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BC-6000 SERIES ANALYZERS

INSTALLATION GUIDE (ENGLISH)

Models: BC-6000/BC-6000 Plus/

BC-6100/BC-6100 Plus/BC-6200

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.
Table of Contents

Chapter 1 Preparations ................................................................................................ 1-1


1.1 Purpose ................................................................................................................. 1-1
1.2 Installation Procedure ............................................................................................ 1-1
1.3 Tools ...................................................................................................................... 1-2
1.4 Consumables ......................................................................................................... 1-2

Chapter 2 Installation Requirements .......................................................................... 2-1


2.1 Notes for Analyzer Installation ............................................................................... 2-1

Chapter 3 Unpacking ................................................................................................... 3-1


3.1 Checking before Unpacking .................................................................................. 3-1
3.2 Unpacking the Main Unit ....................................................................................... 3-1
3.3 Unpacking the Accessories ................................................................................... 3-4
3.4 Unpacking the Autoloader ..................................................................................... 3-5
3.5 Checking Packing List ........................................................................................... 3-6

Chapter 4 Removing Fixing Components .................................................................. 4-1


4.1 Removing High Temperature Adhesive Tape ........................................................ 4-1
4.2 Removing Plastic Ties ........................................................................................... 4-1

Chapter 5 Connections ................................................................................................ 5-1


5.1 Autoloader Connection .......................................................................................... 5-1
5.2 Connecting the Reagents ...................................................................................... 5-2
5.3 Connecting External Devices ................................................................................ 5-4
5.4 Tubes and Tube Racks .......................................................................................... 5-5

Chapter 6 Start-up ........................................................................................................ 6-1


6.1 Startup Process ..................................................................................................... 6-1
6.2 Inspection after Startup .......................................................................................... 6-1

Chapter 7 Setup............................................................................................................ 7-1


7.1 System Setup ........................................................................................................ 7-1
7.2 Setting User Accounts and Passwords ................................................................. 7-8
7.3 Auxiliary Setup ....................................................................................................... 7-8
7.4 Maintenance Setup.............................................................................................. 7-12
7.5 Setting Auto-loading Mode .................................................................................. 7-13
7.6 Confirming HGB Gain .......................................................................................... 7-14
7.7 Setting Auto Startup/Shutdown Time ................................................................... 7-15
7.8 Save Settings after Changes ............................................................................... 7-16

Chapter 8 PerformanceVerification ............................................................................ 8-1

1
Table of Contents

8.1 Background Verification ......................................................................................... 8-1


8.2 Optical System Status Verification ......................................................................... 8-2
8.3 Optical Gain Adjustment ........................................................................................ 8-4
8.4 Initial Verification of Scattergram ........................................................................... 8-5
8.5 Carryover Verification ............................................................................................ 8-6
8.6 Reproducibility Test ............................................................................................... 8-8
8.7 Calibration ........................................................................................................... 8-13
8.8 Verification of Deviation between Different Modes .............................................. 8-15
8.9 Reliability Verification........................................................................................... 8-16

Chapter 9 Body Fluid Performance Verification ........................................................ 9-1


9.1 Body Fluid Background Verification....................................................................... 9-1
9.2 Body Fluid Carryover Verification .......................................................................... 9-2
9.3 Verification of Body Fluid Reproducibility .............................................................. 9-3

Chapter 10 Installation Checklist .............................................................................. 10-1

Appendix A Scattergram introduction ....................................................................... A-1

Appendix B Differentiating Direct-Connected Network Cable and Cross Network


Cable…………………………………………………………………………………………..B-1

Appendix C Installation and Upgrade Instruction of labXpert Software ................ C-1


C.1 Software Installation ..............................................................................................C-1
C.2 Run the Software ...................................................................................................C-7
C.3 Connecting Setup ..................................................................................................C-9
C.4 Connect the Server PC to the Network which can Access LIS ........................... C-11
C.5 Update .................................................................................................................C-12
C.6 Installing DTU Software .......................................................................................C-13

2
Chapter 1 Preparations
1.1 Purpose
This installation guide is intended to assist the service people to install the instrument and
update the software properly in order to ensure the safe and effective operation of the
analyzer on site.

1.2 Installation Procedure

1 Install the DMU


1 Tools DMU insta llati on
2 Connection settings of the IPU and main unit
2 Accessories Pre parations

3 Installation software

1 Initial start-up

Start-up 2 Inspection after startup

3 Mechanical verification
1 Working environment

2 Space requirements Installa tion


3 Power requirements
Require me nts
1 Date format
4 Customer's tube type
2 Auxiliary setup

3 Reagent setup

4 Maintenance setup

5 Autoloader setup
1 Check before unpacking
Setup
6 Built-in barcode setup
2 Unpack the main unit

3 Unpack the accessories 7 Communication setup


Unpacking
5 Unpack the autoloader 8 HGB background voltage setup

6 Check packing list 9 Advanced setup

10 Sensor level setup

1 Background verification

2 Optical system status verification


1 Remove the fixing components of the
pneumatic unit 3 Initial verification of scattergram
Remove the fixin g
2 Remove the fixing cable ties 4 Performance stability verification
componen ts
3 Remove the foams stuffing the air 5 Carryover verification
pump Per forman ce
verifica tion 6 Fresh blood samples scattergram
verification

7 Calibration

8 Reproducibility test

9 Verification of deviation between


1 Install the autoloader different modes

10 Reliability verification
2 Connect reagent and waste containers
Installa tion Repo rt
3 Connect the pneumatic unit Conne ctions
4 Connect the optional devices

5 Connect the power supply

End

Figure 1-1 Installation flow chart

1-1
Preparations

1.3 Tools
Table 1-1 Tool list

Type Name Quantity

Scissors or cutting pliers 1


Cross-headed screwdriver (M3) 1
Tools for installation
Cross-headed screwdriver (M4) 1
Pipette (200ul) 1

1.4 Consumables
Table 1-2 Consumable list

Type Name Quantity

Empty tube 10
Glass pipette 20
Gloves 2
Frequently-used
Tissue paper 1 (roll)
Empty waste container and
1
carton
Mechanical verification Empty tube 3-5
Background verification Empty tube 3-5
Optical system status 7um standard particle and A7312
5 drops
verification fluorescent standard particle
Initial verification of scattergram Fresh blood sample 3-5
Performance stability verification Fresh blood sample 3-5
Carryover verification High-level QC 1
Fresh blood samples
Fresh blood sample 30
scattergram verification
Calibration Calibrator or fresh blood sample 1
Fresh blood sample or
Reproducibility test 2
normal-level QC
Verification of deviation between
Fresh blood sample 3-5
different modes
Reliability verification Fresh blood sample 50

1-2
Preparations

NOTE
 Prepare the 7μm standard particles and A7312 fluorescent standard particles
beforehand to proceed with the later confirmation of the optical gain. Use controls and
fresh blood samples as alternatives.

1-3
Chapter 2 Installation Requirements
2.1 Notes for Analyzer Installation
The analyzer is rigorously tested before leaving the factory. To avoid collision during transport,
the analyzer has been carefully packed before delivery. When you receive your analyzer,
carefully inspect the package for physical damage. To report damage of packages, contact
Mindrary Customer Service department or your local distributor immediately.

2.1.1 Space Requirements


To ensure efficient maintenance and heat dissipation, as well as to prevent the liquid pipe at
the rear side of the main unit from being squeezed that affect the normal circulation of
reagent, a recommended installation environment should have:

 proper height to place the main unit;

 at least 500 mm from walls on each side of the main unit;

 at least 600 mm above the main unit;

 at least 250 mm behind the main unit;

 The diluent container must be placed within 1.0 meter's reach under the main unit, and
the lyse container must be placed in a place of the same level with the main unit or within
850 mm's reach under the main unit.

 The table where the analyzer is placed shall be able to withstand at least 160 kg of
weight.

CAUTION
 When installing or using the analyzer, at least ensure that two inside supporters of the
autoloader are on the work surface of the main unit, so as to ensure correct positions of
the autoloader and the main unit.

2.1.2 Power Requirements

WARNING
 Make sure the analyzer is properly grounded.

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

2-1
Installation Requirements

CAUTION
 Using a plugboard may introduce additional electrical interference and lead to incorrect
analysis results. Place the analyzer near the power outlet to avoid using the plugboard.

 Use the original power cable shipped with the analyzer. Using other power cable may
damage the analyzer or lead to incorrect analysis results.

Voltage Frequency Power


Main Unit 100-240V~ 50 Hz/60 Hz 500 VA

2.1.3 Environment Requirements


Working Operating
Storage Environment
Environment Environment
Ambient 15°C ~ 32°C -10°C ~ 40°C 5°C ~ 40°C
Temperature
Relative Humidity 30% ~ 85% 10% ~ 90% 10% ~ 90%
Atmospheric 70 kPa ~ 106 kPa 50 kPa ~ 106 kPa 70 kPa ~ 106 kPa
Pressure

 The environment should be as free as possible from dust, mechanical vibrations,


contamination, loud noises and electrical interference.

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


analyzer.

 Do not use this analyzer in close proximity to sources of strong electromagnetic radiation;
as these may interfere with the proper operation.

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

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

 The environment shall be well ventilated.

 Do not place the main unit on a slope.

 The analyzer should be reliably grounded.

 Only use this analyzer indoors.

2-2
Installation Requirements

2.1.4 Fuse Requirements

WARNING
 The fuse used in the equipment is not a replaceable one.

2.1.5 Moving and Installing the Analyzer


The analyzer's center of gravity is angled to one side during packaging. The engineer needs
to pay attention to this when transporting and placing the analyzer and prevent it from
dropping. The analyzer packaging position is shown below:

Figure 2-1 Analyzer packaging position

CAUTION
 After the autoloader and the main unit are installed, do not exert too much pressure to it
or transport the analyzer by holding the autoloader.

2-3
Chapter 3 Unpacking

CAUTION
 Unpacking or installation by personnel not authorized or trained by Mindray may
damage your analyzer. Do not unpack or install your analyzer without the presence of
Mindray-authorized personnel.

3.1 Checking before Unpacking


 Check for completeness
The package of BC-6000 contains one main unit pack that includes one main unit and
one autoloader, and one accessory pack. Optional devices are one printer, one monitor,
and one PC.
 Package inspection
Check if the straps outside the package are firm and if the package is damaged. If the
package is found damaged, please take photos to be used as evidence, and contact
your distributor and the logistics agency to check if there is any accident during
transportation. Make sure you install the instrument after it is confirmed that there is no
damage to the instrument during transportation.

3.2 Unpacking the Main Unit


1. Check if the two tiltwatch labels on the external carton of the main unit are silver, if yes, it
means the transportation of the analyzer went OK; if the labels are red, that means over
80-degree tilting occurred during transportation, and the issue must be recorded in the
installation exception log. The appearance of package is shown in Figure 3-1 External
carton of the main unit Cut off the binding straps before unpacking.

3-1
Unpacking

2-tilt watch labels


(attached to
adjacent surfaces)

Figure 3-1 External carton of the main unit

 Cut off the binding straps and remove the wooden cover and cardboard, as shown in
Figure 3-2, Figure 3-3 Take off the accessory box on the left and the protective foam
and film above the main unit.

Figure 3-2 Taking off the wooden cover and the cardboard

3-2
Unpacking

Figure 3-3 Taking off the protective foam and film

NOTE
 When moving the analyzer, keep it as level as possible and avoid strong impact. Never
move the analyzer under the autoloader.

 Always lift the left, right and rear side of the analyzer to move it. Do not lift the analyzer
from the front size, because that may damage the front cover.

3-3
Unpacking

3.3 Unpacking the Accessories


1. The accessory box is placed by the main unit. Its appearance is shown in Figure 3-4.

Figure 3-4 External carton of the accessory box

2. Cut off the adhesive tape, and take out the waste container, cap assemblies, power cord
and other accessories, as shown in Figure 3-5.

Figure 3-5 Taking out accessories

3-4
Unpacking

3.4 Unpacking the Autoloader


1. The appearance of the autoloader package is shown in Figure 3-6. Cut off the binding
straps before unpacking.

Figure 3-6 External carton of the autoloader

 Cut off the adhesive tape, and open the top cover. Then, you can see the autoloader
cushion material.

Upper surface of
3206 autoloader
cushion material

Lower surface of
3206 autoloader
cushion material

Figure 3-7 Opening the autoloader package

 Autoloaders for open-sampling type analyzers and closed-sampling type analyzers

Figure 3-8 Autoloader

3-5
Unpacking

3.5 Checking Packing List


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

NOTE
 Any inconformity between the delivered parts and items on the packing list, contact
Mindray Customer Service Department or your local distributor.

3-6
Chapter 4 Removing Fixing Components

4.1 Removing High Temperature Adhesive Tape


4.1.1 Sample Compartment Door

Figure 4-1 High temperature adhesive tape for fixing the compartment door

4.1.2 Position of Gripper on the Autoloader

Figure 4-2 High temperature adhesive tape of feeding mechanism

4.2 Removing Plastic Ties


4.2.1 Removing Plastic Ties of Aspiration Assembly and Mix

Assembly

The tie fix the


aspiration
assembly from up
and down
movements

4-1
Removing Fixing Components

Fix the mix


assembly and
The tie fixing the
gripper
aspiration assembly
from up and down
movements

Figure 4-3 Removing plastic ties of aspiration assembly and mix assembly

4.2.2 Removing the Tie Fixing the Fluorescent Dye Bag

Figure 4-4 Removing fluorescent dye bag tie

4.2.3 Removing the Ties Fixing the Sample Compartment Cable

Figure 4-5 Removing ties fixing the sample compartment cable

4-2
Removing Fixing Components

4.2.4 Removing the Ties Fixing the Air Pump and Removing the

Foam Boards

Ties

Foam boards

Figure 4-6 Remove the ties and foam boards of the air pump

4-3
Chapter 5 Connections

5.1 Autoloader Connection


5.1.1 Installing the Autoloader
1. Fix the cross bar of the autoloader and the L-shape bracket for the cross bar together
using two M4X8 cross recessed pan head screws. As shown in Figure 5-1, the L shape
faces forward and the required torsion is 6-8 kfgcm.
2. Use M4X8 cross recessed pan head screws to fix the two sets of autoloader cross bar
assemblies to the main unit. The required torsion is 6-8 kfgcm.
3. Install the sample probe in the probe seat, use the sample probe fixing plate to press it
according to the direction shown in the figure, and use two M4X8 cross recessed pan
head screws to fix it. The required torsion is 4-6 kfgcm.
4. Interconnect the autoloader connecting cables, and insert the joint in the machine. Put
the autoloader on the cross bar of the autoloader, push it to the bottom, and use two
M4X8 cross recessed pan head screws to pre-fix it on the cross bar. For connection of
the analyzer system, refer to the following diagram:

Sample probe
fixing plate

Figure 5-1 Autoloader connecting method

5-1
Connections

5.2 Connecting the Reagents


Connect the reagent containers to the analyzer as shown in the following figure.

Figure 5-2 Connecting reagents - connecting fluorescent dyes

Types
① *FR Dye

② FD Dye

③ FN Dye
* Only applicable to BC-6000Plus/BC-6100Plus and BC-6200 model.

5-2
Connections

Figure 5-3 Connecting reagents - lyses and diluent

Types
① DS diluent

② *DR diluent

③ LD lyse

④ LN lyse

⑤ LH lyse

⑥ Waste container
* Only applicable to BC-6000Plus/BC-6100Plus and BC-6200 model.

5-3
Connections

5.3 Connecting External Devices


Make sure the connections are correct and firm.

Figure 5-4 Connecting the network, power supply and external devices

Interface Connection

① Power Connecting to the power supply

② Network Connecting to the network port on the PC

③ USB Connecting to external devices such as a


printer, a scanner, etc., as required

5-4
Connections

5.4 Tubes and Tube Racks


5.4.1 Tubes Used with Closed-sampling Type Analyzers
Mode Tube type Sample setting Cap open
position
Auto loading mode Evacuated blood Tube rack No
collection tube
BD micro tube Tube rack No
Syringe tube Tube rack No
CT-WB Evacuated blood WB tube position Either
(closed-sampling type) collection tube
CT-Micro WB Small closed PD/Micro-WB Either
(closed-sampling type) anticoagulated tube tube position
1.5 ml centrifugal tube PD/Micro-WB Yes
tube position
1.5 ml centrifugal tube PD/Micro-WB Yes
tube position
CT-PD (closed-sampling Small closed PD/Micro-WB Yes
type) (diluent excluded) anticoagulated tube tube position
1.5 ml centrifugal tube PD/Micro-WB Yes
tube position
CT-BF (closed-sampling Evacuated blood WB tube position Either
type) collection tube
Uncapped hard/soft WB tube position Yes
tube

CAUTION
 Do not use BD micro tubes or syringe test tubes to run samples in closed-tube mode.

 Uncap the tube before capillary or prediluted sample analysis.

5.4.2 Use BD Micro Tubes and Syringe Tubes under Auto

Loading Mode
To analyze the samples collected with BD micro tubes and syringe tubes under auto loading
mode, use tube racks specially made for the micro tubes and syringe tubes. The tube racks
for BD micro tubes and syringe tubes have colored adapters installed at every tube position.
Provide users light blue, dark green, yellow green, orange, and red adapters. According to

5-5
Connections

the users’ use habits, set different colors for adapters used with BD micro tube or syringe
tube racks on the software. Make sure the adapter colors set for the BD micro tube rack and
for the syringe tube rack are different (if both are used). Besides, do not install different colors
of adapters on a same tube rack.

Figure 5-5 Special tube racks made for BD micro tubes and syringe tubes-Colored
adapters

5-6
Chapter 6 Start-up
6.1 Startup Process
6.2 Inspection after Startup
6.2.1 Version Information
1. Tap "Status" - "Version Info." in the main menu.
2. Check the version information of the analyzer.

Figure 6-1 Version information screen

3. Tap "Details" to view the information.

6-1
Start-up

Figure 6-2 Version Info. - Details screen

Check whether the version of the installation CD-ROM is the latest. If not, update it where
appropriate.

6.2.2 Temperature and Pressure


Temperature

1. Tap "Status" - "Temp.&Pressure" in the main menu.


2. Confirm whether each temperature value of the analyzer is in the range. If not, tap
"Remove Error" to remove this error. If the error still exists, handle it according to the
troubleshooting mechanism.
Pressure

1. Tap "Status" - "Temp.&Pressure" in the main menu.


2. Check each pressure value, make sure there is no alarm, and all the pressures are in
the the reference ranges in Figure 6-3.
3. If a red alarm is displayed for the pressure during installation, tap the "Build Pressure"
button. If the alarm still exists after pressure building, handle it according to the
troubleshooting mechanism.

6-2
Start-up

Figure 6-3 Temperature and pressure

6.2.3 Confirmation of Other Statuses


 Tap "Status" - "Floater Status" to check the floater status;

 Tap "Status" - "Sensor" to check the sensors status;

 Tap "Status" - "Current&Voltage" to check current and voltage.

The related status of analyzer can be viewed according to the above path. If there is any
abnormal status during installation, the related alarm will be prompt. Just handle it according
to the troubleshooting mechanism.

6.2.4 Mechanical Verification


When assembling the autoloader, note to check whether the wires on the back of the
autoloader protrude from the sheet metal plane (see Figure 6-4 and Figure 6-5). If yes, tidy
up the wires first.

6-3
Start-up

Before assembling the autoloader, make sure the


wires do not protrude from the sheet metal plane

Figure 6-4 Note to check wires on the autoloader back

Avoid pressing the wires when


assembling the autoloader

Figure 6-5 Make sure the wires on the back of the autoloader back from protruding
from the sheet metal plane

After connecting the wire harness connector of autoloader with the connector led from the
main unit, insert the connectors and excessive wires into the hole at the lower left corner in
the front of the main unit (see Figure 6-6). When pushing the autoloader to the main unit,
make sure wires are not clamped at the position indicated by the arrow in Figure 6-7;
otherwise the autoloader cannot fit with the main unit.

6-4
Start-up

After connecting the connectors, insert the


connectors and excessive wires into the hole at
the lower left corner in the front of the main unit

Figure 6-6 Inserting the autoloader connector and excessive wires into the main unit

Make sure the wires are not clamped


between the autoloader shield and
the front cover of main unit

Figure 6-7 Make sure the wires are not clamped between the autoloader shield and the
front cover of main unit

6.2.5 Confirming/Adjusting Positions


Confirming/Adjusting the Autoloader Position

When installing the autoloader to the main unit, make sure that the positioning pins of the
autoloader are inserted into the corresponding pin holes, and the left and right sides of the

6-5
Start-up

autoloader back sheet metal are attached to the analyzer soleplate (see Figure 6-8 and
Figure 6-9; if they are not attached, wires may be clamped or the autoloader is not pushed to
position), and then pre-fix the connecting screw for the autoloader bottom and cross bar.

Figure 6-8 Autoloader attached to the main unit (right side)

Figure 6-9 Autoloader attached to the main unit (left side)

Before powering on the main unit, follow below instructions to confirm the relative positions of
the main unit and autoloader: pull the aspiration assembly to a front position above the
floating blood barrier, and visually check whether the centre of the probe wipe groove on the
aspiration assembly is aligned with the center of floating blood barrier limit piece (the
deviation should not be greater than ±0.5 mm). If it is inconvenient to observe it, use a hand
to press down the sample probe, and see if the probe tip is aligned with the center of floating
blood barrier limit piece. In the process, note to protect the sample probe from touching any

6-6
Start-up

hard object. After confirmation, make sure to raise the sample probe. Otherwise the sample
probe may get bent when dragging the aspiration assembly horizontally.
If the center of probe wipe groove on the aspiration assembly is not aligned with the center of
floating blood barrier limit piece, or the probe tip is not aligned with the center of floating
blood barrier limit piece (in theory, unless the autoloader does not matches the main unit, the
positions should be confirmed before the analyzer is out of the factory), remove the right side
cover of the main unit, loosen the positioning pin hole screw of main unit (see Figure 6-10),
and move the autoloader leftward and rightward to adjust the autoloader’s position against
the main unit. When moving the autoloader, always make sure that the back side of the
autoloader is attached to the main unit. After the adjustment, lock the positioning pin hole
screw of main unit and the connecting screw for the autoloader bottom and the cross bar.

Probe wipe

Blood barrier
limiting piece

Figure 6-10 Checking the main unit and autoloader positions

6-7
Start-up

Figure 6-11 Checking the main unit and autoloader positions

Figure 6-12 Positioning pin holes of main unit

Confirming/Adjusting the Tube Stabilizing Mechanism

Select Menu  Service  Debug & Self-Test Self-Test, and select "Autoloading Assembly"
to access the autoloader self-test screen.

6-8
Start-up

Figure 6-13 Entering the self-test screen


⑤ ⑥

Figure 6-14 Autoloader assembly self-test screen

Tap the "Initialization" button, place an empty tube rack in the front of loading tray. Tap the

6-9
Start-up

"Feeding" button for five times (keep an interval between each tapping, namely, tap the
button again only after the previous mechanism action is completed) to send the first tube
position of tube rack to the piercing position. Press the roller of stabilizing mechanism, and
observe whether the press block of stabilizing mechanism is appropriately aligned with the
center of the tube position opening (in theory, the positions should be confirmed before the
analyzer is out of the factory). Either the left or right side of the press block of stabilizing
mechanism is too close to the tube rack, readjust the stabilizing mechanism position in
left-to-right direction.

Figure 6-15 Ideal position of the press block of stabilizing mechanism relative to the
tube rack

6-10
Start-up

Confirming/Adjusting the Tube Fixing Mechanism

After confirming the stabilizing mechanism position, do not take out the tube rack. Continue to
confirm the position of tube fixing mechanism. Tap the "Fix Tube" button, and observe
whether the roller is approximately centered with the tube rack hole position (use the left and
right hole positions of this tube rack as a reference, with the deviation not greater than ±0.5
mm; in theory, the positions should be confirmed before the analyzer is out of the factory). If
there is a deviation larger than ±0.5mm, readjust the stabilizing mechanism position in
left-to-right direction (a large deviation may easily lead to false alarm from the autoloader
counter)

Figure 6-16 Autoloader assembly self-test interface

Figure 6-17 Ideal position of the press block of tube fixing mechanism relative to the tube
rack

6-11
Start-up

Confirming/Adjusting the mix mechanism position

After confirming the tube fixing mechanism position, do not take out the tube rack. Continue
to confirm the position of mix mechanism. Select Menu  Service  Debug & Self-Test 
Adjust Autoload Pos., and select "Autoloading Assembly" to access the autoloader self-test
screen. Select the mix mechanism, tap "Init" and "Gripper Forward" in turn, and visually
check whether the gripper is aligned with the center of the tube rack opening in the
left-to-right direction. If yes, tap "Gripper Backward", place an empty tube in the mix position,
tap the "A&M (1)" button, and observe whether the tube obviously presses against the tube
rack position when the gripper puts it down. If yes, tap "To Adjust Pos.", and then tap the
"Forward", "Backward", "Left", and "Right" buttons to finely adjust the gripper position. If the
deviation is very large (though the situation is very unlikely), adjust the mix mechanism
position in left-to-right direction on the front plate (see Figure 6-18) and the tube gripper
position in the anterior-to-posterior direction on the rotation shaft (see Figure 6-19), and then
tap the "Forward", "Backward", "Left", and "Right" buttons to adjust the gripper position finely.
After that, tap the "Save Steps" button, and then tap "Exit". Tap the "A&M (1)" button, and
check again to see whether the whether the tube squeezes the tube rack hole position
apparently when the gripper puts down the tube.

Figure 6-18 Path of accessing "Adjust Autoload Pos."

6-12
Start-up

Figure 6-19 Mix mechanism adjusting screen

Figure 6-20 Confirming the mix mechanism position in the left-to-right direction

6-13
Start-up

Coarse adjustment
holes for the mix
assembly position
adjustment in the
left-to-right
direction

Figure 6-21 Coarse adjustment hole of the mix mechanism position adjustment in the
left-to-right direction

Coarse adjustment structure for


the tube gripper position
adjustment in the anterior-to-
posterior direction

Figure 6-22 Coarse adjustment structure of the tube gripper position in the
anterior-to-posterior direction

6-14
Start-up

Confirm the gripper position relative to the tube rack in the left-to-right direction and the
anterior-to-posterior direction, and then confirm the gripper position in the vertical direction.
The spacing from the gripper bottom to the tube rack top surface should be controlled in the
range of 2.0 to 2.5 mm. If slides are available in the hospital, use two slides (usually the slide
thickness is about 1.1 to 1.2 mm; use only one if the slides are non-standard thick slides) as
an auxiliary tool in the check. If no slides are available, check the position visually.

Figure 6-23 Checking the tube gripper position in the vertical direction

After confirming the tube gripper position in the vertical direction relative to the tube rack,
confirm the gap between the gripper body and the power-down protection piece. Select "Mix
mechanism” on the screen, tap "Gripper Forward""To Center", and observe whether the
spacing between the tube gripper body and the power-down protection piece is about 1.5 to
2.5 mm. Two slides can be used as a confirming fixture.

6-15
Start-up

(1.5~2.0)mm

Figure 6-24 Spacing requirement between the tube gripper and the power-down
protection piece

Confirming/Adjusting the Scanner Position

This section applies to the machine with the rotary scanning function only. This section can
be skipped if the user will not use the sample barcode scanning function.
Select Menu  Service  Advanced Toolbox to access the configuration setting screen, and
confirm that the "With internal barcode scanner" option has been selected.

6-16
Start-up

Figure 6-25 Access to the internal barcode scanner setting screen

Figure 6-26 Internal barcode scanner setting interface

6-17
Start-up

Select Menu  Setup  Auxiliary Setup to access the “Get Sample Information” setting
screen, and confirm that the "Auto-Scan rack No." option have been selected.

Figure 6-27 Access to the auto scan setting interface

6-18
Start-up

Figure 6-28 Auto scan setting interface

Use the code scan software or machine barcode recognition function to first identify the
barcode system used by the client, select Menu  Setup  System Setup  Barcode to
access the internal barcode setting screen, and select the corresponding code system,
length and check bit. It is not advised to select the code system and length not used by the
client.

6-19
Start-up

Figure 6-29 Access to the internal barcode setting scren

After the above setting is completed, select Menu  Service  Debug & Self-Test 
Self-Test, and select "Autoloading Assembly" to access the autoloader self-test screen.
Tap the "Initialization" button, place a tube with a barcode on the client at the rotary scanning
position, and tap "Auto-Read Barcode" to check whether the barcode content is displayed in
the barcode content display box and whether the barcode recognition rate box is displayed
as 100%. If not, first confirm whether the red light of the scanner is turned on when the
"Auto-Read Barcode" button is tapped. If the light is turned on but the barcode cannot be
scanned, the scanner position in the left-to-right direction is not adjusted properly. In this case,
remove the right front cover of the main unit (the right panel needs to be removed
beforehand), and readjust the scanner position in the left-to-right direction.

6-20
Start-up

Figure 6-30 Path of entering the self-test interface


Figure 6-31 Autoloader assembly self-test interface

6-21
Start-up

Right front
cover

Figure 6-32 Right front cover of the analyzer

Adjusting device of
scanner position in
the left-to-right
direction

Figure 6-33 Adjusting device of scanner position in the left-to-right direction

6-22
Chapter 7 Setup
7.1 System Setup
("Menu" > "Setup" > "System Setup" > "Print Setup")

7.1.1 Print Setup


Print Setup option ("Menu" > "Setup" > "System Setup" > "Print Setup")
You can perform print setting on the "Print Setup" interface.

Follow below instructions:

1. Select "Menu" > "Setup" > "System Setup" > "Print Setup" to access the "Print Setup"screen.

2. Perform print setting as needed.


See below for setting descriptions:

Print Device Select a print device in the network Administrator authority


from the pull-down list. setting
Printer Driver Select the proper printer driver from For the problems related to
the pull-down list: print device and printer driver,
Auto Identification please contact the service
personnel of your printer
PCL6
supplier.
Raster print
Paper Select the required paper type from
the pull-down list.

7-1
Setup

The ananlyzer supports two types of


paper:
A4
A5
Blood Sample Select a blood sample or body fluid
Report sample report title from the
Title/Body pull-down list.
Fluid Sample Input the needed title in the edit box.
Report Title
The set blood/body fluid sample
report title will be displayed on the
printed report.
Blood Sample Select a blood sample or body fluid When "One page with
Report sample report template from the histogram" is selected, the
Template/Body pull-down list. print result includes the
Fluid Sample Select the required template format parameter result and graphic
Report from the corresponding pull-down result of the sample.
Template list: When "One page with without
One page with histogram histogram" is selected, the
print result includes the
One page without histogram
parameter result of the
sample only, but not the
graphic result.
Para. Select a parameter language from When "Chinese" is selected,
Language the pull-down list: the Chinese name of
Chinese parameter is displayed on the
printed report.
Chinese/English
When "Chinese/English" is
selected, both the Chinese
and English names of
parameter are displayed on
the printed report.
Copies Input the number of printed report
copies when the "Print" button is
tapped.
The default value is 1 copy. The
setup range is [0-20].
Printing Select the corresponding option to
content select the information to be
displayed on the report:
Print flags of edited result
Print reference range flags

7-2
Setup

Print suspect flags


Print flags
Print reference range
Auto print after Select this option to enable the
sample corresponding auto print function:
analysis Auto print after analysis Select "Auto print after
analysis". The analyzer will
print the sample result
automatically after the
analysis ends each time.
Auto print after validating Select "Auto print after
validating". The analyzer will
print the validated sample
result automatically.
Auto print after QC count Select "Auto print after QC
count". The analyzer will print
the QC count result
automatically after the QC
count ends each time.

7.1.2 Communication Setup


Communication option ("Menu" > "Setup" > "System Setup" > "Communication")

Note: the default IP address of the main unit is 10.0.0.12. The user can set the IP address of
the main unit as needed.

Users at administrator's level can set up the following communication settings:


Protocol Setup
Transmission Mode

Protocol Setup

1. Tap "Menu" > "Setup" > "System Setup" > "Communication" to enter the
"Communication" interface.
2. Set up the communication protocol in accordance with the real needs in your laboratory.

7-3
Setup

Figure 7-1

Transmission mode setup

1. Tap "Menu" > "Setup" > "System Setup" > "Communication" to enter the
"Communication" interface.
2. Set up the transmission mode in accordance with the real needs in your laboratory.

See below for setting descriptions:


Transmission Check to enable one or more The "Auto Retransmit" function
Mode transmission functions: becomes available only when
Auto Retransmit "ACK Synchronous
Transmission" is enabled.
Auto Communicate
Auto Fetch Info From LIS
Transmit as Print Bitmap
Data
Data channel Select from the pull-down list: When you are using Mindray's
LIS labXpert software, select
"labXpert" as the data channel.
labXpert
Scattergram Select from the pull-down list:
transmitted Not to be transmitted
as /Histogram
Bitmap
transmitted as
Data

7-4
Setup

7.1.3 Setting Internal Barcode System


("Menu" > "Setup" > "System Setup" > "Barcode")
Administrators may set up barcode system as needed.

The analyzer supports the following barcode types:


 CODE128
 CODE39
 ITF
 CODE93
 CODABAR
 UPC/EAN/JAN

1. Tap "Menu" > "Setup" > "System Setup" > "Barcode" to enter the "Barcode" setup
screen.
2. Tap the desired code type to go to the corresponding setup screen.

3. Select the number of digits used on site in the “Digits” area.


4. (Optional) If you are using CODE39, ITF, and CODABAR with check bit, check the
"Check Bit" box.

NOTE
 When the ITF, CODE39, and CODABAR barcodes with check bit are used as sample
barcodes, the actually checked length of barcode digits should be the total length of the
barcode information length plus one check bit.
 If a 9-digit barcode is used actually and "Check Bit" is checked, "10" should be selected
for the barcode length.

7-5
Setup

5. Check the “Apply” box to apply the code type.


6. (Optional) Set other code types if needed.

NOTE
 For code types supporting check bit, use check bit in barcode labels if possible to
reduce the rate of misreading.
 The code types and length limits set on the analyzer shall be those used in your
laboratory.
 Do not select the code types that are not used, which may increase the rate of
misreading.
 Barcodes longer than 20 digits will not be read correctly. Barcodes longer than 20 digits
will not be read correctly.

7.1.4 Enable “Low Speed Scan” for Low Quality Sample

Barcode
This function is only available on analyzers configured with a built-in barcode scanner.
When the barcode labels used at customer’s site are not of good quality, for example, not
clear, or are contaminated, or get worn out, enable “Low speed scan”.

NOTE
 When “Low speed scan” is enabled, inform the user that the analyzer throughput will
lower down a little.

1. Tap "Menu" > "Service" > "Advanced Toolbox" to enter the “Advanced Toolbox” screen.

2. Check “With internal barcode scanner” and “Low speed scan”.

7.1.5 Setting Date/Time


("Menu" > "Setup" > "System Setup" > "Date/Time Setup")
Users may set up date and time on the "Date/Time Setup" screen.

7-6
Setup

1. Tap "Menu" > "Setup" > "Date/Time Setup" to enter the "Date/Time Setup" screen.

2. Set up the date and time as necessary.


Date Enter the current date
Time Enter the current time The analyzer uses the 24-hour clock
Date Format Select the desired date format from
the pull-down list

7.1.6 Setting Lab Information


("Menu" > "Setup" > "System Setup" > "Lab Info Setup")
Users may enter necessary laboratory information on the "Lab Info Setup" screen.
1. Tap "Menu" > "Setup" > "System Setup" > "Lab Info Setup" to enter the "Lab Info Setup"
screen.
2. Enter laboratory information as needed.

7-7
Setup

7.2 Setting User Accounts and Passwords


("Menu" > "Setup" > "User Management")
The "User Management" screen displays all the user accounts registered on this analyzer.

7.3 Auxiliary Setup


("Menu" > "Setup" > "Auxiliary Setup")

7.3.1 Setting Sample Information Getting Way


("Menu" > "Setup" > "Auxiliary Setup" > "Get Sample Information")

Sample information getting way

You can choose the following ways to get sample information:


 Run as per worklist
 2-Way LIS/HIS
 Auto-Scan sample ID
 Input the manual No. manually.

1. Tap "Menu" > "Setup" > "Auxiliary Setup" > "Get Sample Information" to enter the "Get
Sample Information" screen.

7-8
Setup

2. Set the appropriate getting way in the "Get Sample Information" area.
See below for setting descriptions:
Options Functions Note
Run as per The analyzer runs When your analyzer is
worklist samples per the worklist connected to Mindray's
set in the labXpert. labXpert software, select
"Run as per worklist".
Auto-Scan sample The analyzer Make sure the barcode
ID automatically scans the labels on the sample tubes
sample ID. are properly placed, intact
and readable.
2-Way LIS/HIS When you are using the Check the option when you
2-Way LIS/HIS, the are using the LIS/HIS.
analyzer automatically
fetches information from
the LIS/HIS. You do not
need to enter Sample ID
or rack no.
Check none of the Users enter the first
above options Sample ID for each of the
auto-loading analysis
cycle; the Sample IDs for
the following samples
automatically increase.

7-9
Setup

Setting the entry method of next sample ID under the autoload mode

(Tap "Menu" > "Setup" > "Auxiliary Setup" > "Get Sample Information" to enter the "Get
Sample Information" screen.)
When you are using the auto-loading analysis mode with "2-Way LIS/HIS" or "Auto-Scan
sample ID" enabled, you do not need to set how to enter the next sample ID.
When you are using the auto-loading analysis mode, but not with "2-Way LIS/HIS" or
"Auto-Scan Sample ID", enter the first sample ID, and the following sample IDs in the same
batch will automatically increase.
If necessary, set prefix rules for sample IDs on "Setup" > "Auxiliary Setup" screen.
1. In the "Setting of the next sample" area, select "Auto Increase" from the "Entry of next
sample ID" pull-down list.

2. Set up a value for the "Prefix Length" when necessary.


For example, if you set "Prefix Length" to 6, the first 6 figures of the first sample ID will be
applied to all sample IDs in the same batch.

7.3.2 Other Settings


("Menu" > "Setup" > "Auxiliary Setup" > "Other settings")
You can set the following functions on the "Other settings" interface:

 Predilute Mode Prompt


 Pop-up Keyboard
 Enable waste direct discharge
 Enable fluorescent reagent detect sensor
 Monitor Reagent Expiration Date
 Flags
 Alarm Volume

1. Tap "Menu" > "Setup" > "Auxiliary Setup" > "Other settings" to enter the "Other settings"
screen.

7-10
Setup

2. Define the settings as needed.


See below for setting descriptions:
Predilute Mode When "Predilute Mode Prompt" is
Prompt checked, in the predilute mode, when
you press the aspirate key on the
sample analysis screen to start
analysis, a dialog box will pop up to
remind you that the current analysis
mode is predilute.
Uncheck the "Predilute mode prompt"
to disable the function.
Pop-up Keyboard Check to enable the pop-up keyboard.
Tap on the edit area on each screen,
the pop-up keyboard will display for you
to input information.
When you are using an external
keyboard, you can uncheck "Pop-up
Keyboard" to disable the function.
Enable waste direct Check "Enable waste direct discharge"
discharge when you not using waste containers,
but directly discharge the waste.
Enable fluorescent When " Enable fluorescent reagent
reagent detect detect sensor" is checked, if the
sensor fluorescent reagents are not sufficient,
the analyzer will give alarms.
Monitor reagent Check "Monitor Reagent Expiration
expiration date Date" to enable the function. When the
function is enabled, the analyzer gives
warning when a reagent gets expired.
Flags Select from the pull down list to define Suspect: R, r
the suspect, high and low flags (default: High: H, h, 

7-11
Setup

"R" for suspect, “H” for high and “L” for Low: L, l, 
low).
Alarm Volume Tap the “Alarm Volume” pull-down list to The options are:
select the volume of alarm sound. Low, Medium,
High, Max

NOTE
 If waste direct discharge is adopted, make sure that the waste tube is lower than the
waste outlet.

7.4 Maintenance Setup


7.4.1 Setting Waiting Time before Entering Standby Mode
("Menu" > "Setup" > "Maintenance")
When the time for which the analyzer is free from fluidics operations reaches that you have
set on the "Maintenance" screen of the analyzer, the analyzer automatically enters the
standby status.
Administrators may set the waiting time before the analyzer enters the standby status on the
"Maintenance" setup screen.

1. Tap "Menu" > "Setup" > "Maintenance" to enter the "Maintenance" setup screen.
2. Set up the wait time before the analyzer entering the standby status.

NOTE
 The allowed range is 30~60 minutes. Make sure that the input value is in the valid range and
the format meets the related requirement.

7.4.2 Setting Probe Cleanser Maintenance Time


Set the probe cleanser maintenance time ("Menu" > "Setup" > "Maintenance")

Administrators may set the start time for daily probe cleanser maintenance on the

7-12
Setup

"Maintenance" setup screen.

1. Tap "Menu" > "Setup" > "Maintenance" to enter the "Maintenance" setup screen.
2. Set up the start time for daily Probe Cleanser maintenance as needed.

Note
 The allowed range is 0:00 to 23:59. Make sure that the input value is in the valid range
and the format meets the related requirement.

7.5 Setting Auto-loading Mode


("Menu" > "Setup" > "Auto-loading")
Administrators may set the following functions regarding the autoloading of samples in
accordance with the real needs in your laboratory.

 Autoloader Stop Condition

 Blood/Analysis Mode Inquiry Failed

 When there is tube vacancy, sample ID

 Autoloading Summary Display


1. Tap "Menu" > "Setup" > "Auto-loading" to enter the "Auto-loading" setup screen.

2. Set how to proceed when blood/analysis mode inquiry failed, to set the next sample IDs
when there is tube vacancy and whether to display summary after auto-loading finishes.

7-13
Setup

See below for setting descriptions:


Blood/Analysis Mode Set up how to proceed when blood/analysis mode inquiry from
Inquiry Failed LIS/HIS fails.
If you have selected "Skip after n seconds", set up the wait time
(n) in seconds (the maximum wait period is 15 seconds);
If you have selected "Use specified mode", select a mode from
the pull-down list.
When there is tube Tap the radio button to select the rule of sample ID increment
vacancy, sample ID when there is tube vacancy in the tube rack:
increases
does not increase
Autoloading Summary When you have checked "Display summary after autoloading
Display finished", the screen displays the auto-loading summary,
including finished blood samples, rack vacancies, ID reading
errors, etc.

7.6 Confirming HGB Gain


("Menu" > "Setup" > "Gain setup")

.1 Tap "Menu" > "Setup" > "Gain setup" > "WB" to enter the WB "Gain setup" screen.

2. Adjust the HGB default gain in the HGB "Set" text box, until the HGB blank voltage is
in the range of [4.30, 4.50].

NOTE
 When you modify the HGB default gain, the HGB blank voltage will chan
accordingly.

7-14
Setup

3. If necessary, repeat above procedure to adjust the HGB voltages for other modes.

7.7 Setting Auto Startup/Shutdown Time


("Menu" > "Setup" > "Auto Startup/Shutdown")

Administrators may set up the auto startup and shutdown time for the analyzer on the "Auto
Startup/Shutdown" screen.
When you have set the auto startup/shutdown time, the analyzer automatically starts and
shutdown at the set time.

1. Tap "Menu" > "Setup" > "Auto Startup/Shutdown" to enter the "Auto Startup/Shutdown"
screen.
2. Check the days you want the analyzer to start up/shut down automatically.

NOTE
 Define the auto startup complete time in the auto startup "Complete Time" field.
For example, if you set the "Complete Time" for auto startup to 8:00 on
Monday, the analyzer automatically starts the startup procedure at 7:40, and
completes the procedure at 8:00.
 Define the auto shutdown time in the auto shutdown "Time" field.
For example, if you set the "Time" for auto shutdown to 17:00 on Monday, the
analyzer automatically starts the shutdown procedure at 17:00.

7-15
Setup

NOTE
 To use the auto startup function, do not power off the analyzer.

7.8 Save Settings after Changes


After you have changed or modified analyzer settings, follow below steps to save the
changes.
1. Tap "Menu" > "Setup" and select the setting item you want to change.
2. Make necessary changes on the setting screen.
3. Tap another button on the software screen.
A dialog box displays asking if you want to save the change.

4. Tap "Yes".
The new setting is saved.

7-16
Chapter 8 PerformanceVerification
8.1 Background Verification
 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.
The background specification of the analyzer is as follows:

Table 8-1 Background Specifications for Blood Sample Tests

Parameters Background/blank count requirements


≤ 0.1 × 109 / L
WBC
≤ 0.02× 1012/ L
RBC
≤1g/L
HGB
≤ 5 × 109 / L
PLT

 Procedure
1. Tap "Performance" > "Background" in the menu.
2. Tap "Mode" to select sample mode, select OV/CT-WB-Micro WB, OV/CT -PD or AL-WB
mode, and then select the analysis mode.

Figure 8-1 Background mode selection

3. When you select the OV/CT vial mode, put diluent to the sample probe or in the sample
compartment and press the [Aspirate]/[Start] key to start analysis.
4.  When you select the autoloader mode, define the “Runs” for the background tests.
Place the diluent sample to the tube rack and put the rack on the autoloader, then click
"Start Count" to start analysis. The analyzer performs the background tests for the

8-1
PerformanceVerification

defined times.
5. The background requirement is under the CDR analysis mode. At least three times of
test results should be provided for CT/OV-Micro WB, CT/OV-PD or AL-WB respectively.
6. When the test finishes, the analyzer will evaluate the background results and report
Pass or Fail at the bottom of the screen.
7. Finally, you can tap "Export" to export data to a USB drive.

Figure 8-2 Background test

8.2 Optical System Status Verification


Prepare the 7 um standard particle:
Mix the 4k-07 standard particle bottle, use a centrifugal tube to add 4 drops of the standard
particles into 1mL of de-ionized water to form a standard particle sample.

1. Tap Service > Debug & Self-Test > Optical Debug to access the screen shown in below
figure.

8-2
PerformanceVerification

Figure 8-3. Confirm that the FS blank voltage is normal.

2. Use the prepared standard particles to carry out counting once respectively.
3. Confirm that the gravity center position, total number and CV of valid particle clusters of
each kind of standard particles in the above counting result comply with the
requirements of Table 8-1.

Figure 8-3

8-3
PerformanceVerification

Table 8-1 4k07 (6.982 um) standard particle (debugging) index requirements

Items Acceptance Criteria


Center of gravity 480.00~615.00
WNB
CV ≤2.5%
FS
Center of gravity 480.00~615.00
DIFF
CV ≤3.2%
Center of gravity 998.0~1350.0
WNB
CV ≤19.0%
SS
Center of gravity 998.0~1350.0
DIFF
CV ≤19.0%
Forward optical background voltage ≤100mv
Total number of particles 1000~6000

8.3 Optical Gain Adjustment


1. Tap "Calibration" > "Optical Gain Calibration" in the menu bar to access the screen
shown in Figure 8-4. Select "Calibrator" as a working substance, and then always enter
the calibrator target in the corresponding column in the "Target" column.
2. Use the calibrator to perform counting, align the calibrator with the results of two columns
to display "OK", and tap "Save". Meanwhile, the gain factors are recorded in the table.
3. Tap "Setup" > "Gain setup" in the menu bar to display the interface shown in Figure 8-4.
Check whether "Set" for the gain of each channel has been updated (the value is the
default gain of the system if it is not updated).
4. On the gain setup interface, confirm whether the HGB blank voltage is in the range of
4.40 V to 4.50 V.

Figure 8-4 Optical gain calibration

8-4
PerformanceVerification

8.4 Initial Verification of Scattergram


 Introduction
By testing fresh blood, you can verify if the scattergram of the analyzer is normal, and
check the function of the reaction, reagent, heating and fluidic systems. The position and
shape of different cell populations on the scattergram are observed to achieve the
objective above.

 Procedure
1. Sample selection

Select 5 tubes of fresh (collected no more than 4 hours before) anticoagulated venous
blood sample, and run the samples in the AL-WB mode.

The selected samples shall meet the following requirements:

Table 8-2 Requirements

No flags of left shift, immature cell, abnormal/atypical lymphocyte, or abnormal scattergram


WBC 6 ~ 10 (109/L) Bas% 0 ~ 1%
Lym% 20% ~ 50% Eos% 0.5% ~ 8%
Mon% 3% ~ 8%

The scattergrams of the selected sample must be normal (different cell populations are
clearly apart, while each single population is aggregated).

 Checking the scattergrams


Analyze 5 fresh blood samples meeting the above requirements under the OV (or
AL)-WB-CBC+DIFF+NRBC+RETmode, the shape and position of DIFF, BASO, WNB and
RET scattergrams should resemble Figure 8-5-Figure 8-6.

Figure 8-5 DIFF scattergram

8-5
PerformanceVerification

Normal sample Abnormal sample with NRBC

Figure 8-6 WNB scattergram

Figure 8-7 RET scattergram

Figure 8-8 PLT-O scattergram

8.5 Carryover Verification


 Introduction
The carryover test tests if high value samples have carryover effect on low value
samples. The equation of carryover rate is as follows:

The first low value sample result - The third low value sample result
Carryover (%) = The third high value sample result - The third low value sample result

The samples for carryover test and carryover requirements of BC-6000 series
analyzers:

8-6
PerformanceVerification

Table 8-3 Carryover requirements


Parameters Carryover
WBC ≤ 1.0%
RBC ≤ 1.0%
HGB ≤ 1.0%
HCT ≤ 1.0%
PLT ≤ 1.0%
RBC-O ≤ 1.5%
WBC-D ≤ 1.0%

 Procedure
1. Prepare 1-2 high value controls or samples, and prepare 1-2 low value controls or
samples.
2. The refrigerated controls must be warmed up for 15 minutes in ambient temperature and
then mixed throughly. See the appendix for mixing requirements.
3. Tap "Performance" > "Carryover" in the main menu.
4. Tap "Mode" to enter the mode selection screen, select blood sample or control as the
test sample. Select analysis mode and tap "OK" to confirm the selection, see the
following figure.

Figure 8-9 Mode selection for carryover test

5. If AL-WB mode is selected, place the high-value sample in the first position of the tube
rack, and the low-value sample in the second position of the tube rack, then put the rack
on the autoloader. Click "Start Count" to start analysis. The analyzer automatically tests
the high-level and low-level samples, each for 3 times. If OV/CT-WB or OV/CT -PD
mode is selected, present sample to the sample probe or in the sample compartment
and press the [Aspirate]/[Start] key to start analysis.

8-7
PerformanceVerification

6. After running 3 high value sample tests, run 3 low value sample or diluent tests.
7. The system will calculate the carryover rate of all parameters per the tested results
automatically, and report Pass or Fail, as shown in the following figure.

Figure 8-10 Carryover results

8.6 Reproducibility Test


 Introduction
Reproducibility refers to the deviation between the measurements results of the
same sample. It is expressed by the CV result or deviation of multiple analysis.

CV Value

Range = MAX - MIN

The reproducibility requirements of BC-6000 series parameters are listed in the


following table:

Table 8-4 Reproducibility requirements

WB PD
Parameters Range (CV/absolute deviation (CV/absolute
d*) deviation d*)
WBC ≥ 4×109/L ≤ 2.5% ≤ 4.0%
RBC ≥ 3.5×1012/L ≤ 1.5% ≤ 2.0%
HGB (110 ~ 180) g/L ≤ 1.0% ≤ 2.0%
MCV (80 ~ 100) fL ≤ 1.0% ≤ 3.0%

8-8
PerformanceVerification

WB PD
Parameters Range (CV/absolute deviation (CV/absolute
d*) deviation d*)
HCT (30 ~ 50)% ≤ 1.5% ≤ 3.0%
MCH / ≤ 1.5% /
MCHC / ≤1.5% /
RDW-SD / ≤ 2.0% /
RDW-CV / ≤ 2.0% /
PLT ≥ 100×10 /L 9
≤ 4.0% ≤ 8.0%
PDW / ≤ 10.0% /
MPV / ≤ 3.0% /
P-LCR / ≤ 15.0% /
P-LCC / ≤ 15.0% /
PCT / ≤ 5.0% /
Neu% ≥ 30.0%
Neu% ≤ 6.0% ≤ 12.0%
WBC ≥ 4 × 109/L
Lym % ≥ 15.0%
Lym% ≤ 6.0% ≤ 12.0%
WBC ≥ 4 × 109/L
Mon % ≥ 5.0%
Mon% ≤ 16.0% ≤ 32.0%
WBC ≥ 4 × 109/L
Eos% WBC ≥ 4 × 109/L ≤ 20.0% or ±1.5%(d) ≤ 40.0% or ±3.0%(d)
Bas% WBC ≥ 4 × 10 /L 9
≤ 30.0% or ±1.0%(d) ≤ 60.0% or ±2.0%(d)
NRBC% WBC ≥ 4 × 10 /L 9
≤ 20.0% or ±1.5%(d) /
Neu# ≥ 1.20 × 10 /L 9
≤ 6.0% ≤ 12.0%
Lym# ≥ 0.60 × 109/L ≤ 6.0% ≤ 12.0%
Mon# ≥ 0.20 × 109/L ≤ 16.0% ≤ 32.0%
≤ 20.0% or ±0.12 × ≤ 40.0% or ±0.24 ×
Eos# WBC ≥ 4 × 109/L 9
10 /L(d) 109/L(d)
≤ 30.0% or ±0.06 × ≤ 60.0% or ±0.12 ×
Bas# WBC ≥ 4 × 109/L 9
10 /L(d) 109/L(d)
WBC ≥ 4 × 109/L /
IMG% ≤ 25.0% or ±1.5%(d)
IMG% ≥ 2%
≤ 25.0% or ±0.12 × /
IMG# ≥ 0.10 × 109/L 9
10 /L(d)
≤ 20.0% or ±0.12 ×
NRBC# WBC ≥ 4 × 109/L /
109/L(d)
RBC ≥ 3 × 1012/L
RET# ≤ 15% ≤ 30%
RET%1% ~ 4%
RBC ≥ 3 × 1012/L
RET% ≤ 15% ≤ 30%
RET%1% ~ 4%
RET# ≥ 0.02 ×
RHE ≤ 5% /
1012/L
LFR RBC ≥ 3 × 1012/L ≤ 30% /

8-9
PerformanceVerification

WB PD
Parameters Range (CV/absolute deviation (CV/absolute
d*) deviation d*)
RET%1% ~ 4%
LFR ≥ 20%
RBC ≥ 3 × 1012/L
MFR RET%1% ~ 4% ≤ 50% /
MFR ≥ 20%
RBC ≥ 3 × 1012/L
HFR ≤ 100% or ±2.0%(d) /
RET%1% ~ 4%
RBC ≥ 3 × 1012/L
IRF RET%1% ~ 4% ≤ 30% /
IRF ≥ 20%
PLT ≥ 50 × 109/L
IPF ≤ 25% /
IPF ≥ 3%
*Note: Absolute deviation d = Measured value - Mean of measured values.
**Note: Range = Maximum measured value - Minimum measured value.

 Procedure
1. Prepare 2 normal controls or several normal fresh blood to perform the reproducibility
test under AL-WB, CT/OV-Micro WB and OV-PD modes. Ensure the following sample
volume if fresh blood samples are used.
AL-WB: 2.5 mL
OV-Micro WB: 2.0 mL
CT-Micro WB: 2.0mL
2. Tap "Performance" - "Reproducibility" in the main menu to enter the screen.
3. Tap "Mode", select blood or control as the sample, and select test mode, then tap "OK"
as shown in the following figure.

8-10
PerformanceVerification

Figure 8-11 Selection of reproducibility test mode

4. If AL-WB mode is selected, put a sample at the first position of the tube rack, then put
the rack on the autoloader. Define the “Runs” of the tests, and then click "Start Count" to
start analysis. The analyzer automatically runs the samples contiuously for the runs you
defined.

Note: The default value of “Runs” is 10, allowed range [1, 20].
If OV/CT -WB or OV/CT -PD mode is selected, present sample to the sample probe
or in the sample compartment, and press the [Aspirate]/[Start] key to start analysis.
5. Then select a sample, its reproducibility test result of each parameter (Pass/Fail) will be
displayed on the screen, tap the single or double arrow button to review the parameter
results.

8-11
PerformanceVerification

Figure 8-12 Results of reproducibility test

6. To see the reproducibility result of each parameter, tap the "Statistics" button.

Figure 8-13 Reproducibility CV value

7. Under predilute mode, the samples are mixed by dispensed diluent and 20 uL of sample.
Select predilute mode, prepare 1 centrifugal tube, and tap the "Diluent" button on the
upper right of the main screen.

8-12
PerformanceVerification

8.7 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

 Calibrator mode

1. Prepare one calibrator, and mix it thoroughly according to the mixing instructions.
2. Tap Calibration > Calibrator in the system menu to enter the screen.
3. Access the AL-WB page, enter the lot number and expiry date of calibrator, as well as
the target value of each main parameter under the AL-WB mode.
4. Place the calibrator on the tube rack to run analysis for 6 consecutive times.
5. Check if the CV value of the 6 results meet the reproducibility requirement of the AL-WB
mode. If yes, the calibration data are effective.

Figure 8-14 AL-WB calibration screen

6. After AL-WB calibration succeeds, you can switch to the predilute mode to perform PD
calibration. The preparation proportion of prediluted sample is 20 (blood):100 (diluent).
The target value does not need to be filled in the PD calibration page.
7. After the predilute mode calibration is successfully performed, switch the page to the
Micro WB mode for calibration. Note that the target value of Micro WB mode of calibrator
is different from that of the AL-WB mode.

 Fresh blood mode

1. Prepare several normal fresh blood sample and record the targets of the samples on the

8-13
PerformanceVerification

standard comparator.
2. Tap Calibration > Fresh Blood on the system menu to enter the screen.
3. Select Blood Sample 1 on the left of the screen and enter its target, and analyze the
sample to get 10 analysis results. See the following figure. Only the AL-WB mode is
supported for fresh blood calibration.

Figure 8-15 Fresh blood calibration screen

4. Analyze the other samples per the same procedure of step 3.


5. After the analysis finishes, check if the CV result of each sample meets the whole blood
reproducibility requirement.
6. Tap the "Calculate" button on the left of the screen. The calibration factor of each sample
will be calculated, and the mean of calibration factors will be displayed as shown in the
following figure.

8-14
PerformanceVerification

Figure 8-16 Mean of fresh blood calibration factors

7. When calibration finishes, tap "Yes" on the pop-up dialog box to save the new factor.
Note: Perform the calibration either with the calibrator or fresh blood samples, unless
required by the customer.

8.8 Verification of Deviation between Different Modes


 Introduction

The verification aims to check if the deviation of results between the WB mode and
Micro WB mode, and the WB mode and PD mode is within the required range.

 Procedure
1. Prepare a normal fresh blood sample, analyze the sample for 5 times under the WB
mode, Micro WB mode and PD mode respectively, and calculate the mean (analysis
under the OV and PD modes is not compulsory).
2. Compare the means of different modes to see if the deviations are within required range.

Table 8-5 Deviation requirements between the WB mode and Micro WB mode

Parameters Relative deviation/absolute deviation


WBC ±0.2/±3%
RBC ±0.03/±2%
HGB ±2.0/±2%
MCV ±2.0/±3%
PLT ±10/±5%

8-15
PerformanceVerification

Table 8-6 Allowed deviation between the WB mode and PD mode

Parameters Relative deviation/absolute deviation


WBC ±0.8/±10%
RBC ±0.20/±4%
HGB ±6.0/±4%
MCV ±4.0/±4%
PLT ±30/±14%

8.9 Reliability Verification


 Introduction
The verification aims to confirm the analyzer reliability, namely, the autoloader and
analyzer operate normally on the whole, without any exception alarms.

 Procedure
1. Draw 50 samples with a sample volume not less than 1.5 ml (fresh blood recommended),
and place them in a sample rack.
2. Enable the barcode scanning function if the internal barcode function is configured.
3. Execute the autoloading function to test these 50 samples. The requirements are as
follows: There is no exception alarm in the entire counting process, the results and
scattergram are normal, and the rotary scanning function of barcode is normal, without
the problems of scanning leakage or scanning error.
4. Test these 50 samples again when conditions permit. The requirements are the same as
above.

Table 8-7 Reliability requirements

Sample requirements Reliability requirements


1. The sample volume is not less 1. There is no exception alarm in the counting
than 1.5 ml. process.
2. The number of samples is 50. 2. The results and scattergram are normal.
3. Rotary scanning is normal, and the barcode is
scanned correctly without omission.

8-16
Chapter 9 Body Fluid Performance Verification

9.1 Body Fluid Background Verification


 Requirement
This section aims to verify the body fluid background. The body fluid background
requirements are as follows:

Parameters Background/blank count requirements


WBC-BF ≤ 0.001 × 109 / L

RBC-BF ≤ 0.003 × 1012 / L

 Procedure
1. Tap Performance > Background in the system menu to access the test interface.
2. Tap the "Mode" interface and select the "CT/OV-BF" mode.
3. Place the tube containing diluent under the open-vial sample probe, and press the
[Aspirate] key to start counting at the same time.
4. Perform background counting for three times at least.
5. After the test is completed, the analyzer provides the background result automatically.
Confirm that the result is "Pass".

Figure 9-1 Body fluid background test

9-1
Scattergram introduction

Figure 9-2 Interface for selecting the mode

9.2 Body Fluid Carryover Verification


 Requirement
The table below provides the sample requirements and carryover rate requirements
of body fluid carryover:

Sample types Parameters Units High value sample Low value sample
9
WBC-BF × 10 /L > 0.200 < 0.01
Cerebrospinal fluid 12
RBC-BF × 10 /L > 0.010 < 0.005
9
Serous cavity fluid WBC-BF × 10 /L > 1.000 < 0.05
12
RBC-BF × 10 /L > 0.100 < 0.005

Parameter Carryover
WBC-BF ≤ 0.3% or ≤ 0.003 × 109/L
RBC-BF ≤ 0.3% or ≤ 0.003 × 1012/L

Note: The high value sample is prepared by mixing control and diluent uniformly. For
details, see the description in the procedure. Diluent can be adopted for the low value
sample.

 Procedure
1. Tap "Performance" > "Carryover" on the main screen to access the test screen.
2. Tap the "Mode" interface and select the "OV-BF" mode.
3. Take an empty tube, add 2 ml of diluent and 500 ul of normal-level control, and mix them
thoroughly.

9-2
Scattergram introduction

4. Execute count under OV mode for three times for this uniformly mixed sample ad use the
results as high value sample results of body fluid. Then, execute count under OV mode of
diluent for three times and use the results as low value sample results.
5. After the test, the analyzer automatically calculates the carryover rate value and confirms
that the result complies with the specification requirement:
6. WBC-BF ≤ 0.3% or 0.003 × 109/L, RBC-BF ≤ 0.3% or 0.003 × 1012/L

Figure 9-3 Body fluid carryover test

9.3 Verification of Body Fluid Reproducibility


 Requirement
The table below provides the body fluid reproducibility requirements:

Parameters Range CV/Range


WBC-BF 9
(0.015 - 0.100) × 10 /L ≤ 30%
RBC-BF 12
(0.003 - 0.050) × 10 /L ≤ 40% or ≤ 7000/μL (d)

 Procedure
1. Tap "Performance" > "Reproducibility" on the main screen to access the test screen.
2. Tap the "Mode" interface and select the "OV-BF" mode.
3. Take an empty tube, add 4 ml of diluent and 20 ul of normal-level control, and mix them
thoroughly.
4. Take the prepared sample to execute count under OV mode for 10 times.
5. After the test is completed, tap "Rightward", find the WBC-BF and RBC-BF parameters, and

9-3
Scattergram introduction

confirm that the reproducibility result is "Pass".

Tap this button


continuously to find the
WBC-BF and RBC-BF
parameters

Figure 9-4 Body fluid reproducibility test

9-4
Chapter 10 Installation Checklist
No. Inspection Item Description Reference Result Remarks
1 Ambient Within the 15°C~32°C □Pass □Fail
temperature operating
temperature range
2 Ambient Within operating 30% ~ 85% □Pass □Fail
humidity humidity range
3 Atmospheric Within operating 70 kPa ~ 106 kPa □Pass □Fail
Working
Pressure atmospheric
Environment
pressure
4 Electromagnetic Keep away from / □Pass □Fail
interference the
electromagnetic
interference
source
5 Space requirements Main unit space Meet the □Pass □Fail
installation
requirements
6 Heat dissipation Space requirement At least 100 mm □Pass □Fail
for radiator fan to each side of
the analyzer

No. Inspection Item Description Reference Result Remarks


1. The package box and Package and Package and □Pass □Fail
appearance of the main appearance appearance
unit
2. Package box and Package and Good package □Pass □Fail
appearance of appearance and appearance
pneumatic unit
3. Autoloader package Package and Good package □Pass □Fail
and appearance appearance and appearance
4. Item List Items in the package All items included □Pass □Fail
5. Aspiration assembly Cut the cable ties □Pass □Fail
6. Removing the fixing Fluorescent dye Cut the cable ties □Pass □Fail
components of the bottle
7. analyzer Sample Cut the cable ties □Pass □Fail
compartment
8. Removing the cable ties Cable ties on the Cut the cable ties □Pass □Fail
on the autoloader autoloader
9. Connecting the Correctly installed □Pass □Fail
Installing the autoloader
cables and air tubes to obtain a smooth

10-1
Scattergram introduction

No. Inspection Item Description Reference Result Remarks


bend without
flattening the tube
10. Installed by aligning Installed by □Pass □Fail
it with the pin hole aligning it with the
hole position
11. Connection of waste Waste tube and Properly □Pass □Fail
container sensor connected and not
bent
12. Connection of diluent Connection of Properly □Pass □Fail
diluent container cap connected and not
bent
13. Connection of lyse Connection of lyse Properly □Pass □Fail
container cap connected and not
bent
14. Card installation Waste container and Install the card □Pass □Fail
diluent container
15. Lyse height Lyse height to the Not lower than 850 □Pass □Fail
main unit mm
16. Diluent height Diluent height to the Not lower than 1 m □Pass □Fail
main unit
17. Fluorescent reagent Fluorescent reagent Properly □Pass □Fail
connection connected and not
bent
18. Connections of the Printer connection Properly □Pass □Fail
optional equipment connected and not
bent

No. Inspection Item Description Reference Result Remarks


1. Main unit IP setup Main unit IP setup Normally □Pass □Fail
connected
2. Analyzer version Version No. Correct version □Pass □Fail
information
3. Analyzer pressure Pressure values Meet the □Pass □Fail
status requirements
4. Analyzer temperature Temperature values Meet the □Pass □Fail
status requirements
5. Voltage and current Voltages and Meet the □Pass □Fail
currents requirements
6. Sensor status Sensor values Meet the □Pass □Fail
requirements
7. Software function Configurations Correct □Pass □Fail
configuration

10-2
Scattergram introduction

8. Tube position Aspiration position Meet requirement □Pass □Fail


9. Gripper position Gripper position Meet requirement □Pass □Fail
confirmation
10. Date Format Date Setup Meet client's □Pass □Fail
requirement
11. Auxiliary Setup Auxiliary setup items Meet client's □Pass □Fail
requirement
12. Reagent Setup Barcode and lot No. Correctly set □Pass □Fail
setup
13. Maintenance Setup Maintenance setup Meet client's □Pass □Fail
content requirement
14. Autoloader Setup Setup content Meet client's □Pass □Fail
options requirement
15. Barcode Barcode content Code system □Pass □Fail
options used by the
customer
16. HGB blank voltage HGB blank voltage 4.5±0.1 V □Pass □Fail
value

No. Inspection Item Description Reference Value Result Remarks


WBC ≤ 0.1 × 10 / L
9 □Pass □Fail
WBC-D ≤ 0.2 × 10 / L
9 □Pass □Fail
WBC-N ≤ 0.2 × 10 / L
9 □Pass □Fail
Background RBC ≤ 0.02× 10 / L 12 □Pass □Fail
1.
(OV-WB) RBC-O ≤ 0.02× 10 / L 12 □Pass □Fail
HGB ≤1g/L □Pass □Fail
PLT ≤ 5 × 10 / L
9 □Pass □Fail
PLT-O ≤ 5 × 10 / L
9 □Pass □Fail
WBC ≤ 0.1 × 10 / L
9 □Pass □Fail
WBC-D ≤ 0.2 × 10 / L
9 □Pass □Fail
WBC-N ≤ 0.2 × 10 / L
9 □Pass □Fail
Background RBC ≤ 0.02× 10 / L 12 □Pass □Fail
2.
(AL-WB) RBC-O ≤ 0.02× 10 / L 12 □Pass □Fail
HGB ≤1g/L □Pass □Fail
PLT ≤ 5 × 10 / L
9 □Pass □Fail
PLT-O ≤ 5 × 10 / L
9 □Pass □Fail
WBC ≤ 0.1 × 10 / L
9 □Pass □Fail
WBC-D ≤ 0.2 × 10 / L
9 □Pass □Fail
WBC-N ≤ 0.2 × 10 / L
9 □Pass □Fail
3. Background (PD)
RBC ≤ 0.02× 10 / L 12 □Pass □Fail
RBC-O ≤ 0.02× 10 / L 12 □Pass □Fail
HGB ≤1g/L □Pass □Fail

10-3
Scattergram introduction

PLT ≤ 5 × 109 / L □Pass □Fail


PLT-O ≤ 5 × 109 / L □Pass □Fail
Background WBC-BF ≤ 0.003× 10 / L
9 □Pass □Fail
(OV-BF) □Pass □Fail
4.
Can be ignored for RBC-BF ≤ 0.003× 1012/ L
the non-BF model
Total number of □Pass □Fail
1000 ~ 6000
particles
DIFF FS center of □Pass □Fail
480.0~615.0
gravity
WNB FS center of □Pass □Fail
480.0~615.0
gravity
5. Standard particle
WNB FS CV ≤2.5% □Pass □Fail
DIFF FS CV ≤ 3.2% □Pass □Fail
DIFF SS center of □Pass □Fail
998.0~1350.0
gravity
WNB SS CV ≤ 19.0% □Pass □Fail
DIFF SS CV ≤ 19.0% □Pass □Fail
Diff channel Shape and / □Pass □Fail
position normal
Baso channel Shape and / □Pass □Fail
Fresh blood position normal
6.
scattergram Nrbc channel Shape and / □Pass □Fail
position normal
Ret channel Shape and / □Pass □Fail
position normal
Stability of RBC ≤2 □Pass □Fail
7. Stability value
channel
Stability of DIFF Stability value □Pass □Fail
8. ≤ 2.5
channel
Stability of BASO Stability value □Pass □Fail
9. ≤ 2.5
channel
Stability of WNB Stability value □Pass □Fail
10. ≤ 2.5
channel
Stability of RET Stability value □Pass □Fail
11. ≤ 6.5
channel
WBC ≤ 1.0% □Pass □Fail
RBC ≤ 1.0% □Pass □Fail
HGB ≤1.0% □Pass □Fail
Carryover
12. HCT ≤ 1.0% □Pass □Fail
(OV-WB)
PLT ≤ 1.0% □Pass □Fail
RBC-O ≤ 1.5% □Pass □Fail
WBC-D ≤ 1.0% □Pass □Fail

10-4
Scattergram introduction

WBC-N ≤ 1.5% □Pass □Fail


WBC ≤ 1.0% □Pass □Fail
RBC ≤ 1.0% □Pass □Fail
HGB ≤ 1.0% □Pass □Fail
Carryover HCT ≤ 1.0% □Pass □Fail
13.
(AL-WB) PLT ≤ 1.0% □Pass □Fail
RBC-O ≤ 1.5% □Pass □Fail
WBC-D ≤ 1.0% □Pass □Fail
WBC-N ≤ 1.5% □Pass □Fail
Carryover ≤ 0.3% or
WBC-BF □Pass □Fail
(OV-BF) ≤ 0.003× 109 / L
14.
Can be ignored for ≤ 0.3% or
RBC-BF □Pass □Fail
the non-BF model ≤ 0.003× 1012/ L
Scattergram Gravity center / □Pass □Fail
Meet the index
15. verification position of cell
requirements
population
WBC 75 ~ 125 □Pass □Fail
RBC 75 ~ 125 □Pass □Fail
Calibration
16. HGB 75 ~ 125 □Pass □Fail
Factors
MCV 102.5 ~ 106.5 □Pass □Fail
PLT 75 ~ 125 □Pass □Fail
WBC ≤ 2.5% □Pass □Fail
RBC ≤ 1.5% □Pass □Fail
Reproducibility HGB ≤ 1.0% □Pass □Fail
17.
(OV-WB) MCV ≤ 1.0% □Pass □Fail
HCT ≤ 1.5% □Pass □Fail
PLT ≤ 4.0% □Pass □Fail
WBC ≤ 2.5% □Pass □Fail
RBC ≤ 1.5% □Pass □Fail
Reproducibility HGB ≤ 1.0% □Pass □Fail
18.
(AL-WB) MCV ≤ 1.0% □Pass □Fail
HCT ≤ 1.5% □Pass □Fail
PLT ≤ 4.0% □Pass □Fail
Reproducibility WBC-BF ≤ 30% □Pass □Fail
(OV-BF)
19. ≤ 40% or ≤
Can be ignored for RBC-BF □Pass □Fail
7000/μL
the non-BF model
WBC ±5% or ±0.4 ×
□Pass □Fail
109/L
Deviation between
RBC ±2% or ±0.1 ×
20. modes □Pass □Fail
1012/L
(between AL-OV)
HGB ±2% or ±4 g/L □Pass □Fail
HCT ±2% or □Pass □Fail

10-5
Scattergram introduction

±0.3HCT%
PLT ±7% or ±20 ×
□Pass □Fail
109/L
No error report □Pass □Fail
Result and □Pass □Fail
Reliability scattergram
21. Auto-loading test
verification normal
Barcode □Pass □Fail
scanning normal

10-6
Appendix A Scattergram introduction

DIFF scattergram

Normal blood sample Abnormal sample with NRBC

WNB scattergram

RET scattergram

A-1
Scattergram introduction

PLT-O scattergram

A-2
Appendix B Differentiating
Direct-Connected Network Cable and
Cross Network Cable
B.1 Identification of Straight Through Network
Cable
1) With the spring clip side of the connector down, 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. See below:

Connector of the straight through network cable


2) Define one end of the cable as end A randomly, and the other end as end B. The way to
connect ends A and B is shown in below.

End A End B

End A and End B of the straight through 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-1
Differentiating Direct-Connected Network Cable and Cross Network Cable

B.2 Identification of Crossover Cable


1. With the spring clip side of the connector down, 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 below

Connector of the network cable

2. Define one end of the cable as end A randomly, and the other end as end B. The way
to connect ends A and B is shown in below

End A End B

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 are interchanged; 2 and 6 are interchanged)
End B: white and orange, orange, white and green, blue, white and blue, green, white
and brown, and brown.

B-2
Appendix C Installation and Upgrade
Instruction of labXpert Software
C.1 Software Installation
C.1.1 Pre-Installation
C.1.1.1 Setting up the Firewall

Before installing the software, shut down the firewall on your computer. Below figure
shows the setting on a WIN7 operating system. The settings on other operating systems are
similar.

Figure 1 Firewall setting

C.1.1.2 Setting up the User Account Control Settings

Set the “User Account Control” setting to “Never notify”. Below figure shows the setting
on a WIN7 operating system. The settings on other operating systems are similar.

C-1
Installation and Upgrade Instruction of labXpert Software

Figure 2 User account control setting

C.1.2 Installing the Client Software


Install the client software on the PC for manual validation or the smear validation.
Ensure the PC has installed WIN7 or above operation system before installing the software.
Use winrar or other decompression tools to unzip the client software installation ISO file.
Run Setup.exe file. And select the language:

Figure 3 Language Selecting

The system detects and installs the essential run-time library automatically:

C-2
Installation and Upgrade Instruction of labXpert Software

Figure 4 Installing the Run-time Library

Note: After the run-time library is installed, the PC will restart automatically. Save the
files before the installation.

After the run-time library is installed, application programs will be installed automatically.

C-3
Installation and Upgrade Instruction of labXpert Software

Figure 5 Automatic Installation

As needed, check “Starting labXpert client automatically after powering on” and “Starting
labXpert client automatically after the installation is completed”, and click “Next”:

Figure 6 Select When to Auto Start

C-4
Installation and Upgrade Instruction of labXpert Software

Select the path to save the data file and click “Next”:

Figure 7 Save the Data File

Note: Whenever possible, save the data on a non-system disk.


Select the location to install the program and click "Next":

Figure 8 Software Installation Location

C-5
Installation and Upgrade Instruction of labXpert Software

After the settings, click “Install” to install the application software:

Figure 9 Installing the sever

After the automatic installation is completed, click “Finish” to end the installation process.

Figure 10 Complete the Installation

C-6
Installation and Upgrade Instruction of labXpert Software

C.1.3 Installing on the Server


Install the server software on the PC used as a server. Ensure the server has installed
WIN7 or WIN8 operation system before installing the server software. Decompress the server
software ISO file. The detailed installation process is similar to that of installing on the client
software. Please refer to the installation process of installing on the client.

C.2 Run the Software


C.2.1 Run the Client Software on the Client PC
Click the icon on the desktop, or select from the start menu "labXpert server" folder ->
"labXpert server". The login screen is as the following figure:

Figure 11 Set the client type

Select the current client type, and click “Next”-“OK”. The following dialog box appears.

C-7
Installation and Upgrade Instruction of labXpert Software

Figure 12 Set the server IP

If the client software and the server software are installed on the same PC, enter
127.0.0.1. Otherwise, you need to enter the IP address of the server PC first.
When you do not know the server IP address, check if the server software runs normally,
and the network connection is OK. If so, use the IP Auto Detection function to acquire the
server IP. When the client software finds the server, it enters the IP address to the IP address
field.
After setting up the IP address, click “Next”:

Figure 13 Current setting

C-8
Installation and Upgrade Instruction of labXpert Software

Confirm the setting is all right, and click “OK”.

Figure 14 Login screen

The default account ID and password are both “admin”. This account has the
“administrator” authority. The account ID and password of the service level are the same as
other products.

C.3 Connecting Setup


C.3.1 Use administrator or service account to login
C.3.2 Connect the server PC to each workstation
using the Ethernet cable
Note: If you need to connect the sample processing line, please connect the Ethernet
cable to the router on the sample processing line.

C.3.3 Instrument Connection


1. Use the administrator or service authority to enter the labXpert software setup screen,
click “System Setup”->”Instrument Connection” as shown below:

C-9
Installation and Upgrade Instruction of labXpert Software

Figure 15 Instrument connection setup

2. Connect the second phase processing line or desktop workstation, click the “Auto Detect
CAL8000” or “New CAL 3000” button in the above figure, the software will automatically
search the existed sample processing line and standalone instrument in the current
network as shown in the below figure:

Figure 16 Auto detect screen

3. After searching, type the current instrument name into the “Name” column, then leave
this screen, a prompt message will ask you to save the information.

 Click “New SPL” and “New Analyzer” to add the new sample processing line and
standalone instrument, then leave this screen, a prompt message will ask you to

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Installation and Upgrade Instruction of labXpert Software

save the information.


 If you need to connect the 6800/6900 analyzer through LIS, click the “Connect a
6800/6900 analyzer” button to enter the following screen, set the IP address and LIS
port of the target instrument in the IP Address and Port column as shown in the
following figure:

Figure 17 Standalone instrument and labXpert connection through LIS

C.4 Connect the Server PC to the Network which can


Access LIS
C.4.1 LIS Connection Setup
1. Use the administrator or higher authority to enter the labXpert software setup screen,
click “System Setup”->”Comm. Setup”:

Figure 18 LIS setup

2. Type in the IP address, port, protocol type, and protocol version (Refer to the version
number of connecting LIS to the 6800 analyzer or sample processing line).
3. After setting up all connections, the corresponding indicator in the labXpert status bar
will light up as shown in the following figure:

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Installation and Upgrade Instruction of labXpert Software

Figure 19 Connection status

4. (Optional)Click “Setup”-“System Setup”-“Others”-“Comm. Setup”, and check “Auto


transmit QC data”; and the labXpert automatically tramsmits the QC settings to the
corresponding instrument.

C.5 Update
1. Turn off the running server program.
1) Find out the server status icon of labXpert in the right lower corner on the computer
as shown below:

Figure 20 Server status icon

2) If you can’t find the server status icon, please double click the “labXpert Server”
icon, launch the icon as shown in the figure:

Figure 21 Server launch icon

3) Right click the icon in the Figure 18, then a menu in the Figure 20 will show up:

Figure 22 Server status icon

4) Click “Stop Service”, when the server status icon turns red, click “Exit” as shown
below:

Figure 23 Stop service

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Installation and Upgrade Instruction of labXpert Software

2. Turn off the running client program.

 Unzip the new installation package (Select the related installation package
respectively for the client program or server program).
 Run setup.exe.
 The installation program will automatically detect if the system has already installed
the old version, it will automatically enter the update process if the old version is
detected.
 The update process is the same as the installation, but it will skip the installation
directory selection and data directory selection.
 After the installation, the update program will automatically update the user database
to the new version. The data update process will cost a lot of time, please wait with
patient and do not turn off the computer.
 After updating the matching server program and each client program, restart the
server program first then each client program, check if the program is running
normally, and the data is complete or not.

C.6 Installing DTU Software


Before installed the labXpert software, remember to install the DTU software.
After installed the DTU software, tap “Setup”-“System Setup”-“Others” on the labXpert,
and check “Enable” External QC.

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P/N: 046-011139-00 (7.0)

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