ha-86 (89) auto hematology analyzer user’s manual

HA-86 (89) Auto Hematology Analyzer

User’s Manual

3, Hagavish st. Israel 58817 Tel: 972 3 5595252, Fax: 972 3 5594529 [email protected]

MRC.7.17

HA-86 (89) User's Manual

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How to use this Manual

Thank you for using HA-86 (89). Before operating the analyzer, be sure to read the

Manual carefully.

To get the best results, you must be aware of our analyzer and its performance before clinical

diagnosis and testing.

This is the User’s Manual for MRC HA-86 (89). It describes the installation, daily use and

maintenance, etc. of the analyzer. After reading the Manual, please keep it properly for

future reference.

The functions may vary depending on the version or configuration of the analyzer.

Please keep all packing materials for future storage, transport or return to the manufacturer

for repair.

If you have any questions, contact your dealer.

Meaning of Symbols

Warning: Indicates when the user ignores this symbol and misuses the

analyzer, casualties, serious injury or serious property loss may

be caused to the user.

Caution: Indicates when the user ignores this symbol and misuses the

analyzer, personal injury, wrong output results or property loss

may be caused to the user.

Precautions for Diagnosis

Caution: The product is a clinical examination analyzer for inspection.

Clinical diagnosis based on testing results should be performed

by doctors according to the clinical symptoms of the patients by

combining other inspection results.

Representation

MRC reserves the right for the final explanation of the User’s Manual.

The illustrations in the Manual give typical examples only and may not be completely

consistent with the actual displaying on the product. Take practicality as standard. Never use

the illustrations for other purposes.

Without written consent of MRC, no individual or organization may duplicate, modify or

translate the contents of the Manual.

MRC will be responsible for the safety, reliability and performance of the product only when

all the following requirements are met:

● Assembly, re-debugging, expansion, improvement and repair should be performed by

persons recognized by MRC;


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● The product is operated according to the Manual;

● The related electrical equipment complies with the national standards.

Caution

● The analyzer must be used by medical examination professionals or trained doctors, nurses

or laboratory technicians.

WWaarrnniinngg

● If no satisfied maintenance/repair plan is achieved, the analyzer may fail abnormally and

may endanger personal health.

● Ensure to use the analyzer in the conditions specified in the Manual. Otherwise, it may

cause the analyzer’s failure to function normally and unreliable measurement results,

damage the components of the analyzer, and endanger personal safety.


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Graphics and Symbols

Temperature Limit The temperature limit of the transport package.

Refer to the User’s Manual.

In vitro diagnostic equipment.

Fragile Objects The transport package contains fragile objects. Be careful in handling.

Upward The correct position of the transport package is straight up.

Prevent Rain Protect the transport package against rain.

Layers Limit The maximum number of layers stacked for the same kind of package. “n” indicates the layers limit.

Prevent Sunshine Avoid direct sunshine.

Do Not Roll Do not roll the transport package.

Caution. The general caution icon appears adjacent to an explanation of conditions that could interfere with the proper functioning of the instrument.

Biological and chemical hazards

Laser Warning

High Voltage Warning


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The general warning icon alerts users to other potential health or safety hazards.

Protective grounding

Pierce Warning

Lifting Position Indication


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Warning and Precautions

This analyzer is only provided for in vitro diagnosis, please carefully read the following

warnings before use. They are required to be strictly followed.

Warning: Read the following precautions carefully before using the

analyzer.

In case of peculiar smell, smog or noise during use, immediately turn

off the power and remove the plug from the socket, and immediately

apply for inspection with the dealer or our agent. If you continue to use

the analyzer in that case, fire, electric shock or casualties may be

caused.

Prevent blood, reagent or metal pieces, such as staple, etc., from

entering the analyzer. Otherwise short circuit or fire may be caused. In

case of abnormality, immediately turn off the power and unplug the plug

from the socket, and immediately apply for inspection with the dealer or

our agent.

Do not open the shell of the live analyzer for operation. Do not touch the

electronic circuit in the analyzer. Particularly, touch with wet hand may

cause electric shock.

Wear rubber gloves and use the specified tools, parts and components

when maintaining and inspecting the analyzer. Prevent scalding caused

by out-of-control heating of the DIFF bath or failure of the motor. When

the operation is ended, wash hands with disinfectant. Otherwise the

skin in contact with blood may be infected.

Be very careful when treating samples. Be sure to wear rubber gloves,

otherwise infection may be caused. In case the sample enters the eye or

wound, immediately rinse with plenty of clear water and receive

examination by a doctor.

Do not touch the internal devices when the analyzer is operating,

especially the moving parts, otherwise personal injury may be caused.

The analyzer uses a laser for measurement. Follow the specifications

when operating the laser to prevent the laser from shining in eyes and

causing damage.

Use and Disposal of Reagent

Prevent the reagent from being in contact with skin and clothing during

operation. In case it is in contact with skin or clothing, rinse with plenty

of clear water to prevent injury.

In case the reagent enters the eye, immediately rinse with plenty of

clear water and receive examination by a doctor.

If you swallow the reagent, immediately consult a doctor and drink

water generously to spit the reagent.

Used test tubes and other consumables for the analyzer should be


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disposed properly as medical waste or infectious waste. If contaminated

by blood, etc., they may be infected by pathogen.

Voltage, Connection and Grounding of Power Supply

Ensure the power supply and grounding environment of the analyzer

are good and steady.

Never insert the power plug into a socket other than 220V AC socket.

Otherwise fire or electric shock may be caused.

Be sure to use the three-core electric cable supplied with the analyzer in

installation, ensure good grounding, and put the analyzer in a place for

easy power off operation. Otherwise fire or electric shock may be

caused.

Never damage the insulating covering of the electric cable. Do not jerk

the electric cable or hang heavy objects with the electric cable.

Otherwise short circuit or open circuit may be caused, thus causes

electric shock or fire.

Be sure to turn off the power before connecting peripheral equipment.

Otherwise electric shock or failure may be caused.

In accordance with the Pharmaceutical Affairs Law, modification of medical

instruments is prohibited.

HA-86 (89) User’s Manual

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Table of Contents

HOW TO USE THIS MANUAL ........................................................... 1

GRAPHICS AND SYMBOLS .............................................................. 3

WARNING AND PRECAUTIONS ....................................................... 5

TABLE OF CONTENTS ..................................................................... 7

CHAPTER 1 INTRODUCTION ....................................................... 10

1.1 Introduction .............................................................................................. 10

1.1.1 Product Name Auto Hematology Analyzer ............................................................. 10

1.1.2 Model HA-86 (89) ............................................................................................. 10 1.1.3

Features ............................................................................................................................ 10 1.1.4

Parameters ....................................................................................................................... 10 1.2

Composition and Structure ........................................................................ 11 1.3

Performance ............................................................................................ 13 1.4

Intended Use ............................................................................................ 15 1.5

Technical Parameters .............................................................................. 15 1.6

PC Configuration ...................................................................................... 16 1.7

Model of Vacuum Blood Collection Tube.................................................. 16 1.8

Barcode Specification .............................................................................. 19

CHAPTER 2 OPERATION PRINCIPLE .......................................... 21

2.1 Overview .................................................................................................. 21

2.2 Sample Aspiration .................................................................................... 21

2.3 Diluted Sample ......................................................................................... 21

2.4 White Blood Cell (WBC) Measurement .................................................... 21

2.5 Hemoglobin Concentration (HGB) Measurement ..................................... 23

2.6 Red Blood Cell (RBC)/Platelet (PLT) Measurement ................................. 24

2.7 Parameters .............................................................................................. 24

CHAPTER 3 INSTALLATION ......................................................... 27

3.1 Unpacking ................................................................................................ 27

3.1.1 Steps of Unpacking ......................................................................................................... 27

3.1.2 Handling Method ............................................................................................................. 27

3.2 Installation and Use Environment ............................................................ 28

3.3 Requirements of Power Supply ................................................................ 28

3.4 Installation ................................................................................................ 29


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CHAPTER 4 START-UP ................................................................. 30

4.1 Precautions before Power-on ................................................................... 30

4.2 Logging on System .................................................................................. 30

CHAPTER 5 SYSTEM SETUP ....................................................... 33

5.1 Normal Limits ........................................................................................... 33

5.2 Units ......................................................................................................... 34

5.3 Print ......................................................................................................... 35

5.4 Time and Language ................................................................................. 37

5.5 Optional Functions ................................................................................... 38

5.6 Shortcut Input ........................................................................................... 40

5.7 User Management ................................................................................... 41

5.8 Maintenance ............................................................................................ 43

5.9 Abnormal Prompt ..................................................................................... 44

5.10 Communication ........................................................................................ 44

5.11 Optional Item ............................................................................................ 46

5.12 Other ........................................................................................................ 46

CHAPTER 6 DAILY OPERATIONS ................................................ 48

6.1 Daily Quality Control ................................................................................ 48

6.2 Sample Preparation ................................................................................. 48

6.2.1 Venous Blood Collection ................................................................................................ 48

6.2.2 Peripheral Blood Collection ........................................................................................... 48

6.2.3 Blood Sample Blending .................................................................................................. 48

6.3 Sample Analysis ...................................................................................... 49

6.3.1 Work List ........................................................................................................................... 49

6.3.2 Sample Analysis in Closed Sampling Mode ................................................................ 52

6.3.3 Sample Analysis in Automatic Sampling Mode ........................................................... 54

6.3.4 Processing of Analysis Results ..................................................................................... 58

CHAPTER 7 DETAILS .................................................................... 61

CHAPTER 8 ARCHIVES ................................................................ 64

CHAPTER 9 QUALITY CONTROL ................................................. 68

9.1 L-J Quality Control ................................................................................... 68

9.1.1 Setup ................................................................................................................................. 68

9.1.2 Analysis ............................................................................................................................ 69

9.1.3 Graphs .............................................................................................................................. 71

9.1.4 List ..................................................................................................................................... 72

9.2 X-B Quality Control .................................................................................. 74

9.2.1 Setup ................................................................................................................................. 74

9.2.2 Graphs .............................................................................................................................. 76


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9.2.3 List ..................................................................................................................................... 77

9.3 X-R Quality Control .................................................................................. 78

9.3.1 Setup ................................................................................................................................. 78

9.3.2 Analysis ............................................................................................................................ 79

9.3.3 Graphs .............................................................................................................................. 81

9.3.4 List ..................................................................................................................................... 83

9.3.5 Calculation ........................................................................................................................ 84

CHAPTER 10 CALIBRATION ......................................................... 86

10.1 Preparation before Calibration ................................................................. 86

10.2 Manual Calibration ................................................................................... 86

10.3 Auto Calibration ....................................................................................... 87

10.3.1 Calibration with Calibrator .............................................................................................. 88

10.3.2 Calibration with Fresh Blood.......................................................................................... 90

10.3.3 Inspection of Calibration Coefficient ............................................................................. 91

CHAPTER 11 EXIT ......................................................................... 92

CHAPTER 12 SERVICE ................................................................. 94

12.1 Daily Maintenance ................................................................................... 94

12.1.1 Replacement of Reagent ............................................................................................... 94

12.1.2 Clean ................................................................................................................................. 96

12.1.3 Upkeep.............................................................................................................................. 97

12.1.4 Fluidics Maintenance .................................................................................................... 103

12.2 Sleep ...................................................................................................... 107

12.2.1 Automatic Sleep ............................................................................................................ 107

12.2.2 Exit Sleep ....................................................................................................................... 107

12.3 Data Maintenance .................................................................................. 108

12.4 Logs ....................................................................................................... 108

12.5 System Status ........................................................................................ 109

12.6 Version Information ................................................................................ 109

12.7 Statistical Information .............................................................................. 110

12.8 Mechanical Check ................................................................................... 111

12.9 Prompt of Sampling Probe Replacement ................................................ 112

12.10 Fuse Replacement .................................................................................. 113

CHAPTER 13 TROUBLESHOOTING ........................................... 114

APPENDIX I: NAMES AND CONTENTS OF TOXIC/HAZARDOUS

SUBSTANCES OR ELEMENTS ..................................................... 120


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Chapter 1 Introduction

1.1 Introduction

1.1.1 Product Name Auto Hematology Analyzer

1.1.2 Model HA-86 (89)

1.1.3 Features

This analyzer has two sampling modes, i.e. Automatic and Closed. The Automatic sampling

mode provides the whole blood test mode and supports one-time start and

reciprocating sampling quantity can be up to 25 tube racks. The autoloader of HA-86

carries up to 5 tube racks, each of which holds up to 10 samples. The autoloader of HA-89

carries up to 10 tube racks, each of which holds up to 10 samples. The Closed sampling

mode provides the Whole Blood and Pre-diluted analysis modes. After sampling, the

analyzer performs the analysis automatically and provides WBC 5-part differentiation

results and scattergram, parameter results and histograms of RBC and PLT.

1.1.4 Parameters

The analyzer has two test modes, i.e. CBC and CBC+DIFF. The CBC mode provides 14

blood parameters and 3 histograms. The CBC+DIFF mode provides 24 blood parameters, 4

study parameters, 2 scattergrams, and 2 histograms.

Table 1-1 Parameter Table

Mode CBC CBC+DIFF

Parameter

WBC WBC

RBC RBC

HGB HGB

HCT HCT

MCV MCV

MCH MCH

MCHC MCHC

RDW-SD RDW-SD

RDW-CV RDW-CV

PLT PLT

MPV MPV

PCT PCT

PDW PDW

P-LCR P-LCR

- NEU%

- LYM%

- MON%

- EOS%

- BAS%

- NEU#

- LYM#

- MON#

- EOS#

- BAS#

Study Parameter

- ALY%

- ALY#

- IG%


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- IG#

Graph

WBC histogram -

RBC histogram RBC histogram

PLT histogram PLT histogram

- Main scattergram

- Side scattergram

Caution: (1) “-” indicates that the current test mode does not provide it.

(2) Study parameters are used for study only and can’t be used as

basis for clinical diagnosis.

1.2 Composition and Structure

The analyzer mainly includes shell assy, frame assy, optical system, power supply, sampling

assy, pump valve, bath assy, etc. Its structure is shown in the figure below.

Front View of Analyzer

1- Shell 2 - Sample Compartment 3 - Autoloader 4 - Tube Rack 5 – Aspirate Key 6 -

Open Compartment Door Key 7 - Status Indicator Board (Power Supply, Running, Alarm,

Laser)


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Back View of Analyzer

1 - Network Port 2 - Earthing Rod 3 - Waste Liquid Sensor 4 - Waste Liquid Tube

Connector 5 - Cleanser 6 - Diluent 7 - 86H Lyse 8 - 86D Lyse 9 - Power Supply

Connector (including 2 fuses)

Left Side View of Analyzer

1 - Power Supply Switch 2 - Power Supply 3 - Liquid Detection Sensor 4 - Liquid Valve

5 - Syringe 6 – Sample Compartment 7 - Liquid Pressure Sensor


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Right Side View of Analyzer

1 - Sampling Assy 2 - DIFF Bath 3 - RBC/HGB Bath 4 - Pump Assy 5 - Circuit Board

6- Cooling Fan

1.3 Performance

For performance indicators not specified in this section, they are applicable to both the Whole

Blood and Pre-diluted modes.

1. Blank

Table 1-2 Blank Requirements

Parameter Limits

WBC ≤0.2 x910 /L

RBC ≤0.02 x 1210 /L

HGB ≤1g/L

PLT ≤10 x 910 /L

HCT ≤0.5%

2. Carry-over

Table 1-3 Carry-over

Parameter Carry-over, %

WBC 0.5

RBC 0.5

HGB 0.5

PLT 1


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3. Repeatability

Table 1-4 Repeatability

Parameter Whole Blood Mode CV(%) or Absolute

Deviation Reference Range

WBC ≤2 (4~15) x 910 /L

RBC ≤1.5 (3.5~6) x 1210 /L

HGB ≤1.5 (110~180)g/L

HCT/MCV ≤1 35%~50% /(70~120)fL

PLT ≤4 (100~500) x 910 /L

MPV ≤4 /

NEU% ±4 (Absolute

Deviation) (50%~60%) and WBC ≥ 4 x

910 /L

LYM% ±3 (Absolute


910 /L

MON% ±2 (Absolute


910 /L

EOS% ±1.5 (Absolute


910 /L

BAS% ±0.8 (Absolute

Deviation) (0.5%~1.5%) and WBC ≥ 4 x

910 /L

4. Linearity

Table 1-5 Linearity

Parameter Whole Blood Mode (%) Measurement Range

WBC Within ±0.3 x

910 /L (1.0~6.0) x 910 /L

Within ±5% (6.1~99.9) x 910 /L

RBC Within ±0.05 x

1210 /L (0.30~1.00) x 1210 /L

Within ±5% (1.01~7.00) x 1210 /L

HGB Within ±2g/L (20~70)g/L

Within ±2% (71~240)g/L

PLT Within ±10 x

910 /L (20~125) x 910 /L

Within ±8% (126~999) x 910 /L

HCT ±3% or ±2HCT% 0-67%

5. Comparability


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Table 1-6 Comparability

Parameter Deviation Requirements, %

WBC Within ±3

RBC Within ±2

HGB Within ±2

PLT Within ±5

HCT/MCV Within ±2

6. Display Range

Table 1-7 Display Range

Parameter Value

WBC 0.00-999.99 x 910 /L

RBC 0.00-99.99 x 1210 /L

HGB 0-300 g/L

HCT 0.0-100.0%

PLT 0.0-9999.9 x 910 /L

1.4 Intended Use

The analyzer is mainly used to test human blood samples, make qualitative and quantitative

analysis of the visible components of blood, and provide the related information. It is suitable

for testing white blood cell quantity (WBC), red blood cell quantity (RBC), platelet quantity

(PLT), hematocrit (HCT), hemoglobin (HGB), and WBC 5-part differentiation. It is used in

experiments made by medical units, inspection units, disease control centers, scientific

research institutions, etc.

1.5 Technical Parameters

Testing

Principle:

WBC/RBC/PLT: Electrical impedance; HGB: Colorimetry; WBC

5-part differentiation: Laser scattering method

Measuring

Speed:

Automatic

Sampling Whole Blood mode: ≥60 tests/hour

Closed

Sampling

Whole Blood mode: ≤70s/test

Pre-diluted mode: ≤70s/test

Min. Blood

Volume: 1ml

Display: External PC

Connector: Ethernet port

Work

Environment: 15C~30C; RH 30%~85%; Air Pressure 70kpa-106kpa

Storage

Environment: 0C~40C; RH ≤ 85%; Air Pressure 50kpa-106kpa

Transport

Environment: Temperature -20℃~55℃; RH ≤ 93%; Atmospheric Pressure 50kPa~106kPa

Mains Input: a.c.100V-240V, 50Hz/60Hz


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Input Power: ≤600VA

Analyzer

Noise: Standby ≤ 60dB; Running ≤ 66.5dB

1.6 PC Configuration

The operational software of this analyzer is installed on the PC. The recommended PC

configuration is as follows:

CPU: 1.6GHz or above

Memory: 512MB or above;

HDD Capacity: 160GB or above;

Display: Best Display Resolution 1366*768

OS: Microsoft Windows XP、Windows Vista、Windows 7 or above;

Hardware Configuration: At least one network port is used to connect to the analyzer.

If the analyzer needs to be communicated with the lab information system, dual NIC

is required. Two USB ports.

Before using the analyzer, set the IP address of the PC to the fixed address 192.168.1.64

and the subnet mask to 255.255.255.0. For the specific operations, refer to the Help file of

Windows.

1.7 Model of Vacuum Blood Collection Tube

In the Closed Sampling mode, the test tubes of the following specifications can be used:

Ф13 x 75(mm) (excluding cap size) Vacuum Blood Collection Tube, applicable to the

Whole Blood mode;

Ф10.25 x 64(mm) (excluding cap size) BD Vacuum Blood Collection Tube, applicable

to the Whole Blood mode;

Ф11.5 x 66(mm) (excluding cap size) SARSTEDT Vacuum Blood Collection Tube,

applicable to the Whole Blood mode;

Ф11 x 40(mm) (1.5ml centrifuge tube), applicable to the Pre-diluted mode;

Ф8.5 x 40(mm) (excluding cap size) 0.5ml MiniCollect Blood Collection Tube,

applicable to the Pre-diluted mode.

Each type of blood collection tube can be used normally when it is used with the

corresponding type of adapter. The figure below shows three types of adapter:


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Adapter 1 Adapter 2 Adapter 3

Put the corresponding adapter into the sample compartment. The corresponding

relation between each type of blood collection tube and the adapters is shown in the

table below. “√” indicates the type of blood collection tube uses that type of adapter.

Table 1-8 Corresponding Relation Table of Blood Collection Tubes and Adapters for

Closed Sampling

Adapter Specification Adapter 1 Adapter 2 Adapter 3

Ф13 x 75(mm) √

Ф10.25 x 64(mm)

√

Ф11.5 x 66(mm) √

Ф11 x 40(mm) √

Ф8.5 x 40(mm) √

The sample compartment is shown in the figure below:


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In the Automatic Sampling mode, the following test tubes can be used:


Whole Blood mode;

Ф10.25 x 64(mm) (excluding cap size) BD Vacuum Blood Collection Tube, applicable

to the Whole Blood mode;

Ф11.5 x 66(mm) (excluding cap size) SARSTEDT Vacuum Blood Collection Tube,


Ф13 x 65(mm) (excluding cap size) SARSTEDT Vacuum Blood Collection Tube,



Whole Blood mode.

For automatic sampling, each type of blood collection tube can be used normally when it

is used with the corresponding type of adapter or when the adapter is removed. The test

tube rack uses the following two types of adapter:

Adapter 1 Adapter 2

Put the corresponding adapter into the test tube rack. The corresponding relation

between each type of blood collection tube and the adapters is shown in the table below.

“√” indicates the type of blood collection tube uses that type of adapter.


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Table 1-9 Corresponding Relation Table of Blood Collection Tubes and Adapters for

Automatic Sampling

Adapter Specification Adapter 1 Adapter 2

Ф13 x 75(mm) √

Ф10.25 x 64(mm)

√

Ф11.5 x 66(mm) √

Ф13 x 65(mm) √

Ф15 x 75(mm)

If the φ15 x 75(mm) Vacuum Blood Collection Tube is used, the test tubes can be put

into the test tube rack only after the adapter on the test tube rack has been removed, as

shown in the figure below:

Note: The height of the vacuum blood collection tube including the cap size does not

exceed 83mm.

1.8 Barcode Specification

The sample barcode symbology and barcode digits supported by the built-in barcode

scanner are show in the table below.

Barcode Type Number of Digits of Barcode

Code 39 1~20

Code 128 1~20

ITF25 Even number between 1~20

Codabar 1~20

UPC/EAN Controlled by built-in barcode scanner

CODE 93 1~20

Barcode Height: A≥10mm

Barcode Label Width: B ≤45mm

Clear Zone on Both Sides of Barcode: C ≥5mm


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Width to Narrow Ratio of Barcode: 2.5:1 to 3.0:1

Barcode Precision: Above 0.127mm

Barcode Quality: According to the ANSI MH10.8M standard, ≥ Level C

For correct reading of barcode, the barcode should be affixed within the range of 50mm

shown in the figure below.


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Chapter 2 Operation Principle

2.1 Overview

This analyzer adopts the Coulter Principle to test the quantity and volume distribution of WBC,

RBC and PLT, adopts the colorimetry to measure hemoglobin concentration, and adopts the

semiconductor laser flow cell analysis technique to obtain WBC 5-part differentiation. Based

on this, the analyzer calculates the results of other parameters.

2.2 Sample Aspiration

In the Whole Blood work mode, the analyzer aspirates 20μL (CBC+DIFF mode) or 10μL

(CBC mode) whole blood sample.

In the Pre-diluted work mode, you should first blend the 20μL peripheral blood sample and

180μL diluent outside the analyzer to form a 1:10 diluted sample, and send the diluted

sample to the analyzer for sampling. Here, the analyzer aspirates 80μL (CBC+DIFF mode) or

40μL (CBC mode) diluted sample.

2.3 Diluted Sample

The sample to be analyzed, after aspirated to the analyzer, is divided into two parts, which,

through the different reagent effects during dilution, form the test samples used for WBC test

/HGB measurement, RBC/PLT measurement, and WBC differentiation measurement

respectively. According to the different needs, the analyzer provides two analysis modes, i.e.

Whole Blood and Pre-diluted analysis modes.

1) Dilution Ratio of Each Channel in Whole Blood Mode

WBC test /HGB measurement channel: 1:370

RBC/PLT measurement channel: 1:18000

WBC differentiation channel: 1:100

2) Dilution Ratio of Each Channel in Pre-diluted Mode

WBC quantity /HGB measurement channel: 1:760

RBC/PLT measurement channel: 1:24420

WBC differentiation channel: 1:250

2.4 White Blood Cell (WBC) Measurement

The basic principle for WBC testing is the electrical impedance method (Coulter Principle)

and laser scattering method.

The testing principle for the electrical impedance method (Coulter Principle) is shown in the

figure below.


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During the test with the electrical impedance method, the sample being tested, after diluted,

enters the WBC test unit which has a small opening called “Detection Aperture”. The aperture

has a pair of positive and negative electrodes on both sides that are connected to the

constant current power supply. As blood cells have the features of bad conductor, when the

blood cells in the diluted sample pass through the test aperture under the constant negative

pressure, the resistance between electrodes will change, thus forms a pulse signal with the

size in proportion to the volume of the cell on both ends of the electrode. When the cells pass

through the aperture continuously, a series of electrical pulses will be produced on both ends

of the electrode. The quantity of these electrical pulses reflects the number of blood cells.

Compare the amplified electrical pulses collected with the channel voltage threshold

corresponding to the normal WBC range, and calculate the number of electrical pulses in the

WBC channel of the electrical pulse amplitude. Thus, all electrical pulses collected are

classified according to the different channel voltage thresholds, and the number of electrical

pulses in the WBC channel is the number of WBCs. The number of cells in each channel

range divided based on the pulse voltage amplitude decides the volume distribution of cells.

The two-dimensional diagram with the x-coordinate representing cell volume and the

y-coordinate representing relative cell quantity is the histogram reflecting the cell population

distribution.

In the laser scattering method, when a certain amount of diluted blood sample is injected into

the flow cell, wrapped by the sheath fluid formed by the diluent, the cells lining up one by one

pass through the center of the flow cell. When the blood cells suspending in the sheath fluid

pass through the laser detection area, the blood cells are irradiated by the laser beam, and

the nature of the scattered light produced is relating to the cell size, cytomembrane, and

refractive index of the internal structure of cell. The schematic diagram of laser scattering

method is as follows:


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The small-angle, large-angle and side-angle scattered lights in the direction of laser beam

are measured, which reflect the size of blood cell, complexity of cell nucleus, and granularity

respectively. The DIFF channel scattergram is obtained based on these scattered lights, as

shown in the figure below. From the scattergram, the respective proportion of lymphocyte,

monocyte, eosinophil, neutrophil and basophil in the total number of WBCs can be obtained.

BASOMON

LYM

NEUT

EOSSiz

e

Complexity

Siz

e

Granularity

MON BASO

LYM

2.5 Hemoglobin Concentration (HGB) Measurement

In the colorimetric pool, after lyse is added to the diluted sample, the RBCs are dissolved,

and hemoglobins are released. The hemoglobins are combined with the lyse to form


24

hemoglobin compound. At one end of the colorimetric pool, let the LED light tube emit

monochromatic light with the wavelength of 550nm to irradiate the hemoglobin compound. At

the other end, the phototube receives transmission light; the optical intensity signal is

amplified and converted to voltage signal which is compared with the voltage produced by

the blank transmission light measured before the sample is added to the colorimetric pool

(that is, there is only diluent in the colorimetric pool) to obtain the HGB of the sample.

2.6 Red Blood Cell (RBC)/Platelet (PLT) Measurement

The analyzer uses the principle of impedance method to test the number of RBCs/PLTs in the

RBC analysis unit. The test unit has a small opening called “Detection Aperture”. The

aperture has a pair of positive and negative electrodes on both sides that are connected to

the constant current power supply. As blood cells have the features of bad conductor, when

the blood cells in the diluted sample pass through the test aperture under the constant

negative pressure, the resistance between electrodes will change, thus forms a pulse signal

with the size in proportion to the volume of the cell on both ends of the electrode. When the

cells pass through the aperture continuously, a series of electrical pulses will be produced on

both ends of the electrode. The quantity of these electrical pulses reflects the number of

blood cells.

Compare the amplified electrical pulses collected with the channel voltage threshold

corresponding to the normal RBC/PLT volume range, and calculate the number of electrical

pulses in the RBC/PLT channel of the electrical pulse amplitude. Thus, all electrical pulses

collected are classified according to the different channel voltage thresholds, and the number

of electrical pulses in the RBC/PLT channel is the number of RBCs/PLTs. The number of cells

in each channel range divided based on the pulse voltage amplitude decides the volume

distribution of cells. The two-dimensional diagram with the x-coordinate representing cell

volume and the y-coordinate representing relative cell quantity is the histogram reflecting the

cell population distribution.

2.7 Parameters

The parameters are calculated as follows:

White Blood Cell Quantity (WBC)

The analyzer obtains the WBC quantity by directly measuring the number of

electrical pulses corresponding to WBC.

Neutrophil Percentage (NEUT%)

%100channel DIFFin area in WBCquantity Particle

channel DIFFin area neutrophilin quantity Particle% NEU

Lymphocyte Percentage (LYM%)


channel DIFFin area lymphocytein quantity Particle% LYM

Monocyte Percentage (MON%)


channel DIFFin area monocytein quantity Particle% MON


25

Eosinophil Percentage (EOS%)


channel DIFFin area eosinophilin quantity Particle% EOS

Basophil Percentage (BAS%)

%100% channel DIFF in area WBCinquantity Particle

channel DIFF in area basophil inquantity ParticleBAS

Neutrophil Quantity (NEUT#)

%# NEUTWBCNEU

Lymphocyte Quantity (LYM#)

%# LYMWBCLYM

Monocyte Quantity (MON#)

%# MONWBCMON

Eosinophil Quantity (EOS#)

%# EOSWBCEOS

Basophil Quantity (BAS#)

%# BASWBCBAS

Hemoglobin Concentration (HGB)

intensity light Sample

intensity light Backgroundonstant LNCHGB

Red Blood Cell Quantity (RBC)

The analyzer obtains the RBC quantity by directly measuring the number of

electrical pulses corresponding to RBC.

Mean Corpuscular Volume (MCV)

MCV is obtained from the RBC histogram.

Hematocrit (HCT)

10

RBCMCVHCT

Mean Corpuscular Hemoglobin (MCH)

RBC

HGBMCH

Mean Corpuscular Hemoglobin Concentration (MCHC)

100HCT

HGBMCHC

Red Cell Distribution Width - Coefficient of Variation (RDW-CV)

RDW-CV is obtained from the RBC histogram, with the unit of %.

Red Cell Distribution Width - Standard Deviation (RDW-SD)

RDW-SD is obtained from the RBC histogram, with the unit of fL.

Platelet Quantity (PLT)

The analyzer obtains the PLT quantity by directly measuring the number of electrical

pulses corresponding to PLT.

Mean Platelet Volume (MPV)

MPV is obtained from the PLT histogram.


26

Platelet Distribution Width (PDW)

PDW is obtained from the PLT histogram and is a heterogeneity parameter

reflecting the platelet volume, with the unit of fL.

Platelet Hematocrit (PCT)

10000

PLTMPVPCT

Platelet Large Cell Ratio (P-LCR)

%100quantity particle PLT

area cell large PLT inquantity ParticleLCRP , with the unit of %.


27

Chapter 3 Installation

3.1 Unpacking

3.1.1 Steps of Unpacking

Unpack the analyzer and remove the materials for transport. Keep the packing case and

packing materials properly for future repacking.

1) Put the packing case upright and ensure the arrow on the packing case points upward.

2) Open the side plates of the packing case with tools, take out the accessories and check

the objects against the accessories list. If any object is missing, immediately inform

MRC’s Customer Service Department or the retailer. Check the contents in the packing

case and check that the following are included:

HA-86(89) Analyzer

User’s Manual

Packing List&QC Certificate

HA-86(89) System Software CD

HA-86(89) Brief Operating Instruction

Power Cable

Network Cable

Protective Grounding Wire

Fuse 250V 10A

LASER Key

Bottleneck Holder

Waste Bottle Lid Assembly

Diluent Bottle Lid Assembly

Cleanser Bottle Lid Assembly

86H Lyse Bottle Lid Assembly

86D Lyse Bottle Lid Assembly

3) Take out the upper buffer. At least four persons carefully take the analyzer from the

packing case by grasping the carrying handles at the bottom on both sides of the

analyzer and put it on the operation desk.

4) Unbind the movable mechanism, such as sampling assy, etc.

Caution: The accessories packed should be consistent with the packing list.

If any component is missing or damaged or any accessory is

inconsistent with the packing list, please contact the retailer.

3.1.2 Handling Method

Ensure to securely bind the movable mechanism, such as sampling assy, etc.,

particularly the sampling probe should be put on the top, before handling.

For short-distance transport in the smooth and steady condition, a trolley, etc. can be

used.

During handling and transport, take care to protect the front panel, sampling probe,

and liquid path connector on the rear side against external force or contact with other


28

objects or damage.

During handling and transport, the product must be kept upright and must not be

inclined or put on its side.

Try to avoid vibration during handling. After handling, check and debug the machine

before use.

Caution: (1) Keep the packing case for packing before long-distance transport. The analyzer must be put on a level operation desk, rather than angular surface.

(2) The analyzer is heavy. Prevent it from falling and injuring people.

3.2 Installation and Use Environment

This analyzer must be installed by professionals. In order to ensure the analyzer works

normally, put it in a workplace meeting the following requirements:

No direct sunshine;

No large amounts of dust;

No strong electromagnetic radiation;

Easy power off operation;

A level, solid desk that is big enough;

With good ventilation;

Avoid moist and high temperature;

Avoid violent vibration and impact.

Caution: (1) The normal working environment for the analyzer is

temperature 15~30℃ and HR 30%~85%.

(2) After installation, try to avoid frequent movement. To move the

analyzer, use a steady cart. The angle of inclination should not

be greater than 15° when it is moved.

(3) It must be installed and moved by authorized professionals

3.3 Requirements of Power Supply

a.c.100V-240V

50Hz/60Hz

≤ 600VA


29

Warning: (1) The AC power supply must be well grounded.

(2) Check that the input voltage meets the requirements of the

analyzer. The AC power supply must be stable. Sharing a

power supply with high power electrical appliances is

prohibited. It is better to be equipped with a regulated power

supply.

(3) Before connecting the electric cable, check that the switch of

the analyzer is off.

(4) In case of smog, peculiar smell or abnormal noise, immediately

turn off the power and contact the retailer.

(5) To unplug the electric cable, grasp the plug, rather than the

wire.

3.4 Installation

a) Space Requirements: The distance between the right door of the analyzer and the wall

shall be ≥ 100cm, and the distance between the rear side of the analyzer and the wall

shall be ≥ 50cm. Make sure there is adequate space on the operation desk and under

the analyzer for the diluent, cleanser and waste liquid containers. (Ensure the space for

repair and maintenance; consider the heat dissipation of the analyzer and protect the

liquid path tube on the back of the analyzer against extrusion which may impact the

normal flow of reagents);

b) Use a network cable to connect the analyzer and the external PC, and use an electric

cable to connect the analyzer to the circuit;

c) The cleanser, diluent, lyse and waste liquid containers are connected to the connectors

on the analyzer respectively according to the silk-screen mark.


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Chapter 4 Start-Up

4.1 Precautions before Power-on

Before you power on the analyzer each time, pay attention to the following to ensure the

system is ready:

Reagents

You should use the reagents designated by the Company and store and use them

strictly according to the instructions of the reagents.

Before using the analyzer, check that the reagents are connected correctly.

Before use, ensure the reagent bottles or containers have adequate reagents.

Waste Liquid Container

Check whether the waste liquid container is full. It is suggested to empty the waste

liquid container before powering on the machine.

Liquid Tube

Check whether the reagent and waste liquid tubes are bent and whether the

connection is reliable.

Power Supply

Check whether the power plug of the analyzer has been fully inserted into the power

socket.

Keyboard, Mouse, and External PC

Check whether the network cable of the external PC has been connected to the

analyzer.

Check whether the power cables of the keyboard and mouse have been connected

to the external PC.

Check whether the IP address of the external PC has been set to 192.168.1.64 and

whether the date/time is consistent with the fact.

Printer (optional)

Check whether the paper for the printer is adequate and whether it is installed in

place. Check whether the power plug of the printer has been inserted into the power

socket and whether its electric cable has been connected to the external PC.

4.2 Logging on System

To start the analyzer

1. Turn on the power of the analyzer.

2. Check that the indicator on the analyzer is lit up.

To start the external PC and run the software

1. Turn on the external PC.

2. Turn on the display.

3. After the PC is started and enters the OS, run the software kit installed.

4. After the software is started, the login dialogue box will be popped up, as shown in

the figure below:


31

The initial administrator username and password are admin.

Caution: Password is shell-sensitive.

5. Input the correct username and password and click the “Login” button, and the

analyzer will execute the startup initialization operation, as shown in the figure below:

NOTE: (1) Before running the software, check that the electric cable of the external PC has been connected to the analyzer. If the analyzer is not connected to the PC, wait till the two are connected. The analyzer will begin to execute the initialization operation. If they are not connected within 1 minute, the system will enter the analysis software automatically.

(2) In case of error during startup, you can make troubleshooting by referring to “Troubleshooting” in this Manual. If the error can’t be resolved, contact our Customer Service Department or the agent.

(3) When the analyzer is being powered on, the sequence of starting the analyzer and running the system software is not restricted.


32

6. During the initialization, the cleaning and blank test will be performed. When the

blank test is ended, the system will enter the sample analysis interface and display

the result of the blank test, as shown in the figure below:

For the blank test, only the test values of WBC, RBC, HGB, HCT, and PLT are displayed. The

acceptable range is as follows:

Table 3-1 Acceptable Limits of Blank

Parameter Limits

WBC ≤ 0.2 x 109 / L

RBC ≤ 0.02 x 1012

/ L

HGB ≤ 1g / L

HCT ≤ 0.5%

PLT ≤ 10 x 109 / L

NOTE: (1) The blank test refers to the measurement of the background noise by the analyzer.

(2) If the result of the first blank test during start-up is out of the range, the analyzer will automatically run a blank test again.

(3) The serial number of the result of blank test is “0”. (4) If the test is performed when the result of blank test is out of the range, an

unreliable test result will be obtained.

7. After the initialization is finished, if you have selected to execute analysis according to

the worklist, when any entry is detected to be not screened in the list, the following

prompt box will be popped up on the interface:

Click “Yes” and take the first entry not shielded in the worklist as the next sample to be

analyzed.

Click “No” to shield all entries in the worklist.


33

Chapter 5 System Setup

The analyzer has been initialized before leaving factory. You can set some parameters to

meet the different needs, In order to ensure the safety of setup and data, the analyzer divides

the operators into administrators and common users and open different setup functions for

different user authorities. Administrators have higher authority than common users and can

set more items.

The setup functions for an operator logging as an administrator are described below.

5.1 Normal Limits

The range of normal values is the range of reference values based on different normal

groups. If the analysis result is out of the range of normal values, this will be deemed clinical

abnormality. On the interface and the printed report, “↑” indicates the analysis result is higher

than the upper limit of the range of normal values; “↓” indicates lower than the lower limit.

The analyzer has universal, adult male, adult female, child, infant, newborn, and 10

user-defined reference ranges. The default setting is “General”. You should select

appropriate reference groups according to the actual situation of the samples and set

appropriate range of reference values.

From the Population Classification dropdown box, select the class to be set, and the software

will automatically read the corresponding setting. The default upper and lower limits of

user-defined reference ranges are 0. In the edit box, input the corresponding values and click

the “Save” button to save the current settings.

On the System Setup interface, select the “Normal Limits” item to enter the Range of Normal

Limits Setup interface, as shown in the figure below:

To check the information on the range of reference values or modify the name, age range


34

and sex of a user-defined reference group, click the “Set Reference Group” button to open

the Reference Group Setup dialogue box, as shown in the figure below:

The reference group name and other information of the 6 fixed reference groups in the list of

reference groups can’t be modified. You can modify the name, age range, and sex of the 10

user-defined reference groups as needed.

Caution: (1) The reference group name must not be empty.

(2) The name of a user-defined reference group must not be the

same as that of any fixed reference group, and the names of the

user-defined reference groups must be different from each

other.

If “Automatically match user-defined reference groups according to the sex and age” is not

selected, when the sample information is input, the system will automatically select one of the

fixed reference groups according to the sex and age. Otherwise, the system will select a

matching group from the fixed reference groups and user-defined reference groups, and you

need not to input the information manually.

5.2 Units

This analyzer provides 6 fixed units and 1 user-defined unit. You can directly select fixed

units or define the units of the parameters according to the actual needs. The units of all

modules of the system are set here.


35

For other options other than “User-defined”, the units of the parameters can be viewed only

and can’t be modified. If “User-defined” is selected, the units of the parameters can be

modified .Click the “Save” button to save the user-defined unit settings.

5.3 Print

Default Printer

The default printer will be used for the printing for all modules. If you have modified

the default printer in the Windows OS, the printer name in this combo box will

change. At the same time, if the printer is modified here, the default printer in the

Windows OS will also change.

Format of Report

For report printing, A4, A5, and B5 are supported. The formats include 1. A5 all

parameters with graphs; 2. A5 all parameters without graphs; 3. A4 all parameters


36

with graphs; 4. A4 all parameters without graphs; 5. B5 all parameters with graphs;

6. B5 all parameters without graphs. “All parameters” means all parameters

measured by the analyzer are printed. The parameters to be printed can be

modified with the “User-defined” function. “With graphs” means histograms and

scattergrams are printed.

Reporting Title

The name of the unit printed on the report heading.

Remarks of Report

Printed in the bottom left corner of the report to explain the report.

Auto Printing

If “Auto Printing” is selected, when the sample analysis is ended, the test result will

be printed automatically.

Auto Printing after Verification

If this option is selected, the test result will be printed automatically after the sample

has been verified on the List Review and Details Review interfaces.

Printing Alarm Flag

If this option is selected, the alarm messages of the parameters and graphs will be

printed on the sample result report.

User-defined

Click the “User-defined” button to open the following dialogue box:

On the Sample Information tab, the fields and sequence of printing of the report can


37

be set. The items added to the right list are the printing items, and the printing

sequence is from top to bottom. On the Result tab, the number and sequence of

printing parameters can be set. There are CBC and CBC+DIFF templates for setup.

The number of parameters of each template and their sequence on the report are

adjustable.

Font Size

“Title Font Size” is used to set the font size of the heading of the report to be printed;

“Fields Font Size” is used to set the font size of the sample information fields and

inspection information fields; “Results Font Size” is used to set the font size of the

test parameters and results.

5.4 Time and Language

It is used to set the date and time and their formats as well as the language used by the

software.


38

5.5 Optional Functions

Sample No.

The start sample number of each day can be set, with the default of 1. The sample

number for the day is the last sample number plus 1. To use a date prefix, tick the

Use Prefix option. An example of the sample number format is 201312091. By

default, this option is not ticked.

Automatically delete finished entries in the worklist

If “Analysis according to Worklist” is selected, when the sample analysis is ended,

the corresponding sample entry in the worklist will be deleted automatically.

Prompt for Pre-diluted Mode

In the sample analysis, if the blood sample mode is Pre-diluted, when the analysis is

going to begin, the system will prompt whether to analyse in the Pre-diluted mode. If

you select “Yes”, the analysis in the Pre-diluted mode will begin; if you select “No”,

no operation will be executed.

Analysis according to Worklist

If this option is selected, the test and analysis will be performed according to the

sample information input in the worklist. Each sample newly analyzed matches the

entry “To be Run” in the worklist.

After verification, automatically skip to the next sample to be verified

If this option is selected, after the sample is verified on the Details Review interface,

the system will automatically display the next sample not verified.

Display research use parameters

If this option is selected, when the sample analysis is ended, you can click the

“RUP” button to open the Research Use Parameters interface to view the result of

the research use parameters.

Verifier

When you enter the interface for the first time after installing the software, if you

have the verification authority, the field will display your username by default;


39

otherwise, it will display the username of the first operator with verification authority

in the User Management list by default.

The dropdown list displays all usernames with verification authority set on the User

Management interface. After the settings are saved, if you have the verification

authority, when the verification operation is executed successfully, the Verifier field

will display your name set here; otherwise, the username in the login dialogue box

popped up will be displayed.

Use Barcode Scan

If the autoloader is equipped with a barcode scanner, select this option to enable the

Barcode Scan function.

Scan Tube Rack No. Automatically

After selecting the Use Barcode Scan function, you can select “Scan Tube Rack No.

Automatically”. The tube rack number will be obtained from the barcode affixed to

the test tube rack.

Scan Sample No. Automatically

After selecting the Use Barcode Scan function, you can select “Scan Sample No.

Automatically”. The sample number will be obtained from the barcode affixed to the

test tube.

Display Statistical Information Automatically

After selecting the “Display statistical information automatically when auto sampling

ended” option, after the automatic sampling analysis, the analyzer will pop up the

following dialogue box automatically which displays the statistical result of this

automatic sampling.

Obtaining of blood sample/analysis mode failed and adopt mode for previous

sample to continue analysis

If this option is selected, in the automatic sampling, when “Analysis according to

Worklist” is selected and no entries in the worklist are matched, or in the System

Setup -> Communication Setup module, the communication mode is set to Two-way

and no sample information is obtained from the LIS/HIS server, the sample will be

analyzed in the mode for the previous sample, otherwise, this sample will be

skipped.

Alarm Buzzer

After the Alarm Buzzer is started, the buzzer in the analyzer will give alarm sound in

case of alarm; if the Alarm Buzzer is turned off, the buzzer will not give alarm sound.


40

5.6 Shortcut Input

When Shortcut Input is set, you can input the item information of a sample with the

shortcut code, without inputting the full name. The items that can be set include

department, deliverer, patient type, sex, and charge type.

Add

Input the field name, shortcut code, and remarks in the fields of “Edit Information”. If

“Default item of sample profile” is selected, before the sample information is input,

the default set will be displayed in the corresponding field. It is suggested to use

numbers and letters or their combination to form a shortcut code. The remarks

information can be empty

Modify

When an item is selected, the information on this item can be modified.

Delete

When an item is selected, this item can be deleted, and the sample information

fields input for this item will also be deleted.


41

5.7 User Management

Add

The “Add” function is used to add users. Click the “Add” button to open the following

Add User dialogue box:

Input the contents in the edit box, click the “Authority” combo box, and set the

authority of the new user to “Common User” and “Administrator”. If it is set to

“Common User”, you can select whether to open the verification authority; if it is set

to “Administrator”, the verification authority is opened by default, which can’t be

changed. Click “OK” to save the settings or “Cancel” to directly exit.

Edit

In the user list, click the user cell to be modified. Click the “Edit” button to pop up the

following dialogue box:


42

You can modify your username and authority as needed. Click the “OK” button to

save the user information modified.

Caution: (1) The username must not be empty or repeated.

(2) If the administrator who has logged in changes his authority to

that for “Common User”, the settings will be valid only after he

logs out and logs in again.

Delete

In the user list, select a user line and click the “Delete” button to pop up the

confirmation dialogue box. After you click “OK”, the current user will be deleted.

Caution: (1) The current user may not be deleted.

(2) The user admin may not be deleted.

Change Password

“Change Password” is used to change the password of the current user. Input the old

password of the user correctly, input the new password, click “OK”, and the system will

prompt “The password has been changed”. Click “OK” to exit the “Change Password”

dialogue box.


43

5.8 Maintenance

Auto-sleep Waiting Time

When there is no action of the fluidics, the analyzer will enter the sleep mode

according to this set time, with the range of 10 to 60 minutes and the default of 30

minutes.

Time of Cleanser Soak

It is used to set the time of soak in cleanser, with the range of 10 to 30 minutes and

the default of 10 minutes.

Frequency of Automatic Cleanser Soak

Used for setting how many tests can be performed before “Soaking in Cleanser”

operation start automatically, with the range of 30 to 150 pcs and the default of 100

pcs. If the analyzer kept power on without “Soak in Cleanser” performed for 24

hours, the “Soak in Cleanser” operation will also be started automatically.

Frequency of Automatic Concentrated Cleanser Soak

Used for setting how many tests can be performed or how long time keep working

before the “Soak with Concentrated Cleanser” operation start automatically, with the

range of 200 to 800 samples and the default of 400 samples or the range of 1 to 7

days and the default of 7 days.


44

5.9 Abnormal Prompt

You can set some alarm prompts of the analyzer on this interface. If the result of analysis

exceeds the alarm limit set, the analyzer will give the corresponding text prompt. For

Immature Gran, Left Shift, Atypical/Abn Lympho, etc., the analyzer will display information

according to the internal judgment standard, and you need not to set it.

5.10 Communication

It is used to set the parameters of data communication between the analysis software of the

analyzer and the external information system (such as LIS).

When the operational software is opened, the system will automatically connect to the

workstation according to the communication address set. After the system is connected to

the workstation, the connection icon of the LIS will display the Connected status; otherwise it

will display the Disconnected status.


45

Interface Setup

Including IP address and port. Fill in the IP address and port number of the main

machine of the external information system connected to this system.

Communication Mode

Including one-way and two-way modes. One-way: Sending test results and other

information to the external information system only and not obtaining sample/patient

information from the LIS/HIS. Two-way: Sending test results and other information

to the external information system and obtaining sample/patient information from the

LIS/HIS.

Send result instantly

If this option is selected, each time a analysis result comes out, the system will send

the result to the external information system automatically. When the

communication mode is set to “Two-way”, this check box will be selected

automatically and be greyed out, that is, it can’t be set to “Off”.

Wait for Communication Response

If this option is selected, whenever the operational software sends a sample result

or Quality Control result message, it will wait for ACK. When the ACK is received or

in the event of timeout, it will send the next message. If this option is not selected,

after the operational software sends a sample result or Quality Control result

message, it will immediately send the next one and ignore the ACK message sent

by the LIS.

Mode of Histogram Transmission

(1) Not Transmit: The histogram is not transmitted during communication for

sample entries;

(2) Transmit with bitmap: The histogram is directly transmitted to the LIS/HIS of

the client in the form of graph during communication for sample entries;

(3) Transmit with binary data: The histogram is transmitted to the LIS/HIS of the

client in the form of raw binary data respectively during communication for

sample entries.

The default is “Not Transmit”.


46

Mode of Scattergram Transmission

(1) Not Transmit: The scattergram is not transmitted during communication for

sample entries;

(2) Transmit with bitmap: The scattergram is directly transmitted to the LIS/HIS of

the client in the form of graph during communication for sample entries;

(3) Transmit with binary data: The scattergram is transmitted to the LIS/HIS of

the client in the form of raw binary data respectively during communication for

sample entries.

The default is “Not Transmit”.

5.11 Optional Item

Through the setup of this module, blood type input can be added.

Select “Input Blood Type” and click the “Save” button to save the settings, and ABO blood

type and Rh blood type input and selection box will be added to the Worklist and Details

Review interfaces, where you can input blood type and print it on the report.

5.12 Other

Enter this interface to view the serial number of the analyzer.


47


48

Chapter 6 Daily Operations

6.1 Daily Quality Control

Quality Control analysis of the analyzer should be performed before sample analysis. For the

specific operations, see Chapter 9 “Quality Control”.

6.2 Sample Preparation

Blood sample collection is divided into venous blood collection and peripheral blood

collection.

Warning: Do not directly touch the blood sample, QC or calibrator. The

disposal of such items must follow the relevant SOP.

6.2.1 Venous Blood Collection

Venous blood can be collected with a vacuum negative pressure tube or with the common

collection method under ordinary pressure. Anticoagulant must be dropped to all venous

blood collection containers beforehand. At present, EDTA.K2.2H2O is the commonly-used

anticoagulant, with the content of 1.5-2.2mg/mL.

In the Closed Sampling and Automatic Sampling modes, the volume of whole blood sample

must not be less than 1mL.

6.2.2 Peripheral Blood Collection

Blood Collection Site:

For adults, the appropriate collection site is the inner side of the fingertip of the middle finger

or ring finger of the left hand; for children above half a year old, the middle finger; for infants

under half a year old, the typical appropriate collection site is the thumb or the outer side of

the bottom of the foot.

Blood Collection Method:

The peripheral blood collection specification of the health department should be followed. In

general, the local puncture method is adopted for peripheral blood collection. The typical

collection method is collection through puncture in the fingertip. The blood collection tubes

are 20μL constant volume blood collection tubes or bullet shaped blood collection tubes. For

convenient review, it is suggested to use blood not less than 30μL.

In blood collection, in the event of poor blood flow, slightly apply pressure on the far end of

the wound. Never apply force around the puncture to prevent the interstitial fluid from

entering the blood, which may impact the accuracy of the result of test and analysis.

6.2.3 Blood Sample Blending

When running a test in the Closed Sampling mode, blend the sample manually. The

suggested method is: shake the test tube up and down and rotate it for 3-5 minutes. Do not

shake it too vigorously.


49

Caution: (1) The sample for WBC differentiation or PLT test should be stored in the room temperature and analyzed within 8 hours after collection.

(2) If the result of PLT, MCV or WBC differentiation is not needed,

the sample can be stored in a 2℃-8℃ refrigerator for 24 hours.

The refrigerated sample can be analyzed only after it is put in the room temperature for at least 30 minutes.

(3) The sample placed still for a period of time can be analyzed only after it is blended. If the sample has been placed still for too long or is not fully blended, the accuracy of the test result may be impacted.

6.3 Sample Analysis

All articles (sample, control, calibrator, reagent, waste liquid, etc.)

and areas in contact with such articles have the potential hazard of

biological infectivity. When touching the related articles and areas in

the laboratory, you should follow the Laboratory Safety SOP and wear

the personal protective equipment (such as laboratory protective

clothing, gloves, etc.)

Warning: (1) The sampling probe is pointed and may carry blood sample,

QC and calibrator with the potential hazard of biological

infectivity, so avoid touching the sampling probe.

(2) The test object of the analyzer is blood sample. If other

substances are sucked, the analyzer may not work normally.

Caution: (1) Do not used disposable goods repeatedly.

(2) If the vacuum blood collection tube is pierced repeatedly, the

rubber tube cap may be damaged, and the debris produced may

cause inaccurate analysis result. It is suggested to pierce a

blood collection tube no more than three times.

6.3.1 Work List

Before sample analysis, sample information can be input through the worklist. During sample

analysis, the settings in the worklist will be read automatically; when the sample analysis is

finished, the sample information will be saved to the database. Click the “Worklist” menu item

under the menu or the “Worklist” button on the toolbar to enter the Worklist interface, as

shown in the figure below:


50

The Worklist functions include Data Reading and Display, Add, Insert, Save, Delete, Search,

Screen, Copy, and Print.

Add: Adds an entry to the end of the worklist. The analysis status of the added entry

is “To be Run”.

Insert: Inserts an entry before the selected entry, and the serial numbers will be

resorted. If there is not any entry in the list, “Insert” equals to “Add”.

Save: Saves the entry information edited.

Delete: Deletes the selected entry. If the status of this entry is “Running”, it can’t be

deleted.

Search: Searches related entries according to the designated search criteria.

Search criteria include sample number, medical record number, and name. You can

select Fuzzy Search or Exact Search. The entries searched are highlighted in the

current list.

Shield: Shields the selected sample to be analyzed. This entry will be skipped in

analysis, and the next sample to be analyzed not shielded will be selected. Entries

being analyzed and analyzed can’t be shielded. Shielded entries can be edited and

deleted. If any shielded entry is selected, the button will become “Cancel”, and the

shielding of the selected entry will be cancelled and the selected entry will be greyed

out.

Copy: Copies the selected entry.

Print: Prints the selected entry in the worklist.

For a sample being analyzed, the sample number, sampling mode, and test mode cant’ be

modified. The information on a sample analyzed can’t be edited or modified. If edit or

modification is required, this should be performed in the history data.

If the sample information is set in the worklist, you can select whether to delete the entry

automatically when the analysis is ended. If you select “Not Delete”, when you check the

entry in the worklist, you can see the analysis status of the sample is “Finished”.


51

The input fields are described below:

Sample No.: The ID number identifying a sample. It can be directly input or read

with a barcode scanner. 20 characters and numbers are permited. In sample

analysis, if the last one or several digits of the Sample No. is or are numbers, the

Sample No. will be accumulated automatically; otherwise, the Sample No. is

generated with the default rule.

Sampling Mode: Automatic-Whole Blood, Closed-Whole Blood, and

Closed-Pre-diluted can be selected. The default is Automatic-Whole Blood.

Test Mode: The CBC+DIFF or CBC mode can be selected. The default is

CBC+DIFF.

Tube Rack No., Test Tube No.: If the blood sample mode is Automatic-Whole Blood,

then “Rack No.” and “Tube No.” are activated, and the position of the sample on the

test tube rack can be input.

Name: Up to 50 letters.

Sex: Male or Female can be selected. If none is selected, the default is empty.

Date of Birth: The date of birth of the patient. After the date of birth is input, the Age

field will be automatically calculated according to the difference between “Current

System Date” and “Date of Birth”, and the age value newly calculated and the unit

will be displayed in the Age Value edit box and the Unit combo box. If the date of

birth input is after the current date, the date of birth will be deemed invalid.

Age: The age value is input in the edit box, and the unit of age is selected. The unit

of age can be year(s) old, month(s), day(s), and hour(s). The range of values is

0-150. If 0 is input, the age value will not be displayed in the report printed.

Reference Group: Universal, Adult Male, Adult Female, Child, Infant, Newborn, and

10 user-defined reference groups can be selected, with the default of Universal. The

name, age range, and sex of user-defined reference groups can be set in “System

Setup”. The system will automatically match reference groups according to the sex

and age. If “Automatically match user-defined reference groups according to the sex

and age when the sample information is input” is selected in the reference value

setup, the user-defined reference groups will be included in the range of automatic

selection. When the age range of a user-defined reference group is the same as

that of a fixed reference group, the user-defined reference group will be selected. If

“Automatically match user-defined reference groups according to the sex and age

when the sample information is input” is not selected, then only the six fixed

reference groups will be matched. If the reference group matched is inconsistent

with the previous selection, the reference group automatically matched will be

adopted.

Charge: The type of fee payment for test of the patient.

Medical No.: The number of the medical record of the patient.

Bed No.: The number of the bed where the patient is located

Department: The name of the department can be directly input or selected from the

dropdown box.

Deliverer: The name of the deliverer can be directly input or selected from the

dropdown box.

Delivery Time: The time the sample is submitted can be directly input or adjusted


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with the increase/decrease button on the right side.

Patient Type: Can be directly input or selected from the dropdown box. The system

has set 4 patient types, i.e. Outpatient Service, Hospitalization, Emergency

Treatment, and Physical Examination.

Clinical Diagnosis: Information on suspected and diagnosed cases can be input

here.

Remarks: Information to be declared is input in the “Remarks” box.

NOTE: (1) Before sample analysis, the appropriate normal range should be set, otherwise,

incorrect alarm prompt will be obtained when the sample analysis is finished.

(2) If analysis is performed according to the worklist, other samples “To be Run” can

be added, edited, deleted, etc. during the analysis. For entries “Running”, the

“Sample No.”, “Mode”, “Rack No.” and “Tube No.” (in the Automatic Sampling

mode) in the information input area can be edited, but other information can’t.

(3) If analysis is not performed according to the worklist, the sample analysis has no

impact on the sample information input in the worklist.

(4) If “Two-way LIS/HIS Communication” is selected in Setup, after the sample

number is input with the keyboard or barcode scanner and saved, the related

information will be read from the LIS/HIS and the analysis will be performed

according to such information. When the analysis is finished, the result data,

graph, sample/patient information will be immediately uploaded to the LIS/HIS.

6.3.2 Sample Analysis in Closed Sampling Mode

For the analysis in the Closed Sampling mode, the sample should be blended manually. If a

standard test tube is used, the test tube needs not to be opened; if a centrifuge tube is used,

the test tube cap should be opened manually.

If the sample to be analyzed is a pre-diluted sample, it should be pre-diluted outside the

analyzer. The specific steps are:

1. Click the “Diluent” button on the toolbar, and the analyzer will automatically prepare

for diluent spitting and display the following dialogue box:

2. Put the test tube into the sample compartment door and close the compartment door.

Press the “Aspirate Key”, and the analyzer will aspirate 180uL diluent through the

sampling probe and prompt “Dispensing diluent…” on the interface. If you do not exit

the interface, the diluent can be spit continuously.

3. Collect 20uL peripheral blood, rapidly inject it into the centrifuge tube containing

diluent, cover the tube, and blend the contents.

4. Click the “Exit” button, and the analyzer will carry out cleaning. After the cleaning, the


53

prompt dialogue box will close automatically.

Caution: (1) You can also dispense 180uL diluent with the pipette.

(2) After the peripheral blood and the diluent fully react, the

solution should be placed still for 3 minutes and reblended

before analysis.

(3) The analysis should be finished within 30 minutes after the

sample is diluted, otherwise the analysis result may not be

reliable.

(4) To analyze the pre-diluted sample in the sample compartment,

the adapter supplied with the product should be used.

The sample anlsysis in the Closed Sampling mode can be performed on the “Analysis”

interface or “Details” interface. The specific operation steps are:

1. On the “Analysis” interface, click the “Next Sample” button to open the Setup dialogue

box, as shown below:

Select the corresponding sample type and test mode and click the “OK” button. The

sample compartment door will be opened automatically. Put the prepared sample into

the sample compartment and close the compartment door manually.

2. Click the “Start” button on the “Analysis” interface or the “Aspirate Key” on the front

shell of the analyzer, and the analyzer will begin to aspirate the blood sample for

analysis. The status bar of the software will prompt the sample analysis status, and

the green status indicator on the front shell of the analyzer will also flash, which

indicates the test is being performed. When the test is finished, the result and graph

of the parameter will be displayed, as shown in the figure below (take the Whole

Blood mode and CBC+DIFF mode as an example):


54

After aspirating the blood sample, the analyzer will open the sample compartment

door automatically. Take the test tube away.

3. Sample information can be input or modified before and after sample analysis:

a) Before analysis, sample information can be input in the worklist beforehand;

b) After analysis, sample information can be input on the Details interface.

4. To cancel the Closed sampling, click the “Next Sample” button to select the

Automatic Sampling mode.

NOTE: (1) When the system enters the Sample Analysis interface for the first time, the next

sample is the current sample.

(2) In the Closed Sampling mode, the Aspirate Key has the equivalent function to the

“Start” button on the interface.

(3) The Sample No. is generated automatically and can be changed according to the

actual situation. If the last digit of the Sample No. is a number, the Sample No.

can be accumulated automatically; otherwise, the next Sample No. will be

generated automatically by the system.

(4) If analysis is performed according to the worklist, the first entry that is not shielded

and is to be analyzed (or that is error) in the corresponding worklist is the next

sample to be analyzed in the Closed Sampling mode till the worklist becomes

empty or has no entries that are not shielded.

6.3.3 Sample Analysis in Automatic Sampling Mode

The sample analysis in the Automatic Sampling mode is performed with the autoloader. After

the autoloader is started, the analyzer will automatically complete tube rack pushing, test

tube blending, pierce, sampling and analysis, and result processing and display without

manual intervention.

Sample analysis mainly includes the following cases:

1. Neither automatically scan Sample No. or Tube Rack No. nor run analysis

according to the worklist

In System Setup, the “Analysis according to Worklist”, “Automatically Scan Sample


55

No.”, and “Automatically Scan Rack No.” options are not selected. Sample No. is

generated automatically or set by the user; Tube Rack No. is accumulated from 1.

The sample entries in the worklist are not impacted.

2. Not automatically scan Sample No. or Tube Rack No., but run analysis


In System Setup, the “Analysis according to Worklist” option is selected, but the

“Automatically Scan Sample No.” and “Automatically Scan Rack No.” options are

not. Before starting analysis, compare the information on the sample entries in the

worklist, indicate Sample No. on the prepared sample test tube label and put the

test tube into the corresponding test tube position.

NOTE: (1) The analyzer automatically runs analysis of the samples in the worklist that are

not shielded and are to be analyzed in the Automatic Sampling mode (or that is

error) in the sequence of the sample positions.

(2) The information on the next sample is obtained from the related information on

the entry at the foremost in the worklist that is not shielded and is to be

analyzed in the Automatic Sampling mode (or that is error).

(3) For analysis according to the worklist, if the current position has a test tube and

the worklist does not have the information on this test tube, and “Obtaining of

blood sample/analysis mode failed and adopt mode for previous sample to

continue analysis” is set in System Setup, then Sample No. is automatically

generated by the system and the analysis is performed in the analysis mode for

the previous sample, otherwise this test tube will not be grabbed and will be

skipped.

(4) If “Automatically delete finished entries in the worklist” is selected in Setup, the

samples analyzed will be automatically deleted from the worklist.

3. Automatically scan Sample No. and/or Tube Rack No., but not run analysis


In System Setup, the “Analysis according to Worklist” option is not selected, but the

“Automatically Scan Sample No.” and (or) “Automatically Scan Rack No.” option is

selected. The sample analysis has no impact on the sample information input in the

worklist. If the “Automatically Scan Sample No.” option is selected, affix the barcode

label with the method described in the “Barcode Label” section of this chapter. If the

“Automatically Scan Rack No.” option is selected, when the tube rack number scan

is invalid during the test, the test tubes on this tube rack will not be tested, and the

samples on the subsequent tube racks will be analyzed.

Caution: If the Sample No. displayed is “NOREAD”, this indicates the scan is invalid. You can re-input the sample number when reviewing the sample result.

4. Automatically scan Sample No. and/or Tube Rack No. and run analysis


In System Setup, the “Analysis according to Worklist” option and the “Automatically Scan

Sample No.” and (or) “Automatically Scan Rack No.” option(s) are selected. After the

analysis is started, the analyzer will begin to scan Sample No. and/or Tube Rack No. and

run analysis of the samples matching the work order in sequence. If the “Automatically

Scan Sample No.” option is selected, affix the barcode label with the method described


56

in the “Barcode Label” section of this chapter. If the “Automatically Scan Rack No.”

option is selected, when the tube rack number scan is invalid during the test, the test

tubes on this tube rack will not be tested, and the samples on the subsequent tube racks

will be analyzed.

NOTE: (1) If the “Automatically Scan Rack No.” option is not selected, the system will look

for the entries matching the sample number scanned in the worklist and assign

the Tube Rack No. and Test Tube No. of the sample to the entry (to override the

existing information input), and the analysis status of the entry will also be

changed from “To be Run” to “Running”.

(2) If the number scanned does not match the entry in the worklist or the number

scanned is wrong, and if “Obtaining of blood sample/analysis mode failed and

adopt mode for previous sample to continue analysis” is set in System Setup,

then the sample will be analyzed in the mode for the previous sample, otherwise,

this sample will be skipped.

(3) If the Sample No. displayed is “NOREAD”, this indicates the scan is invalid. You

can re-input the sample number when reviewing the sample result.

(4) If “Automatically delete finished entries in the worklist” is selected in Setup, the

samples analyzed will be automatically deleted from the worklist.

The specific operation process is as follows:

1. Put the test tube into the test tube rack and place the test tube rack on loading

platform on the right side horizontally in sequence, with the slot of the test tube rack on

the right side. The default analysis mode is CBC+DIFF. To change the mode, click the

“Next Sample” button to open the Setup dialogue box, as shown below:

Select the corresponding analysis mode, set the start sample number, tube rack

number and test tube number, and click the “OK” button.

NOTE: (1) Start the analysis in Automatic Sampling mode, and the “Next Sample” button will

be greyed out, which can’t be changed.

(2) The tube rack number and test tube number in the “Next Sample” setup are the

start positions, and the test tubes before these positions will not be analyzed. If

the tube rack number set is 1 and the test tube number is 3, then Samples 1-1

and 1-2 on the test tube rack will be skipped, and Sample 1-3 will be analyzed.


57

2. Click the “Start” button on the Sample Analysis interface or the Aspirate Key on the

front shell of the analyzer, and the analyzer will begin to push the test tube rack and

run blood sample analysis in sequence. If “Analysis according to Worklist” is

selected, the sample information will be automatically matched and saved. If the test

tube rack-test tube position where the sample is located is inconsistent with the

setting, and if “Obtaining of blood sample/analysis mode failed and adopt mode for

previous sample to continue analysis” is set, the next sample will be analyzed.

During blood sample analysis, the status bar of the software displays the status of

the current and next samples, and the green status indicator on the front shell of the

analyzer also flashes, which indicates the test is being performed. When the test is

ended, the test tube rack will be automatically pushed to the unloading tray on the

left side of the autoloader, and the result and graph of the parameter will be

displayed on a real time basis during the analysis. The figure below shows the result

when the running of the autoloader is ended (take the CBC+DIFF mode as an

example):

Click “Start”, and the button prompt will become “Stop”. Click this button, and the

autoloader will end the sample analysis and push the test tube rack in the feeding

area to the unloading tray, and will not continue to load other test tube racks to the

feeding area.

3. Sample information can be input or edited in the worklist before sample analysis, or

input or modified on the detailed review interface after the sample analysis is

finished.

4. To insert an STAT sample during the analysis in Automatic Sampling mode, click the

“STAT” button, and the autoloader will suspend operation. When the current sample

analysis is finished, the STAT Sample Information Setup dialogue box will be

popped up, and the sample compartment door will be opened automatically. You

can complete the subsequent operations according to the steps of sample analysis

in the Closed Sampling mode. After the STAT is inserted, the “STAT” button prompt

will become “Cancel STAT”. Click the “Cancel STAT” button to continue the analysis


58

in the Automatic Sampling mode.

5. When the analysis in the Automatic Sampling mode is ended, a Statistical Result

dialogue box will be popped up on the interface.

NOTE: (1) In “System Setup”, “Display statistical info. automatically when automatic

sampling ended” can be set.

(2) If the statistical value of the corresponding statistical item in the “Statistical

Info.” dialogue box is not 0, you can click the “Details…” button to view the

sample number, test time, and sample position of the corresponding sample.

6. When the automatic sampling is ended, all test tube racks have been automatically

moved to the left slot of the autoloader, and you can take the sample away safely.

7. You can enter the “List review” interface or “Details” interface to verify and print the

sample result. Before printing, the printing can be set through “System Setup”.

NOTE: (1) When the system enters the Sample Analysis interface for the first time, the next

sample is the current sample.

(2) In the Automatic Sampling mode, the Aspirate Key has the equivalent function to

the “Start” button on the interface.

(3) If analysis is performed according to the worklist, the next sample is the sample

entry that has the same tube rack number and test tube number, that is not

shielded and is to be analyzed in the Automatic Sampling mode (or that is error)

in the corresponding worklist. If the test tube barcode scan is selected, the test

tube barcode scanned will be corresponded to the sample number of the entry

in the Automatic Sampling mode in the worklist. If the same sample number is

found, the tube rack number and test tube number in the worklist will be

updated with the actual position of the test tube.

(4) If multiple test tube racks of sample are required for the analysis of a batch of

samples, the additional test tube racks should be put into the right side slot of

the autoloader during the sample analysis, and those in the left side slot should

be taken out timely.

6.3.4 Processing of Analysis Results

The analyzer can automatically save analysis results. When the number of samples tested

reaches the upper limit of storage, the earliest entry will be overridden. The upper limit of

sample result storage is 100,000 entries.

When the result analysis is finished, the analyzer will give alarms of parameters. The specific

alarm messages include:

“↑” and “↓” on the right side of the parameter result indicate the test result is out of the

set range of reference values of the parameter, but is still in the display range.

The parameter result “:::::” indicates aperture blockage or channel blockage.


59

The parameter result “-----” indicates that the parameter is invalid or can’t be

calculated.

“*” displayed together with the parameter result indicates the parameter result is

suspected.

The parameter result “+++++” indicates the parameter is out of the display range,

with its calculation parameters and relevant parameters replaced with “-----” and its

affected parameters added with “*”.

“+” displayed together with the parameter result indicates the parameter is out of the

measurement range, with its calculation parameters and relevant parameters added

with “*”.

The suspicion sign “*” of parameters indicates the confidence level of the parameter result is

not high. The possible causes corresponding to the parameters are shown in the table below:

Parameter Possible Causes

WBC Poor hemolysis Nucleated red blood cells, large PLT / PLT

Clumps interference Electrical noise and bubble interference Aperture blockage

NEU%, LYM%, MON%, EOS%, BAS%

Poor DIFF channel hemolysis Low-level white blood cell Nucleated red blood cells, large PLT / PLT

Clumps interference White blood cell fragment Electrical noise and bubble interference Dirty or blocked flow cell

HGB The analyzer has not been calibrated. High white blood cell interference, high lipid

blood sample Abnormal hemoglobin voltage

RBC Large PLT / PLT Clumps interference Small red blood cell interfered by platelet Abnormal red blood cell distribution Electrical noise and bubble interference Aperture blockage

PLT Large PLT / PLT Clumps Small red blood cell interference PLT Abn Distribution Electrical noise and bubble interference Aperture blockage

Alarm messages explain results with alarm. The specific contents are shown in the table

below:

Type Alarm Message Description

WBC Flag

WBC Abn Scattergram

Possible causes: The sample is abnormal. The flow cell is dirty or blocked.

WBC Abn Histogram

Possible causes: The hemolysis is poor. There is nucleated red blood cells, large PLT / PLT

Clumps interference.


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There is electrical noise and bubble interference. The aperture is blocked.

Leukocytosis WBC is greater than the set value (default: 18 x 109/L).

Leukocytopenia WBC is less than the set value (default: 2.5 x 109/L).

Neutrophilia NEU# is greater than the set value (default: 1 x 109/L).

Neutropenia NEU# is less than the set value (default: 1.0 x 109/L).

Lymphocytosis LYM# is greater than the set value (default: 4.0 x 10

9/L).

Lymphopenia LYM# is less than the set value (default: 1.0 x 109/L).

Monocytosis MON# is greater than the set value (default: 1.0 x 10

9/L).

Eosinophilia EOS# is greater than the set value (default: 0.7 x 10

9/L).

Basophilia BASO is greater than the set value (default: 0.2 x 10

9/L).

Blasts? In the DIFF scattergram, the number of particles in the Blasts area is big.

Immature Gran? In the DIFF scattergram, the number of particles in the Immature Gran area is big.

Left Shift? In the DIFF scattergram, the number of particles in the Left Shift area is big.

Atypical/Abn Lympho?

In the DIFF scattergram, the number of particles in the Atypical/Abn Lympho area is big.

RBC Lyse resistance?

In the DIFF scattergram, the number of undissolved RBCs is big.

RBC Flag

RBC Abn Distribution

Possible causes: There is large PLT / PLT Clumps interference. Small RBC is interfered by platelet. There is electrical noise and bubble interference. The aperture is blocked.

Dimorphic Population

The sample is abnormal, for example, the patient is under treatment of iron deficiency or under blood transfusion, etc.

Erythrocytosis RBC is greater than the set value (default: 6.5 x 1012

/L).

Anisocytosis RDW-CV is greater than the set value (default: 20%) or RDW-SD is greater than the set value (default: 60fL).

Anemia HGB is less than the set value (default: 100g/L).

Macrocytosis MCV is greater than the set value (default: 110fL)

Microcytosis MCV is less than the set value (default: 70fL).

Hypochromia MCHC is less than the set value (default: 290g/L).

RBC Agglutination? RBC channel parameters are abnormal.

HGB Interference? RBC channel parameters are abnormal.

Iron Deficiency? RBC channel parameters are abnormal.

PLT Flag

PLT Abn Distribution

Possible causes: There is large PLT / PLT Clumps. There is small RBC interference. There is electrical noise and bubble interference. The aperture is blocked.

Thrombocytosis PLT is greater than the set value (default: 600 x 109/L).

Thrombocytopenia PLT is less than the set value (default: 60 x 109/L).

PLT Clumps? The PLT histogram is abnormal.


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Chapter 7 Details

On the Details interface, the data and graph information of a single sample in the database

are browsed in the form of scattergram + histogram. This interface displays the updated

information and test results by default, as shown in the figure below:

Browse Data

Click the “Last” and “Next” buttons to browse the last and next samples. The

samples can also be browsed with the “Page Up” and “Page Down” keys on the

keyboard.

Edit Information

To change or input sample information, input information in the edit box or select

information from dropdown box on the top of the interface. When the focus leaves

the edit box, the information will be saved automatically. If the input is invalid, a

prompt message will appear on the right of the edit box, and the information will not

be saved. Press the Enter key to switch the input.

Quick input is supported for Department, Sender, Patient Type, Sex, and Charging

Type. Shortcut codes can be set in System Setup. When a shortcut code is input,

the corresponding information will be called out.

Print

Click the “Print” button and print the information, result data, histogram, and

scattergram of the current sample according to the set report template.

Verify

After the sample information and analysis results are verified, click the “Verify”

button to verify the sample.

If you are a common user without verification authority, click the “Verify” button to

pop up the Authority Authentication dialogue box, input the username with


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verification authority and the password. When the correct username and password

are input, the “Verifier” field will display the username input. If you are an

administrator or above or a common user with verification authority opened, click

this button, and the Authority Authentication dialogue box will not be popped up. You

can verify the sample directly. The “Verifier” field for the current sample will display

the name of the verifier set in the Setup module.

When the verification is successful, no information on the sample can be modified,

the sample/patient information will be greyed out, and the “Verify” button will

become a “Cancel” button.

If “After verification, automatically skip to the next sample to be verified” is set in

System Setup, then, after the verification, the system will automatically skip to the

next sample to be verified. If “After verification, automatically print report” is set, then,

when the “Verify” button is clicked and the verification is finished, the report for this

entry will be printed automatically.

Lock

Click the button to lock the current entry. You can switch to other interfaces. When

the updated test result comes out, the interface will not be refreshed automatically

and will still display the information, result data and graph of the current entry, with

the values of position and total refreshed only. If you have not locked the current

interface, when the updated result comes out, the updated result will be refreshed.

Edit Result

1. Click the “Edit” button, the edit box will appear at the result of the measurement

parameters and percentage of WBC differentiation parameter. You can directly

modify the result in the edit box.

2. After the result is modified, click the “Save” button to save the modification. If the

focus is in the edit box, you can press the Enter key to save the modification.

When the modification is saved, the edit box will disappear automatically.

NOTE: (1) Only users at the administrator level have the authority of editing results.

Common users can’t edit results before inputting the username and

password of the administrator.

(2) If the result of a measurement parameter is modified, the result of its relevant

parameters will also change, and the alarm of high/low/suspected will be

given again according to the modified result.

(3) Only the results of the measurement parameters (WBC, RBC, HGB, HCT,

and PLT) and the percentage of WBC differentiation parameter can be

modified.

(4) After the result of WBC differentiation percentage is edited, the absolute

values corresponding to the WBC differentiation parameter will be

recalculated.

(5) If, after the result of WBC differentiation percentage is edited, the sum of the

percentages of the parameters does not equal to 100%, the prompt “Invalid

result. The sum of differentiation percentages is not equal to 100%!” will

appear when the data are being saved.


63

(6) After the result is edited, the “E” tag will appear before the parameter result

directly modified manually. The “e” tag will appear before the result data of its

relevant parameters modified as the parameter result is directly modified

manually.

(7) The results of the background sample and the verified entries can’t be edited.

Restore Result

“Restore” can restore the results of the parameters to the original measurement

values of the analyzer and remove the tag (“E” or “e”) produced after “Edit Result” is

executed.

NOTE: (1) Only users at the administrator level have the authority of restoring results.

Common users can’t restore results before inputting the username and

password of the administrator.

(2) The results of the background sample and the verified entries can’t be edited.

Delete

Click the button to pop up the prompt “Are you sure to delete the record?” Click “OK”

to delete the sample entry displayed on the current Details interface and close the

dialogue box. Samples deleted are divided into two cases:

(1) If the sample deleted is the updated sample, after it is deleted, a new sample

before it will appear on the interface;

(2) If the sample deleted is not the updated sample, after it is deleted, the sample

immediately after it will appear on the interface.

If you click “Cancel”, the sample will not be deleted, and the confirmation dialogue

box will be closed. The system will return to the Details interface and still display the

current sample.

NOTE: (1) The “S” tag appears on the left top corner of the Sample No. edit box for STAT

samples.

(2) After the sample information is set on the Sample Analysis interface, the sample

analysis, including analysis in the Automatic Sampling mode and the Closed

Sampling mode, can be started with the Aspirate Key on the Details interface.


64

Chapter 8 Archives

Whenever a sample is tested, the system will save the test data automatically. The analyzer

can save the measurement values of parameters, Flag messages, histograms, and

scattergrams of up to 100,000 samples. You can view the result information of the samples

through the List or Graph Review, print, delete, modify and search the sample data meeting

the designated criteria.

Click the “Archives” button on the toolbar to open the History Data List window, as shown in

the figure below:

From the history list, you can view the sample results for the current day or a week that meet

the search criteria. The entries for the current day are displayed by default. The entries in the

list are sorted from left to right according to the test time (from new to old) of the samples.

The first entry in the list is the entry newly analyzed. If new test result comes out, the list

interface will be refreshed automatically to display the updated sample information. The red

parameters displayed in the list indicate the test result is lower or higher than the range of

normal values of the parameter. Each page of the list displays up to 500 entries.

The function buttons are described below:

<<-

Switch the displayed page to the previous page.

->>

Switch the displayed page to the next page.

CV Value

Click a single column of the list with the mouse and select a historic datum. With the Ctrl or

Shift key on the keyboard, select multiple columns and click the “CV Value” button, and the

CV Value statistics dialogue box will be popped up. You can view the SD (Standard Deviation)

and CV (Coefficient of Variation) of WBC, NEU%, LYM%, MON%, EOS%, BAS%, RBC, HGB,


65

MCV, and PLT.

Verify

You can verify one or more entries selected. If the selected sample has been verified, the

button will become “Cancel”; if the selected entries include entries verified and those not

verified, the verification status of the last selected entry will decide the status of the “Verify”

button. The processing tag “V” is added to verified samples.

Search

You can look for entries meeting the designated criteria in the range of all samples. Click the

“Search” button to open the combined search dialogue box.

The default interval between the start date and the end date is the recent year.

You can use one or more criteria for search. Input the information and click “OK”. If there is

any entry meeting the criteria, it will be displayed in the history list; otherwise, the system will

pop up the following prompt:

Delete

The Delete function can be used to delete the selected data and all history data. Click a

single column of the list with the mouse and select a historic datum. With the Ctrl or Shift key

on the keyboard, you can select multiple columns to delete. If no data are selected, the

system will prompt that all sample data will be deleted.

Details

The “Details” function is used to view the detailed information of a sample. Select an entry

from the history list, double-click or click the “Details” button to enter the sample graph review

window. For the operation, refer to Chapter 7 “Details”.

Export

You can export test results to an Excel sheet for data analysis. The operation steps are as

follows:

1. Click the “Export” button to open the Data Export dialogue box.


66

2. The default export folder of the software is “C:\HA-86_History”. To change the

folder, you can directly input a valid folder name in the edit box or click the “...” button

to open the Browse Folders dialogue box and designate a folder.

3. Select the desired export mode and click the “OK” button to pop up the Export Prompt

Message box, which indicates the export is successful. You can open the Excel file

for View, Edit, and Statistics.

4. Click the “OK” button to return to the history list interface. You can repeat the above

steps for multiple exports.

Print

Click a single column of the list with the mouse and select a historic datum. With the

Ctrl or Shift key on the keyboard, you can select multiple columns.

Click the “Print” button, and the analyzer will print the history data of the selected

samples in the printing mode set in System Setup.

The processing tag “P” is added to printed samples.

Communicate

With the Communicate function, the sample data can be transmitted to the external

information system. If network connection between the operational software and the

external information system has been established, the “Communicate” button will be

activated, and the LIS/HIS icon in the status bar will display the online status. Click

the “Comm.” button to open the Communication dialogue box, as shown in the

figure below:


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Select the data to be transmitted and click the “Start” button to begin to transmit the

data to the external information system. The dialogue box will be closed, and the

communication status icon in the status bar will flash. To stop the transmission, click

the “Comm.” button again to open the Communication dialogue box. During data

transmission, the “Start” button will become a “Stop” button. Click the “Stop” button

to stop data transmission.

The processing tag “C” is added to samples communicated.

NOTE: (1) The HL7 protocol is used for the communication between the system and the

LIS/HIS and data management software. The protocol specification is not

attached to this Manual. If you need it, please contact our Customer Service

Department.

(2) The number of an STAT sample is yellow.


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Chapter 9 Quality Control

Quality control reflects the accuracy and repeatability of the system. The quality control

procedure provided by the analyzer provides a reliable and effective method for detecting

and preventing the possible system errors. If any system error exists, the results of sample

analysis may be unreliable. In order to always keep accurate analysis results and find and

timely clear the system errors of measurement of the analyzer, it is suggested to perform

quality control of the analyzer regularly.

This analyzer provides three quality control methods, i.e. L-J quality control, X-B quality

control, and X-R quality control.

Caution: You should use the QC and reagents designated by the Company

and store and use them strictly according to their instructions.

9.1 L-J Quality Control

L-J Quality Control is a frequently used quality control method in inspection and quality

management and a common indoor quality control method for laboratories. It is very

important for ensuring reliable test results and improving the test quality.

L-J Quality Control has the Whole Blood and Pre-diluted modes. You can perform quality

control of all or some parameters.

9.1.1 Setup

Click “L-J QC” under the “QC” menu and select “Setup” or directly click “L-J QC” on the

toolbar to enter the Quality Control Setup interface.

No.: The Quality Control setting of each lot no. corresponds to a file. The selection

range of file numbers is 1-60.


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Lot No.: Lot no. of the QC. It can’t be empty.

Expiry Date: Expiry date of the QC.

QC Name: The name of the QC set by the operator.

Level: High, medium, and low. The default is medium-level Quality Control.

Mode: Closed-Whole Blood, Closed-Pre-diluted, and Automatic-Whole Blood. The

default is Closed-Whole Blood.

Operator: The username currently logged in. After the Quality Control settings are

saved, the system will record automatically.

Modification Date: After the Quality Control settings are saved, the system will

automatically record the current date as the creation date.

Target Value, Limits Value: According to the target value table corresponding to the

lot no., input its reference value and tolerance in the edit box after the parameter for

Quality Control respectively. If no reference value and (or) tolerance are (is) input,

the parameter will not participate in quality control.

Save: Used to save the Quality Control setting of the current Quality Control file. If

this Quality Control file has data, the data will be updated.

Caution: The lot no. and Quality Control mode of a Quality Control file must

not be repeated at the same time.

Delete: The Quality Control data, including setup data and test data, of the selected

Quality Control file are deleted.

9.1.2 Analysis

After the Quality Control parameters of the selected Quality Control file are set, the Quality

Control analysis of the Quality Control file can be performed. Click “L-J QC” under the “QC”

menu and select “Analysis” or directly click “L-J QC” on the toolbar to enter the Quality

Control Analysis interface.

All articles (sample, control, calibrator, reagent, waste liquid,

etc.) and areas in contact with such articles have the potential hazard

of biological infectivity. When touching the related articles and areas

in the laboratory, you should follow the Laboratory Safety SOP and

wear the personal protective equipment (such as laboratory protective



control and calibrator with the potential hazard of biological


(2) The sample may spill out of the blood collection tube not

covered and cause biological pollution. Be careful when

operating a blood collection tube with the cap opened.

(3) The reagents may irritate eyes, skin, and mucosa. When

touching the reagents related articles in the laboratory, you


70

should follow the Laboratory Safety SOP and wear the

personal protective equipment (such as laboratory protective


(4) Once any reagent is in contact with the skin, immediately rinse

with plenty of water and, when necessary, receive treatment

by a doctor. Once any reagent is in contact with the eye,

immediately rinse with plenty of water and receive treatment

by a doctor.

1. Check that the information in the Quality Control file is consistent with the QC to be

tested, and the QC is not expired.

2. Prepare the QC according to the QC instructions.

a) If the mode is Closed Sampling, press the Open Compartment Door Key on the

front shell to open the compartment door. Put the QC into the sample

compartment door and close the compartment door. Press the Aspirate Key on

the front shell or the “Start” button to begin the test. If the mode is Pre-diluted,

click the “Diluent” button on the toolbar and prepare a pre-diluted sample

beforehand. The specific steps are described in the “Daily Operations” chapter.

Start analysis.

b) If the mode is Automatic Sampling, put the tube rack on loading platform on the

right side of the autoloader, and press the Aspirate Key on the front shell or the

“Start” button to begin the analysis in the Automatic Sampling mode.

3. When the analysis is finished, the Quality Control result will be displayed on the

current interface and will be automatically saved in the current Quality Control file.

4. Each Quality Control file can store up to 500 Quality Control results.

Caution: If the test tube is pierced repeatedly, the rubber tube cap may be damaged, and the debris produced may cause inaccurate analysis result. It is suggested to pierce a test tube no more than three times.


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9.1.3 Graphs

Click “L-J QC” under the “QC” menu and select “Graphs” or directly click “L-J QC” on the

toolbar to enter the Quality Control Graphs interface.

Quality Control Graphs display the Quality Control data distribution graphically for easy

understanding of the deviation trend of the analyzer. The information displayed on the

interface and the functions of buttons are as follows:

Lot No.: Lot no. of the QC corresponding to the Quality Control file.

Expiry Date: Expiry Date of the QC.

Mode: Closed-Whole Blood, Closed-Pre-diluted, or Automatic-Whole Blood.

Time: Test time of data corresponding to the Quality Control point.

S/N: Serial number of the Quality Control point among all Quality Control data

points.

Each screen displays the Quality Control graphs of the 5 parameters and the Mean (Mean

Value), SD (Standard Deviation), and CV% (Coefficient of Variation) of each parameter.

The 3 values on the left of the Quality Control graph, from top to bottom, are: target value +

limits value of QC, target value of QC, and target value - limits value of QC.

The vertical scroll bar is used to switch between parameters to be displayed.

The horizontal scroll bar, when used with the “←” and “→” keys, is used to display the Quality

Control data of different serial numbers.

Print

Used to print the Quality Control graph of the current group of parameters.

Order

“Order” can be used to adjust the display sequence of parameters according to the

actual needs. Click the “Order” button to open the following dialogue box:


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The sequence of parameters can be adjusted with “Top”, “Up”, “Down”, and

“Bottom”. “Order” is applicable to the display of Quality Control list.

Delete

Can be used to delete the data of the selected Quality Control point and all Quality

Control data. Click the “Delete” button to open the following dialogue box:

“Selected Data” refers to the Quality Control point corresponding to the current

position of the blue browse line in the Quality Control graph.

9.1.4 List

Click “L-J QC” under the “QC” menu and select “List” or directly click “L-J QC” on the toolbar

to enter the Quality Control List interface:


73

Print

All data or the data for the designated date can be printed. Click the “Print” button to

pop up the Printing Mode Selection box, as shown in the figure below. Click the

“OK” button to print data:

Delete

Click the “Delete” button to delete the Quality Control data selected in the list. If no

data are selected, all data will be deleted.

Export

Quality Control data can be exported to a .csv or .txt file.

Communicate

Quality Control data can be transmitted to the external information system. If

network connection between the operational software and the external information

system has been established, the “Comm.” button will be activated, and the LIS/HIS

icon in the status bar will display the online status. Click the “Communicate” button

to open the Communication dialogue box, as shown in the figure below:


74

Select the data to be transmitted and click the “Start” button to begin to transmit the

data to the external information system. The dialogue box will be closed, and the

communication status icon in the status bar will flash. To stop the transmission, click

the “Communicate” button again to open the Communication dialogue box. During

data transmission, the “Start” button will become a “Stop” button. Click the “Stop”

button to stop data transmission.

NOTE: The HL7 protocol is used for the communication between the system and the

LIS/HIS and data management software. The protocol specification is not attached

to this Manual. If you need it, please contact our Customer Service Department.

9.2 X-B Quality Control

X-B Quality Control does not use QC and runs statistical analysis according to the samples

actually tested. As the physiological change in MCV, MCH, and MCHC of RBC is very small,

the X-B mean can manage the accuracy of the system. The analyzer conducts X-B Quality

Control of 3 parameters, i.e. MCV, MCH, and MCHC. X-B Quality Control data come from

random samples and are not classified by disease. Whole blood or pre-diluted samples can

be used as sample sources. A reference range is composed of the given value and the upper

and lower limits. The change trend in the reference range of each batch of X-B values is

observed.

The analyzer stores up to 100 X-B Quality Control data. When the number of Quality Control

results stored exceeds the maximum, the new Quality Control result will override the earliest

result.

9.2.1 Setup

Click “X-B QC” under the “QC” menu and select “Setup” to enter the Quality Control Setup

interface:


75

In the “Samples/Batch” edit box, input the number of sample results selected whenever an

X-B Quality Control point is calculated, with the range of 20-200, the default of 20, and the

maximum number of groups of 100 groups.

If X-B Analysis is set to “On”, the valid results of the tested sample will be also taken as data

of X-B Quality Control analysis.

If the sample meets either of the following criteria, it will be deemed invalid and will not be

included in the Quality Control calculation:

1. Samples with the RBC result out of the linear range of the analyzer and other

parameters out of the following ranges: 50≤MCV≤150fL, 20pg≤MCH≤40pg,

240g/L≤MCHC≤440g/L;

2. Blank result;

3. Other Quality Control data analysed;

4. Error of the analyzer that impacts the sample measurement during the analysis.

The sample data are divided into groups, with each group including n samples. The mean of

each group of data is calculated. The general mean, general standard deviation (SD), and

general coefficient of variation (CV) are calculated based on the means of the batches of

data. The initial value can be set according to the empirical value. The tolerance is set to ±3%.

When the number of statistical samples reaches 400, the general mean of X-B can be set as

a target value.

The default initial values of the reference values of the parameters are:

MCV: 89.5fL

MCH: 30.5pg

MCHC: 340g/L


76

The default initial values of the deviation values of the parameters are:

MCV: 2.7fL

MCH: 0.9pg

MCHC: 10g/L

Caution: The target value and limits value should not be empty.

9.2.2 Graphs

Click “X-B QC” under the “QC” menu and select “Graphs” to enter the Quality Control Graph

interface:

Current/Total: Displays the position and total of X-B Quality Control analysis of the

current Quality Control data point.

The 3 values on the left of the Quality Control graph, from top to bottom, are: target

value + limits value, target value, and target value - limits value.

Mean: Displays the mean of all Quality Control data points.

SD: Standard Deviation

CV%: Coefficient of Variation


Control data of different serial numbers

Print

Click the “Print” button to print the Quality Control graphs of the 3 parameters.

Delete




77



9.2.3 List

Click “X-B QC” under the “QC” menu and select “List” to enter the Quality Control List

interface.

The data of the X-B Quality Control point are displayed in the list on the top of the window.

The specific calculation process is described below.

Assume the number of samples of each group is N. The calculation formula of mean is:

21 /)( NFFSGNXX BiBi

In which

BiX : Mean of the current batch; 1BiX : Mean of the previous batch

SGN: Sign function.

N

BiijBiij XXXXSGNF1

11)(


78

SGN(number)

If number is SGN returns

> 0 1

= 0 0

< 0 -1

ijX : Sample data of the current batch.

Each BiX calculated is drawn as the point in the Quality Control graph. If the number of

data in the last batch does not reach N, BiX will not be calculated.

For the first group of data, where there is no XB for the previous batch, the target value set

will be used.

Data List: Click “Data List” to open the Detailed Data List dialogue box, where the

detailed sample data of each Quality Control point can be viewed.

Print: Prints the Quality Control list.

Export: The Quality Control data can be exported to a .csv or .txt file.

Delete: Can be used to delete the selected or all X-B Quality Control data.

Communicate:Transmit QC data to the external information system. If network

connection between the operational software and the external information system

has been established, the “Comm.” button will be activated, and the LIS/HIS icon in

the status bar will display the online status.

9.3 X-R Quality Control

X-R Quality Control, i.e. Mean-Difference Quality Control, is a common quality control

method in the industry and an effective method for adjusting and forecasting whether there is

any abnormal fluctuation. This Quality Control and the L-J Quality Control are complementary.

X -R Quality Control reflects the degree of stability of Quality Control data mainly through the

control graph, and its Quality Control graph is a composite graph.

9.3.1 Setup

Before X-R Quality Control, necessary setup of Quality Control parameters is required. Click

“X-R QC” under the “QC” menu and select “Setup” to enter the Quality Control Setup

interface:


79

No.: The QC setting of each lot no. corresponds to a file. The selection range of file

numbers is 1-60.

Lot No.: Lot no. of the QC. It can’t be empty.


QC Name: The name of the QC set by the operator.

Level: High, medium, and low. The default is medium-level Quality Control.

Mode: Closed-Whole Blood, Closed-Pre-diluted, and Automatic-Whole Blood. The

default is Closed-Whole Blood.

Operator: The username currently logged in. After the Quality Control settings are

saved, the system will record automatically.

Modification Date: After the Quality Control settings are saved, the system will

automatically record the current date as the creation date.

Save: Used to save the Quality Control setting of the current Quality Control file. If

this Quality Control file has data, the data will be updated.

9.3.2 Analysis

After the Quality Control parameters of the selected Quality Control file are set, the Quality

Control analysis of the Quality Control file can be performed. Click “X-R QC” under the “QC”

menu and select “Analysis” to enter the Quality Control Analysis interface:

All articles (sample, control, calibrator, reagent, waste liquid, etc.)

and areas in contact with such articles have the potential hazard of

biological infectivity. When touching the related articles and areas in

the laboratory, you should follow the Laboratory Safety SOP and wear

the personal protective equipment (such as laboratory protective



80


QC and calibrator with the potential hazard of biological


(2) The sample may spill out of the blood collection tube not

covered and cause biological pollution. Be careful when

operating a blood collection tube with the cap opened.

(3) The reagents may irritate eyes, skin, and mucosa. When

touching the reagents related items in the laboratory, you

should follow the Laboratory Safety SOP and wear the

personal protective equipment (such as laboratory protective


(4) Once any reagent is in contact with the skin, immediately rinse

with large amount of water and, when necessary, receive

treatment by a doctor. Once any reagent is in contact with the

eye, immediately rinse with large amount of water and receive

treatment by a doctor.

1. Check that the information in the Quality Control file is consistent with the QC to be

tested, and the QC is not expired.

2. Prepare the QC according to the QC instructions.

a) If the mode is Closed Sampling, press the Open Compartment Door Key on the

front shell to open the compartment door. Put the QC into the sample

compartment door and close the compartment door. Press the Aspirate Key on

the front shell or the “Start” button to begin the test. If the mode is Pre-diluted,

click the “Diluent” button on the toolbar and prepare a pre-diluted sample

beforehand. The specific steps are described in the “Daily Operations” chapter.

Start analysis.

b) If the mode is Automatic Sampling, put the test tube rack on loading platform on

the right side of the autoloader, and press the Aspirate Key on the front shell or


81

the “Start” button to begin the analysis in the Automatic Sampling mode.

3. When the analysis is finished, the interface will display the result of the first

analysis.

4. Prepare the QC and execute the second Quality Control analysis.

5. When the analysis is ended, the Quality Control results (2 Quality Control test

values and, X (Mean) and R (Difference)) will be displayed on the current interface

and automatically saved in the current Quality Control file. The analyzer can display

the Quality Control results of all parameters in the Quality Control list. If Quality

Control is not performed for some parameters, the corresponding cells will be

empty.

6. Click the “Cancel” button to delete the data for the first analysis and begin the

analysis again.

Caution: (1) If the Quality Control quantity is measured once only, the result will not be saved.

(2) After the results of the second Quality Control analysis are obtained, the histogram and scattergram displayed on the interface will refresh the graphs corresponding to the results of the second Quality Control analysis.

(3) Each Quality Control file can store up to 500 Quality Control results (X (Mean) and R (Difference)).

(4) If the test tube is pierced repeatedly, the rubber tube cap may be damaged, and the debris produced may cause inaccurate analysis result. It is suggested to pierce a test tube no more than three times.

9.3.3 Graphs

X-R Quality Control Graph can visually reflect the degree of stability of the analyzer. When

the analyzer is in the control status, the points in the graph will be randomly distributed near

both sides of the center line. For the points away from the center line, the nearer to the upper

and lower control limits, the fewer points there are. Click the “Graphs” button to view the

Quality Control graph.


82

Quality Control graphs display the Quality Control data distribution graphically for easy

understanding of the deviation trend of the analyzer. The information displayed on the

interface and the functions of buttons are described below:

Lot No.: Lot no. of the QC corresponding to the Quality Control file.


Mode: Closed-Whole Blood, Closed-Pre-diluted, and Automatic-Whole Blood.

Time: Test time of data corresponding to the Quality Control point.

S/N: Serial number of the Quality Control point among all Quality Control data

points.

Each screen displays the X and R graphs of the 2 parameters and the Mean (Mean Value),

SD (Standard Deviation), and CV% (Coefficient of Variation) of each parameter.

The 3 values on the left of the Quality Control graph, from top to bottom, are: upper limit,

mean, and lower limit.

The vertical scroll bar is used to switch between parameters to be displayed.


Control data of different serial numbers.

Print

Used to print the Quality Control graph of the current group of parameters.

Order

“Order” can be used to adjust the display sequence of parameters according to the

actual needs. Click the “Order” button to open the following dialogue box:

The sequence of parameters can be adjusted with “Top”, “Up”, “Down”, and

“Bottom”. “Order” is applicable to the display of Quality Control list.

Delete




83



9.3.4 List

Click the “List” button to view the list of Quality Control results, as shown in the figure below:

Print

All data or the data for the designated date can be printed. Click the “Print” button to

pop up the Printing Mode Selection box, as shown in the figure below. Click the

“OK” button to print data:

Delete

Click the “Delete” button to delete the Quality Control data selected in the list. If no


84

data are selected, all data will be deleted.

Export

Quality Control data can be exported to a .csv or .txt file.

9.3.5 Calculation

The calculation formulas of X and R are as follows:

n

XX

n

RR

X : Mean of 2 tests R: Difference between 2 tests (absolute value)

X : General mean R : Mean of ranges

n: Number of groups (each group is tested twice)

The calculation formulas of the upper and lower limits of X and R are as follows:

Upper limit of X (UCL) = X + 3

2dk

R

Lower limit of X (LCL) = X - 3

2dk

R

Upper limit of R (UCL) = R + 3

2

3

d

Rd

RX QC reflects the degree of stability of QC data mainly through the control graph, and

its QC graph is a composite graph. Each parameter has X (Mean) graph and R (Range)

graph. The X (Mean) graph is shown below:

1

2

3

The 1st line is the upper limit of X (UCL); the 2nd line is X ; the 3rd line is the lower limit

of X (LCL). The maximum value is X + 6

2dk

R; the minimum value is X - 6

2dk

R.

The maximum value line and the minimum value line are not drawn.


85

The R (Difference) graph is shown below:

2

1

3

The 1st line is the upper limit of R (UCL); the 2nd line is R ; the 3rd line is the zero point.

In the formula, 2d and

3d are the coefficients decided by the number of Quality Controls

each day, which can be looked up from the table below:

Table 7-1 X-R Quality Control Graph Coefficient Table

Coefficient k 2d 21 d 3d

2 1.128 0.8862 0.853

3 1.693 0.5908 0.888

4 2.059 0.4857 0.880

5 2.326 0.4299 0.864

6 2.534 0.3946 0.848

7 2.704 0.3698 0.833

8 2.847 0.3512 0.820

9 2.970 0.3367 0.808

10 3.078 0.3249 0.797

This analyzer uses k=2 for calculation.


86

Chapter 10 Calibration

The analyzer has been strictly tested and calibrated before leaving factory and does not need

frequent calibration. However, the measurement results may drift due to many causes during

transport and use. The purpose of analyzer calibration is to ensure accurate test results.

In order to ensure the accuracy of measurement of the analyzer and obtain stable and

reliable test results, the analyzer must be calibrated in the following cases.

1. When the analyzer is used for the first time or reinstalled in a different place.

2. The analyzer is repaired.

3. The Quality Control results are deviated.

This analyzer supports 3 calibration modes, i.e. manual calibration, calibration with calibrator,

and calibration with fresh blood.

Six parameters, i.e. WBC, RBC, HGB, MCV, PLT and MPV, can be calibrated in the Whole

Blood mode or Pre-diluted mode.

Caution: The measurement data can be used as valid data only after the

analyzer has been calibrated.

10.1 Preparation before Calibration

This analyzer can be calibrated with fresh blood and calibrator. This analyzer has 2 sets of

calibration coefficient for the Whole Blood mode and the Pre-diluted mode respectively.

Before calibration, inspect the analyzer by following the steps described below and check

that the machine works normally. If any problem is found, stop the calibration.

1) Inspect the analyzer and the reagents to ensure the analyzer is in the normal status,

the reagents are adequate, and the materials required are complete.

2) Perform the blank check and check that the blank measurement value meets the

requirements.

3) Perform repeated measurements with the medium-level blood sample on the

Analysis interface and check that the machine works within the accuracy range.

4) Test the carry-over. The carry-over should be within the range specified for the

analyzer.

Caution: (1) The calibrator should be the commercial calibrator designated

by the Company and should be stored and used according to

the requirements. Before checking that all calibrations are

completed correctly, do not use the measurement results for

medical or clinical diagnosis.

(2) During calibration with fresh blood, perform collection,

blending, etc. strictly according to the Laboratory SOP.

10.2 Manual Calibration

Click “Manual Calibration” under the “Calibration” menu to enter the Manual Calibration


87

interface, as shown in the figure below:

Caution: If you are a common user, you can view the calibration coefficient

on the interface only and can’t run calibration. To run calibration,

you should log out first and log in again as an administrator.

The steps of manual calibration are as follows:

1. In the Sample Analysis window, use the calibrator to perform multiple measurements (at

least thrice).

2. Record the measurement data of the item.

3. Calculate a new calibration coefficient.

Calculate a new calibration coefficient with the following formula:

4. In the “Manual Calibration” interface, select the blood sample mode and input the new

calibration coefficient in the calibration value input box.

5. Click the “Save” button to save the current calibration result. In which, the calibration date

will be automatically updated to the current date, and the operator is updated to the

username currently logged in.

6. Click the “Print” button to print the saved calibration coefficient.

Caution: The calibration coefficient input should be within 75%-125%, with

up to two decimal places. If the calibration coefficient calculated

is out of this range, check whether the sample has not been fully

blended or whether the operation is wrong, etc. Calibration can’t

be operated before the cause is determined.

10.3 Auto Calibration

When “Auto Calibration” is selected, the analyzer can automatically calculate a new

Current calibration coefficient x Reference value of calibrator New calibration coefficient= Mean of measurements


88

calibration coefficient after the calibrator is tested. The analyzer performs calibration in the

Closed Sampling mode. The coefficient calibrated will be automatically delivered to the

Automatic Sampling mode. Click “Auto Calibration” under the “Calibration” menu to enter the

Automatic Calibration interface.

For calibration with calibrator or fresh blood, whenever the calibration test is finished, the

analyzer will automatically make the following processing:

1. If the test value of a parameter in the current test results is out of the linear range of

the parameter, but within its display range, the calibration data will be displayed. At the same

time, a dialogue box will be popped up to prompt that the data of this calibration are invalid.

Click “OK” to close the dialogue box, and the data of this calibration in the list will be deleted

automatically.

2. If the test value of a parameter in the current test results is out of the display range of

the parameter, “---” will appear in the list. At the same time, a dialogue box will be popped up

to prompt that the data of this calibration are invalid. Click “OK” to close the dialogue box,

and the data of this calibration in the list will be deleted automatically.

If part of the data have been tested and the calibrator coefficient has not been calculated or

the calibration coefficient has been calculated but is not saved, when you exit the Automatic

Calibration interface, the software will give prompt to ask whether you are sure to exit.

10.3.1 Calibration with Calibrator

The steps of calibration with calibrator are as follows:


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1. Set calibrator.

Click the “Setup” button to open the Auto Calibration Settings interface and set the

parameters of the calibrator.

Lot No.: Lot number of the calibrator. After the Lot No. is input and saved, when

you log in next time, you can select it from the dropdown list and view or change

the data of this Lot No.

Expiry Date: Expiry date of the calibrator. If the expiry date is less than the current

system date, when you click “OK” to return, the analyzer will give warning. You

must use other types of calibrator for calibration.

Sample Type: Mode in which the calibration will be performed.

Targets: Reference value of each parameter of the calibrator. If the calibration of a

parameter is not required, its Targets input box will be left empty.

Click the “OK” button to save the settings and exit.

2. Press the Open Compartment Door Key on the front shell of the analyzer to open the

compartment door, put the calibrator into the compartment door, and close the

compartment door.

3. Press the Aspirate Key to begin the analysis. The interface will prompt that the

analysis is in progress. When the analysis is ended, the result will be displayed on

the current interface. After 3 tests, the system will automatically calculate a new

calibration coefficient.

4. Repeat the test process. When the number of valid data in the list reaches 11, a

prompt box will be popped up to prompt that the calibration has been finished and no

test is allowed any more.

5. After the calibration coefficient is obtained, the system will judge whether the

calibration coefficient is valid. If the calibration coefficient meets the following two

criteria, it is invalid and can’t be saved.

a) Either calibration coefficient is outside the deviation range of 75%-125%.


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b) The CV value of either calibration parameter exceeds the repeatability index of

the analyzer.

6. If the new calibration coefficient is valid, click the “Save” button, and the system will

save the new calibration coefficient. The coefficient on the Manual Calibration

interface will also be updated.

10.3.2 Calibration with Fresh Blood

The steps of calibration with fresh blood are as follows:

1. Prepare 3-5 normal fresh blood samples.

2. Use the prepared 3-5 normal fresh blood samples to perform at least 3

measurements on the reference analyzer, calculate the mean, and take this mean as

a reference value; or perform measurements and calculation according to the

reference method and take the data obtained as a reference value.

3. Click the “Setup” button to open the Automatic Calibration Setup interface and set

the parameters of the fresh blood sample.

Sample Type: Mode in which the calibration will be performed.

Targets: Reference value of each parameter of the fresh blood. If the calibration of

a parameter is not required, its Targets input box will be left empty.

Click the “OK” button to save the settings and exit.

4. Return to the Automatic Calibration Test interface, which displays the number of the

current calibration blood sample.

5. Prepare whole or pre-diluted fresh blood sample. Press the Open Compartment

Door Key on the front shell of the analyzer to open the compartment door, put the

vacuum tube or centrifuge tube into the compartment door, and close the

compartment door.

6. Press the Aspirate Key to begin the analysis. The interface will prompt that the

analysis is in progress. When the test is ended, the result will be displayed on the

current interface. After 3 tests, the system will automatically calculate a new


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calibration coefficient.

7. Repeat the test process. When the number of valid data in the list reaches 11, a

prompt box will be popped up to prompt that the calibration has been finished and no

test is allowed any more.

8. After the calibration coefficient is obtained, the analyzer will judge whether the

calibration coefficient is valid. If the calibration coefficient meets the following two

criteria, it is invalid.

a) Either calibration coefficient is outside the deviation range of 75%-125%.

b) The CV value of either calibration parameter exceeds the repeatability index of

the analyzer.

9. Repeat Steps 3~8 to finish the testing of other calibration blood samples. If the

calibration coefficient of a blood sample calculated is invalid, the reference value, all

existing calibration data and various calculated values, including calibration

coefficient, of the current blood sample will be cleared before the blood sample is

switched. If the calibration coefficient of the current blood sample has not been

calculated, the blood sample will be directly switched to another one after the

reference value and all existing calibration data are cleared. When the test is finished,

the calibration coefficients of the various blood samples will be displayed on the

calibration coefficient line at the bottom of the Automatic Calibration interface. If the

blood sample test reaches 3 groups, the mean calibration coefficient will be

calculated automatically.

10. If you are sure to use the new mean calibration coefficient, click the “Save” button,

and the system will save the new calibration coefficient. The coefficient on the

Manual Calibration interface will also be updated.

10.3.3 Inspection of Calibration Coefficient

After the calibration is finished, the calibration coefficient should be inspected. The

suggested steps are:

1. Analyze the calibrator at least 3 times and check whether the analysis result is

within the permissible range.

2. Analyze the high-, medium- and low-level QC. Measure each concentration at least

3 times and check whether the analysis result is within the permissible range.

3. Analyze at least 3 normal fresh blood samples with the reference value known,

measure each sample at least 6 times, and check whether the analysis result is

within the permissible range.

Caution: If the vacuum blood collection tube is pierced repeatedly, the rubber tube cap may be damaged, and the debris produced may cause inaccurate analysis result. It is suggested to pierce a blood collection tube no more than three times.


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Chapter 11 Exit

“Exit” includes Minimize, Logout, Shut Down, and Exit System.

Minimize

Used to minimize the analysis software to the status bar.With the shortcut keys

ALT+W, the software can be directly minimized. To restore, use ALT+Q.

Logout

Click the “Logout” button to pop up the following dialogue box:

You can log on to the system only after inputting the correct username and

password.

Shut Down

It is suggested to execute the power-off operation after the analyzer has been

working for 24 hours continuously. To turn off the analyzer, the analysis software

should be connected with the analyzer. When the power-off operation is finished,

the power-off prompt will be popped up, as shown in the figure below:

After the analyzer is turned off, click the “OK” button or wait till the prompt box

closes automatically. Here, you have not exited the analysis software, and you can

still execute other operations not relating to the analyzer. To exit the software, select

“Exit System”.

Exit System

To turn off the analyzer and exit the analysis software, select “Exit System”. Click

“OK”, and the analyzer will begin to execute the same operation as “Shut Down”.

When the operation is finished, the power-off prompt will be popped up to ask

whether you are sure to exit the software. Click “OK”, and the whole analysis

software will be turned off.


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Caution: (1) The analyzer can’t be turned off if the analyzer is not connected

to the external PC.

(2) Do not force a power-off of the analyzer during a test or other

sequences.

(3) You can’t exit the system software before turning off the

analyzer.


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Chapter 12 Service

12.1 Daily Maintenance

This analyzer is a clinical precision analyzer. In order to keep the analyzer in the good

condition, get reliable measurement results, and reduce the frequency of faults of the

analyzer, daily upkeep and maintenance should be performed. This section describes the

relevant maintenance operations.

Warning: Maintenance operations should be performed according to the

User’s Manual and the Service Manual, otherwise, damage of the

analyzer may be caused.

All articles (sample, control, calibrator, reagent, waste liquid,

etc.) and areas in contact with such articles have the potential hazard

of biological infectivity. When touching the related articles and areas

in the laboratory, you should follow the Laboratory Safety SOP and

wear the personal protective equipment (such as laboratory protective


Caution: (1) If cleaning is not done according to the recommended

procedure every day, the stability of the analyzer and the

accuracy of analysis results may be impacted.

(2) During maintenance, prevent touching the tip of the sampling

probe.

(3) The components and parts provided by the Company must be

used for analyzer maintenance. If you have any question, please

contact our Customer Service Department or the agent.

12.1.1 Replacement of Reagent

Warning: (1) The reagents may irritate eyes, skin, and mucosa. When

touching the reagents, you should wear the personal

protective equipment.

(2) Once any reagent is in contact with the skin, immediately

rinse with plenty of water and, when necessary, receive

treatment by a doctor.


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Caution: (1) Before use, let the reagent sit for a period of time, so that it

becomes stable.

(2) After replacing the reagent, you should run a blank test to

ensure the value of the blank test is within the required range.

You need to replace the reagent in the following cases:

The reagent is replaced with the whole container/whole bottle of new reagent.

The reagent in the tube is contaminated.

There is bubble in the tube.

Click the “Service” button on the main menu and select “Daily Maintenance” on the menu

popped up or directly click the “Daily Maintenance” button on the toolbar to enter the Daily

Maintenance interface. Select the “Replace Reagent” tab to enter the following interface.

You can replace the following reagents:

Diluent

Cleanser

86H lyse

86D lyse

The steps of reagent replacement are as follows:

1. Click the button for the reagent to be replaced and input the lot no., shelf life and

total amount of the replacement reagent on the dialogue box popped up.


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2. The “Set” button is used to set reagent information, where the analyzer will not

execute the replacement operation or change the internal record of remaining

reagent. Click the “Replace” button to save the lot no. and shelf life input. Set the

remaining reagent to the total amount of reagent currently set. The Replace

Reagent prompt box will be popped up, as shown below.

3. After the reagent is replaced, the following dialogue box will be popped up to prompt

that the reagent has been replaced.

4. Click the “OK” button to close the dialogue box.

5. Replace other reagents according to the above steps.

12.1.2 Clean

You should clean the corresponding components when the following are observed:

The WBC or HGB blank result is out of the blank range. The WBC bath cleaning can

be executed.

The RBC and (or) PLT result is out of the blank range. The RBC bath cleaning can be

executed.

There are many particles in the scattergram of the blank result. The DIFF bath

cleaning can be executed.

There are many particles in the scattergram of the blank result or the differentiation

effect of the WBC scattergram is not good. The flow cell cleaning can be executed.

The sampling probe is dirty. The sampling probe cleaning can be executed.

If the blank parameter results of the parameters are out of the blank range, the

fluidics cleaning can be executed to clean all tubes once.

Click the “Service” button on the main menu interface and select “Daily Maintenance” on the


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menu popped up or directly click the “Daily Maintenance” button on the toolbar to enter the

Daily Maintenance interface. Select the “Clean” tab to enter the following interface.

You can clean the following components:

WBC bath

RBC bath

DIFF bath

Pipeline

Sampling probe

Flow cell (DIFF optical measurement channel)

The steps of cleaning are as follows:

1. Click the button for the component to be cleaned to begin to clean the component

and pop up the prompt of the corresponding function.

2. When the cleaning is finished, the following dialogue box will be popped up to

prompt that the cleaning has been finished.


4. Clean other components according to the above steps.

12.1.3 Upkeep

You should keep the analyzer in good repair in the following cases:

The aperture of the counting bath is blocked. Unclog, Zap Apertures, and Back

Flush can be executed.


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After running large amount of samples, the blank test values of the analyzer are out

of the blank range, the differentiation effect of WBC scattergram is not good or the

aperture is blocked. After other cleaning operations, the situation has not been improved.

The Soaking in Cleanser operation can be executed.

The analyzer in use should be soaked in concentrated cleanser every week.

Click the “Service” button on the main menu and select “Daily Maintenance” on the menu

popped up or directly click the “Daily Maintenance” button on the toolbar to enter the Daily

Maintenance interface. Select the “Maintain” tab to enter the following interface.

You can execute the following maintenance operations:

Blockage removal of aperture

Burning of aperture

Back-flushing of aperture

Fluidics Soak in Cleanser

DIFF Bath Soak in Concentrated Cleanser

WBC/RBC Bath Soak in Concentrated Cleanser

Fluidics Soak in Concentrated Cleanser

12.1.3.1 DIFF Bath Soak in Concentrated Cleanser

If abnormal measurement values are caused in the DIFF channel, which is not improved after

other maintenance operations, the DIFF Bath Soak in Concentrated Cleanser maintenance

function can be performed.

The steps of DIFF Bath Soak in Concentrated Cleanser are as follows:

1. Click the “DIFF Bath Soak in Concentrated Cleanser” button to pop up the dialogue

box for prompting you to confirm soaking.


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2. Click the “OK” button. The sample compartment door will open automatically, and

the dialogue box for prompting you to put the test tube containing concentrated

cleanser into the sample compartment will be popped up.

3. Close the compartment door manually and press the Aspirate Key on the front shell

of the analyzer to pop up the following prompt box and begin soak preparation.

4. When the preparation is finished, a countdown dialog box shown below will be

popped up, and the soaking process will begin.

5. The soaking time is 5 minutes, during which, the soaking can’t be terminated.

6. When the soaking is ended, cleaning will be performed.

7. When the cleaning is finished, the following dialogue box will be popped up.


9. When necessary, repeat the “DIFF Bath Soak in Concentrated Cleanser” operation

by following the above steps.


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12.1.3.2 WBC and RBC Bath Soak in Concentrated Cleanser

If abnormal measurement values are caused by the blockage of the aperture, which is not

improved after other maintenance operations, the WBC and RBC Bath Soak in Concentrated

Cleanser maintenance function can be performed.

The steps of WBC/RBC Bath Soak in Concentrated Cleanser are as follows:

1. Click the “WBC/RBC Bath Soak” button to pop up the dialogue box for prompting

you to confirm soak.





of the analyzer to pop up the following prompt box and begin soak preparation.




6. When the soaking is ended, cleaning will be performed.


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7. When the cleaning is finished, the following dialogue box will be popped up.


9. When necessary, repeat the “WBC/RBC Bath Soak” operation by following the

above steps.

12.1.3.3 Fluidics Soak in Cleanser

The steps of Soaking in Cleanser are as follows:

1. Click the “Cleanser Soak” button to pop up the dialogue box for prompting you to

confirm soaking.

2. Click the “OK” button to begin to clean pipeline and baths.

3. The preparation for soaking in cleanser will begin.



5. The soaking time is 10 minutes. You can end the soaking early by clicking the

“Terminate” button. When the soaking is ended, cleaning will be performed.


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6. When the cleaning is finished, the following dialogue box will be popped up


8. When necessary, repeat the “Cleanser Soak” operation by following the above

steps.

12.1.3.4 Fluidics Soak in Concentrated Cleanser

The steps of Fluidics Soak in Concentrated Cleanser are as follows:

1. Click the “Fluidics Conc. Cleanser Soak” button to pop up the dialogue box for

prompting you to confirm soaking.





of the analyzer to pop up the following prompt box and begin the preparation for the

first soaking.

4. When the preparation is finished, the prompt box prompting you to aspirate

concentrated cleanser will be popped up again, and the liquid aspiration will be

performed again.


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5. Press the Aspirate Key on the analyzer to pop up the following prompt box and

begin the preparation for the second soaking.




8. When the soaking is ended, assy reset will be performed.

9. When the initialization is finished, cleaning will be performed.

10. When the cleaning is finished, the Finish dialogue box will be popped up.


12. When necessary, repeat the Fluidics Soak in Concentrated Cleanser by following

the above steps.

12.1.4 Fluidics Maintenance

Click the “Service” button on the main menu interface and select “Daily Maintenance” on the

menu popped up or directly click the “Daily Maintenance” button on the toolbar to enter the


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Daily Maintenance interface. Select the “Fluidics Maintenance” tab to enter the following

interface.

You can execute the following functions:

Empty WBC bath

Empty RBC bath

Empty DIFF bath

Empty Fluidics

Empty Flowcell

Analyzer Initialization

Pack (before containerization and transport)

Prime

12.1.4.1 Empty WBC bath

To replace the components corresponding to the WBC bath, execute the Empty WBC

bath function first.

12.1.4.2 Empty RBC bath

To replace the components corresponding to the RBC bath, execute the Empty RBC


12.1.4.3 Empty DIFF bath

To replace the components corresponding to the DIFF bath, execute the Empty DIFF



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12.1.4.4 Empty Fluidics

Before short-distance transport of the analyzer (transport time < 2 hours), the Empty

Fluidics operation should be executed.

12.1.4.5 Empty Flowcell

To replace the components corresponding to the flow cell, execute the Empty Flowcell

function first.

12.1.4.6 Pack

The analyzer needs packing upon drain before it is let sit out of service for a period of time

(more than 1 week) or before long-distance transport (transport time > 2 hours).

The steps of packing are as follows:

1. Click the “Pack” button to pop up the following prompt dialogue box.

2. Loosen the bottleneck joint of the reagent bottle according to the prompt. Click the

“OK” button to begin the Drain function, and the following prompt will be popped up.

3. When the drain is finished, the following prompt dialogue box will be popped up.

4. Put the tube into the distilled water container according to the prompt. Click the “OK”

button to begin the distilled water perfusion, and the following dialogue box will be


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popped up.

5. When the distilled water perfusion is finished, the following prompt dialogue box will

be popped up.

6. When cleaning is finished, the following prompt dialogue box will be popped up.

7. Take the tube out of the distilled water container according to the prompt. Click the

“OK” button to execute the Drain function again, and the following promptwill be

popped up.

8. When the drain is finished, the following dialogue box will be popped up to prompt

that the packing has been finished.


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9. Click the “OK” button to turn off the analysis software. Power off the analyzer.

12.1.4.7 Initialize

You should execute analyzer initialization in the following cases:

Any main component is replaced, or the fluidics system of the analyzer is repaired.

Any error occurs. There is a prompt of device run-time error.

12.1.4.8 Prime

To replace all reagents at a time, the Prime function can be executed.

12.2 Sleep

12.2.1 Automatic Sleep

If the analyzer is let sit without fluidics operation for 30 minutes (default), it will enter the sleep

mode automatically. During the sleep, sample analysis is impossible.

You can set the time before the analyzer enters the sleep mode automatically. On the

“System Setup” interface, select “Maintenance”. Fill in the time (range: 10-60 minutes) in the

“Automatic Sleep Latency” filed.

Caution: (1) When there is any fluidics action, the analyzer can’t enter the

sleep mode automatically.

(2) When any operation relating to the analyzer is required, exit

the sleep mode first. During the sleep, actions unrelated to the

analyzer, such as communication, printing, etc., are not

impacted.

During the sleep, click a button for a fluidics function, and the following prompt box will be

popped up.

12.2.2 Exit Sleep

Depending on the duration of sleep of the analyzer, different degrees of tube cleaning (for

different lengths of maintenance time) will be executed automatically when you exit the

sleep mode.

You can exit the sleep mode by pressing the Aspirate key on the front panel of the analyzer:


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After you have exited the sleep mode, the above prompt box will close automatically, and

the analyzer will exit the sleep mode.

12.3 Data Maintenance

The Data Maintenance module provides data export, data recovery, data clear, etc. The

interface is shown in the figure below:

System Data: Backup and recovery of database and graph data of samples.

Config Parameters: Parameters relating to performance and the analyzer, such as

gain, calibration coefficient, mechanical parameter setup, etc.

Data Clear: Historic data of samples, Quality Control results, and log data can be

cleared here.

Conventional Sample Data Import: Results of sample analysis can be imported to

the current database from another one.

12.4 Logs

Select the “Logs” menu to enter the following interface. You can view calibration records,

parameter modification, error information, daily maintenance, and other log information

relating to the operations of the analyzer.


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Print: Prints the current log record.

Export: Exports the log record to a .txt file for viewing.

12.5 System Status

“System Status” displays the environment temperature of the analyzer and the heating

temperature of the DIFF bath. “Reagent” can be used to view the current remaining reagent

and the estimated remaining number of times of analysis.

12.6 Version Information

Select the “Version Information” menu to enter the following interface, where you can view

the version of the configuration.


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12.7 Statistical Information

Select the “Statistical Information” menu to enter the following interface.

You can view the number of sample tests, number of Quality Controls, and number of

calibrations.

Click the “Detail...” button after “Sample count times”, and the interface will display the

detailed statistical result of the number of sample tests.


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Click the “Detail...” button after “QC Times”, and the interface will display the detailed

statistical result of the number of Quality Controls.

Click the “Detail...” button after “Calibration Times”, and the interface will display the detailed

statistical result of the number of calibrations.

“Probe piercing times” records the number of tests of sample analysis, Quality Control and

calibration in the Whole Blood mode and records how the sampling probe is used.

12.8 Mechanical Check

Click the “Service” button on the main menu interface and select “Mechanical Check” from

the menu pooped up to open the following dialogue box.


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1. You can test various parts and components. Click the button corresponding to the

item to begin self-tests and observes whether the corresponding parts and

components move.

2. Valve Self-test. Select the number of the valve to be tested, such as valve “1”. Click

the “Check” button to test the condition of valve 1. Judge whether the valve works

normally according to whether the valve has opening/closing sounds.

3. If “All” is selected, when you click the “Check” button, all valves will be tested in the

ascending order of valve numbers.

12.9 Prompt of Sampling Probe Replacement

When the number of piercing of a sampling probe reaches or exceeds 40000, the system will

prompt replacement of sampling probe.

Operate according to the prompt and click the “OK” button to close the prompt dialogue box.

Caution: (1) When the criteria of automatic prompt of sampling probe replacement are met, if the analyzer is in the running status, the prompt won’t be given before the current operation is finished.

(2) When the prompt of sampling probe replacement is popped up, if the sampling probe is not replaced, the system will give prompt again whenever 100 sample tests have been executed.


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12.10 Fuse Replacement

If there is no power supplied to the analyzer and the analyzer can’t be powered on, fuse

burn-out may be one of the causes. Check whether the fuse is in good condition. To replace

the fuse, refer to the following figure and screw off the fuse holder indicated by the arrow with

a straight screwdriver to replace the fuse.


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Chapter 13 Troubleshooting

In case of error of the analyzer, the status bar of the analysis software will give text prompt,

and the background color of the status bar will change. The background color for general

errors is yellow; for severe errors, red. If the buzzer is not set to Off in System Setup, the

buzzer will also give out alarm sound. Click the red exclamation mark icon appearing

on the text status bar or status bar to open the following dialogue box, where you can view

and clear the error.

The table below lists the common errors of the analyzer and their solutions. If the error can’t

be cleared according to the tips in this chapter or more detailed information is required,

please contact our Customer Service Department.

Error Solution

1)The analyzer can’t be started.

1. Check whether the analyzer is powered on.2. Check whether the power plug has got loose.3. Check the voltage.4. If the error still exists,please contact our customer service

department.

2) The analyzer is powered offautomatically.

1. Check whether the power supply of the analyzer is poweredon.

2. Check whether the electric cable has got loose.3. Power off the fuse in the analyzer, turn off the power supply,

and restart the analyzer. 4. If the error still exists,please contact our customer service

department.

3) Pressure abnormal. 1. Click the "Remove error" button to execute assy initialization.2. If the error still exists,please contact our customer service

department.

4)Diluent syringe action abnormal.

1. Click the “Remove error” button to execute assy initialization.2. If the error still exists,please contact our customer service

department.

5)Sample syringe action 1. Click the “Remove error” button to execute assy initialization.


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abnormal. 2. If the error still exists,please contact our customer servicedepartment.

6)Sheath fluid syringe action abnormal.

1. Click the “Remove error” button to execute assy initialization.

2. If the error still exists,please contact our customer servicedepartment.

7)Lyse syringe action abnormal.



8)Sampling syringe action abnormal.



9)Waste syringe action abnormal.



10)Pressure of sheath fluid exceeds the limit.

1. Click the "Remove error" button to clean flow cell.


11)Sheath fluid pipeline leaks. Please contact our customer service department.

12)Sample pipeline blocked. 1. Click the "Remove error" button to clean flow cell.


13) Sample pipeline leaks. Please contact our customer service department.

14) Flow cell blocked. 1. Click the "Remove error" button to clean flow cell.


15)External drain pipeline blocked.

1. Check whether the connection of the waste tubes is normal.


16) Liquid drain pipeline leaks. Please contact our customer service department.

17)Back bath pipeline leaks. Please contact our customer service department.

18)Positive pressure establishment failed.

1. Click the "Remove error" button to execute assy initializationand positive pressure test.


19)Negative pressure establishment failed.

1. Click the “Remove error” button to execute assy initializationand negative pressure test.


20) No cleanser. 1. Check whether the cleanser container is empty.

2. If there is no cleanser, install a new container of cleanser.Then click the "Remove error" button to prime cleanser.

3. If there is still plenty of reagent, or the error still exists aftercleanser is primed, please contact our customer service department.

21) No Diluent. 1. Check whether the diluent container is empty.

2. If there is no diluent, install a new container of diluent. Then


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click the "Remove error" button to prime diluent.

3. If there is still plenty of reagent, or the error still exists afterdiluent is primed,please contact our customer service department.

22) No 86H lyse. 1. Check whether the 86H lyse container is empty.

2. If there is no 86H lyse, install a new container of 86H lyse.Then click the "Remove error" button to prime 86H lyse.

3. If there is still plenty of reagent, or the error still exists after86H lyse is primed,please contact our customer service department.

23) No 86D lyse. 1. Check whether the 86D lyse container is empty.

2. If there is no 86D lyse, install a new container of 86D lyse.Then click the "Remove error" button to prime 86D lyse.

3. If there is still plenty of reagent, or the error still exists after86D lyse is primed,please contact our customer service department.

24) Waste is full. 1. Empty the waste container or install a new waste container.


25) WBC clog. 1. Click the "Remove error" button to unclog.

2. If the error still exists,execute "WBC/RBC Bath Soak"maintenance function.


26) RBC clog. 1. Click the "Remove error" button to unclog.

2. If the error still exists,execute "WBC/RBC Bath Soak"maintenance function.


27)Left door open. 1. Close the left door,and the error will disappear.


28)Right door open. 1. Close the right door,and the error will disappear.


29)Front shell open. 1. Close the front shell,and the error will disappear.


30)Temperature exceeds working range.

.

1. Make sure the ambient temperature is within the normalrange [15, 30]℃.

2. Analysis results may be incorrect if the ambient temperatureis out of the normal range.

3. If the ambient temperature is within the normal range, theerror will disappear automatically.


31)DIFF bath temperature 1. Click the "Remove error" button to reset the temperature of


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abnormal. the DIFF bath.

2. If the temperature is still abnormal,power off the analyzer andrestart it later.


32)Probe horizental action abnormal

1. Click the "Remove error" button to execute assy initialization.


33)Probe vertical action abnormal

1. Click the "Remove error" button to execute assy initialization


34)Drive board communication error.

1. Click the "Remove error" button to execute assy initialization.

2. Please power off the analyzer and restart it later.


35)The repeatability of blank test values is high.

1. Check whether the reagent has been used up.

2. Check whether the reagent has deteriorated or has beencontaminated.

3. Execute cleaning.

4. Calibrate the analyzer.

5. Check whether the ambient temperature is abnormal.


36) The printer can’t print. 1. Check whether the printer lacks paper.

2. Check whether the connection is normal.

3. Check the printer settings in System Setup.

37) The QC is out of the targetvalue range.

1. Check the shelf life of the reagent.

2. Check whether the settings are correct and whether it isnecessary to modify the parameters.

3. Check that the QC is not contaminated.

4. Run the test again.

38)Autolader board communication error.

1. Click the "Remove error" button to unload rack,then restartautoloader.

2. If the error still exists,power off the analyzer and restart itlater.


39)Openning sample compartment door failed.

1. Click the "Remove error" button to open sample compartmentagain.


40)Sample compartment door not closed.

1. Please close sample compartment again.


41)Loading motor action abnormal.


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42)Feeding motor action abnormal.

1. Click the "Remove error" button to initialize the motor,thenrestart autoloader.


43)Elevating motor action abnormal.

44)Pinch motor action abnormal.

45)Mix motor action abnormal.

46)Unloading motor action abnormal.

47)Scanner elevating motor action abnormal.

48)No tube rack on loading platform.

1. Check whether any tube rack is placed on load platform and ifthe position is correct,and restart autoloader.


49)Autoloader module action abnormal.

1. Check whether the tube rack is damaged and whether thereis any foreign matter on load platform,and click "Remove error" to unload rack.


50)Mix module action abnormal#1057.

1. Open the front shell to check whether any tube has fallen off.If yes, take out the tube manually, click the "Remove error" button to initialize the autoloader, and restart the analysis.









1. Click the "Remove error" button to initialize the autoloader,and restart the analysis.



1. Click the "Remove error" button to initialize the autoloader,and restart the analysis.


55)Unloading tube rack error. 1. Check if there is any skew placed tube rack or foreign matters which blocks next tube rack in the unloading area,then click the "Remove error" button to unload rack.



119

56)Unloading tray is full. 1. Remove the tube rack in the unloading area and click the "Remove error" button.


57)Scan action abnormal. 1. Click the "Remove error" button to unload rack, and restart the analysis.


Warning: (1) In case of error of the analyzer, immediately contact the agent

to obtain technical support!

(2) Only professionals confirmed by the Company can repair this

analyzer. For replacement of accessories, contact the

manufacturer or agent for supply.


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Appendix I: Names and Contents of Toxic/Hazardous Substances

or Elements

1. Names and Contents of Toxic/Hazardous Substances or Elements

Component

Toxic/Hazardous Substance or Elements

Lead (Pb)

Mercury (Hg)

Cadmium (Cd)

Hexavalent Chromium (Cr (VI))

Polybrominated

Biphenyls (PBB)

Polybrominated Diphenyl

Ethers (PBDE)

Built-in circuit board

x ○ ○ ○ ○ ○

Shell x ○ ○ x ○ ○

Display x ○ ○ ○ ○ ○

Photoelectric components x ○ ○ ○ ○ ○

Internal electronic

wire ○ ○ ○ ○ ○ ○

Accessories x ○ ○ ○ ○ ○

○: Indicates the content of the toxic/hazardous substance in all homogeneous materials of thecomponent is below the limit specified in the SJ/T11363-2006 standard.

x: Indicates the content of the toxic/hazardous substance in at least one homogeneous material of the component exceeds the limit specified in the SJ/T11363-2006 standard.

2. Description of Mark

Environmental protection use period mark

Meaning of the mark: The electronic information product contains certain toxic/hazardous

substances, with the environmental protection use period of 20 years. You can use it within

this period. When this period expires, the product should enter the recycling system.

ha-86 (89) auto hematology analyzer user’s manual

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