Professional Documents
Culture Documents
CL-2000i&2200i Installation Guidance V3.0 en
CL-2000i&2200i Installation Guidance V3.0 en
OTY-12001 (2.0)
CL-2000i&2200i
Chemiluminescence Immunoassay
Analyzer
MINDRAY CONFIDENTI AL
Installation Guidance
Table of Contents
Table of Contents ................................................................................................................................... 2
Chapter 1 Check before Installation .................................................................................................. 4
1.1 Installation Environment ...................................................................................................... 4
1.2 Space and Accessibility Requirements for Unpacking.................................................... 4
1.2.1 Space and Accessibility Requirements for Installation ....................................... 5
1.2.2 Power Supply and Noise ......................................................................................... 5
1.2.3 Drainage Check (if draining water through a sewer) ........................................... 6
1.3 Recommended PC Configuration ...................................................................................... 6
1.4 Configuration Check............................................................................................................. 7
Chapter 2 Instrument installation ...................................................................................................... 8
2.1 Tools ....................................................................................................................................... 8
2.2 Installation Procedure .......................................................................................................... 8
2.2.1 Unpacking .................................................................................................................. 8
2.2.2 Interconnection ....................................................................................................... 15
2.2.3 Installing Peristaltic Pump Tube ........................................................................... 23
2.2.4 Removing Retaining Screws on the Reagent Carousel ................................... 24
2.2.5 Remove the drawer mounting plate of wash buffer ........................................... 25
2.2.6 Fluidic Connection .................................................................................................. 26
2.2.7 Connect the computer............................................................................................ 30
2.2.8 Check the connectors on both ends of substrate outlet valve ......................... 31
2.2.9 Connect external vacuum pump (Optional) ........................................................ 32
2.2.10 Software Installation ............................................................................................... 33
Chapter 3 Power on and alignment ................................................................................................. 35
3.1 Preparation for Powering On ............................................................................................ 35
3.2 Initial Startup ....................................................................................................................... 36
3.3 Main Unit Position Confirmation and Alignment............................................................. 38
3.4 Installing Probe ................................................................................................................... 46
3.4.1 Installing Sample Probe......................................................................................... 46
3.4.2 Installing Reagent Probes ..................................................................................... 47
3.4.3 Check after power-on............................................................................................. 47
3.5 SDM Position Confirmation and Alignment .................................................................... 47
3.6 Fluidic Prime........................................................................................................................ 49
3.7 Setting up ............................................................................................................................. 65
3.7.1 Loading Special Reagents .................................................................................... 65
3.7.2 Initial Maintenance Record.................................................................................... 69
CL-2000i
Chemiluminescence
Immunoassay Analyzer
2 3
Figure 1 Space and accessibility requirements for unpacking the CL-2000i package
Power cable
Data cable
800mm
Waste tube
Waste tank
LIS server
PC
2467mm
UPS
CL-2000i SDM
1445mm 705mm
WARNING
Make sure the power socket is grounded correctly. Incorrect grounding may lead to electric
shock or equipment damage.
Check if the power socket outputs voltage meeting the specified requirements and has a proper
fuse installed.
Rated input power of analyzer: 3200VA; rated input power of SDM: 800VA. The SDM
should be connected to a power socket with load no less than 16A.
If the user is going to use a UPS to power the instrument, make sure that the UPS can
provide power supply greater than or equal to 5000VA (analyzer + computer + printer).
The installation site should be kept away from big noise and power supply interference.
Keep the system away from brush-type motors and electrical contact devices that are
frequently switched on and off.
Do not use such devices as mobile phones and radio transmitters near the system.
BIOHAZARD
Dispose of liquid waste according to the local regulations.
2.1 Tools
Hexagon wrenches (M3~M6), 13# box spanner, tape measure, 200mm spanner, cross
screwdriver, flathead screwdriver and snap-off knife
Figure 3 Tools
2.2.1 Unpacking
1. Check against packing list: Check the instrument configuration against the packing list
before unpacking according to section 1.3 System Configuration.
Serial No.
Packing list
2. Unloading: Unload the analyzer and SDM from the truck with a forklift over 1.5m. (A
short forklift may fail to lift the analyzer and hinder the transportation.)
Note: There is a tilt warning label on the main unit package, which can change in color for
tilting. When the center of the label turns red, it means the package has been seriously
tilted and instrument damage may be caused. Contact the logistics company immediately
to prevent unexpected results.
3. Unpacking analyzer: Use a 13# box spanner (or an adjustable wrench) to loosen the
retaining screws on the upper cover of the package, remove the upper cover. Loosen the
retaining screws on the side covers, lay down the slope cover and keep 3.0m space in front
of it (1.5m for the slope cover and 1.45m for the instrument).
NOTE
After unpacking, remind the user to keep the packaging materials for 3 months for use in
returning or replacing the instrument.
Slope
board
4. Removing mounting plates of analyzer: There are 6 mounting plates, 3 in the front and
3 in the back. Follow this procedure:
Remove the retaining screws that have been vertically installed on the 6 mounting
plates.
Note: Before removing the 3 front mounting plates, open the front door
assembly for convenient operation.
Screw down the 4 anchors to remove the retaining screws that have been
horizontally installed.
Note: Before removing the 3 mounting plates in the front, open the front
door assembly for convenient operation.
Remove the retaining screws that have been horizontally fixed on the 6 mounting
plates.
Remove the 6 mounting plates.
5. Pushing out analyzer: Restore the anchors and push out the analyzer from the bottom
plate. Operate carefully to prevent scratches.
CAUTION
Since the instrument is heavy with great inertia, 3~4 persons are recommended and at
least 2 persons should slow down the instrument in front of the slope cover.
6. Unpacking SDM: Untie the belts on the SDM package, and remove the upper cover
and side covers.
7. Removing mounting plates of SDM: Refer to Step 4 to remove the mounting plates
of the SDM:
8. Pushing out SDM: Restore the anchors and push out the SDM. 2 persons are
required to complete this operation.
Note: The gravity of the SDM is not in its center. Attention your force during
transportation.
9. Placing analyzer and SDM in clinical laboratory department: Push the analyzer
and SDM to the specified position along the planned path. 2-3 persons are required to
Tapes for fixing the upward shift mechanism of the auto loader
2.2.2 Interconnection
1. Connection of network cable and serial cable:
Connect the analyzer to the computer via a network cable Fix the network cable on the
right side of the analyzer, cut the cable tie of the fixed cable, lead the cable through the
SDM, and connect it to the communication adapter board at the back end of the SDM. The
cable is used for communication between the analyzer and the PC.
1. Lead the SDM power 2. Fix the SDM power cable on the 3. Fix the SDM power cable on the
supply cable out bottom plate at the bottom of bottom plate at the bottom of the
from the right side of the rack rack
the analyzer, and
bundle it with the
network cable
MCB-LCB(1)-J6
MCB-LCB(1)-J2
CADB-LCB(0)-J2
3) Connect system power cable On the SDM backplane, the original air switches
and connection slots have been eliminated. Connect the power cable to the AC
drive board on the right side of the analyzer.
System power
cable
1. Lead system
power cable
through cord
holes.
3. Fixing analyzer: Confirm the analyzer's position and lift the anchors. Use a spanner, if
necessary, to spin the anchors for 5-10 circles to fix the analyzer. Ensure all of the 4
anchors are span for the same circles.
Note: Prior to interconnection, protect the connection cable on the right of the front track to
prevent it from being damaged.
Interconnecti
on cable
4. Interconnection cable: Lead the interconnection cable through the hole below the
scanning channel and connect it to the SDM conversion board (1# conversion board on the
top), and then fix the cable with the cable ties in the accessory kit.
Note: The two hanging connectors are reserved for M2 and should be left aside.
5. Fixing SDM: Align the SDM with the analyzer and screw down the anchors. Adjust the
anchors to keep the SDM level.
Note: Use the following two methods to check if the SDM is level: 1) sliding a track
alignment tool (or 2 sample racks) on the track; and 2) check if the gap between the
frameworks is even.
The gaps
between the
frames are even.
6. Fix connecting screws: Install the four connecting screws of the analyzer and SDM with
one fixed on the front, one at the back, one on the left and one on the right. The screws are
supplied in the accessory kit. If you fail to install the screws, adjust the analyzer and SDM
and retry. Do not tighten screws at first. Check the positions according to Step 3 and then
tighten the screws.
Note: Do not forget the flat and spring washers of the screws to ensure
interconnection effects. The holes marked in red circle are IN holes and those on the
top are OUT holes. You can install them from either direction.
NOTE:
NOTE:
1. The
1. Theeight
eight buckles
buckles of four
of the the pump
four pump tubes
tubes should
be fixed in the slots without deviation.
should be fixed in the slots without deviation.
2. Tighten the inner nut to its shoulder first and
2.
thenTighten
tighten the inner nut
the second to its
screw. Do shoulder
not tightenfirst
the
and then tighten the
two screws at the same time.second screw. Do not
tighten the two screws at the same time.
Figure 25 Install dispersion peristaltic pump
NOTE:
Figure 27 After removing retaining screws from the new reagent carousel
CL-2000i Chemiluminescence
Immunoassay Analyzer
Sensor of
external vacuum
pump
23
1
Outlet
Note:
Do not connect the waste tube of CL-2000i with that of other instruments to drain the waste
together otherwise the waste liquid of other instruments will flow back to CL-2000i and the
waste pump and vacuum pump of CL-2000i will be burnt.
BIOHAZARD
Dispose of liquid waste according to the local regulations.
Figure 31 Fix the tape and package bag of the cap assembly of the wash buffer tank
2. Remove the cap assembly of the wash buffer tank and fix the plug of the cap assembly of
the wash buffer tank to the hanger on the door (as shown below).
Figure 32 Fix the plug of the cap assembly of the wash buffer tank to the
hanger on the door to prevent contamination
Figure 34 Put the tank cap assembly into the wash buffer tank and tighten the cap
5. Put the wash buffer on the drawer and remove the connector on the hanger and connect it.
Figure 35 Load wash buffer tank and connect the fluidic connector
Figure 36 Connect the wash buffer tank (clean the wash buffer tank (X2))
Note: The arrow on the wash buffer tank should face the analyzer so that the slots that
you can put your hands in when handling it are on the left and right.
Substrate protection
tube assembly
Check
connector
Substrate bottle (1)
Substrate
syringe
MINDRAY CONFIDENTI AL
Note: If you cannot find the InstrServerConfig.ini file, you need to power on the analyzer
and run the operating software to allow it to connect to the analyzer once. Then this file
can be generated. Then exit the operating software and go to the path to change this
configuration file.
Note: When control software upgrade is completed, power off the analyzer and then
power on it again after 10 seconds to validate the control software.
1 The system skips the initialization procedure when detecting that the fluidic prime is not
performed. Enter the username “ServiceUser” and password “#BS8A#SEU” in the login
window.
2. Set up the local atmospheric pressure. (If the altitude is high, configure the atmospheric
pressure by checking the altitude of the installation site of the analyzer and determining the
corresponding atmospheric pressure according to Appendix A.)
3. Select Utility -> Maintenance -> Alignment -> M1 -> Hydro Unit, select the Vacuum
Pressure Check button, enter the atmospheric pressure as indicated in the figure below,
and then select Config to save the input.
Note: Configure parameters in the order of "inquiring parameters -> modifying
parameters -> confirming configuration" and exit the current window. Access the
configuration window again and inquire the parameters to ensure they have been
configured successfully.
1 3
After the main position alignments are completed, power off the instrument and exit the
operating software.
2. Installing probe: Remove the spring guide post and spring, and insert the probe
downwards into the hole on the probe arm while aligning the screw hole on the probe plate
to the rod inside the arm.
3. Connecting tube: Align the tube connector to the probe connector according to the figure
below, and screw them clockwise. Insert the plug on the end of the probe into the jack on
the liquid level detection board.
4. Installing spring: Sleeve the spring on the rod and tighten the retaining screw. After
installation, pinch the probe by the part near the probe arm, push the probe upwards and
then release it to check if the spring works well. If it does, proceed to the next step. If not,
check if the spring is clamped or fixed too tightly.
2. Perform SDM and front track cycle test according to the SDMDemo User Guide.
3. If the test cannot be completed, check and verify the locations listed in the following table.
For details of the alignment procedure and method, refer to CL-2000i Alignment Guide:
3) Select OK directly.
6) Select Continue, the Water Pressure Test dialog box will pop up. At this time, do not test the
water pressure. Select OK and skip the water pressure test.
2) Select Continue and then Start. Prime the probe for 20 times and remove the air bubbles in
the sample and reagent syringe.
Probe interior clean and prime: Observe if wash solution is sprayed out straightly from
inside of the sample probe and reagent probe interior.
Exterior clean and prime: liquid is sprayed from the wash wells of sample probe and reagent
probe continuously.
During the priming process, observe the connector between the sample probe and the
reagent probe to ensure that there is no leakage during the priming process.
4) Remove the dispersion dispense probes and put them in a proper container, and then select
Continue. (Pay attention to the markers D1, D2, D3, and D4, and do not confuse
dispense probes with aspirate probes; otherwise, overflow may be caused.)
5) Make sure the dispersion dispense probes have been removed and put in a proper
container, and then select Continue.
6) Select Start to prime the dispense probes for 50 times, observe the 4-phase dispense
probes till they continuously dispense wash solution without air bubbles.
Note: The prime times should not be less than 50 times otherwise the following
performance may Fail.
8) Wipe the dispense probes with clean fiber cloth and install them properly.
9) Check that the dispense probes are installed properly, and select Continue to exit.
10) Select 10 Probe Wash Tube Pressure Test, and select Continue.
Note: There is no priming operation in this step, and you only need to follow the
prompts, without testing the water pressure.
11) Select Continue until all 10 steps are completed. It is not necessary to follow the prompts to
perform any operation on the analyzer.
During the process, the Water Pressure Test countdown dialog box of Dispersion Dispense
Tubes, exterior and interior wash tubes of the sample and reagent probes will pop up. At
this time, the water pressure does not need to be tested. Select OK and skip the water
pressure test.
12) Select Continue to end the Probe Wash Tube Pressure Test process.
13) Install the reagent probe and sample probe arm cover and tighten the screw.
Note: Excessive force may scrape the white paint off the arm cover and damage the
plastic arm cover. Do not try too hard when tightening the screws.
2) A Warning dialog box will pop up as shown in the figure below. Select OK directly.
3) Remove the substrate spikes and hang them over a waste container, (Prevent the substrate
spikes from contacting other objects or liquid; otherwise, wash them with ultra-pure water.)
and select Continue.
4) Empty the substrate tube (If there are no foreign matters in the tube, skip this step.)
Remove the substrate bottles and select substrate 1 and 2 receptively. Input 50 times and
start substrate prime.
5) Wash the substrate tube with ultra-pure water. (If there are no foreign matters in the
tube, skip this step.)
Fill the clean substrate bottle with ultra-pure water and load it into the channel 1 position
and then select Substrate 1 on the software screen; input 50 times and click Start to clean
substrate path 1 with the ultra-pure water.
Use the same method to clean substrate path 2.
10) Use ultra pure water to clean the substrate tubes again.
3.7 Setting up
1
3
4
MINDRAY CONFIDENTI AL
5
2
Select W Buffer 1 and select Load F1. Ensure the reagent volume is 100%, and then select
Load. Select Exit F5 to close the window. Select W Buffer 2 and load it in the same way. After all
operations, check that the two buffers have been loaded.
2. Loading substrate:
Tighten the substrate bottle used for prime and remove it.
Select Reagent-special reagent -Substrate 1, click Load and use the bar code reader to scan
the bar code. The software refreshes the inventory as 500T. Restore the substrate bottles after
bar code scanning.
Note: Because the substrate is consumed during fluidic prime, the remaining inventory that the
software displays is incorrect. After installation, the substrate bottles used for installation must
be unloaded and discarded and before analyzing samples, load new substrate.
Select Import to display the Import window. Select Load Default to display all Mindray reagent
chemistries in the left column. Select Add All to add all chemistries to the right column. Select
Select Import and then select Exit. The default chemistry parameters are imported.
3. Record the Relative Extreme Difference, which should be less than 1.5%.
Figure 61 Background Test, Reagent Probe Test, and Sample Probe Test
Prepare a sample rack and load 1ml system check solution in 1# position of the rack, select
Execute and wait for results.
CV≤5%
Fill the test results into the Basic Performance Test Record file attached, it will show if the
repeatability test is pass or failed:
Basic
Performance Test Record.xlsx
Note: if prompt the test cannot be run because daily clean is not performed, please select
utility-system setup-instrument F1-auto maintenance and then deselect daily clean
completed before test.
MINDRAY CONFIDENTI AL