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BC-5800&5600

AUTO HEMATOLOGY ANALYZER


INSTALLATION GUIDE

Model BC-5800/5600

Warning!
1. Reproduction or photocopy of this manual in any manner whatsoever
without the written permission is forbidden.
2. The manufacturer takes no legal obligation to inform the users before
making any change to this guide.
Revision History

Version Date of Cause of Revision Page No. SER. Come into


No. Revision

(month/year) /Revised by Revision No. Effect on


Details

1.0 11/2009 Dong Beibei


Symbols and Precautions
1. Symbols used in the guide
You will find the following cautionary symbols in this guide:

When you see... Then...

read the statement below the symbol. The statement is


alerting you to a potentially biohazardous condition.

read the statement below the symbol. The statement is


alerting you to an operating hazard that can cause
personnel injury.

read the statement below the symbol. The statement is


alerting you to a possibility of analyzer damage or
unreliable analysis results.

read the statement below the symbol. The statement is


alerting you to information that requires your attention.

2. Symbols on products
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

I
PROTECTIVE EARTH (GROUND)

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 or maintenance.

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

III
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 the normal operation, removal and maintenance.

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.

IV
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.

V
Table of Contents
1 Preparations.................................................................................................................... 1-1
1.1 Purpose ............................................................................................................... 1-1
1.2 Tools .................................................................................................................... 1-1
1.3 Accessories ......................................................................................................... 1-1
2 Installation Requirements................................................................................................ 2-1
2.1 Space Requirements ........................................................................................... 2-1
2.2 Power Requirements ........................................................................................... 2-1
2.3 Environment Requirements ................................................................................. 2-2
2.4 Confirming the Tube Type on Site ....................................................................... 2-2
3 Package Checking and Unpacking ................................................................................. 3-1
3.1 Checking before unpacking ................................................................................. 3-1
3.2 Unpacking the main unit ...................................................................................... 3-1
3.3 Unpacking the pneumatic unit ............................................................................. 3-3
3.4 Unpacking the accessories.................................................................................. 3-5
3.5 Unpacking the autoloader (optional).................................................................... 3-6
3.6 Packing list check ................................................................................................ 3-8
4 Removal and Installation................................................................................................. 4-1
5 Connections .................................................................................................................... 5-1
6 Start-up............................................................................................................................ 6-1
6.1 Inspection before Startup..................................................................................... 6-1
6.2 Initial start-up ....................................................................................................... 6-1
6.3 Inspection after Startup........................................................................................ 6-5
7 Setup and Adjustment..................................................................................................... 7-1
7.1 Setting Parameters.............................................................................................. 7-2
7.2 Adjusting the HGB blank voltage......................................................................... 7-7
7.3 Adjusting Positions .............................................................................................. 7-8
7.4 Testing Other Functions..................................................................................... 7-19
8 Calibration and Performance Test................................................................................... 8-1
8.1 Background Count............................................................................................... 8-1
8.2 Confirming the Gain of the Optical System ......................................................... 8-1
8.3 Checking the scattergrams.................................................................................. 8-6
8.4 Calibration............................................................................................................ 8-8
8.5 Reproducibility ................................................................................................... 8-11
9 Appendices .....................................................................................................................A-1
A Fluidic diagrams ......................................................................................................A-1
B Method to Identify the Cross Network Cable and the Direct-Connected Network
Cable ...............................................................................................................................B-1

1
1 Preparations

1.1 Purpose
Install the instrument and update the software properly as per the procedures introduced in this
chapter, in order to ensure the safe and effective operation of the analyzer on site.

1.2 Tools
Blade or clipper

Monkey wrench

USB flash disk

Pipette (200ul)

Cross-headed screwdriver

1.3 Accessories
Plastic test tube

Glass pipette

7m standard particles

Gloves

Tissues

Calibrator

Control (high and normal level)

Do prepare the 7m standard particles firstly to proceed with the later


confirmation of the optical gain. Prepare controls and fresh blood samples
as alternatives.

1-1
2 Installation Requirements

2.1 Space Requirements


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

at least 100cm to both left and right sides;

at least 50cm behind;

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

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

2.2 Power Requirements


Voltage Frequency Input power Fuse
Analyzer a.c.100 V240 V 50/60 Hz 300 VA 250 V T5 A
a.c.110/115 V 50/60 Hz 300VA/60Hz 125 V T5 A
450VA/50Hz
Pneumatic unit
a.c.220/230 V 50/60 Hz 300VA/60Hz 250 V T2.5 A
450VA/50Hz

WARNING
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.

Use the original electrical wire shipped with the analyzer.

2-1
Installation Requirements

2.3 Environment Requirements


The installation environment of analyzer must meet the following requirements:

Optimal operating temperature: 15 -30

Running temperature: 10 -40

Optimal operating humidity: 30 %-85 %

Atmospheric pressure: 70 kPa-110 kPa

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

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;

Do not use this analyzer in close proximity to sources of strong electromagnetic radiation;

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

Do not place the analyzer on a slope;

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

The environment shall be good ventilation.

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

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

NOTE
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.

2.4 Confirming the Tube Type on Site


It is required to confirm the tube type on site before installation. Tubes supported by
BC-5800/BC-5600 include: 12X75mm, 12X76.5mm, 12.5X75mm, 13X75mm,
13X78mm, 14X75mm and 15X75mm evacuated blood collection (tube cap not taken into
account), and the height with tube cap should be no larger than 83mm. Tube model for the
predilute mode: 11X40mm (1.5ml centrifugal tube).

2-2
3 Package Checking and Unpacking

3.1 Checking before unpacking


Check if the package is intact before unpacking.
For a model configured with an autoloader, there shall be 4 packages, for the main unit,
pneumatic unit, accessories and the autoloader respectively.
For a model without autoloader, there shall be 3 packages, for the main unit, pneumatic unit
and accessories respectively.

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

Wooden top cover

Figure 3-1 Exterior package of the main unit

2. Cut off the binding straps and remove the wooden cover, as shown in Figure 3-2.

Figure 3-2 Removing the wooden cover

3-1
Package Checking and Unpacking

3. Remove the cardboard upward. You can see the main unit protected by foams, as shown in
Figure 3-3.

Accessories of
the main unit

Figure 3-3 Getting the accessories of the main unit

4. Remove the foams on the left and right of the main unit, as shown in Figure 3-4. Then
remove the plastic package and the foam protecting the sample probe shown in Figure 3-5.
Grasp the handles at bottom left and right of the analyzer and move it to the countertop (at
least 2 people are required), as shown in Figure 3-6.

Figure 3-4 Removing foams protecting the analyzer

3-2
Package Checking and Unpacking

Figure 3-5 Removing the foam protecting the sample probe

Figure 3-6 Handles at the bottom of the main unit

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

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.

3.3 Unpacking the pneumatic unit


1. The appearance of the pneumatic unit package is shown in Figure 3-7. Cut off the binding
straps before unpacking.

3-3
Package Checking and Unpacking

Figure 3-7 Exterior package of the pneumatic unit

2. Cut off the binding straps and the adhesive tape. Open the top cover of the pneumatic unit
package, and remove the paper protective corners. Take out the accessory kit of the
pneumatic unit first, as shown in Figure 3-8.

Figure 3-8 Removing the top cover of the pneumatic unit package

3. Firmly grip the two ends of the cardboard and lift the pneumatic unit out of the box. Then
remove the top foam and take out the pneumatic unit, as shown in Figure 3-9.

3-4
Package Checking and Unpacking

Figure 3-9 Taking out the pneumatic unit

NOTE
Do not use the relief valve as a handle to move the pneumatic unit.

3.4 Unpacking the accessories


1. The appearance of the accessory package is shown in Figure 3-10. Cut off the binding
strap before unpacking.

Figure 3-10 Exterior package of the accessory box

2. Cut off the adhesive tape, and take out the waste container, cap assemblies and other
accessories, as shown in Figure 3-11.

3-5
Package Checking and Unpacking

Figure 3-11 Taking out the accessories

Take out the cardboard, and then the data management software, operator's manual, packing
list, and material kit of the barcode scanner (optional), as shown in Figure 3-12.

Figure 3-12 Taking out the data management software and the operator's manual

3.5 Unpacking the autoloader (optional)


1. The appearance of the autoloader package is shown in Figure 3-13. Cut off the binding
straps before unpacking.

3-6
Package Checking and Unpacking

Figure 3-13 Exterior package of the autoloader

2. Cut off the binding straps and the adhesive tape. Open the top cover of the package and
remove the protective cardboard. Take out the tube racks as shown in Figure 3-14.

Figure 3-14 Opening the autoloader package

3. Hold the foams on both sides of the autoloader to lift it out of the box. Then remove the
foams to take out the autoloader and the stop bars, as shown in Figure 3-15.

Figure 3-15 The autoloader

3-7
Package Checking and Unpacking

3.6 Packing list check


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

NOTE
If any inconformity between the delivered parts and items on the packing list
is found, contact Mindray Customer Service department or you local
distributor.

3-8
4 Removal and Installation
Removing the fixing bolts and their sleeves at the bottom of the pneumatic unit

To protect the air pump from damage during transportation, the pump is fixed by four bolts at
the bottom of the pneumatic unit. Before using the pneumatic unit, place the pneumatic unit at
the edge of the countertop to remove the bolts.

(a) (b) (c)

Figure 4-1 Removing the fixing bolts and sleeves at the bottom of the pneumatic unit

Use a monkey wrench to loosen one of the four bolts (as shown in Figure 4-1 (a)); Use a
cross-head screwdriver to loosen the two M3X8 screws on the bracket that fixes the bolt (as
shown in Figure 4-1 (b)); move the bracket, and then remove the bolt with its sleeve (as
shown in Figure 4-1 (c)). Re-fix the bracket. Repeat the steps above to remove the other
three bolts.

Removing the adhesive tapes fixing the stop bar of the front cover

Open the front cover, and then remove the adhesive tapes fixing the stop bar shown in Figure
4-2.

Adhesive
tapes

Figure 4-2 The adhesive tape fixing the stop bar of the front cover

Removing the plastic cable tie fixing the wipe block

4-1
Removal and Installation

Open the front cover, and then use diagonal pliers or scissors to cut off the plastic cable tie
fixing the wipe block, as shown in Figure 4-3.

Plastic cable tie

Figure 4-3 Plastic cable tie fixing the wipe block

Removing the plastic cable ties fixing the cylinder and the tube pincher

Open the front cover, and then you can see the plastic cable ties fixing the cylinder and the
tube pincher next the sample mixing assembly. Use a pair of scissors to cut off the plastic
cable ties, as shown in Figure 4-4.

Plastic
cable tie

Figure 4-4 Plastic cable ties fixing the cylinder and the tube pincher

Removing the adhesive tapes fixing the communication cables of the autoloader

To facilitate the connection with the autoloader, remove the adhesive tapes to fix the
communication cables of the autoloader at the lower part of the front cover, as shown in Figure
4-5.

4-2
Removal and Installation

Adhesive tapes

Figure 4-5 Adhesive tapes fixing the communication cables of the autoloader

Removing the adhesive tape and plastic cable ties on the autoloader

Remove the adhesive tape on the autoloader and cut off the plastic cable ties fixing the
accumulation tray and the stop bars of the autoloader, as shown in Figure 4-6.

Figure 4-6 Removing the adhesive tape and plastic cable ties

Removing the plastic cable tie that fixes the longitudinal feeding pusher

Cut off the plastic cable tie fixing the longitudinal feeding pusher, as shown in Figure 4-7.

4-3
Removal and Installation

Autoloader Cut the 2 positions


with scissors

Figure 4-7 Plastic cable tie fixing the longitudinal feeding pusher

Installation by personnel not authorized or trained by Mindray may damage


your analyzer. Do not install your analyzer without the presence of
Mindray-authorized personnel.

4-4
5 Connections
Installing the autoloader (optional)

1. Installing the stop bars


There are two stop bars for the autoloader. Insert the bars into the slots on the bottom plate of
the main unit. Then fix the bars onto the bottom plate with two M48 cross-recessed panhead
screws, as shown in Figure 5-1.

Figure 5-1 Installing the stop bars

2. Connecting the communication cables


After installing the stop bars, place the autoloader onto the bars, and insert the connector of
the communication cable into the corresponding sockets of the autoloader. Then put the
cables inside the autoloader, as shown in Figure 5-2.

5-1
Connections

Note: The
communication cable of
the autoloader cannot be
pressed against the
lower cover of the main
unit or against the
enclosure of the
autoloader. Otherwise,
short-circuit will occur to
burn the chip of the
driver board.
The cable is first led through this hole, then along the edge of the
sample transport unit, and finally inserted to the adapter plate.
Figure 5-2 Installing the communication cable

The communication cables of the autoloader cannot be pressed against the


lower cover of the main unit by the enclosure of the autoloader. Otherwise,
short-circuit will occur to burn the chip of the driver board.

3. Installing the autoloader


Place the autoloader to the front cover, move the autoloader to fit the holes under it to the
connecting holes of the stop bars, and drive 2 screws into the holes to fix the autoloader (as
shown in Figure 5-3). Note: Do not tightly fix the screws, since the autoloader may need further
adjustment.

Screws fixing the autoloader

Figure 5-3 Installing the autoloader

Removing the adapter from the tube rack

If the hospital uses the 1475 (mm) or 1575 (mm) tubes, remove the adapter from the tube
rack before loading the tubes, as shown in Figure 5-4.

5-2
Connections

Figure 5-4 Removing the adapter from the tube rack

Connecting reagents and the waste container

See Figure 5-5 for connections of reagents and the waste container. Note that the M-58LEO(I)
lyse, M-58LEO(II) lyse, M-58LH lyse and M-58LBA lyse are placed on the same level as the
analyzer; the M-58D diluent, M-58 cleanser, and waste container should be placed under the
countertop where the analyzer is placed; a supporting board for the diluent container shall be
installed as instructed by the operator's manual; as shown in Figure 5-7. Make sure none of
the tubes are pressed or bent.

Figure 5-5 Reagents/Waste connections

5-3
Connections

NOTE
Make sure the M-53LEO (I) lyse, M-53LEO (II) lyse, M-53LH lyse and M-53
cleanser are placed on the same level as the analyzer.

Make sure the tubes are electrically isolated.

Proper connections of reagents and the waste container shall be as shown


in Figure 5-6. Note that the tube connectors and their counterparts on the
analyzer shall be of the same colors.

Figure 5-6 Properly connected wires and lines

Figure 5-7 Installing the supporting board for the diluent container

5-4
Connections

Connecting the pneumatic unit

See Figure 5-8 for connections between the analyzer and the pneumatic unit.
Ensure proper and reliable connections.

Figure 5-8 Connections between the analyzer and the pneumatic unit

Connecting the optional equipments

See Figure 5-9 for connections between the analyzer and the optional equipments.
Ensure proper and reliable connections.

5-5
Connections

Figure 5-9 Connections between the analyzer and optional equipments

Do not connect or disconnect the printer, barcode scanner, keyboard or


mouse when the analyzer is on.

Be sure to use external devices of the specified models only.

Be sure to use the cross network cable to connect the analyzer and the PC.

Connect the analyzer to the exchanger using direct-connected network


cable.

Connecting to the power supply

Connect the main unit and the pneumatic unit to their specified power outlets. Pay attention
that the power requirements of the main unit are not totally the same to those of the pneumatic
unit. Be sure they are connected to the right power outlets.

5-6
6 Start-up

6.1 Inspection before Startup


Before starting the analyzer, you need to open the front cover to check the open vial unit and
the autoloader unit to see if the connections are proper, as shown in Figure 6-1 and Figure 6-2.

Check that the tubes of


the wipe block move
smoothly and will not
wear.

Check that the SRV


tubes do not get loose
or bent

Figure 6-1 Checking the open vial unit

Check that the tubes of


the autoloader do not get
bent, loose; and do not
interfere with the front
cover or the moving
parts.

Figure 6-2 Checking the autoloader unit

6.2 Initial start-up


After connecting the main unit and the pneumatic unit to their power source connectors, power

6-1
Start-up

on the pneumatic unit first and then the main unit, switch on the main unit by pressing the
power button on the front cover.
Since the fluidic system of the analyzer has been drained before delivery, the fluidics
initialization procedure runs automatically at the initial startup to prime the fluidics. This
process takes about 20 minutes. During the startup, a login dialog box will pop up after the
self-test and the fluidics initialization.
Enter the service engineer ID "Service" and password "Se s700" (note: there is a space
between "e" and "s") in the box to enter the main screen, as shown in Figure 6-3.

Figure 6-3 "Main" screen

If error occurs during startup, the analyzer will not run the fluidics initialization, and a dialog box
shown in Figure 6-4 below will pop up.

6-2
Start-up

Figure 6-4 "Skip initialization?"

Click "No", and then go to the "Count" screen to check the error report, as shown in Figure 6-5.
Perform the troubleshooting procedures, and then click "Remove Error". The initialization runs
automatically and lasts for about 15 minutes.

Figure 6-5 Removing error

6-3
Start-up

After entering the "Main" screen (shown in Figure 6-3), click the "Setup" icon to go to the
screen shown in Figure 6-6.

Figure 6-6 "Setup" screen

After entering the "Setup" screen, click "Advanced" button to go to the advanced setup screen
shown in Figure 6-7.

Figure 6-7 Advanced setup screen

6-4
Start-up

In the advanced setup screen, select "Laser Diode Test temp." to activate the laser diode
temperature detecting function. For the autoloading model, select "Barcode configured" (if the
barcode scanner is configured) and "Sensor configured" (select as required by the customer)
to activate the barcode scan and blood volume detecting functions.

6.3 Inspection after Startup


Checking the version and configuration information

Click "Menu""Service""Status" "Version" to enter the version screen shown in Figure


6-8.

Figure 6-8 "Version" screen

Check whether the version of the installation CD is the latest. If not, consider whether it is
necessary to update it.

To decide whether the installation CD needs to be updated, consult


technicians for the manufacturers recommendation on how to deal with old
versions.

Checking the voltage and current

Click "Vol. & Cur." to enter the voltage and current screen. Check if all the values at this screen
are within the predefined normal ranges. If not, perform troubleshooting according to relevant

6-5
Start-up

sections in the service manual until all the values are within corresponding normal ranges, as
shown in Figure 6-9.

Figure 6-9 "Vol. & Cur." screen

Adjusting the temperature and pressure

Click the "Temp & Pres" button at the "Status" screen to enter the screen shown in Figure 7-9.
Check if all the values at this screen are within the predefined normal ranges. If not, adjust the
pressure/vacuum regulators to make the pressure values fall within corresponding ranges. For
how to adjust the temperature and pressure, see "Adjusting pressure and temperature" in
Section 7.1 "Setting Parameters".

6-6
7 Setup and Adjustment

Setting Parameters Setting the system date

Selecting reminder of
the predilute mode

Selecting the pop-up


keyboard

Entry of next sample ID

Setting reagent-related
information

Adjusting the
temperature and
pressure

Adjusting the HGB


blank voltage

Adjusting the position of


the probe wipe

Adjusting the tube rack


distance

Adjusting the
autoloading positions

Adjusting positions Checking the position of


the pincher arm (2mm)

Adjusting the piercing


position (along the axis
of the tube)

Adjusting the piercing


depth (1-2mm from the
probe wipe pedestal and
the probe fixing
pedestal)
Testing other
functions

Figure 7-1 Flow chart of analyzer setup and adjustment

7-1
Setup and Adjustment

7.1 Setting Parameters


Setting the system date

You can customize the date, time and the date format of the analyzer. The date and time at the
screen and the printout will change if the settings are changed.
The "Date/Time" screen is the default screen after you click the "Setup" button. If the current
screen is not the "Date/Time" screen, click the "Date/Time" button to enter the "Date/Time"
screen shown in Figure 7-2.

Figure 7-2 "Date/Time" screen

Enter the current date and time in the date field and time field respectively.
If the year entered is out of the range of 2000 2036, a dialog box shown in Figure 7-3 will pop
up when you try to exit the date/time setup screen. Click "OK" to close the dialog box. Change
the date into a valid one.

Figure 7-3 Dialog box

7-2
Setup and Adjustment

Selecting the date format

There are three date formats available: "YYYY-MM-DD", "MM-DD-YYYY" and "DD-MM-YYYY".
To select the desired format, click the corresponding radio button.

Selecting reminder of the predilute mode

At the "Setup" screen, click the "Assistant" button to enter the screen shown in Figure 7-4.

Figure 7-4 "Assistant" screen

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

Figure 7-5 Predilute mode reminder

To activate the reminder, click the "Prompt" radio button. To deactivate the reminder, click the
"No prompt" radio button. The default setting is "Prompt". The default setting is "Prompt".

Selecting the pop-up keyboard

7-3
Setup and Adjustment

This setting determines whether to use the pop-up keyboard.


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

Entry of next sample ID

Two ID setup methods for new samples are provided for the open-vial sampling mode.
If "Auto increment" is selected, when there is a new sample to be run, the next ID increases by
1 based on the current ID; if "Manual entry" is selected, when there is a new sample to be run,
the default next ID is empty; as shown in Figure 7-4.

Enabling/disabling the waste sensor

This setting determines whether to use the waste sensor.


To enable the blood sensor, CLICK "Open", and to disable the blood sensor, CLICK "Close".
Once enabled, the blood sensor will detect whether sufficient blood is aspirated and warn
operators about insufficient aspiration. The default setting is "Close", as shown in Figure 7-4.

For bi-directional LIS mode, the "Entry of next sample ID" is set to "Manual
entry" and cannot be changed.

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

The blood sensor only works in the autloading mode.

Setting reagent-related information

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

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

At the "Setup" screen, click the "Reagent" button to enter the screen shown in Figure 7-6.

7-4
Setup and Adjustment

Figure 7-6 "Reagent" screen

Click the box of the desired reagent and enter the expiration date.
If the year entered is out of the range of 20002036, a dialog box shown in Figure 7-7 will pop
up when you try to exit the reagent setup screen. Click "OK" to close the dialog box. Change
the date into a valid one.

Figure 7-7 Dialog box

If an external barcode scanner is connected, you can click the "Barcode scanner" check box
shown in Figure 7-8 to enable it. Scan the barcode with the external barcode scanner. If you
hear a beep, it means the entry is finished. The expiration date of reagents will appear in the
corresponding boxes.

7-5
Setup and Adjustment

Figure 7-8 Selecting the "Barcode scanner"

For any reagent, the entered expiration date should be either the expiration
date printed on the labeling or the open-container expiration date,
whichever is earlier. The open-container expiration date is calculated as
follows: the date that container is opened + the open-container stability
days.

Adjusting the temperature and pressure

Click "Service" at the main screen to go to the "Service" screen. Click "Status" "Temp &
Pres", and then check if all the values at this screen are within the predefined normal ranges,
as shown in Figure 7-9. If not, adjust the pressure/vacuum regulators to make the pressure
values fall within corresponding ranges. See the next step for how to make adjustment.

7-6
Setup and Adjustment

Figure 7-9 "Temp & Pres" screen

Adjust PS1 to PS4 in turn. Wait 10-15 seconds for the values to stop changing after adjustment.
Check if the P5 value is within the normal range (as shown in
Figure 7-10). Tighten the pressure/vacuum regulators after you finish adjusting and make sure
all the values are still within corresponding normal ranges.

Vacuum: -40 Pressure: 70 Pressure:


Press and Tighten the 160
tighten the socket cap Tighten the
Locknut PS1: 250
valve after screw after socket cap
finish finish screw after
adjusting adjusting finish

Figure 7-10 Adjusting the pressure/vacuum regulators

7.2 Adjusting the HGB blank voltage


After transportation and fluidic initialization, the HGB blank voltage may be different from the

7-7
Setup and Adjustment

factory setting. In this case, you can adjust the HGB blank voltage through gain setup.

1. Entering the setup screen


Click "Setup" at the "main" screen, and then click "Gain" on the "Setup" screen to enter the
screen as shown in Figure 7-11.

Figure 7-11 "Gain" screen

2. Adjusting the HGB gain


By adjusting the HGB channel gain, the HGB blank voltage is changed. The HGB blank
voltage should be 2.0-2.4V. The value of 2.28V is recommended. To adjust HGB gain, click
"HGB" "Current value" cell at the "Gain" screen to enter a new value for HGB gain adjustment
and save it before exiting.

7.3 Adjusting Positions


Adjusting the position of the probe wipe

1. Click "Service""Debug""Wipe block". Click the "Initialization" button to initialize the


position of the wipe block. Click "Middle place" and "Hold moment" in turn, as shown in Figure
7-12. Check the height of the wipe block using the positioner. Bring the positioner into contact
with the bottom of the sample probe and make sure it is seemlessly pressed against the wipe
block. If the result is not acceptable, adjust the height of the wipe block manually until it
measures up, and then fix the block.

7-8
Setup and Adjustment

Figure 7-12 Wipe block debugging screen

Figure 7-13 Adjusting the position of the wipe block

2. Pull down the wipe block to make it apart from the sample probe. Check if the probe aims
right at the hole in the wipe block. If not, loosen the four screws shown in Figure 7-14 to make
adjustment.

7-9
Setup and Adjustment

Loosen these four socket cap screws to adjust the height of the wipe block

Unscrew the four


socket cap screws
to adjust the
positions of the
sample probe and
the wipe block

Figure 7-14 Adjusting the positions of the wipe block and the sample probe

3. Check if the belt is properly strained and there is no strident noise while the wipe block is
moving.

Adjusting the tube rack distance (optional)

This section only applies to analyzers configured with an autoloader.


Take out the tube rack distance adjusting fitting from the accessory bag. Push the fitting
against the inside front of the sample transport unit, and then move it breathwise to the
position between the front supporting board and back supporting board. Note that the side with
more grooves shall face the back supporting board.

Figure 7-15 Adjusting the tube rack distance

7-10
Setup and Adjustment

Check if the front and back of the tube rack distance adjusting fitting is close to the front and
back supporting boards. If the fitting is too far away from either supporting board or unable to
get through, remove the 2 screws fixing the front supporting board to adjust the distance.

Adjusting the autoloading positions (optional)

This section only applies to analyzers configured with an autoloader.


Make sure the screws fixing the autoloader (see Figure 5-3) are not tightly secured before
adjusting the left and right positions.
Click "Debug" at the bottom of the screen to go to the "Debug" screen, and then click "Mix unit"
to go to the mix unit debugging screen.

Figure 7-16 "Debug" screen

7-11
Setup and Adjustment

Figure 7-17 Mix unit debugging screen

On the mix unit debugging screen, click "Initialization" in the "Manipulator" area to initialize the
manipulator; then click "Initialization" in the "Autoloader" area to initialize the autoloader. Note:
if the buttons gray out, click the "Open compressor" button. After the compressor is open, the
buttons will be activated.
Place an empty tube rack onto the autoloader load platform, and click the "Load" button in the
"Autoloader" area. When the tube rack comes to the loading position, click the "Feed" button 3
to 4 times to load the tube until it comes to the pinching position. Note: Do not click the "Feed"
button before the former movement is done.
Click the "Pinch cylndr fwd" button in the "Manipulater" area to move the manipulator to the
pinching position and place the alignment fixture into the pincher (with the bottom of the fixture
fully covering the upper surface of the tube rack).

7-12
Setup and Adjustment

Figure 7-18 Adjusting the autoloader position

Adjust the position of the autoloader so that the center of the tube position coincides with that
of the fixture.
a) Right-and-left adjustment: move the autoloader left and right until the center of the tube
position coincides with that of the fixture, and then tighten the two screws fixing the autoloader
(as shown in Figure 5-3). Check after the adjustment and then remove the fixture.
b) Fore-and-aft adjustment (this step is for reference in manufacture): Do the following before
installing the lower cover. Loosen the four screws shown in Figure 7-19 to move the mix unit
forward and backward until the center of the tube position coincides with that of the fixture (as
shown in Figure 7-18) and then tighten the four screws.

Figure 7-19 Fore-and-aft adjustment

c) Verification: remove the fixture, click the "Pinch cylndr bkwd" button in the "Manipulater"
area to reposition the manipulator and then place the fixture into the tube position (as shown in
Figure 7-20); Verify the autoloader position as per the following steps:

7-13
Setup and Adjustment

Click the "Pinch cylndr fwd" button to pinch the fixture (as shown in Figure 7-21), and then click
the "Elvt cylndr up" button to remove the fixture out of the rack. Click the "Elvt cylndr down"
button to place the fixture back into the rack, and then click the "Pinch cylndr bkwd" button to
reposition the pincher. Repeat these steps 3 to 5 times to confirm that the fixture can be placed
in the rack smoothly. Otherwise, repeat steps a) and b) until it passes the inspection.

Figure 7-20 Home position of the pincher

Figure 7-21 Pinching position

Click the "Feed" and "Unload" buttons to remove the rack and the adjustment of the autoloader
position is completed.

7-14
Setup and Adjustment

After the adjustment, fix the autoloader cover to the front cover by 2 screws, as Figure 7-22
shows.

Figure 7-22 Fixing the protective cover of the autoloader

Adjusting the mix unit positions (optional)

This section only applies to analyzers equipped with a mix unit.

1. Click "Service""Debug""Mix unit" to enter the screen shown in Figure 7-23.

Figure 7-23 Mix unit debugging screen

2. Click the "Initialization" button in the "Mix motor", and "Initialization" and "Pinch cylndr
bkwd" buttons in the "Manipulator" area. Check if the position of the pincher arm is 1mm from

7-15
Setup and Adjustment

the connecting pedestal, as shown in Figure 7-24. If not, adjust its position.

Figure 7-24 Adjusting the position of the pincher arm

3. Click "Mix" and check if the distance between the top of the pincher and the wipe block is
28mm, as shown in Figure 7-25. If not, loosen the corresponding screws to make adjustment.

Figure 7-25 Adjusting the position of the wipe block

4. Use a gummed paper to envelop the opening of a standard test tube and place the tube
into the rack. When the tube is placed back after sampling, check the position of the piercing
hole to determine if the tube and the piercing needle are coaxial. If not, make adjustment as
per Figure 7-26 until they become coaxial.

7-16
Setup and Adjustment

Loosen these five screws to adjust the position of the test tube
relative to the locating axis and piercing hole central axis.

Figure 7-26 Adjusting the piercing position

5. Place a standard tube in the tube rack, and click "Sample&Mix&pierce". Check if the
distance between the probe wipe pedestal and the probe fixing pedestal is 1-2mm; if not,
adjust the stroke of the pierce cylinder by tuning the cylinder stroke adjusting knob and then
secure the cylinder stroke fixing ring, as shown in Figure 7-27.

Figure 7-27 Adjusting the piercing depth

Checking the autoloader (optional)

For analyzers equipped with autoloaders, click the "Initialization", "Load", "Feed" and "Unfeed"
buttons in the "Autoloader" area in turn to check if the unit moves properly, as shown in Figure
7-28.

7-17
Setup and Adjustment

Figure 7-28 Mix unit debugging screen

Checking the valves

Click "Service""Self-test""Valve" to enter the screen shown in Figure 7-29. Click the "Test
all" button to check if all the valves are functioning properly (the valves make clicking sounds if
they function well).

Figure 7-29 Valve self-test screen

7-18
Setup and Adjustment

Checking the dobber

Click "Service""Self-test""Dobber" to enter the screen shown in Figure 7-30. Check the
dobbers in turn to see whether they are functioning properly or need to be repaired or
replaced.

Figure 7-30 Dobber self-test screen

7.4 Testing Other Functions


It is necessary to test other functions of delivered analyzers for reliable performance. Do as
follows:

Network connection

Connect the analyzer and the PC with a network cable, and check if the corresponding icon
shows that they are successfully connected.

Data communication

Go to the "Review" screen and choose the table review or graph review. Select the sample
results you need and perform transmission.

Printing

Go to the "Review" screen and choose the graph review. Select results with sample data and
graphs to print, and the printer shall print out all these data and graphs in a clear and correct
way.

7-19
8 Calibration and Performance Test

8.1 Background Count


Perform background count in the OV-WB-CBC+DIFF, OV-PD-CBC+DIFF and
AL-WB-CBC+DIFF mode in turn (as shown in Figure 8-1). The test results shall meet
corresponding specifications: WBC0.3109/L, RBC0.031012/L, HGB1g/L, HCT0.5%,
PLT10109/L.

Figure 8-1 Selecting the work mode

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

Click "Review""Graph""Special" to check the special information of the background count.


Put down the special information on the installation record sheet. Requirements for the special
information of the background count: 80RBC count time180; 40Start delay70;
WBC/BASO Peak Length100; WBC/DIFF Peak Length100; RBC peak/pulse length100.

8.2 Confirming the Gain of the Optical System


1. Optical gain confirmation (calibrator)
At the "Count" screen, select the mode "OV-WB" and "CBC+5DIFF", and then run the
specified calibrator three times. Select the first analysis record of the calibrator, and click
"OpAdjust". Select "Calibrator" mode and click "Calculate". Record the "LAS CG Position" and
"MAS CG Position" of the particle with larger "LAS 0.1max Number", and then check the "LAS
CG Position" and "MAS CG Position" of the other 2 analyses. Calculate the mean values of the

8-1
Calibration and Performance Test

"LAS CG Position" and "MAS CG Position" of the 3 analyses, and make sure the following
requirements are met: LAS CG position mean within 2.80 from the target; MAS CG position
mean within 3.20 from the target. Record the mean values, as shown in Figure 8-2.

2.8 from the target

3.2 from the target

Figure 8-2 Checking the calibrator CG position

If the mean values is out of the range, enter the "LAS CG Target" and "MAS CG Target" and
click ">>>" to get the gain values. Click "Gain setup" to apply the calculated gain values, as
shown in Figure 8-3.

Enter the targets

Click "Gain setup"

Figure 8-3 Calibrator gain setup screen

8-2
Calibration and Performance Test

Configure gain setup of the other 2 analyses in the same way, and record the gain values.
Calculate the mean values of the LAS gain and MAS gain of the 3 analyses as the final gains.
Click "Setup""Gain", and enter the final gains in the "WBC_LAS(DIFF)" and
"WBC_MAS(DIFF)" fields, as shown in Figure 8-4. In the "Corresponding Factor of DIFF and
BASO" area, enter 1.87 in the LAS field and 1.48 in the MAS field.

Figure 8-4 Optical gain setup screen

Run the calibrator again, and check if the following requirements are met: LAS CG position
within 2.00 from the target; MAS CG position within 2.00 from the target.

2. Optical gain confirmation (CBC-5DMR control)

Perform the optical gain confirmation with the CBC-5DMR control only when
the specified calibrator is not available.

At the "Count" screen, select the mode "OV-WB" and "CBC+5DIFF", and then run the
specified control three times. Select the first analysis record of the control, and click
"OpAdjust". Select "Control" mode and click "Calculate". Record the "LAS CG Position" and
"MAS CG Position" of the particle with larger "LAS 0.1max Number", and then check the "LAS
CG Position" and "MAS CG Position" of the other 2 analyses. Calculate the mean values of the
"LAS CG Position" and "MAS CG Position" of the 3 analyses, and make sure the following
requirements are met: LAS CG position mean within 2.80 from the target; MAS CG position

8-3
Calibration and Performance Test

mean within 3.20 from the target. Record the mean values, as shown in Figure 8-5.

2.8 from the target

3.2 from the target

Figure 8-5 Checking the calibrator CG position

If the mean values is out of the range, enter the "LAS CG Target" and "MAS CG Target" and
click ">>>" to get the gain values. Click "Gain setup" to apply the calculated gain values, as
shown in Figure 8-6.

Enter the targets

Click "Gain setup"

Figure 8-6 Calibrator gain setup screen

8-4
Calibration and Performance Test

Configure gain setup of the other 2 analyses in the same way, and record the gain values.
Calculate the mean values of the LAS gain and MAS gain of the 3 analyses as the final gains.
Click "Setup""Gain", and enter the final gains in the "WBC_LAS(DIFF)" and
"WBC_MAS(DIFF)" fields, as shown in Figure 8-7. In the "Corresponding Factor of DIFF and
BASO" area, enter 1.87 in the LAS field and 1.48 in the MAS field.

Figure 8-7 Optical gain setup screen

Run the control again, and check if the following requirements are met: LAS CG position within
2.00 from the target; MAS CG position within 2.00 from the target.

3. Optical gain confirmation (7um standard particle)


Go to the "Gain" setup screen shown in Figure 8-4. Record the gain of WBC_MAS(DIFF), and
enter "20" in the WBC_MAS(DIFF) field. On the "Count" screen, run the 7m standard
particles in the OV-WB-CBC+5DIFF mode, and then go to the "Review" screen. Select the
analyses record and click "OpAdjust".
Click "Calculate", and check the particle with larger "LAS 0.1max Number" (requirements: LAS
0.1max Width9; MAS 0.1max Width13). In case of incompliance with the requirements,
perform troubleshooting as instructed by relevant sections of the service manual.

8-5
Calibration and Performance Test

No larger than 9

No larger than 13

Figure 8-8 Optical gain setup screen

Go to the gain setup screen, and enter the gain value you've just recorded in the
WBC_MAS(DIFF) field.

8.3 Checking the scattergrams


1. Sample selection
Select 5-10 tubes of fresh (collected no more than 6 hours before) anticoagulated venous
blood sample, and run the samples in the OV-WB mode.
The selected samples shall meet the following requirements:
no flags of left shift, immature cell, abnormal/atypical lym, or abnormal scattergram
WBC 6-10109/L Bas% 0-1
Lym% 20-50 Eos% 0.5-8
Mon% 3-8

Scattergrams of the selected samples shall be in normal status (all the sub-populations are
well separated from each other, and each of them is well aggregated), as shown in Figure 1;
the scattergram is not qualified if the sub-populations are not well separated from each other,
not well aggregated, too loose in a general view, or have too many unidentified spots, as
shown in Figure 2; samples which is clearly mis-differentiated by the algorithm are not qualified,
as shown in Figure 3;

8-6
Calibration and Performance Test

Figure 1Typical normal scattergram Figure 2 Abnormal scattergram

Figure 3 Abnormal scattergram Figure 4 Abnormal scattergram


If there is no qualified samples available, first check if the analyzer is in good condition (by
running the calibrator or control); if it is a hematopathy hospital or the hospital only analyzes
capillary blood samples, try to get qualified blood sample in other ways;
2. Checking the scattergrams
Run 10 qualified fresh blood samples in the OV/AL-WB-CBC+5DIFF mode, and then click
"TableOpAdjustBlood ModeCalculate". For Particle 1, check and make sure the LAS
CG position is within [49, 57], and MAS CG position within [27, 32]; for Particle 2, check and
make sure the LAS CG position is within [103, 112], and MAS CG position within [84, 95], as
shown in Figure 8-9. If 7 or more out of the 10 samples meet the above-mentioned
requirements, the analyzer is regarded as in good condition; otherwise, further adjustment (to
the optical system for example) shall be performed. If the results of these samples are all
higher or lower than expected, you may need to adjust the gain setup.

Figure 8-9 Checking the scattergram

8-7
Calibration and Performance Test

8.4 Calibration
Both the specified calibrator and fresh blood samples can be used for calibration.

OV-WB calibration

Go to the "Calibration" screen, click "Calibrator" and select "OV-WB" mode (as shown in Figure
8-10). Enter the lot No., expiration date and assigned values (into the "Mean" fields) of the
calibrator. Run the calibrator in the open-vial module and perform auto calibration.

Figure 8-10 OV-WB calibration screen

The CV values and the new calibration factors calculated by the system are displayed at the
bottom of the table. The calibration factors shall be 75%-125% of the assigned values, and the
CV values shall meet the specifications.

OV-PD calibration

Select the "OV-PD" mode (as shown in Figure 8-11), and enter the assigned values (into the
"Mean" fields) of the calibration. Click "Diluent" to get ready to dispense diluent.

8-8
Calibration and Performance Test

Figure 8-11 OV-PD calibration screen

Present a centrifugal tube to the sample probe. Press the aspirate key to dispense 120ul of
diluent into the tube. Repeat this procedure until you get 600ul diluent.
Add 200ul of specified calibrator by pipette into the tube of diluent and shake the tube to mix
the sample. Present the well mixed sample to the sample probe and press the aspirate key.
The analyzer will perform the auto calibration.
The CV values and the new calibration factors calculated by the system are displayed at the
bottom of the table. The calibration factors shall be 75%-125% of the assigned values, and the
CV values shall meet the specifications.

AL-WB calibration (optional)

If the analyzer is equipped with an autoloader (optional), select the "AL-WB" mode (as shown
in Figure 8-12), and enter the lot number, expiration date and assigned values (into the "Mean"
fields) of the specified calibrator.

8-9
Calibration and Performance Test

Figure 8-12 AL-WB calibration screen

Place a vial of specified calibrator in the tube rack. Run the calibrator in the AL-WB mode and
OV-WB mode, no less than 3 times for each mode.
The CV values, the new calibration factors calculated by the system, and the factory
correlation coefficients are displayed at the bottom of the table. The calibration factors shall be
75%-125% of the assigned values, and the CV values shall meet the specifications.

Calibration using fresh blood samples (if required by the customer)

Go to the calibration screen and click "Blood", as shown in Figure 8-13.

8-10
Calibration and Performance Test

Figure 8-13 Calibration with fresh blood samples

In the "Mean" fields, enter the analyses results of the blood sample on the instrument (which
shall be in good condition) specified by the customer. After the calibration in the whole blood
mode, run a blood sample consecutively for 3 times in the WB-CBC+5DIFF mode, and then
use the mean values of the 3 analyses as the targets (rounded up to 2 decimal digits) for the
following calibration in the predilute mode.
After the calibration with fresh blood samples, run 5 vials of sample consecutively for 3 times in
the AL-WB-CBC+5DIFF mode, OV-WB-CBC+5DIFF mode and OV-PD-CBC+5DIFF mode
respectively. Then check and make sure the mean values of the analyses are within the limits
from the assigned values (as specified for the batch of calibrator)
Note: Perform the calibration either with the calibrator or fresh blood samples, unless required
by the customer.

8.5 Reproducibility
It is necessary to perform the reproducibility test to delivered analyzers for reliable
performance. Do as follows:
Enter the "Count" screen and run a vial of specified normal-level control consecutively for 10
times in the OV-WB-CBC+5DIFF mode and AL-WB-CBC+5DIFF mode respectively.
Enter the "Review" screen to check the reproducibility of the 1-10 runs. Click the "CV" button to
check if the CV values meet the following requirements (shown in Figure 8-15), as shown in
Figure 8-14.

8-11
Calibration and Performance Test

Figure 8-14 Reproducibility CV screen

If fresh blood samples (see the Operator's Manual for detailed specifications) can be attained,
perform the OV-WB-CBC+5DIFF reproducibility test in the WB-CBC+5DIFF mode, and then
record the CV values of WBC, RBC, HGB, MCV and PLT.

Figure 8-15 Specifications for reproducibility test results

8-12
9 Appendices

A Fluidic diagrams

A-1
Appendices

A-2
B Method to Identify the Cross Network Cable and the
Direct-Connected Network Cable

Identify the Cross Network Cable


1. With the metal contactors' side up, mark the 8 lines in the connector from left to right with 1-8.
Accordingly, the colors of the lines are: white and orange, orange, white and green, blue, white
and blue, green, white and brown, and brown, as shown in Figure B-1.

Figure B-1Connector of the network cable

2. Define one end of the cable to be A randomly. Then, the other end is B. The way to connect
the end A and B is shown in Figure B-2.

Figure B-2 End A and End B

End A: white and green, green, white and orange, blue, white and blue, orange, white and
brown, and brown (1 and 3 is exchanged; 2 and 6 is exchanged)
End B: white and orange, orange, white and green, blue, white and blue, green, white and
brown, and brown

Identify the Direct-Connected Network Cable


1. With the metal contactors side up, mark the 8 lines in the connector from left to right with 1-8.
Accordingly, the colors of the lines are: white and orange, orange, white and green, blue, white
and blue, green, white and brown, and brown, as shown in Figure B-3.

B-1
Appendices

Figure B-3 Connector of the direct-connected network cable

2. Define one end of the cable to be A randomly. Then, the other end is B. The way to connect
the end A and B is shown in Figure B-4.

Figure B-4 End A and End B of the direct-connected network cable

End A: white and orange, orange, white and green, blue, white and blue, green, white and
brown, and brown
End B: white and orange, orange, white and green, blue, white and blue, green, white and
brown, and brown

B-2
P/N: 046-000685-001.0

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