
 Input power: ≤250VA
 Frequency: 50/60 Hz


A.7 EMC Description

This equipment complies with the emission and immunity requirements of the IEC 61326-1:2012, EN 61326-
1:2013, IEC 61329-6-2-6:2012 and EN 61326-2-6:2013.
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.

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 Appendix A Specification

A.8 Environment Conditions

Be sure to use and store the analyzer in the specified environment.

Environment Conditions Operating Storage Running

Environment Environment Environment

Ambient temperature 15°C~30°C -10°C~40°C 10°C~40°C

Relative humidity 30%~85% 10%~90% 10%~90%

Atmospheric pressure 70kPa~110kPa 50kPa~110kPa 70kPa~110kPa

A.9 Dimensions and Weight

Height

Depth

Width

Analyzer Dimensions and Weight

Width(mm) ≤650

Height(mm) ≤540

Depth(mm) ≤630

Weight(Kg) ≤58

A.10 Expected Service Life

More than 5 years.

None

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 Appendix B Terms and abbreviations

Appendix B Terms and Abbreviations

Auto-CWB/AWB Auto-Venous Whole Blood

CWB Capillary Whole Blood

PD Predilute Blood

RUO Research use only

VWB Venous Whole Blood

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 Appendix C Packing List

Appendix C Packing List

No. Name Quantity

1 Auto Hematology Analyzer 1

2 Power cord 1

3 Data cable (network cable) 1

4 Grounding cable 1

5 Operator’s Manual 1

6 Software installation CD-ROM 1

7 Quick Operation Guide Card 1

8 Cellalyse BASO Lyse Adapter Tube Assembly 1

9 Cellalyse DIFF 1 Lyse Adapter Tube Assembly 1

10 Cellalyse DIFF 2 Lyse Adapter Tube Assembly 1

11 Diluent Adapter Tube 1

12 Waste Float Adapter Tube 1

13 Air Filter 6

14 Waste container 1

15 Auto Hematology Analyzer Inspection Record 1

16 Tube rack 6

17 Packing list 1

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