BC-5380&BC-5180

AUTO HEMATOLOGY ANALYZER

INSTALLATION GUIDE

Warning!

Reproduction or photocopy of this manual in any manner whatsoever without the

written permission is forbidden.

The manufacturer takes no legal obligation to inform the users before making any
change to this guide.
Symbols and Precautions
1. Symbols used in the guide

You will find the following cautionary symbols in this guide:

Symbols: It means...
read the statement below the symbol. The statement is
alerting you to an operating hazard that can cause
personnel injury.
read the statement below the symbol. The statement is
alerting you to a possibility of analyzer damage or
unreliable analysis results.

read the statement below the symbol. The statement is

alerting you to information that requires your attention.

read the statement below the symbol. The statement is

alerting you to a potentially biohazardous condition.

2.Indication of Safety Symbols

You may find the following symbols on the analyzer, reagents, controls or calibrators.
When you see... It means...

CAUTION, CONSULT ACCOMPANYING

DOCUMENTS.

BIOLOGICAL RISK

HIGH VOLTAGE

WARNING, LASER BEAM

WARNING, HOT SURFACE

PROTECTIVE EARTH (GROUND)

I
 EARTH (GROUND)

ALTERNATING CURRENT

FOR IN VITRO DIAGNOSTIC USE

BATCH CODE

USE BY

SERIAL NUMBER

DATE OF MANUFACTURE

Manufacturer

TEMPERATURE LIMITATION

CONSULT INSTRUCTIONS FOR USE

II
3.Precautions

Be sure to observe the following precautions during installation for the safety of patients and
operators.

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

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

All the analyzer components and surfaces are potentially infectious, so take
proper protective measures for operation and maintenance.

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

It is important for the hospital or organization that employs this equipment to
carry out a reasonable installation plan. Neglect of this may result in machine
breakdown or injury of human health.

Never use combustible gas (e.g. anesthetic) or combustible liquid (e.g.

ethanol) around the analyzer. Otherwise, the risk of explosion may exist.

Contacting exposed electronic components while the equipment is attached

to power can cause personal injury from electric shock or damage to
electronic components. Power down before removing covers to access
electronic components.

Connect the analyzer to a socket having sole fuse and protective switch. Do
not use the same fuse and protective switch with other equipment (e.g. life
supporting equipment). Otherwise, the equipment failure, over current or
impulse current that occurs at the startup moment may lead to tripping.

To prevent personal injury during the maintenance, keep your clothes, hairs
and hands from the moving parts, such as sample probe, pincher and piercer.

Possible mechanical movement of the warned position may lead to personal

injury during normal operation, removal and maintenance.

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

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

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

Improper installation may damage the analyzer. Install the analyzer strictly as
instructed by the installation guide and inspect the analyzer carefully after the
installation.

For problems not mentioned in the installation guide, contact Mindray

customer service department for installation advice.

To prevent personal injury or damage to equipment components, remove

metal jewelry before maintaining or servicing electronic components of the
equipment.

Electrostatic discharge may damage electronic components. If there is a

possibility of ESD damage during installation, then work at an ESD
workstation, or wear an antistatic wrist strap while installing.

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

IV
 Table of Contents
1 Preparations ................................................................................................................................. 3
1.1 Purpose .......................................................................................................................... 3
1.2 Tools ............................................................................................................................... 3
1.3 Accessories ................................................................................................................... 3

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

2.1 Environment Requirements ........................................................................................ 4
2.2 Space Requirements ................................................................................................... 5
2.3 Power Requirements ................................................................................................... 5
2.4 Confirming the Tube Type on Site.............................................................................. 6

3 Unpacking ..................................................................................................................................... 7
3.1 Checking Before Unpacking ....................................................................................... 7
3.2 Unpacking the Main Unit ............................................................................................. 7
3.3 Checking Packing List ................................................................................................. 9

4 Removing the Fixing Components ............................................................................................ 10

5 Connections ................................................................................................................................ 11

6 Installation of IPU Software ...................................................................................................... 14

6.1 Installing IPU ............................................................................................................... 14
6.2 Connection Setup of the IPU and Analyzer ............................................................ 17

7 Start-up 20
7.1 Initial start-up ............................................................................................................... 20
7.2 Inspection after Startup ............................................................................................. 22

8 Setup and Adjustment ............................................................................................................... 24

8.1 Reagent Setup ............................................................................................................ 24
8.2 Maintenance Setup .................................................................................................... 25
8.3 HGB Blank Voltage Setup ......................................................................................... 26
8.4 Advanced setup .......................................................................................................... 27

9 Testing Other Functions ............................................................................................................ 28

9.1 Printing Test ................................................................................................................. 28
9.2 Testing External Barcode Scanner .......................................................................... 28
9.3 Testing Tube Scanning and Piercing ....................................................................... 29

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10 Calibration and Performance Test ......................................................................................... 31
10.1 Background Validation ............................................................................................... 31
10.2 Optical System Status Validation ............................................................................. 31
10.3 Validation and Calibration of Optical System Gain ................................................ 33
10.4 Calibration.................................................................................................................... 34

11 Installation Checklist ............................................................................................................... 38

2
 1 Preparations

1.1 Purpose
Following this installation guide ensures proper installation of the analyzer. This installation
guide is intended to ensure safe and effective operation of the analyzer at the client's.

1.2 Tools
1. Blade or clipper

2. USB

3. Pipette (200ul)

4. Cross-headed screwdriver

1.3 Accessories
1. Plastic test tube

2. Glass pipette

3. 7μm standard particles

4. Gloves

5. Tissues

6. Calibrator

7. Control (normal)

Do prepare the 7μm standard particles and controls firstly to proceed with the later
confirmation of the optical gain.

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 2Installation Requirements

2.1 Environment Requirements

Make sure the operating environment of the analyzer meets the requirements in Table 2-1
before installation.

Table 2-1 Operating environment requirements

Operating
Storage Environment Running Environment
Environment
Requirements Requirements
Requirements

Ambient
15℃～30℃ -10℃～40℃ 10℃～40℃
Temperature

Relative Humidity 30%～85% 10%～90% 10%～90%

Atmospheric
70kPa～106kPa 50kPa～106kPa 70kPa～106kPa
pressure

Besides, the installation environment must meet the requirements below:

a. The environment should be as free as possible from dust, mechanical vibrations,and

electrical interference;

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

analyzer. Make sure the electromagnetic interference is less than CLASS B. Do not use
this analyzer in close proximity to sources of strong electromagnetic radiation;

c. Do not place the analyzer near brush-type motors, flickering fluorescent lights, and
electrical contacts that regularly open and close;

d. Do not place the analyzer on a slope;

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

f. The environment shall be well ventilated.

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

Do not move the analyzer. Contact Mindray or your local distributor if
necessary.

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 If the ambient temperature is out of the specified operating range, the
analyzer will alarm you for abnormal ambient temperature and the analysis
results may be unreliable.

2.2 Space Requirements

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

a. at least 100cm to both left and right sides;

b. at least 50 cm behind the analyzer;

c. enough room on or below the countertop to accommodate the diluent, lyse and
waste containers.

Make sure all the requirements listed above are met. Otherwise, the
performance of the analyzer might be compromised.

2.3 Power Requirements

See table 2-2 for power requirements of the analyzer. Make sure the requirements are met
before installation.

Table 2-2 Power Requirements

Input
Voltage Frequency
Power

Analyzer (100V-240V～)±10% ≤300 VA (50Hz/60Hz)±1Hz

Make sure the analyzer is properly grounded.

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

pneumatic unit.

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

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 Use the original electrical wire shipped with the analyzer.

2.4 Confirming the Tube Type on Site

1. Tube size of closed tube mode
The following tubes can be used for closed tube mode
Evacuated collection tube Ф12～15×75mm (without tube cap), for whole blood mode;
Small closed anticoagulated tube Ф10.7×42mm(without cap) (No. 365974 of BD), 0.5ml,
false bottom, for whole blood mode
Note: Length of the evacuated collection tube (with cap) shall not exceed 83mm.
Centrifugal tube Ф11×40mm(1.5ml and 0.5ml), for predilute mode.

2. Tube size of autoloading mode

The tubes for closed tube whole blood mode can all be used for autoloading mode
except the "small closed anticoagulated tube Ф10.7×42mm (without cap) (No. 365974 of
BD), 0.5ml, false bottom".

3. Recommended tubes of autoloading mode(whole blood mode)

Table 2-3 Recommended tubes of autoloading mode (whole blood mode)

Tube outer

Tube Volume diameter× tube

Manufacturer Product Product No. Anticoagulant
material (mL) length (without

cap) (mm)

Vacutainer
BD 367835 Plastic EDTA-K2 3 13x75
Plus

Vacutainer
BD 367841 Plastic EDTA-K2 2 13x75
Plus

Anticoagulant

Guangzhou evacuated
80715 Glass EDTA-K2 2 12.6×75
Yangpu blood collection

tube

Anticoagulant
Jiangsu 12×75
tube for routine / Plastic EDTA K2 2
Changjian
blood test

Anticoagulant
Jiangsu 13×75
tube for routine / Plastic EDTA K3 3
Changjian
blood test

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 3 Unpacking

3.1 Checking Before Unpacking

Check if the package is intact before unpacking.

3.2 Unpacking the Main Unit

1. The appearance of the main unit package is shown in Figure 3-1. Cut off the binding straps
before unpacking.

Binding
straps

Top
cover

Figure 3-1 Exterior package of the main unit

2. Cut off the binding straps and remove the wooden cover. Then, take out the accessory box
shown in Figure 3-2.

Accesso
ry box

Figure 3-2Removing the wooden cover

3. Lift the carton to expose the main unit, as shown in Figure 3-3.

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 Carton

Figure 3-3Take out the accessory box

4. Remove the protection foam from both sides of the main unit, as shown in Figure 3-4.

Protection
foam

Figure 3-4Remove the protection foam

5. Remove the plastic bag from the main unit. Grab the bottom of the main unit and lift it onto
a countertop. Note that the main unit must be lifted by at least two persons, as shown in
Figure 3-5.

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 Figure 3-5 Lift the main unit

3.3 Checking Packing List

Check the delivered components against the packing list to see if everything is delivered.

When lifting the main unit, keep it as level as possible and avoid strong
impact. Never lift the autoloader to move the analyzer.

Always lift the left and right side of the main unit to move it, as lifting the
front of the analyzer may damage the front cover.

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 4 Removing the Fixing Components
Open the right side door of the main unit with the slot head screwdriver in the accessory box,
remove the plastic cable tie vertically fixing the sampling assembly and remove the clamp
fixing the synchronous belt. Pull the sampling assebly manually to make sure it can move
smoothly, as shown in Figure 4-1.

Clamp Plastic
cable tie

Figure 4-1Removing the plastic cable tie and the clamp

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 5 Connections
1. See Figure 5-1 for connections of reagents and the waste container. Note that the
M-53LEO(I) lyse, M-53LEO(II) lyse, M-53LH lyse and the analyzer should be placed in a
plane of the same level, and the M-53D diluent and waste containers should be placed under
the countertop.

Figure 5-1Connections of reagents and waste container

Remove the plugs of the fluidic interfaces on the back of the analyzer.

Make sure the M-53LEO (I) lyse, M-53LEO (II) lyse and M-53LH lyse are placed
on the same level as the analyzer, and the cap assemblies are alright.

Install a supporting board on the cap assembly of the M-53D diluent container,
as shown in Figure 5-2.

The diluent container must not be placed1.0 meter higher or lower than the
analyzer.

Install the
supporting
board

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 Figure 5-2 Installing the supporting board
2. Connect the tubes according to their colors, and connect the sensor connectors (diluent
and waste sensor). See Figure 5-3, color of the tube and its connector must be the same.

Analyzer
network
port

M-53D
diluent
Power sensor
interface interface

Waste
sensor
interfa
ce
Waste
outlet
M-53D diluent
interface
M-53LH lyse
interface
Install the
supporting board
M-53LEO (II) lyse
interface M-53LEO (I) lyse interface
Figure 5-3Properly connected wires and lines

3. Connect the BC-5390analyzer to PC of the IPU; plug the power cords of the PC and
analyzer to the electrical outlets, as shown in Figure 5-4.

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Figure 5-4 Connecting the PC and the main unit

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 6 Installation of IPU Software

6.1 Installing IPU

Open the installation disk, right click the file setup.exe, and select "Run as administrator" to
start installation.

Figure 6-1 Run installation program

2. The "User Account Control" dialog box displays, select "Yes" to install the application.
3. The installation program checks system environment, such as operation system version
and database, and then the following dialog box displays.

Figure 6-2 Database installation

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4. If there are modules missing for installation of the IPU, install the modules, and restart the
PC when the prompt message instructs so.
5. After all necessary modules are installed, the language selection screen displays, select
the desired language of the IPU here.

Figure 6-3 Language selection dialog box

6. Click OK to enter the model selection dialog box to select the desired model of the
"Analyzer IPU Software" (select based on the actual model of your analyzer).

Figure 6-4 Model selection dialog box

7. Click "Next"to enter the installation path selection dialog box. The installation program is
normally installed in non-system disk. To make sure the "Analyzer IPU Software" can run

15
properly, the residual space of the installation disk shall be more than 100M.

Figure 6-5 Installation path selection dialog box

8. Click "Next" to start the installation process of "Analyzer IPU Software".

9. Click OK to finish installation. Shortcut icons of the installation program will be created on
the desktop and in the system menu.

Figure 6-6 Installation finished

Figure 6-7 Shortcut icon on the desktop

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6.2 Connection Setup of the IPU and Analyzer
Note:
The default IP address of the analyzer is 10.0.0.7. To modify the IP address of the analyzer,
see section 7.1.
If the PC configured has dual network ports, select the right one when setting up PC of the
analyzer.

The connection procedure is as follows:

1. Open the local network connection of the PC, as shown in Figure 6-8.

Figure 6-8 Local connection

2. Click the button "Properties" and select "Internet Protocol Version 4 (TCP/IPv4)" in the
dialog box to set up IP address of the PC, as shown in Figure 6-9.

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 Figure 6-9 Property selection

3. Set the IP address to "10.0.0.1" (the last digit shall be different from that of the analyzer IP),
and the subnet mask to "255.0.0.0", and then click "OK" to exit. The IP address of PC and
analyzer shall be in the same network segment, as shown in Figure 6-10.

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Figure 6-10 Setting up IP address

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 7 Start-up

7.1 Initial start-up

1. Close the right door, power on the analyzer and wait for a moment. When the icon
in Figure 7-1 displays, the IPU is connected to the analyzer network.

An exclamation
mark appears on
the icon.
Figure 7-1 Network connected

2. Double click the icon of IPU on the PC desktop to enter the log-on screen. Enter
user name: service, password: Se s700 (Note: The password contains 7 characters,
there is a space between “e” and “s”.), and then click OK to enter the IPU software.
The analyzer starts to initialize automatically.

Figure 7-2 Logon screen

3. During the initialization, a dialog box "Skip fluidic initialization?" will pop up. Click
"No" to continue the initialization.See Figure 7-3.

Figure 7-3 Prompt during initialization process

4. To modify analyzer IP, click "Setup" - "Analyzer Setup" - "Communication" to enter

the screen shown in Figure 7-5, and then set up IP address and subnet mask. Save
the change and restart the analyzer and IPU, modification of analyzer IP is done.

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 Figure 7-5 Communication setup
5. If the analyzer is connected to LIS, before transmitting data, make sure PCs of the
LIS and analyzer are working, so that the IPU program could locate the destination
for transmitting.
6. Click "Setup" - "General Setup" - "Communication" to set up IP address and port
information as required by the LIS.

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 Figure 7-6 LIS communication setup
7. If the connection between PC of the IPU and analyzer is established, the “LIS” icon
in the IPU screen will turn colorized, as shown in Figure 7-7, indicating you can start
transmitting data now.

Figure 7-7 Connecting the PCs of IPU and LIS

7.2 Inspection after Startup

1. Click "Menu→Service→Version and Config. Information", as shown in Figure 7-8 to
enter the "Version and Config. Information" screen shown in Figure 7-9.

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 Figure 7-8Menu of Version and Config. Information

Figure 7-9 Version and Config. Information screen

The specified version here means the PC end software should be complied with
that of the main unit end. Update the main unit end software to match the PC end
software if necessary.

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 8 Setup and Adjustment

8.1 Reagent Setup

1. At the main screen, click "Menu→Setup→Reagent" to enter the reagent screen
where you can set the expiration date for reagents, as shown in Figure 8-1.

Figure 8-1 Click "Reagent"

2. Set the expiration date for the following reagents: "Diluent", "LEO (I) Lyse", "LEO (II)
Lyse", and "LH Lyse", as shown in Figure 8-2.

Figure 8-2Setting the expiration date of reagents

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 3. If the analyzer is equipped with a built-in barcode scanner, set up the barcode
information by clicking "Barcode Info." and the code systems according to the
barcode digits used by the customer. Click "Ok" to save the settings, as shown in
Figure 8-3.

Figure 8-3Setting the barcode information

8.2 Maintenance Setup

1. Click "Setup" - "Analyzer Setup" - "Auto Maintenance" to enter the auto maintenance
setup screen.
2. Set up the waiting time before entering standby mode automatically, which means for
how long the analyzer stays inactive, it will enter the standby mode automatically.
3. Set up probe cleanser maintenance settings base on the client's needs, including
start time and reminding time of the maintenance. "Time-Based Maintenance Start
at" means at when the analyzer reminds the operator to perform probe cleanser
maintenance, while "Remind every" means the interval of sending the reminder
again after the maintenance has been canceled. See Figure 8-4.

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 Figure 8-4 Maintenance setup

8.3 HGB Blank Voltage Setup

After transportation and fluidics initialization, the blank voltage for HGB measurement may be
different from the factory setting, the ambient temperature may also affect the voltage, so it
needs to be reset after installation of the analyzer.
The HGB blank voltage shall be adjusted to around 4.5V. To adjust HGB gain,
1. Click "Setup" - "Analyzer Setup" - "Gain" to enter the gain setup screen.
2. Click the arrows in the“HGB current value” box to adjust the value.

26
 Figure 8-4 HGB blank voltage

8.4 Advanced setup

Click "Setup" - "Analyzer Setup" - "Advanced" to enter the advanced setup screen.
Select "Upload WAVE file" if it is needed. When it is selected, the WAVE file of all sample
pulses will be sent to the PC simultaneously.

Figure 8-5 Advanced Setup

Note: Make sure "Upload WAVE file" is selected for installation in evaluation or trial use
phase to collect data for analysis of possible errors.

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 9 Testing Other Functions

9.1 Printing Test

Click "Menu→Setup→Print" to enter the print screen. Select the printer connected to the IPU
computer and click "OK" as shown in Figure 9-1, to check if the report can be printed
successfully.

Figure 9-1 Print setup screen

9.2 Testing External Barcode Scanner

If the customer requires an external barcode scanner, plug the connector of the scanner into
the USB port of the PC as shown in Figure 9-2.

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 Figure 9-2 Connecting the external barcode scanner

To read barcodes with the barcode scanner, select"Use barcode scanner" in the reagent
setup screen, and point to the scanner to the barcode to read it and then click "Loading".

9.3 Testing Tube Scanning and Piercing

Do as follows:
1. Prepare a tube rack and 10 tubes with barcodes (for closed tube model not
configured with built-in barcode scanner, tubes without barcodes can be used), and
paste high temperature tapes on the tube caps, as shown in Figure 9-4.

Figure 9-4 Pasting high temperature tapes

2. Set up barcode system in the "Setup" - "Barcode Info." screen. Check the barcode
system and digits of the client end. Select the barcode system used and fill in the
number of digits allowed, or select "Unlimited number of digits", as shown in Figure
9-5.

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 Figure 9-5 Setting the barcode information

3. Put the tubes in the tube rack. Click "Mode" on review screen and select the mode
"ALWB-CBC+DIFF” set rack No. and tube No. to 1 and sample ID to "ZDCS-01". For
analyzers configured with built-in barcode scanner, sample ID can be scanned
automatically.
4. Observe the fetching and placing motions of the mechanical arm. It is required that
the motions shall be smooth. Check position of the piercing hole in the tube cap, it is
required that the hole is within Φ4mm of the cap center, as shown in Figure 9-6.

Φ4mm

Figure 9-6 Position of piercing hole

5. For analyzers configured with built-in barcode scanner, check if the tube rack No.
and sample ID are correct.
6. Select mode "CT-WB-CBC+DIFF", place a tube pasted with high temperature tape to
the tube position, and then start analysis to see if the piercing hole is within Φ4mm of
the cap center.

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 10 Calibration and Performance Test

Note: Before validating performance, please select"Upload WAVE file" as stated in 8.4.

10.1 Background Validation

 Introduction
Test the background results of the analyzer; make sure the results meet the requirement of
the analyzer specification. Note: use diluent for background test.
 Procedure
Enter the “Graph” review screen. Perform the background count in both the "WB-CBC+DIFF"
and "PD-CBC+DIFF" modes. The background results shall meet the specified requirement:
9 12 9
WBC: ≤0.2×10 /L, RBC: ≤0.02×10 /L, HGB: ≤1g/L, HCT: ≤0.5%, and PLT: ≤10×10 /L.

10.2 Optical System Status Validation

 Introduction
This chapter describes how to test the optical system by using standard particles to verify
the status of the optical system.
Test points:
When graph of the standard particle is in the specified range of the DIFF scattergram (i.e.,
the position of gravity center of the standard particle is within the target range), check if the
FS 0.1max width (SD) and SS 0.1max width (SD) of the standard particle meet the
requirements. Beside, when position of gravity center is in the specified range (target range),
the FS and SS gains shall also be in specified range.
Validation criteria:
1. When position of gravity center of the standard particle is within the target range, but the
FS 0.1max width (SD) and SS 0.1max width (SD) do not meet the requirements (after
performing maintenance procedures), then the optical system status validation fails.
2. When position of gravity center of the standard particle is not within the target range, after
recalculating the gain, the position of gravity center, FS 0.1max width (SD) and SS 0.1max
width (SD) all meet the requirements, but the gain calculated is outside the specified range,
then the optical system status validation also fails.
 Procedure
1. Prepare a vial of 7μm standard particles and mix it. Add 3-4 drops of the 7μm standard
particle solution to a 1.5ml centrifugal tube, and dilute the solution with deionized water
to 1 ml, and then cap the tube to mix the solution again, as shown in Figure 10-1.

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 Figure 10-1 Preparing 7um standard particles

2. Select analysis mode OV-WB-CBC+DIFF or CT-WB-CBC+DIFF, and run analysis with

7um standard particles. After the analysis, select test data in the review screen, and click
the button "Optical" on the top right of the screen to enter the optical debug screen, as
shown in Figure 10-2.

Figure 10-2 Optical debug screen of standard particles

3. Select "Standard Particle Mode", and click "Calculate". Check if the "FS Gravity Center
Position" and "SS Gravity Center Position" of particle 1 are within the ranges 17.6±0.5
and 105.3±1.0, if not, enter the target (FS 17.6, SS 105.3) of 7um standard particles to
the FS and SS peak targets of particle 1, then the analyzer will calculate the gain
automatically. Click the button "Gain Setup" to save the gain.
4. Run analysis with 7um standard particles in the sample analysis screen again, and
check if the "FS Gravity Center Position" and "SS Gravity Center Position" of particle 1
are within the ranges 17.6±0.5 and 105.3±1.0 in the optical debug screen. Repeat step
2-4 until the they falls in the ranges.
5. If the "FS Gravity Center Position" and "SS Gravity Center Position" of particle 1 meet
the requirements, check if the following requirements are met too.
FS 0.1max width (SD) ≤7.20

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 SS 0.1max width (SD) ≤15.21
And check if the FS and SS gain is within the following range in the screen "Setup→Analyzer
Setup→Gain".
FS gain ≤150
SS gain ≤220
6. If yes, then optical system status validation is completed, and result is Pass. If not, the
flow cell may be dirty, and flow cell maintenance shall be performed. After the
maintenance, repeat step 2-5, and see if the results meet the requirements. If the results
fail to meet the requirement, refer to the service manual for solution. And the analyzer
can be concluded as open-case defective

10.3 Validation and Calibration of Optical System Gain

After maintenance or replacement procedures are performed to the optical system, or the
analyzer has been idled for a long time, or the environmental conditions change significantly,
or the analyzer has been transported for long distance, the optical system gain shall be
re-calibrated to make sure the optical system is in its optimal state. The calibration procedure
is as follows:
1.Select analysis mode OV-WB-CBC+DIFF or CT-WB-CBC+DIFF, and run analysis with
controls. After the analysis, select test data in the review screen, and click the button
"Optical" on the top right of the screen to enter the optical debug screen,
2. as shown in Figure 10-3. Select "Control Mode" and then click "Calculate". The "FS
Gravity Center Position" of particle 2 shall be within the range ±1.94 of the BC-5D control
target, and the "FS Gravity Center Position" shall be within the range ±2.6 of the control
target. If they are not within the target range, continue with gain calibration.

Figure 10-3 Optical debug screen of controls

33
3. Enter the FS and SS gravity center target of the controls to the "Peak target of particle 2",
the analyzer will calculate the gain automatically, and display it in the "Gain" column. Click the
"Gain Setup" button, the current FS and SS gains will be refreshed to the calculated gain.
4. Run control analysis again, and enter the optical debug screen to check as per step 2. If
the values are still not in the target range, repeat step 1-3 until they fall into the target range.

10.4 Calibration
 Introduction
Calibration is the process to calibrate the key parameters of the analyzer to a standard
comparator, making the results of the analyzer close to those of the comparator. You can
calibrate the analyzer under fresh blood or calibrator mode.
 Procedure
A. Calibration under whole blood mode
1. Click "Menu→Calibration", and then click "Calibrator" to enter the "Calibrator" screen.
Select the calibration mode as "Whole Blood"; enter the lot No. and the expiration date
of the calibrator, and then enter the WBC, RBC, HGB, MCV and PLT targets of the
calibrator into the table. Click "Start". See Figure 10-12.

Figure 10-12 Calibration setup (WB)

2. Well mix the calibrator and then open the cap and present the calibrator under the
sample probe, and then press the aspirate key, as shows in Figure 10-13.

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 Press the
[Aspirate]
key

Figure 10-13 Calibration count

NOTE
Be sure to immerse the tip of the sample probe into the calibrator.
If the customer need to use the analysis results generated by the specified analyzer as
references, run the calibrator on the specified analyzer in the whole blood mode
consecutively for 3 times, and use the mean values of the results as targets. Type these
values into the target column at the "Calibration" screen and calibrate.

3. Repeat running the calibrator for 11 times as instructed by procedure 2. Then, the
setup of whole blood calibration factors is completed. When the calibration completes,
the calibration factor will be displayed at the bottom of the table automatically.

B. Calibration under predilute mode

1. Click "Diluent" and then present the tube under the sample probe, and then press
the aspirate key to start dispensing the diluent. Dispense the diluent into the tube
for 6 times consecutively, and then click "Cancel" to close the dialog box.
2. Add 120ul of calibrator into the tube with a pipette, and mix the calibrator with
diluent.
3. Go back to the “Calibrator” screen, and then select the calibration mode as
"Predilute". Enter the lot No. and the expiration date of the calibrator, and then enter
the WBC, RBC, HGB, MCV and PLT targets of the calibrator into the table. Click
"Start".
4. Present the calibrator well mixed to the sample probe, making sure the sample
probe is plunged into the calibrator, and then press the aspirate key. When you hear
the beep, remove the calibrator. The analyzer will start running automatically.
5. Repeat running the calibrator for 11 times. Then, the setup of predilute calibration
factors is completed. When the calibration completes, the calibration factor will be
displayed at the bottom of the table automatically.

3 Fresh blood calibration (administrator level)

1. Prepare 3-5 (at least 3) fresh blood samples, run the samples for at least3 times on
the reference analyzer and then calculate the means, and make them the reference
values; or perform analysis and calculation as per the reference method of the lab,
and take the calculated results as the reference values.

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2. Click "Menu" - "Calibration" to enter the "Calibration Factors" screen. Click the
Mode button and select fresh blood calibration.
3. Click the "Fresh Blood" tab on the top of the "Calibration Factors" screen to enter
the "Fresh Blood" calibration screen.

4. Select the calibration sample ID of the current sample from the "Current sample ID"
pull-down list.

5. Select the parameters to be calibrated by clicking on the check boxes in the first line
of the table.

6. Enter the reference value of the parameter to be calibrated into the edit box "Ref.
value".

7. Prepare whole blood or prediluted fresh blood samples.

Figure 10-16 Calibration with fresh blood samples

8. Click the button "Start", the dialog box as shown in Figure 10-17 displays.

Figure 10-17 "Start" dialog box

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9. Press the aspirate key to start calibration count.

10. When valid calibration counts of each sample reach n (n≥6), the analyzer will
automatically calculate the Mean, CV% and calibration factor of all calibration data
marked with "√" (calibration data of the first count is not marked with "√", so it is not
included in the calculation).

11. Select other calibration samples from the "Current sample ID" pull-down list, and
perform calibration counts of the samples as instructed in step 8～12 to get their
calibration factors.

12. After getting 3 or more calibration factors of the fresh blood samples, click
"Calculate" to enter the calculate screen of fresh blood calibration. See Figure
10-18.

Figure 10-18 Calculated Result screen

13. When there are 3 or more calibration factors marked with "√", the CV% of the
calibration factors has been re-calculated as per the calibration factors marked with
"√".
14. When calibration finishes, click "Yes" on the pop-up dialog box to save the new
factor.

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 11 Installation Checklist

No. Inspection Item Description Reference Result

1 Ambient Within the 15℃～30℃ □Pass □Fail
Temperature operating
temperature range
2 Ambient Within the 30%～85% □Pass □Fail
humidity operating humidity
range
Operating
3 Atmospheric Within the 70KPa～ □Pass □Fail
Environment
pressure operating 106KPa
atmospheric
pressure range
4 Electromagnetic Away from sources / □Pass □Fail
radiation of electromagnetic
radiation
5 Space Requirements Analyzer Space Meet installation □Pass □Fail
requirement
6 Power Requirements Power supply, Meet the □Pass □Fail
voltage and requirements of
frequency Table 2-2
7 Tube size Tube size meets Meet □Pass □Fail
specification requirements in
requirements section 2.4

No. Inspection Item Description Reference Result

1. The package box and Package and Package and □Pass □Fail
appearance of the main appearance appearance are in
unit good conditions
2. Packing List Items on packing list All items are □Pass □Fail
found
3. Removing the fixing Sample collection Strips and □Pass □Fail
components of the assembly long-tail clips
analyzer
4. Connection of waste Tube and sensor Properly □Pass □Fail
connected without
bend
5. Connection of diluent Tube and sensor Properly □Pass □Fail
connected without
bend
6. Connection of lyse Connection of cap Properly □Pass □Fail
assembly connected without

38
 bend
7. Supporting board Positions of Supporting board □Pass □Fail
installation supporting board is properly
and sensor installed
8. Height of diluent Relative height of No less than1m □Pass □Fail
diluent and the
analyzer

No. Inspection Item Description Reference Result

1. IPU connection setup IP setup of the The connection is □Pass □Fail
analyzer and IPU OK
2. LIS connection setup Communication with Transmission □Pass □Fail
LIS is OK goes on well
3. Analyzer version Version No. The version is □Pass □Fail
information correct
4. Analyzer temperature All temperatures Within the □Pass □Fail
status required range
5. Voltage and current Voltages and Within the □Pass □Fail
currents required range
6. Reagent Setup Barcode or lot No. The settings are □Pass □Fail
setup correct
7. Print setup Print device and Meet client
template requirements
8. Maintenance Setup Maintenance Setup Meet client □Pass □Fail
contents requirements
9. HGB background voltage HGB background 4.5±0.1 V □Pass □Fail
voltage
10. Check tube piercing Piercing position Meet requirement □Pass □Fail
11. Barcode Barcode options Barcode system □Pass □Fail
used by the client

No. Inspection Item Description Reference Value Result

≤ 0.3  10 / L
9
1. WBC □Pass □Fail
≤ 0.03  10 / L
12
2. RBC □Pass □Fail
3. Background HGB ≤1 g/L □Pass □Fail
4. HCT ≤0.5 % □Pass □Fail
≤ 10  10 / L
9
5. PLT □Pass □Fail
6. FS gravity center 17.6±0.5 □Pass □Fail
7. SS gravity center 105.3±1.0 □Pass □Fail
Standard particle
8. FS 0.1max width ≤6.8 □Pass □Fail
9. SS 0.1max width ≤15 □Pass □Fail

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10. WBC [90, 125]% □Pass □Fail
11. RBC [90, 125]% □Pass □Fail
12. Calibration factor HGB [90, 125]% □Pass □Fail
13. MCV [95, 105]% □Pass □Fail
14. PLT [90, 125]% □Pass □Fail
15. WBC ≤2.0% □Pass □Fail
16. RBC ≤1.5% □Pass □Fail
17. Reproducibility HGB ≤1.0% □Pass □Fail
18. (whole blood) MCV ≤1.0% □Pass □Fail
19. PLT ≤4.0% □Pass □Fail
20. MPV ≤4.0% □Pass □Fail
21. WBC ≤4.0% □Pass □Fail
22. RBC ≤3.0% □Pass □Fail
23. Reproducibility HGB ≤3.0% □Pass □Fail
24. (predilute) MCV ≤2.0% □Pass □Fail
25. PLT ≤8.0% □Pass □Fail
26. MPV ≤4.0% □Pass □Fail

40
P/N: 046-000352-00 (2.0)