Professional Documents
Culture Documents
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
1
Table of Contents
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.
3 Installation software
1 Initial start-up
3 Mechanical verification
1 Working environment
3 Reagent setup
4 Maintenance setup
5 Autoloader setup
1 Check before unpacking
Setup
6 Built-in barcode setup
2 Unpack the main unit
1 Background verification
7 Calibration
8 Reproducibility test
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
End
1-1
Preparations
1.3 Tools
Table 1-1 Tool list
1.4 Consumables
Table 1-2 Consumable list
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.
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.
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.
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.
2-2
Installation Requirements
WARNING
The fuse used in the equipment is not a replaceable one.
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
Unpacking
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
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
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.
3-4
Unpacking
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
3-5
Unpacking
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
Figure 4-1 High temperature adhesive tape for fixing the compartment door
Assembly
4-1
Removing Fixing Components
Figure 4-3 Removing plastic ties of aspiration assembly and mix assembly
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
Sample probe
fixing plate
5-1
Connections
Types
① *FR Dye
② FD Dye
③ FN Dye
* Only applicable to BC-6000Plus/BC-6100Plus and BC-6200 model.
5-2
Connections
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
Figure 5-4 Connecting the network, power supply and external devices
Interface Connection
5-4
Connections
CAUTION
Do not use BD micro tubes or syringe test tubes to run samples in closed-tube mode.
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.
6-1
Start-up
Check whether the version of the installation CD-ROM is the latest. If not, update it where
appropriate.
6-2
Start-up
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.
6-3
Start-up
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
Figure 6-6 Inserting the autoloader connector and excessive wires into the main unit
Figure 6-7 Make sure the wires are not clamped between the autoloader shield and the
front cover of main unit
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.
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
6-7
Start-up
Select Menu Service Debug & Self-Test Self-Test, and select "Autoloading Assembly"
to access the autoloader self-test screen.
6-8
Start-up
④
⑤ ⑥
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
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 6-17 Ideal position of the press block of tube fixing mechanism relative to the tube
rack
6-11
Start-up
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.
6-12
Start-up
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
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
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
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.
6-18
Start-up
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
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
④
⑤
6-21
Start-up
Right front
cover
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")
1. Select "Menu" > "Setup" > "System Setup" > "Print Setup" to access the "Print Setup"screen.
7-1
Setup
7-2
Setup
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.
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
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.
7-4
Setup
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.
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
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.
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.
7-6
Setup
1. Tap "Menu" > "Setup" > "Date/Time Setup" to enter the "Date/Time Setup" screen.
7-7
Setup
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.
1. Tap "Menu" > "Setup" > "Auxiliary Setup" > "Other settings" to enter the "Other settings"
screen.
7-10
Setup
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.
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.
Administrators may set the start time for daily probe cleanser maintenance on the
7-12
Setup
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.
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
.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.
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.
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:
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.
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.
1. Tap Service > Debug & Self-Test > Optical Debug to access the screen shown in below
figure.
8-2
PerformanceVerification
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
8-4
PerformanceVerification
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 scattergrams of the selected sample must be normal (different cell populations are
clearly apart, while each single population is aggregated).
8-5
PerformanceVerification
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
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.
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.
CV Value
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
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
6. To see the reproducibility result of each parameter, tap the "Statistics" button.
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.
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.
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.
8-14
PerformanceVerification
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.
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
8-15
PerformanceVerification
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.
8-16
Chapter 9 Body Fluid Performance Verification
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".
9-1
Scattergram introduction
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
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
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
10-1
Scattergram introduction
10-2
Scattergram introduction
10-3
Scattergram introduction
10-4
Scattergram introduction
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
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:
End A End B
B-1
Differentiating Direct-Connected Network Cable and Cross 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
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.
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
The system detects and installs the essential run-time library automatically:
C-2
Installation and Upgrade Instruction of labXpert Software
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
As needed, check “Starting labXpert client automatically after powering on” and “Starting
labXpert client automatically after the installation is completed”, and click “Next”:
C-4
Installation and Upgrade Instruction of labXpert Software
Select the path to save the data file and click “Next”:
C-5
Installation and Upgrade Instruction of labXpert Software
After the automatic installation is completed, click “Finish” to end the installation process.
C-6
Installation and Upgrade Instruction of labXpert Software
Select the current client type, and click “Next”-“OK”. The following dialog box appears.
C-7
Installation and Upgrade Instruction of labXpert Software
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”:
C-8
Installation and Upgrade Instruction of labXpert Software
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-9
Installation and Upgrade Instruction of labXpert Software
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:
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
C-10
Installation and Upgrade Instruction of labXpert Software
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:
C-11
Installation and Upgrade Instruction of labXpert Software
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:
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:
3) Right click the icon in the Figure 18, then a menu in the Figure 20 will show up:
4) Click “Stop Service”, when the server status icon turns red, click “Exit” as shown
below:
C-12
Installation and Upgrade Instruction of labXpert Software
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-13
P/N: 046-011139-00 (7.0)